chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low fever; Body aches; Injection site pain; Felling tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low fever), MYALGIA (Body aches), VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Felling tired) 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 15-Feb-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021 at 8:00 PM, the patient experienced PYREXIA (Low fever), MYALGIA (Body aches), VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Felling tired). At the time of the report, PYREXIA (Low fever), MYALGIA (Body aches), VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Felling tired) had not resolved.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Several Vaccines lost Temperature when the power went out; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of incorrect storage of drug in a male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis, HAV (Havrix) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Kinrix, Infanrix, Havrix, Rotarix lyophilized formulation, Engerix B, Boostrix and Menveo. On an unknown date, an unknown time after receiving Kinrix, Infanrix, Havrix, Rotarix lyophilized formulation, Engerix B, Boostrix and Menveo, the patient experienced incorrect storage of drug (Verbatim: Several Vaccines lost Temperature when the power went out).  The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 11-SEP-2023 The reporter reported that several vaccines lost temperature when the power went which led to Incorrect storage of drug. The reporter consent to follow up.
Mom reports just noticed last night that arm is red, hot and swollen. It also feels hand. She report seems more than normal side effect.
I possibly had symptoms on Monday the 20th, but I was packing for vacation and didn't really pay attention. On Tuesday the 21st I flew and my throat was sore and I had a headache. I got in at about 10:30 that night and my sister picked me up from the airport. The next morning I was nauseous and had diarrhea and a sore throat. The diarrhea lasted about half a day, but I have Crohn's so it wasn't alarming. My throat was still sore and I had headache, bad congestion and drainage, trouble breathing. My sister and I decided to contact Urgent Care, I found one online and did a telehealth visit. I was sick with symptoms like a bad head cold for about 2-3 days. The doctor told me that I had to contact my doctor about Paxlovid, but because of my chronic conditions I opted not to do that, and that I wasn't contagious after 5 days, and not to retest. I flew home on Tuesday 2/28, I still have nasal drainage, congestion. Its all sinus/head cold type of stuff. If its not better soon Ill call my PCP.
This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.  On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a full series of hepatitis B with an unknown brand 16 years ago. The patient had titers drawn recently, but they were found low (therapeutic response decreased) so they went ahead and gave a 4th dose of Engerix-B was administered on 11th June 2018. At the time of reporting, the nurse stated that she did not have time to give information on further details the representative. No additional questions were asked because the nurse was in a hurry. Lab Comments: Lab test performed on an unknown date.
pt woke up next morning after taking the vax with severe chills, severe headache, extreme fatigue, muscle aches, nausea, and heart burn.  She felt like she had fever.  These symptoms lasted for about 8 hours.  she slept 19 our of 24 hours.  Pt says she felt fine after about 24 hours.
Vaccine given 1/15/21, on 1/16 and 1/17/21 reports arm soreness "felt like my arm was being ripped off"  on evening of 1/7/21 bad headache, On 1/18/21 symptoms continued and overnight into Tuesday 1/19/21 Temp 101.3 chills and aching body, headache continues.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with RECOMBIVAX HB dose 3 for prophylaxis. On 21-JUL-2017, 3 months 16 days after onset of therapy the patient experienced inappropriate schedule of drug administration. No adverse event reported. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to RECOMBIVAX HB. This report is linked to the case# 1707USA010084, due to same reporter source.  Additional information has been requested.; Sender's Comments: US-009507513-1707USA010084:
Left arm hurting 2 hours after shot. Hand to left shoulder. Benadryl, 100 mg, & warm pack & bedrest. Motrin 500 mgs.
18APR95 inj started turning red & hard in inj area; 19APR95 came into our ofc to f/u; area was red approx 3cm x 2in w/some hardness in area;
Erythematous, tender, indurated localized reaction on left thigh at injection site.
