chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Night of Feb 13. Felt tired around 10 pm, headed for bed. Lay down and room started spinning. Started feeling nauseous. (Note no alcohol consumed since New Year?s.) sat up, read a while, tried lying down again 3 times with same result. Got up to walk, threw up. After about 15 min was able to lie down and sleep. Process took about 2 hours in all. Mild nausea and dizziness continuing to now, Monday afternoon. Note lifelong history of motion sickness related to boats, planes, swaying motions, sometimes car travel.
Got my Covid vaccine on the 20th and then I came back positive for Covid last week; Got my Covid vaccine on the 20th and then I came back positive for Covid last week; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  It was reported that the patient got the COVID vaccine on the 20th (20Dec2020) and then came back positive for COVID on an unspecified in Jan2021 (reported as last week), then tested negative on 08Jan2021 and was due for vaccine on 09Jan2021. It was asked if the patient will be able to get the vaccine. The outcome of the events was recovered on 08Jan2021.  Information on the lot/batch number has been requested.
red spots appeared all over chest, back, abdo, face areas, sl discomfort (similar to mild sunburn) on back; sore throat & feeling borderline feverish; all appeared 2 wks following vax;
Left arm has become 3" by 6" red, patchy swollen spot with itchiness, burning, bee sting like feeling. Uncomfortable but bearable.
24hrs after vaccine pt developed cold sx which progressed to fever, chills, night sweats, decreased appetite, cough, ST. Dx 9/21 = influenza.
The day I received my second vaccine I started menstruating. I have an iud and had not had a period prior to this episode for 8 months. I had a abnormally heavy period lasting 6 full days of saturatin; I had a abnormally heavy period lasting 6 full days of saturating tampons; The day I received my second vaccine I started menstruating. I have an iud and had not had a period prior to this episode for 8 months.; This is a spontaneous report from a contactable nurse (patient).  A 35-year-old non-pregnant female received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via intramuscular route of administration, on right arm on 12Jan2021 11:00 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medication was not reported. The patient had allergy to penicillin. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was not specified) via intramuscular route on right arm on 21Dec2020 at 09:00 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. The patient did not COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not any other vaccine in 4 weeks. On 12Jan2021 14:00, the patient experienced, the day I received my second vaccine I started menstruating, I have an iud and had not had a period prior to this episode for 8 months and I had a abnormally heavy period lasting 6 full days of saturating tampons. I continue to have a monthly period to this day following the vaccine. The iud was still in place. Patient did not receive any treatment. Outcome of the events was recovered with sequel.
Chest pain; Shortness of breath; This is a spontaneous report from a contactable nurse. A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: ER8736), intramuscularly administered in the left deltoid on 12Jun2021 08:00 (at the age of 14-years-old) as dose 2, single for COVID-19 immunization. Medical history included dog bite. Concomitant medication included an unspecified antibiotic for dog bite. The patient previously received the first dose of BNT162B2 (lot number was not reported) on an unspecified date; and experienced increased inflammatory markers, pneumonia, and inflammation to the heart. On 13Jun2021, the patient experienced chest pain and shortness of breath. The events required physician office visit and were considered serious (important medical event). Treatment included antibiotics. Pneumonia was ruled out. Chest CT was performed with unknown results. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of chest pain and shortness of breath due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
45m red, swollen tender area on left deltoid 2 days following administration of immunization. Home treatment with ice packs, OTC TYLENOL, or ibuprofen and BENADRYL advised.
Part of the High Dose flu vaccine dose came out at the base of the needle and ran down arm. Unable to determine how much of the vaccine was received. Gave 2nd HD flu vaccine. All of vaccine administered. These were two different lot numbers Sanofi Pasteur UJ895AB and UJ900AA
This spontaneous report as received from a registered pharmacist via a field employee refers to a male patient of unknown age. On an unknown date, reported as "years ago", the patient was vaccinated with ZOSTAVAX VIAL DRY SD 19.4 MUNIT (dose, duration and lot number were not reported). No concomitant medications were reported. On an unknown date, reported as "recently", the patient developed shingles. As of 18-NOV-2013, the patient had a rash on his stomach and was experiencing postherpetic neuralgia. The patient sought medical attention, went to pharmacist. The outcome of rash on his stomach, postherpetic neuralgia and shingles was unknown. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild
hot flash; top lip puffed up / lip swelling was very slight; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EN5318, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 06Feb2021 (at the age of 79-years-old) as dose 1, single for COVID prevention. The patient has no relevant medical history and concomitant medications. On 06Feb2021, the patient experienced hot flash and top lip puffed up / lip swelling was very slight. The patient stated that the hot flash like a wave that went right through her, started from the shoulders, and spread throughout her body and her top lip puffed up, lip swelling was very slight, it took about an hour to go back down. The patient was wondering if that events were a reaction to the vaccine and if there was a recommendation for her second dose after having these reactions to the first dose. The outcome of the event hot flash was unknown while the outcome of the event top lip puffed up / lip swelling was very slight was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information expected.
