chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Underarm started hurting really bad and to the point where it really hurt even bad now; Started to get like a little bit lethargic; Low grade fever like 99.3 or 99.5; My arm was getting sore; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 13Feb2021 (at the age of 52-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included patient take it for stomach and surgery, stated that, no, she just had a surgery, actually, tomorrow makes 3 months. So, she was not able to take pills form because of surgery (further clarification unknown). The patient's concomitant medication included omeprazole, the patient taken it for stomach. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration on 23Jan2021 (at the age of 52-year-old) as a dose 1, single for COVID-19 immunization. Stated that, the patient got the second shot on 13Feb2021. When she got the shot, she felt like her arm was getting sore on 13Feb2021 and then the next day, on 14Feb2021, she started to get like a little bit lethargic and a low grade fever like 99.3 or 99.5 which was fine, so nothing big. But then, her underarm started hurting really bad and to the point where it really hurt even bad now, like today. Stated that, today it was like 15 and it got worse (not clarified further). Was it harming and something on her armpit. The patient was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department. The patient was informed that, Pfizer medical information was the concerned department for all queries. Stated that, the patient don't have the card with her right now. She had the picture of card for the first shot. Stated that, for second shot, it was in her bag which she left at her sister's. It was EN5318, this was for first shot, for the second one she don't have. (Consumer had Lot# for the first shot, however consumer was experiencing events after the second shot, hence Lot# not captured in tab). The consumer stated that, first one was on 23Jan2021 and second shot was on 13Feb2021 (hence, date for second shot captured in tab as consumer was experiencing events after the second shot). Stated that, treatment received for the events was reported as no, she did not. On 14Feb2021, the patient underwent lab tests and procedures which included low grade fever (body temperature), resulted as low grade fever like 99.3 or 99.5 which was fine, so nothing big. The outcome of the events for started to get like a little bit lethargic and low grade fever like 99.3 or 99.5 was recovered on an unspecified date in 2021 and for my arm was getting sore was unknown while for the other event was not recovered.  Information about Lot/batch number has been requested.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 06-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
3/16/21 - small fever Tuesday evening Ok rest of week 3/20/21 - unable to get up 7:00 am. From 7:00 am, developed bad headache and very dizzy. Unable to keep food/liquids down. Started to feel better 3/21/21 in the AM. Still have light headache 3/22/21
About one hair after immunization, child's arm become red, warm, with swelling at injection site. Cool compress applied office visit 1-30-07 and 1-31-07 for continued redness, swelling, and warmth.
Weak & tired, arm a "little" sore; Next day felt lousy; Not seen by MD initially, only phone report; Developed rash abd; Rash & temp got worse; Given antibiotic feeling better by not well;
Patient reported vomiting twice and feeling lightheaded. Patient also reported feeling hot and sweating. Patient ate some food and felt better later that afternoon. Patient also started taking ARICEPT the same morning as the ZOSTAVAX was administered.
Caller reporting a 4-month-old patient inadvertently received a dose of VAXELIS instead of the intended PREVNAR. Caller reporting the patient was supposed to receive PENTACEL and PREVNAR, and the MA accidentally administered PENTACEL and VAXELIS; Caller reporting a 4-month-old patient inadvertently received a dose of VAXELIS instead of the intended PREVNAR. Caller reporting the patient was supposed to receive PENTACEL and PREVNAR, and the MA accidentally administered PENTACEL and VAXELIS; This non-serious spontaneous safety report, with reference number 2023SA068119/ 01511126 was received by a partner on 28-FEB-2023 and forwarded on 01-MAR-2023 from a health professional.   Due to the nature of the event, the causality between the events "Caller reporting a 4-month-old patient inadvertently received a dose of VAXELIS instead of the intended PREVNAR. Caller reporting the patient was supposed to receive PENTACEL and PREVNAR, and the MA accidentally administered PENTACEL and VAXELIS" and Vaxelis was not applicable.  Further information is expected.
