chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 103.8F (under arm) and Tylenol and Motrin was given. Rash on chest, abdomen and back. Had a fever of 101F and lower after initial 103.8F. Had fever for 2 days and rash for 4 days.
DOSE ADMINISTERED FROM VIAL PUNCTURED FOR MORE THAN 6 HOURS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced dose administered from vial punctured for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose administered from vial punctured for more than 6 hours was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 20-JUN-2016, the patient was vaccinated with one dose of VARIVAX (lot # L048465 and expiration date 02-DEC-2017, route of administration was not reported) that was improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. It was stated that there was previous temperature excursion (date unspecified) with minus 7.7 Celsius degrees for 18 hours and 16 minutes. On 20-JUN-2016, the temperature of excursion was minus 7.0 Celsius degrees and the time frame of excursion was 16 hours and 44 minutes. On 21-JUN-2016, the temperature excursion was minus 10.4 Celsius degrees and the time frame of excursion was 3 hours and 6 minutes. The cumulative time out of range, including present excursion was 35 hours in the refrigerated range and 3 hours 6 minutes in unlimited range. It was stated that the conditions were back in range. Additional information has been requested.
within 3 to 5 months was diagnosed with Guillain-Barre syndrome. The patient experienced effects that resulted in physical therapy and additional follow-ups for diagnosis; This spontaneous report was received from a consumer via a company representative, referring to a 11-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient received "all three adolescent vaccines" including hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis, meningococcal vaccine (unspecified) (manufacturer unknown) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) (strengths, anatomical sites of injection, routes of administration, lot numbers and expiration dates were not reported).  On an unknown date (reported as withing 3 to 5 months), the patient was diagnosed with Guillain-Barre syndrome. The patient experienced effects that resulted in physical therapy as treatment and additional follow-ups for diagnosis. The patient sought medical attention.  The outcome of Guillain-Barre syndrome and the causal relationship between the events and the suspect therapy were not reported.  Upon internal review, the event Guillain-Barre syndrome was determined to be medically significant.
Moderna COVID-19 Vaccine EUA Fever of 100.7, chills, body aches and pains, sore arm at injection site, swelling at injection site, throbbing headache.
Administered live H1N1 nasal spray vaccine instead of inactivated H1N1 vaccine.
Tingly, pain starting in toes/feet progressing to lower limbs, upper limbs, and lower back within 24 hours of vaccine administration. Weakness/inability to walk without taking effort, SOB after walking short distance or stairways. Exhaustion. Lower back pain. Unsteady gait/falling/stumbling.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 7-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Redness below injection site; Itchy shoulder; Shoulder soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy shoulder), VACCINATION SITE ERYTHEMA (Redness below injection site) and ARTHRALGIA (Shoulder soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRALGIA (Shoulder soreness). On 03-Feb-2021, the patient experienced PRURITUS (Itchy shoulder). On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness below injection site). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy shoulder) had resolved and VACCINATION SITE ERYTHEMA (Redness below injection site) and ARTHRALGIA (Shoulder soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications for itchy shoulder included hydrocortisone and OTC Benadryl.
shortness of breath, lump in throat, eyes secreting mucus and scratchy and my body broke out in a rash. Emergency room administered ranitidine, diphenhydramine, methylprednisolone and I have to take prednisone for 5 days and Benadryl for the itchy rash
Humira not effective; Drug interaction Humira with Vaccine Bnt162b2; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4161040-00.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single and intramuscular, administration date 11Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Humira not effective"; DRUG INTERACTION, outcome "unknown", described as "Drug interaction Humira with Vaccine Bnt162b2". The action taken for adalimumab was unknown.  Additional information: Causality: Causality for the event not effective was not reported by the reporter with respect to HUMIRA. Causality for the event for the event not effective was assessed as possible by the reporter with respect to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information, Suspect product Humira no effective after the administration of the company suspect product BNT162b2, a causal association can be derived due to its interaction with Humira.
left side of my face tingled after the first shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tingling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 45 min after receiving Shingles vaccine, the patient experienced tingling (Verbatim: left side of my face tingled after the first shot). The outcome of the tingling was resolved.   It was unknown if the reporter considered the tingling to be related to Shingles vaccine.     It was unknown if the company considered the tingling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023 The case was received from the patient via interactive digital media. The reporter stated his/her left side of face tingled after the first shot of Shingles vaccine. It started about the 45 minutes after the administration of vaccine after until he/she woke up the next day. It was not super bad and might not be related. His/her doctor advised against the second dose.
Gout flare; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 08Sep2021 at 12:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included gout flare on an unspecified date in Aug2021 (reported as had 1 gout flare up the month prior). Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C); both for unknown indications from an unknown date and unknown if ongoing. 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 vaccination. On 08Sep2021 at 17:00, (also reported as approximately 3 hours after 1st dose of the vaccine), the patient had a gout flare and noticed the left toe joint in his foot began to swell and turn red. He stated that he had 1 gout flare up the month prior and he was sure that it was another flare up happened. The next day he could hardly put pressure on the joint and it was very painful, which lasted about 4 days. Reportedly, it was during a low purine diet period, being active and usually that happens after alcohol or unhealthy food intake. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event gout flare was resolved on an unspecified date in 12Sep2021.
