chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brief generalized convuls x 2 (approx 15 sec each) 24 hrs p/vax recvd; t100.8 taken @ home about 9AM;
Fever, Chills, aches, nausea, diarrhea, fatigue, dizziness
PATIENT STATES THAT ON 9-14-09 AT ABOUT 8PM HER RIGHT ARM BECAME SORE AT INJECTION SITE, THE FOLLOWING DAY SHE STATES SHE WAS UNABLE TO LIFT HER RIGHT ARM ABOVE HER HEAD WITHOUT IT HURTING SIGNIFICANTLY, SHE ALSO STARTED HAVING SOME TINGLING IN HER RIGHT ARM THAT WENT FROM HER SHOULDER TO HER HAND, THIS SYMPTOM WOULD COME AND GO, THE FOLLOWING DAY (9-16-09) THE TINGLING CONTINUED ALONG WITH THE OTHER SYMPTOMS, PATIENT TOOK SOME BENADRYL, HER ARM BECAME NUMB AROUND 10AM AND REGAINED FEELING AT 11 AM, SHE ALSO HAD PAIN THAT RADIATES FROM HER RIGHT ARM ACROSS HER SHOULDERS TO HER LEFT SHOULDER, SHE TOOK SOME IBUPROFEN THIS AFTERNOON. ENCOURAGED PATIENT TO GO TO HER PRIMARY DOCTOR OR URGENT CARE IF SYMPTOMS CONTINUED
In the morning following a few days after the vaccine I had diarrhea, which can cause my body to have an electrolyte imbalance and cause a fibrillation problem. I went to the doctor for the symptoms. I have had ongoing stomach issues since. The diarrhea has come and gone.
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
Missed second dose within 35 days.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose within 35 days.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose within 35 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose within 35 days.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No further adverse event reported; The patient was vaccinated with improperly stored one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ); The spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were not reported.   On 08-FEB-2022, the patient was vaccinated with improperly stored one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1821791, expiration date: 26-JUL-2022) (dose and vaccination site were not provided) as prophylaxis (product storage error). The vaccine underwent a temperature excursion of above 47 Fahrenheit for 0 hours 20 minutes 0 seconds. There was no previous temperature excursion. No further information provided. No further adverse events reported.
This case was reported by a healthcare professional (nurse supervisor), via a sales representative, and described the occurrence of injection site tenderness in a 4-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; unknown route; left thigh given on 5 December 2011. Concurrent medications included Tuberculin. On 5 December 2011 at 09:54 the subject received 5th dose of INFANRIX (.5 ml, unknown route, left thigh). On 7 December 2011, 2 days after vaccination with INFANRIX, the subject experienced injection site tenderness, injection site warmth, tightness at injection site and swollen thigh. The healthcare professional reported that the skin was tender, warm and tight to the touch at and surrounding the injection site and the "whole thigh area" was swollen. The healthcare professional explained that injection site of the other vaccine was administered in the same leg; however, the events were clearly seen to be generated from the INFANRIX site. The other vaccine was not considered co-suspect according to the healthcare professional. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with INFANRIX. Follow-up information was received on 3 January 2012 from the healthcare professional. On 6 December 2011, 1 day after vaccination with INFANRIX, the subject experienced injection site tenderness, injection site warmth, tightness at injection site and swollen thigh (updated from the previously reported onset date of 7 December 2011). No biopsy was performed. The healthcare professional considered all the events non-serious. All the events resolved on 09 December 2011.
Chills overnight into mild fever 10 hours later.  Slept till fever broke.  General uneasiness, mild headache, and malaise since then.
Patient stated that she had some body aches and dizziness, alos stated that she was unable to work after getting shot at work.
Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-2023.; no adverse event; Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-2023.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-2023.).    No concomitant medications were provided. Dosage text reported as unknown. The vial was initially stored in the refrigerator on 06-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 4th of 10 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case
Treated in ER approx. 13:00. Eyes tearing and swollen shut, slight wheezing. Treated with Prelone and Benadryl and observation.