Adverse events started at about 10 PM that night after receiving injection. Right side of face slightly swollen, face felt like it was going to explode from pressure/pain. Vomitted soon after; also had cold sweats and weakness. Next day (10/8/18) experienced congestion, injection site swelling, headache, runny nose, drip down throat. Still experiencing these symptoms but has improved (10/9/18).
A week after the vaccine, my smallpox vaccine scar started getting red and inflamed.  It was on the same side as the vaccine but not really near the shot.  I had the smallpox vaccine as a child in the early 1980s when I was a kid.  Have never had this problem before with any other vaccine.  Now, a week after this reaction started the redness has mostly subsided but not completely.
urse administered Covid Pfizer vaccine to Left Deltoid per policy.  Patient instructed to monitored waiting room for 15 minutes. Approximately clerk announced STAT nurse to waiting room where patient was sitting. Syncope episode with Mother at side.  Patient did not fall but was caught by Mother in her arms.  Responded , RN, APRN;, RN; , LPN and -administrator.  Vital signs: B/P 92/54 2nd (10 mins later) 117/75.  Patient shortly alert and oriented x4 and left with family. No injuries or complains from patient or family.
At 11:30am on April 6th my dad had a type A Aortic Dissection.  He was rushed in an ambulence to Hospital.  4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery.  Dr. performed the surgery which my dad survived.  He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery.  While in the ICU, he contracted pneumonia and his lungs and kidneys began declining.  20 days after the aortic dissection he died in the hospital.
02/21/22 presents to ED for "shortness of breath with associated cough, fatigue, chills, loss of taste and smell". PMHx of "chronic congestive heart failure, end-stage renal disease on hemodialysis, anxiety, hypertension, A. fib"
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient felt lightheaded/dizzy and fainted after receiving first vaccine dose. Paramedics were called and all vitals were stable. Patient stated she did not eat prior to receiving her vaccine and has a needle phobia, where she tends to pass out after recieving an injection. Patient was given fluids and a snack to eat. She was further monitored for another half hour before leaving the store.
This case was reported by a pharmacist via call center representative and described the occurrence of taste altered in a adult patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced taste altered. On an unknown date, the outcome of the taste altered was unknown. It was unknown if the reporter considered the taste altered to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st of the two SHINGRIX vaccine. Over the weekend, she called saying that she got altered taste in her mouth. She said it started as a bad taste. The reporter was asking was that a normal side effect.
Fever; Swelling; Redness; Pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain) and FATIGUE (Fatigue). On 25-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller states that she received the 1st dose of the moderna 23Feb2021. Fever the first 2 days.Swollen and red at first, it went down now. Had very little use of the right use, was given IM in the shoulder and had pain all the way down to the arm which subsided but its still too painful to move it. She is fatigued too.
Numbness/tingling in hands and feet which progressed to elbows and knees. Two to three days post vaccination developed upper respiratory illness.  ER visit 12/3/14 with diagnosis of parathesia upper and lower extremities.  Follow-up visit on 12/5/14 with PCP, diagnosis of Guillain Barre related to influenza vaccine. Scheduled neurologic visit this date for further evaluation.
Patient was initially admitted for psych admission for depression management but due to persistent fever and tachycardia, patient was transferred to medical service and onto medical floors. Patient denies coughing prior to ED presentation, denies vomiting while she was intoxicated or during alcohol consumption, no recent URI SXS noted. She denies IV drug use as well.
Pfizer-BioNTech Covid vaccine, first shot developed a blood clot in a superficial vein the day after the vaccine, was diagnosed by a doctor as "superficial thrombophlebitis, pain swelling in leg. Treatment of ibuprofren started.   Wondering if I should take my second shot  which is scheduled for MArch 26
BREAKTHROUGH COVID: FULLY VACCINATED, 41-year-old male who presents to the emergency department a chief complaint of weakness over the past 2 weeks.  DKA, POA.  Newly diagnosed DM with A1C of 13.6 and blood glucose of >1200 on arrival.  Acute kidney injury with hypernatremia, present on admission, improved.  No leukocytosis.   The patient was incidentally found to be COVID positive however he denies any other symptoms such as fever, shortness of breath, chest pain, nausea or vomiting. And, essential hypertension. COVID TX monitor for O2 requirement, no indication for treatment.
pertussis vax encephalopathy of a mild nature marked to head tone/control, slowly improving; dazed appearance, poor eye contact/ no smiling; all sz began 24hr p/vax; 48 hr p/vax sleeping longer, high pitch cry
Palpitations  Narrative:  Pt experienced palpitations and chills after receiving covid vaccine, leading to ED visit where IM diphenhydramine was given.
