chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 days after having the flu shot and Gardasil vaccine simultaneously, experienced an episode of nausea, dizziness, severe headache, seeing black spots, fainted and seizure activity (her teacher reported that she was shaking). She continues to have frequent headaches, nausea and occassional dizziness, & anxiety over the above.
Patient received Pfizer Bivalent vaccine on 6/1/2023. Patient received another Pfizer Bivalent Vaccine on 07/13/2023.
This spontaneous report as received from physician assistant refers to a female patient of unknown age. No medical history and concurrent conditions reported. On an unknown date of April-2011 the patient was vaccinated with ZOSTAVAX (dose, route, lot#, frequency not reported). There was no concomitant medication reported. On 20-JAN-2015, (also reported as 2 weeks ago) the patient was diagnosed with rash on the trunk. On 26-JAN-2015 the patient was diagnosed with shingles. On 09-FEB-2015 the patient experienced back pain. On each of these reported dates the patient was seen in the office by the physician assistant. The patient not sought medical attention. At the time of the report the patient's status was unknown. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a male patient of 0 day old. On 18-JUL-2014, the patient was vaccinated with an improperly stored RECOMBIVAX HB lot number J012520, exp date: 30-JAN-2016, intramuscular at 10:41 am, first dose, (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temp dipped to 0-1 degree for 18 different episodes between May 14 and July 21 according to minimum/maximum. It was not possible to identify how long the temps were down. All recorded temps, before midday and after midday were the normal within 2-8 degrees.  The vaccine was removed once problem was identified and has been used after 21-JUL-2014. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
I broke out in a rash on face and legs, had extremely severe headaches, one day of incontinence, 2 days of heart palpitations and shortness of breath. Also, I ate some peanuts and my throat swelled up. This is the FIRST TIME I have ever had a rash, incontinence, net allergy, or shortness of breath.
Initial misuse infoinformation was received from a healthcare professional in on 25 Sep 2013. A 13 month old patient whose demographic details, medical history and concomitant medication were not reported received a 0.5 ml dose of FLUZONE on an unspecified date. (Batch number not reported). It was reported that on an unspecified date patient received incorrect does of vaccination. Laboratory investigation were not reported.  No adverse event was reported. List of documents held by sender: none
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:38 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 31.64.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-April-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 06-April-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-April-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of both VARIVAX lot # N017700, expiry date 09-JUN-2019 or lot # N023960, expiry date: 01-SEP-2019 and M-M-R II lot # N009800, expiry date: 24-MAR-2018, lot # N013280, expiry date: 28-APR-2019 or lot # N034411, expiry date: 04-DEC-2019 for prophylaxis (strength, dose, frequency, route and anatomical location were not provided). It was unknown which of the lots of VARIVAX and M-M-R II were administered to the patient. Also, the nurse reported that sterile diluent (MERCK) used for reconstitution of vaccines was properly stored. No adverse effects reported. The temperature excursion and time frame for VARIVAX was between -14 degree C to -10 degree C (-9.9 degree C) for a time frame of 3 hours and 57 minutes and for M-M-R II was between 9 degree C to 25 degree C (13.4 degree C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004216: US-009507513-1808USA004217: US-009507513-1808USA004218: US-009507513-1808USA004219: US-009507513-1808USA004220.
transient, but consistent, heart palpitations; This is a spontaneous report from a contactable consumer. A patient (doctor) of unspecified age and gender received the second dose of BNT162B2 (Pfizer/BioNtech covid-19 vaccine details, lot number: ER8729), via an unspecified route of administration in left arm on 26Apr2021 17:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included mirtazapine 15 mg as sleep aid. The patient previously received the first dose of BNT162B2 (lot number: ER8734) on 05Apr2021 in left arm for COVID-19 immunisation. Patient had been out of work for a week following his second dose of the Pfizer vaccine due to transient, but consistent, heart palpitations from 27Apr2021 19:00, which ultimately brought him into the ER to take his own electrocardiogram (EKG). Event resulted in: Emergency room/department urgent care. No treatment was received. Outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a 22-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was reported he heard while he was at his cardiologist's office a female experienced myocarditis after receiving the Moderna COVID-19 vaccine.  No treatment drugs were reported.  Company comment:This Spontaneous case concerns a 22-years-old male patient with no medical history reported, who experienced the expected serious AESI event of Myocarditis (seriousness criteria medically significant) The event Myocarditis occurrence was unknown with respect to the non-specified dose of mRNA-1273 vaccine received on unknown date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 22-years-old male patient with no medical history reported, who experienced the expected serious AESI event of Myocarditis (seriousness criteria medically significant) The event Myocarditis occurrence was unknown with respect to the non-specified dose of mRNA-1273 vaccine received on unknown date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Felt weird; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt weird) in a female patient of an unknown age 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 FEELING ABNORMAL (Felt weird). At the time of the report, FEELING ABNORMAL (Felt weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided.   This case was linked to MOD-2021-255604 (Patient Link).
