chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and soreness in arm after coadministration of flu and Prevnar13; Pain and soreness in arm after coadministration of flu and Prevnar13; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. An elderly (over 65 years old) female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization, co-administrated with influenza vaccine (FLU), via an unspecified route of administration on an unspecified date at unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain and soreness in arm after co-administration of influenza vaccine and pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date. Events took place after use of product. The outcome of events was unknown.   No follow-up attempts are possible.  No further information is expected
Patient's mother reported an area of redness about 4 inches above and below the injection site on her deltoid, along with warmth and swelling. The patient denied itching, no hives noted, no swelling or redness anywhere other than the patient's left arm. Patient's mother has been giving her tylenol. Primary care provider instructed the mother to give her benadryl as well.
pt recvd 1st dose of vax w/no noted problem; pt recvd 2nd dose of Hep B vax on 18AUG92 w/in an hr following vax pt exp sore arm w/pain @ inject site; sx resolved w/in 24 hrs; No further details were provided;
he says he was feeling like a heart burn/heart pain; pain in his upper chest/He says this primarily now this is like in his upper chest and throat and he is pointing to upper chest now.; he actually vomited yesterday. He feels like all day today.; he is in bed; This is a spontaneous report from a contactable consumer (parent) or other non-HCP. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0168, Expiration date: unknown) via an intramuscular route of administration in left arm on 17May2021 (age at vaccination 13-year-old) as first dose, 0.3 ml single for covid-19 immunisation. The patient medical history included ongoing depression and ongoing attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications included escitalopram oxalate (LEXAPRO) 15mg daily, methylphenidate hydrochloride (CONCERTA) 36mg daily, escitalopram 15mg daily and vitamins nos. Consumer reported that she has been reading about reports that young men have been having myocarditis after getting the Pfizer covid vaccine and her son, who received his first dose on 17May2021 began having symptoms like heartburn and pain in his upper chest on 23May2021, and now the pain was below his neck and he was hurting all day before the date of event reported  and on the day of report . Patient also threw up. On unspecified date patient was in bed. Patient said primarily now this was like in his upper chest and throat and he was pointing to upper chest now. consumer was watching a news with her husband on day of report (tonight), the story on a news about some heart information and young vaccine recipient and patient was 13 years old and consumer was trying to work out whether there was something the consumer need to go emergency room over. Consumer just did not know if this related to patient's never ever complained chest pain, so consumer was just worried about. Consumer was asking if patient's symptoms were due to heart inflammation. She asked if this was due to heart inflammation and asked if she should take him to the emergency room. Consumer reported that she just spoke with DSU to file a report, no reference number for that encounter. Reporter stated that she was working on prescription and there was NDC. Treatment included consumer just gave patient some pills same and omeprazole 20 milligram and set it on other to. She gave on the night before event reported (tonight) and on the day of report. The outcome of all events was unknown  Follow up #01 (24May2021): ):This is a follow up spontaneous report from a female consumer (patients mother) new information included suspect product detail, event detail, medical history, concomitant medication.
Passed out; She almost died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Passed out"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "She almost died". Clinical course: Reporter stated that his grandma passed out a few months ago and she almost died, right before that, the day before she took the vaccine, he thought it might have been adverse effect. Caller mentioned his grandma was the first to pass out.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225285 same reporter/drug, different patient/event;US-PFIZER INC-202300225284 same reporter/drug, different patient/event;US-PFIZER INC-202300225069 same reporter/drug, different patient/event;
Acute malleoli ankle fractures status post casting by orthopedic surgery.  Nonweightbearing with use of crutches.  PT/OT consulted.  Patient does not own a wheelchair.  Pain currently controlled.  Management per orthopedic surgery. -Surgical repair ORIF of right ankle on 8/24/22 - discussed with ortho resident. Follow up with orthopedic surgery outpatient. Patient is being discharged.
Pt. received Janssen COVID-19 vaccine on 3/31/21 and was admitted to the hospital on 4/1/21 with COVID-19.
Swollen red, warm L arm at site of DTaP vaccine 10x4 cm size and itchy. No fever, no SOB, no wheezing.
