chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feverish; hypertension; heart palpitations; increased heart rate; hypotension; injection site swollen about 4 inch diameter and bright red and warm; injection site swollen about 4 inch diameter and bright red and warm; loss of appetite; nausea; swollen throat; injection site swollen about 4 inch diameter and bright red and warm; lymph nodes in armpits swollen/painful; lymph nodes in armpits swollen/painful; lethargic; disoriented; unable to speak or think coherently; unable to speak or think coherently; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 12:30 (Lot Number: EW0170) as single dose for covid-19 immunisation.  Medical history included Polycystic Ovarian Syndrome.The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 lot_number EP6955 on 13Apr2021,01:30 PM,at Left arm for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient reported that on 05May2021 15:00 she started to notice lymph nodes in armpits swollen/painful. Around 3 pm incredibly lethargic, disoriented, unable to speak or think coherently. Around 05May2021 18:00  loss of appetite, slight nausea, swollen throat, worsening pain in armpit lymph nodes, injection site swollen about 4 inch diameter and bright red and warm. Around 19:00 began to experience severe hypotension even when trying to move around to get blood flow. About 1.5 hours later 20:30 she began to experience severe hypertension, increased heart rate, heart palpitations, etc. All symptoms noticed from earlier in the afternoon had become worse at this point so went to bed.The patient did not received any treatment. As of 06May2021 the patient was still very disoriented, feverish, lack of appetite. The outcome of the events disoriented, loss of appetite and feverish was not resolved and for other events was resolving.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 Committees, and Investigators, as appropriate
Fever, arm sore, arm swelling, chills. Missed day of work on 3/7/19.
Fever of 101.6 Shivering Headache Paracetamol 500mg was taken
BODY ACHES; BODY CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced body chills. On MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, body chills and headache was not reported. This report was non-serious.
Patient c/o pain, swelling after receiving PNEUMOVAX. Patient unable to lift arm due to pain.
Admitted with Positive COVID 19 to hospital on 9/2/21; developed severe fatigue and worsening dyspnea.
Put me into full blown active Epstein Barre Virus again, Throwing up & Diaherra since shot
Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday.  She states that she woke up at 0200 with chest tightness, achyness and headache.  She rates the discomfort 7/10 last night and improved now to 5/10.  She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening.  She denies any SOB or chest pain--just feels tight.  Doesn't feel like she can't get a full breath or get the air out of her lungs either.  She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours later woke up from sleep with this chest tightness as well as achyness and headache.    She states that she had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days.  At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology.  She does have history of LV non-compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed "mild LV non compaction at the apex" at that time. He did not need to see her again until she is 18 unless she has problems.  She states that she generally does very well and other than this tightness she does not have any other significant symptoms.
A non-serious, spontaneous report of anxiety attack has been received from a nurse concerning a 13-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose FLUMIST on 21-Oct-2009. On 21-Oct-2009, within minutes after administration of FLUMIST, the patient experienced an anxiety attack. Paramedics were called and the patient was not hospitalized. After deep breathing exercises, the patient recovered. Anxiety attack was considered resolved 21-Oct-2009. Causality was not reported.
sz, t102 1 wk p/immun @ hosp on 30SEP91 got 4th DTP/OPV/MMR no problems;
Only diluent administered; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 7-Apr-2023 The health care professional reported that there were a number of patients that might had received the Shingrix with diluent only.  The reporter would like one dose vs 3 dose efficacy of Shingrix and already received Shingrix administration recommendations when only the diluent was given.  No patient identifiers and no reactions were reported.  The reporter did not state whether he would vaccinate patients with a 3rd dose or not vaccinating with an additional dose after just the diluent was given.  The reporter was the middle man and did not had additional information to share. The reporter consented to follow-up via email. The patients received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
I have been experiencing extreme hair loss since my second dose of the Pfizer Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 (Lot number: ER8736) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. There were no concomitant medications. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol. Vaccination history included: Bnt162b2 (dose number=1, dose lot number=FW0151, dose vaccine location=Right arm), administration date: 13Apr2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset 22Aug2021, outcome "not recovered", described as "I have been experiencing extreme hair loss since my second dose of the Pfizer Vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Additional information: No Other medications in two weeks; No Other vaccine in four weeks, No covid prior vaccination ;covid tested post vaccination: Yes   No follow-up attempts are possible. No further information is expected.
