chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received 23 February 2009 from a health care professional. An eight-year-old male patient with no past medical history, had received an injection of FLUZONE 2008-2009, lot number U2758AA on 13 October 2008 and moments after vaccination, he experienced syncope. The event did not require an emergency room visit. The event lasted a few seconds and the patient recovered. This patient has a brother and sister who each experienced a syncopal event post vaccination with FLUZONE which have been captured in case numbers 2008-03955 and 2009-00669. The reporter for this case is the same as for case numbers 2008-03955 and 2009-00669. Documents held by sender: None.
Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003960 is a spontaneous case report initially received on 05-Oct-2022 from nurse via agency (reference number: USBAV22-1628) and concerns a patient of unknown demographics (fourth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 03-Oct-2022 and 04-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via agency (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003956, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Rash outbreak on bilateral elbows and right knee, a few days later, an emerging rash on left knee and ankle. Photos sent to primary provider and identified as psoriasis.
spontaneous abortion; This is spontaneous report from a contactable nurse. A 27 year old female patient who was not pregnant at the time of vaccination received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot Number: EL3247) dose 1 intramuscular administered on Arm left on 15Feb2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Seriousness criteria was reported by the patient that it was not serious, no death life-threatening or cause of prolonged hospitalisation. It was not disabling and did not have any congenital birth defect. COVID-19 vaccine was administered at the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. 12Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test negative. On 29Mar2021, the patient had spontaneous abortion and was taken to emergency room in hospital. On 25Apr2021, the device date given. vaccine facility, race and ethnicity information was available. The outcome of the event was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, spontaneous abortion cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021458221 mother/baby case
patient received second dose of Moderna 2 weeks after first dose - no known adverse effects reported by patient
COVID breakthrough. Patient presented to the hospital on 3/12/22 with generalized body aches, weakness, and mild cough. He was discharged home on 3/16/22.
?COVID arm? - raised rash/welt that is warm to the touch and very painful. Rash may have started last night but I didn?t see it until this evening. Pain and sensitivity around injection site and moderate pain radiating down left arm
Patient had to go for open heart surgery, because he had clogged arteries.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTERIAL OCCLUSIVE DISEASE (Patient had to go for open heart surgery, because he had clogged arteries) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced ARTERIAL OCCLUSIVE DISEASE (Patient had to go for open heart surgery, because he had clogged arteries.) (seriousness criterion hospitalization). The patient was treated with Surgery (open heart surgery) for Arterial occlusive disease. At the time of the report, ARTERIAL OCCLUSIVE DISEASE (Patient had to go for open heart surgery, because he had clogged arteries.) outcome was unknown.            No concomitant information provided  Reporters good friend had to go for open heart surgery, because he had clogged arteries. I just realized that he got vaxed with Moderna Covid-19 vaccine. The Dr said it wasn't from the vaccine. But reporter thought it was and his Dr was lying.  No treatment information provided  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no relevant medical history reported, who experienced the unexpected serious (caused/prolonged hospitalization) event of Arterial occlusive disease which occurred unknown number of days after receiving a dose of COVID-19 vaccine mRNA-1273 bivalent BA.4/BA.5. Patient was reported to have had to undergo open heart surgery because he had clogged arteries. There is no additional information regarding clinical course, diagnostic tests/procedures, and treatment medication. There is also no available information regarding other doses of COVID-19 vaccine, if any. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no relevant medical history reported, who experienced the unexpected serious (caused/prolonged hospitalization) event of Arterial occlusive disease which occurred unknown number of days after receiving a dose of COVID-19 vaccine mRNA-1273 bivalent BA.4/BA.5. Patient was reported to have had to undergo open heart surgery because he had clogged arteries. There is no additional information regarding clinical course, diagnostic tests/procedures, and treatment medication. There is also no available information regarding other doses of COVID-19 vaccine, if any. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report.
