chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt a lot of pain; This is a solicited report by a contactable consumer (patient) based on information received by Pfizer from Manufacturer Report Number: UNT-2021-007034). This case is a solicited report received on 16Apr2021, from a consumer via (specialty pharmacy). This 47-year-old, 125-lb, female, patient began therapy with Orenitram (treprostinil diethanolamine), on 17Jan2020 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 2.5 mg and the current dose was reported as 2.5 mg, every 8 hours (q8h) via oral (PO) route. On 27Mar2021, the patient felt a lot of pain from COVID vaccination (pain, hospitalization). Co-suspect medication included: Covid-19 vaccine. Concomitant medications included: Opsumit (macitentan) and Adcirca (tadalafil). Relevant medical history included: primary pulmonary arterial hypertension. On 27Mar2021, 1 year 2 months 11 days after initiating PO (Orally) Orenitram, the patient was hospitalized because she felt a lot of pain from COVID vaccination. The patient received 2nd COVID vaccination on 25Mar2021. She was discharged on 04Apr2021. Action taken with PO (Orally) Orenitram dose for the event of pain was not reported. Action taken with Covid-19 vaccine dose for the event of pain was not applicable. At the time of reporting the outcome of the event of pain was unknown. The reporter did not provide causality for the event of pain. Comment: The company has assessed the serious adverse event of pain as not related to oral treprostinil. The event was likely related to COVID vaccination in view of the safety profiles of current COVID vaccines.  The reporter's assessment of the causal relationship of the pain with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The event pain is considered related to suspect product COVID 19 vaccine (unspecified), in view of the safety profiles of current COVID vaccines. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Intense adverse reaction; She was very very sick; Vomiting; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Intense adverse reaction), ILLNESS (She was very very sick), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 025B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced VOMITING (Vomiting), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (Intense adverse reaction) and ILLNESS (She was very very sick). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Intense adverse reaction), ILLNESS (She was very very sick), VOMITING (Vomiting), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No concomitant medications reported by reporter  The whole night patient experienced vomiting, fever, chills, and headache. Patient stated the shot itself was a weird experience because the person who administered it is an anti-vaxxer.  It was reported that patient received her first and second doses in her deltoid muscle.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: significant  follow-up received include additional information of reporter, patient, suspect product, treatment medication and new events.
2-28-14 patient called to say she had a bump (size of her hand) that was hard and hot. Vaccine given 2-26-14. No pain unless pressing on area. Had headache day of administration.
developed a 104 fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Dec2021 16:00 (Batch/Lot number: unknown) at the age of 11 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (administration time: 01:00 PM, dose number: 1, vaccine location: left arm), administration date: 06Nov2021, when the patient was 11 years old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant) with onset 12Dec2021 23:00, outcome "recovered", described as "developed a 104 fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Clinical course: the patient developed a 104 fever that was difficult to treat. She had a steady 104 fever for 24 hours in which during that time, the lowest they could get it down to with alternating Ibuprofen and Acetaminophen was 103.6 but stayed steady at 104 the majority of the 24 hours. The patient had no Covid prior vaccination, had not tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient reports labored breathing starting on 9/3 and a burning/itching across front of midriff. No redness or rash visible.
8-years-old boyvaccinated for recurrent respiratory papillomatosis (RRP); 8-years-old boyvaccinated for recurrent respiratory papillomatosis (RRP);  Information has been received from the authors in a published literature article entitled as stated above concerning a 8-year-old male patient who was diagnosed with RRP (HPV serotype 6) at 22 months and required 26 surgeries by age six.   On an unspecified date, the patient failed adjuvant therapies, including quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, , administered for respiratory papilloma (strength, dose description, lot #, expiry date, and route of administration were not provided), and nineteen intralesional bevacizumab injections. Systemic bevacizumab-awwb treatment was planned under pediatric oncology supervision (product used for unapproved indication) (Product use in unapproved population).   This is one of two reports received from the same source.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2304USA005625:
received 2 high dose flu shots within 2 weeks; Initial information was received on 11-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who received 2 high dose flu shots wthin 2 weeks while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 2 high dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, form, route, administration site, lot number and expiration date) for Prophylactic vaccination within 2 weeks (extra dose administered).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  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.