Blood in diarrhea; Throwing up; Fever of 102; Nausea; feeling overheated; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EW 0162), via an unspecified route of administration, administered in the right arm on 28Apr2021 at 11:00, as a single dose for COVID-19 immunization. Medical history included allergy to Cephzil (as reported) from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included lithium (manufacturer unknown); clonazepam (KLONOPIN) and clonidine (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced blood in diarrhea, throwing up, fever of 102, nausea and feeling overheated on 29Apr2021 at 21:00. The patient did not receive treatment for the events. The outcome of the events was not recovered.
bruise at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bruise at the injection site on an unspecified date. The outcome of the event injection site bruising was unknown. Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
persistant and pervasive ache in left shoulder/arm, unable to raise arm, unable to reach steering wheel, unable to adjust my bed covers at night, arem is nearly useless.
Doesn't feel well; Migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Migraine) and VACCINATION COMPLICATION (Doesn't feel well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced MIGRAINE (Migraine). On an unknown date, the patient experienced VACCINATION COMPLICATION (Doesn't feel well). At the time of the report, MIGRAINE (Migraine) and VACCINATION COMPLICATION (Doesn't feel well) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
patients who received a vaccine which was more than 30 days in the refrigerator; received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator) 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 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
This spontaneous report as received from a 60 year old female patient, who was also a nurse refers to herself. The patient's pertinent medical history included Multiple Sclerosis (MS). On 13-OCT-2014, the patient was vaccinated with ZOSTAVAX lot # J008802, expiration date: 19-OCT-2014 (also reported as 17-OCT-2014) 1 injection (dose and route of administration were not reported). Other suspect therapy included AVONEX (dose, route of administration and indication was not reported) which was taking weekly, since an unknown date, before being injected with ZOSTAVAX. Concomitant therapies included COREG, MOBIC, ZYRTEC, LASIX, PRILOSEC and SEPTRA DS (one dose on 12-OCT-2014 and one dose on 13-OCT-2014). On 14-OCT-2014, the patient experience an outbreak that looked more like a bright red radiation burn. The area was hot to the touch and it was very smooth, not raised. The outbreak stings. The red area extended from her knee to her ankle. she also had red blotches sporadically in her inner thigh area on both legs. There was no treatment given for the adverse events. Action taken with AVONEX was unknown. The outcome of the events was unknown. The relatedness between the events and the ZOSTAVAX was unknown. The relatedness between the events and the therapy with AVONEX was also unknown. The patient did not seek medical attention. Additional information has been requested.
SLEEPINESS; SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 73 year old male. 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: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced sore arm. On 24-MAR-2021, the subject experienced sleepiness. On 24-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, sleepiness, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210619315, 20210619408 and 20210619407.
I started to have hives form along essentially my whole body besides my face starting 36 hours after my initial vaccine. My legs are the most concentrated with hives. I awoke up with swelled up hands, eye lids and wrists. Today, I woke up with a swollen upper lip and swollen bottoms of my feet.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test again; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received any other medication in 2weeks of vaccine. Anti viral details included COVID 19 Treatment, brand was Paxlovid, started on 21Jul2022 to 25Jul2022, (lot number: Gd2995). Rebound symptoms and positive test again was reported. No known allergies were reported.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events and the suspect drug cannot be excluded.
The pt developed possible autism, communication delay (Severe), and occupational and speech therapy. The pt had a diet change and was on vitamin therapy.
patient developed seizure 5 to 6 minutes after vaccine administration . 911 was called  and patient  was taking to the hospital
FLUMIST given within 1 week of having received MMR and Varicella vaccines. Patient was on aspirin therapy.
Patient fainted on the way out to the chair for 15 minutes resting in her father's arm.  Face pale, nausea, dizziness and tingling of finger. Problem resolved after 10 minutes
BREAKTHROUGH COVID 19 INFECTION ON 11/12/21 REGEN-COV ON 11/12/21 MILD SX INCLUDING COUGH AND MILD SOB.
Patient was given booster dose of pfizer 12+ after FDA removed approval of monovalent vaccines for boosters.
Patient did not experience any adverse events. The 2nd dose was just administered after 3 weeks instead of 4 weeks.
