chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 77-year-old, White female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.
Extreme pain in L arm though vaccine was in R. Intense headache. Then blinding headache.
106 degrees temp. Febrile seizure for 5 minutes. Turned blue, eyes rolled back, foaming at the mouth. 102-103 degrees for 5 days following rash on trunk on the 3rd day. Saw neurologist - recommended no further Pertussis vaccinations.
Client received VARIVAX 17 days after MMR and the interval should have been 28 days.
has an elevated temperature of 99.8; This case was reported by a consumer via call center representative and described the occurrence of body temperature increased in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 10th June 2021 and felt achy refer case US2021169796). Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)), acetylsalicylic acid (Aspirin) and paracetamol (Tylenol).   On 10th August 2021, the patient received the 2nd dose of Shingrix. On 11th August 2021, 1 days after receiving Shingrix, the patient experienced body temperature increased. On an unknown date, the outcome of the body temperature increased was not recovered/not resolved.   It was unknown if the reporter considered the body temperature increased to be related to Shingrix.  Aditional details were provided as follows: The patient reported this case for himself. The patient stated he had taken Tylenol and also takes a low dose aspirin every morning. The patient also stated that he received the COVID vaccine in the winter. The patient received Shingrix and experienced elevated temperature of 99.8 degree F. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169796:Same reporter
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Vaccine given at 4:05pm. Pt's dad reported dizziness at 4:10pm. Pt appeared pale/had pale lips, was otherwise alert & oriented. Rx called 911. EMS arrived ~10 mins later. EMS check vitals & asked pt to go to the ER, however pt was feeling better and pt's dad refused. Pt's dad stated he'll take her to the ER if symptoms do not improve. Pt denied any pain, shortness of breath, palpitations, nausea/vomiting, or rash. EMS escorted pt and dad out of pharmacy.
This spontaneous report as received from a physician refers to a female patient of unknown age who on 03-FEB-2013, on 03-MAY-2011 and on 09-APR-2013, was vaccinated with the first, second and third dose of GARDASIL (doses and lot numbers not reported) respectively. No adverse effects were reported. Additional information has been requested.
This patient received his COVID booster of Moderna on 11/19/2021 and per patient report started developing a rash on his body around 11/23/2021 , but did not report to medical staff until 12/23/2021 when patient bit his tongue while chewing on ice and via medical exam, petichiae noted. Platelets noted same day at <2, confirmed upon repeated lab. Later diagnosed with TTP.
Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back pain, joint pain, that started approximately 10 hours post injection and lasted for approximately 36 hours.
extreme fatigue; couldn't get out of bed, still lingering; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE QUAD) for prophylaxis.   Previously administered products included Prevnar with an associated reaction of no adverse event (He had many vaccines over his whole life including Prevnar (and states he has never had a problem any prior vaccine)). Concurrent medical conditions included asthma and chronic obstructive pulmonary disease. Concomitant products included fluticasone furoate + vilanterol trifenatate (Breo Ellipta).   On 3rd September 2022 15:00, the patient received the 1st dose of Shingrix (intramuscular) and FLUZONE QUAD (intramuscular). On 3rd September 2022, less than a day after receiving Shingrix, the patient experienced fatigue and mobility decreased. In September 2022, the patient experienced diarrhea. On an unknown date, the outcome of the fatigue and diarrhea were not recovered/not resolved and the outcome of the mobility decreased was unknown.   The reporter considered the fatigue, diarrhea and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's comment: The reporter was the patient and stated that he had got the Shingrix 1st shot on Saturday 3rd September 2022 around 3:00 intramuscularly in the left deltoid. (He also got Fluzone Quad on Saturday 03-Sep-2022 around 3:00 intramuscularly in the right deltoid). He was not able to find the lot number or expiration date of the Shingrix administered but had provided the contact information for the pharmacy that had administered the product. They should have that information on file. From Saturday to Monday he had such extreme fatigue that he could not get out of bed. It took every ounce of energy to climb out of bed. As of the day of the report (Wednesday 7th September 2022) he indicated that the fatigue had not resolved completely yet. It was still lingering. Less than a week after receiving the Shingrix and FLUZONE QUAD the patient was also still experiencing fatigue, diarrhea and mobility decreased. It was unknown if the reporter considered the fatigue, mobility decreased and diarrhea to be related to FLUZONE QUAD. The reporter had consented to follow-up
This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (route, dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Swollen red area on arm at injection site. Felt like a bug bite but area was raised (2 inches x 3inches) Very itchy and bumpy and a little tender.
