chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination related malaise; fatigue; local reaction/ sore arm; Fever; local reaction/ sore arm; undiluted second dose of pfizer-biontech covid-19 vaccine; Administered undiluted second dose of Pfizer-BioNTech Covid-19 Vaccine; Paronychia; This is a spontaneous report from a contactable other health care professional. A 14-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0191 and expiration date: 30Sep2021) via an intramuscular route of administration in right deltoid on 11Jun2021 at 11:55 AM (age at vaccination 14-year-old) as DOSE 2, 0.3 ml, SINGLE for covid-19 immunisation at physician's office. The patient's medical history included GERD from Dec 2020 to Feb 2021, ongoing paronychia from Jun2021, ongoing obesity from Mar2019, ongoing allergic rhinitis from Jun2016. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0177) on 19May2021 10:55 AM (age at vaccination 14-year-old) at via intramuscular route of administration in left deltoid as DOSE 1, SINGLE for covid-19 immunization. On 11Jun2021, a 14-year-old male patient administered undiluted second dose of Pfizer-Biontech covid-19 vaccine. On 19Jun2021, the patient experienced local reaction/ sore arm, fatigue, fever. On an unknown date, the patient experienced vaccination related malaise and paronychia. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures, which included on 18Jun2021 Brain natriuretic peptide: 21 pg/mL (normal low: 0, normal high: 99), C-reactive protein: less than 0.5 mg/dl (normal high: 0.5), electrocardiogram: normal, ESR (red blood cell sedimentation rate): 10 mm/hr (normal low: 0, normal high: 15), troponin I: less than 3 ng/l (normal high: 45). The NDC number of Pfizer-BioNTech Covid-19 Vaccine: 59267-1000-1. These events local reaction/ sore arm, fatigue, fever were considered non-serious. The outcome of the events local reaction/ sore arm, fatigue, fever was recovered in 2021 and unknown for other events. The physician considers the Pfizer product had a causal effect to the adverse event.  Information on Lot/Batch number was available. Additional information has been requested.  Follow up (06Jul2021 and 09Jul2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to the HCP letter sent that included: The physician considers the Pfizer product had a causal effect to the adverse event. Added new events local reaction/ sore arm, fatigue, fever, vaccination related malaise and paronychia. Added all lab data. Added all medical history.  Follow-up attempts are completed. No further information was expected.
Narrative: Discharge DIAGNOSES: 1). CHF exacerbation 2). COVID 19 viral syndrome HPI: He reported several day history of increasing shortness of breath. He has a history of congestive heart failure and has been taking his medications intermittently. He did not take his medications today. He has some chest heaviness due to the swelling of his abdomen arms and legs. He has been seen here in December 2021 for similar problem. He continues to smoke tobacco products. He is on oxygen at home. History provided by: Patient, Medical Record PMH: CAD, CHF, Hypertension Obstructive sleep apnea
2/10/22  73-year-old female presents with abdominal pain which is lower for several days.  She is had cough, congestion with chills.  Her cough is been nonproductive and she has had increasing shortness of breath particular with cough and is experiencing chest pressure.  She denies any chest pain.  She denies any known fevers but has felt hot and cold.  She has had increasing trouble breathing.  She is had generalized myalgias aches pains as well.  She denies any constipation or diarrhea Review of Systems  Constitutional: Positive for chills, diaphoresis, fatigue and fever.  Respiratory: Positive for cough, chest tightness, shortness of breath and wheezing.   Review of Systems  Cardiovascular: Negative for chest pain. Review of Systems  Gastrointestinal: Positive for abdominal pain.  Allergic/Immunologic: Negative for immunocompromised state.  Neurological: Negative for dizziness.  All other systems reviewed and are negative.
Cough; Pressure in his chest; Shortness of breath; Fatigue; Body aches; A spontaneous report was received from a consumer who was a 54-year old, male patient, who received Moderna's COVID-19 vaccine and experienced fatigue, body aches, cough, pressure in his chest, and shortness of breath.   The patient's medical history was not reported.  No relevant concomitant medications were reported.   On 03 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient developed fatigue and body aches, especially in his back. He provided self-treatment and the events resolved on 05 Jan 2021. On 05 Jan 2021, he began to develop a cough, pressure in his chest, and shortness of breath. Treatment for the events included paracetamol, dextromethorphan hydrobromide/paracetamol/ phenylephrine hydrochloride, and dextromethorphan hydrobromide/mepyramine maleate/paracetamol/ phenylephrine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fatigue and body aches, was considered recovered/resolved on 05 Jan 2021.  The outcome of the events, pressure in chest and shortness of breath, was considered recovering/resolving on 08 Jan 2021.  The outcome of the event, cough, was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 54- year-old male patient, who experienced non-serious uexpected event of Fatigue and non-serious unexpected events of Pain, Chest discomfort, Cough, and Dyspnea. The events of Fatigue and Pain occurred on the same day after first dose of mRNA-1273, lot # unknown. The events of Chest discomfort, Cough, and Dyspnea occurred approximately 2 days after first dose of mRNA-1273, lot # unknown.Treatment for the events included paracetamol, dextromethorphan hydrobromide/paracetamol/ phenylephrine hydrochloride, and dextromethorphan hydrobromide/mepyramine maleate/paracetamol/ phenylephrine hydrochloride. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
We had horrible runny noses, a cough, sore throat, congested including our ears, and fatigue. Lots of mucous. We tested ourselves for COVID-19 At Home. We were sick and in bed for a good 10 days. We reached out to our physician and they prescribed Paxlovid.