Vaccination site pain; COVID-19; COVID-19; This is a Solicited report based on the information received by Pfizer from  (Manufacturer Control No: 21K-163-3819448-00) from a non-contactable female consumer reporting for herself. This is the second of two report.  A 66-year-old female subject received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization.  Medical history was none. No known allergies. Concomitant medications included adalimumab (HUMIRA) subcutaneous, start and stop date were not reported for an unspecified indication.  The subject experienced COVID-19 in Jul2021 with outcome of recovered and vaccination site pain on an unspecified date with outcome of recovered.   The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previously reported information: BNT126B2 product wrongly coded to BLA instead of EUA, BNT162b2 coding updated.; Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information. Based on the known drug safety profile the causal association between the suspect vaccine BNT162B2 and the reported Vaccination site pain 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101241813 same patient, different event and drug
This spontaneous report as received from a medical assistant via field representative refers to a female patient of unknown age. There was no pertinent medical history and no drug reactions/allergies. On 07-OCT-2014 the patient was vaccinated with ZOSTAVAX, 1 injection, subcutaneous (lot # and expired date were not reported). There was no concomitant medication. On an unknown date (approximately in October 2014), the patient developed pain and swelling as well as redness at the ZOSTAVAX injection site. The representative reported this adverse event as soon as they learned of it, and within the 24 hours reporting period. No treatment was given for adverse events. Non lab diagnostics studies were performed. The outcome of adverse events was not reported. The causality between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
1/29 /21 Increased fatigued, congestion, BP elevated Stat CBC/BMP/CXR. CXR. CXR-CHF with superimposed bilateral infiltrates and bilateral pleural effusions. N.O. Rocephin 1gm IM QD x 7 days. CBC am. Consult with cardiology. 2nd covid vaccine not given.  2/2-2/5 Sent to ER for ongoing significantly elevated BP's. Remains on Rocephin. Hospitalized 3 days for Acute on Chronic Diastolic and Systolic Heart Failure-Diuresed with IV Lasix, Multiple changes in medications by cardiology for poorly controlled HTN. Head CT negative, Covid negative. 2/5 Readmission from Facility-Followed closely by cardiology. Losartan was increased, Hydralazine was increased, Norvasc was increased. Continue Atenolol. Monitoring daily weights and vital signs.  Resident with increased lethargy and then behaviors at times, and refusing meds. Oral intake poor. Continued on Coumadin for A-Fib with monitoring of INR. Palliative consult ordered. Continued to be followed by Mental Health and APRN in addition to PCP.   2/6 CBC/BMP/CXR-BUN/Creatinine elevated 44/2.2 and upon readmission to facility. MD changed from Lasix to Demadex. CXR-Continued PNA. Started on Rocephin 1gm IM x 7 days.  2/8 MD visit. Palliative consult ordered 2/11 Critical labs with elevated BUN/Creatine and Na level. MD ofered hospitalization to ADPOA who declined and wanted to pursue  Hospice instead. Resident was seen by APRN from Home Health and Hospice Services who discussed plan of care with  ADPOA requested comfort care and no further hospitalizations.  2/12 Resident admitted to Hospice Services. Compassionate visit with ADPOA 2/14 resident with further decline, periods of apnea evident, comfort maintained.  2/18 Passed at facility with Hospice services in place and compassionate visits with ADPOA
Patient received a bivalent booster formulation instead of the monovalent formulation for their 1st dose of the primary series.
I had a sore throat, dry cough, aches and chills while on a cruise. My husband had been diagnosed with COVID-19 about three or four days prior so I figured I had contracted it from him. I took an at-home COVID-19 on 03/09/2023 when my results came back positive. We were isolated in our room; we felt terrible. We were prescribed the antiviral medication for recovery. Afterwards, I felt pretty bad for about 5 days and got a pretty bad cold afterwards that I'm still recovering from.
sz activity unk if related to closed head injury or breath holding spell; sz activity had occurred prior to vax per MD;
Headache, sweating, chest tightness, dizziness day after shot given. Saw MD 4 days later and given steroids po.
