chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presented for her second Pfizer vaccine January 11, 2021. She waited 15 minutes and started to pull away when she noticed that she was beginning to get warm. She looked in her car mirror and noticed a rash on her neck and chest. She then notified staff of reaction. Vital signs checked. BP was 122/68. HR was 97. Sp02 was 99% on RA. She denied any SOB. She was given diphenhydramine po that she swallowed without any difficulties. She reported that she began to feel better. Rash started to look better. Patient waited another 15 minutes. Patient was alert and oriented x4 and was talking without difficulty.
pt recv vax & was disoriented getting out of bedroom having petit mal sz every day kept getting worse everyday;made MD appt had 3 grand mal sz day a/appointment;EMS-hosp AM on Dilantin & Phenobarb;memory loss since;
One week after receiving second anthrax vaccine dose patient noted decreased vision in her left eye. On initial examination visual activity measured 20/25 in right eye and 20/70 in the left. Intraocular pressures were 12 mmHg bilaterally. Slit lamp examination results were normal. Fundoscopic examination of the right eye eye had normal results. The left fundus showed subretinal fluid within the central macula. Fluorescein angiography revealed a focus hyperfloresence in early transit followed by late leakage and pooling consistent with CSC. The results were review with the patient and vaccinations were halted, and she has been examined monthly. Her visual acuity remained at 20/100 in her left eye for 3 months and slowly improved. Seven months after presentation the vision in her left eye measured 20/30 so a mild visual deficit still remains. This report is may be a duplicated of VAERS case 197330.
First symptoms were site injection discomfort followed by body aches, chills, and low grade fever that reached a peak ~18 hrs after injection. Symptoms subsided greatly 36 hrs post injection.
This spontaneous report as received from a physician refers to an unknown number of patients. As unknown number of patients may have received improperly stored GARDASIL (strength, dose and lot # were not provided) RECOMBIVAX HB (strength, dose and lot # were not provided) and VAQTA (strength, dose and lot # were not provided) since 20-JUL-2013 to present (05-SEP-2013), (exact date of administration unspecified). No adverse event reported. Additional information has been requested.
I had a fever of 100.9 and 100.8 on two separate occasions, headache, body aches, chills, sore throat. Lasted 24 hours. I took Tylenol. After 24 hours, I felt better. However, I do still have lingering joint pain on/off and sometimes headaches.
Woke up from nap screaming and mom noticed hives to left cheek and back of left thigh, brought into office at 2:15pm and hives fading without any treatment given. DTaP recorded as given to Left thigh and Varicella reported as given to Left bicep.
I had vertigo at 5 am. I feel dizzy only when turn on right side only when I got up from bed ( positional vertigo)
This spontaneous report was received from a physician refers to approximately 4 month old male patient. No concurrent or medical history was reported. On 15-APR-2015 the patient was vaccinated with ROTATEQ, (2 ml, oral). Concomitant therapies included PENTACEL and PREVNAR. On 15-APR-2015, the patient vomited immediately after the vaccine was administered. The child was crying at the time of administration. The outcome of vomiting was unknown. The reporter did not provide the causality between the event and the suspect drug. No product quality issue was involved. This is one of the 2 reports from the same reporter. Additional information has been requested.
03 Apr 2021.  - 0230: Woke up with facial pain  - 1000: Noticed facial pain and intense swelling at the cheeks.  - Rest of day: N/V/D, muscle aches, chills, headache, and fatigue 04 Apr 2021.  - Same symptoms as day before. 05 Apr 2021.  - Fatigue persisted, facial swelling present but improved with Diphenhydramine use.
Had titers drawn for Hep B and did not have immunity, completed the series as a child   Approx 15-20 min after vaccine given patient began to have R tongue swelling, no difficulty breathing, Benadryl and Allegra given over a 12 hour period with symptoms resolved the following day
This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 12-AUG-2014, the patient was vaccinated with PNEUMOVAX23 (lot #J014399, expiry date: 20-NOV-2014 (strength, dose, route of administration were not reported). Concomitant therapies included FLUVIRIN administered on the same day. On an unknown date in 2014 the patient was diagnosed with cellulitis near the injection site of the PNEUMOVAX23. It was unspecified if any treatment was given for th event. There was no product quality complaint involved. The outcome of cellulitis near the injection site of the PNEUMOVAX23 was unknown. The causality of the event was not provided.  This is one of several reports received from the same reporter. Additional information has been requested.
