chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported her arm swelling the night after receiving her PNEUMOVAX shot. She came to the pharmacy the next day mid-afternoon. Her left arm was swollen, red, and mildly warm to the touch. She said she was experiencing no pain. The majority of the swelling was well below where she received the vaccine, but located mostly above the elbow. She was instructed to go to her PCP's office and show them the reaction.
Patient has symptoms of left arm and forearm pain after 2nd Pfizer dose dated 4/28/2021.
product was frozen for 48 hours; Initial information was received on 02-Aug-2021 regarding an unsolicited valid non-serious case from pharmacist via call center via Global Medical Information (reference number- 00706346).  This case involves a patient of (unknown demographics) who received suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was frozen for 48 hours by thawed it (product storage error).  The patient's past medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to product storage error temperature too low.  It was reported that, "HCP requests to know if we have any efficacy information"  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  There will be no information available on the batch number for this case.
c/o subjective fever, chills, H/A, sweating, rhinorrhea, and nausea since receiving COVID vaccine Wednesday evening around 1800.  Symptoms have improved, per pt, but have not subsided completely. Has tylenol and ibuprofen at home but has not taken it. HPI: 22yo AD M presents to ED for above symptoms that began shortly after receiving the J&J COVID vaccine 3 days ago. He has no focal neuro symptoms, no LE swelling, no pleurisy or dyspnea. No URI/LRI symptoms. No rash. L deltoid vaccination site. Pt has generalized malaise after vaccine. No red flags for HA, no acute abdominal symptoms/signs, unlikely PE or DVT, unlikely CVA. Unlikely anaphylaxis. F/u and return precautions discussed. Stable for D/C.
large red bumps that itched and when faded left red marks, after a while bumps that appeared were smaller and didn't itch as much and skin around bump peeled off leaving  red mark which is fading.  Started at ankles and worked way up to face and arms.  Still have large red marks on legs.  Didn't seek treatment as it seemed to be an allergic reaction to the shot and figured nothing could be done about it. Self treated with cortizone cream and benedryl.  Helped some but not a lot.  New bump appeared on face today.
Cold sore after taking the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sore after taking the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (Cold sore after taking the vaccine). At the time of the report, ORAL HERPES (Cold sore after taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information provided.
4-12-07 Mother called office. Had vaccines 4-11-07. Vomited x 1 4-12-07 during the night. Mom concerned vomiting was side effect of one of the shots
Had a severe colonic seizure and stopped breathing.  He said he felt funny after the shot, like he was light-headed and dizzy. Then out of nowhere I heard him moan and saw he was foaming at the mouth and violently convulsing and turning blue. I did cpr and the paramedics arrived and took him to the hospital. We are following up with a neurologist tomorrow.
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Migraine medication stopped working and no other medications, injections or infusions have worked. Migraine now presents with hallucinations of all 5 senses, paranoia, neuropathy in arms/legs, episodic fevers and loss of consciousness; among other symptoms.
11:15 pm. I experience chills, Dizziness and weakness for about 10 minutes sitting in the chair
I caught Covid 19 after being fully vaccinated. I thought I had the flu or cold. I had sore throat, coughing, low grade fever- nothing over 102, fatigue, taste/smell was a little off, nasal congestion and sneezing.
1 day post vax, the pt experienced an area where the shot was given, that was hot to the touch, swollen, red, itchy and sore. Pt experienced same symptoms (not at severe) 3-4 days after receiving the vax.