few aches and pains; joint pain; muscle pain; headaches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as age: 51; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced some symptoms, such as a few aches and pains on an unspecified date. The patient mentioned "joint pain, muscle pain and headaches" on an unspecified date. The outcome of the events was unknown. The patient was querying on how soon after the shot can he take other medications, such as Advil and Advair.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The day after receiving the Flu vaccine, patient had numbness in right hand. Numbness progressed to both hands, arms and legs with weakness. On 10/8/2007, patient was admitted through the ER with Guillain Barre Syndrome.  GBS confirmed by Spinal Tap.  Patient treated with gamma globulin for 5 day, but continues to experience worsening numbness and weakness.  11/27/07 Reviewed hospital medical records which reveal patient experienced tingling & numbness of both hands & bilateral LEs, ataxia, weakness & difficulty ambulation which progressed since 10/1.  Admitted 10/8-10/30/2007.  Neuro & vascular surgery consults done.  Areflexic Tx w/IVIG x 5 days w/improvement in pain but remained weak & deconditioned.  D/C to rehab s/p discharge. FINAL DX: Guillain Barre syndrome. Per 60 day follow up: Aortic Aneurysm surgery 12/26/2007. Left leg vascular surgery 12/28/2007. Vision loss 01/05/2008. Pt. hospitalized for 5 wks fwith GBS & discharged to home. Aortic aneurysm aggravated by pt. use of arms to lift & move self. Pt re-admitted to hospital with severe back pain later determined to be aortic aneurysm. 1/19/2010 Still has drop foot.
1 Day of the vaccination: Swelling in the left arm, pain in my armpit and left breast pain and discomfort in the left leg sensation of heaviness, stomach pain nausea, headache. 2 Day: 4 bruises appeared on different parts of my body, 1 on the inside of the arm where I received the vaccine, another on my left breast that was small and two more on my 2 feet right on the instep where the veins are In the following days a lot of muscle pain in my legs that does not let me rest, the nausea has not stopped. So I went to the emergency room on April 17, 2021.
Per mom patient received the flu vaccine Friday 1-16-15. Saturday morning he woke up with hives on his face and they quickly spread to his body. Mom called Dr on-call and gave him BENADRYL.
patient had complain of numbness that started in her arms and numbness on the right side of her neck. Provider onsite was called to assess the patient. Vital signs were taken and random blood sugar was taken. Patient was closely monitored for additional 15 mins. Prior to discharged, Provider on site was called to assess patient again prior to discharged.  1:46pm Blood Pressure: 148/84 Pulse: 101  O2 Sat: 100%  2:05pm Blood Pressure: 134/74 Pulse: 88 O2 Sat: 100%  Blood Sugar: 134  2:25pm Blood Pressure: 117/80 Pulse: 74 O2 Sat: 100%  Discharge Time: 2:30 pm  Patient was given ER precautions and if the numbness still persist, she is to contact her PCP to schedule a follow up appointment. Patient is aware.
muscle ache; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date(refer case US2019127856)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in an unknown arm. The reporter was the patient who wanted to remain anonymous and refused to answer questions. The patient received dose of Shinrix in the opposite arm and experienced deep muscle ache for 6 weeks before it resolved. Limited data were reported, as the patient did not want a report filed and wanted to get off phone. For the tollerence of 1st dose, refer case US2019127856, reported by same reporter. This case has been linked with master case US2019AMR128562, reported by same reporter.
