Received May 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM / RA |
heartburn; acid reflux; pain in what the shot where I got the Moderna shot; I got a burning sensation and pain; I got a burning sensation and pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I got a burning sensation and pain), BURNING SENSATION (I got a burning sensation and pain), DYSPEPSIA (heartburn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and VACCINATION SITE PAIN (pain in what the shot where I got the Moderna shot) in an 81-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Erythromycin for an unknown indication. The patient's past medical history included Pacemaker insertion (cardiac) (with a pacemaker), Physical therapy (had physical therapy for 4.5 months following Pfizer shot) and Hospitalization (I was in the hospital for a week). Previously administered products included for Drug use for unknown indication: z-pack erythromycin tablets (Z-Pack Erythromycin tablets), z-pack erythromycin tablets (Z-Pack Erythromycin tablets), Penicillin, Maxide, Maxide and Maxide; for Product used for unknown indication: Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 2) and Flu shot. Past adverse reactions to the above products included Adverse drug reaction NOS with Pfizer vaccine, Pfizer vaccine and z-pack erythromycin tablets; Allergic reaction NOS with Penicillin; Concussion with Maxide; Fall with Maxide; Frozen shoulder with Pfizer vaccine and Pfizer vaccine; Neck stiffness with Pfizer vaccine and Pfizer vaccine; Pain in arm with Pfizer vaccine, Pfizer vaccine and z-pack erythromycin tablets; Passed out with Maxide; and Vaccination adverse reaction with Flu shot. Family history included Penicillin allergy (diagnosis from childhood) since an unknown date. Concurrent medical conditions included Allergy (have so many allergy issues) and Allergy to antibiotic (reaction from antibiotic). In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In April 2025, the patient started Erythromycin (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (I got a burning sensation and pain), BURNING SENSATION (I got a burning sensation and pain), DYSPEPSIA (heartburn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and VACCINATION SITE PAIN (pain in what the shot where I got the Moderna shot). The patient was treated with Doxycycline at an unspecified dose and frequency. At the time of the report, PAIN (I got a burning sensation and pain) and BURNING SENSATION (I got a burning sensation and pain) had resolved and DYSPEPSIA (heartburn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and VACCINATION SITE PAIN (pain in what the shot where I got the Moderna shot) outcome was unknown. No concomitant medications were reported. It was reported that patient had a weight of around 103104 lbs, and she had been 5 feet tall. She also reported that, due to having many allergy issues, it had been very difficult for her to distinguish them from a normal reaction. She had received a couple of Moderna shots, with the last one administered in late September or early October of 2024. She reported that she had known it had been "banned" because she had visited her sister in another state.She had received the shot and, upon seeing the actual vaccine and the needle going into her arm, had experienced a burning sensation and pain. This discomfort had lasted intermittently for around 33 weeks before subsiding. Then, moving forward to late March or early April, she had not had the data on her regarding a visit to the doctor but had been prescribed medication, of which she had taken one pill and had subsequently experienced heartburn and acid reflux. She had also taken Doxycycline, after which she had contacted the doctor's office and discarded the pills.She had reported that she had not been sick until the time of reporting; however, she had mentioned that, in the past, she had taken Z-Pack Erythromycin tablets, for which she had obtained a prescription that had been filled on April 4th or 5th. She had been uncertain but had reiterated that it was likely the 5th when she had taken only one of the tablets, which had caused her to have a very severe reaction. It had been the same reaction she had previously experienced when she had received her first COVID-19 shots at the beginning of the pandemic, during which she had "taken" two namely, the two original Pfizer vaccines and the second Pfizer vaccine. This case was linked to US-MODERNATX, INC.-MOD-2025-785837 (E2B Linked Report). This case was linked to MOD-2025-785844 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2025: Live follow-up received contains non-significant information and reference ID added On 28-Apr-2025: Live follow-up received contains non-significant information and reference ID added On 29-Apr-2025: Live follow-up received contains non-significant information and reference ID added; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785837:Reporter sister-in-law's mother case
Allergy (have so many allergy issues); Allergy to antibiotic (reaction from antibiotic); Penicillin allergy (diagnosis from childhood)
Medical History/Concurrent Conditions: Hospitalization (I was in the hospital for a week); Pacemaker insertion (cardiac) (with a pacemaker); Physical therapy (had physical therapy for 4.5 months following Pfizer shot)
Erythromycin