Information was received from a medical assistant concerning unspecified patients (demographics not provided). The medical assistant reported that an unspecified number of unspecified patients received doses of Oral ROTATEQ on unspecified dates that underwent a supported temperature excursion. No adverse experiences reported. No further information provided. This is one of three reports from the same reporter (see case #1411USA012708 and 1412USA007353). Additional information has been requested.
Per pt report on 12/9, within 24-48 hours of vaccination on 11/21, widespread hives/welts developed over pt's body that resolved after 7-10 days. As of 12/8, it started coming back up again and is spreading. Rash is very itchy & uncomfortable. Pt is intending to visit her physician to have it evaluated.
allergies have intensified; Urticaria with itching, on exposed parts and after exposure to cold; itching on exposed parts and after exposure to cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (itching on exposed parts and after exposure to cold) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (itching on exposed parts and after exposure to cold). At the time of the report, HYPERSENSITIVITY (allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (itching on exposed parts and after exposure to cold) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company comment: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.; 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.
Massive Headache, Dizziness, Severe Vomiting, Chills, Cold Wet Sweats, Fatigue, Joint Aches, Loss of Appetite,  Family Doctor Called
Knot under the right arm. Soreness if moved a certain way. It is the size of an egg.
Joint pain; Nausea; Feeling unwell; Dizziness; Muscle pain; Woke up with feeling of pressure in her chest that she normally doesn't have; Diarrhea; Decreased appetite; 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 female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, Manufacturer Unknown.), for COVID-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset Oct2023, outcome "unknown"; DIARRHOEA (non-serious) with onset Oct2023, outcome "unknown", described as "Diarrhea"; DIZZINESS (non-serious) with onset Oct2023, outcome "unknown"; MALAISE (non-serious) with onset Oct2023, outcome "unknown", described as "Feeling unwell"; ARTHRALGIA (non-serious) with onset Oct2023, outcome "unknown", described as "Joint pain"; MYALGIA (non-serious) with onset Oct2023, outcome "unknown", described as "Muscle pain"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown"; CHEST DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "Woke up with feeling of pressure in her chest that she normally doesn't have".  Additional information: The caller got her booster dose of Comirnaty last Tuesday, 24Oct2023, and was having all of the symptoms on the paper they gave her to include muscle pain, joint point, feeling unwell, and dizziness. Agent stated that caller reported at first she thought it was her arthritis, but when the feeling unwell, nausea, and dizziness started caller thought it was from the vaccine. Today caller woke up with feeling of pressure in her chest that she normally doesn't have. It doesn't feel like a heart attack but caller was concerned with things that have to do with the heart muscle that can happen with the vaccine. She had experienced diarrhea and decreased appetite, but no fever or headache. Transfer agent provided caller had just disconnected the line. Caller had asked Medical Information agent for side effect information for an 85-year-old. Referred caller to either go to the ER or to contact her physician to be evaluated today due to the chest pressure.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pt received po vivotif, started roughly on July 27 2019, prescribed by PCP, picked up at local pharmacy, in last 3-4 days, tmax 100.4, headache, nausea, better today. Of note, also started weekly mefloquine for malarial prophylaxis; pt was made aware to update PCP on current symptoms as well. Advised if tolerating, to complete entire vivotif at this time to ensure immunitycontinue antimalarial mefloquine to ensure prophylaxis. May take ibuprofen with food or tylenol prn. Patient to call her PCP who prescribed medications to update them as well and discuss alternative should pt not be tolerating SE. Rev worsened signs/symptoms, reactions and when to seek more emergent care
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 75 year old female of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: food intolerance (wheat, dairy, soy, walnuts, pecans), penicillin allergy, and nitrofuratine allergy. The patient was not pregnant at the time of vaccination. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with 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, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 8 decade old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient additionally received non-company suspect vaccine elasomeran (Moderna) (Dose number in series 3) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered to left arm on 05-OCT-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 3).  The patient was treated with Unspecified drug from Pfizer (form of admin was not reported, route of admin, batch number and expiry were not reported) dose was not reported, start therapy date were not reported for covid-19 treatment. On 25-JAN-2023 21:00, the patient experienced Covid rebound and had symptoms of head stuffed, sore top of mouth (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
After both the first shot on May 19 and the second on June 23, I endurred severe stomach cramps for well over one week after both shots. It was accompanied by severe constipation. I was living on laxatives. Both times I came down with diverticuloitis. The cramps were extremely painful. On a scale of 1 to 10, with 10 the worse, I rate the pain I endurred at a 10. Had I known the reaction would have been this bad, I never would have taken the vaccination,
This spontaneous report has been received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of GARDASIL, (Lot # K011562, exp. date 08-APR-2017 and Lot # reported as L005560, exp. date 18-DEC-2016), (strength, route of administration and dose were not provided), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt came to ER c/o dizziness, generalized weakness, high blood pressure, epigastric pain, vomiting, dry cough, and SOB for the past 5 days.
