chrisvoncsefalvay/vaers-outcomes huggingface dataset:
\This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 10Feb2021 as dose2, single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included hydrochlorothiazide taken for blood pressure and lisinopril taken for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. After two weeks of second dose of COVID vaccine patient developed a side effect with a swollen lymph node, his gland was swollen (in Feb2021). He had been experiencing low blood pressure and asked if the vaccine had any ingredients in it that would cause low blood pressure, because he was diagnosed with high blood pressure. The patient underwent lab tests and procedures which included blood pressure: 105/58 on 08Mar2021 7:30 AM, blood pressure: 103/51 on 08Mar2021 12:30 PM, blood pressure: 101/56 on 08Mar2021 1:05 PM, blood pressure: 108/52 on 08Mar2021 2:10 PM, blood pressure: 114/61 on 08Mar2021 4:20 PM, blood pressure: 121/61 on 08Mar2021 8:00 PM, blood pressure: 109/61 on 08Mar2021 10:00 PM, blood pressure: 122/63 on 08Mar2021 11:45 PM, blood pressure: 106/58 on 09Mar2021 6:30 AM, blood pressure: 115/54 on 09Mar2021 7:30 AM, blood pressure: 112/65 on 09Mar2021 9:30 AM, blood pressure: 112/58 on 09Mar2021 12:40 PM, blood pressure: 110/60 on 10Mar2021 12:30 AM, blood pressure: 121/64 on 10Mar2021 5:30 AM, blood pressure: 128/69 on 10Mar2021 10:15 AM, blood pressure: 115/61 on 10Mar2021 12:15 PM. Pulse: 71 on 08Mar2021 12:30 PM, Pulse: 75 on 08Mar2021 12:30 PM, Pulse: 75 on 08Mar2021 1:05 PM, Pulse: 74 on 08Mar2021 2:10 PM, Pulse: 72 on 08Mar2021 4:20 PM, Pulse: 64 on 08Mar2021 8:00 PM, Pulse: 67 on 08Mar2021 10:00 PM, Pulse: 62 on 08Mar2021 11:45 PM, Pulse: 72 on 09Mar2021 6:30 AM, Pulse: 79 on 09Mar2021 7:30 AM, Pulse: 79 on 09Mar2021 9:30 AM, Pulse: 71 on 09Mar2021 12:40 PM, Pulse: 65 on 10Mar2021 12:30 AM, Pulse: 64 on 10Mar2021 5:30 AM, Pulse: 64 on 10Mar2021 10:15 AM, Pulse: 67 on 10Mar2021 12:15 PM. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
sx started 17MAR96; lt arm severe swelling & redness;cont crying lasted 2 days; tx w/DPH & APAP-all sx gone in 2 days
The spontaneous report as received from a medical assistant refers to a 11-month-old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, intramuscular (lot # J006358, expiry 23-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I had covid rebound occur 15 days after my first positive test; (20Jun2022) Positive, notes: positive antigen test. Therapeutic measures were taken as a result of covid-19, drug ineffective. Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 05Jun2022 Treatment stop date: 09Jun2022, indication: Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Generalized rash to extremities 5 days after receiving 1st Moderna COVID-19 vaccine, treated with IM steroids.
Patient was given vaccine in the left arm noted some itching the day after the vaccine but reported swelling and warmth the day after that was progressively worsening.
temp 99.6 F (axillary) swelling of thigh, cried for 4-5 hours after shot
No additional AE reported; Temp excursion of 47.9°F for 47 min on Dec. 1st, 2022; This spontaneous report was received from a Health Care Professional and refers to a 6-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) administered orally (lot# 1892784, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and upon internal validation established as 03-DEC-2023) and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), administered intramuscularly in left tight (lot# W006596, has been verified to be a valid lot number for haemophilus b conjugate vaccine [meningococcal protein conjugate][LIQUID PEDVAXHIB], expiration date reported and upon internal validation established as 11-OCT-2024). Both vaccines were given as prophylaxis.  The administered doses of the vaccines experienced a temperature excursion (product storage error) on 01-DEC-2022. The vaccines administered were stored at a temperature excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes.   No adverse event was reported.  This is one of several reports received from the same reporter.
Wrong formulation of Covid-19 vaccine administered to patient. Parents informed of incident by Provider, at time of error. Patient monitored for 15 minutes in case of adverse reaction. All up to date EUA statements for Pfizer Vaccine Gray Cap given to patient's Guardians prior administration. Parents encouraged to contact or return to clinic for any questions or concerns.
