chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm was sore after receiving the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm was sore after receiving the first vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Patient's medical history was not reported.  Concomitant products included BISOPROLOL FUMARATE for Blood pressure high, LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) for Epilepsy, VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation, CLOPIDOGREL, PHENYTOIN (DILANTIN [PHENYTOIN]) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (left arm was sore after receiving the first vaccine). At the time of the report, VACCINATION SITE PAIN (left arm was sore after receiving the first vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2022-517834 (Patient Link).
After receiving the shot, my arm was red and swelling.  I developed a fever the next day.  A few days later my arm had lump.  A couple of months my arm formed 2 lumps.  The lumps got harder and opened up.  Discharge/blood came out.  They stayed open a bit.  Went to a dermatologist surgeon.  She removed them and sent to lab.  She stitched it up.  Went back 2 weeks later.  One healed, the other we still open.  She removed more, and sent samples to lab, and stitched it up.  The next week, the other hole opened up.  She removed more and stitched it up.  Went back 2 weeks later and stitches removed from both.  Waiting to see if it opens up again.  Will have to return to her for another visit.       11 years ago, I received this shot in my right arm.  Similar thing happened but didn't realize it was the shot.  Hole opened, discharged, and closed on and off for years.   Went to surgeon in 2020 and she removed it.       10 years before this in the same (right) arm, had similar issue but nobody identified it as a reaction to the shot.
This case was reported by a other health professional via other manufacturer and described the occurrence of drug allergy in a 68-year-old female patient who received Hepatitis B vaccine. Co-suspect products included DYAZIDE unknown for product used for unknown indication and LAMICTAL tablet for product used for unknown indication. The patient's past medical history included hyperlipidemia, hypothyroidism, partial seizures, benign monoclonal hypergammaglobulinemia, neuropathy peripheral, esophageal stenosis, gastroesophageal reflux, pancreas cyst, hiatal hernia, coronary artery disease, myopathy, gait disturbance, anemia, irritable bowel syndrome, bronchiectasis, atrial fibrillation, cataract and drug allergy. Concurrent medical conditions included pain. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose, DYAZIDE at an unknown dose and frequency and LAMICTAL at an unknown dose and frequency. On an unknown date, an unknown time after receiving Hepatitis B vaccine, DYAZIDE and LAMICTAL, the patient experienced drug allergy. The action taken with DYAZIDE was unknown (Dechallenge was unknown). Rechallenge with DYAZIDE was unknown. The action taken with LAMICTAL was unknown (Dechallenge was unknown). Rechallenge with LAMICTAL was unknown. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to Hepatitis B vaccine, DYAZIDE and LAMICTAL. Additional details were reported as follows: The age at vaccination was not reported. The patient's medical history included allergies to PLAQUENIL, LASIX, methotrexate, potassium, sulfosalicylic acid, tramadol, ACTIFED, ampicillin, ARAVA, ciprofloxacin, colchicine, COMPAZINE, contrast dye IV, Cyclosporine, DIAMOX,  DILAUDID, doxycycline, erythromycin, GEODON, iron, and KEFLEX. The patient also received various medications including Vitamin D2, BACTROBAN, TYLENOL, SINGULAIR, SYNTHROID, ZOLOFT, MVI, RESTASIS, Folic acid, NASOCORT, ADVAIR, PREVACID, FLEXERIL, VICODIN, REFRESH, FOSAMAX, PHENERGAN, TAZACT, Vitamin D, SYSTANE, ISOPTO tears, MOBIC, DIAMODE, NEXIUM, Calcium, ZANAFLEX, Retin, Vitamin D3, NORCO, Hydrocortisone, Zinc, ZADITOR, RUBRAMIN, ZANTAC, DELTASONE, Vitamin B12 and PROTOPIC. No other information was provided.
