chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN, Dose 1), for COVID-19 Immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2), for COVID-19 Immunization. The following information was reported: OSTEOARTHRITIS (medically significant), outcome "unknown", described as "Hip osteoarthritis". Therapeutic measures were taken as a result of osteoarthritis. Additional Information: Caller states she had a steroid injection this morning for hip osteoarthritis and would like to know if the steroid may interfere with her Pfizer Covid-19 booster vaccine because she read that it may interfere with it. She got Steroid injection to hip this morning and thought maybe she should not get it. It is not systemic steroid therapy which she read about not to get. She was a drug rep for 30 years with (Withheld) and was not having any adverse reaction. She did not wish to create a report and wanted to be transferred to find out if Pfizer thinks it is ok for her to get the booster shot having just had the hip steroid injection. She got Steroid injection to hip this morning and thought maybe she should not get it. It is not systemic steroid therapy which she read about not to get. She was a drug rep for 30 years with (Withheld) and was not having any adverse reaction. She did not wish to create a report and wanted to be transferred to find out if Pfizer thinks it is ok for her to get the booster shot having just had the hip steroid injection. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
wrongful death; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On or about 19-OCT-2014, the 68-years-old patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions in a pharmacy by a pharmacist. Subsequently, the patient was treated by a healthcare provider at a hospital (unspecified if hospitalized or not) for the following injuries resulting from  zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was unknown. Specific allegations also included wrongful death on an unspecified date. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
fainted; This is a spontaneous report from a contactable consumer (patient). This consumer reported different events for both doses of BNT162B2. This is the second report for first dose.  A 32-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 32 years old, via an unspecified route of administration in left arm on 27Sep2021 at single dose for COVID-19 immunisation. Medical history included seasonal allergy. Patient had no epilepsy no history of that whatsoever. There were no concomitant medications. The patient experienced fainted in Sep2021. He was not with anybody he just thought he fainted and they said that was normal at the pharmacy. No treatment received. Outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101407743 same patient and drug, different event separated in time
p/vax pt devel facial paralysis which was Dx as Bell's palsy; tx & outcome were not specified
Patient's husband reported that she passed out ~5-10 minutes after vaccine. Patient was responsive when I went to check on her, but then she started to complain of trouble breathing and tightening in the throat. Administered one 0.3 mg dose of epinephrine. About a minute later, patient stated that her breathing was starting to improve.
feet restless and jittery; feet restless and jittery; Increased high anxiety, difficulty calming down; legs jittery/feet jittery; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 13Mar2021 at 14:30 (at 72 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included diabetic, hypothyroid, high blood pressure, gastroesophageal reflux disease (GERD), chronic kidney disease, and restless legs; all from unspecified date. Concomitant medications included dioxybenzone/padimate o (SUNGARD) 12.5 mg x2/day and glimepiride 2 mg x2/day, both from unspecified date for unspecified indication. It was unknown if the patent had COVID prior to vaccination. The patient was tested for COVID post vaccination (results unknown). The patient increased high anxiety, legs jittery, feet restless and jittery. The patient had difficulty calming down. All events were non-serious on 13Mar2021 at 17:00. The patient took muscle relaxant, tizanidine 4 mg, but had very little help. No treatment received for other events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch no cannot be obtained.
She rec'd the shot abt. 10 or 10:30am & 8 to 10 hrs. later she had severe flu symptoms - body extremely achy, her skin felt hot but had chills. She didn't take any medication for it, fell asleep but eventually woke up at 2-3 am & it was resolved.
Swollen glands in my neck 9 days after the vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Jul2023 at 08:45 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 03Aug2023 at 14:00, outcome "recovering", described as "Swollen glands in my neck 9 days after the vaccination". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no other vaccine in four weeks and no other medications in 2 weeks. The patient had swollen glands in my neck 9 days after the vaccination. It was reported that the patient had no covid prior vaccination and was not covid tested post vaccination. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
02jun97 pt recv vax; subsequently the pt exp nausea & vomiting & was hosp; subsequently the pt died."the autopsy results were not complete, but indicated some liver involvement. There were two hosp before the pt death;
This is a spontaneous report from a contactable nurse via a sales representative. A male patient of unknown age (may be 17 or 18-year-old) and ethnicity received first single dose of TRUMENBA at 0.5 ml in the arm on an unknown date. Concomitant medications and medical history were unknown. The patient was lethargic and experienced nausea, vomiting, fever and fatigue. This happened on an unknown date, several weeks before this report. The patient only received one dose and decided to not get the subsequent doses. Outcome was not provided. Follow-up (12FEB2016): Follow-up attempts are completed. No further information is expected.
Patient received vaccine even though they are only 17 years old. Patient did not have any adverse effects.
patient stated he was sitting after receiving the vaccine he start feeling a tingling feeling on his forehead then he started feeling light headed then bust into a feverish sweat patient was assessed vitals are as follows 5:27p b/p 154/96 p 89 r 18 sat 100% 5:45p b/p 148/93 p 87 r 18 sat 99% 6:00p b/p 152/93 p 81 r 18 sat 99% patient stated he is feeling better patient will be wheeled out to the front entrance where patient will be released to go home.
