chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports some redness around the injection site after vaccination. About 2 weeks after the vaccine was administered, patient reports itchiness on his upper arm around the injections site. It has been about a week since it started and it is on and off according to the patient but the itchiness has remained about the same. Because of the itchiness, patient has been scratching his arm which in turn has been getting red and now he has a few open wounds. He reports the injection site as having a red dot in the middle and redness around it.
Redness and swelling and pain  saw at 630am this morning 9-27-21
No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 05-year-old female patient. on 10-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
This case was reported by a nurse via sales rep and described the occurrence of vasovagal attack in a 16-year-old female patient who received BEXSERO for prophylaxis. On 2nd April 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced vasovagal attack. On an unknown date, the outcome of the vasovagal attack was unknown. It was unknown if the reporter considered the vasovagal attack to be related to BEXSERO. Additional details were provided as follows: After receiving the SHINGRIX, the patient experienced vaso vagal response.
Initially there were severe flu like symptoms: chills, shaking, headache & body aches, fatigue starting apx 2 hours following. These continued until apx 24 hours later when additional mental fog set it, difficulty focusing attention, lethargy, trouble walking, dizziness then brief loss of consciousness occurred, extreme difficulty staying awake. I was taken to the emergency room where additional tests were done due to "stroke- like" symptoms.  Tests were okay with hospital staff reporting that likely/only known cause was the COVID  vaccine given the day before. Symptoms have gradually reduced but occasional mental fog, occasional dizzy spells & chronic fatigue persist.
Diarrhea, fever, sweats and chills, extreme body ache and headaches, light headed ness, feels like I?m not getting a full breath while breathing in. Felt as though I was going to pass out multiple times. I took Tylenol for my fever but it didn?t help. This has been going on for almost 2 days
Red blotchy irregular rash over R thigh (injection site) with swelling and itching lasting for 3 days.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included METOPROLOL, APIXABAN (ELIQUIS), LISINOPRIL, LISINOPRIL (TENSOLISIN), ATORVASTATIN, AMLODIPINE, VITAMIN D [VITAMIN D NOS] and VITAMIN E NOS for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-310836, MOD-2021-310835 (Patient Link).
ADMINISTERED TIME EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287 expiry: 15-SEP-2021) dose was not reported, administered on 02-JUL-2021 10:41 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced administered time expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered time expired vaccine was not reported. This report was non-serious.
Kidney infection; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced KIDNEY INFECTION (Kidney infection). The patient was treated with CIPROFLOXACIN for Adverse event, at an unspecified dose and frequency. At the time of the report, KIDNEY INFECTION (Kidney infection) outcome was unknown.            Patient had kidney infection. Patient insisted in it not having anything to do with the vaccine. Patient needs to take an antibiotic.  Company Comment: The only reported evens in this case is non-serious, hence no CC is required.   This case was linked to MOD-2021-435541, MOD-2021-026441 (Patient Link).; Sender's Comments: The only reported evens in this case is non-serious, hence no CC is required.
This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number : Ew0169), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:30 as DOSE 2, SINGLE for covid-19 immunization.Medical history included hypertension and cosine-rash from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported.The patient previously took bnt162b2 for covid-19 immunization and experienced arthralgia, cosine and experienced rash.On an unspecified date the patient experienced extremely aching thumb, wrist and shoulder joints in both arms (pain in extremity), extremely aching thumb and wrist and shoulder joints in both arms (arthralgia) .The outcome of all the events was not recovered.  No follow up attempts are possible. No further information is expected.
About ten hours after my vaccine, I experienced chills, shakiness, sweats but no fever. I felt really tired and my body felt achy as well.  I took OTC Tylenol and by the following evening my symptoms went away.  I am also currently 39 weeks pregnant.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
I have not had a period for 15 months, on the date of my first modern vaccine a I started a ?normal? period which lasted for 8 days. It was exactly like my periods pre menopause.
rash on neck; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264, Expiration date: unknown) in Left arm on 04Feb2021, at 09:00 PM as single dose for COVID-19 immunization. Patient medical history included recently diagnosed with asthma. concomitant medications included Trelegy, Meloxicam, C abergilene, Yuvafem Olmesartan. Patient experienced rash on neck on 08Feb2021.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had known allergies to penicillin and sulfa (nausea from either). The outcome of the event was not recovered.