Began feeling a slight fever with body aches once I woke up Saturday morning. Max Body Temp measured = 100.0 at 1:40 pm. Body temp at 5:00 pm = 99.9. Body temp measured at 7:30 pm = 99.6.  Sunday March 14: Woke up feeling much better without symptoms. Body temp at 11:00am = 88.1
Pt c/o burning sensation at injection site. Slightly swollen, looks like pimples or blisters under skin. Monitor for now, Tylenol and ice for pain/discomfort.
weight is too much; she developed a rash on her body/blotches/rash on chest, small amount on arms, and a couple on legs; face very red; This is a spontaneous report from a contactable consumer(patient). A 76-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9264, Expiry date: May2021), via an unspecified route of administration on 31Jan2021 at 15:30 into left upper arm as a 1st dose single dose for COVID-19 immunization at hospital. The patient had an allergy to penicillin. No other vaccine given the same day or 4 weeks prior. No problems with vaccines in past. On 04Feb2021, patient developed a rash on her body, blotches/rash on chest, small amount on arms, and a couple on legs and face very red. On an unspecified date, patient experienced shrinking, weight is too much. She got the first Covid-19 shot at (hospital) this past Sunday. Went to take a shower today and her face was very red so she looked at her chest and there were blotches that looked like a rash. Had a small amount on her arms, but not at the injection site. Also had a couple of blotches on the legs. Had called the doctors at (hospital name) and had a virtual visit and was told to take Benadryl. This was 4 days after and wants to know if we have found out any information about her. She asks should she get the second dose in the same arm. Mentions she and her husband did take a COVID test because her husband had a belly ache so they wanted to make sure it wasn't that or something that he ate. They suspected it was something he ate and it was, they both were negative. Clarifies this was before getting the Covid-19 shot. Later mentions she has an allergy to penicillin and was not sure if that is related. Had a reaction as a child and has not taken it since. The patient was not visited to emergency room for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date Jan2021.The outcome of the events was unknown for overweight and recovering for other events  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
experienced severe abdominal pain; severe back pain after receiving the Moderna COVID-19 vaccin; toenail fell off as well; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN (experienced severe abdominal pain), BACK PAIN (severe back pain after receiving the Moderna COVID-19 vaccin) and ONYCHOMADESIS (toenail fell off as well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (experienced severe abdominal pain), BACK PAIN (severe back pain after receiving the Moderna COVID-19 vaccin) and ONYCHOMADESIS (toenail fell off as well). At the time of the report, ABDOMINAL PAIN (experienced severe abdominal pain), BACK PAIN (severe back pain after receiving the Moderna COVID-19 vaccin) and ONYCHOMADESIS (toenail fell off as well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Menopausal no periods for 9 months prior to 2nd vaccine and then 2 days later started spotting for 2 days then full blown period with cramps for next 5 days on eighth day flow decreased by the hour and it was over and done by morning of day 9.
4/21/2022-Transfer from SNF. Hypoxia since 8am. Placed on 6L NRB o2 sat 89%.  T: 101, P-105 and RR-26. CXR-perihilar intersitial and patchy alveolar opacities. Admit sepsis with acute hypoxic respiratory failure Covid pneumonia. Start Decadron, remedesivir, Unasyn and Vanco.  4/23/2022-D/C vanco continue unasyn as pt improved more likely aspiration pneumonia. Afebrile. VSS. Now on 2l via NC 96% 02.  4/25/2022-Sepsis resolved. VSS.  4/27/2022- VSS, improved. D/C to SNF.