He experienced chest pain on the left side of this chest (pain 8 out of 10), had difficulty breathing, and felt his heart was beating really fast and coming out of his chest.
Woke up later than usual, was sleepy all day.  Developed hives in the morning, that rapidly spread from the diaper area to the abdomen and thighs, then to the ears, with associated ear swelling and redness.  Left side of face also developed urticarial type rash.  He was taken to the Emergency Room where his symptoms began to resolve (approximately 1-2 hours).  He was given Prelone and Benadryl even though the symptoms were already improving.  Rash has not recurred.  No more medicines have been given.
Fever; Flu like symptoms; In bed 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, influenza-like symptoms and activities of daily living impaired. On an unknown date, the outcome of the fever, influenza-like symptoms and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the fever, influenza-like symptoms and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The patient wanted to find out the ingredients of the vaccine.  The patient had a bad reaction to the first shot, was in bed 4 days with fever and flu like symptoms.  For tolerance of 2nd dose, refer case US2021AMR043058.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043058:Same reporter.
Fever, shaking chills, body aches, headache, brain fog, fatigue, bloody nose that was difficult to stop
SINUS HEADACHE; 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 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-MAR-2021, the subject experienced sinus headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus headache. This report was non-serious.
NUMBNESS IN THE RIGHT LEG; RIGHT LEG A LITTLE HOT; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced numbness in the right leg. On MAR-2021, the subject experienced right leg a little hot. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in the right leg, right leg a little hot and tired was not reported. This report was non-serious.
Employee here with COVID vaccine reaction was given shot in right upper arm in deltoid area on 12/30/20. Redness came on after the vaccination but went away then on 01/07/21 it came back. The site is red, swollen, warm to the touch, with clearly defined borders. Site is 3.5 X 2.5cm and outlined in ink for monitoring. Explained conservative measures including cool compresses, if allowed by PCP taking OTC IBU and OTC antihistamines. If area worsens skin becomes taught or streaking develops to seek further care form PCP or walk in clinic. Employee verbalizes understanding and agrees with plan.
severe left arm and shoulder pain; severe left arm and shoulder pain; This is a spontaneous report from a contactable Nurse, a Pharmacist and a Physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced severe left arm and shoulder pain. The outcome of the events was not recovered.  This follow up report contains no new medically significant safety information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This pt received his first vax on 04/27/00. One day post vax, he experienced lightheadedness, malaise and a slight fever. No outcome was provided.
Large Red patch on arm around injection site.  If it?s relevant, my first two doses were Pfizer, and I chose Moderna for the booster so this was my first time getting the Moderna injection.
Patient had severe diarrhea for about 3 days then a week after the vaccine she developed a red rash from shoulder to elbow that burned and was hot to the touch. That resolved 2 days after.
Information has been received from a medical assistant concerning a 21 month old female child with no known allergies, or pertinent medical history who on 10-JUN-2008 was vaccinated SQ with 0.5ml of MMR II (Lot # 660208/0454X). There was no concomitant medication. Subsequently, on 23-JUN-2008 the patient was seen back in the office for a fever and a rash. It was noted that the rash started on the patient's legs and spread upwards onto her body. The patient's mother reported the patient had a fever as high as 103.0 degrees F. The patient's eyes were also red with a discharge. There was no itching noted. It was also reported that the patient had a low grade temperature at the physician's office. "Blood work" was obtained. The results showed "no measles, probably a reaction to the vaccine." At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from a medical assistant concerning this 21 month old female patient who, on 13-JUN-2008, was vaccinated S.Q. in the left deltoid with a first dose of MMR II (lot # 660208/0454X). The patient had otitis media and an upper respiratory tract infection at the time of vaccination. On 23-JUN-2008 the patient developed a measles-like rash, fever and conjunctivitis 13 days after vaccination. It was noted that the patient was on amoxicillin at the time (day 9 of 10) of vaccination for otitis media. Subsequently, the patient recovered on 25-JUN-2008. Additional information is not expected.
