chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic cough has worsened; Chronic cough has worsened; Extreme dizziness 4 hours after shot; nausea; vomiting; body aches and pains; headache; fatigue/I tire easily; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received third dose (BOOSTER, SINGLE), of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 301308A and expiry date was not reported), via intramuscularly, administered in Arm Left on 28Sep2021 at 12:00 (age at vaccination: 74-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included nausea, pain, hyperlipidaemia and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medication(s) included prochlorperazine edisylate (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) taken for nausea from 28Sep2021 to 02Oct2021, via oral route of administration, ibuprofen taken for pain from 28Sep2021 to 02Oct2021, via oral route of administration and atorvastatin taken for hyperlipidaemia, blood cholesterol from 2018 to an unspecified stop date. The patient was not diagnosed with covid prior to covid-19 vaccine. The patient was not tested for covid-19 post vaccination. The patient was not allergic to any medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date: Jun2021), via intramuscularly in left arm, on 03Feb2021 at 13:00 (age at vaccination: 73-years-old), as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date: 30Jun2021), via intramuscularly in left arm, on 22Feb2021 at 12:00 (age at vaccination: 73-years-old), as DOSE 2, SINGLE for COVID-19 immunization. It was reported that, approximately 4 hours after 3rd dose was received, I experienced sudden onset of severe Dizziness, Followed by Nausea and Vomitting those sysmptoms persisted for nearly 7 days, then lessened. 10 days later, I am still experiencing Dizziness, but am able to walk and drive. I tired easily and my chronic cough has worsened. On 28Sep2021 at 17:00 PM, the extreme dizziness, nausea, vomiting, body aches and pains, headache, fatigue/I tired easily and chills. 10 days later, he was still experiencing dizziness, but he was able to walk and drive. On an unspecified date, his chronic cough had worsened. The patient did not receive any treatment for the events. Outcome of the event nausea and vomiting was recovered on an unspecified date in 2021, outcome of the events, dizziness, body aches and pains, headache, fatigue/I tired easily, chills was recovering and outcome of the other events was unknown.
53 y/o patient received Engerix-B pediatric; 53 y/o patient received Engerix-B pediatric; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 53-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comments:  The Nurse reported that a 53 year old patient received a pediatric 10 mcg dose of Engerix-B prefilled syringe. The reporter give consent to follow up. Additional Supportive Information: 53 year old patient received a pediatric 10 ug dose which led to underdose and adult use of child product.; Sender's Comments:  US-GSK-US2022133285:Same reporter.
still got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the shot and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
LOST TWO FRIENDS; This spontaneous report received from a consumer via a company representative concerned multiple patients (2 friends) of an unspecified age, sex, race and ethnicity.  The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the reporter lost two friends (death). The reporter stated that "I lost two friends and one very sick after taking vaccines in relation to Covid19. I never took any of them after researching the data and the complexity of the double tongue information coming out when the outbreak first appeared.  The cause of death and date of death was not reported. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221257738 and 20221261382.; Sender's Comments: V0: 20221257837-Lost two friends. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I started out with a stuffing nose on 11/13/2022 but I tested negative for COVID-19. Then 2 days later I woke up with a sore throat, sneezing, coughing, tired, and muscle aches. On that same day I tested positive for COVID-19. I called my doctor, and she prescribed me Paxlovid. I still have a little stuffy nose and cough.
Pt. with facial edema, hives on body, redness/swelling to injection sites.
Rash noted on both thighs where PREVNAR & PENTACEL given had bandaids over site.
Intestinal distress; Gas; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Intestinal distress), FLATULENCE (Gas) and DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EPINEPHRINE (EPIPEN) for Bee sting.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Intestinal distress), FLATULENCE (Gas) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN (Intestinal distress), FLATULENCE (Gas) and DIARRHOEA (Diarrhea) outcome was unknown.            No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. He had experienced similar side effects as the 1st dose after the 2nd dose.   This case was linked to MOD-2021-006269 (Patient Link).
THIS WAS A DUPLICATE ADMINSTRATION OF BIVALENT BOOSTER.  PATIENT HAD BIVALENT BOOSTER ON 10/13/22 AND 10/25/22.  ADMITTED TO HOSPITAL VIA ED WITH SYMPTOMS SUGGESTIVE OF TIA ON 10/28 (CONFUSION, FACIAL DROOP) Note that patient ALSO had duplication of high-dose seasonal influenza vaccination 9/29/22 and 10/19/22.
Nausea, vomiting, myalgia, HA (after second Pfizer dose, dose given 9/2, felt symptoms 9/3) 9/4-  chest pain (4-6hrs)
Within hours, severe conjunctivitis, muscle pains, back pains,  knees swelling.  One knee required swelling.  Debilitation and difficult to walk.   I've visited 5 different doctors in 3 weeks.  Some symptoms subsided but then they returned following the second shot 3 weeks later.