Injected (R) arm -> developed inability to move arm/very decreased ROM -> seen ive our clinic -> placed on MEDROl -> to follow up.
Pt developed redness, warmth and swelling of left upper extremity to forearm. No temperature. Rx'd Keflex 500mg po qid X 10 days.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 at 09:30 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Sep2022 at 12:15 as dose 4 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown results, notes: Experienced rebound COVID symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received any other medication with in 2 weeks of the vaccination. The patient received Paxlovid from 18Sep2022 to 22Sep2022 for the treatment COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events COVID-19, DRUG INEFFECTIVE, Interchange of vaccine products  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient passed out, potentially may have had small seizure. Only occurred for about a minute, 911 was called and paramedics took her to the hospital to evaluate her.
Client was 15 yo when he presented for the second Pfizer shot.  Pediatric age adjustment did not occur yet before his first shot was given 4/5/21.  I had consulted with officers, who determined it was ok to give his second shot.  Client did well after first shot, and had no adverse reactions after the observation period after his second shot.
The patient stated the reaction occurred the following day. Stated under her neck became swollen, developed bumps under her neck, severe itching under her neck and developed a headache. She stated she took BENADRYL to stop the itching and help decrease the swelling. She stated that under her neck is still swollen a little today.
My very first symptom was tachycardia, it was around dinner I noticed my heart beating fast and I had a low grade fever. I went to sleep and went to work the next morning I was walking from parking lot to the ICU my heart rate was in 140's and then after an hour my heart was still racing, I was sweating, shaking and chills and I still had a low grade fever. I had dizziness when I was exerting myself. All my symptoms went away within 24 hours except my tachardia, and I was fatigued. Then on Tuesday my heart rate was getting higher in 160s. I saw my doctor, the only time my heart rate is normal when I'm lying down. I went to ER because I couldn't even get a reading on my pulse oximeter. I was referred to a cardiologist. I wore a monitor for 2 weeks, They put me on metoprolol. I'm waiting to see a cardiologist for a full work up.
Patient was supposed to receive Tdap. Patient was given Dtap. Patient did not have any reaction to the vaccine at that point in time. I advised Mom to keep monitor, if patient had a reaction to call us immediately.
Patient DID NOT have an adverse. Patient got a high dose instead of low dose vaccine. Patient was called and notified, patient states she has been doing fine and did not even have soreness at injection site.
Pt presented to Urgent Care on 9/3/18 with a three day history of rash that was consistent with the appearance of Variicella, though it started on the face and spread to the trunk and child was not itchy or feverish. Child had received VARIVAX on 8/14/18.
Had the shot, had shingles/ Suspected vaccination failure; Had shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and had shingles. The reporter stated the Shingles shot did not prevent from getting shingles. But it could lessen the severity of the disease. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient called and stated day after receiving her second dose of Moderna she began to have generalized edema BLE, BUE, and swelling around joints, she states her vision doesn't seem the same, slightly blurry, but she can see, states hard to describe. States she had a fever 101. on day after and took Tylenol - fever resolved. Other symptoms continue.
This is a spontaneous report from a contactable consumer. A 68-year-old female patient of an unspecified ethnicity received PREVNAR 13, (Lot # T52790, Exp date Jan2020) via an unspecified route of administration at 0.5 ml, single on 23Aug2018 for immunisation, administered at pharmacy. Medical history included high blood pressure and hypothyroidism, both diagnosed many years before and ongoing. There were no concomitant medications. On 29Aug2018 the patient experienced like cellulitis and is hot, the area was red and swollen up. The outcome of the events was not recovered. There were relevant tests. She will see the doctor about 31Aug2018. She was putting ice on the area in the morning, lunch, and in the evening. She said that she was also taking Naprosen 500mg 3 times a day and an antibiotic CLEOCIN 300mg. Information about lot number already provided.
pt recvd vax & next day was dizzy on awakening; 20oct94 cont to feel sluggish, dizzy & tired;
Moderna COVID-19 Vaccine EUA:  Patient was underage. Vaccine recipient was 17 years, 3 months, and 30 days old when they received their first dose of Moderna vaccine. Vaccine recipient was 17 years, 4 months, and 30 days old when they received their second dose of Moderna vaccine.
Herpes Zoster infection; This is a spontaneous report from non-contactable Other healthcare professional (HCP). A 27-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on Jan2021 (Lot Number: EL9262) as SINGLE DOSE (at age of 27 years old) for covid-19 immunisation.  Medical history included infant chicken pox (positive varicella titer) from an unknown date and unknown if ongoing. The patient did not have a history of allergies. Concomitant medication(s) included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported.  Historical vaccine information included BNT162B2 lot number= EL0142, administration date Jan2021, dose number 1 for Covid-19 immunisation (at 27 years old). Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient received the vaccine at clinic. Approximately 4 weeks following the second dose, he experienced Herpes Zoster infection in Feb2021. He had no prior history of Zoster or any other herpes infection aside from infant chicken pox (positive varicella titer). Therapeutic measures were taken as a result of herpes zoster infection included Valtrex. Outcome of the event was recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.