Esophageal Spasms, GERD, chest/back pains, starting 03/20 at 7 AMA
No family history of stroke. I had bilateral cerebellar CVA. No arrthymias had been detected.
On 12/25/2022, patient presented to the emergency department due to shortness of breath with activity, cough, sore throat, headache body aches, hoarse voice, intermittent chest pressure, and fever of 101.3F. Her symptoms started 1-2 days prior (12/23/2022-12/24/2022) to ED visit; She went to a funeral on 12/20/2022 and some of the attendees were sick. In the emergency department on 12/25/2022, patient tested positive for both COVID and influenza A; She has a history of COVID-19 infection in June 2022 which was treated with Paxlovid; She is fully vaccinated, boosted, and up to date on COVID-19 vaccinations. While in the emergency department, patient had hypoxia with oxygen saturation in the 88-89% range on room air, which improved with supplemental nasal cannula oxygen. Her chest x-ray showed no acute findings, and her D-dimer were within normal limits. Patient was treated with Decadron, Tamiflu, and DuoNeb nebulizer, vitamin C, vitamin E, antitussive/mucolytic therapy, and incentive spirometry; Antiviral treatment for COVID-19 was deferred to the inpatient treatment team. Patient was admitted to the hospital for further treatment of COVID-19 and Influenza A.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Fever of 100.1 10:30 am 11/14/07  sent home from school.   Fever rose to 103.5 by 12:00 pm 11/14/07 extreme chills  redness of entire body then extremely pale aching body dizziness headache  stomachache. Contacted doctor was told to give motrin/ tylenol and put her in a tepid bath.Gave her soup and tea for stomachache. I did that and fever subsided for a few hours. it then returned  103.2 along with all the symptoms listed above, again i called the doctor at 6:00 pm 11/14/07 was told to give more tylenol and get her back in the bath. Gave her tea and a 1/2 bagel.The fever subsided again until 11:00 pm and again the symptoms returned 102.3,  again I put her back in the bath and gave more tylenol. Gave tea and toast for stomachache. Symptoms again subsided until 3:30 am 11/15/07 101.9 i then gave her more tylenol and a cup of tea to settle her stomach.  7:00 am 11/15/07 fever returned and the shot area is very swollen  chills are again back and fever is 100.4 i gave her more tylenol tea and a small amount of plain yogurt to try and settle her stomach  also an ice pack was applied to the swollen area. 8:27am 11/15/07 fever is returning it is 100.9 and she is jhaving chills and stomachache headache.
Severe total body itching for 1 1/2 months after the injections. Flushing of skin, resolved in ER, MD and allergy visits.
Vaccine stored outside of manufacturer guidelines, product stability is unknown. Potential expired product used for immunization. pt did not report experiencing any adverse reactions to vaccine after administration
Vaccine reconstituted with a diluent that expired 8/7/20. No know adverse reaction or harm to patient at time of this form's completion.
Pt was inadvertently administered DTp instead of TD on 7JUN91; following day pt called to report had a swollen & red arm; Seen in office 10JUN; redness was 8x10cm in size; dx cellulitis; tx ATB:
Several minutes after the first vaccine, I experienced SOB and tachycardia at rest while in observation, I was then sent to ER and HR remained elevated >180 despite sleeping and resting. I am continuing to still experience intermittent rapid heart rate.   After third vaccine I experienced signifcant hair loss (50-75%) with continued shedding. My skin has signicantly gotten worse. Red raised splotchy bumps generalized throughout the body.   after receiving vaccine my thyroid levels and iron level have dramatically changed.
chest discomfort and dyspnea on mild exertion, such as walking up a gentle incline, malaise, easily fatigued. This improved somewhat and slowly but was renewed after the 2nd vaccine 3 weeks later. It never got as significant as the initial symptoms but has persisted over these months, still affecting stamina and activity level. Some sense of chest pressure, dyspnea on exertion, easily fatigued, need to rest frequently are significant still. I had not seen a physician about this as it did seem to be diminishing but has leveled rather than cleared.
pt recv vax;later in the pm had fever & cont cont w/ fever off & on for 2 days;woke up w/ v;given apap;started w/ d & c/o ear ache;devel red spots on torso that resembles measles;fever cont;
Face swelling at day 3 after vaccine.  Lasted 3 days, very itchy rash on chest, neck started on day 10 and spreading to back of head - extremely itchy - skin feels hot
Upon receiving 2nd injection, pt became unresponsive with sl. tenderness to arms. Within 5 seconds, pt responded to nurse. Initial pulse was 104, BP 110/60. Pt became unresponsive again for another 5 seconds, but came to and was able to answer questions. Pt's parent was called and he was taken home with recommendations to father to monitor pt and see his family physician.
At the time I got the second dose I had a slight soreness of the injection area. I went to bed and I had a lot of fatigue, tiredness and it felt like I had the Flu but I didn't. Another symptom I noticed was that I had some floaters in my eyes, it comes and goes. I didn't have that before the vaccine.