High fever accompanied with some twitching overnight; in am nausea with heaves but no substantial emesis--fever resolved with one dose of Tylenol, but it is still early in the day; she rec'd DTaP, MMR, Polio and Varivax, so it is hard to know the cause of the reaction.
Accelerated heartbeat for about 20 minutes.  This symptom had an onset approximately 45 minutes after receiving the first vaccine injection.
Tired; 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 FATIGUE (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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.            Concomitant product details was not reported.  Treatment details was not reported .     This case was linked to MOD-2021-104792 (Patient Link).
This spontaneous report was received from a physician referring to a 19 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with a complete series of RECOMBIVAX HB (strength, dose, route, anatomical location, lot # and expiration date were not provided), for prophylaxis. On an unspecified date, a post-vaccination testing was performed and the patient did not show "a protective level of anti-HBs". At the reporting time, the outcome of hepatitis b surface antibody negative was unknown. The causal relationship between the event and the RECOMBIVAX HB was not reported.
Pain in the back of neck; Pain in lower back; Pain in forehead; This spontaneous case was reported by an other and describes the occurrence of NECK PAIN (Pain in the back of neck), BACK PAIN (Pain in lower back) and HEADACHE (Pain in forehead) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Pain in the back of neck), BACK PAIN (Pain in lower back) and HEADACHE (Pain in forehead). The patient was treated with SEMAGLUTIDE (OZEMPIC) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Pain in the back of neck), BACK PAIN (Pain in lower back) and HEADACHE (Pain in forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient was administed expired Covid-19 Moderna Vaccine. Notified Moderna when we were made on 11/17/21 and by Public Health. Patient has been called and informed of incident and advised to come in and be given an additional full dose of Covid-19 Moderna Vaccine per the instructions of both Moderna and Public Health.
arm was little sore; he was tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a Corporate(Pfizer) Social media platforms. The reporter is the parent.  A 14 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was little sore"; FATIGUE (non-serious), outcome "unknown", described as "he was tired".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NOT AN ADVERSE EVENT. THE PATIENT RECEIVED THE WRONG VACCINE. NOT YET 65. SHOULD HAVE BEEN INFLUENZA QADRIVALENT; NOT HIGH DOSE.
patient stated: started feeling like he had the flu on 10/26 at 2am(vaccine administered 10/25)., then his arm swelled(not whelps but swelling), he thought he had covid but he tested negative. He called me at pharmacy on 10/30 and I told him to go to a doctor. He went to urgent care and they said he has cellulitis and he got an oral antibiotic from pharmacy
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time o the second time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Within 24 hours post vacc, pt developed a generalized rash which appeared to be erythema multi forme.  It started at the inject site and then developed over legs, trunk and head. Rash resolved after 7 days.  No other complaints.
fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 62-year-old female patient 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 PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-060327 (Patient Link).
Morning after injection, arm very sore and heavy, could not lift arm. Continued muscle pain in left shoulder and neck.  After one, week, continued pain in shoulder and neck. Used heat and cold on shoulder to alleviate pain. Will see physician om 3-10-21
Patient reported that his upper arm became red around the injection site and "ached" for about the next day. He said the pain was now gone but the redness was still evident on 11/12/2017.
While administering the vaccine, the vanishpoint syringe needle retracted prematurely without the user depressing the safety mechanism for needle retraction. This resulted in the patient receiving a partial, invalid dose. Per facility guideline, the invalid dose was immediately repeated in the opposite arm.
Patient reports sore arm, fever, malaise, headache and body aches occurring the evening after receiving her vaccine.  The episode lasted through the night and began to subside the following day.  She experienced a strong reaction to her first dose of the vaccine.  She received the vaccine from Walmart.