Awoke with bad headache, chills, stayed home from work. Took laxative. 8:30 pm felt chest pressure "like someone sitting on my chest". Went to sleep. Woke up 9/16 with chest pain and SOB. To hospital via car at 6AM. Seen in ER, R/O MI and did stress test, admitted overnight. Released 9/17 to home with no restrictions.
Left arm, she is noticing that her left arm is sore too.; she has an elevated White blood Cell Count; Blurry vision right eye; tiredness; This is a spontaneous report from a contactable consumer(patient). A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 14:45 (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia, accident, blindness. There were no concomitant medications. The patient reported, blurry vision upon waking up, and tiredness on 29Jan2021. She clarified that she actually only has vision in one eye. The blurry vision is in right eye. With the Left eye, she had an accident as a child and lost her vision in the left eye. She is noticing that her left arm is sore too and had an elevated white blood cell count on an unspecified date. Outcome of the event for blurry vision right eye was recovering and for the other events it was unknown.   Follow-up attempts are completed. No further information is expected.
Pt. states approximately 1 hr after Flu vaccine, onset acute diarrhea, vomiting, nausea which lasted 2 days. Later that day, 9/25/18 onset increased SOB/ tightness take breath (hx asthma/seasonal allergies and pt. had stopped allergy Rx after rheumatologist visit as PFT and Chest Xray WNL on 9/24/18) and restarted using inhalers. Then 9/26/18 onset hives over body, up face and itching, swelling eyelids and external eyes. Pt thought from Clindamycin at 1st as just started use on face 9/24/18. PMD gave ATARAX for allergies 10/2/18 then PMD gave PO Prednisone taper on 10/3/18. Dr gave KENALOG shot on 10/8/18 and PA (dermatologist) told pt didn't think it was contact dermatitis on 10/8/18 and said maybe due to flu shot. Pt told EH of rxn 10/9/18 and at that time said had rxn to Flu shot 10 yrs ago, but had not said before received Flu shot at EH. Seen in EH 10/10/18.
Conjunctivitis in right eye; Conjunctivitis in right eye. Prolonger swelling; Conjunctivitis in right eye. Prolonger swelling, redness; Conjunctivitis in right eye. Prolonger swelling, redness, itching; Tearing; Sensitivity; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 11:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any concomitant medications within two weeks of vaccination. On 06Apr2021 at 20:00, the patient experienced conjunctivitis in right eye, prolonger swelling, redness, itching, tearing and sensitivity. The patient reported that currently 7plus days, slowly improving and has not seen a doctor. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events conjunctivitis in right eye, prolonger swelling, redness, itching, tearing and sensitivity was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
death  - COVID-19  - Pneumonia due to coronavirus disease 2019  - Acute kidney failure, unspecified
Information has been received from a health professional concerning a greater than 12 week old patient who was vaccinated with an initial dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The child displayed no symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.This is in follow-up to reports previously submitted on 10/10/2006. Information has been received from a health professional concerning a greater than 12 week old patient, with no medical history and no allergies, who was vaccinated with an initial dose of ROTATEQ. There was no illness at the time of vaccination and no adverse events following prior vaccination. The child displayed no symptoms. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from an office manager in a physician's office indicated that the patient's parent refused any more doses of ROTATEQ. No adverse signs or symptoms had presented. Additional information is not expected.
Information was received from a pharmacist regarding an 81 year old male patient with hypertension and allergies to NSAID's and iodines. On 17-OCT-2013, the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscularly in the left arm. Concomitant therapies included DIOVAN. The wife of the patient presented to the pharmacy on 29-OCT-2013 to report that the patient now has pneumonia. The patient was treated with Z-PAK. The outcome of pneumonia was reported as not recovered. Additional information has been requested.
Patient received Pfizer COVID vaccine on 3/14/21 and 4/1/21. On 8/23, she was admitted to our facility with COVID-19 pneumonia (acute on chronic respiratory failure with hypoxia) and viral sepsis. She was given weight dosed remdesivir and completed a 5-day course.  She was able to wean down to her home oxygen.  Due to intermittent desaturations with coughing fits, and ongoing COPD exacerbation, she was treated with 5 day course of dexamethasone starting 8/28.  Her wheezing improved on steroids and she was stable on her home oxygen.  As of 8/29 she was at her baseline and was discharged to home.
Body aches, fatigue, cold/clammy, chills, stomach cramps, runny nose, shakiness and vomiting. Rest, fluids Tylenol or Motrin as needed.  After 2 days patient was feeling better.
Approximately 5-15 minutes after vaccine patient reported to health department staff that patient felt "funny." Upon assessment patient appeared flushed and pale. Patient reports tightness in throat.
c/o arm tingling after injection, 78-16-114/76 98% RA 1c/o R ear fullness, denies dizziness-A&Ox3, 77-18-120/7 ; full ROM noted-provided ginger ale 1016 78-18-112/61-97% RA R arm continues with "hot wire on 1/2 of Right forearm, continues feeling dizzy but not worse, using Zailo patch for pain control x 2 weeks; at 10:22, 74-18-110/59-98% A&Ox3, Right ear fullness/dizziness improving ;  at 10:32 71-18-119/63-99% reports decreased ear fullness dizziness, more normal feeling on RFA, full ROM; @ 10:41, 71-18-102/56-98% denies dizziness or arm burning, ear fullness gone, no n/v
Reporting that patient received Pfizer Covid 19 vaccine 0.3ml IM & this was NOT diluted.
