chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient who was fully vaccinated with Pfizer's vaccine and got treated with Paxlovid for COVID-19 4 weeks ago. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got treated with Paxlovid for COVID-19 4 weeks ago". Therapeutic measures were taken as a result of Covid-19. Caller would like to know if there's any interval (waiting time) between the end of Paxlovid treatment and the second booster. Pharmacist stating that she has a patient that already took 3 booster shots and wants to get the 4th booster shot and also mentioned that the patient took the Paxlovid pill 4 weeks ago. Caller wants to confirm if the Patient can get the 4th booster shot today or should they still wait. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of Covid-19 and drug ineffective is: expected. The case will be reassessed further upon receipt of additional information.
COVID breakthrough. Patient had cough, SOB starting on 12/20/21. Came to Emergency Dept on 12/22/21.
Injection site soreness/tenderness; Fatigue; Malaise; Chills; Nausea; Dizziness/foggy; Dizziness/foggy; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 13Apr2021 at 10:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included congenital complete heart block and anxiety. Concomitant medications taken within two weeks of vaccination included estrogens conjugated (PREMARIN) and omeprazole (MANUFACTURER UNKNOWN); both from unknown date for unknown indication and unknown if ongoing. The patient previously received prednisone (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) and experienced drug allergy to both drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 15:45, the patient experienced injection site soreness or tenderness, fatigue, malaise, chills, nausea, dizziness or foggy. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness or tenderness, fatigue, malaise, chills, nausea, dizziness or foggy was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Tender left cervical node and left axillary nodes mild erythema to left deltoid with tenderness.
Information has been received form a nurse and a medical assistant concerning a 36 year old white male who on 11AUG2003 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. On 23AUG2003 the pt developed a temperature of unknown degree and the next day, on 24AUG2003, broke out in 100-120 spots. The majority of the spots were on his chest and back. 20 on his face and the rest on his arms and legs. The report indicated that this was a "severe" case of chickenpox breakthrough. The pt was treated with calamine lotion and is "now healing" , with only a few crusty spots left. Follow up information indicated that the pt became covered with 100-120 pox with the majority being on the trunk. There were approximately 20 on the face and the remaining were on arms and legs. On 31AUG2003 all the pox were scabbed over. It was noted that the patient recovered. No additional information is expected.
Patient received vaccine on 1/11/2021. Patient passed away 1/15/2021, cause not reported, unaware if related.
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (albumin status: rHA; lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Three days after my first dose of the Pfizer-BioNTech COVID-19 vaccine, I had a routine wellness check at my primary care doctor.  They found in my bloodwork that I was very hyperthyroid with nearly undetectable TSH levels and very high T3 and T4.  I was not symptomatic at the time of the initial bloodwork, the only thing I had noticed from the day of my vaccine through the following week was that my resting heart rate had skyrocketed from an average of high 50s to 60bpm to 80+.  By March 18th, I had started to feel intense heart palpitations, sweating, shakiness, and dizziness. Further testing found that I had subacute thyroiditis likely caused by the COVID vaccine.  I ended up going very hypothyroid with high TSH levels a month after the initial testing and am currently on levothyroxine hoping for a full recovery of my thryoid function.  The reason for concluding the vaccine was likely the cause was that I have no history of thyroid issues, had not been recently ill with anything, and it had been 1.5 years since I last had my baby.  I had last had my thyroid tested October 2020 with my OBGYN as part of her routine checks and had normal TSH levels then.  The timing and events led us to conclude the vaccine was likely the cause of the thyroiditis.  I ended up delaying my second dose for six weeks due to the unknown status of my thyroid at the time.  I received my second dose on April 22 and had zero side effects from that second dose.
