chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 week after receiving the dose, I had a reaction near the injection site on my right shoulder.  There is redness, swelling, itchiness, and it is warm to the touch.
Fever; Chills; Aches; Feeling Sick; Nausea; This case was reported by a physician via call center representative and described the occurrence of fever in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced fever, chills, pain, feeling unwell and nausea. On an unknown date, the outcome of the fever, chills, pain, feeling unwell and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, pain, feeling unwell and nausea to be related to Shingrix.     Additional Information: GSK receipt date: 22 Nov 2022 Reporter comment: This case was reported by physician. The physician reported patient received his first dose of Shingrix yesterday that is 21st November 2022. The patient was experiencing, fever, chills, aches, feeling sick and nausea. The reporter provided limited information The reporter believes the patient received the vaccine at a drug store. Additional supportive information : The outcome was captured as not recovered, as patient is experiencing events however in field as per code it is unknown, hence not recovered was captured conservatively.
Pt c/o nausea, Headache, dizziness, dyspnea 2 hours after vaccine administration, given PO Prednisone 60mg. Pepcid 20mg Benadryl 50 mg PO.
"very infected" with COVID-19 after receiving the first dose; "very infected" with COVID-19 after receiving the first dose; This is a spontaneous report received from a contactable consumer (patient's son-in law). This consumer reported same events for three patients. This is the third of three reports.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (lot number and expiry date unknown) as 1st dose, single for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The reporter himself, his wife and his wife's mother received the first dose of Pfizer's COVID-19 vaccine on 04Mar2021. At the time of the report, they were due to get the second dose and wanted to know what to do, since three of them were very infected with COVID-19 after receiving the first dose. This patient was delicate because she was in bed, because of her age and because she was diabetic. He would like to know when they would get the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329502 same reporter/drug/events, different patients;US-PFIZER INC-2021333614 same reporter/drug/events, different patients
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 09:00 (Lot number: EW0186) at the age of 47 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "lymphoma", start date: 1985 (unspecified if ongoing), notes: cancer survivor, he was 13 years old, diagnosed 1985-1986. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Pfizer Covid 19 Vaccine, LOT: EN0180, NDC: Unknown, Expiry Date: Unknown, Injection, unknown dosage, left shoulder), administration date: 22Jul2021, when the patient was 47 years old, for COVID-19 Immunisation, reaction(s): "shoulder hurts twice as much as the first shot". The following information was reported: CHILLS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "light headed/real lightheadedness"; PYREXIA (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "fever"; TENDERNESS (non-serious) with onset 12Aug2021 22:30, outcome "not recovered", described as "lower back was tender"; BONE PAIN (non-serious) with onset 12Aug2021, outcome "not recovered", described as "his bones, it's not as bad as his back"; BACK PAIN (non-serious), outcome "unknown", described as "his back hurt so damn bad, he couldn't touch it"; ARTHRALGIA (non-serious) with onset 12Aug2021, outcome "not recovered", described as "His shoulder hurts twice as much as the first shot, he had it in the same arm."; ABNORMAL DREAMS (non-serious) with onset 12Aug2021, outcome "not recovered", described as "dreaming kind of funny"; TREMOR (non-serious), outcome "unknown", described as "got the shakes"; INSOMNIA (non-serious), outcome "unknown", described as "couldn't go back to sleep"; PAIN IN EXTREMITY (non-serious) with onset 12Aug2021, outcome "unknown", described as "had the second dose in the same arm, it hurt about an hour after, the muscle ache because of the needle"; MYALGIA (non-serious) with onset 12Aug2021, outcome "unknown", described as "it hurt about an hour after, the muscle ache because of the needle"; PAIN (non-serious) with onset 12Aug2021 10:30, outcome "unknown", described as "pain".  Additional information: Patient confirms all symptoms are dragging on, persisting. Patient's events did not require any emergency Room and physician office visit. Patient hasn't been to a doctor. Patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Started to become nauseated with dry heaving, observed for 30 minutes. Vitals remained. Stable, nausea resolved, liquid challenge.
An initial report was received in the USA from another manufacturer (HQWYE049823FEB05) on 7/5/05. It was reported from the pt's relative to them that a female child, age not specified, was found to have autism that was diagnosed on 3/24/04. She received Act-Hib, (lot numbers, sites and routes not reported), on 12/10/02 and 10/8/02 and IPOL, (lot numbers, sites and routes not reported), on 10/8/02, 12/10/02 and 4/24/03. Exact latency, concomitant medicaitons and past medical history were no provided.
