chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A 72-year-old female patient received PREVNAR13 on unknown date at single dose for immunization. 2 days later her arm began to turn extremely red. She went to her physician and he diagnosed cellulitis. He prescribed an antibiotic. The cellulitis last for 6-7 days. The outcome of the other event was unknown. Sender's Comments: Based on the information currently available, a causal relationship between the administration of PREVNAR13 and the occurrence of the reported events cannot be completely excluded based on the temporal relationship. 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.
Received immunization 9:13am.   Approximately 10 minutes later, patient complained of a feeling of her lower lip swelling.  Also complained of chest tightness and clearing her throat. 9: 27am patient was given 0.30cc epinephrine at the doctor's office.  She was then sent to the emergency room where she was given Benadryl and sent home.
COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive) in a 73-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) for Ulcerative colitis.    The patient's past medical history included Ulcerative colitis.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second 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) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19 virus test positive). At the time of the report, COVID-19 (COVID-19 virus test positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment-This spontaneous case concerns an elderly female patient aged 73 years with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (reported as COVID-19 virus test positive ) on unknown date (in 2021) in the context of mRNA-1273 vaccination.  Patient had received first and second dose of same vaccine at an interval of 28 days in 2021. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was resolving at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly female patient aged 73 years with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (reported as COVID-19 virus test positive ) on unknown date (in 2021) in the context of mRNA-1273 vaccination.  Patient had received first and second dose of same vaccine at an interval of 28 days in 2021. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was resolving at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.
Received Seasonal Influenza Vaccine at approximately 11:30 am, returned to clinic at 12:00 with reddish rash around mouth. Slight swelling inside lower lip. No difficulty breathing, no itching, no rash on any other body part. Refered to Private MD, called prior to leaving clinic and mom waiting on return call. Discussed with mom that if and shortness of breath or spreading of rash, to call 911 and seek Emergency care.
Dizziness, imbalance, nausea (without vomiting), body aches, sleeplessness, extreme fatigue. lasted almost 24 hours. Not getting any more of these vaccines if I am going to react like this, I do not want any more of this being put in my body.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "IBS/IBD" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: Jan2010; CYMBALTA, start date: Jan2018; TROKENDI XR, start date: Jan2012; OMEPRAZOLE, start date: Apr2012; FISH OIL, start date: Jan2018; MAGNESIUM, start date: Jan2018; ALIGN, start date: Jan2000.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment/tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (21Dec2022) Positive, notes: 1st tested positive 21Dec with symptoms; (24Dec2022) negative, notes: Tested negative on 24Dec; (31Dec2022) Positive, notes: 31Dec - Tested positive again; (02Jan2023) Positive, notes: 02Jan still positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Leg cramps in both legs; Feels like a rubber band, like tightening; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps in both legs) and FEELING ABNORMAL (Feels like a rubber band, like tightening) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Leg cramps in both legs) and FEELING ABNORMAL (Feels like a rubber band, like tightening). At the time of the report, MUSCLE SPASMS (Leg cramps in both legs) and FEELING ABNORMAL (Feels like a rubber band, like tightening) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications and treatment details were not provided.  The patient  started with the leg cramps in both legs. It was terrible for 3-4 days. Se still have it when she first wake up and get out of bed. It feels like a rubber band, like tightening.
Pt is under conservatorship of step mother. Step mother called the clinic to inform us pt had localized reaction 1 day after injection of vaccine, pt R arm swollen, raised and warm to touch and was 3 in in diameter. Step mom gave BENADRYL symptoms went away after 5 days.
7.5 x 8 cm warm tender red indurated area over rt deltoid given 10JAN92;
pt recv vax; local redness, swelling & tenderness caused by vax;pt to ofc, local rxn worsened to include red streaks down arm despite use of local heat & apap; referred to PMD;
experienced arthalgia for several weeks.; This case was reported by a physician via sales rep and described the occurrence of arthralgia in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was recovered/resolved.   It was unknown if the reporter considered the arthralgia to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The physician reported that the patient received Shingrix and experienced arthralgia for several weeks. The reporter consented to follow up. This case was linked with case US2021AMR136260, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR136260:Same reporter
I contracted Covid sometime after the 3rd dose. I had fatigue, and cough, and brain fog. It all lasted about 6 weeks. I did not see a doctor, I just tested positive for COVID. I also lost my taste and smell. I also had an odd taste and smell going for a while, I do not recall how long that lasted, but it did also go away with time.