approx 15 mins p/vax pt exp SOB; began wheezing & was treated w/ventolin; VS otherwise stable; pt then had hives covering arms/legs/abdo; eyes became puffy;
I've had shingles and I've had the vaccine; I've had shingles; All pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I've had shingles and I've had the vaccine) (serious criteria GSK medically significant), shingles (Verbatim: I've had shingles) and pain (Verbatim: All pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Apr-2023 Shingles hurt (no itch).  The vaccine was just awful too.  The patient would not do it again. No itch, all pain. The patient had shingles and had the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
anaphylaxis, difficulty breathing, throat swelled, shortness of breath.  Epinephrine and benedryl  given at 1:08 by MD in office (I work in a doctor's office).  Went to ER when able to breathe better.  Pain and swelling at injection site- notice upon waking the following day
Within 15 minutes of administration pt has itching of face and neck and dry cough. Whelps on body with hive reaction (2 on neck and 4 on body) Given 2mg DECADRON IM, Epinephrine 0.1 ml SQ - 20 min later wheezing on auscultation. XOPENEX Neb tx and hospitalized for observation and support. 9/4/09-records received date of service 7/29-7/30/09-DC DX: anaphylatic reaction to vaccine about 20-30 minutes after injection.  Hives.  ICD-9 code 995.0  8/10/09 ICD-9 Code: 995.0 anaphylaxis,  E941.1 Adverse effects of drugs affecting the autonomic nervous system, parasympathetics (anticholinergics, antimuscarinics), spasmolytics.
After about 24 hours, headache, cough, low grade fever of 100.0, palpitations, general malaise.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 10-SEP-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On an unknown date in January 2015, the patients were vaccinated with RECOMBIVAX HB (lot # H014132, dose and route of administration not provided). It was reported that the vaccines which was administered were improperly stored. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link (1507USA000660). Additional information has been requested.
Mild vomiting, rash from neck to bottom, ears, and face, twitching, fever.
This literature market report has been received from the authors of a published literature article concerning 10 of 14 students presented with clinical mumps. The patients were male university students aged 19 to 22 years. Nine of them were members of the same sports team; 1 had used the same gym facility as the infected athletes; and 1 was a hall mate of an infected athlete. The patients had received 2 childhood MMR (manufacturer unknown) (lot#, dose and route unspecified) vaccinations. On unknown dates, the patients presented with a chief complaint of unilateral parotitis. Fever was the second most common symptom, followed by upper respiratory symptoms. At the time of the initial student health visit, the patients were found to have high mumps immunoglobulin G (IgG) levels of greater than 4 index (positive was greater than or equal to 1.10) and negative immunoglobulin M (IgM) levels (less than 1:20). All patients had detectable buccal swab mumps virus ribonucleic acid (RNA) reverse transcription polymerase chain reaction (RT-PCR). The outcome of the event was unknown. The reporter considered parotitis to be related to MMR (manufacturer unknown). This is one of several reports received from the same source (linked with MARRS # 1608USA002099, 1608USA014935, 1608USA015164). Additional information has been requested.
for the first few hours I had a Chronic pounding headache that transferred to a headache that causes my  Head and ears to ringing within a few days ..  I was given  steroids that could have possibly helped with the headaches but I received the second shot.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. It was reported that the patient was vaccinated with expired PNEUMOVAX23 (lot # (669380/1397Z), exp 04-AUG-2012) on 15-AUG-2012 (route was unspecified). No adverse effect reported. The outcome of patient was unknown. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L016283, expiration date: 07-AUG-2016) (dose, anatomical location, route of administration and frequency were unspecified). No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same source. Additional information has been requested.
55 year old female c/o itching, swelling, and pain on left arm that radiates to wrist x 2 days. Patient was given Tdap, MMR, and PNUPs on left arm on 05/26/2016. Was seen by NP on 06/02/2016 and diagnosed with Cellulitis of left arm, approx. 25cm x 7cm. NP referred patient to Urgent care for further evaluation and treatment.
misadministration of the MMR II vaccine/ the patient received her first dose of MMR II vaccine on 2/20/2023 and her second dose on 3/9/2023; No additional AE's; This spontaneous report was received from a consumer and refers to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 20-FEB-2023, the patient received her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and her second dose on 09-MAR-2023 (exact dose, injection site, route of administration, lot # and expiration date were not reported for both) for prophylaxis (inappropriate schedule of vaccine administered).  No additional adverse events were reported.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 6 year old patient. On 06-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
On 3/09/2021 My left side of my cheek (upper jaw) swelled up size of ping pong, and tender to the touch. Lasted for two days.