became raised (bumps) again; injection site became red; Redness at site of Injection; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (became raised (bumps) again), INJECTION SITE ERYTHEMA (Redness at site of Injection), VACCINATION SITE PAIN (Soreness of arm) and INJECTION SITE ERYTHEMA (injection site became red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at site of Injection) and VACCINATION SITE PAIN (Soreness of arm). On 04-Feb-2021, the patient experienced INJECTION SITE MASS (became raised (bumps) again) and INJECTION SITE ERYTHEMA (injection site became red). At the time of the report, INJECTION SITE MASS (became raised (bumps) again), INJECTION SITE ERYTHEMA (Redness at site of Injection), VACCINATION SITE PAIN (Soreness of arm) and INJECTION SITE ERYTHEMA (injection site became red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Events were resolved and patient denied further follow-up
Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 13:00 as dose 2 (booster), single (Lot number: Fg3527) at the age of 49 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Apr2021 at 12:00 as dose 1, single (Lot number: 043a21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Dose:1 Jnj, Dose: 2 Pfizer. There were no concomitant medications.  The following information was reported: COVID-19 (medically significant) with onset 25Apr2021, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 25Apr2022, outcome "not recovered" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) positive; (09May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was stated that patient experienced rebound COVID. Tested positive 25Apr2022, got better. Got sick again 08May2022. Tested positive again 09May2022. There was no other medication in 2 weeks. There were no known allergies. Treatment details to COVID was anti-viral product, Paxlovid, start date was 25Apr2022 and stop date was 29Apr2022. There was no other medical history.
My Whoop showed very elevated respiratory rate and BPM; My Whoop showed very elevated respiratory rate and BPM; elevated skin temperature; Fatigue; Achiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 10:45 as dose 4 (booster), single (Lot number: 10046) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: 7182, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular, is bivalent=False), administration date: 26Nov2021, when the patient was 50-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose:2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (Dose:1, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "recovering", described as "Achiness"; FATIGUE (non-serious) with onset 2022, outcome "recovering"; RESPIRATORY RATE INCREASED (non-serious), HEART RATE INCREASED (non-serious) all with onset 17Oct2022, outcome "recovering" and all described as "My Whoop showed very elevated respiratory rate and BPM"; BODY TEMPERATURE INCREASED (non-serious) with onset 17Oct2022, outcome "recovering", described as "elevated skin temperature". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pain, respiratory rate increased, heart rate increased, body temperature increased.  Additional information: Patient had no known allergies. The patient did not have covid prior vaccination nor tested post vaccination. Fatigue and achiness. Also the night of the injection his whoop showed very elevated respiratory rate and BPM and elevated skin temperature. He did not received other medications in two weeks. He received other vaccine i.e. flue vaccine in four weeks.
I started coughing sneezing and sore throat. On 02/23/23 I tested negative for COVID-19.  I went to an outpatient clinic and was negative for flu, it was negative. On the 02/24/2023 I was still not feeling well and tested positive.  I got a prescription for Paxlovid, I had taken it for five days and felt fine, then the symptoms came back. The second round lasted another 5 days and I felt better again. I am feeling fine now.
Facial rash appeared 2 days after vaccine, and has continued to get worse. She was seen at an outpatient facility due to the rash and they prescribed her a antihistamine and hydrocortisone cream.
NAUSEA AND VOMITING; HEADACHE; BODY ACHES Narrative:  Symptoms lasted 3-4 days
Developed varicella after receiving vaccine. Had been on steroid burst BD prior to immunizing.
asymptomatic covid positive test on 1/21/22 due to routine testing of OB patients
This is in follow-up to report (s) previously submitted on 12/12/2008. Information has been received from a physician concerning an "around 4 months old" male who on an unspecified date, was vaccinated with the second dose of ROTATEQ vaccine, 2ml, oral (lot# not provided). Subsequently the patient experienced blotchy redness in face and around lips. It was reported that the patient had no reaction after first dose of ROTATEQ vaccine (lot# 663033/0894X) and the physician had decided not to administer the third dose. The patient's mother has not contacted the office since the last visit so the doctor is assuming that there have been no further problems. The doctor would be seeing the patient again in 2 weeks. Unspecified medical attention was sought. Additional information has been requested. Follow up information has been received from the physician reporting that the 17 week old male with no medical history or drug allergy received his second dose of ROTATEQ 2ml oral (lot# 661582-0595X) on 06-NOV-2008. On 06-NOV-2008, the nurse had just started to administer vaccine, the tube was just touching the patient's mouth and had started to transfer contents when a few pink/red blotches were noted on the patient's face. They resolved quickly. No vomit or respiration difficulty was reported. The physician instructed the nurse to try again and same rash appeared. The patient was observed in office for 30 minutes. No respiration and no rash noted before the patient left. Additional information is not expected.
A 33 year old female, with a medical history of an epidermoid brain tumor, received the 3rd dose of Anthrax vaccine (lot Fav0489) on 05/02/2001.  No other vaccines were given at that time.  The patient received the 2nd dose of Anthrax vaccine on 04/12/2001 and experienced a local reaction.  Concomitant medications reported were Paxil and Orthotricycline.  On 05/03/2001, the patient experienced swelling, redness, heat, and induration in the right upper arm. On 05/03/2001, the patient noted induration, swelling, heat, and redness in the right upper arm and was to be seen later that day at a local hospital for treatment advice. The patient was seen by a physician who prescribed Allegra, two times a day for 5 days, and application of ice to the area as tolerated for fifteen minutes each treatment, for 3 days.  By 05/09/2001, the patient reports all symptoms have resolved.
About 30 mins post vaccination, pt developed hot, itchy feeling, skin flushing, and feeling of "lump" in her throat.  50 mg oral benadryl was administered and pt was monitored for approx 1 hour w/good improvement of symptoms.  Pt was able to go home and continue home benadryl and pepcid.
MMR II vaccine was reconstituted and not given so was placed in the fridge for 8 hours in case it could be used. It was not discarded after 8 hours and was used 26 hours later in a patient that came in for their second MMR vaccine.
Patient received unapproved booster dose due to the booster currently being approved for a minimum age of 16 years old and this patient is 15 years old.
11/28/21 42 yr/o male who complains of Generalized Body Aches (congestion,ear hurt, poss fever) Physical Exam:        BP 125/70  | Pulse (!) 116  | Temp 98.3 °F (36.8 °C)  | Resp 19  | Ht 6' 1" (1.854 m)  | Wt 251 lb 12.3 oz (114.2 kg)  | SpO2 99%  | BMI 33.22 kg/m²    Eyes:   Conjunctivae and lids normal   ENT:    Otoscopic exam of external canal and TMs normal             OP: normal, no erythema, no exudates   Resp:  Normal respiratory effort             Normal breath sounds, No rales, rhonchi or wheezes    C/V: RRR, nl s1/s2, no M/G/R    Lymph: No AC or PC lymph node tenderness/swelling    Skin: no rashes present
Fever , t max 101.8- started 20 hours after vaccine, lasted over 24 hours. Minor symptoms of chills and headache and myalgia
02/10/2022: High fever (max 101.5 F), extreme fatigue, sweating, exhaustion, body ache, swelling and pain at injection site 02/11/2022: Low fever (99.5 F), moderate fatigue, increased swelling and pain at injection site, body ache and joint pains, stomach ache. 02/12/2022: No fever, mild fatigue, continued swelling and pain at injection site, large red rash of 3cm diameter around injection site. stomach ache. 02/13/2022: Continued swelling and pain around injection site, Red rash continued as well. Skin at injection site hot and rough, stomach ache. 02/14/2022: Pain, rash and itching around injection site continue, stomach ache.
Case PHEH2016US022994, is an initial spontaneous report received from a nurse on 07 Sep 2016. This report refers to a 3 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185886) at a dose of 0.5 ml intramuscularly on 07 Sep 2016, when she was at 03 years old. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered doses of ZOSTAVAX experienced a temperature excursion between 15 and 46 Fahrenheit degrees for 1 hour. Digital data logger was used to capture the temperature excursion. Previous temperature excursions occurred, but no details were provided. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA004743: US-009507513-1709USA008479: US-009507513-1709USA008477:
A report was received from a health care professional on 9/2/03, concerning a 52 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 9/2/03. On 9/2/03, the vaccinee inadvertently received Fluvirin vaccine. No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending, all information received. See PJP200300722 and PJP200300723.
Vaccine was given on left arm.  Approximately five hours later, my left arm starting to hurt.  It hurt so badly, I could  not lift my arm.  The pain was a level 10 (ten being the worse).  This is day five and I am still experiencing pain. Friday thru Tuesday was the worst, I could not sleep, the pain kept waking me up.
rash on arm has faded but is still there; rash on arm is warm at times; red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash on arm is warm at times), VACCINATION SITE ERYTHEMA (red rash on arm) and VACCINATION SITE RASH (rash on arm has faded but is still there) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (rash on arm is warm at times) and VACCINATION SITE ERYTHEMA (red rash on arm). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (rash on arm has faded but is still there). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (rash on arm is warm at times), VACCINATION SITE ERYTHEMA (red rash on arm) and VACCINATION SITE RASH (rash on arm has faded but is still there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The rash on arm had faded but was still there.  Treatment included diphenhydramine and ice.  Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Numb skin; Dizzy; Very unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient also received first dose of measles, mumps and rubella vaccine (MMR) (MANUFACTURER UNKNOWN) via an unspecified route of administration on 03Mar2021 for an unknown indication. Medical history included asthma and allergy to seafood. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. On 01Apr2021 at 19:00, the patient experienced numb skin, dizzy and very unwell. On 16Apr2021, the patient underwent rapid test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events numb skin, dizzy and very unwell were resolved on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
second dose given early; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given early) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given early) had resolved.        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 were not reported. Treatment information was not provided.