5cm x 5 cm Red, Swollen, Hardness, warm to touch. Patient admitted to scratching the arm at the injection site.
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (lot number and expiration date were not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. HCP of the reporter who received first dose, was later diagnosed with COVID-19 and was given monoclonal antibodies. The reporter asked for advice regarding second dose administration. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable consumer (Patient). A 77-year-old female patient received BNT162B2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 14Feb2021 14:30 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history none. The patient's concomitant medications were not reported. On an unspecified date, the patient reported potential missed second covid 19 vaccine dose due to scheduling issues. Her husband and she had first dose Covid 2 week yesterday. Next Sunday would be her 2nd appointment. She wants to clarify if she is going to get her second dose next Sunday. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021243835 Same reporter, event, product/ different patient
5/18/2010 states she felt dizziness, nausea, vomiting some discomfort L deltoid injection site. 5/19/10 states she has dry heaves, low back pain 10/10, with radiation to upper legs front and back pain 10/10, L deltoid and L arm pain 9.5/10 with numbness L fingers. Examined by Occupational Health Doctor. No treatment. 5/21/10 Denies low back pain 0/10, denies leg pain 0/10. denies nausea, vomiting & dry heaves, states L deltoid still painful 5/10. Has reddened area 40mm X 75mm, warm to touch. States she wants to see her PCP for possible cellulitis treatment. 5/21/10 Started on Amoxicillin 875 mg one BID for 7 days. 5/27/10 States she has no pain L deltoid, reddness has resolved. She will call clinic if has any further or unresolved symptoms.
Reported Symptoms: Confusion; Encephalopathy; Tachypnea; Troponin increased; Narrative: Patient received three Pfizer COVID 19 vaccine in Feb/Mar 2021 and Jan 2022. The patient presented to the ED on 2 November 2022 with shortness of breath. The patient was admitted with hypoxia, encephalopathy, and elevated troponin due to COVID and the patient was treated with remdesivir and dexamethasone. The patient was discharged in 17 November 2022 in stable condition. Reported per EUA. Other relevant HX:  Other: encephalopathy, elevated troponins, COVID 19
Information has been received from a nurse practitioner concerning a 10 year old female with no known allergies or pertinent medical history who on 02-JUN-1998 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #623652/0805D). There was no concomitant medication. On 12-MAY-2007, the patient experienced a varicella like rash of over 50 lesions. The rash developed over her neck and chest and has spread to the face and all extremities. The patient was told to take Benadryl. As of 15-MAY-2007, the patient had not recovered. Medical attention was sought. No labs were performed. Follow up information received from the physician indicated that the patient was seen in the office with varicella. No additional adverse experiences were reported. No further information was provided. No further information is expected.
Fevers, uncontrollable shaking, chills, sweats, muscle aches, chest tightness, painful enlarged left axillary lymph node, left arm pain, fatigue, weakness, and nausea. Adverse effects started approximately 12 hours after vaccination and lasted up to 48-72 hours.
Swelling in the left side of neck area; rash in upper chest and neck area; pain in arm and neck; pain in arm and neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2022 at 14:30 as dose 1, single (Lot number: FR2583) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MOTRIN [IBUPROFEN]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: SWELLING (non-serious) with onset 09Dec2022 at 06:15, outcome "not recovered", described as "Swelling in the left side of neck area"; PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious) all with onset 09Dec2022 at 06:15, outcome "not recovered" and all described as "pain in arm and neck"; RASH (non-serious) with onset 09Dec2022 at 06:15, outcome "not recovered", described as "rash in upper chest and neck area". Therapeutic measures were not taken as a result of swelling, rash, pain in extremity, neck pain.  Additional information: Vaccine location was upper left arm. No other vaccine received in four weeks. Received multi-vitamins in two weeks. No covid prior to vaccination. Not tested for covid post vaccination.
Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening,  reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly