chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The platelet count exhibited marked decrease after dose 2.; Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Concurrent medical conditions included Immune thrombocytopenia. Concomitant products included ELTROMBOPAG for Immune thrombocytopenia.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses). The patient was treated with ELTROMBOPAG for Adverse event, at a dose of 50 milligram once a day and ELTROMBOPAG for Adverse event, at a dose of 75 milligram once a day. At the time of the report, IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: Three days after taking dose 2 of vaccine the platelet count fell to 27 x 10^9/L (86%decrease) prompting an increase in eltrombopag to 75 mg daily and 205 10^9/L (Inconclusive) In response to 3 doses of eltrombopag, the platelet count increased to 205 x 10^9/L. In 2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses) to be possibly related.    The eltrombopag daily dose was adjusted to compensate for dynamic platelet destruction   This case was linked to MOD-2021-263889, MOD-2021-263965, MOD-2021-263970 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Chronic Immune Thrombocytopenia could be potentially confounders/co-suspects for the events.
left side facial paralysis, unable to move face. Went to ER locally  ER Doc diagnosed with bells palsy on 1/20
patient almost fainted shortly after the vaccine was given. he was sweating, skin turned red, happened around 7:10 pm on 02/08/2022
FLU VACCINE L ARM ON 11/14/2011. REDNESS TO EDEMA BELOW INJECTION SITE TWO DAYS LATE. DR. VIEWED AND RECOMMENDED ALEVE AND WARM COMPRESSES BID.
Seen in clinic on 07/22/2021 for upper respiratory infection symptoms x1 week.  Symptoms started 07/15 and consisted of sore throat, sinus congestion, sinus drainage, headache, dry cough. Symptoms initially mild, and worsened throughout the week with sinus symptoms more prominent. Patient presented to believing he had a sinus infection.  Rapid test was positive and patient notified. He was frustrated as he thought he was protected by vaccine status. We collected a second sample for confirmatory Coronavirus PCR testing and sent this out later in the day. Patient was notified of the positive confirmatory test on 07/24. No current information on his recovery.
No adverse event occurred, this submission is to document a 48 year old female received a Shingrix vaccine, which is not indicated until she is 50 years old per agency guidelines.
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 10:00 as dose 1, single (Lot number: EL1284), in right arm, on 10Feb2021 at 10:00 as dose 2, single (Lot number: EL1284), in right arm and on 28Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 41 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative for COVID on two at home antigen tests; (unspecified date) Negative, notes: tested negative for COVID on two at home antigen tests; (Jun2022) Positive, notes: My worsening symptoms corresponded to a positive at home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Experienced a rebound of symptoms on day six after completing the treatment. I had previously tested negative for COVID on two at home antigen tests. My worsening symptoms corresponded to a positive at home antigen test. None of the known allergies reported. Other medication in 2 weeks were unknown.
Breastfeeding exclusively an 11 week old infant boy.  I have no adverse effects other than sore arm but within 24 hrs baby appetite decreased and vomited once so far.
3-4 inch very red bumpy rash where shot was administered.  It is very painful and itches.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning an 81-year-old, elderly, patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 12-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This cases (201804096) was cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Med info number (SEQ18-04086) was added in the additional information tab. No changes were made to the narrative.
like a flare of her rheumatoid arthritis; soreness in her legs; fatigue; HA; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional and consumer reported that a 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation; tofacitinib citrate (XELJANZ), oral from 07May2021 and ongoing, at 10 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient was fine the day of the injection, but the following day she had what seems like a flare of her rheumatoid arthritis. She notes soreness/fatigue, particularly in her legs ever since she received the COVID vaccine. She also reports having a headache (HA). An organization recommends holding a dose of tofacitinib citrate for one week after receiving the vaccine but patient was not aware of that so she did not do that. The action taken in response to the events for bnt162b2 was not applicable while for tofacitinib citrate was unknown. Outcome of the events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event rheumatoid arthritis flare up.  The disease nature should also be considered, which may flare up as natural disease course. 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.
