chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/17/2021: Sudden onset of redness around the site of injection 1 week and 1 day prior. Slightly warm to the touch but not terribly. Has not grown, but tends to vary degree of redness with body temperature.
Approximately 12-14 hours status post HPV administration patient had grand mal seizure requiring EMS transport and ER evaluation for 6-8 hours.  7/30/08 ER rec received for DOS 7/24/08 with DX:  Seizures. Pt presented via EMS following an episode of seizure-like activity consisting of arms shaking and eyes rolling back in the head on the day of 2nd HPV4 vax.  Drowsy on exam, coarse respirations noted in upper lobes,  otherwise WNL. GCS 15.
Breakthrough positive case of COVID-19; Breakthrough positive case of COVID-19; This is a spontaneous report from a contactable consumer (patient, self-reported). A 25-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration, in Right arm, on 16Feb2021 at 10:00 AM (age at vaccination: 25 years), as a single dose for COVID-19 immunization at workplace clinic. The patient's medical history was not reported. The patient did not have known allergies. Concomitant medications included iron, plantago ovata fibre (FIBER SUPPLEMENT), and emtricitabine, tenofovir disoproxil fumarate (TRUVADA). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN 5318 and expiry date was not reported), via an unspecified route of administration, in Right arm, on 26Jan2021 at 10:00 AM (age at vaccination: 25 years), as a single dose for COVID-19 immunization at workplace clinic. The patient did not received any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. On 20Aug2021 at 11:00 AM, the patient had breakthrough positive case of COVID-19. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included COVID-19 Antigen test: positive (Nasal Swab) on 20Aug2021. Outcome of the events was recovering.
Patient was nervous according to mom as he waited to get his third dose.  When entering  the immunization room  the immunizer noticed he was nervous and gave him his vaccine first  so he could get  more time to sit while his mother received her third dose. Both was told to have a seat in the lobby for 15 minutes before leaving. Soon after the mom received her vaccine they both left the lobby of the pharmacy.
PNEUMONIA; BODY ACHE; WEIGHT LOSS 20 LBS; This spontaneous report received from a patient concerned a 6 decade old white male of an unspecified ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not sedentary and has not been impacted by any major health issues prior to vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported. Frequency time of 01 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms of pneumonia for 10 days. The patient was hospitalized for 3 days and discharge information (date unspecified) was not reported and received the treatment with anticoagulant and antibiotic therapy. The patient also experienced headache, body ache, inability to eat and weight loss of 20 pound (lbs). Laboratory data (dates unspecified) included: Corona Virus Disease-19 (COVID-19) virus test (NR: not provided) resulted as Negative and Weight (NR: not provided) 20 lbs was lost. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pneumonia, body ache, and weight loss 20 lbs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  20211119868-Covid-19 vaccine ad26.cov2.s-Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Has a little cold; Bones started to hurt; Very weak; Injection arm soreness; Very tired/Feels a little tired; Fever of 108F/105F; Headache; Body aching; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (Fever of 108F/105F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included DOXEPIN for Sleep disorder NOS, OLOPATADINE, ONDANSETRON, LOSARTAN POTASSIUM, TRAMADOL, MONTELUKAST SODIUM, MOMETASONE FUROATE, HYDROCHLOROTHIAZIDE, CHOLESTEROL, PANTOPRAZOLE, METFORMIN, ALENDRONATE SODIUM, METOPROLOL, OXYBUTYNIN, LORAZEPAM, CYANOCOBALAMIN and CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE VITAMIN D3) for an unknown indication.    On 30-Apr-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced HYPERPYREXIA (Fever of 108F/105F) (seriousness criterion medically significant). 30-Apr-2021, the patient experienced PAIN (Body aching) and HEADACHE (Headache). On 01-May-2021, the patient experienced BONE PAIN (Bones started to hurt), ASTHENIA (Very weak), PAIN IN EXTREMITY (Injection arm soreness) and FATIGUE (Very tired/Feels a little tired). On 02-May-2021, the patient experienced NASOPHARYNGITIS (Has a little cold). At the time of the report, HYPERPYREXIA (Fever of 108F/105F), NASOPHARYNGITIS (Has a little cold), BONE PAIN (Bones started to hurt), ASTHENIA (Very weak), PAIN (Body aching), PAIN IN EXTREMITY (Injection arm soreness), HEADACHE (Headache) and FATIGUE (Very tired/Feels a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included benzonate.  The patient applied cold compress and took diphenhydramine medication as treatment. 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Based on the additional information received, additional events (including a serious event), concomitant medications and treatment information added.; 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.