Patient presented to BWH ED on 10/16/21 with worsening confusion superimposed on dementia and unwitnessed fall. Patient is fully vaccinated.  Patient's covid test came back positive, however asymptomatic. Patient was treated appropriately and was discharged on 10/26/21
Pt had swelling at injection site, itchiness that spread throughout body no fever or headache. Went to urgent care - was prescribed KEFLEX, prednisone, ATARAX.
numbness in arm & legs;evaluated by neurologist 2mo p/vax w/ sx gradually resolving;
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 15-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 25-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
This spontaneous report as received from a medical assistant referring to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 (dosing details were not reported) lot # L043214, expiry date: 30-AUG-2017. It was reported that the vaccines were exposed to a temperature of 0.7C during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Per employee:  "Got the second COVID vaccine (Moderna), and a few hours shortly after I felt cold and temp was 103.2 with body aches, nausea, headaches, swelling in the left arm and light headedness. still have some symptoms the next following "
Redness, swelling, pain and itching on the site as well as the whole upper arm. Redness is spreading and have not got any better in last 6 days. patient has taken tylenol for pain and will take benadryl
10 min after receiving injection developed itching of scalp, along hair line right upper forehead, left upper arm, left lower leg.  At approx 20 min after receiving injection continued to develop itching right lower lip, anterior neck, left ear, right lower arm.  Small hive noted anterior neck and right lower arm. Hives resolved in approx one hour without treatment.  Approximately 2 hrs after receiving injection continued to have itching and 'prickly' feeling on skin.  Benadryl 25mg taken, with some relief of itching.  Approximately 4 hours after injection an additional Benadryl 25mg taken.  Itching resolved.  On 1/28/21, day after injection, at approximately 12:00 pm, body aches and chills, Temp 100 degrees developed.  Tylenol was taken.  Approximately 4:00pm chills and body aches worsened, Temp 99.6.  Ibuprofen 400mg taken.  at 10:30pm increase of body aches and chills Temp 102 Ibuprofen 800mg taken, Benadryl 50mg taken.  Day 3, 1/29/21,  temp normal mild body aches and chills continue at 1:45 pm.
21 hours after vaccine, developed hives and itching at injection site, wrist and torso (bra line). no other sx
She was diagnosed with Covid on board a ship and the next day her symptoms got worse. She was given Paxlovid; She was diagnosed with Covid on board a ship and the next day her symptoms got worse. She was given Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 25Feb2021 as dose 2, single (Lot number: CH6200), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FS4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme disease" (ongoing), notes: Has had 2 exacerbations since being diagnosed with Lyme disease. Was diagnosed in May2015 or May2016. Concomitant medication(s) included: ATOVAQUONE oral taken for lyme disease (ongoing); AZITHROMYCIN taken for lyme disease (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jan2023, outcome "not recovered" and all described as "She was diagnosed with Covid on board a ship and the next day her symptoms got worse. She was given Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jan2023) Positive; (01Feb2023) Negative; (02Feb2023) Negative; (03Feb2023) Positive, notes: Weak positive; (08Feb2023) Positive, notes: Strong positive; Weight: (unspecified date) 137-138 lbs. Therapeutic measures were taken as a result of vaccination failure, covid-19 included PAXLOVID from 26Jan2023 to 31Jan2023.
Within 24 hours post vax, the pt's nose became swollen and red. Within 48 hours post vax, the sores broke open on his nose with yellowish pus that seeped out for approximately 48 hours. There were open, bleeding sores on my nose for 7 days, then the sores started to heal. By 10 days post vax, the sores were gone. Sores were accompanied by headache, cough, and lethargy.