Headache, nausea, dizziness, occasional chills between 2 pm and 4 am the following morning.  Sleeve taken for symptoms, but it didn?t seem to help.  5:45 am itchy ness and injections site redness, itchy eyes and face.  20 mg prednisone
Severe migraines accompanied by mild seizure; Severe migraines accompanied by mild seizure; No appetite after dosage; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCIN), first dose, via an unspecified route of administration, administered in arm left on 11Sep2021 10:00 at the age of 24 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine which the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe migraines accompanied by mild seizure, no appetite after dosage, all on 13Sep2021. It is unknown if treatment received. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Feeling Confused; Feeling faint; Blood pressure rose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (Feeling Confused), DIZZINESS (Feeling faint) and HYPERTENSION (Blood pressure rose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included FAMOTIDINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CONFUSIONAL STATE (Feeling Confused), DIZZINESS (Feeling faint) and HYPERTENSION (Blood pressure rose). At the time of the report, CONFUSIONAL STATE (Feeling Confused), DIZZINESS (Feeling faint) and HYPERTENSION (Blood pressure rose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure measurement: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included blood pressure medication, antacids, and vitamins.  The MD increased the patients blood pressure medication up to 10mg.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: No new information was added.
Tachycardia/My resting heart rate is mid 50s bpm. After the second vaccine, I was hitting 100+ bpm even during minimal motion.; abnormally fast heart rate (if I moved or stood up); tightness in chest; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 14Apr2021 09:45 (Batch/Lot Number: EW0158) as DOSE 2 (Age at vaccination: 56-years-old), SINGLE for COVID-19 immunisation. Patients Medical history: ongoing insomnia and ongoing seasonal allergy. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) taken via oral route for seasonal allergy from an unspecified start date and ongoing; ibuprofen taken for an unspecified indication, start and stop date were not reported and zolpidem taken via oral route of administration for insomnia from an unspecified start date and ongoing. The patient was not pregnant at vaccination. Historical vaccine included as bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm left on 24Mar2021 at 04:15 AM (Batch/Lot Number: EW0158) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no Covid prior vaccination and not tested for COVID post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced abnormally fast heart rate (if I moved or stood up) and tightness in chest. Her resting heart rate was mid 50s bpm. On 14Apr2021 06:30 PM, After the second vaccine, she was hitting 100+ bpm even during minimal motion. Tachycardia symptoms started in the afternoon following second covid-19 vaccine dose in the morning if she moved from bed/resting position. my heart rate shot up to over 100bpm. the high heart rate was sustained until complete physical in action. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021 Nasal Swab 3x/wk (ended 24May2021) testing PCR,covid test result=Negative,heart rate: abnormally fast heart rate on abnormally fast heart rate (if I moved or stood up). The outcome of the event (tachycardia, chest discomfort and heart rate increased) was recovered on Apr2021.  Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a contactable physician who reported for her daughter. A 19-year-old female patient of an unspecified ethnicity received third dose of TRUMENBA, intramuscular in the left arm at single dose on 20Aug2015 at 7 PM. The patient medical history and concomitant medications none. Previously the patient received two doses of vaccine in Feb2015 and in Mar2015 without reaction. On 21Aug2015, the patient developed a diffused more like an inflammatory cutaneous response, on her arm. The event was described as "very diffused superficial but erythematous reaction involving more than the injection site. At the time of the third injection it involved a pretty much whole interior surface of her upper arm." The routine blood work performed in Aug2015 (in the following 48 hours) was normal. Event resolved on 25Aug2015. The physician considered that there was a reasonable possibility that the event was related to suspect product. Follow-up (14Sep2015): New information received from a contactable physician includes: Start date for previous vaccinations, time of third dose, anatomical location, physician's assessment. Follow-up attempts completed. No further information expected.
Havrix, Adult A vaccine, expiration date 9-30-2022 administered to client on 10-4-2022.
Shoulder replacement; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4240225-00.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (40mg/0.4ml, 40 mg,1 in 2 wk)) for rheumatoid arthritis. Relevant medical history included: "Tooth extraction", start date: Sep2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 20Jan2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: SHOULDER ARTHROPLASTY (medically significant) with onset 03Aug2021, outcome "unknown", described as "Shoulder replacement". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for BNT162B2 for events shoulder replacement and tooth extraction; Causality as per reporter (Drug/Vaccine): Possible.  Causality for Humira 40mg/0.4ml (Adalimumab):The reporter's causality for the event(s) of Shoulder replacement and Tooth extraction was not provided. Agency's opinion is that there is no reasonable possibility that the events of Shoulder replacement and Tooth extraction are related to Humira 40mg/0.4ml (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious event and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
contracted the Delta variant; contracted the Delta variant; sick/a general feeling of illness; fever; aches; head congestion; fatigue; brain fog; lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both dose via unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that had been double vaccinated early in Jan2021 with Pfizer and contracted the Delta variant from someone who also had the Pfizer. The person gave it to the patient. All of them got very sick with fever, aches, head congestion, fatigue, brain fog and a general feeling of illness. The patient had now lost taste and smell. This had been ongoing for 6 days. Outcome of the events was unknown.   Information about Lot/batch number has been requested.