Patient stated that the day after the shot she had extreme fatigue and she went to take  a breathing treatment her pulse started going up. Patient was transferred to hospital by Ambulance. She was given blood thinners.
elevated heart rate-in the range of 90-170 while just sitting/not engaging in activity; sore throat with discomfort; sore throat with discomfort; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 08:15 (at the age of 28-year-old) as single dose for covid-19 immunisation. COVID-19 vaccine was administered at Public Health Clinic/Administration facility. Medical history included drug hypersensitivity to penicillin, amoxicillin. Concomitant medications included ethinylestradiol, norgestimate (TRI-LO-SPRINTEC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, the patient experienced elevated heart rate-in the range of 90-170 while just sitting/not engaging in activity, sore throat with discomfort. The patient underwent lab tests and procedures which included heart rate: elevated in the range of 90-170 on 18Mar2021, normal range of inactivity 65-75. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 31-AUG-2017, the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not reported) batch# M032260 and expiration date on 18-AUG-2017. On 31-AUG-2017, the patient experienced expired product administered. No adverse event was reported. Lot number M032260 is an invalid lot number for zoster vaccine live.
Elevated heart rate: sleeping 1a-9a average heart rate was 96 bpm (compared to normal average of 66 bpm). Heart rate remained elevated (resting, 90-120 bpm) until early afternoon 4/18
Itchy sensation, red, swelling at injection site starting exactly 1 week after shot with some blood spots on the skin, easily brought on by scratching.  Lasting for 3-4 days.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot number not provided) on 04-OCT-2012. Other suspect therapies included FLUZONE which was also vaccinated on 04-OCT-2012. No concomitant medications were reported. On 04-OCT-2012 the patient developed "a low grade fever, body aches and bilateral thumb swelling where the patient's thumbs are warm to touch". The patient sought medical attention via office visit. The outcome of bilateral thumb swelling, a low grade fever, body aches and bilateral thumb swelling where the patient's thumbs are warm to touch was reported as not recovered/not resolved. Additional information has been requested.
After the patient received the shot she stated she was dizzy and then passed out. She was only unconscious for about 2  minutes. After she gained consciousness she started to feel better within 5 minutes. She did not need any medical attention.
PATIENT WAS GIVEN TDAP ON 10-02-2007. DOSE WAS NOT CHARTED. WAS GIVEN TDAP AGAIN ON 6-09-2008. I CALLED NEXT TO CHECK ON PATIENT & NOTIFY OF EXTRA DOSE TDAP. MOTHER SAID PATIENT WAS "FINE".
Initial Complaint:  Tingling/numbness of tongue. Vaccine given at 2:45.  Reported symptoms at 3:02  This was her second dose of Moderna.  Patient reports she had an adverse reaction to the first one as well.  At that time she felt as if her tongue was swollen.  She took Benadryl and symptoms resolved in an hour or two.  She has since been in contact with her Allergist who recommended she take Zyrtec and Pepcid before she receives the second dose and then again after.  3:02  Tingling /numbness in back of mouth.  Reports she had taken the Zyrtec and Pepcid prior to appointment. 3:15  Reported she had eaten recently.  There was no increase in symptoms. 3:20  BP 110/72  HR 66  3:30  Patient reported no progression f symptoms.  Denied SOB, no difficulties breathing or swallowing.  No Cardiovascular/GI/other resp symptoms.  A friend was driving her home.  Planned to take Zyrtec and Pepcid again at 4:45.  Concerning symptoms reviewed with patient and when to call 911.  Patient left in private vehicle.   Follow up call placed 4/27.  patient reports she is doing well.  Symptoms resolved about an hour after leaving the clinic.  She has been in contact with her Allergist.  No further issues reported.  Denied any questions or concerns.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 29-APR-2014, the patient was vaccinated with second dose of VARIVAX from lot # H018451 with expiry date of 09-OCT-2014 which was improperly stored.  No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness in left arm began the evening of the PCV 23 shot.  Severe pain . It seemed to get a bit better with benadryl and prednisone, but even after slight improvement on day 1, has continued to be painful in the high deltoid where the shot was given.
Vaccine 6/3/16 on 6/13/16 presented for other medical reasons and asked to check site. Has 70x25 mm ovoid, red, hard, raised lesion on Rt thigh, parent reports after immuniz. never got better and now worse. Dx: Cellulitis.