A spontaneous report was received from a licensed practical nurse concerning a female who was 32 years old. On 28-APR-2015 the patient received GARDASIL as 32 years of age. No adverse effect was reported. Additional information has been requested.
Body aches, fever, upset stomach, chills, very tired. I basically slept the whole next day. Tylenol seemed to help.
On Saturday the 11th I woke that morning feeling some moderate chest pain around my heart and in back near my shoulder blade. At 02:30PM I went to the ER and had an EKG, Heart Enzymes testing and It was concluded it was not a problem a with my heart. It was muscular strain. That was consistent with the work I was doing the days before. I still feel discomfort, but I have not found it necessary to see anyone else about it so far.
Got booster and felt ill      ill after Covid booster-started 11/18 after wednesday's booster-had high fever, felt lethargic/blister on lips/mouth-feeling somewhat better except for mouth sores   He got shot wed 3 pm, then woke next day, and temp 99.  Went to work, sent home by lunch, and then not back til sat  Thursday and Friday up to 102 temp.  Headache/ body ache,  No nausea.   By sat feeling a bit better, and went to work for the tournament.    The inside of his mouth is very sore , not just one sore.     No rash on the body hasnt got cold sore in yrs
Mom called to say child favoring right leg and had swelling and redness at site of injections given yesterday. No fever. Hard lump on right leg remained as of 3/7/01. No warmth or redness or fever. No more lump.
screaming x3hr;t102 8AUG96;temp 100 9AUG(6;
2 1/2" Erythema, edema (R) deltoid warm to touch.
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions 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 (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 10:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions 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.   Patient age was reported age 71.24.  No concomitant medication was reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. It was reported that each time a vial was put into a cooler, sometimes there was a period of time 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 using a traceable temperature monitor at every hour. Vial was moved to fridge on 11-Feb-2021 and moved to clinic on 17-Feb-2021.  Vial was punctured right before administration. Vial best before use date was 13-Mar-2021. Vial was undergone temperature excursion at 09:00 AM with 22 degree Fahrenheit. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
pt recvd vax;mom c/o rxn to dtp on rt thigh; area of  induration 3cm w/ central area of erythema 1.3cm; no fluctuation; pt alert, active & responsive;
Patient given TDaP and meningococcus vaccines on 11/27/07.  The next day, he developed muscle aches, malaise and low grade fever.  That night, he had chest pain.  The chest pain worsened over 24 hours.  He was admitted to the hospital on 11/29/07 with myocarditis.  His function was normal on echo and CT angio.  His ekg showed inferior lead ST elevation.  His troponin peaked at about 9 and his CPK and CK-MB were both quite elevated.  He was treated with IVIG and NSAIDs.  His chest pain resolved over 24 hours and his cardiac enzymes returned to normal over about 72 hours.  He had no ectopy.  12/06/2007 MR received for OV 11/27/07 for 15yr WCC and hospital DOS 11/30-12/03/2007 with D/C DX:  Myocarditis. Child presented to ER on 11/30/07 with chest pain/heaviness x 2 days.  Pt developed muscle aches and fever 1 day after receiving Menactra and Adacel vax. That night pt developed squeezing chest pain which was worsening.  Pain increased on laying down.  ROS (+) for chest pain and near syncope. Cardiac Consult with DX:  Likely vaccination related myopericarditis. Txd with IVIG and Indocin.  By D/C Chest pain resolved EKG and Echo WNL
This spontaneous report was received from a certified medical assistant and refers to a female patient of unknown age. The patient did not have any pertinent medical history or drug reactions or allergies. The patient's concurrent conditions were not provided. On 12-MAY-2016, the patient was vaccinated with ROTATEQ, orally (lot number and dose were not reported). The patient did not have any concomitant medications. On 14-MAY-2016, the patient developed diarrhoea and a 100 degrees Fahrenheit fever. As a result, the patient was taken to the emergency room; however, no treatment was given for the mentioned events, no laboratory diagnostic studies were performed and the patient was not admitted to the hospital. The patient went home on the same date and, at that time, her status was reported as recovering from the events (reported as "she is doing better"). No product quality complain (PQC) was involved. The reporter did not provide causality assessment between the events and the ROTATEQ. Additional information has been requested.
