chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild fatigue; Moderate headache from 5hrs after dose through bedtime (12.5hrs after dose).  And very mild on/off headaches the following day.  I also took a 30min nap on day two which is unusual for me.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 10:30 (Lot number: EPG955) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, administration time:10:30 AM,, vaccine location Left arm, lot number: EL3247), administration date: 09Mar2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021 16:00, outcome "recovering", described as "Moderate headache from 5hrs after dose through bedtime (12.5hrs after dose). And very mild on/off headaches the following day. I also took a 30min nap on day two which is unusual for me."; FATIGUE (non-serious) with onset 02Apr2021 16:00, outcome "recovering", described as "mild fatigue". Therapeutic measures were not taken as a result of headache, fatigue.  Additional Information: The patient started to get a headache on 01April2021, around 4:00PM (awareness date). He believe the report says 3:30 PM, but he would revise it to 4:00 PM because he remember that he was on a work call when he experienced the headache. He reported the event on 02Apr202 around 3:30-4:00 PM so that he reported his event within 24hours per policy. He waited the 24 hours to see if any additional symptoms happened. Per his report, he only experienced headache and mild fatigue.   No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 13Feb2021 as dose 1, single (Lot number: EL9261), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: Abbott antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient received no other medication in 2 weeks. Anti viral details product=COVID 19 Treatment, brand=Pfizer, treatment start date=11Jul2022, treatment stop date=15Jul2022. Adverse event relapse after paxlovid 5 day treatment. Symptoms resumed and tested positive on Abbott antigen test 7 days later. Adverse event start date 23Jul2022, not recovered, no treatment. No known allergies.  No follow-up attempts are possible. No further information is expected.
Swelling on right thigh, felt warm to touch, pt not walking, complaining of pain. At 6:00 pm swelling got worse extending to knee. Pt slept overnight with no issues, on 05/23/2013 pt did not walk at all and complained of pain. On 05/22/2013 mother brought pt to see provider Benadryl recommended.
LEFT ARM, OUTER ASPECT, "OLIVE" SIZE HARD LUMP, PAINFUL, WARM TO TOUCH.  UNSURE OF REDNESS DUE TO MULTICOLORED TATTOO COVERING ENTIRE OUTER PORTION OF ARM.  PAIN TO ELBOW.  GOOD RANGE OF MOTION.  SOME "TIGHTNESS" WITH FLEXION OF LEFT ARM.
A flutter begins between the back of the both eye when the first one was injected; Was feeling sensation on both breast, of pain like tenderness, you know sensitivity; Was feeling sensation on both breast, of pain like tenderness, you know sensitivity; got tested for COVID-19, which was positive; she "felt bad"; This is a spontaneous report from contactable consumers (one of them was the patient). This consumer reported similar events for 2 patients. This is one of 2 reports.  A 36-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 08Apr2021 (also reported as 28Mar2021, PENDING CLARIFICATION, Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included COPD and diabetes. The patient's concomitant medications were not reported. The patient, her husband and their 16-year-old daughter received the first dose of Pfizer's COVID-19 vaccine on 08Apr2021. Unfortunately, last Monday (Apr2021) she "felt bad", on Tuesday she left work and got tested for COVID-19, which was positive in Apr2021. Her husband was also positive and is scared. The 16-year-old daughter did not test positive to COVID, but the pediatrician told them she'll probably test positive later, because she lives with them. In addition, they have a 1-and-a-half year-old baby that was also positive. Their 12-year-old son was negative to COVID. It was also reported that the patient had first COVID Pfizer Vaccine on Mar 28 (PENDING CLARIFICATION) and tomorrow will be 21 days and second shot is due but since then she had been having some concerns. The patient reported, "Well I have some immediate reactions with my first one. I had basically like a flutter like a flutter begins between the back of the both eye when the first one was injected then I was feeling sensation on both breast, of pain like tenderness, you know sensitivity" on an unspecified date. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Apr2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
On 12/15/2022, my nose started running a lot and I had a slight sore throat. It was mostly a runny nose though. Because of my asthma, I use a spirometer every day and I was having trouble getting a reading from that. I don't have terrible asthma, but I take two medications a day and this was the first time that I had to use my rescue inhaler. It effected my oxygen. I took an at home COVID-19 test and the results were positive, but very light. I isolated and called my doctor, who prescribed Paxlovid. I can't remember the exact days of it, but I started feeling better and then had a rebound. I was still testing positive on 12/31/2022, but it was getting lighter. I think it was around January 3rd-5th that I finally tested negative.
hit me so bad; Pain; I tore a ligament; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it in shoulder).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: hit me so bad), pain (Verbatim: Pain) and ligament rupture (Verbatim: I tore a ligament). The outcome of the shingles, pain and ligament rupture were not reported.   It was unknown if the reporter considered the shingles, pain and ligament rupture to be related to Shingles vaccine.     It was unknown if the company considered the shingles, pain and ligament rupture to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she got the Shingles shot and 3 weeks later shingles hit him/her so bad tried to ease the pain and the patient tore a ligament. The patient reported that was the only shot he/she took and would not chance it again. The patient reported that was 4 years ago. The follow-up could not be possible as no contact details were available.
pt recvvax & devel full blown varicella;chickenpox all over face, trunk & extremities;
Vaccine given about 4:42 PM; without about 5-10 minutes at around 4:50 PM   patient began experiencing subjective sensation of "facial swelling" and tingling sensation around the cheeks, forehead, and lips, no wheezing, no shortness of breath, no dizziness, no difficulty swallowing or throat swelling, no actual facial swelling noted, no nausea, no vomiting, no visual changes, some sensation of numbness about the lips.  No chest pain.   Symptoms persisted for about 25 minutes or so then began to abate by about 5:15 PM, nearly resolved by about 5:30 PM.  Vital signs remained stable during this period, with O2 sat 99%.   Patient was referred subsequently to ER for further observation and evaluation at about 5:35 PM in improved and stable condition.  Unknown at this time about further disposition.
This spontaneous report as received from a physician via a company representative refers to a 60 year old female patient with allergic to monosodium glutamate (MSG). On 27-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The physician reported to the representative that "the patient experienced numbness of the tongue and high blood pressure, after receiving ZOSTAVAX" on 27-AUG-2014. Patient sought medical attention by office visit on an unspecified date. The outcome of numbness of the tongue and high blood pressure was reported as recovered/resolved. Additional information has been requested.
Pt recvd 2 doses of Hep B vax on 29MAY91 & 1JUL91 & on 12JUL91 pt refused as a blood donar because was told that had Hep C; @ time of report pt was asymptomatic;
Information has been received from a consumer concerning her 16-year-old daughter with no medical history nor drug reactions/allergies who was vaccinated with the last dose of GARDASIL in April 2009, the reporter was not sure when the first dose was given but stated that the doses of GARDASIL were given "on time". There were no concomitant medications. After receiving the third dose of GARDASIL the patient's hair has been "falling out in clumps". The patient had not sought medical attention. At the time of the report, the patient's status was not recovered. Additional information has been requested.
No adverse event. Patient asked for meningitis vaccine and was given MMR by mistake. Patient is ok
Vertigo/Dizziness  starting the same day of vaccination. More noticeable over time and persisting almost 4 days post vaccination. Settles when at rest. Becomes increasingly noticeable and to the point of debilitating when moving/bending/driving.
Sore arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Pain, at an unspecified dose and frequency. On 12-Jan-2021, VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.; 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.
I feel to bad; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (I feel to bad) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEELING ABNORMAL (I feel to bad). At the time of the report, FEELING ABNORMAL (I feel to bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
Hedaches; Fever; General soreness and aching across entire body; A little soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Mar2021 at approximately 8:30 (at the age of 32-year-old) (Lot Number: EK5730) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications included lisinopril for unknown indication, start and stop date not provided. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 04Mar2021 (at the age of 32-year-old) (Lot Number: EJ1685) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced besides a little soreness at injection site on Thursday 25Mar2021 and had hedaches, fever of 100.1-100.5, general soreness and aching across entire body (not just at site of injection) symptoms subsided after 36 hours on 26Mar2021 (reported as between 24 -36 hours after taking vaccination and between 8 to 9:30). The patient received treatment with ibuprofen (ADVIL) for fever. The outcome of event pain was recovered and the outcome of other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a nurse referring to a 5 months old patient of unknown gender. On 28-OCT-2015 the patient was vaccinated with a first dose of oral, ROTATEQ (lot # L002042, expiration 28-JUL-2016, dose was not reported) orally (Inappropriate schedule of vaccine administered). The patient received the first dose of oral, ROTATEQ at an age that was older than what is specified in the oral, ROTATEQ Pl. No product quality complaint was involved. Additional information has been requested.
died after the second one when they had covid; died after the second one when they had covid; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died after the second one when they had Covid because there were too many antibodies on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died after the second one when they had covid; died after the second one when they had covid
pt recv vax 4/6/99 & for the next 3 days had fever to 101 & redness, swelling (size of a grapefruit) @ inj site;
No additional adverse effect reported; Adult dose 50U Ped dose 25U, administered 1ml syringe of adult dose; This spontaneous report was received from a primary health care provider (PHCP) referring to a 14 years old female patient. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.    On 09-JUL-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (50 U, 1 ml syringe; lot# and expiration date were not provided) intramuscularly for prophylaxis. The pediatric dose was 25U. The patient was administered 1ml syringe of adult dose (incorrect dose administered). The patient tolerated well. No additional adverse effect was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Erythema, redness, swelling, pain around site area approximately 3in x 2in.  The site was itching as well.  The area was tender starting around 6:15 - 6:30 the night of the injection.  Patient was advised to use ice and ibuprofen early the next morning.  Around 1:00 on Aug. 18, 2011, the patient and her mother came to clinic to confer with doctor before going out of town.  She was advised to continue with ice and ibuprofen as wel as given samples of Zyrtec and Rx for Prednisone.
Seen for her one year physical 4 days; mom notes that she developed a rash about 24 hours after vaccination; noted initially on the chin and the neck, few on the forehead at the hairline; she started to feel warm but no documented fever as per mom; that evening and the next day the rash started to move towards her chest, trunk and her legs; she is acting normally and she doesn't appear to be itching/in pain; she was uncomfortable the night of her vaccinations but this resolved; there is no lesion at the injection sites; she had mildly decreased po intake the day of the vaccines but this also resolved; no other rash in the family; no runny nose or cough; normal urine output and no vomiting or diarrhea; no creams or lotions; using aveeno; she has no new foods introduced; no wheezing;
Patient received Pfizer vaccination on 8/25/21 & 9/20/21 patient had a 4-day history of progressively worsening cough with dyspnea on exertion, shortness of breath, low-grade fevers, nausea and decreased appetite.  He was + 10/4/21. Currently admitted in hospital as of 10/7/21
Tachycardia, palpitations, lightheadedness/near syncope, and numbness/tingling to tongue and lips 10 minutes after receiving vaccine. All symptoms resolved in about 15 minutes with the exception of  numbness/tingling to tongue and lips which lasted 3 hours. Symptoms resolved on their own without treatment/medication other than lying flat with feet up and drinking a bottle of water. I was assessed by medical professionals at the vaccine clinic which was located inside of the hospital. I consulted with an ED physician but did not require any additional treatment.
Pt received the Trumemba vaccine instead of the Vaxelis vaccine. That same night the patient started running a fever.  Pt ran a fever until 06/04/2022.  He was very fussy miserable.  Baby would perk up and condition improved with mom alternating Tylenol and ibuprofen. No other symptoms were reported during this time only fevers and fussiness.  We will continue to keep in contact with mom to monitor any other possible reactions.
2 hrs p/vax DTP/OPV had h/a & vomiting twice; No rxn @ inject site; 3hrs later was sleepy; h/a had subsided had chills; was ill for next 2 days;
Day 1 and 2, shoulder was sore and left ankle was so stiff I couldn't bend it. I had broken it 13 years before but by now it was completely healed and functional. I did my rehab exercises again and those brought back flexibility. ??But then, what became so concerning that I visited the doctor about it on 4/7/21, was that, on Day 2 or 3 after the vaccine, I became so sleepy that I almost felt as though I had sleeping sickness. Would sleep for a few hours. then be up for 3-4 hours, then suddenly become so sleepy again that I could hardly even sit upright. Had to go back to sleep immediately. After a few hours, I would be up for 3-4 hours again, then have to go back to sleep. This lasted for a month.
About 12 hrs after receiving had chills, fever (unmeasured), emesis, lethargy, but did not feel sick, next day was without symptoms.
On 8/22/21, when giving the patient her second Moderna shot, she said for me to give it in the right arm due to last time in the left arm she had knot where given the injection  and heat at the spot for 2 weeks. On 8/22/21, I gave the second shot in the right arm.
Pt developed fever within 1 hour of receiving vaccine which rose to 104 deg. F. Trated with Motrin, alternating with Tylenol. Fever continued to stay at 104 deg F. and above. Listless on second day following vaccines. Pt sent to the ER.
Extreme malaise, chills, fever of 100 degrees, gi discomfort, diarrhea. Slept for 16 hours and had to call out of work following day. Symptoms lasted for 24 hours. I took Tylenol 500mg on 1/8 for fever.
C/O FACIAL FULLNESS, HEAVINESS, JAW, HEAVINESS, DIZZINESS, SLIGHT SPEECH SLURRING 5 MIN AFTER VACCINE
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history concurrent conditions or concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with multiple doses of improperly stored doses of RECOMBIVAX HB (dose, frequency and route of administration were unspecified) for prophylaxis, following a prior temperature excursion that was supported. The temperature and time frame was: 0 to 1 Celsius degrees for 2 hours and 53 minutes and there was a previous temperature excursion to 1 Celsius degree for 1 hour and 30 minutes. The excursion was found because of a digital data logger. The lot numbers involved were: M018625 (expiration date 11-AUG-2018), M040423 (expiration date: 03-JUL-2019), and N006321 (expiration date: 08-NOV-2019). No adverse event was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004346: US-009507513-1709USA004345: US-009507513-1709USA004047: US-009507513-1709USA004344.
Shot at 9:30 am Chills starting in lower back at 4:00pm  by 7:00 pm severe flu symptoms.   High temp, chilled with no way to get warm, headache.  Arm was not sore. Did not have nausea.  From 7-11 was the worst.  Did take Tylenol. Symptoms did not completely go away until 5:00pm following day. It was rough.
No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 22-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion (on 01-JAN-2021) for prophylaxis (product storage error). No additional adverse event reported.   The administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA007559: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007563: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232: US-009507513-2102USA007557: US-009507513-2102USA007556: US-009507513-2102USA003923:
Pt noticed that he has a swollen spot on his arm the size of a peach that is warm to the touch and looks rashy.  It does not have any pain, just got swollen at injection site