Patient reported that her right arm swelled, became stiff, red, and itchy about one week after administration of Moderna.  She called her doctor who advised her to apply ice and use Aleve and Claritin.  She stated the issue was mostly resolved at this point (approximately two weeks after development).  She did not want to receive the second dose.
2/12/2023 I had been exposed to COVID. I started having a little chest congestion and began coughing. I took cough medicine and went to bed. The next morning, I was still coughing and had a nasal drip. I took a home COVID test and it was positive. I called the doctor and he gave me some cough pills which I took for 3 days. The cough only lasted for 1 ½ days. My cough was gone after taking the cough pills for three days. By 2/16/23 I was fine, I was not coughing any more. The cough was very mild. 3/2/23 I had a negative at home COVID test.
Red rash and egg-sized swelling developed within minutes of vaccine administration on bilateral legs and on chest. Patient was administered Synagis for RSV, Hepatitis A vaccine and DTap vaccines. 25mg PO Benadryl was given and patient was observed for 20 minutes post-Benadryl, reaction was subsiding, patient was discharged with instructions for further care.
Pt had swelling and redness measuring several inches around injection site. Pt came in Thursday to show arm and said that it was also warm. The swelling had subsided since Tuesday. It was still a little red. Pt instructed to apply ice and can take ibuprofen or BENADRYL at night. If it were to get worse, Pt would be calling Dr.
Patient came in to pharmacy on Sun. 10-19-14. Had a large bruise on arm and complained of pain from neck to hand after receiving vaccine. Recommended that she to go MD or ER.
pt recv vax & devel an inj site rxn characterized by a golfball size area of redness & swelling;rxn was described as cellulitis;pt self treated w/applications of ice & recovered w/in 2 days;
Developed painless "rash" on right calf approximately one day after vaccination- after 3 weeks sought telehealth care on October 17, 2022 to determine why it wasn't going away. Telehealth doctor suspected DVT and was sent to ER. ER completed a "Doppler ultrasound deep veins unilateral lower extremity" which was negative for a DVT.  The tentative diagnosis was livedo reticularis. Was referred to a GP and dermatology for follow-up.  I saw GP 10/21/2022 with no further clarification provided, monitoring for now with potential for follow-up ultrasound or additional testing based on resolution and symptoms. Dermatology appointment set for 10/27/22.
This spontaneous report was received from a consumer and refers to an unspecified number of male patients of unknown ages. No medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. On unknown dates, the patients were presented with "new physical and psychological problems". The patients, reportedly, could not perform sexually, with some describing the problem as "something is wrong down there." The reporter went further on to state that such patients needed help in order to cope with a dysfunctional male organ and/or a swollen or painful scrotum. Moreover, the embarrassment was given a note, when the patients could no longer achieve an erection or hold their bladder. The outcomes of the aforementioned events were unknown. The reporter did not explicitly state any causal relationship between the events and vaccination with the suspect vaccine with a notable exception to the event of male sexual dysfunction, which was considered to be related since it was believed that impotency was associated with GARDASIL. This is one of the several reports received from the same reporter. Additional information has been requested.
12 month old toddler developed characteristic modromsal fever for 2 days prior to rash on face and behind eyes which then mogressed to involve body c/w measles. Toddler received MMR vaccine 13 days prior to evaluation on 5/1/08 which is about 10-11 days before onset of fever.
The mother reported "on right upper leg there was a red streak going outward from the shot site and a noduale under the skin.  The child was seen by Dr. and given Bactroban and Cefzil medicine.  The Doctors office confirmed this information and said there was lab work done and improvement seen by 12/19/11 at follow up.
Suspected vaccination failure; We caught the virus; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that the patient received both shots and still caught the virus. Those shots were probably the thing that kept us old folks (80's )from dying from it.  The patient recommended to get the shots. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. The case has been linked with the case US2021AMR195652 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195652:Same reporter.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female patient who received an expired dose of ADACEL lot U5593AA, expiry date: 07-Mar-2019 via intramuscular route in the left deltoid on 11-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was MENACTRA. It was an actual medication error due to expired vaccine used. Nurse manager stated that they used an expired ADACEL on a patient and states that it is so tiny so she needed a minute to read it. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient received the Pfizer BioBTech Bivalent booster before completing primary series. This was her first and only COVID-19 vaccination. Patient experienced no symptoms after receiving the bivalent booster.