Breast cancer; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported for a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced breast cancer but was not in active treatment. It was not clarified that the patient had breast cancer before taking either dose of the Covid vaccine. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Breast Cancer and the suspect BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
SATURDAY INTO SUNDAY AFTER RECEIVING THE SHOT I WAS FEELING EXTREME CEHST PAIN, DIZZINESS, COLD SWEATS, HEART WAS POUNDING. MY CHEST STILL DID NOT FEEL RIGHT ON MONDAY AND TUESDAY.
UTI; Sore; pain in my shoulder; back pain; Sleeplessness; no appetite; This is a spontaneous report from a contactable consumer (Patient). This 80-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el9266) via an unspecified route of administration on 19Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history included knee and shoulder replacement. Concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el9261) via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunisation. The patient reported that she had never been so sore in her whole life and to tell how healthy she usually was, she only takes one pill for her bladder and she was 80 years old. After receiving the second dose, the third day on 22Feb2021, she got a UTI (Urinary tract infection), it may have been a coincidence but this was the first time in her life, she had a UTI. Also, the body pain was excruciating, She had been active and healthy up until this. Yesterday, she could hardly get out of bed because the pain in her shoulder was so excruciating, she could not move. She has never been so miserable in her life and had knee and shoulder replacement, this was the worse. She had no appetite and all wanted to do was sleep. People said they had the pain and ache but she never had back ache like that, it was in one spot and it was on fire and it did not do anything to aggravate it or to bring it on, and all this sleeplessness. Her UTI has been treated and she takes ibuprofen for the pain. Outcome was resolved for event UTI and unknown for rest of the events.  No follow-up attempts are possible. No further information is expected.
Fatigue every day.   Dizziness. At least twice a day for about 6 days, everything would go black and I would collapse.  I would check my BP and my PulseOx and there would be no problems.  I don't know if this has stopped.
This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a female patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. In November 2017, less than a year after receiving KINRIX, the patient experienced sickness. On an unknown date, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and sickness were unknown. It was unknown if the reporter considered the therapeutic response decreased and sickness to be related to KINRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received KINRIX 6 months ago and pertussis levels were drawn, IgG and IgM levels were lower than expected, which led to decreased therapeutic response. No further information was provided.
pt w/egg allergy MMR administered 10FEB93; pt seen @ ER 21FEB for 1st sz; pt was febrile dx w/OM;
She and her daughter received the 1st dose on 03Sep2021 and the 2nd dose on 03Dec2021; I had a pain in my left side/ had pain on her upper left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 03Sep2021, for COVID-19 Immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "She and her daughter received the 1st dose on 03Sep2021 and the 2nd dose on 03Dec2021"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "recovering", described as "I had a pain in my left side/ had pain on her upper left leg". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient asked what is the efficacy of the two vaccines, since they were given further apart. Enquired about the booster shot. Asked about the efficacy of the second dose. Investigation Assessment was not provided. After her 2nd dose, she had a pain in her left side. She took Advil and felt better. Patient was advised to call her vaccination provider or healthcare provider if she had any questions about the safety or efficacy of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bell's Palsy on the left side of face. Including the left eye and mouth on the left side. Pain behind the left ear.
Headache, Myalgia, LEFT ARM PAI AND SLIGHT SWOLLOWING ISSUES Narrative:
had a miscarriage; had vaccine during the first 10 weeks and had a miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (had a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (had a miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (had a miscarriage) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment drug was reported.  It was reported that the baby died  Company comment: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.; Sender's Comments: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.