chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low-grade Fever, 99.8 - 100.8; moderate headaches; moderate exhaustion; moderate muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202); via an unspecified route of administration in the left arm on 03Mar2021 (at the age 69-year-old) at 08:30 as a single dose for COVID-19 immunisation. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249); via an unspecified route of administration in the left arm on 11Feb2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included asthma, atrial fibrillation (A-fib), fibromyalgia, high blood pressure, cerebellar ataxia. The patient had known allergy to propantheline, codeine, eggs and milk. 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 COVID vaccine. Concomitant medications included ELIQUIS, guaifenesin (MANUFACTURER UNKNOWN), carbidopa-levodopa (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN); all from an unknown date administered for unknown indications. On 04Mar2021, the patient experienced low-grade fever 99.8- 100.8 (unspecified units) for 24 hours, moderate headaches for 48 hours, moderate exhaustion for 72 hours and moderate muscle aches for 48 hours. On an unknown date, the patient underwent body temperature recording and the result was 99.8-100.8 (Unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of low-grade fever resolved on 05Mar2021 and clinical outcome of the events moderate headache and muscle ache were resolved on 06Mar2021 whereas, event moderate exhaustion was resolved on 08Mar2021. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
TIRED; PAIN AT THE INJECTION SITE; SEVERE BODY ACHES; UNCONTROLLABLE SHAKING; NAUSEA; HEADACHE; HIGH FEVER; This spontaneous report received from a patient 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced severe body aches. On 07-APR-2021, the subject experienced uncontrollable shaking. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced pain at the injection site. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, severe body aches, and pain at the injection site, had not recovered from tired, and the outcome of uncontrollable shaking, nausea and headache was not reported. This report was non-serious.
I have no energy.; Because since the 2nd in June 2021 I am always tired I have to take naps during the day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I have no energy.) and FATIGUE (Because since the 2nd in June 2021 I am always tired I have to take naps during the day) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (I have no energy.) and FATIGUE (Because since the 2nd in June 2021 I am always tired I have to take naps during the day). At the time of the report, ASTHENIA (I have no energy.) and FATIGUE (Because since the 2nd in June 2021 I am always tired I have to take naps during the day) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant medication reported.  Patient year of birth was reported.  No Treatment medication reported.
patient had swelling of the lips 2 days after receiving their bivalent pfizer and fluarix influenza vaccine.  Still swollen 5 days later.
COVID-19; Migraine; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), VOMITING (Vomiting) and COVID-19 (COVID-19) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and Psoriatic arthritis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced MIGRAINE (Migraine) and VOMITING (Vomiting). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, MIGRAINE (Migraine) and VOMITING (Vomiting) had resolved and COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 28-year-old, female patient with history of co-suspect administration of Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19, and other associated non-serious events. The event COVID-19 occurred on an unspecified date after receiving the first dose of the mRNA-1273 vaccine on an unspecified date in Oct2021. The other non-serious events occurred on unspecified dates in 2021 after receiving the first dose of the mRNA-1273 vaccine on an unspecified date in Oct2021. Treatment information was not provided. The outcome of the event COVID-19 was unknown, while the other non-serious events had resolved at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 28-year-old, female patient with history of co-suspect administration of Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19, and other associated non-serious events. The event COVID-19 occurred on an unspecified date after receiving the first dose of the mRNA-1273 vaccine on an unspecified date in Oct2021. The other non-serious events occurred on unspecified dates in 2021 after receiving the first dose of the mRNA-1273 vaccine on an unspecified date in Oct2021. Treatment information was not provided. The outcome of the event COVID-19 was unknown, while the other non-serious events had resolved at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
kidney stones; blood in the urine; her arm is a little sore; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history included kidney stones. The patient's concomitant medications were not reported.   The patient reported that she got her 1st vaccine and her arm was a little sore and they said that is normal. Caller relayed that she just went to the bathroom and there was blood in the toilet, she thought shoot she was getting kidney stones. Caller asked if vaccine side effect could be blood in the urine or kidney stones (which she has done before). The patient outcome of the events was unknown.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
patient received the first dose of SHINGRIX on September 8, 2023, and the second dose of SHINGRIX  on September 23, 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2R375, expiry date 28-MAY-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 23-SEP-2023, the patient received the 2nd dose of Shingrix. On 23-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received the first dose of SHINGRIX on September 8, 2023, and the second dose of SHINGRIX  on September 23, 2023).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 26-Sept-2023 The case was received from the pharmacist. The reporter did not consent to follow-up. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
REDNESS, HEAT, AND ITCHING AT INJECTION SITE, TREATED SUCESSFULLY WITH BENADRYL
Less than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number X9KC7, expiry date 25-OCT-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 07-AUG-2023, the patient received the 2nd dose of Shingrix. On 07-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Less than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: Receipt Date: 07-AUG-2023 They provided information about event, vaccine and patient. The vaccine administration facility was the same as primary reporter The pharmacist called to report that a patient received their second dose on 07 August 2023 after receiving the first in July 18th 2023, which led to shortening of vaccine schedule The reporter consented to follow up.