It started with pain and spasms in the back and afterward difficulty breathing, blurry vision, involuntary tremors, loss of balance, pressure and headache, dizziness, weakness, tachycardia, numbness of leg, pressure in head and seizures.
Infrequent bowel movements/Less frequent bowel movements; Diarrhea; Vaccination site pain/vaccines caused to had sore arm; Tiredness/little tired; This spontaneous case was reported by a consumer and describes the occurrence of INFREQUENT BOWEL MOVEMENTS (Infrequent bowel movements/Less frequent bowel movements), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain/vaccines caused to had sore arm) and FATIGUE (Tiredness/little tired) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   In December 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Dose increased. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free (1 in 1 wk). On an unknown date, the patient experienced INFREQUENT BOWEL MOVEMENTS (Infrequent bowel movements/Less frequent bowel movements), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain/vaccines caused to had sore arm) and FATIGUE (Tiredness/little tired). At the time of the report, INFREQUENT BOWEL MOVEMENTS (Infrequent bowel movements/Less frequent bowel movements), VACCINATION SITE PAIN (Vaccination site pain/vaccines caused to had sore arm) and FATIGUE (Tiredness/little tired) outcome was unknown and DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On unknown dates, the patient experienced less frequent bowel movements, diarrhea and vaccines caused to had sore arm and be a little tired.  No treatment details reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Action taken with Co-suspect Humira was reported as Dose increased.  The reporter's causality for Humira (adalimumab) with response to the event less frequent bowel movements was not provided. The reporter's causality for the event(s) of diarrhea with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of vaccines caused to had sore arm and be a little tired unknown onset and vaccines caused to had sore arm and be a little tired unknown onset with humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
After the first dose glands in breast were painful and swollen.     After the 2nd dose within 8 hours an oral herpes lesion appeared.   I began taking Zovirax as prescribed but then contacted my doctor to see if Zovirax 400mg would alter the efficacy of the vaccine.    Glands in breast still swollen.
It was the wrong vaccine. Patient was requesting to get meningitis vaccine, but the pharmacist who was working gave M-M-R. Talked to patient he was okay and had no adverse side effects.
had a bad skin break out post meningitis vaccine; Initial information was received on 19-Mar-2021 regarding an unsolicited valid non-serious received from a consumer/non-healthcare professional.  This case involves a 17-year-old female patient who experienced had a bad skin break out post MENINGOCOCCAL VACCINE (meningitis) (rash), while treated with DUPILUMAB [DUPIXENT].  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It is unknown if the patient had any concomitant disease or risk factor.  At the time of report the patient had Atopic dermatitis.  On 20-Jul-2020, the patient started taking DUPIXENT (DUPILUMAB) 300 mg via subcutaneous route (with an unknown formulation, batch number and expiry date) for Atopic dermatitis.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported that, : Patient mom was counseled in regards to COVID Vaccine. She understands no drug-drug interaction [DDI].  Details of laboratory data were not reported.  On an unknown date, the patient developed non-serious had a bad skin break out post meningitis vaccine (rash) unknown latency following the administration of MENINGOCOCCAL VACCINE and 7 months 27 days from first and last dose intake of DUPILUMAB.  No action was taken with DUPILUMAB (DUPIXENT).  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown.  There will be no information available on the lot number for this case.
Muscle Weakness, Extremely tired, high blood pressure, Muscle aches and bone aches
Parent reports the day following immunization administration, the patient developed redness, swelling, and tenderness to the right thigh overlying the injection site that has been worsening.
patient called and stated that she had a terrible headache and body aches as well as muscle cramps. I suggested she alternate ibuprofen and tylenol. she does have sone tramadol at home and she said she did take 1 of those. She was given rx for isosorbide and the dr instructed her to stop if she got a headache. She did stop that. She also had seen the obgyn yesterday and they sent in 2 rxs today. So it is possible that the issues are related to the dr visit she had on the day of the vaccine. I did call her later  and she was still not feeling well. She is going to start on the meds called in and see if that helps. I suggested she call her dr tomorrow if she is not feeling better