Tested Covid positive; Tested Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: ER8730) and as dose 2, single (Lot number: EW0167) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Oct2021 as dose 3 (booster), single (Lot number: 011F21A) for covid-19 immunisation. The patient's relevant medical history included: "MCADD" (unspecified if ongoing), notes: (reason for using L-carnitine daily); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). Concomitant medication(s) included: ZINC.The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 29Apr2022, outcome "not recovered" and all described as "Tested Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (29Apr2022) Positive; (30Apr2022) Positive; (04May2022) Positive; (05May2022) Positive; (06May2022) Negative; (08May2022) Negative; (09May2022) Positive, notes: Started sniffling on 09May (Day 10), and rapid test resulted positive(rebound).Tested Covid positive (Cue NAAT test) on 29Apr2022. Tested Covid positive on rapid test (iHealth) on 30Apr2022. Started Paxlovid treatment on 30Apr2022. Tested positive on rapid tests on 04May and 05May (Days 5 & 6). Tested negative on 06May and 08May (Day 7 and Day 9). Started sniffling on 09May (Day 10), and rapid test resulted positive (rebound).Therapeutic measures were taken as a result of covid-19.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown ages and genders. The nurse reported that on unknown dates, unknown number of patients might have been vaccinated with doses of VARIVAX (Merck) (dose, lot #, expiration date and route of administration not reported) that had multiple excursions. No adverse effects were reported. Follow up information has been received from another registered nurse who reported an unspecified patient was in the office at the time of the report and was about to be administered (it was not reported whether the patient received the vaccine) a dose of VARIVAX (Merck) (dose not reported, lot # J005726 and expiration date 08-MAY-2015) which was stored outside of recommended temperature range as noted in prescribing information. Follow up information has been received from the registered nurse who stated that she was not in the office when the temperature excursion occurred. This is one of several reports received from the same source. Additional information has been requested.
Approximately 10 hours after my vaccination all of my lymph nodes were swollen, my right arm (which I got the shot) was so swollen - I wasn't able to breathe well. Everything felt tight. I wasn't able to taste anything. I also developed a cough then I went to the ER 2 days after because I wasn't getting any better. They did not test me for COVID because I told them that I have gotten the vaccine 2 days ago and then I went home but I still wasn't feeling any better so I went again after 2 - 3 days, they told me to quarantine myself. It took me 12-13 days to start feeling better but wasn't at a 100% until Day 14.
really low energy/feeling weak; blood sugar has gone up; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (really low energy/feeling weak) and BLOOD GLUCOSE INCREASED (blood sugar has gone up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (really low energy/feeling weak) and BLOOD GLUCOSE INCREASED (blood sugar has gone up). At the time of the report, ASTHENIA (really low energy/feeling weak) and BLOOD GLUCOSE INCREASED (blood sugar has gone up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by the reporter.  No treatment medication reported by the reporter.
cellulitis in whole upper arm; neurological symptoms; temperature 103 F; allergic to tetanus shot; Initial information was received on 18-Aug-2020 regarding an unsolicited valid serious courtesy case from a consumer/non-health care professional (patient) via Pfizer.  This case involves a female patient (age unspecified) who had cellulitis in whole upper arm (cellulitis), neurological symptoms, temperature 103 F (body temperature increased) and was allergic to tetanus shot (allergy to vaccine), while she received TETANUS TOXOID.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious cellulitis in whole upper arm (cellulitis) (unknown latency) following the administration of TETANUS TOXOID. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious neurological symptoms, temperature 103 F (body temperature increased) and was allergic to tetanus shot (allergy to vaccine) (unknown latency) following the administration of TETANUS TOXOID.  The patient did not have an anaphylaxis reaction. It was reported that she was supposed to get the Prevnar 13 vaccine today but did not receive it yet.  Relevant laboratory test results included: On an unknown date, the body temperature was 103 F.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient (age unspecified) who had cellulitis, neurological symptoms, pyrexia and allergy to vaccine (unknown latency) after vaccination with TETANUS TOXOID. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 03/03/ at 1:00AM. Patient has not reported to Medical Clinic with symptoms at this time.
Initial and follow-up information has been received from a registered pharmacist concerning a 51 year old female patient who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX (lot # 661529/0868X).  Within 24 hous of vaccination, the patient developed swelling and warmth down at the injection site.  The patient's reaction was not as severe and was not seen by a doctor.  This is one of three reports received from the same source.  Additional information has been requested.
Day following vax, she had sensation of things around her moving/disequilib. Later had headache that has persisted.
Pain in veins in legs and arms, pulsing in legs, swollen lymph node, chest pain, headache, blurry vision.  Blood test shows low potassium and think blood.