With the 1st dose I only experienced fatigue, and the 2nd dose I did have a sore arm but everything seemed pretty okay afterwards. A few months later on July 5th is when you found out that I had COVID-19. July 23rd I went in to do a follow up Covid test and it still came back positive. I was only experiencing chills and allergy like symptoms such as runny nose and a slight cough.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: 14939) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostrate cancer" (unspecified if ongoing); "thyroid problems" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; LEVOTHYROXINE; EZETIMIBE; DIGOXIN; ELIQUIS; LOSARTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive treatment for AE, Patient did not known allergies.  Follow-up attempts are completed. No further information is expected.
Bothersome sciatica-like pain in right leg, primarily in front part of thigh
Less than 24 hours after receiving the Moderna Booster shot, I became dizzy and laid down. After 20 minutes I stood up and began to walk. After 20 steps I became nauseous and proceed to vomit violently, emptying the contents of my stomach. I then laid down again. Every time I moved my head I felt dizzy. Finally after six hours I was able to stand up and eat and drink a little. Two days following the first episode the symptoms returned, but this time much worse. At three in the afternoon I felt extremely dizzy almost to the point where I could not walk and in less than a minute vomited violently again. At this point I could not stand up, and crawled to my bedroom and laid down on the floor. I eventually got myself into my bed. After 12 hours and still not able to walk, let alone move my head in the slightest, I called 911 and was taken to the emergency room, where I was diagnosed with vertigo.
pt recv vax & that noc exp local redness @ inj site;next day c/o hot flashes;called MD;
She developed non-productive cough 5 hours after receiving the vaccine. Given BENADRYL 25 mg q 6 hours x 3 days. Prescribed ROBUTISSIN Cough Suppressant. Symptoms resolved past 3 days.
extreme pain-burning sensation approx 2-3inches below inj site;unable to raise arm w/o assistance;extreme pain started approx 10hr later;used ibuprofen, ice & heat;
vomiting, diarrhea, fatigue, headache. called in sick to work.
Her arm was aching; heart feeling like it was raising/beating so much; she wasn't able to go to sleep; Ache in the arm slightly, where she got the vaccine; her heart was racing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Heart problem" (unspecified if ongoing), notes: pre-existing heart problem. Concomitant medication(s) included: OMEPRAZOLE; HYDROCHLOROTHIAZIDE; LOSARTAN; ASPIRIN [ACETYLSALICYLIC ACID]; METOPROLOL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "unknown", described as "Her arm was aching"; HEART RATE INCREASED (non-serious) with onset 11Mar2021, outcome "unknown", described as "heart feeling like it was raising/beating so much"; INSOMNIA (non-serious) with onset 11Mar2021, outcome "unknown", described as "she wasn't able to go to sleep"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "Ache in the arm slightly, where she got the vaccine"; PALPITATIONS (non-serious) with onset 11Mar2021, outcome "unknown", described as "her heart was racing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, Can't stop falling; sleepiness; Weakness; Migraines; Insomnia; Shaking and tremors; Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction; Backache; Crappy like if you were sick like  the flu; total fatigue; Muscle and body aches:; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines) and INSOMNIA (Insomnia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lyme disease, Fibromyalgia and Normal pressure hydrocephalus.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), TREMOR (Shaking and tremors), PRURITUS (Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction), BACK PAIN (Backache), INFLUENZA (Crappy like if you were sick like  the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:). At the time of the report, DIZZINESS (Dizziness, Can't stop falling), SOMNOLENCE (sleepiness), TREMOR (Shaking and tremors), PRURITUS (Itching,  I have dug holes in skin, feels like similarly experienced allergic reaction) and BACK PAIN (Backache) had not resolved and ASTHENIA (Weakness), MIGRAINE (Migraines), INSOMNIA (Insomnia), INFLUENZA (Crappy like if you were sick like  the flu), FATIGUE (total fatigue) and MYALGIA (Muscle and body aches:) outcome was unknown.            No information concomitant medications were reported. No information on  treatment medications were reported. Patient felt like a bomb went off in my body as one of the event.