Pain at injection site for 2-3 days following injection. On day 8 developed headache, muscle aches, stuffy nose, fever up ton101.6 and fatigue
36 hours post vax, the pt experienced erythema and edema with urticaria extending from injection site to just above the elbow according to Mom. There was a small knot at the injection site. No other symptoms were observed. Treated with Ice, Benadryl and Tylenol.
pt recv vax 28APR97 & same day approx 5 min p/vax pt became pale & sweating;w/in 10 to 15min pt fell asleep;p/approx 15min pt awoke & was feeling okay;pt recovered;
mild fatigue, mild headache, chills, slight nausea, malaise within an hour of shot, duration 3-4 hours
Trumenba was the required vaccine and administering that instead of the MENACTRA, with no reported adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient to whom TRUMENBA was the required vaccine and administering that instead of the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], with no reported adverse event.      The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date the patient developed a non-serious event to whom trumenba (dose, strength, formulation, batch and expiry date was unknown) was the required vaccine and administering that instead of the menactra (dose, strength, formulation, batch and expiry date was unknown), with no reported adverse event (wrong product administered) (latency: same day)for Immunization. The Pharmacist asks if Trumenba and Menactra can both be given to the patient, or if they need to wait to give the Menactra.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a nurse concerning a 17 year old female patient who on 19-JUL-2010 was vaccinated IM with the first ml dose of GARDASIL (lot # 665266/1378Y, exp date 09-JUL-2010). Concomitant therapy included LOESTRIN FE 1/20. The nurse reported that 4 days later, on 23-JUL-2010 the patient developed a hive type rash on the scalp which was painful and itchy. On 28-JUL-2010 the patient went to an unspecified primary care physician and was diagnosed with folliculitis. The patient was put on KEFLEX and hydrocortisone cream. The patient still had "bumps" but not as much. At the time of the report, the patient was recovering and had scheduled an appointment with the Primary care physician. Additional information has been requested.
Mistakenly gave DTAP #4 to 8 month old. Received DTAP #3 on 1/21/2009. Mistakenly gave ROTATEQ #4 same time. ROTATEQ #3 on 1/21/09
Pt. states that after receiving the 1st dose of Shingrix 08/30/2021, started experiencing symptoms 12hrs later of a rash (hives/chicken pox rash) no itchiness associated. Primary care visit 09/24/2021 no recommendations other than observation. 2019 Diagnosed previously with Shingles. Symptoms have subsided.
Shingrix that had been reconstituted with sterile water; Shingrix that had been reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: The nurse reported she administered a dose of Shingrix that had been reconstituted with sterile water. The Vaccine Administration Facility was the same as Primary Reporter. Follow up was not asked. Additional Supportive Information: Shingrix that had been reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Information has been received from a lawyer concerning a 14 year old female who in July 2007, April 2009 and January 2010 was vaccinated with the doses of GARDASIL (LOT#s not reported). It was reported that at the time of the report, "now", the patient experienced and in the future will continue to suffer from the neurological effects including seizures, unnatural motor reflexes, headaches, dizziness, fatigue and other symptoms associated with GARDASIL. Upon internal review, a seizure was considered to be an other important medical event. Additional information has been requested.
2 hours post vax, the pt complained of dizziness, after lying down for several hours, the pt woke up with a complaint of swollen face, tongue, cotton throat, was taken to ER by sister. Treated with Benadryl, Prednisone. The pt was advised to see PMD the following day. Unable to contact pt for follow up.
Client complained of fever of 100.7 and one bout of diarrhea. Denied rash, itching, SOB, wheezing.
Day 84 mumpy measles on skin, high fever, body rash, vomiting, hair loss, diarrhea, chronic in all ears, screaming, coughing. Breathing difficulties, swelling neck, face, etc, etc, etc. Infectious disease, arthritis Dr neurologist. Breast swollen. Seizure activities.
didn't feel good after; Elevated heart enzyme; Elevated heart rate; Felt like he was having a heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYOCARDIAL NECROSIS MARKER INCREASED (medically significant) with onset 10Oct2021, outcome "unknown", described as "Elevated heart enzyme"; HEART RATE INCREASED (non-serious) with onset 10Oct2021, outcome "unknown", described as "Elevated heart rate"; FEELING ABNORMAL (non-serious) with onset 10Oct2021, outcome "unknown", described as "Felt like he was having a heart attack"; MALAISE (non-serious), outcome "recovered", described as "didn't feel good after". The events "elevated heart enzyme", "elevated heart rate", "felt like he was having a heart attack" and "didn't feel good after" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (10Oct2021) Elevated; Myocardial necrosis marker: (10Oct2021) Elevated.  Clinical course: This report concerns the reporter's son. Reporter was father of the patient. The reporter states that he is calling about the first two shots of the Pfizer COVID Vaccines. States that he took the first shot and didn't feel good after, but a couple of days later he was okay. Caller states that his wife took the caller and the caller's son to the Emergency Room. The reporter's son had an elevated heart rate. The reporter states that they kept him and his son overnight for observation and then released them the next day. The reporter states that his son experienced an elevated heart rate and an elevated heart enzyme on 10Oct2021. The reporter's son was taken to the Emergency Room, kept overnight for observation, and released on 11Oct2021. The reporter states that his son said he felt like he was having a heart attack. The reporter denies any other medical conditions, medications, labs, testing, or treatments for his son relevant to these events. NDC number and Expiry Date of COVID Vaccine were not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197909 Same reporter/drug, different patients;
Received part of the dose but not full; Needle issue; Syringe issue; A spontaneous report was received from a nurse concerning a patient of an unknown age and sex who received Moderna's COVID-19 vaccine (mRNA-1273) and needle and syringe came apart, fell on the ground and received part of the dose but not full,  Medical history was not reported. No concomitant medication was reported.  On an unknown date, prior to the onset of the events needle and syringe came apart, fell on the ground and received part of the dose but not full, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via an unknown route in an unknown anatomical location for prophylaxis of COVID-19 infection.  Treatment medication was not reported.  Action taken with mRNA-1273 in response to the events needle and syringe came apart, fell on the ground and received part of the dose but not full was not provided.  The outcome of the events needle and syringe came apart, fell on the ground and received part of the dose but not full  was resolved.; Reporter's Comments: This report refers to a case of patient of an unknown age  who experienced non-serious unexpected events of needle and syringe came apart, fell on the ground and received part of the dose but not full (needle issue, syringe issue and incomplete dose administered) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of needle and syringe came apart, fell on the ground and received part of the dose but not full.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, lot number, expiry date, route and dose were not reported), which was improperly stored by exposed to 31.5F for 29 hours. No adverse effects were reported. This is one of several reports received from the same reproter linked to 1501USA008154, 1501USA012473, 1501USA012475, 1501USA012476). Additional information has been requested.