Anxiety; BP 122/72; HR 82; RR 20; T 98.4; O2 sat 100%. Pt stable & released
(L) arm deltoid area with 8cm diameter of erythema with mild induration; round appearing macule.
Got COVID. Symptoms started on 7/16.  Tested negative via rapid test but positive via PCR on 7/17.  Pretty sick for about 48 hours with fever and cough.  Never had trouble breathing and started feeling better by 3rd day.  One month after infection still have a lingering cough.
Positives antigens for Hepatitis B virus; hepatitis B antibody positive; This case was reported by a nurse via call center representative and described the occurrence of hepatitis b virus test positive in a 23-year-old female patient who received HBV (Engerix B) (batch number N754X, expiry date 11th November 2001) for prophylaxis.   On 19th September 2019, the patient received Engerix B. On 12th December 2019, 84 days after receiving Engerix B, the patient experienced hepatitis b virus test positive and hepatitis b antibody positive. On an unknown date, the outcome of the hepatitis b virus test positive and hepatitis b antibody positive were unknown.   It was unknown if the reporter considered the hepatitis b virus test positive and hepatitis b antibody positive to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. A nurse reported that a patient received Engerix B vaccine and after the test it was confirmed that they had positive results for hepatitis B virus, and positive antibodies as well. The precise virus test and antibody test were not specified. The reporter denied consent to follow-up.      Lab Comments: On 12th December 2019, they had positive results for Hepatitis B virus, and positive antibodies
24 hours after receiving vaccines 10/1/08 complaints of burning sensation from RT deltoid muscle RT arm down to RD hand fingers; 48 hours later complained of burning in RT chest area to parent - parent will me know if she takes her in for medical evaluation (RN). 10/6/08 10:15 pt back to parent - child doing fine - burning numbness resolved - did not seek medical assessment.
Diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy (Normal) in 2019.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 17-FEB-2021 the patient experienced Inflammatory bowel condition   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
I had the 2 shots but still had Shingles/suspected vaccination failure; I had the 2 shots but still had Shingles; worst pain in life; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the 2 shots but still had Shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had the 2 shots but still had Shingles) and pain (Verbatim: worst pain in life). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2023  This case was reported by patient via interactive digital media. The reporter stated that it was scary. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
IMZ ADMINISTERED IM AND PATIENT COUNSELED WHAT ADVERSE EFFECTS TO WATCH FOR. PATIENT FORMED A SMALL BUMP, AND SOME REDNESS ON THE SITE WHERE THE VACCINE WAS ADMINISTERED.
no adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient).    Patient ID was reported.  Concomitant medication was not reported.  Reportedly, in this report the patient was eligible for COVID-19 vaccine.  Treatment medication was not reported.
runny nose, body aches, sore throat, congestion, slight body aches, headaches, . starting 12/25/21
This study case was received from the investigator on 27 September 2012. A 25 year-old female subject with no significant medical history was found to have chest pain, unspecified 7 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 21 February 2012. Relevant laboratory data included: not available Troponin I, a normal ECG, a normal Echocardiogram, a not available MRI (brain, spinal cord, heart) and a not available Lumbar puncture. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Approximately 3 weeks subsequent to receiving varicella virus vaccine live the pt developed a flat red rash over her entire body. It was indicated that the pt did not appear to act sick.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or alleriges were not specified. On 02-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, one, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982).
Initial information received on 13-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a four months old female patient who had a fever, while she received vaccines PENTACEL, ROTAVIRUS VACCINE SHANTHA, DAPTACEL and PREVNAR. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Jan-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, ROTAVIRUS VACCINE SHANTHA (lot number and Expiry date unknown) via unknown route in unknown administration site). On 11-Feb-2019 DAPTACEL and PREVNAR  (lot number and Expiry date unknown) via unknown route in unknown administration site). On an unknown date, the patient developed a non-serious running a fever (pyrexia) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, ROTAVIRUS VACCINE SHANTHA, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE and PREVNAR. It was an actual medication case error due inappropriate schedule of vaccine administered. (Other relevant tests included no lab data.) Final diagnosis was fever. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. 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.