fatigue and fever began initially, felt he was coming down with something by 6pm. He felt "bad by 7pm".  He felt, "achy and painful to move". Was in bed by 10pm and had tried using heating pad as he felt, "severe chills, body aches, and sweating". He remained in bed until 10am the following morning. He still felt sore the following day
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, race, ethnicity, and sex. Initial information was processed along with the additional information received on 04-NOV-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: irritable bowel syndrome (IBS), leaking heart valve, gastroesophageal reflux disease (GERD), sulfa drug allergy, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, 1 total administered on 27-OCT-2021 to left arm for covid-19 prophylaxis. Concomitant medications included chlorhexidine gluconate, levothyroxine sodium (levothyroxin), lisinopril, omeprazole, and pravastatin.  On an unspecified date in 2022, the patient experienced symptoms of runny nose and mild diarrhea (Dose number in series 2).  The patient received non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 13-OCT-2022 to 17-OCT-2022 for treatment of COVID-19.  On 21-OCT-2022, Laboratory data included: COVID-19 virus test Negative. On 23-OCT-2022 (2 days after testing negative), patient tested positive for covid-19. Thus patient had confirmed covid-19 infection and confirmed clinical vaccination failure (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000257968.; Sender's Comments: V0: 20221107596- confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
10/30/04 Injection site red, warm to touch, measures about a quarter diameter. On 10/31/04, patient was noted to be sleepy/tired, appetite poor, fever 100.8, 96, 20, 120/70. Site fading in color and size. Temp 99.8 on 11/01/04; remains tired with poor appetite. No treatment. 2/16/05 Discharge summary received which revealed COD to be CVA with PMH of profound Alzheimers, HTN, arthritis w/chronic pain & venous insufficiency.
acute varicella rash (50) pox lesions, fever, h/a, lymphadenopathy;
Fever of 102 that night, high pitched scream, stopped breathing for a minute.  Doctor was very nonchalant.  Told me to give her Motrin to bring down her fever. Never shared with us that she had an adverse reaction.  2 weeks later, she stopped breathing in my arms again when I asked the doctor about this; she said she was holding her breath on purpose.  Any time patient has ever had shots, her personality would change for about a week.  Usually a very docile and delightful baby, she would actually glare at people, bite and slap when she wasn't getting her way.  A week would pass and she'd go back to being herself.
Scratchy throat; Injection site rash; This spontaneous case was reported by an other health care professional and describes the occurrence of THROAT IRRITATION (Scratchy throat) and VACCINATION SITE RASH (Injection site rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021 at 12:26 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). On 14-Jan-2021 at 12:26 PM, the patient experienced THROAT IRRITATION (Scratchy throat). At the time of the report, THROAT IRRITATION (Scratchy throat) and VACCINATION SITE RASH (Injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
STARTED 2 DAYS AFTER VACCINATION, LASTED 1 WEEK. SYMPTOMS: SORE RED CIRCLE THAT IS PAINFUL TO TOUCH. PATIENT TOOK 2 TYLENOL EXTRA STRENGTH (500MG), AND RESOLVED ON ITS OWN WITHOUT ADDITIONAL INTERVENTION
Approximately 5-6 days after vaccine patient developed a red, itchy rash on arms and trunk. Rash progressed to raised bumps that became sore and scabbed. Went to family doctor that provided Medrol Pak for treatment, and referred to dermatologist. Dermatologist provided Triamcinolone cream as treatment and also performed a biopsy (results of biopsy pending). Patient currently still has the rash.
Moderna Vaccine- first injection One week after the vaccine was injected, developed a raised, red, itchy rash on right shoulder in the area where the vaccine was given.   Rash was localized- no other symptoms symptoms improving two days later
Caller had the shot 4 hours ago and all they are doing is sneezing; nose running; a little breathing problem; they feel tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Caller had the shot 4 hours ago and all they are doing is sneezing), RHINORRHOEA (nose running), DYSPNOEA (a little breathing problem) and FATIGUE (they feel tired) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced SNEEZING (Caller had the shot 4 hours ago and all they are doing is sneezing), RHINORRHOEA (nose running), DYSPNOEA (a little breathing problem) and FATIGUE (they feel tired). At the time of the report, SNEEZING (Caller had the shot 4 hours ago and all they are doing is sneezing), RHINORRHOEA (nose running), DYSPNOEA (a little breathing problem) and FATIGUE (they feel tired) outcome was unknown.      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Reported that caller had the shot 4 hours ago and all they are doing is sneezing. 20 sneezing in a row, nose running, they feel tired. Nothing really really bad, a little breathing problem.
Patient was 17 years old at time of vaccination the approved age for Johnson & Johnson is 18. No events occurred.