Pt recvd 1st Engerix-B vax 2MAY91 & exp chest tightness & stuffy head in the evening p/the dose; events lasted a couple hrs; on the 3rd day post vax had generalized ache in joints, specifically hips & more pain; talked to MD;
This spontaneous report was received from a pharmacist refers to an approximately 46 year old male patient. Patient's pertinent medical history included acute myelogenous leukemia s/p stem cell transplant during January 2014. The patient was allergic to CEFATIN, bee stings and adhesive tape. On 23-SEP-2014 the patient was vaccinated with one dose of M-M-R II, 0.5 ml, subcutaneously (site of administration and lot number unspecified). Concomitant therapy included tacrolimus. On 09-OCT-2014, the patient was hospitalized. The patient was initially diagnosed with a possible skin manifestation of graft vs host disease. A skin punch biopsy revealed folliculitis. The patient was also diagnosed with an ongoing systemic gram positive bacillus fortuninum infection and a new onset of diarrhea. The stool culture was negative for clostridium difficile. Result of blood culture was unknown. The patient was not discharged from the hospital at the time of this report. Outcome of all events were reported as not recovered. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
pt said she got covid arm 1 week after dose administered and now has tingling and numbness in her arms and legs
Had received 2 Dose of Sputnik V vaccine for Covid-19 prophylaxis in 1st dose on Jan-2021 and 2nd dose on Feb-2021. In 22-NOV-2022 had upper abdomen pain was performed with USG scan and found Gall Bladder Polyp (GB Polyp), and elevated LDL (96) in Lipid profile. No Active treatment received.
Chest was painful, after the first vaccine; Breath was hard, and it was painful, after the first vaccine; Breath was hard, and it was painful, after the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 20May2021 (at the age of 24-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In May2021 morning, the patient experienced chest was painful, after the first vaccine and breath was hard, and it was painful, after the first vaccine. The patient called about his situation and to ask for some advice. The patient did not know what to do. He read online that if people have had side effects like chest pain, they should go to the hospital. The patient asked if he should go to the hospital. He was outside of a hospital at the time of reporting. The patient reclarified that if people are young and under 25 years old, they do not have to worry and the side effects usually last for 2 or 3 days and then disappear. His effects have lasted for 4 days. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Patient started to feel very light headed. Did not pass out. Put on 6 liters of O2 and had Doctor come to look at her. Gave her some water and juice. Monitored for 15 minutes. Patient started to feel really sleepy. Called doctor again, left O2 on patient and monitored for 30 more minutes. Released by Dr. at 1354.
Narrative:  72 yo male with PMH of COPD, HLD, and tobacco use reported a "red painful rash" after he got pneumovax vaccine on 4/26/2021. Pt was evaluated by PCP on 4/27/2021 via telephone. Per patient, rash went for L upper arm all the way to L elbow. He rated pain as 4-5/10. Pt denied other symptoms. Per records, patient denied any problems with past vaccination (has not received covid-19 vaccines). Pt was dx'd with localized edema of L upper arm post vaccination and was prescribed ibuprofen prn and non pharmacologic measures.
Twenty minutes after first dose severe dizziness (unable to steadily walk), motion sickness, headache, feeling faint.    Advised by Pharmacist to wait until symptoms resolved before taking second dose.  Waited 14 weeks, dizziness did not resolve completely but became less severe.  Took second dose 9/2/2021.  1 day after second dose (24 hours later), severe vertigo returned, sporadic feeling faint, unable to drive long distances.  Also had common symptoms of sore arm, slight fever, exhaustion, light headed foggy brain.  Light headedness/ feeling faint, vertigo still have not resolved after 8 days and are severe at times.
Patient received Moderna on 7/10 and developed a facial droop 10 days after the first vaccine. Patient was sent to emergency department for fear of stroke, but full work up was normal. Patient was ruled to have Bells Palsy that could possibly be related to the Moderna Vaccine.
Per patient, he developed a fever, myalgia, and headache after first vaccine.  Fever and myalgia resolved after a few days, but headache persisted.  At the time of the patient's second dose (1/21/21), patient reported that he continued to experience headache
Became unresponsive and was unarousable to sternal rub.  A code blue was called and she woke up. Her BP was elevated (176/120) and HR 45, o2 sat 100%, RR 16. About 15 minutes later, she had a repeat syncopal episode and was transferred to the emergency dept
dizziness; headache; flu-like symptoms; fever; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided.).    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 DIZZINESS (dizziness), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.