transient abdominal pain; a patient received a dose of MMRll and VARlVAX on 05/06/2019 and another dose of each vaccine on 06/06/2019; a patient received a dose of MMRll and VARlVAX on 05/06/2019 and another dose of each vaccine on 06/06/2019, the patient also received a dose ofGARDASIL 9 on 6/29/2019/ Pregnancy test was "positive".; a patient received a dose of MMRll and VARlVAX on 05/06/2019 and another dose of each vaccine on 06/06/2019; This spontaneous prospective pregnancy report was received from a nurse and refers to a 13-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 06-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live( M-M-R II) lot # N023142, expiration date 24-AUG-2019, subcutaneouslyand with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R021098, expiration date 23-JUL-2020, subcutaneously, both for prophylaxis.  On 06-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live( M-M-R II) lot # R008697, expiration date 22-MAR-2020, subcutaneously and with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R021098, expiration date 23-JUL-2020, subcutaneously, both for prophylaxis.  On 29-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot #, exact dose and expiration date were not reported) for prophylaxis.  On 29-OCT-2019, the patient had transient abdominal pain and was instructed by teacher to go to urgent care. On that same day, the patient visited unspecified urgent care, and had a pregnancy test completed. Pregnancy test was positive. Nurse stated that abdominal pain was transient so it resolved quickly. The patient saw her obstetrician on 05-NOV-2019 with no knew difficulties. The patient's father came to clinic on 12-NOV-2019, and reported that both the patient and her baby were doing well. Nurse reported that the patient was 33 weeks and 2 days pregnant at the time of the report. The last menstrual period (LMP) was calculated as 26-MAR-2019, and estimated date of delivery (EDD) was calculated as 31-DEC-2019. It was also reported that baby was due around 02-JAN-2020. The pregnancy outcome was pending. The outcome of abdominal pain was reported as recovered/resolved on an unknown date in 2019. The causality assessment between the event and suspect therapy was not provided.
Pt. states 3 hrs. after receiving flu shot c/o cough, throat tightness, sore throat & eye redness.
pt recvd flu vax 4NOV93 & exp tiredness; pt was unable to keep eyes open which reporter stated is very unusual for the pt; sx abated the following day;
Back Pain; shoulder pain; headache; had a little lump; cold; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), MASS (had a little lump), NASOPHARYNGITIS (cold), ARTHRALGIA (shoulder pain) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MASS (had a little lump) and NASOPHARYNGITIS (cold). On 15-Mar-2021, the patient experienced ARTHRALGIA (shoulder pain) and HEADACHE (headache). On an unknown date, the patient experienced BACK PAIN (Back Pain). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, BACK PAIN (Back Pain), MASS (had a little lump), NASOPHARYNGITIS (cold), ARTHRALGIA (shoulder pain) and HEADACHE (headache) outcome was unknown.        Concomitant medications were not provided.
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Fever; 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 PYREXIA (Fever) 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 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            No concomitant medication reported. No treatment information reported.
Child with development of chills and "teeth chattering" along with abd pain and subjective fever last night about 2.5 hours after getting bexsero. No rash, no hives, no trouble breathing, no vomiting.
Pt called clinic p/got flu vax 27OCT92 & 29OCT92 devel body ache, temp, sore throat, stuffy nose; treated as a cold;
Patient was administered vaccine. Patient tensed up at time of administration. Approximately 30 seconds to a minute following vaccine administration, patient had what appeared to be a vagal response, followed by passing out. 911 was called and EMS was dispatched. Patient left scene under his own power and was not transported.
This case was reported by a nurse and described the occurrence of an allergic reaction in a 4 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The reporter submitted this report directly to VAERS. On 8/4/03, the patient received the 5th dose of Infanrix (lot DTPA598B2) in the left arm. On that date, the patient also received injections of inactivated poliomyelitis virus vaccine in the left arm and MMR in the right arm. Two days post immunization, on 8/6/03, the patient began to experience burning on urination, two blisters measuring 1cm on the left leg, and an injection site reaction characterized by blisters, redness, and swelling. The swelling extended from the left arm to the pectoral area. In the evening of 8/6/03, the patient was taken to the local emergency room. The emergency room physician made a diagnosis of allergic reaction and prescribed cephalexin. The events resolved after an unspecified period of time. The nurse considered the events were possibly related to vaccination with Infanrix.
Information has been received from a Nurse concerning a female who on 22-MAY-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot # 656923/0451U). On 22-MAY-2007, the patient received a second dose of varicella virus vaccine live (Oka/Merck) and experienced an injection site rash that measured 2" X 3" to 3" X 3" in diameter which was red, hot to the touch and swollen. Subsequently, the patient recovered from the injection site rash 2 days later after treatment with an antihistamine (therapy unspecified) and cold compresses. This is one of several reports received from the same source. Additional information is expected.