sore arm; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration and administered in right arm on 26Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She has had the Flu vaccine and shingles no reaction. Not received any vaccine prior 4 weeks. No family medical history relevant. she has a twin sister. They went together for the covid vaccine on the same day but they are fraternal and not identical. All she remembers is a sore arm for 24 hours. The outcome of event was recovered on unknown date in 2021.  Information on Lot/Batch information has been requested.
blood clots in couple of toes near nails; observed swollen; This is a spontaneous report from a non-contactable consumer.   A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 24Feb2021 15:15 as a single dose for covid-19 immunisation . The patent has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. In Mar2021, the patient was observed with swollen and blood clots in couple of toes near nails. The events was not treated. The outcome of the events was not recovered. The patient has not had covid prior to vaccination and was not testes for Covid post vaccination.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
CHEST PAIN AND INFLAMMATION (LEFT SIDE) IN VICINITY OF HEART. OCCURS RANDOMLY FOR A DURATION OF APPROXIMATELY 5 MINUTES UP TO 1-2 HOURS. PAIN IS MILD ACHING AND AT SOMETIMES FEELS LIKE THE AREA IS ON FIRE.
I felt sick, four days and then I had no central vision in my left eye. All tests resulted in me not having CSR, MS, genetic tendencies and a conclusion reached that the retina was blistered and now it is concave, scar tissue (too extensive for return of sight).
tenderness in right arm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and TENDERNESS (tenderness in right arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. P5M2P0A and P25A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Itching). On an unknown date, the patient experienced TENDERNESS (tenderness in right arm). At the time of the report, PRURITUS (Itching) and TENDERNESS (tenderness in right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-056601 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056601:CROSS LINKED for Dose 2
Red, swollen, warm to touch - painful at injection site 3 inches in cir. Advised Motrin-cool compress.
pt recvd flu vax 15OCT sick in a wk or about lack of use lt arm 31OCT;
Patient reported felling hot and dizzy.  Pt was alert and oriented.   Patient was relocated to clinic room bed and placed in supine position..  Extremeties were elevated.  Pt began to report feeling better almost immediately.  Blood pressure was obtained at 1:03pm.  BP was 146/96, HR 55.  Pt was instructed to remain in reclined position.  She was alert and conversational throughout.  At 1:10p, another BP was obtained of 138/68.  HR 58bpm. Pt continued to report feeling better.  She was able to sit up and remained seated for several minutes to ensure no orthostatic hypotension.  She was able to stand and left clinic at 1:16pm.  Impression of vasovagal reaction post injection.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 12-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
On 12.21.2022 patient had acute onset of confusion, dizziness upon standing, and shortness of breath at a restaurant. EMS was called and patient was brought to the ER.
Pneumococcal vaccine 1043L-exp 06/16/02. Temp 101.3.
Local board of health nurse administered 0.25 of FLULAVAL QUADRIVALENT vaccine to a 20 month old patient. (Vaccine licensed for 3 and older). She contacted State Department of Public Health, who let her know that most likely the patient would needed to be contacted and revaccinated. The Local Board of Health nurse stated there were no adverse events noted in the patient. The nurse at the State DPH contacted GSK to ensure that this was indeed the case. A pharmacist at GSK stated that they do not have any data on the 0.25 dose, only on 0.5 dose and that they had recently filed papers to extend the age limit down 6 months on FLULAVAL, but using a 0.5 dose. The GSK pharmacist confirmed that this patient should be revaccinated with the correct flu vaccine for her age. This was communicated to the Local Board of health nurse by the State DPH nurse.
Hives appeared suddenly on left leg around ankle. They have continued to appear on the left leg, both upper and lower leg for around 3 days. Most recently the right leg has hives appearing.
Swelling of left leg started 24 hrs after injection red swollen and warm to hot to touch.
