chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patient identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023928. An 85 year-old female patient, had received on 26 September 2014 in the morning, an intramuscular left arm injection of FLUZONE HIGH DOSE, lot number 45024CA with expiration date of 12 May 2015 and 3 days later on 29 September 2014 the patient experienced pneumonia and Flu. Illness at the time of vaccination was reported as none, healthy. Concomitant medications and pre-existing conditions were reported as "NA". Laboratory tests were reported as unknown. No further information was provided. Outcome was recovered, date not reported. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
Information has been received from a medical assistant concerning a 75 year old male patient who on 13-MAY-2010 was vaccinated SQ with a 0.5 ML dose of VARIVAX (Merck) into the left arm (lot number 664934/0882Y, exp 22-JUN-2011) instead of ZOSTAVAX (Merck). Medical assistant reported that there were no adverse effects at this time. The patient sought for unspecified medical attention. Additional information has been requested.
no additional adverse events reported; the patient was not up to date with his MMR II; the patient received a dose of MMR II in 24Apr2015 and their office administered a dose today (15Sep2021), the patient potentially received a dose in August 2019; This spontaneous report was received from a registered nurse and refers to a 7-year-old child patient of unknown gender. No information regarding patient's pertinent medical hisotry, drug reactions, allergies and concomitant medications.   On 24-APR-2021, the patient was vaccinated with his first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose for prophylaxis (lot #, expiration date, exact dose, route and anatomical location were not reported). The patient's father stated that the patient was not up to date with his measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and received a next dose on 15-SEP-2021 lot # T018893, expiration date was not reported but upon internal validation it was established as 06-FEB-2022 ((albumin status: recombinant Human albumin (rHA)). The patient's mother called back and stated that the patient potentially received a second dose on an unknown date in August 2019 (extra dose administered) (lot #, expiration date, exact dose, route and anatomical location were not reported). No additional adverse events reported.
pt recv vax 5JUN96 & on 30MAY97 pt devel chickenpox;another pt was reported w/same exp (WAES97062013);
He received 50% of the vaccine.; 50% of the vaccine had leaked out during administration; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  An 8-year-old male patient received bnt162b2 (COMIRNATY), administration date 08Nov2021 (Batch/Lot number: unknown) at the age of 8 years 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: UNDERDOSE (non-serious) with onset 08Nov2021, outcome "unknown", described as "He received 50% of the vaccine."; PRODUCT LEAKAGE (non-serious) with onset 08Nov2021, outcome "unknown", described as "50% of the vaccine had leaked out during administration". Additional information: The pharmacist was inquiring about an invalid pediatric dose which was administered on 08Nov2021 to an 8-year-old patient. The patient received 50% of the vaccine. The pharmacist declared that 50% of the vaccine had leaked out during administration.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Lymphoma, Lung disorder (missing lower 2 lobes of left lung) and Sulfonamide allergy (sulfa). Concomitant products included GABAPENTIN from 01-Dec-2018 to 21-Apr-2023 for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-2021).    Patient received Moderna Dose 4 on 8-Jul-2022 Batch/Lot No: Unknown and Location of injection: Arm Left. Patient received Moderna Dose 5 on 8-Sep-2022 at 07:30 PM Batch/Lot No: Unknown and Location of injection: Arm Left. Patient received Paxlovid for treatment of COVID-19 from 6-Apr-2023 to 10-Apr-2023. Patient had Recurrence of COVID-19 on 16-Apr-2023 09:30. The patient took other medications/products within 2 weeks of starting COVID-19 treatment. No treatment information was reported.
fever; This is a spontaneous report from a contactable consumer (friend). A patient of unspecified age and gender received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever on an unspecified date and it went away and patient was getting ready to take the second dose. The outcome of the event was recovered on unspecified date.  Information on the lot/ batch number has been requested.