This spontaneous report as received from a consumer of unknown age and gender, as part of a marketing research program conducted, regarding on himself/herself. In November, the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (route, dose and lot # not reported). On 09-SEP-2013, "2 days ago", the patient experienced shingles despite past vaccination. The outcome of had shingles despite past vaccination was unknown. Additional information is not expected.
Pt passed away 15 days after vaccine, no indication death was related to vaccine.  Narrative:  Patient was a 64 yr old female with stage 4 serious ovarian cancer with extensive lung metastases no longer on treatment with severe CAD, HFpEF who was transitioned to comfort care on 1/23/21.
Redness, swelling of left arm.  Erythema/induration measures 17.5cm up and down and 15.5cm left to right.  Left arm is 2cm larger than right.  Measured 14cm proximal to olecranan.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N019822, expiration date 13-JUL-2019, lot # N022983, expiration date 23-AUG-2019, (strength, dose, route and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported. The vaccines were exposed to a temperature range between 15°F to 46°F (15.3°F), during a time frame of 167 hours, which was called by a data logger. No previous temperature excursions were reported.
Following 1st dose of vaccine, patient developed skin rash on 2nd day, mild maculopapular rash on anterior chest - persisted.  Following 2nd dose of vaccine, developed skin rash involving anterior chest and lower back ~ 7 days after the vaccine. Rash is pruritic, painful, raised.  No fevers/chills/sweats.  No oral/ophtho lesions.  Still getting worse.  Unable to sleep last night due to itching/pain.
Axillary Lymph swelling with erythema extending from insertion site streaking medially to the axilla.  Pain to axillary region and upper arm with tingling and heaviness to lower arm.
Patient just made us aware of hives presenting 24 hours after first dose. Upon looking, patient still had scarring from it 20 days later.  Patient was seen by MD and given Benadryl and prednisone 20 mg.
patient received 12 mo vaccinations on 7/20/2009, at site of vaccine patient with 4 cm area of erythema, induration, pain, and warmth on right upper arm from day after shots to 7/29/09 when seen at providers once again. diagnosed with cellulitis and put on augmentin 125/5 1 tsp po bid X 14 days.
Fever, chills, hot flashes, sweating, nausea, vomiting, headache, weakness, fatigue, body aches
Information has been received from a pharmacist concerning a female with blood pressure high and "some kind of eye disease" who "1 or 2 years ago" in approximately 2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck), (lot number, site and route of vaccination not reported). It was reported that the patient was experiencing blisters in the back and pain. This was a light case of shingles but the patient said it was painful and she could barely walk. The pharmacist mentioned that at time the patient had received ZOSTAVAX vaccine (Merck), she experience soreness and inflammation at an unspecified arm. The patient was given VALTRAX. No date were available for the onset of the blisters and pain or the soreness and inflammation. The pharmacist mentioned the physician may have reported this AE but could not find the case. Additional information has been requested.
pt recv vax 5MAR96 & MAR96 pt exp fever, nausea, vomiting;no further details were provided
I started itching within the first hour, next day my arm hurt a lot and kinda felt like it was on fire. Following day my feet started to swell, then legs, hands, arms, wrists, neck and stomach. I gained 8lbs in fluid and feel exhausted. I can barely walk around my house even a week later from the shot.
At the 15 minute mark, the individual c/o meatallic taste in her mouth, that was followed by tingling in her mouth, sudden sharp headache, then tingling in her right arm.  Vital signs were wnl and stable. There was no SOB or difficuloty swqallowing.  She then slumped in her chair and was immediately placed on the ground.  She remained alert and answered questions apporpriately.  Approximately 5 minutes later, she complained of sharp, left-sided chest pain and sat up quickly and began to dry heave. At this point EMS arrived and the patient was placed on the stretcher, still alert and answering questions appropriately.  She was transported to Hospital by EMS.
Patient reports having a light red circle at the Zostavax injection site.  She reports it does not itch, is not painful, is not raised, and is not warm to the touch.  I have not personally seen the adverse reaction.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included PRAVACHOL, CARDIA, XANAX and XARELTO. On 22nd April 2018 11:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, tiredness, nausea, upset stomach, shivering, muscle pain, headache, feelings of weakness and appetite absent. On 22nd April 2018 12:00, the patient experienced general body pain. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the general body pain, tiredness, nausea, upset stomach, shivering, muscle pain, headache, feelings of weakness and appetite absent were recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. The reporter considered the general body pain, tiredness, nausea, upset stomach, shivering, muscle pain, headache, feelings of weakness and appetite absent to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced injection site pain as the vaccine was administered. By noon, 1 hour after receiving SHINGRIX, the patient experienced to ache all over her body from head to toe and felt weak and tired. The patient stayed in bed for 3 or 4 days. The patient never gets a headache, but less than a day after receiving SHINGRIX, the patient had a severe headache and felt nauseated and did not want to eat. The patient generally feels cold all the time anyway but less than a day after receiving SHINGRIX, she experienced shivering. The patient did not have a fever or swelling.