This case was reported by a physician via call center representative and described the occurrence of anaphylaxis in a patient who received Influenza vaccine Quadrivalent (unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown.  It was unknown if the reporter considered the anaphylaxis to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporting was stating the patient's previous history of anaphylaxis to an unknown influenza vaccine. The healthcare professional was unsure of brand name of Influenza vaccine administered in the past. The healthcare professional stated she was unsure if it was a GlaxoSmithKline product or the date anaphylaxis occurred. The healthcare professional provided no further information for patient or product.
Joint pain, fever, finger tips throbbing. Started approximately 1 day after injection. Has been bed ridden.
Muscle pain on shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   The reporter considered the muscle pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shingles shot. The patient experienced muscle pain on the 2nd day from the vaccination. The patient was asking can he/she rub alcohol on shoulder due to muscle pain. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Information has been received from a woman in a physician's office concerning a 72 year old white female homemaker and pt with no pre-existing medical conditions and no illness at the time of vaccination, who on 23OCT2003 at 10:45 AM was vaccinated in the right deltoid with a second dose of pneumococcal vaccine 23v polysaccharide vaccine. On 25OCT2003 at 07:40 AM the pt developed a red, swollen right arm, which was hot to touch. The pt recovered. The reporter noted that the pt did not have adverse events following prior vaccinations. Additional information has been requested.
PCR confirmed Monkeypox; One Jynneos dose administered two months prior to monkeypox diagnosis; Case reference number US-BN-2022-004666, is a spontaneous case report initially received from a healthcare professional via (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history was not provided.  The patient's concomitant medication was not provided.  On an unspecified date, the patient was negative to human immunodeficiency virus (HIV).  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.   On unspecified date, reported as two months after the Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox. As reported, one Jynneos dose was administered two months prior to monkeypox diagnosis (explicitly coded as 'missed dose').  At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and as possibly related to Jynneos vaccination.   Additional information received from the physician on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004667, US-BN-2022-004668 and US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) two months after the first dose of Jynneos vaccine was administered, which is also considered as missed dose. Monkeypox is unlisted. Missed dose is listed per convention. The patient's medical history and concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. Missed dose is not related to Jynneos, but to a human factor.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) two months after the first dose of Jynneos vaccine was administered, which is also considered as missed dose. Monkeypox is unlisted. Missed dose is listed per convention. The patient's medical history and concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. Missed dose is not related to Jynneos, but to a human factor.
When patient woke up the following morning his leg, where the shots were given was warm, red, and hard. For the following 3 days the injection site kept getting bigger, more red and was still hard to the touch. He never had a fever but we did give him Motrin and Tylenol for the pain.
On 3/24/21 received vaccine and then on 3/31 began breaking out in hives on face/hands front and back and in between fingers/hives on arms/elbows/legs/knees/feet too and bottom hives  also around eyes.Pain really bad in hands and feet. Swelling around eyes/face/hands/some fingers in the joint area. Itching was all over except back and tummy. Priority Care seen by  said serum sickness but had never seen from vaccine recommended to follow up with family Dr . I contacted Dr 's office was told no need to see him as Priority care diagnosed and prescribed predisone 10 mg. I still wanted some answers call back next day and we went in 4/12/21 was told need to get with Infectious disease dr  at major hospital spoke with his nurse  on 4/12/21 and she said I would get call back about a referral appt. I did get call back from Family Dr and they said they spoke with Dr  and he said no need to see him it's very common and he can get the 2nd shot. Never saw him or anything. So we are finishing up predisone script on Saturday 4/17/21 and he is also taking benadryl and the hives disappear but come right back and sometimes worse. Please help
Child received Dtap (r arm) 11 A.M. by 6 p.m. right arm red and swollen in deltoid area. Child seen today 02/26/2005 @ 2:30 p.m.- red, swollen area at dtap site - reaction to dtap confirmed. (no tenderness to site) child given Benadryl.