chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sat 3/13/21 pm got 2nd shot...Sunday evening had a 101.9 Fever, Chills, swollen throat (mostly on right side).  Swollen supraclavicular lymph gland on left side - just above clavicle.  (still have that even though most symptoms have subsided).  Extremely tired, hands and feet swelled.  Symptoms (other than swelling) resembled a bad head cold.  Stuffy, sore throat, deep cough and chills.  By Monday (3/15/21) morning fever was down to 99.0 and by Monday night It fell to 95.6.  Tuesday morning fever normal but still had all other symptoms  Went and saw a NPR at local clinic and she gave me musinex and a zyrtec to help with the head and throat.     Today is Wednesday the 24th and I've almost returned to normal with exception of swollen supraclavicular lymph gland that's still the size of a small marble.
dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: Apr2021) via an unspecified route of administration on left deltoid on 12Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient stated she had a shingles vaccine, got dizzy and nauseous, thought this was about 3 years prior to the report. The patient received the first dose of the vaccine after working a night shift. She went home, went to bed and then woke up very dizzy, nauseated, vomited and experienced cold chills on and off. She also stated that about 10 hours after she got the shot, she got dizzy, nauseous, threw up a couple of times, got chills, and had a little headache on 12Jan2021. She stated she was a little nervous about getting the second vaccine. She also worked nights and that she got off her night shift and got the vaccine on 12Jan2021, didn't know if maybe she was a little dehydrated possibly. The events are reported as serious due to medically significant. The outcome of the events nausea/nauseated/nauseous and vomiting/ vomited was recovered on 13Jan2021, for the events dizzy, cold chills/chills and a little headache were recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Pt rec'd vax and went to observation area. After 3-5 min, pt stated he felt lightheaded and he passed out. Pt was unconscious for @1 minute. Pt slumped to floor w/o hitting his head per pt and observation nurse. Onsite EMTs summoned, pt was able to rise and transfer to w/c w/o assistance. Pt denied continued feelings of dizziness or lightheadness. Pt states he is fasting for religion and has not eaten/drunk anything since 3 am. Pt also expressed anxiety w/ needlesticks. VS taken, WNL. Pt observed by EMT for an additional 20 min, refused add'l assessment at ED, left facility stating he was feeling well. Advised to seek emergent treatment if sx recur.
SARS-COV-19 Infection. Congestion, Diarrhea, Loss of taste, loss of smell, shortness of breath, fatigue, muscle aches.
Received vaccine and he is 16 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received vaccine and he is 16 years old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received vaccine and he is 16 years old). On 15-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received vaccine and he is 16 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used were not reported. No treatment information reported; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number 027A21A) with no associated AEs reported.
Severe joint pains in hips, shoulders, wrists, ankles lasted 2 weeks -> missed work, couldn't walk/sleep so severe.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
equilibrium problem; Dizziness; vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium problem), DIZZINESS (Dizziness) and VOMITING (vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BALANCE DISORDER (equilibrium problem), DIZZINESS (Dizziness) and VOMITING (vomiting). On 29-Mar-2021, BALANCE DISORDER (equilibrium problem), DIZZINESS (Dizziness) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was provided.
1st dose in fall of 2018 / second dose was received 2/5/2021; Headache; Nausea; Stomach pain / colon wasn't calming down / still has some lingering stomach pain; Diarrhea / colon wasn't calming down / still has some / diarrhea; This case was reported by a consumer and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in fall of 2018, reference case US2021034668).   On 5th February 2021, the patient received the 2nd dose of Shingrix. On 5th February 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In February 2021, the patient experienced headache, nausea, stomach pain and diarrhea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache and nausea were recovered/resolved and the outcome of the stomach pain and diarrhea were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, nausea, stomach pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced headache, nausea, stomach pain and diarrhea, less than a week after vaccination. The symptoms lasted for 2-3 days except for the stomach pain and diarrhea. The patient still had some lingering stomach pain and diarrhea at the time of reporting. The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021034668:Same patient, Same reporter, 1st dose.
Severe chills. Recurrent High grade fever, not responding much to ibuprofen and Acetaminophen. Mild chest pain Nasal congestion and post nasal drip
PT came to vaccination site to receive second dose of MODERNA vaccination.  PT stated that she had a previous adverse reaction with the vaccination few weeks back.  Stated she had a feeling of "being punched in the throat."  PT had IM injection in her left arm.  Shortly after the administering the vaccine she started feeling the same as she did last time.  Vitals were taken:  BP: 162/94 Pul: 91 O2: 91  PT stated that last time the ER have her some antihistamine via IV.  PT was offered Benadryl and she accepted.  5ml was given to PT, and then was observed.  PT denied any need for EMS intervention and left under her own power.