Patient experiencing sore arm with warmth, unable to lift beyond shoulder-height, pain has been easing off over the past almost 3 weeks.
temp @ 104 7PM screaming all noc;APAP q 4hr;this AM T99.8 doing better;
Fever of 104.4 lasting for 72 hours. Behavior changes, throwing long lasting fits, saying out ouch when touched or needing to get dressed
pt recvd vax & cried @ time of inject & cont throughout 2DEC92, throughout the 24 period of 3DEC92 & most of the early AM hrs of 4DEC92; APAP given for comfort;
Patient turned pale--complained of dizziness and passed out. I eased him to the floor, elevated his feet and legs, placed pillow under head and broke ammonia strip under his nose...he woke up. Observed him on the floor 10  minutes then eased him to sitting position...then up to chair. Walked him to the lobby...he walked out the door on his own with his sister and mother.
Rash - Information has been received from a physician concerning her 13 month old daughter with no known drug allergies and no past medical history who on 15 Feb 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Concomitant therapy included varicella  virus vaccine live MSD.  On 27 Feb 2001 the patient experienced a red rash on her abdomen and back and for the next few days she had macules head to toe.  It was reported that the rash on her face is starting to fade.  Unspecified medical attention was sought.  Additonal information has been requested.
Six weeks later, I experienced a terrifying and extremely painful condition called Reversible Cranial vasoconstriction syndrome after being hospitalized twice. It happened on three different occurrences within five days. Last episode I was hospitalized for three days. Can sometimes be caused by SSRis but have been on ssri for ten years, did not get off and it still stopped - possibly with help of Verapamil. Neurologist said it couldn?t have been caused by the Ssri and I had no other risk factors. I was very sick for 48 hours after booster shot. Then, this happen 5-6 weeks later and had never had anything like it.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022; Expired vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine expired in Jun-2022, however it was expired in 01-Apr-2022. No temperature excursions.  No treatment information was reported.
Chills with Rigors, fever tmax of 101.7, headache, muscle aches, night sweats.
Patient ordered to receive Bivalent vaccine during hospitalization. When preparing batch of bivalent vaccines, pharmacy erroneously used a monovalent vial and but labeled as bivalent. As a result, patient received the monovalent vaccine when they were intended to receive bivalent.
On 09/22/2022, I noticed while I was at work, that I was having difficulty holding a conversation without being out of breath. I didn't really think anything of it at that point. When I got home, I had more difficulty getting up the stairs than I normally do. I was just really out of breath, more so than normal. Friday, 09/23/2022, I was coming up the stairs and when I got into my home, I walked over to the couch and collapsed, and it took me 30 minutes to recover. The next morning, I went to the local emergency room and after just walking from my car, I collapsed when I made it to the emergency room. They discovered lots of blood clots in both lungs, so they admitted me to the hospital and administered blood thinners. On 09/24/2022, while in the hospital, I began experiencing chest pain. I was released from the hospital on 09/26/2022. The pain in my chest continued and I was still experiencing shortness of breath and could not take too many steps. The pain didn't start to noticeably decline until 10/05/2022. I still experience chest pain when I move wrong or cough too hard.
Fever has been on and off and today its 102.3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 31Dec2021, outcome "not recovered", described as "Fever has been on and off and today its 102.3". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported events experienced after 2nd dose of Pfizer covid vaccine received.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Nausea for over 2 weeks; This is a spontaneous report from a contactable physician, reporting for himself. This adult male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK5730), via an unspecified route of administration, on 05Jan2021 as a single dose for COVID-19 vaccination. The medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. In Jan2021, she experienced nausea for over 2 weeks. The patient did not receive treatment for the event. The clinical outcome of the event nausea for over 2 weeks was not recovered without treatment. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
At approximately 1830 on 11/11/21 patient was confused, disoriented to event, and names of family member and pet.  Patient experienced nausea and chills.  Symptoms were reported to healthcare staff on 11/12/21 at approximately 1300 at which time it was reported that patient's symptoms were improving.  Advised patient to be seen by provider at Urgent Care or ER to be evaluated.