tightness on right side of face; large swelling on right side of face; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 17:45 (Batch/Lot Number: EW0185 KCHD) as dose 1, single (age at vaccination 47-year-old) for COVID-19 immunisation. Medical history included High blood pressure and diabetes mellitus from an unknown date and unknown if ongoing. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced tightness on right side of face and large swelling on right side of face on 21May2021 17:00. It was reported that Vaccine Thursday evening, Friday evening tightness on right side of face. Saturday morning large swelling on right side of face, Video dr visit advised to go to ER, ER prescribed antibiotics. Swelling on right side of face is worse. No other symptoms no relief in very large swollen right side of face, Appointment with primary dr. Therapeutic measures were taken as a result of events. The outcome for all events was not recovered. Follow-up attempts are completed. No further information is expected.
I developed severe hives and itching in random spots of my body.  Was put on a 10 day course of steroids and still no relief after the steroids
Information has been received from a registered nurse refers to a female patient of unknown age. No medical history was reported. On 26-AUG-2005, the patient was vaccinated with a first dose of VARIVAX (Merck) (lot #, expiry not reported0 0.5 ml, subcutaneous. On 25-MAR_2013, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot # H016578, expiry: 05-SEP-2014) 0.5 ml, subcutaneous. On 04-APR-2013, patient was confirmed as being 5 weeks pregnant. It was confirmed that she was given the second dose of VARIVAX (Merck) while pregnant. The patient became pregnant with last menstrual period (LMP) of 26-FEB-2013 and estimated delivery date (EDD) of 03-DEC-2013. The pregnancy outcome was outcome pending. No adverse effects noted. No treatment was received. Patient sought medical attention (office visit). Follow up has been received on 06-NOV-2014. No further information is available. Additional information is not expected.
This spontaneous report was received from other health professional and refers to a patient of unknown demographics. The patient's concomitant therapies included diphtheria toxoid, hepatitis B virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid and VAQTA. On 04-APR-2017 10:30 hrs, the patient was vaccinated with improperly stored VARIVAX (lot # M028553, expiration date: 07-JUN-2018) dose 1, subcutaneously in the left thigh for prophylaxis. No adverse effects were reported. The doses of VARIVAX were stored in the temperatures from 15 Fahrenheit degrees (F) to 46 F (23.2 F) for 96 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. No Product Quality Complaint (PQC) was involved. This case is cross-referenced with 1704USA006422, 1706USA000217, 1706USA000221 and 1706USA000261 (Same reporter link). Additional information has been requested. Sender's Comments: US-009507513-1706USA000221: US-009507513-1706USA000217: US-009507513-1706USA000261: US-009507513-1704USA006422.
DTaP administered left arm 12/02/02. Erythema noted by mom 12/03/02. This AM, (12/04/02) arm noted to be diffusely swollen + pt brought to my office.
She started with hot flashes very badly/She still experiences hot flashes; In June, she started having menopausal symptoms; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (She started with hot flashes very badly/She still experiences hot flashes) and MENOPAUSAL SYMPTOMS (In June, she started having menopausal symptoms) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HOT FLUSH (She started with hot flashes very badly/She still experiences hot flashes) and MENOPAUSAL SYMPTOMS (In June, she started having menopausal symptoms). At the time of the report, HOT FLUSH (She started with hot flashes very badly/She still experiences hot flashes) had not resolved and MENOPAUSAL SYMPTOMS (In June, she started having menopausal symptoms) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
p/vax pt serum varicella zoster virus antibody tests revealed negative varicella virus antibody titers;
Sore arm, fever of 101 after 24-36 hours of receiving shot.
Extreme lower back pain. It?s a deep, dull ache and tightening of the muscles that has not relented for over a month now. It prevents sleep at times. No traditional muscle pain-relieving remedies have helped.