I have been having like severe migraine since then; This is a spontaneous report from a contactable consumer. The consumer (patient) reported that,a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: FC3182) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine details included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient stated that "I got my COVID Vaccine of my second dose of Pfizer yesterday and I have been having like severe migraine since then for the treatment patient have been taking Excedrin; nothing has stopped the migraine .The patient has experienced severe migraine on unspecified date. Outcome of the event was unknown.  The lot number for the Excedrin, was not provided and will be requested during follow up.
5 minutes after vaccine, patient experience dizziness, clammy, weakness, BP and Pulse dropped.  Patient given water, candy and granola bar,  Monitored by ER RN, vitals taken.  Patient started to feel better after 15 minutes.
COVID POSITIVE ON 12/13/21. PATIENT WAS ON HOSPICE SERVICES FOR AAA PRIOR TO TESTING POSITIVE FOR COVID. PATIENT EXPIRED ON 12/22/21.
Pt. c/o nausea and being shaky.  Pt was taken to observation room for assessment.  Pt stated that last well visit was in November which Doctor Lower doses of some meds.  Pt ate some peanut cracker and had some water and started feeling better.  BP 160/90, Pt was escorted to her car and SPO2 98%.  Pt texted my Supervisor stating she made home just fine.
There was not an adverse reaction. The situation is the patient was given an expired BUD Covid 19 Booster Vaccine. The BUD was for 02/03/2022 and the vaccine was given to the patient on 02/07/2022.  Patient has been contacted of the information and was advised that the Covid 19 Booster was not valid for the fact of it being expired due to BUD.  The patient wanted to wait on getting the Covid Booster Vaccine at this time
Adverse Event due to Special Population (Pregnancy); This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Adverse Event due to Special Population (Pregnancy)) in a 34-year-old female patient (gravida 0, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The patient's last menstrual period was on 11-Oct-2020 and the estimated date of delivery was 31-Aug-2021. On 19-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Adverse Event due to Special Population (Pregnancy)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The delivery occurred  on 31-Aug-2021.  On 19-Mar-2021, EXPOSURE DURING PREGNANCY (Adverse Event due to Special Population (Pregnancy)) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Pregnancy test: Positive   Action taken with mRNA-1273 in response to the event was not applicable. No concomitant and treatment drug information was provided.
10-25/26-15 rapid 150 pulse 10-25 & previously skipping beats but <90 bum. Still running 120-150 after urinating. O2 96-97. No other symptoms. Did not eat well till 1900 corn&shrimp. Just 2 donuts & 8 oz OJ prior. Note: had hot flu shot 10-20 -15 muscle aches neck, back, chest 10-24 relieved w/2 Tylenol ea 6 hrs till 10-25 (total 8 pills). O2 @ 2-3 l/min. Pulse rates @ rest! 7 cups coffee no alcohol past 4 days. Constipated 10-25. No fever, sweating, arm or chest pain, not faint, mentally alert. Pulse returned to 90 bpm @ 0320 when I urinated. Checks @ 0545, 0745, & 0945 were 90 90 87! O2 @98 throughout no pains except modest ache in R anterior trapezius radiating to R  shoulder. All normal @ 1000 Mon 10-26-15. Flu shot reactions? Have had vaccine annually sine 1953 with no reaction.  This was the first time the shot hurt when injected.  It was the "hot" shot for those over 65.  Also prior to this event, I experienced back, chest, and neck muscle aches for 16 hrs 10/24/2015 that were relieved with Tylenol. I have COPD and am on supplemental O2 @ 2 lpm. No breathing problems experience and O2 levels remained at 98-97%. I'm a PhD research microbiologist. I hope this information will be helpful.  As of 11:25 AM Monday 10/26/2015 I am back to normal and eating well.
School nurse called at approximately 2:20PM to notify of student came to her at 2:10PM complaining of itching all over and red spots on chest and trunk.  School nurse sated student was not having any SOB or wheezing, no pale or blue coloring of skin/mucous membranes.  Nurse sent client home to mother for treatment with Benadryl.
Neuropathy especially in hands; This is a spontaneous report from a contactable other health care professional. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose number unknown, single for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) for rheumatoid arthritis. It was reported that after receiving COVID-19 vaccine, the patient experienced neuropathy, especially in hands. The patient stated that she was unsure if Xeljanz was making a difference at that time due to having neuropathy. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Neuropathy Peripheral and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-370140 (Patient Link).