chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 19-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in a temperature excursion (on 01-JAN-2021) for prophylaxis (product storage error). No additional adverse event reported.   The administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA007556: US-009507513-2102USA003923: US-009507513-2102USA007558: US-009507513-2102USA007559: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007563: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
Patient reported severe stabbing pain and body aches beginning the evening after the vaccine. Had low-grade temp 99-100 since the day after the vaccine. Her arm is also sore.
Patient complained of increased heart rate(148) and " mu throat feels funny" holding her hand to her throat. mild shortness of breath with great anxiety. 0.5 of epinephrine and 50 mg of Benadryl given IM and EMS notified , after evaluation by EMS ,and 30 minutes of time had elapsed,patient declined transport, stating " I am better" she called and family member and left with them. heart rate was 148, respiration 32 and blood pressure 186/102
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 22-JUL-2015, the patient was vaccinated with an improperly stored doses of PROQUAD (Merck) (lot number L010142 with expiration date 24-SEP-2016 and lot number J013436 with expiration date 24-APR-2015) dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Partial loss of use left arm at shoulder. Extreme pain rotator cuff. Unable to lift arm above shoulder level. Second flu shot pain up spinal cord and reoccurring pain at shoulder, after partial recovery-new onset.
Blacked out: I was attempting to put on a sweater to go to the bathroom. I had my arms up and felt a lot of pain in my arm, and blacked out and fainted. I don't recall the events for the next 60 seconds. My wife said that I fell on the bed, was unresponsive, saw foaming at the mouth, had seizure, and urinated in my pants. She adjusted the bed so that my head is up, and threw cold water at my face, mouth and teeth, which made me responsive, and then walked me to the bathroom.     During the night, I had fever, Chill, pain at injection site, vomit, nausea, headache, light-headed.  I didn't have appetite in the morning and had nausea and headache. I felt better ~3pm when I could finally eat rice, yogurt and chicken. I am feeling well now, but worry that the seizure had caused any long term damage.
VACCINE WAS NOT RECONSTITUTED - PATIENT RECEIVED INJECTION WITH ADJUVANT SOLUTION ONLY.
pt recv vax & stayed for 15min observation p/15min found 4cm round, red area w/o raised area;
Body aches mostly in the the legs and shoulders.  Fever to 102 in the night.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Dec2021 as dose 3, single (Batch/Lot number: unknown), in left arm and on 22Apr2022 as dose 4, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Oct2022, outcome "unknown", described as "vaccine brand other Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. 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.
This is a spontaneous report from a contactable nurse, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3781) via an unspecified route of administration in the left arm on 21Aug2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin (PCN) and unspecified condition. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified prescriptions within two weeks of vaccination, from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 29Jul2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 15Sep2021 at 15:00 (since getting the second Pfizer vaccine), the patient's left arm at injection site felt like something was pinching sticking her. Sometimes that feeling radiated down to her left forearm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm at injection site felt like something was pinching sticking her, sometimes that feeling radiated down to her left forearm was not resolved at the time of this report.
Developed rash on back, stomach, arms and legs.  Outbreaks are fluid filled, some 1/8 inch wide and high, others smaller and not as "bubbly"
pt recv vax & devel a local rxn;no further details available as of the date of this report;this is one of two patients from this site who exp the above rxn p/recv same lot#;
Moderna COVID?19 Vaccine EUA  Fatigue lasted for around 6 hours Nasal congestion ongoing still 8.5 hours after injection Slight headache, may be from nasal congestion
After 12 hours chills, body aches, fever, nausea After 36 hours: body aches, nausea, headache  After 60 hours: neck pain, headache, tiredness
Very ill 12 hours after receiving both the flu and pneumococcal vaccine in same arm.  Sore arm, extreme chills, fever, body aches, no appetite, very thirsty.  Can't imagine how flu could have been any worse.  This is 2 days later and am still extremely tired.  Arm still quite sore and cannot lay on that side not yet.  Husband wanted me to go to hospital 1st night it was so bad.