Fatigue; tiredness; muscle pain; chills; joint pain; This is a spontaneous report received from a contactable consumer or other non HCP. A 66-years-old female patient received 1st dose of  bnt162b2 (COMIRNATY, Batch/Lot number was not reported),via an unspecified route of administration, administered in Arm Left on 28Feb2021 11:00,at the age of 66 years old, as Dose 1,single for covid-19 immunization.Medical history included renal disorder from an unknown date and unknown if ongoing other Kidney disease stage III.The patient previously took codeine,morphine and experienced drug hypersensitivity.The patient experienced fatigue, tiredness, muscle pain, chills and joint pain on 28Feb2021 12:00.The outcome of the events was recovered.The patient had not received any vaccine within 4 weeks.The patient was not diagnosed with covid prior vaccination and not tested for covid post vaccination.The patient didn't receive any treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pt came in complaining of redness & swelling at site of half dollar. Injection site also soreness.
Fever 104.6 rectally, discoloration of skin bilaterally on legs, irritability for 3 hours post vaccination.
A male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Apr2021 13:50 (Lot Number: EW0169; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation.  There was no relevant medical history and concomitant medications. There was no Additional Vaccines Administered on Same Date of bnt162b2. The patient previously received the first dose of bnt162b2 on 29Mar2021 (Lot Number: EP6955; Expiration Date: 30Jun2021) for covid-19 immunisation. The reporter stated he thought he was having side effects. He thought he had a cold, sore throat so he took Nyquil and Tylenol PM. His side effects were nausea and threw up. his whole body was sore from arm to back. Time of Onset was Morning 05:45 on 20Apr2021. The patient also experienced up all night on 19Apr2021. The outcome of Nausea and Threw Up was resolved on 20Apr2021. The events did not require a visit to emergency room or physician office. The outcome of Whole Body is Sore from Arm to Back was not resolved. The outcome of Feels like he has a cold; Sore Throat was resolving. The outcome of up all night and Nausea and Threw Up was resolved on 20Apr2021.  No follow-up attempts are needed. No further information is expected.
fatigue- employee just wanted to lay down, runny eyes, runny nose, elevated BP and @ 101 Narrative:
Immediately after receiving the flu shot, I felt itchy all over my torso, arms and neck. I ignored it and went home, but after about 30-40 minutes, I was having progressively more trouble breathing, wheezing, and tightness in the chest. I felt my throat starting to swell, and I gave myself the EPIPENS around 9:30pm. I had continued trouble breathing, so I went to the hospital (Emergency), where I was treated with BENADRYL and steroids and observation until about 2:30 am (treated by Dr). While in intake, blood was drawn and I started to retch and eventually passed out. Reaction subsided once I started the steroids and BENADRYL. Due to physical exhaustion and the late night, I missed class today (morning of 9/26/17) and called out of work this afternoon. I am refilling my prescriptions for EPIPENS, and also taking more prednisone to follow up. I am also scheduling a doctor's visit.
Patient called. States that ?she received the J&J COVID vaccine on 03/30/2021 and that she developed a rash on her leg month after she got the vaccine.? Patient states that now she has a rash on her arm. Denies any other issues. Patient is under the care of Dr  for Diabetes, HTN and Thyroid issues. Patient states that she has F/U appt with Dr on 05/25/2021. Advise patient to contact Dr  office to notify her about issues with rash. VAERS report completed.
This spontaneous report was received from a nurse refers to a 5 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally 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-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
Pt rec'd the ZOSTAVAX vaccine on 8-4-2012 and has a severe case of shingles starting in September 2016.
Some swelling at injection site, but it occurred about 2 weeks after the shot. Never had reaction to previous vaccine.