Beginning some time in the two weeks after the vaccine my asthma became uncontrolled. Use of my albuterol rescue inhaler increased from once or twice a week to once or twice per day. This continued through the summer and into the beginning of November, when my breathing became better and rescue inhaler use decreased back to baseline. During the period of uncontrolled asthma I experienced daily wheezing, a cough, and heavy mucus buildup in my throat and trachea. I had no fever, and the symptoms were generally not worse during exercise. The rescue inhaler provided only partial relief. There was smoke from forest fires during part of the summer, but the uncontrolled asthma did not align temporally with the smoke, although the smoke made it worse. When I travelled during the summer and fall, the asthma did not significantly change.
Hospitilization, death, fever, chills, SOB, tachycardia, cough, myalgia, light headedness, congestion, super imposed bacterial pneumonia  Second COVID Vaccine, Pfizer, received 11/10/21, Lot # FF2587, RUD IM, Dose 2
Arm pain moderate within 5 minutes Symptoms onset at two hours post vaccination of diffuse myalgias, moderate headache, followed by repeated vomiting. At 4 hours had a Fever of 102. Symptoms remaining intense for 24 hours of frequent vomiting, headache, fevers and myalgias. Improvement by 48 hours. Back to normal at 72 hours.
Approximately 2.5 hours after vaccinations, infant became fussy and irritable, crying inconsolably which lasted, despite TYLENOL and other comfort measures, until he went to sleep that night. This lasted greater than 7 hours.
Slightly blotchy, not raised area. Slight pain and itchy. Advised cool compress to area.
November 22, 12 days after vaccine: Itchy all over, hives appearing randomly on stomach, back, neck, arms, legs, feet, palms, everywhere! Bought OTC cortisone cream to help with itching. Progressively got worse. December 1st it was unbearable and nothing was working, left work early to go to facility and get diagnosed "unknown cause of hives" prescribed Triaminolone Acetonide Cream  to apply where hives breakout to ease the itch/burn & 6-day pill pack, Methylprednisolone which I started taking on December 2nd. Still had random hives entire time taking the steroid pill, but they were less fierce. Hives would appear randomly throughout the day, no specific time or place on my body, no specific food agitations or stressors to set it off.  December 5, Dermatologist apt that recommended Allegra 180mg in AM and Xyzal 5mg in PM, switch everything in house to free-and-clear, (which I already had done). Not being a person to take medications regularly, taking two types right away scared me, so I started with 1 Allegra, 180mg in the AM. Seems to work throughout the day, with hives appearing in the evening, but not to the point where I feel I need to take additional medicine, I just go to bed most nights and then take Allegra again when I wake up, hives being  there every morning as well. Have had several reactions to high histamine foods: Dec 7th: Pealing an orange my hands and face turned bright red, Dec 8: cutting cabbage my hands, arms and stomach broke out in hives, Dec 9: eating peanuts, my chin turned beat red. I have been avoiding foods known to be high in histamine until I am able to get further testing done.
A report has been received from a Health Professional concerning, who had had been receiving FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on an unknown date. HCP reports that a patient received expired FLUMIST vaccine. The patient experienced patient received expired vaccine (medication error). The outcome of the event of patient received expired vaccine (medication error) is unknown. The report was considered to be non-serious by the company physician.
Body aches and cold chills the day after injection.  Symptoms lasted for 24 hours.
High pitched screaming for more than 5 hours after vaccines were given. Also, my son developed eczema within 2 weeks after he received first Vaccination.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L040458, expiration date reported as 04-FEB-2018, lot # K018180, expiration date reported as 17-SEP-2016, lot # L03343, expiration date reported as 13-SEP-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. states that after receiving the 3rd Booster of Phizer 10/01/2021, started experiencing symptoms 10/02/2021 started experiencing symptoms of stiff neck (right side) and low back pain. 3 days subsided, No noted Primary visit.