I took 4 oral typhoid capsules as prescribed two days apart beginning on Dec 1 in morning without food for at least an hour and with full glass of water, and then again on Dec 3, Dec 5, and finally Dec 7. Each capsule was taking at approx. 07:00 AM under the same circumstances, no food for at least an hour and with full glass of water.  Between Dec 5 and Dec 7, I noticed dry, red, puffy skin around my right eye that worsened on Dec 7. I used over-the-counter cetaphil eye gel moisturizer on Dec 7 and that treated the symptoms. I used it on Dec 8 and Dec 9 and by Dec 10 the puffy skin had subsided and gone away.
Itchy rash on forehead, legs and arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-SEP-2023, the patient received the 1st dose of Shingrix (left arm). In SEP-2023, 1 week after receiving Shingrix, the patient experienced itchy rash (Verbatim: Itchy rash on forehead, legs and arms).  The outcome of the itchy rash was not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.     It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2023 The caller reported he received Shingrix dose 1 and a week later he experienced an itchy rash on his forehead, legs and arms.  Some of the rash went away, some was still there on all areas.   The reporter was referred to HCP. The reporter consented to follow up.
Patient has blood diarrhea, diagnosed w/ proctocolitis vs Chrohns flare 6/29. patient reports no other stressors, no other factors that might contribute. Patient endorses chest pain that is persisting.
pt recv vax & presented w/OM & a varicella rash;had approx 100 lesions on face, trunk & back;also exp a bulging ear & a fever of 102.7;tx w/ATB was initiated for bulging ear;pt recovered;
Information has been received from a physician concerning a 3-year-old female who at the age of one-year, in approximately 2005, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 29-Dec-2007, the patient developed shingles. The patient was treated with acyclovir. No other information was available from the physician. No product quality complaint was involved. Additional information has been requested.
Increased upper right quadrant pain, high bili levels, low hemoglobin. This was all very new.
A mild case of Shingles arose after second Moderna shot.  I had approximately 9 shingles bumps on the right side of my torso.
No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# T035408 with an expiration date on 14-APR-2022) for prophylaxis  (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursion of -10°C to 8°C (6.2°C) for 16 hours 0 minutes and 0 seconds (product storage error).    No previous temperatura excursions were reported.  No additional adverse effect were reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003904:Original Case : 2108USA003819 US-009507513-2108USA003819:Original Case : 2108USA003819 US-009507513-2108USA003905:Original Case : 2108USA003819 US-009507513-2108USA003902:Original Case : 2108USA003819
I have lost all feeling of hunger.  There are no signals of being hungry or full.  I have lost 20 lbs since I started the vaccines in September (26th).  I have been having Heart palpitations starting after the second injection.  Now I am having my blood pressure cannot stabilize and my heart rate keeps going up. Never had issues with my BP.  I have also lost the ability to cry.  I am sad but I cannot cry.  I have intermittent numbness in my forehead, and hands and feet.  My toes sometimes get ice cold then burn for hours.  Ever since the first injection I have had horrible menstrual cramping.  I can feel my ovaries they hurt.  Initially after the injections I had this odd rumbling in my stomach for hours. I had a feeling of being crushingly ill at night along with night sweats.  Still have night sweats off and on.  I got misdiagnosed with anxiety.  I still cannot eat.  I tried PPI but nothing seems to make me hungry
Labs indicated a <0.9 Varicella IgG and was provided a Varicella Vaccination on 7/3/2013. He was housed with someone who also had a <0.9 Varicella IgG and was provided a Varicella Vaccination on 7/3/2013. Both patients were vaccinated with the same Merck Varivax Lot#H021386 Expiration date 30NOV14 and both developed Varicella within 7 days of the vaccination.
The second day after getting the shot my right arm was sore. I could not lift my arm. I just felt really tired. I slept but when I would wake up I felt like I was very tired. Sometimes at night I cannot sleep at all. I saw my OBGYN on 09/17/2021 they did a wellness test and mammogram. They came back normal, my blood pressure was a little bit elevated. My OBGYN told me to see my PCP. I went in today 09/21/2021. They said it is all part of the vaccine and to come back if the symptoms persist. They told me to increase my cholesterol and blood pressure medication.