pt recv vax JUL95, AUG95 & JAN96 respectively;8MAR96 pt had an ultrasound which showed poss fetal underdevelopment;no tx was given;pt reported exp a miscarriage @ 12th wk of pregnancy;
Got MMR on Friday. Developed rash on Sat., E multiforme type on arms, legs and trunk mostly not toxic. No other illness, meds, foods identified as possible cause
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 03-AUG-2017 the patient was vaccinated with RECOMBIVAX HB lot # M040422 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for contact the reporter. Sender's Comments: US-009507513-1708USA006417.
noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose; a leftover marble-sized knot on the injection site; noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose; 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 VACCINATION SITE WARMTH (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (a leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (a leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose). At the time of the report, VACCINATION SITE WARMTH (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (a leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose) outcome was unknown. Not Provided          No Relevant concomitant medications was reported. Treatment information was not provided.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-098889 (Patient Link).
1/3/08 - Fever within one day of vaccine to 102 degrees.  Mom gave Tylenol, temp decreased to 100.8.  Started runny nose, clear.  Fussy morning after shots.  1/4/08 - Afebrile, not fussy, with decreased appetite.
improperly stored vaccine administered; This spontaneous report has been received from a medical assistant referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 31-DEC-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route, frequency and anatomical location were not provided) lot # T013204 with expiration date of 03-DEC-2021  for prophylaxis.  The vaccine was exposed to a temperature below 36 F for 5 hours and 40 minutes. There were no previous temperature excursions and the vaccines were back in range. Data logger was used (product storage error).    combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
The patient developed pain and swelling down to her elbow after receiving the pneumovax 23 vaccine on Friday, 9/18/20.  The entire area was hot to the touch as well.  She also  experienced  headache, severe sinus pain, discomfort in her throat, fatigue and chills.  The swelling was less on Saturday, 9/19/20 and she did some arm exercises that she stated helped with the pain and swelling.  She was still fatigued on Saturday.  On Sunday, 9/20/20, she started feeling like herself again and the pain and swelling was much better.  Other symptoms have subsided as well.
Angioedema; Dyspnea; Lightheadedness; Nausea; This is a literature report.  Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant) with onset 2021, outcome "unknown", described as "Angioedema"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Dyspnea"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Lightheadedness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea". The events "angioedema", "dyspnea", "lightheadedness" and "nausea" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: (2021) 17.85, notes: Log2 dilution; skin test: (2021) none positive skin test component. Therapeutic measures were taken as a result of angioedema, dyspnoea, dizziness, nausea. Additional information: Treatment after first dose included Epinephrine. Vaccine was administered between Jan2021 and May2021. Reaction to second dose via graded administration (Step Number) included dyspnea, pruritus. Treatment with graded administration (Step Number) included Albuterol, cetirizine.; Sender's Comments: Based on the information currently available, a role of bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200151789 Same article/drug, different patient
swelling, warmth to lt arm 5.5cm diameter 2 days p/shot;
Pt was normal child until vacination at 15 mos. Post/vax, he started to regress & by age 2, was dx'd w/possible developmental delay. Acute & subacute encephalopathy, following the vaccine. He is recovering everyday.
Child seen in health center on 03/04/09 with a rash that started on 03/03/09.  Rash scattered throughtout body:  slightly raised or macular, erythematous blotchy eruptions.  No fever.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 9:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 9:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.20.  Concomitant products were not provided.  Batch number 014M20A on 27 Feb 2021 underwent temperature excursion was at 09 AM, temperature was 33, Excursion time was 11 AM, 12 PM, 1 PM, 2 PM and 5 PM temperature was 35, Excursion time was 3 PM and 4 PM temperature was 34, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24 Feb 2021, vial was moved to clinic on 27 Feb 2021. 20 vials were sent to clinic. Vaccine BUD date was 26 Mar 2021.  On 27 Feb 2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 PM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD22-013597 (Patient Link).
While attending college in 1997, the pt received an IM INFLUENZA vaccination. He is not sure if this was his first INFLUENZA vaccination. Within 48-96 hours the pt experienced the following sequence of symptoms: rhinorrhea ("massive runny nose"), fatigue (severe), fever, chills and myalgias. The pt states that he was acutely ill for about 2-2.5 weeks and did not feel "normal" for about 4 weeks. The pt did not seek medical care nor did he miss any time from school. He has not had another INFLUENZA vaccination since 1997 based on his experience.