Sore arm, but really just seeing how this website works, as I've seen some impossible reactions listed in the official database
Patient was given vaccine @ 917am, during observation Nurse began to notice patient was crying.  At 932am patient stated needed water and stated having a panic attack. Observing nurse flagged down 2 other nurses to assist with monitoring of patient. Vitals checked BP 231/145, pulse 131 and O2 96%, patient moved to separate observation area onto gurney. Patient  stated feeling of tingling in mouth, soon stated cant move lips and throat felt like it was closing. Nurse proceeded to get emergency Epi-pen. At 9:45am nurse state patient became unresponsive and administered Epi-pen, patient immediately responded to medication administration. Patient soon after transferred to ER.
102.5 Fever, Chills, Fatigue, muscle aches, back aches
This spontaneous report as received from a pharmacist via field representative refers to a two anonymous patients. On an unspecified date the two patients were vaccinated with ZOSTAVAX. Lot no.# and expiry date of vaccine are not provided. No other concomitant medications were reported. On an unknown date the patients experienced unspecified allergic reaction and rashes that were quarter size. The outcome of the both the event was unknown. The causality for unspecified allergic reaction and rashes that were quarter size was not provided. This case is linked to 1312USA010185 via same reporter link. Additional information has been requested.
reported that a 12-year-old patient was inadvertently given a dose of Daptacel instead of Adacel with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (practice manager).  This case involves a 12 years old female patient who was inadvertently given a dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Prophylactic vaccination.  On an unknown date, the patient was inadvertently given a dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], suspension for injection, strength: unknown (lot number: C5980AB, Expiry date: 26-apr-2024) intramuscular route in the left arm for immunization, instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel], suspension for injection (strength, lot number, expiry date: not reported, via unknown route in unknown administration site for immunization, with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested for adacel.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt developed a fever of 105F, redness and swelling at injection site and irritability. Pt was treated with Tylenol and a low grade fever persisted for 48 hours.
hives all over her body; This case was reported by a consumer via call center representative and described the occurrence of hives in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In February 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 16th February 2022, less than a week after receiving Shingrix, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix vaccine, in the left arm, 3 to 5 days before reporting. The patient reported, she had hives all over her body, she went to the emergency room last night before day of reporting because of the hives. The healthcare professional at the emergency room gave her Benadryl and Prednisone to help treat the hives. The patient stated that the hives were still everywhere on her body. The reporter did not consent to follow-up.
Vaccine given on 10/18, on 10/20 I began feeling achy and tired. By that evening the aches turned to severe leg pain that could not be eased with Ibuprofen or Tylenol.  By 10/23 I had weakness in my legs with numbness and tingling all over. My BP was also elevated. I went to Urgent Care on 10/23 and was given a steroid injection and a muscle relaxer. The symptoms continued for another 24 hours and then the pain eased up however the numbness and tingling remained.  On 10/24 I followed up with my PCP who drew labs and the only abnormal lab was an elevated Alk Phos and ESR.  As of today 11/2, I am still having some numbness in my feet with a "sun burnt" sensation over my entire body but more pronounced on the lateral sides of my body. It was painful for anything to touch my skin for a few days and that has improved however I still have the sensation with any movement or touch.  Most of my symptoms seem to be neuropathic.
Redness at vaccine site, arm pain, unable to move the arm of the vaccine, dizziness, headache, shivering, fever
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 15-JUL-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Edema, redness to elbow from left deltoid developed 11/15/2001, twelve hours after injection. Still pain today. Had temperature of 100.0 last night, better today.
Went to the clinic at school with "the worst throbbing headache of his life", and very weak.  Clinic staff took his BP and it was 150/90, pulse 120.  EMS was called and arrived.  Father arrived and called pediatrician and was instructed to monitor him at home.
esophageal reflux resulting in angina-like pain, severe whole body urticaria and pruritis, weakness nausea/vomiting  Treated with 40mg prednisone x 4 days resulting in prednisone-induced hypertension.  Symptoms completely resolved by 14 days
Moderna lot number 038B21A expired in system on 9/25/2021, and vaccine was given 9/27/21.  No expiration on Moderna box or vials
Shallow Breathing, Chest Pain, Heart Pain started 3 days after vaccination (9/18/2021). Emergency Room visit 11 days after visit (9/26/2021) because symptoms kept getting worse. Tests performed (EKG, bloodwork, and X-Rays) Nothing concerning found.   E.R. doctor thought it could be inflammation of the lungs and suggested following-up with an Allergist/Immunologist. Appointment with Allergist/Immunologist scheduled for 10/28/2021
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (lot number not provided) doses which were exposed to -6.8 for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines had been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 10-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
fatigue; chills; headache; A spontaneous report () was received from a consumer concerning 27-year-old,male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache). The patient's medical history was not provided by the reporter.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient experienced FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache). At the time of the report, FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache) outcome was unknown.    Action taken with the drug in response to the event is not applicable. The out come of events was unknown.
next AM 14APR98 nausea, sore throat, flu sx, fever 99.5, swollen lip;17APR98 blistered rash over entire body;26APR98 seen in ER allergic rxn;