Patient is here for labs draw complaining of pain right upper extremity after getting TDAP vaccination yesterday. Patient claims lack night he was having chills and developed shortness of breath on climbing stairs. Denies associated chest pain, palpitation, irregular heart rate, cough, phlegm, pleuritic chest pain. Right arm at injection site: No erythema, no swelling, no tenderness, no discharge noted. Assessment; probable allergic reaction to TDAP, other causes cannot be ruled out.
Pain left arm - lump under arm - states she had swelling in arm, neck, chest, back received 3rd dose, after symptoms appeared.
HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.  This is one of several reports received from the same source. ; Sender Comments: US-009507513-2306USA011972:
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. On 21-JAN-2016, the patient was inadvertently vaccinated with VARIVAX (Merck) injection, lot # K005182 and expiration date on 10-APR-2016, instead of ZOSTAVAX (Merck) (route, dose, frequency and strength were not reported). No concomitant medications were reported. No adverse events were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
high fever, Extreme rash covering my entire body that has lasted 4 days and till there.
TESTED POSITIVE FOR COVID-19; 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: 1808609, and batch number: 1808609 expiry: 09/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) positive for covid (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
Chest pain - short of breath  Inhaler - doesn?t help much  Prednisone - didn?t help , came back beta blocker for HR
Starting within 1-2 days after vaccines on 12/10/2012 pt rolls eyes up in head continuously from time morning awakening until nap. Has continued daily until date of report.
Bivalent Moderna vaccine was ordered, but the monovalent vaccine was administered at a lower than intended dose.
expired Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA657A, expiry date 31st January 2023) for prophylaxis.   On 3rd February 2023, the patient received Menveo. On 3rd February 2023, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The reporter stated that a patient was administered an expired dose of Menveo at the time of reporting.  The reporter did not consent to follow-up from safety team . Additional Supportive Information: The patient was administered with expired dose of Menveo, which led to expired vaccine used.
no adverse effects were reported; received dose of improperlly stored PROQUAD; This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age. On an unknown date the patients received doses of improperly stored PROQUAD (lot # N002915, expiration date: 24-JUL-2018 and N010114, rHA, expiration date: 24-SEP-2018) that were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # N016995, expiration date: 08-OCT-2019) for prophylaxis. No adverse effects were reported. The vaccines were stored under 13.5 Fahrenheit for 10 minutes. It was called because of a "data logger" and no previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002149:
At the nigh of vaccination I was very tired early in the night and I usually stay up late four hours before normal. The next morning I had a lump the size of a grapefruit under my left armpit  that lasted a week. Ended up contracting high blood pressure and diabetes and elevated cholesterol all out of range.
Patient reported that a couple hours after her immunization she felt exhausted and had to go home and go to bed where she proceeded to get a fever and had chills/shakes all night. The adverse event was over by morning.
My symptoms started on Saturday evening, 05/07/22, with sneezing and then a runny nose. By Sunday, 05/08/22, I had nasal congestion. On Monday, 05/09/22, I had a dry cough and hoarseness. It hasn't gotten worse. I was prescribed Paxlovid in the evening and it cleared the congestion. When I woke this morning the congestion was back so I took another dose and am expecting it to kick in soon. The Paxlovid is prescribed for 5 days at twice a day. My symptoms are mild, like a minor head cold. I did 2 home tests for COVID 19 and they were both positive. Yesterday I went to the urgent care for a rapid test that was positive and received Paxlovid.
Sleeplessness; Stomach ache; Slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness), ABDOMINAL PAIN UPPER (Stomach ache) and NAUSEA (Slight nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20M) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INSOMNIA (Sleeplessness), ABDOMINAL PAIN UPPER (Stomach ache) and NAUSEA (Slight nausea). At the time of the report, INSOMNIA (Sleeplessness), ABDOMINAL PAIN UPPER (Stomach ache) and NAUSEA (Slight nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
(03/04/2021) date of first COVID Vaccine, 17 days after the first COVID Vaccine I am experiencing vertigo, fatigue, abdominal discomfort, (all day) if I am active and have food in my stomach I will vomit. Received the second COVID Vaccine (03/05/2021) after returning home from the vaccine I vomited multiple times that day. Symptoms have not improved.  Went to the doctor on 03/29/2021 for an evaluation. She recommended a COVID test. The test was negative. The Dr said my condition is an adverse reaction to the COVID Vaccine