Arm pain immediately following vaccination. 2 hours later, became extremely itchy all over body (no rash.) One raised hive popped up on my stomach. I took Benadryl to reduce itchiness so I could sleep. Today I am dealing with a mild headache and bad diarrhea immediately after eating.
Headache, dizziness with all vaccines After 12-22-21 vaccine I had COVID ON 12-31 symptoms started, after hours clinic said no test needed because my husband was positive for COVID.  I do not think it was related to vaccine but exposure.  I followed with my pulmonologist fir COVID symptoms due to breathing difficulties and feeling like I was drowning a few nights.
Continual dull aching pain in right shoulder, even after initial soreness in arm went away.  The dull aching pain has continued for 6 weeks since the injection.
Swollen glands, (femoral), redness and swollen site, no fever, Hurt - make her cry. Rest made it better - iced +heat
She hasn?t had her period in two months, and she?s in alot of pain.
if someone received a Bivalent Booster dose but has not completed the Primary doses of COVID vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (if someone received a Bivalent Booster dose but has not completed the Primary doses of COVID vaccine) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (if someone received a Bivalent Booster dose but has not completed the Primary doses of COVID vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (if someone received a Bivalent Booster dose but has not completed the Primary doses of COVID vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient received an improperly stored dose of (Oka/Merck) VARIVAX injection, lot # L030158, expiration date: 11-AUG-2017 (dose and route of administration was not reported). There were no concomitant medications provided. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to COVID-19 Vaccine clinic on 02/06/21. Reported listed allergies (see nots above) and pharmacist noted throat swelling and shortness of breath for reaction. Patient received 1st dose of Pfizer COVID-19 Vaccine and reacted to administration. Patient experienced lip swelling, which triggered pharmacy staff to follow Albertson's/Acme Markets Vaccine Emergency Protocol - Patient took diphenhydramine 25mg by mouth. Reaction continued and a rash developed, which spread from her lower extremities and covered her stomach. Patient took another diphenhydramine 25mg by mouth. An ambulance was called and arrived at clinic. At that time, she reported feeling better due to diphenhydramine. She DID NOT receive Epi-pen, and did not take ambulance to emergency department. However, she is reporting to emergency department for follow-up.
The day after the vaccination patient started having chest pain and dizziness/vertigo.  The pain did not radiate down his arm or up his neck and he experienced no shortness of breath.  At times he would have to hold onto something while walking due to the vertigo.  This lasted from Saturday until Wednesday.  He did contact his doctor but did not go in to be seen in person.  Patient stated that he has not had any cardiac problems in the past nor has he experienced this with any other vaccines.  He also had a bumpy itchy rash that formed on his left leg, it was quite itchy for a few days.
Not sure which tdap vaccine it was.  Respiratory- heaviness in chest, sneezing. Could be regular cold, but I?ve been wearing masks still so not sure that?s the case.
About and hour after the pt left the office the pt's mother stated that she started complaining of pain and burning at the injection site of the Menveo vaccine (Left arm/deltoid). She was given tylenol to help with the pain. The next day (12-20-20) the injection site was still very sore and it was starting to get red and swollen, the injection site was also hot to the touch. The pt's mother continued to give her tylenol for the pain and also starting giving her benadryl every four hours to try and help the swelling go down. The next day (12-21-20) the redness and swelling spread to a wider area around the injection site about 3 inches around the injection site. Today (12-22-20) the redness and swelling has traveled to the underside of her left arm and the pt is also having a tingling/numb sensation in the fingers in her left hand.
Immediate lightheadedness, tremor of hands and tingling of toes. Complained of "foggy" sensation. Symtoms resolved after 48 hours.  Also complaint of headache the following day.
Nausea/vomiting x 1 1/2 days. Temp 100-101 x 2 days. Diarrhea and sore throat. Seen in ER on 11/25-Culture of Throat and started on Biaxin.
p/vax pt was difficult to console, high pitched screaming alternating w/limp whimpering; no templ however pt was taking APAP; pt had what mom called tremors p/crying so hard site of inject red, puffy & hot;
Client was vaccinated with Pfizer vaccines for Covid on 7/21 and 8/11/2021.  She was pregnant at time of vaccination.  Admitted to hospital on 9/12 to deliver FT infant and was routinely tested for Covid.  PCR + for Covid on 9/12.  Asymptomatic.  Health infant born.  Infant tested and was negative.  Reported as a case of breakthrough Covid in a fully vaccinated person.