Approx 9/4/10 developed diffuse headache, low grade temp; evolved to altered mental status; admitted 9/7/10. Seizure 9/11/10. Dx: Nonspecific encephalitis.
nightmare; needed help walking; slight loss of short-term memory; food tasted bitter; tired; stayed in bed asleep for 3 days; This case was reported by a consumer via call center representative and described the occurrence of taste bitter in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 1st October 2020, refer case US2022053011).   On 1st March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 1st March 2021, 6 hrs after receiving Shingrix, the patient experienced taste bitter and tiredness. On 4th March 2021, the patient experienced nightmare, unable to walk and short-term memory loss. In March 2021, the patient experienced hypersomnia. On 4th March 2021, the outcome of the nightmare was recovered/resolved. On 4th April 2021, the outcome of the unable to walk was recovered/resolved. On an unknown date, the outcome of the taste bitter and hypersomnia were recovered/resolved and the outcome of the tiredness was unknown and the outcome of the short-term memory loss was not recovered/not resolved.   It was unknown if the reporter considered the taste bitter, tiredness, hypersomnia, nightmare, unable to walk and short-term memory loss to be related to Shingrix.     Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix vaccine on left arm.  The patient reported about 6 hours after the injection she ate dinner and the food tasted bitter.  After dinner less than a day after vaccination patient was so tired, she dragged herself up the stairs and 12 hours after vaccination she stayed in bed asleep for 3 days.  On the third day, she had a nightmare that woke her from the 3-day sleep.  After she awoke, she needed help walking for about 1 month.  The patient also reports she had a slight loss of short-term memory.  On 4th March 2021, 3 days after vaccination the patient experienced nightmare, unable to walk and short-term memory loss. The reporter did not give permission to contact HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022053011:Same patient
Rash around mouth and trunk.  Rash on right leg with blistering x approx. 3 days.  Pt had egg allergy causing allergic rash.  Prescribed Benadryl 6 mg by mouth every 6 hours and hydrocortisone 1% cream twice a day as needed.
Neck where also sore; Left shoulder where also sore; Tired; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck where also sore), MYALGIA (Sore arm), ARTHRALGIA (Left shoulder where also sore), FATIGUE (Tired) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (Sore arm). On 27-Mar-2021, the patient experienced NECK PAIN (Neck where also sore) and ARTHRALGIA (Left shoulder where also sore). 27-Mar-2021, the patient experienced FATIGUE (Tired) and HEADACHE (Headache). On 30-Mar-2021, NECK PAIN (Neck where also sore), MYALGIA (Sore arm), ARTHRALGIA (Left shoulder where also sore), FATIGUE (Tired) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported   This case was linked to MOD-2021-255679 (Patient Link).
Started with intermittent fever 6 - 8 days after vaccination.  Then on 4/3/2020 had persistent high fever.   Fever broke 4/5/2020 and then widespread rash started as fever broke.
headache; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (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 following information was reported: HEADACHE (non-serious) with onset 18Apr2021, outcome "unknown", described as "headache".  Additional Information: The patient asked if he could take acetaminophen (TYLENOL) or ibuprofen (ADVIL) for headache because he was experiencing it after taking the first dose of COVID-19 vaccine last 18Apr2021. He could not remember his second dose schedule because his vaccination card was with his wife. .   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable physician, reporting for a patient.  A 27-year-old non-pregnant female patient received BNT62B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 13Mar2021 (Batch/Lot Number: EN6204) as a single dose (at the age of 27 years old) for covid-19 immunisation.  Medical history included multiple sclerosis from an unknown date. Concomitant medication(s) included dimethyl fumarate (TECFIDERA) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, levonorgestrel (TRI-LEVLEN) taken for an unspecified indication, start and stop date were not reported, and an unspecified Multivitamin taken for an unspecified indication, start and stop date were not reported.  The patient previously took doxycycline and experienced drug allergy.  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. Two weeks after receiving her first dose of BNT62B2, the patient experienced multiple sclerosis exacerbation (myelitis per MRI of the cervical spine) suggesting that it triggered the exacerbation/myelitis on Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included magnetic resonance imaging (MRI): triggered the exacerbation/myelitis on Mar2021 triggered the exacerbation/myelitis. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of multiple sclerosis exacerbation (myelitis per MRI of the cervical spine) suggesting that it triggered the exacerbation/myelitis and include Solumedrol Infusions/ Radiology Testing. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a temporal association, a contributory role of BNT162B2 to the events multiple sclerosis exacerbation and myelitis cannot be completely excluded.  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.
Vaccine was given after the 10 week expiration from being placed in the refrigerator. 10 week expiration should have been April 7, 2022 but vaccine was given on 4/8/22. All other proper storage requirements were followed.
Localized swelling, erythema, warmth at site of injection. Circular area measuring 2-3 inches in diameter. Picture was visualized by MD.
Rash on arm warm and red dr said it is cellulitis put patient on clindamycin 300 mg cap.
One week after boostrix child reported loss of memory. Went to school nurse. Told to see her usual physician. 3/23/06
The tetanus shot completely destroyed my life. I am in a wheelchair. I cannot take care of myself.