After I reeived the booster shot, I went home and prepared for a nap, as I had to work the night shift that night. I laid down and noted that I was dizzy and had a headache. When I woke up four hours later, the headache I had was excruciating. I could not focus and felt nauseous as a result. I went to work, and by 2100, I thought that I was hungry, which could have been to blame for my lightheadedness, headache and bubbly stomach. I ate chicken enchiladas. By 2330, I was pacing the room, unable to find comfort. I felt the need to vomit, and my abdomen was severely cramping. I have given birth naturally, five times. The cramping I experienced was on par with contractions experienced. I had severe diarrhea, which is a classy word for what I experienced. I threw up violently, no less than 5 times. These symptoms lasted through the remainder of my shift, and through the next day. I was able to sleep it off, and within 18 hours I was feeling like myself again. I know this boosters gain outweigh this risk, and I wont have to receive it for another ten years, but it was absolutely horrible.
chest pain/ this morning it was about 10 minutes of acute pain in the upper right side of my chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and the patient experienced lymph node swelling. The patient's medical history and concomitant medications were not reported. The patient experienced chest pain/ this morning it was about 10 minutes of acute pain in the upper right side of my chest. It was reported that patient want to know if that was listed as one of the side effect but in the clinical trial has that appeared as the side effect of Pfizer. It was started abruptly. Patient stated that I contact my doctor because I want to know if this is the emergency and if I wait for another half hour that's really not productive if this is the medical. The outcome of the event was unknown.    Information about lot/batch number cannot be obtained.
Patient developed heat from injection site; patient developed bruising from injection site; patient developed a softball size redness from injection site; patient developed swelling from injection site; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2444885-1. The original narrative from the sender is the following:  On 17-May-2022 patient developed a softball size redness, bruising, swelling and heat from injection site. On 18May2022 patient's redness continued and progressed to be a bit bigger in size, redness and bruising still present. On 19May2022 patient's parents took child to the hospital to be evaluated. Antibiotics was prescribed, but not taken. On 28May2022 redness, swelling, heat and bruising resolved.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient developed a softball size redness, bruising, swelling and heat from injection site".  No further information is expected.
Horrible calf muscle cramps most every night for 3 weeks (skipped 2 nights), feels like electrical current in my leg right before it grabs my muscle, I will jump from bed & put weight on that leg until it releases. Sometimes it doesn't release for 5-10 minutes producing horrible pain! I missed work on 10/13/17 due to lack of sleep because of NUMEROUS cramps that night. I eat mustard, drink pickle juice, eat salt, eat more potassium foods, NP prescribed potassium & recently started tonic water. I started sleeping with 2 heating pads on both calf muscles to keep them warm & relaxed. I keep turning them back on all through the night. My cramps have been less painful and less duration since using the heating pads.
Area around injection site is red and hot to the touch per mother's statement. Denies pain or other symptoms. Declined appointment to evaluate area.
Patient presented to the ED and was subsequently hospitalized for bilateral pulmonary embolism and severe sepsis within 6 weeks of receiving COVID vaccination.
COVID Vaccine Breakthrough Case  Moderna Dose 1 11/22/21 (939909) COVID Positive 12/5/21  12/5/21: The patient presents with patient has been ill for 6 days with harsh cough productive of scant green-yellow sputum, SOB, fever/chills, headache, some occasional nausea, vomiting, and diarrhea, poor appetite, weakness, body aches. He was found to be positive for Covid 19 in the ED, chest x-ray shows bilateral patchy infiltrates. He was hypoxemic on arrival, with room air sats of 88-89%.  12/9/21: Patient was admitted for acute hypoxemic respiratory failure secondary to COVID-19.  Patient tested positive 5 days ago after having been ill for 6 days with fever chills harsh cough shortness of breath some nausea and diarrhea.  Patient has steadily improved is an inpatient and is off oxygen and is saturating well and feeling well to go home.  Patient will receive his final remdesivir does this afternoon prior to discharge home.
TOES NUMB RIGHT FOOT; NUMBNESS IN LEFT HAND; CRAMPING RIGHT HAND; CHILLS; SLEEPY; This spontaneous report received from a consumer concerned a 67 year old female. 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sleepy. On 08-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced cramping right hand. On 14-APR-2021, the subject experienced numbness in left hand. On 16-APR-2021, the subject experienced toes numb right foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy on 17-APR-2021, numbness in left hand on 14-APR-2021, cramping right hand on 13-APR-2021, and chills on 09-APR-2021, and had not recovered from toes numb right foot. This report was non-serious.
p/vax pt devel hives over trunk, face, arms & legs;7hr p/vax no resp or swallowing problems;sx relieves w/OTC antihistamine;resolved by 18hr p/vax;
Got DAPTACEL (L) deltoid 9/5/12, came to office 9/7 c/o itching that started on 9/6/12. Parent tried OTC hydrocortisone & BENADRYL creams to relieve itching.