This spontaneous report was received from a pharmacist refers to 70 year old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified date, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
DYSSTASIA; COVID-19; SARS-COV-2 TEST POSITIVE; ASTHENIA; FATIGUE; DYSPNOEA; COUGH; PAIN; ILLNESS; DEATH; This spontaneous report received from a health care professional concerned an 80 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient experienced drug allergy in past when treated with ACE (angiotensin-converting-enzyme) inhibitors for an unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: unknown) dose was not reported, frequency time was 1 total administered on left arm on 30-APR-2021 for prophylactic vaccination. Concomitant medications included Amlodipine, Atorvastatin, Bupropion, Escitalopram, Furosemide, Lantus (insulin glargine), Levothyroxine, Metoprolol, Mirtazapine and Pantoprazole for an unknown indication.  On an unspecified date in MAY-2021 (reported as about 8 days after vaccination), the patient developed cough, aches, fatigue, and shortness of breath. After another 10 days of illness, the patient was taken to the hospital by ambulance as she was too weak to stand. On 22-MAY-2021, the patient experienced Covid-19, dysstasia and she had her SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) test positive. On an unspecified date in MAY-2021 (reported as on or about 22-MAY-2021), the patient died from unknown cause of death in hospital about 5 days later. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on MAY-2021, and had not recovered from asthenia, cough, covid-19, dyspnoea, dysstasia, fatigue, illness, pain, and sars-cov-2 test positive. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments:  -covid-19 vaccine ad26.cov2.s. Death, cough, covid-19, dyspnea, dysstasia, illness, pain, and sars-cov-2 test positive. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the covid-19 vaccine ad26.cov2.s. Asthenia , fatigue, This events are labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I had a sore arm after the vaccines, swelling and very tender and hot. I was also fatigued and had a headache. All of these lasted between 24 hours to 48 hrs. The soreness of my arm lasted a few days. In January I contracted COVID. I experienced cough which I still have and I noticed the most. I also had fatigue which started about a day or 2 after which is why I tested myself because it was severe fatigue. I tested myself positive. By the 15th of January, so around a day after, I had a sore throat and mucus and congestion. I could not smell things with a mild smell but things like coffee that had a strong smell I could still smell. I had a bit of brain fog but it did not last long. I also had achy joints for about a week. By the 20th of January I saw the doctor and he prescribed I take some over the counter medication and prescribed advere discus. I took around 8 doses. Today, Feburary 10th, I still have a bit of mucus which is still making me cough, but nothing else.
BODY ACHE; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache. This report was non-serious.
Starting at 8:30pm I noticed becoming very fatigued, 9:00pm I started experiencing chills with fever of 101.3.  Overnight I experienced extricating body pain, extricating headache, diarrhea and nausea.  I have memory loss from 4/20/21, I don?t remember the majority of the day.  Memory serves starting around 6:00pm.  I woke up to all the above symptoms, all tolerable with my highest fever of 103.4, and the headache being the most painful.  My fever broke 4/21/21 at 2:30am and all symptoms started subsiding, the headache being the one symptom that seemed to linger the longest.  By 6: 30pm all symptoms had completely subsided.
rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (rash) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    no medical history provided by reporter.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant and treatment medication was provided.
Drowsy; Nausea; Low fever; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 29Mar2021 at 11:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have allergies to medications, food, or other products. The patient did not receive other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 8Mar2021 at 11:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021 at 16:30, the patient experienced drowsy, nausea and low fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of drowsiness, nausea and low-grade fever was unknown.   No follow-up attempts are needed. No further information is expected.
Noticed a lg. area where injection was injected 24 hrs. later. Area was 3"x3". Very red, hot to touch and uncomfortable to touch. Sent to ER, told to apply ice to the area and take Benadryl. The adverse event lasted 36 hours, approximately.
Pt recvd vax & devel t105 for approx 12 hrs p/inject; also had limited ROM of inject site & limb rt leg;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M028546 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Sender's Comments: US-009507513-1708USA013567.
I have covid-19 now, and was wondering how long Pfizer recommends between onset of symptoms and getting the booster shot?; I have covid-19 now, and was wondering how long Pfizer recommends between onset of symptoms and getting the booster shot?; 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 (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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), for COVID-19 immunization. No PQC was present. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have covid-19 now and was wondering how long Pfizer recommends between onset of symptoms and getting the booster shot?".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fainted about 1 min. after vaccine, muscles contract, arms towards chest area with hands clenched. Eyes rolled up, unresponsive, lasted about 20 sec. then pt confused, not aware of what happened, felt tired and sweaty, vomiting. TX: rest, sponge towel and sips fluids.
pt recv vax 215PM by 5PM same PM pt began to cry;cry was high pitched & inconsolable for approx 2 1/2-3hr;temp was 100 w/electronic thermometer;pt recv APAP;inj site red, warm to touch;
Patient awoke this AM with fever, myalgias, fussiness, restlessness, vomiting.