Information has been received from a RN concerning at least 3 patient who were vaccinated with varicella virus vaccine live. The RN reported that the patients developed chicken pox after immunization. Unspecified medical attention was sought. Additional information has been requested.
Multiple blisters at various stages of healing on arms, legs and face, some excoriated.
pt recvd vax 17JUN91 postpartum & 21SEP94 during 2nd pregnancy pt was tested & did not have a titer for rubella;No further details were provided;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; 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 during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 8:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 8:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.73.  No concomitant medications were reported.  Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 35 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 27-May-2021. Product moved to clinic on 22-Jun-2021. and BUD for the vial was reported as 26-Jun-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit.   Temperature recordings were taken at every hour. All doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medications were reported.
sudden paleness, weakness, dizziness, distortion of hearing, sweating, nausea, wretching and vomiting (small amount, no food) within about 5 minutes of vaccine, event lasted about 1 or 2  minutes, no treatment
pt recvd vax 21JUN93 & on 22JUN93 devel a raised, reddened area of 2.5 cm around the inject site which looked like a mosquito bite; lt leg was painful; pt was seen by pediatrician for the exp;
extreme fatigue; nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: FK9729) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; AMLODIPINE; IBANDRONATE SODIUM; COSOPT. Past drug history included: Neurotin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Previous dose details: , Prev dose product: COVID 19, Prev dose brand: pfizer, Prev dose brand unknown: False, Prev dose lot number: Pfizer, Prev dose lot unknown: False, Prev dose administration date: 10Sep2021, Prev dose administration time: 04:00 PM , Prev dose dose number: 2, Prev dose vaccine location: Right arm), administration date: 10Sep2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: pfizer, Prev dose brand unknown: False, Prev dose lot number: EW0173, Prev dose lot unknown: False, Prev dose administration date: 20Aug2021, Prev dose administration time: 04:00 PM , Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 20Aug2021, when the patient was 78 years old, for covid 19 immunization. The following information was reported: FATIGUE (non-serious) with onset Feb2022, outcome "recovered", described as "extreme fatigue"; NAUSEA (non-serious) with onset Feb2022, outcome "recovered", described as "nausea". Therapeutic measures were not taken as a result of fatigue, nausea.  Additional information: Administration time: 11:00 AM. Facility type vaccine: Public Health Clinic/ Administration facility. patient did not receive other vaccine in four weeks. Other medications in two weeks: atorvastatin, amloipine, ibandronate sodium, cosop. Patient had no covid prior vaccination. Post vaccination, patient was not tested for COVID.  No follow-up attempts are possible. No further information is expected.
2:30pm: Bloodshot eyes, fatigue, cough. 4:00pm: Swollen tongue and lower lip, earaches. 8:00pm: Fever, abs and lower back pain. 11:00pm: Bloodshot and burning eyes, endless tearing.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 20-year-old female patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were reported as follows: The age at vaccination was not reported. Nurse noted the patient received the full 3 dose of series of ENGERIX -B and as per titers patient did not develop immunity. Nurse noted on 4th March 2019, the patient was given a 4th dose of ENGERIX -B (batch number 4795H, expiry date 14th July 2020). Lab Comments: lab test were performed on an unknown date.
The evening that I got the first dose of the vaccine. The next day I had headaches, nausea, vomiting. My legs are swollen. My right arm is numb and my right leg is tingling. I have dizziness and I have not been able to sleep. I have been having trouble doing my job. I have not had any appetite and I can't even keep water down. It has been five days and I still have trouble with all these symptoms.  I am having trouble breathing and I feel like I have a weight on my chest.
Right eye drooping and swelling. Red rash on right cheek. Right sided jaw tightness. Right cervical lymph node swelling and discomfort.