Loss of appetite for a couple hours that went away.; sore arm; Feeling kind of fatigued; feeling kind of bla; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling kind of bla), DECREASED APPETITE (Loss of appetite for a couple hours that went away.), PAIN IN EXTREMITY (sore arm) and FATIGUE (Feeling kind of fatigued) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling kind of bla), DECREASED APPETITE (Loss of appetite for a couple hours that went away.), PAIN IN EXTREMITY (sore arm) and FATIGUE (Feeling kind of fatigued). At the time of the report, FEELING ABNORMAL (feeling kind of bla), PAIN IN EXTREMITY (sore arm) and FATIGUE (Feeling kind of fatigued) outcome was unknown and DECREASED APPETITE (Loss of appetite for a couple hours that went away.) had resolved.            No concomitant medications were reported.  It was reported that, patient received 4 doses of the Moderna vaccine and had only minor symptoms including: arm was sore, feeling kind of bla, and feeling kind of fatigued. Patient also had loss of appetite for a couple hours that went away.  No treatment medications were reported.   Reporter did not allow further contact
Severe discomfort and pain in middle of chest. I couldn't breath without pain. Started around midday and by 7 pm decided to go to hospital. Chest X-ray and bloodwork done. They eliminated the worry of heart attack or clotting issues. Cause believed to be pericarditis or myocarditis. Advised to follow-up with primary care physician. Take Advil or Motrin for a few days until discomfort resolved.
23AUG96 body aches that evening;c/o feeling cold-chills, t103.2, vomited 4 times early 24AUG96 from 1AM-3AM;
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine at age 15. Parent was notified onsite and appear to understand that her daughter receive vaccine ahead of schedule age. Individual will return for her second vaccine after her 16th birthday 6/9/2021.
Pt reports arm soreness developed after the injection as expected, but continued up to 4 weeks after. Pt reports taking Tylenol and moving arm for temporary relief. Reports pain has become an ache at the time of this report.
Right arm injection site pain Swelling under arm pit area / lymph node swelling ,  difficulty moving right arm .
The evening of receiving the vaccine the sister of pt noticed that the pt had hives on face and neck and that it appeared red. The next day, the father noticed that the pt's face and neck looked red and edematous. Neither parent noticed whether pt's arm was red or swollen and the pt was not home at the time of anaphylactic shock. The family denied pt had headache, swallowing, breathing, or any wheezing.
itch; sore arm; Vaccination site warmth; hypersensitivity, redness and itch again; hypersensitivity, redness and itch again; hypersensitivity, redness and itch again; vaccination site hypersensitivity; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (REDNESS), PRURITUS (itch), MYALGIA (sore arm), INJECTION SITE WARMTH (warm to touch) and ERYTHEMA (hypersensitivity, redness and itch again) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 23-Jan-2021, the patient experienced ERYTHEMA (REDNESS). On 29-Jan-2021, the patient experienced PRURITUS (itch), MYALGIA (sore arm), INJECTION SITE WARMTH (warm to touch), ERYTHEMA (hypersensitivity, redness and itch again) and PRURITUS (hypersensitivity, redness and itch again). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 23-Jan-2021 to 26-Jan-2021 for Adverse event, at an unspecified dose and frequency. On 26-Jan-2021, ERYTHEMA (REDNESS) had resolved. At the time of the report, PRURITUS (itch), MYALGIA (sore arm), INJECTION SITE WARMTH (warm to touch), ERYTHEMA (hypersensitivity, redness and itch again) and PRURITUS (hypersensitivity, redness and itch again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported
light sensitivity, headache, body aches, vomiting, swollen throat, weakness, tired. starting 1 1/2 hours after shot and to next day.  Horrible pain cant sleep
On 11/09/1999 the patient received his 4th dose of AVA along with IPPD.  Sometime in December 1999 he noticed that both of his hands would itch.  He then noted that his left hand had numbness and tingling in his thumb and the tips of his index finger.  He also noticed weakness in his hands and that he had a tendency to drop things.  He noted that these symptoms were getting worse as time passed and he reported that he went to the doctor who could not find anything wrong.  He stated that for 4-8 weeks these same symptoms would keep coming and going and that the symptoms never resolved completely before his 5th dose of AVA.