This spontaneous report as received from a nurse refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 20-SEP-2018, the patient was inadvertently vaccinated with two doses of M-M-R I) (route of administration, lot number, expiration date were not reported) for prophylaxis. There was no reports of adverse effects.
Same day, felt achy, cold, headache and  could not seem to get warm. Just wanted to wrap up and sleep, was not very energetic, felt lousy and sore. After 2nd day, back to normal. (I am fine now)
Client stated that after receiving Tdap on 11/29/07 she developed a large, red lump on her arm.  She came into city clinic on 12/7/07 to show the lump to a nurse.  At that time the nodule was observed to be approximately 6 mm in size and located one inch below axillary notch and one inch posterior from the midline.  She stated the lump was resolving on its own.
Soreness and erythema (~4 inches red ring in diameter) appeared on 03/06/09, 2 days after receiving the vaccine. Patient also complained of swellling at the site of the injection which was tender to touch. On 03/09/09 patient claimed that the redness was fading away, and she can now touch/rub the injectopn site.
Patient (age 14), started losing her hair 2-3 weeks after 2nd Pfizer vaccine (which was on June 10 2021). Since diagnosed with Alopecia Areata. Did not have this issue before the vaccine.
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient was sitting in the observation area and started to feel faint and called for help. She experienced loss of consciousness as help was arriving and hit her head and face on the floor. She experienced loss of consciousness for 2 minutes. Her nose was bleeding and she bit her lip. She was placed on stretcher by EMS and began to wake up. She refused to the ambulance and did not want to go to hospital. She was left the site accompanied by her spouse.
At 2 AM on day following vaccinations, patient had seizure with shaking of arms and legs, eyes open, lasting 10 minutes.  Parents called 911.  Went to Emergency Room - had fever.  Diagnosed with Otitis Media.
dizziness; anxiety; hypertensive; trembling hands; a mild headache; tachycardic; This is a spontaneous report from a contactable Pharmacist. A 46-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: EN6206), dose 1 intramuscular, administered in Arm Left on 15Mar2021 as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included none. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. There were no known allergies to patient. It was unknown if patient was pregnant. The patient experienced dizziness, anxiety, trembling hands, and a mild headache. Patient was hypertensive, tachycardic, and afebrile on 15Mar2021. The patient took no other vaccine in four weeks, Patient received tylennol medications in two weeks. The patient received no treatment in response to events. The patient had no covid prior to vaccination, no covid test was performed after vaccination. The clinical outcome of all events was recovered on unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
I experienced a significant reaction after receiving the pneumoooooal polysaccharide 23 vaccine on Wednesday, January 6. The right upper arm was the site of the injection. I experienced redness, swelling and the area was very warm. The redness spread down into the foreaarm and encircled my upper arm the next day. My arm became very swollen. It looked like hives. I could not lift my arm or extend my arm without great pain. I went to the urgent care center or Friday and they diagnosed this as cellulitis and prescribed antibiotics. My practicioner did not let me know there were any side effects or provide me with paperwork. I realize now, via articles in NH that there can be allergic reactions. My doctor an the physician assistant both saw this as cellulitis and not allergic reaction. Today, on Sunday my arm is still painful to touch and lift.
I already had high BP, and was being treated. Not sure if it is stress given everything going on in the news, but BP did spike into the urgent zone, but has since come down. My PA prescribed Hydralazine to address....not completely sure this is related to the Pfizer dose. Also, stomach is a tad "crampy" on the 3rd day so I took off from work.
Adverse events are rare; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse events are rare) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse events are rare). At the time of the report, VACCINATION COMPLICATION (Adverse events are rare) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medicine,treatment and Medical history were not reported.
Sore throat, chills, muscle soreness, headache, fuzzy headed, swollen neck glands Symptoms began approx. 7:30p.m. until 3:30 a.m. on Oct. 24, 2020
Chest pain with myocarditis.  Treated with dexamethasone 10mg IV x 1 followed by prednisone.
Tightness across chest, tingling from right shoulder to fingertips, sweating, feeling of warmth
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; JARDIANCE; LOSARTAN; DULOXETINE; OMEPRAZOLE; PRAVASTATIN; FAMOTIDINE; ZOLPIDEM; TAMSULOSIN; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: testing negative for 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Rebound COVID-19 after completing medication and testing negative for 2 days. The patient recovered with lasting effects.  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.
p/vax pt started vomiting for  3 days;rt side hurt, & had a sinus infect;stomach & pain inside got better & started itching all over;states no rash but itched;blood sugar went up;n/v;