Pt.'s Daughter states that after receiving the 2nd dose of Moderna 03/27/2021, started experiencing symptoms 2hrs of Appendicitis with GI bleed. Hospitalized at Hospital (ICU 3 weeks) discharged to Rehabilitation. Suffered a Ischemic Stroke during being Hospitalized. Pt. suffered another Massive Stroke 05/13/2021 during Hospitalization due to Stroke D.O.D 05/15/2021.
pt recv vax & devel acute transverse myelitis 10 days p/vax;27OCT96 pt devel sharp pain between scapula 0 zero SOB, recurring pain w/n/v, urinary retention;dx negative;numbness hips & trunk to T4 level;strength dec;limp;some trunk numbness
Symptoms began on 05/29/2022, I had fever of 100.3 at its highest, fatigue, body aches, congestion, cough, nausea, diarrhea and loss of appetite. I tested positive on 05/30/2022. I had a telehealth appointment on 06/01/2022. I managed my symptoms from home with medication for nausea, over the counter cough medicine, and my inhalers and normal medications for the asthma. Pulse oximeter - the lowest was 96. I finally felt better around 06/16/2022. I did end up with another virus around 06/29/2022. No positive Covid-19 test result.
flu like symptoms; sneezing; sniffles; body aches; fever; fatigue; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th December 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue. On 29th December 2019, the outcome of the influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the left arm. After vaccination, the patient experienced  influenza-like symptoms, sneezing, sniffles, general body pain, fever and fatigue. The reporter consented to follow up with physician on an unknown date.
Rash spreading to legs, knees and upper arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash spreading to legs, knees and upper arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Knee Replacement Surgery). Concurrent medical conditions included Drug allergy (Promethazine, Betadine and Lovenox), Immunocompromised, Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism (Syndrome) and Migraine. Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, PILOCARPINE for Dry mouth, METFORMIN for Dyspepsia, OMEPRAZOLE for Gastrointestinal disorder, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, LEVOTHYROXINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Rash spreading to legs, knees and upper arm). The patient was treated with MUPIROCIN ongoing since an unknown date for Rash, at a dose of 1 dosage form three times a day; PIMECROLIMUS (topical) ongoing since an unknown date for Rash, at a dose of 1 % percent twice a day and TRIAMCINOLONE (topical) ongoing since an unknown date for Rash, at a dose of .1 % percent twice a day. At the time of the report, RASH (Rash spreading to legs, knees and upper arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect The patient dermatologist took a biopsy, and, in the results, they could not detect what it was. On an unknown date, SARS-CoV-2 test: not tested positive (Negative) Had not tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had chronic illnesses not improved or worsened after the vaccination. The patient had not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. The patient had vaccine in her deltoid muscle and had not the vaccination card to provide lot number, expiration date and dose quantity administered. Patient had concomitant policarpine 5 mg 3/4 times a day. Treatment medications information included patient had phototherapy, mupirocin 3 times a day for 5 days, pimecrolimus 1% topical cream twice a day, triamcinolone 0.1 % topical cream twice a day (none of them worked).   This case was linked to MOD-2022-503106, MOD-2022-503107, MOD-2022-503108 (Patient Link).
Miserable; Hurt all over my body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Miserable) and MYALGIA (Hurt all over my body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Miserable) and MYALGIA (Hurt all over my body). At the time of the report, FEELING ABNORMAL (Miserable) and MYALGIA (Hurt all over my body) outcome was unknown.            No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
onset of lt parotitis 2 wks p/vax w/MMR-no other sx reported;
FEELING COLD; SHAKING; FELT MUSCLES OF BACK GETTING TIRED; CLIMBING TEMPERATURE BUT NOT FEVER; CHILLS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, no alcohol use, and nonsmoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient's past medications included birth control vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on left arm on 23-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 01-FEB-2021, Laboratory data included: Pregnancy test urine (NR: not provided) Normal. On 23-MAR-2021, the subject experienced felt muscles of back getting tired. On 23-MAR-2021, the subject experienced climbing temperature but not fever. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced slight headache. Laboratory data included: Body temperature (NR: not provided) 98 to 98.3 F, 100 F, 99.5 F. On 23-MAR-2021 19:00, the subject experienced shaking. On 23-MAR-2021 19:00, the subject experienced feeling cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, climbing temperature but not fever, and chills on 23-MAR-2021, was recovering from slight headache, had not recovered from felt muscles of back getting tired, and the outcome of feeling cold was not reported. This report was non-serious.
After second dose my migraines have been severe.; arthritis pain in my hands has increased exponentially and I'm experiencing joint pain all over my body; Also experience serious fatigue; arthritis pain in my hands has increased exponentially and I'm experiencing joint pain all over my body; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in left arm on 04Mar2021 as dose 2, single (at the age of 24-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included anxiety, depression, arthritis. Also had mild arthritis, panic disorder. Patient was currently being treated for chronic migraine (migraine), panic disorder and major depressive disorder. Patient received unknown concomitant medications in last 2 weeks. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9808) via an unspecified route of administration in left arm on 11Feb2021 13:15 as dose 1, single for COVID-19 immunization and was severely depressed. The patient did not have Covid prior vaccination, did not have any other vaccine in four weeks, did not test covid post vaccination and did not have known allergies. It was reported that after the first administration she became severely depressed, but this could have been a result of outside factors. Had to change medications. After second dose on 04Mar2021 16:00 the patient experienced migraines had been severe for which she had been receiving treatment for them for over a year and now they were as bad as they were prior to starting treatment. On same day, the patient also experienced arthritis pain in her hands on 04Mar2021 16:00 which had increased exponentially, experiencing joint pain all over her body on 04Mar2021 14:00 and also serious fatigue on 04Mar2021 16:00. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
No additional AE reported.; Nurse explained she has a patient who went to another country in Nov 2022 and at the time was 6 months old. The patient received a dose of MMR II and VAQTA prior to going to Ethiopia.; This spontaneous report has been received from a nurse concerning to a 6-month-old patient of an unknown gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 01-NOV-2022, the patient was vaccinated with a dose of  hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once, (strength, route of administration were not provided lot number W006214 that was verified to be valid, expiration date reported and established as 04-MAR-2023); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) subcutaneous injection, once ( lot number U039548 that was verified to be valid, expiration date reported and established as 14-DEC-2023) (strengths and routes of administration were not provided)  for prophylaxis, which was reconstituted with sterile diluent (dose, strength, route of administration and formulation were not reported ;lot number W017640 that was verified to be valid, expiration date: reorted and establisedh as 06-NOV-2024).  No additional adverse events (AEs) reported.
Following adm of Typhoid vax, pt exp mod to severe localized soft tissue swelling in the triceps region; swelling extended from inject site to beyond elbow & to the axilla; Swelling lasted 7 days; tender @ inject site & induration;
Extreme redness inch away from shoulder down to elbow it is oval shape, warm and tender to touch.
Itchy skin followed by rash with bumps and itching under both arms. The rash has not gotten better in fact it's worse now then it was when injection was first received.
a horrible migraine for a few days; Fever 100.2 F after first shot; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (a horrible migraine for a few days) and PYREXIA (Fever 100.2 F after first shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MIGRAINE (a horrible migraine for a few days) and PYREXIA (Fever 100.2 F after first shot). On 24-Jan-2021, MIGRAINE (a horrible migraine for a few days) and PYREXIA (Fever 100.2 F after first shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 100.2 f (High) 100.2 F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-022019 (Patient Link).
warm at  injection site; Itchy at injection site; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at  injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm at  injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, VACCINATION SITE WARMTH (warm at  injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Headache, chills, dizzy, nausea for 3 days and returning 1 week after for 10 days. Still on and off feelings. Swollen axillary nodes both sides, left worse. Still swollen more than 2 weeks later.
Mild swelling on evening of 3/22/2016 and slight red arm. Morning of 3/23/2016 more swelling and red puffiness, arm where injection hard, very hot to touch and a little itchy. By 7p on 3/23/2016 arm was swollen and rash like looking measuring 4 in long and 3 inch wide, very warm. No fever, temp was 99.0 by ear on one side and 98.9 on other ear.
Mother called the Health Department to report redness, tenderness, and warmth at injection site.  Mother reported red area was aobut 3 cm x 3 cm @ Left arm.  No treatment.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In July 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 05-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.