11/29/21 - Got Pfizer booster 11/30- Started getting sore left deltoid at injection site 12/1 - Lymph nodes in left armpit feel swollen 12/2 - Lymph nodes at left collarbone feel swollen, feel itchy around neck/chest for a few days 12/3-12/4 - Armpit feels better, itchiness resolves, collarbone lymph nodes still swollen 12/5 - MAIN ADVERSE EVENT: Woke up with muffled hearing in left ear, felt like cotton in ear. Towards evening, noticed rumbling/high-pitched whine/tinnitus in quiet rooms, hearing still poor. Right ear feels OK.  Took 2 rounds of 2 pills of OTC ibuprofen throughout the day, no change 12/6 - No change, called for ENT appts. Took 1 Aleve around midday, no change 12/7 - Saw ENT, he looked in ears/nose/throat with otascope and said no sign of wax problem or infection, noted swollen lymph nodes at left collarbone. Got prescription for Prednisone: 2x20mg once a day for 4 days, 1x20mg once a day for 4 days after that (12 pills over 8 days total). Took first dose (2X20mg) around 11am. No change in hearing.  Tried to sleep with head elevated and on right side per ENT suggestion. 12/8 - Took 2nd dose (2x20mg) at 8:45am.  No change in hearing.  12/9 - Took 3rd dose (2x20mg) at 8:45am.  No change in hearing thus far. Lymph nodes at left collarbone still seem swollen.
Increased heart rate, blood pressure drops, lightheaded, dizzy, almost passing out, chest pain, numb arms and legs, breaking out in cold sweats
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L008996, exp. 01-DEC-2016) (dose and route of administration not provided. No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 10/25/2021. PATIENT FULLY VACCINATED ON 04/15/2021.
102.5 fever, chills, nausea, vomiting, headache, soreness at injection site.
On 3/23/98 pt recv vax; same day pt exp hives around inject site described as circular blotches and the vax spot appeared white.  The entire area was raised and hard.
Body aches and chills through the night By 9 am Wednesday- 102 fever Severe headache / migraine through Wednesday Fever broke Wednesday night Still fatigued and sore arm (Friday morning)
pt recvd vax; 4 mo after recving 3rd dose, presented to er w/ high t; weakness; dx w/ neutropenia;
No additional AE reported; HCP reported a patient was inadvertently administered an expired dose of RECOMBIVAX HB.; This spontaneous report was received from a medical assitant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-DEC-2022, the patient was inadvertently administered an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter (valid lot #U001837, expiration date: 21-NOV-2022) administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The reporter was provided the "supported" disclaimer per the post expiry memo. No additional information provided. No additional adverse event (AE) was reported (no adverse event).
suspected vaccination failure; shingles; This 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.   The patient's past medical history included shingles (had the shingles 3 times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingle shot and got shingles again. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
generalized weakness; congestion; no appetite; headache; fever; achy arm; Muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 8 hrs after receiving Shingrix, the patient experienced weakness (Verbatim: generalized weakness), nasal congestion (Verbatim: congestion), appetite absent (Verbatim: no appetite), headache (Verbatim: headache), fever (Verbatim: fever), pain in arm (Verbatim: achy arm) and muscle soreness (Verbatim: Muscle soreness). The outcome of the weakness, nasal congestion, appetite absent, headache, fever, pain in arm and muscle soreness were resolved (duration 1 week).   It was unknown if the reporter considered the weakness, nasal congestion, appetite absent, headache, fever, pain in arm and muscle soreness to be related to Shingrix.     It was unknown if the company considered the weakness, nasal congestion, appetite absent, headache, fever, pain in arm and muscle soreness to be related to Shingrix.   Additional Information: GSK receipt date: 25-JUL-2023 The reporter calling in response to a message, where he had shared his adverse event experience following both of his Shingrix vaccinations. The patient experienced an achy arm where the shot was administered, along with fever, muscle soreness, headache, no appetite, congestion and generalized weakness necessitating him staying in bed for 3 days.  These symptoms lasted about one week. This case is linked to the case US2023101963, reported for wife's patient.; Sender's Comments:  US-GSK-US2023101963:Same reporter,female patient
Body Aches; swollen lymph nodes in armpit of left arm that caused soreness; tiredness.  Took one dose of Tylenol at 11:00 am and took a 2 hour  nap.   Took a second dose of Tylenol at 6:00 pm. Went to bed at 9:00 pm.   Continued to have swollen lymph nodes for two days.  Treated with Tylenol for minor pain.
This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant), allergic reaction and allergic reaction to drug excipient. On an unknown date, the outcome of the autoimmune disorder, allergic reaction and allergic reaction to drug excipient were unknown. It was unknown if the reporter considered the autoimmune disorder, allergic reaction and allergic reaction to drug excipient to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's friend. The patient received unknown manufacturer's flu vaccine and had an allergic reaction to the formaldehyde and almost died. The reporter stated the patient now had an auto-immune disorder since having the flu vaccine. This case was linked with US2018221757, reported by the same reporter.
Low grade fever Aching joints Mild head ache 1 day EXHAUSTION 2 days