Bruise/the arm where he received the second dose of the Covid-19 vaccine was bruised/; he would be sick following the second dose of the Covid-19 vaccine; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: AW0153; Expiration Date: Jul2021, NDC Number: 59267-1000-1), via intramuscular route of administration, administered in arm right on 14Apr2021 at 09:30 (at the age of 61-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no family medical history relevant to adverse events. The patient did not receive any other vaccine prior vaccinations within 4 weeks. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number EN6199, Expiration Date: Jun2021, NDC Number: 59267-1000-1), via intramuscular route of administration, administered in arm left on 23Mar2021 as dose 1, single for COVID-19 immunization. On an unspecified date in Apr2021, the patient experienced he would be sick following the second dose of the Covid-19 vaccine. On 14Apr2021, the patient experienced Bruise/the arm where he received the second dose of the Covid-19 vaccine was bruised. Adverse events did not require to visit emergency Room or physician Office. Second dose of Covid-19 vaccine administered at 22 days. Covax agent reported that the patient received his second dose of the Covid-19 vaccine on 14Apr2021. Covax agent reported that the patient had a little bit of a bruise following the second dose of the Covid-19 vaccine, but that other than that the patient was ok. Covax agent reported that the patient is wondering if the Pfizer Covid-19 vaccine is working on him because the caller is not feeling any other side effects other than the bruise. Patient reported that the arm where he received the second dose of the Covid-19 vaccine was bruised for the first 2 days after receiving the vaccine on 14Apr2021, but after that, he had no reaction whatsoever. Bruise: patient reported that the bruise appeared a couple of hours after he received the second dose of the Covid-19 vaccine on 14Apr2021 and was gone the next day on 15Apr2021. Patient reported that he has no headache, upset stomach, fever, or nothing. Patient reported that he thought that he would be sick following the second dose of the Covid-19 vaccine, so he bought all kinds of medication. Therapeutic measures were taken as a result of sick. Outcome of the events sick was unknown and vaccination site bruising was recovered on 15Apr2021.  No follow-up attempts are needed. No further information is expected.
2/27/09 Day 8- joint and muscle pain, fatigue and lymph node swelling. 2/28/09 Day 9- symptoms became severe, site painful. 3/3/09 Day 12- evaluated by Dr. 3/7/09 Day 16- rash-raised red itchy bumps, neck and knees- evaluated by Dr on day 18.  6/22/09 Medical records received DOS 3/9/09 3/18/09. Assessment: Allergic reaction to smallpox vaccination. Patient presents with myalgias, macupapular rash on arms legs stomach neck. Itches. Drainage, bleeding from vaccine site.  7/1/09 Received ER medical records of 5/21/09. FINAL DX: myalgias, vaccine related Records reveal patient experienced malaise, joint pain, body aches, chest pain, SOB, localized injection site swelling, nausea, chills, dizziness & migraine HA  1 day & 2 days s/p DTaP vaccine.  Tx w/NSAIDs & d/c to home for PCP f/u.
sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Lot number: EW017) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1997 (ongoing); "Osteoarthritis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Batch/lot number: EW0150, Location: upper left arm), administration date: 06Apr2021, when the patient was 82 years old, for Covid-19 immunization, reaction(s): "left a blood red spot on her arm the size of a dime and bumping on that spot", "left a blood red spot on her arm the size of a dime and bumping on that spot", "had a sore left arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore left arm".  No follow-up attempts are possible. No further information is expected.
First dose on 2020 hasn't received the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st December 2020, Batch number- N972X).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter called in to inquire and report for Shingrix and asked if the patient should repeat the dose, start over or continue the series. The reporter did not consent to follow up.