chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 include Paxlovid from 12Oct2022 to 16Oct2022, orally. Patient did not take other medication in 2 weeks. No Known allergies. The below information to Safety on 31Oct2022 with the first Pfizer Awareness Date of 15Oct2022. Since the information was reporting outside of the 24hour compliance period for AE reporting, agency is actioned to follow-up on the delayed report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Just 3/4 of the vaccine was injected; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 6-month-old patient who received DTPa (Infanrix) (batch number 4L9e4, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 28th July 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: No complete patient's identifiers were provided. The nurse reported that the when administering the dose of Infanrix the patient started moving and wiggling so just three fourth of the vaccine was injected and the other part leaked, which led to incomplete dose administered. The reporter did not consent to follow up.
1 month old was given Havrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old male patient who received HAV (Havrix) (batch number 4cy9h, expiry date 28th April 2023) for prophylaxis.   On 1st July 2022, the patient received the 1st dose of Havrix (intramuscular) .5 ml. On 1st July 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comments: The reporter was a physician stating that a 1 month old was given Havrix. The patient was not having any side effects from the vaccine. The reporter did not consent to follow-up to the Healthcare Professional (HCP). Additional supportive information: The patient was 1 month old while he had received Havrix vaccine which led to inappropriate age at vaccine administration.
Mom's description: left arm swollen, red, hot to touch. Large swollen area to left shoulder.
administration error - dose administered 6 minutes after 2 hr beyond use expiration time when vial place in room air; patient had no issues
That evening after vaccine my temperature was over 102, I had terrible chills, and nausea that lasted 2 1/2 days. The reason I called into the doctor is because I was over my limit on taking Tylenol and since I hadn't eaten in 2 days. I called to see what I could do to lower my fever, and they recommended Ibuprofens. I couldn't get out of bed and couldn't move and the fatigue lasted for quite a while, weeks even. There was extenuating circumstances so I wasn't sure how much of the stress was because of the vaccine.
Significant headache with light sensitivity, fever 101.2, muscle ache and chills, fatigue.  Unable to complete school day.  Currently resting with acetominophen.
She said she had headache most of the day, most notably when she stood up.; She also had a fever of 99.9 degrees; Complained of swelling and pain under her armpit.; Pain under her armpit; This is a spontaneous report from a contactable reporter (Pharmacist). The reporter is the parent.  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 10Dec2021 at 16:45 (Lot number: FK5618) at the age of 7 years as dose 2 (tris), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot Number: FK5618, Anatomical Location: Left arm, Route of Administration: Intramuscular, Administration time: 16:45), administration date: 20Nov2021, when the patient was 7 years old, for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 11Dec2021 at 08:00, outcome "recovered" (an unknown date in Dec2021), described as "She said she had headache most of the day, most notably when she stood up"; PYREXIA (non-serious) with onset 11Dec2021 at 08:00, outcome "recovered" (an unknown date in Dec2021), described as "She also had a fever of 99.9 degrees"; SWELLING (non-serious) with onset 11Dec2021 at 08:00, outcome "recovered" (an unknown date in Dec2021), described as "Complained of swelling and pain under her armpit"; AXILLARY PAIN (non-serious) with onset 11Dec2021 at 08:00, outcome "recovered" (an unknown date in Dec2021), described as "Pain under her armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, swelling and axillary pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
PT CALLED AND STATED THAT SHE GOT REALLY DIZZY AND LIGHTHEADED AFTER THE VACCINATION. SHE STATED THAT SHE WAS SO DIZZY THAT SHE FELT LIKE SHE WAS DRUNK. SHE HAD HER BOYFRIEND DRIVE HER TO HER DOCTORS OFFICE. SHE STATED THAT IT MIGHT HAVE BEEN DUE TO THE PREDNISONE THAT SHE HAD TAKEN.  SHE WAS DISTRESSED WHEN RECIEVING THE VACCINE AND MAY HAVE BEEN EXPERIENCING EXTREEME ANXIETY AS WELL.
Suffocating; Vaccine went into my lungs and couldnt breathe; Weakness; Fever; Severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASPHYXIA (Suffocating), DYSPNOEA (Vaccine went into my lungs and couldnt breathe), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Severe headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced ASPHYXIA (Suffocating) (seriousness criteria medically significant and intervention required), DYSPNOEA (Vaccine went into my lungs and couldnt breathe) (seriousness criterion intervention required), ASTHENIA (Weakness) (seriousness criterion intervention required), PYREXIA (Fever) (seriousness criterion intervention required) and HEADACHE (Severe headache) (seriousness criterion intervention required). On 03-May-2021, ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Severe headache) had resolved. At the time of the report, ASPHYXIA (Suffocating) and DYSPNOEA (Vaccine went into my lungs and couldnt breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  Patient stated that the shot went into his lungs almost immediately and affected his breathing.  It was like he was suffocating for 4 days. He went to the emergency room and they checked him out. The emergency room ran some tests and wanted to admit him to the hospital, but he refused and left. His primary care physician told him to get the vaccine even though he had COVID-19 in January. He also had a fever, severe headache, and weakness after the vaccine. He was not on any concomitant medication. He had a pulmonary doctors appointment 14-Jun-2021 for this issue.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been receive from a physician concerning a female patient who in approximately August 2003, was vaccinated with a dose of varicella virus vaccine live. On 13-Aug-2003 it was reported that the patient "recently" had a breakthrough with lesions that looked like mosquito bites. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Covid 19 vaccine approved for ages 5-11 was administered to a 4yr old. No  side effects noted.
3 hours after 3rd dose I started having very strong menstrual cramps that lasted that day and I believe for probably 2-3 days I was bleeding excessively. I did go to Doctor for this and they said it was normal. No other occurrences of this. COVID-19 symptoms started on 06/02/2022; tested positive on 06/03/2022. I had fever of 102-103 for 2-3 days, joint pain, cough, non significant headache for one day, chest tightness, hard of breathing for a couple of days, and sore throat. I did a telehealth and they prescribed something for the cough. All other symptoms lasted for 3-4 days. I also had fatigue that lasted for about 10 days. Sometimes I have a small cough in the mornings and at night still.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 22-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777and expiry date 07-JUN-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
My daughter developed shortness of breath Sunday morning 6/27. She thought it was her asthma and took 2 doses of her rescue inhaler. That didn?t help and she said she had chest pain. We went to the emergency room at hospital. She was admitted for pericarditis and elevated troponin level.
burning sensation in throat; mouth with a very metallic taste; mild taste distortion; fever; chills; aches; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EK9231) via an unspecified route of administration in left arm on 21Jan2021 at 17:00 as single dose for COVID-19 immunization. Medical history included CKD2, CAD, HBP, and Diastolic Congestive heart failure. The patient had allergies to medications, food, or other products Demerol, all statins was reported. Concomitant medications included Sertraline hydrochloride, valsartan, Ranexa, and Fenofibrate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that App. 30 min. (21Jan2021 17:30) Post shot, had burning sensation in throat and mouth with a very metallic taste. Metallic taste lasted about day and a half. After that it cleared somewhat, but still have mild taste distortion. About day three did develop some fever, chills, and aches which lasted about three days. Treatment was not received for the adverse events. The events were considered as non-serious. The outcome of events was recovering.
Sight of injection is very itchy, swollen, warm to the touch and red 8 days after the vaccine was administered.  Took 10 ml liquid Benadryl which has taken the edge away but still itches.
The pt received the immunizations on 2/15/02. These were his 1st shots ever. By 2/17/02 PM, he had a 100F fever. From 2/18/02 to 2/25/02, the fevers ranged from 100F to 104F. He was very ill, developed sores around the inside of his mouth and throat. He had a headache, no appetite and had very swollen glands in his neck. He slowly recovered.
No additional AE/ PQC.; 47 year old female who received GARDASIL 9 from her pharmacy, and knowing GARDASIL 9 is not used in patient over 45 years of age; This spontaneous report was received from a Medical Assistant and refers to a 47-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  In May 2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age).  No additional adverse events were reported.
Headache, on left side of head; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 15Apr2021 (after 10:00 as reported; at the age of 68 years old) at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration at the upper right shoulder on 26Mar2021 (after 17:00 as reported; at the age of 68 years old) at a single dose for COVID-19 immunization. The patient experienced headache, on left side of head on 16Apr2021 10:00. The event was reported as serious (disabling). It was reported that the patient decided to take the vaccine because everyone should take the vaccine, and because of the virus. There were no additional vaccines administered on same date of the Pfizer suspect. The AEs did not require a visit to the emergency room and physician office. There were no prior vaccinations (within 4 weeks). There were no AEs following prior vaccinations. The patient had no medical history (including any illness at time of vaccination), no family medical history relevant to AEs and no relevant test. The outcome of the event was not recovered. Relatedness of drug to reaction(s)/event(s): Causality assessment between BNT162B2 and the event headache, on left side of head as per primary source reporter via global introspection was related.  Information on the lot/batch number has been requested.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and the known product profile, the causal relationship between the reported headache , left side head and the BNT162B2 vaccination is possible.  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 agencies as appropriate.
Tingling in arms and legs accompanied by chest tightness. Escalated to entire body and chest pain. Received vaccine around 2 pm per patient and symptoms started around 9pm. Around 10pm the chest tightness started. Patient received Benadryl, iopamidol, lorazepam, solumedrol, and Reglan on 9/24/21. Patient discharged by attending in stable condition.
ears began ringing day after vaccination, has not stopped even though other side effects (fever, nausea, fatigue) have abated.
I took the first dose of Moderna around 15.30 pm at vaccination site on 19th March 2021. On that day, my body felt very cold and did not get sleep at that night. Saturday morning, my head was dizzy and no appetite. But took some meal around 9.30 a.m. Then I started vomiting from  12 p.m. to 3 p.m. several times. My whole body was dizzy and tired for a whole day.
I have a history of high BP and asked to have my BP taken before the shot was given. They said no, they didn't have the equipment and it is not required.  I had been treated fo BP a few months earlier and placed on 100 mg of Losartan daily. My BP had been dropping but was not yet all the way down. My last reading was something like 145/90.   About 15 minutes after the shot I began feeling flush and had chest pains over my heart. My BP was measured at ~175/100 .   They took me upstairs for an EKG where my BP went up to about 220/120 , After they did the ekg my BP came back down to about 157/95.
Extreme drowsiness, rash at injection site, itching, swelling, knot at injection site, light headed, unsteady, redness at injection site, weaknesss. Symptoms lasted four days. Treated with ice pak, Benadryl cream. Unaware at the time, that an injection? was the cause until a return visit to physician's office to ask questions, followed by my own research into the booster (no vaccine?) as PREVNAR. This was first attempt to secure a vaccine against pneumonia. Am I going to seek a "real" vaccination whenever- emphatically NO.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005796, expiration date 26-MAY-2018) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA005606: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438:
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided by reporter. Reporter did not allow further contact.
administered with the vaccine beyond to 30 day use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.