Information has been received from a RN concerning a 7 year old male pt who on 08/29/1997 was vaccinated with a dose of varicella virus vaccine, live. On 05/24/04, the pt presented with "50 +" vesicular lesions over his entire body. No other sx were noted. Unspecified medical attention was sought but tx was not required. A product quality complaint was not involved. Additional information has been requested.
Left Arm above the elbow was red and hard on the first day.  The second day the hardness went away and the redness moved to the underside of the arm.  The patient was counseled to keep an eye on it.  If she experienced any additional symptoms or if the redness did not go away to contact her physician on Monday.
Two weeks after second injection, I developed extensive hives on various parts of my body. I can control the hives with OTC antihistamines, but if I stop taking the antihistamines, the hives return, even though I'm beyond 6 months from vaccination.
This spontaneous report was received from an unspecified reporter. Between 06-FEB-2017 and 07-FEB-2017, 15 doses of VAQTA (lot number M036459 with expiration date of 18-JAN 2018, and lot number M033611 with expiration date of 02-MAR-2018), were improperly stored with a minimum temperature of -0.2 degrees Celsius during 5 hours and 59 minutes with an alarm trigger time at 12:15 hours and alarm ambient temperature of 22.1 degrees Celsius on 06-FEB-2017, and a minimum temperature of 0.1 degrees Celsius during 5 hours and 39 minutes with an alarm trigger time at 00:37 hours and alarm ambient temperature of 21.1 degrees Celsius on 07-FEB-2017. The upper alarm limit status was "ok". As of 08-FEB-2017, the doses experienced a minimum temperature of 1.9 degrees Celsius during 19 minutes with a status reported as in progress". The most recent temperature excursion for VAQTA was between 0 degrees Celsius and 2 degrees Celsius for 7.5 hours. In addition, it was reported that the upper alarm limit was above 8.0 degrees Celsius for 1 hour, and the lower alarm limit was below 2.0 degrees Celsius for 15 minutes. Additional information has been requested. Sender's Comments: US-009507513-1703USA006474: US-009507513-1703USA006475: US-009507513-1702USA007965.
Swollen and red right arm. Tired. Decreased activity. "Too tired to walk". Referred to PCP.
Heart fluttering, pounding feeling, irregular heartbeat on 5/5. Occasional shortness of breath when working out through 6/10, more than expected from normal exercise. On 6/10 evening and 6/11 felt "heartburn." Treated with Alka-Seltzer. 6/12 pain had still not subsided. Went to ER.
Feeling of fever then feeling of swollen face when she woke up in the morning of May 26 2016.
HEART RATE INCREASED; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, hypothyroid, gout, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A,expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Heart rate (NR: not provided) Fluctuates around mid 90s in the afternoon and nights. On 10-APR-2021, the subject experienced heart rate increased. Laboratory data included: Heart rate increased (NR: not provided) 115 beats per minute. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart rate increased. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
DIZZINESS; TEMPORAL HEADACHE; This spontaneous report received from a health care professional concerned an elderly of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: Raynaud's syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, and temporal headache. Laboratory data (dates unspecified) included: MRI (NR: not provided) No blood clot was found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temporal headache and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210856312.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Pt received Prevnar #2 on 11/27/00 and on 11/29/00 was admitted with intussusception requiring surgical reduction.
vaccines being administered post excursion, with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom vaccine was  being administered post excursion, with no reported adverse event , and it involved vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   The reporter stated that the condition was 31.5F for 1 hour and 58 a refrigerator malfunction (not human error). The product was not supported by the extended stability data.   On 13-Jul-2022, the patient received a  dose of 0.5 ml of  suspect HIB (PRP/T) VACCINE, with an unknown formulation and strength, ( lot: UJ604AAA; expiry date: 29-Oct-2022)  via intramuscular route in the right thigh for immunization.  It was reported that on 13-Jul-2022, the  vaccine was  being administered post excursion, with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  Action taken : not applicable.  Outcome: unknown  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.
Day 1 swelling from shoulder to injection site - hot to touch. Day 2 swelling continued to elbow. Day 3 tingling feeling across back of fingers (numb). 6/11 mentioned tingling from nose to temple. MD diagnosed as mild case of shingles.
This spontaneous report was received from a physician referring to-11-15 year old male patient, who was enrolled in a Market research. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (route of administration, lot #, expiration date, dose, dosage number and anatomical location were unknown). Concomitant or co-suspect therapies were not provided. On unspecified date (reported as sometime between 2008-2016) the patient fainted when he received GARDASIL. At the time of reporting,, the action taken with GARDASIL was reported as "did not prevent administration of 2, 3 doses". The outcome of the adverse event was reported as recovering. The reporter considered the adverse event to be related to GARDASIL. Additional information is not expected as the reporter did not consent for provide further information.
1 day after immunization to r/deltoid, pt developed sore r/arm, shoulder to elbow then continued pain in hips and back and both arms.