Brain fog, fatigue increasing over 3 days resulting in 2 episodes of sleep paralysis. First lasting about 2 minutes, second lasting about 15 minutes
90 mins after vaccine pt got cough, chest tightness and took BENADRYL that improved sx. Eye swollen with mild D/C. Developed next fever to 101.7 and chills. Migraine like HA with nausea and vomiting.
C/o arm stiffness since vaccination. Had PT, MRI and bone bx/ culture due to severe bone marrow edema in proximal humerus. Referred to an Arthritis center due to elevated ANA/Homogeneous pattern.
11 days later suffered Grand Mal Seizure with 10-15 min LOC.  Called 911.  Transported to ER.  Held for observation.  Tests run
pt rcvd vax; pt devel fever; t 102-103; MD contacted; findings: right facial palsy;
Sore throat, muscle aches, cough, weakness, chest pain. Admitted to ER with chest pain r/o MI. MI ruled out after admission to hospital admitted with hypotensive shock, sepsis, acute renal failure.  Patient was coded in ICU on 11/15/09.12/9/2009 ED records for 11/13/2009, patient with c/o's SOB and change in mental status, IV ABX, Lasix, Morphine for pain, hypertensive and tx'd with betablockers and NTG, transferred to another facility for continued care 12/10/2009 ED, MR, H&P, Consult notes and DC summary for 11/14-11/25/2009, patient admitted with c/o's cough, myalgias, sore throat, weakness, chest pain, abdominal pain, febrile on admission at 103.9,  diaphoretic and pale, now extremely hypotensive, admitted to CICU,  intubated, cardiac monitoring, CVP line placed, Heparin, Ng tube placed,  kidney  function worsened, Quinton catheter for dialysis placed 11/19/2009, Dx's Septic Shock, Shock Liver, Pneumonia, Renal failure, CHF
Information ahs been received from a female with a history of allergic rhinitis to bee sting and no pertinent medical history who was on an unspecified date vaccinated with a first dos eof RECOMBIVAX HB. There was no concomitant medication. Subsequently the patient developed tachycardia, dizziness and nearly passed out. Medical attention was sought, and she was give OTC BENADRYL. No lab studies were performed. Subsequently, the patient recovered. The vaccine series was discontinued. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
I received my COVID 19 vaccine (1st dose) on March 27th, 2021. My cycle was then due on March 31st, 2021. I am never late with my cycle, but due to the vaccine, I was 10 days late. I think it is extremely important to advise and inform women of the possibility of this side effect. If you are trying to conceive, it can be very misleading.
Influenza vaccine given, patient presented to the ED immediately after c/o dizziness, double vision, headaches, nausea, and diaphoresis. Had EKG done, medications given Benadryl and Methylprednisone IVP. Observed and discharged home with prescription for prednisone and Diphenhydramine PRN.
sinus infection; This is a spontaneous report received from contactable consumer (patient) via Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for injection, Lot Number were not reported) via on an unspecified route on unknown date as DOSE 1, SINGLE for COVID-19 Immunization. On an unspecified date patient had experienced sinus infection. And reported that had first dose already second dose due to get on 16th wanted to know if he can get second dose or should he postpone it. Therapeutic measures were taken for the event sinus infection and included treatment with Zpack. The clinical outcome of the event was unknown.    Information on the lot/batch number has been requested.     Follow-up (11May2021): Follow-up attempts completed. No further information expected.
12/18/21 presenting today for Cough (cough and body ache, runny nose started Wednesday    History of Present Illness: Desires a covid test. His boss saw me coughing at work and recommended that I get tested. I was vaccinated in May. Having non productive cough. No fevers. No fever     Review of Systems  Respiratory: Positive for cough.   All other systems reviewed and are negative.
Dizziness, Headache, HYPOtension, CHILLS; FATIGUE; ARM SORENESS; NO APPETITE Narrative: STATES GOT DIZZY AND FAINTED- HIT HEAD; HEADACHES; AND HYPOTENSION; STIFF NECK