At the injection site, soreness, burning, achy, painful and huge knot in collarbone area. Dr. said infection from the COVID19 shot. prescribed antibiotics.
felt weak; hard to move; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) and MOVEMENT DISORDER (hard to move) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Diabetes and Depression. Concomitant products included METFORMIN for Diabetes.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak) and MOVEMENT DISORDER (hard to move). At the time of the report, ASTHENIA (felt weak) and MOVEMENT DISORDER (hard to move) had resolved.      The patient had no chronic conditions.  Concomitant medication of the patient also included anti-depressant medication.  The patient had adverse events for 24 hours and then symptom stopped. The patient reported that her healthcare provider did not recommend booster shot.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-029273 (Patient Link).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxocilin, reaction(s): "known allergies: AMOXOCILIN", notes: known allergies: AMOXOCILIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Plaxovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368713 Same patient, different product and event;
Itchy rashes all over my body; My entire tong felt thick and tingly; My entire tong felt thick and tingly; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; Nausea; Diarrhea; Throw-up once; Sweating; Shivering; Body ached all over; I woke-up feeling warm; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:15 (at the age of 37-year-old) as DOSE 2, SINGLE DOSE for covid-19 immunisation. Medical history included thyroid and asthma. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. List of any other medications the patient received within 2 weeks of vaccination was reported as yes. Patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Feb2021 09:15 (at the age of 37-year-old) as DOSE 1, SINGLE DOSE for covid-19 immunisation and experienced Itchy, Rashes all over my body, The back of my tong felt thick and tingly, Difficult to swallow, Wheezing, the site of injection was red, warm, itchy, and raised. On 18Mar2021 09:45, the patient experienced itchy rashes all over her body, her entire tong felt thick and tingly, the injection site was red, warm, itchy, and raised. That night, she woke up sweating and shivering and her body ached all over. She had diarrhea for two days and throw up once. She was still experiencing body pains, nausea, thick and tingly tong, and itchy rashes all over. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient received treatment for events as she was prescribed steroid pack and OTC Benadryl. The outcome of events diarrhea, vomiting was recovered and rest all other events was recovering.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient experienced bi lateral raised lesions on elbows and additional raised lesions on right upper arm and left forearm. L forearm lesion measured 5"x 4".  No other signs of anaphylaxis noted.
Breakthrough bleeding for about three days between menstrual cycles, and then having a regular period after that about a week earlier than typical.
Pt. states that after receiving the 3rd Booster of Moderna 10/26/2021, started experiencing symptoms 10/27/2021 of tingling sensation above the right thigh, outer right hip area *red dots with sensation of burning and right backside. 10/29/2021 Hospital communications with Nurse with recommendations for Emergency Room visit. 10/29/2021 Emergency Room visit *Ultrasound and X-Ray examined for Blood Clots (Normal). Treating Physician diagnosed with *Immune-Response to Vaccine. Still continuing to experience symptoms.
Headache, Arthralgia, Fever, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, Narrative:
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 07/24/2022 while on a vacation on a cruise. I had stuffy nose, no fever, sore throat, like of energy and overall mild symptoms. I was given cough drops and cough syrup from the cruise. I was isolated in our cabin for the last few days of our cruise.
Right after vaccine was administered pt stated he felt dizzy. MA had pt lay down and then he started twitching, contracting his forearms and his eyes rolled back into his head. At that time mother in the room got upset and multiple doctors including myself went into the room. He had a second episode both lasting only about 5-10 sec. He was in a slight post-ictal state- somewhat confused/not responding at baseline. EMS was called and by the time they arrived he was closer but not quite at baseline.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Between 09-NOV-2015 and 12-NOV-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L016959, (dose, route, lot # and expiration date were not provided). No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
As reported by patient, he began to complain of generalized itching, then nausea approximately 30 min. to 1 hr. after Hep B vaccine administration.  He was taken to local Urgent Care where he was assessed, determined to be having an allergic reaction and Epinephrine was administered.  He was discharged.
Symptoms started most significantly about 26 hours after receiving vaccine.  Symptoms included: fever (100+, even after several doses of Tylenol); headache; chills; body aches - especially left side of neck and left shoulder (vaccine was administered in left arm) - back ached and legs did too; bloody nose; redness, soreness and 'goose egg' at injection site; fatigue.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient. A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 08Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Peanuts" (unspecified if ongoing); "Known Allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient reported receiving Paxlovid for COVID-19 treatment from 08Oct2023 to 12Oct2023. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My hurts it did that last time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "My hurts it did that last time".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.