Vaccine exposed to a temperature excursion and products were determined to be not suitable to use with no reported adverse event; Vaccine was administered after it was not suitable to use post temperature excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2022SA390611(CLUSTER).  This case involves a 23 months old female patient who was administered vaccine after it was not suitable to use post temperature excursion with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A).  On an unknown date, the INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion and products were determined to be not suitable to use with no reported adverse event (product storage error).  On 19-Sep-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation and strength not reported; lot UT7695JA and expiry date: 30-Jun-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 19-Sep-2022, (latency: same day) the patient was administered vaccine after it was not suitable to use post temperature excursion with no reported adverse event (poor quality product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 the 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.; Sender's Comments:  01286160: 01286040: 01286171: 01286178: 01286213:
10 days after receiving the Janssen vaccination I was driving and experienced blurred vision. Pulled over, waited a while then continued driving when vision improved.  Arrived home and family member noticed facial drooping on right side as well as slurred speech.  Immediately called 911 and was transported to hospital within 30-45 minutes.
fevers for the last 4 months and the highest was 104; Initial information received on 25-Sep-2020 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 12-month-old male patient who experienced fevers for the last 4 months and the highest was 104 (hyperpyrexia), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  On 15-May-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious fevers for the last 4 months and the highest was 104 (hyperpyrexia) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant.  It was reported that the reporter thinks there may be something in the vaccine that has caused her son to have fevers for the last 4 months, the highest was 104. Currently the patient not having and elevated fevers. They visited to seven doctors for testing and all the results were normal.    On 15-Sep-2020, the patient received another 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  Relevant laboratory test results included: Body temperature - On an unknown date:  [104] Laboratory test - On an unknown date:  [Normal]  It was not reported if the patient received any corrective treatment.  On an unknown date, event outcome was not reported (unknown).  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a 12-month-old male patient who experienced hyperpyrexia following the vaccination with PENTACEL. The time to onset is unknown. However, the patient's medical history, concomitant medications, condition at time of vaccination and lab data ruling out other etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
3/1/21, 2:30 p.m. slight headache & fatigue began, terrible night of sleep, didn't sleep more than 1 to 1.5 hours at a time 3/2/21, 6:00 a.m. extreme pain in left shoulder, fatigue, chills, body aches & stomach upset all day, around 3:20 p.m. temp was 102F. At 10 p.m. severe chills & uncontrollable shivers began when I went to bed, Had too wear  sweat pants, sweat shirt, wool socks, hat & gloves to bed. Took 2 hours to warm up. terrible night sleeping. 3/3/21, similar to previous day except temp was around 100F
Symptoms began with soreness, redness, and swelling at injection site. Symptoms progressed to low grade fever, chills, and lethargic. All symptoms except arm soreness gone within 24 hours. Arm soreness persisted for almost 48 hours.
Expired doses of Moderna COVID-19 were administered beyond the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. For Lot number 033H21A, 2 doses were administered that was initially stored in the refrigerator on 30-Dec-2021. The vial did not undergo any temperature excursions. No treatment medications were provided.   This case was linked to MOD-2022-584673, MOD-2022-584680 (Patient Link).
102 fever, chills for 12 hours  Chest pain near heart for 1 month after fever subsided.
Patient is a 70 y.o. female with a history of Afib,HTN, L MCA stroke s/p NIR for TICI 2c reperfusion, Asthma and morbid obesity who was admitted 2/6/23 for AMS , Seizure and found to have hemorrhagic shock due to GIB and acute respiratory failure requiring intubation. She was just discharged home with HHC after she refused facility and represented RMH 2/13/2023 with  cough and increased SOB. She was found to have positive COVID-19. CTPA without PE, noted b/l GGO. Discharged to home w/ HHC 2/17/23.    1. COVID-19 Pneumonia: Vaccinated.  Test positive 2/13/23. CTPA as above. Of not pt was intubated from 2/6-2/9/23 and weaned to room air prior to discharge. Hypoxia noted and initiated decadron and remdesivir 2/15/23. Improved.  2. Acute Hypoxic Respiratory Failure: due to COVID-19. BNP 7000s. TTE 02/2023 with EF 50-55%. On room air and not overloaded on exam. Given IV Lasix x1. Did not qualify for home O2. Resolved.  3. Generalized weakness: due to recent critical admission and deconditioning. Reportedly pt refused SNF on prior admission and dc with HHC. Therapies followed
p/vax pt arm was red & swollen;advised to use APAP;pt T102 & lt arm was red gain & swollen;had non ASA & swelling had gone down a little;then pt devel blotchy pink & looked like pin dots in shot area;size of baseball & hot pink;mouth hurt;
This spontaneous report as received from a healthcare worker refers to several patients of unknown age and gender. The healthcare worker reported that several patients have been administered with a dose of oral ROTATEQ, RECOMBIVAX HB and VARIVAX (Merck) (lot # and expiry unknown) between 04-MAR-2014 and 06-MAR-2014 which were exposed to temperatures outside the prescribing information although supported. No adverse effects reported. The case is linked to 1403USA008919, 1403USA008920 and 1403USA005434 (same reporter link). Additional information has been requested.