Nasal congestion; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL CONGESTION (Nasal congestion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion). At the time of the report, NASAL CONGESTION (Nasal congestion) had not resolved.            Treatment information included antibiotics and nasal spray.  No concomitant medication was provided.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of an unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (dose, route of administration, lot# and expiry date were not reported) for prophylaxis. Temperature excursion was between -9 degrees Ceslius to 8 degrees Celsius (-1.3 degrees Celsius) within time frame: 2 hours and 40 minutes. Digital data logger was not involved. Concomitant therapies included sterile diluent that was not involved in temperature excursion. No adverse effects reported.
The day after receiving 1st dose of COVID19 exam, patient developed rash on her chest,  spreading across her neck and arms.  NO airway involvement (SOB, difficulty breathing or swallowing, etc).  Otherwise feels fine.   NO rash at injection site. Took Benadryl with resolution of symptoms- did see a provider to double check.
Dizziness, Hallucinations, Myalgia, Arthralgia, Fever visit  & NauseaVomiting  Narrative:    Other Relevant History:
Pain in injection site.; Headache; Nausea; Odd feeling; Pale in color; Light headed; Minor harm pain; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 10Mar2021 at 08:00 as a single dose for COVID-19 immunisation. Medical history included irritable bowel, known allergies to shellfish, nickel and minor hives to most antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021, the patient experienced headache, light headed, pale in colour, nausea, odd feeling and minor harm pain. On the same day, at 10:00, 2 hours after the vaccination, the patient experienced pain in injection site and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, light headed, pale in colour, nausea, odd feeling, minor harm pain and pain in injection site was resolved on 10Mar2021.   No follow-up attempts are possible. No further information is expected.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/12/2021 and 03/12/2021. The individual had presented to emergency department on 09/13/2021 and a COVID-19 test at that time was negative; they were discharged to home. They then presented to a clinic on 09/17/2021, where they tested positive for COVID-19 was positive. They also presented to emergency department on 09/17/2021, where they tested positive for COVID-19 again. They were not admitted to hospital at that time. They presented to emergency department again on 10/01/2021 but was discharged to home due to lack of hospital beds. They presented to emergency department again later on the same day and was admitted this time. They were found to be having complications of pulmonary embolism, acute respiratory failure, acute hypoxia, COVID-19 pneumonia. The individual had stated upon admission they did not want to be intubated. The individual died on 10/02/2021.
1ST shot  experienced swelling lower rt leg 2ND shot pain injection site injection site redness injection site induration injection site swelling injection site itching injection site bruising
pt presented to the clinic 2 days following injection with a large red, non warm area on right thigh.  Pt was afebrile.  suggested to use benadryl as well as warm packs .
Narrative: SOB, decreased appetite, falls, cough, pneumonia. Remdesivir, dex. D/c to home. Moderna #2
No adverse effects; patient was administered an improperly stored dose; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, drug allergy/reaction, concomitant medication was not reported. On 20-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019581 with expiration date of 25-JUN-2021 (dose, frequency, route and anatomical location were not reported) for prophylaxis (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of minus 0.2 degree celsius for a time frame of 2 hours and 40 minutes. There was previous temperature excursion of 42.5 degree celsius for 2 hours and 40 minutes. Data logger was involved. No product quality complaint (PQC) was associated with this report.
The patient has not suffered any adverse effect. He turned 5 years old during the series of the vaccine schedule. This was the third dose for vaccines indicated for 6months- less than 5 years. The first dose of his vaccine was 8/30/2022  and the second dose was 9/22/2022.  First attempt to contact parent was 12/1/2022 PM. The second attempt was 12/2/2022 mid-afternoon. The third attempt will be 12/7/2022 after completion of this form.
At around 9:00 pm, patient became agitated and was resting on the couch. Had little appetite for dinner. Father heard a noise and turned around to see patient having a generalized tonic clonic seizure. She was taken to Hospital wher she had several subsequent GTC seizures.
COVID-19 symptoms started on 06/21/22; tested positive on 06/25/22. We were on vacationand I wore an N95 mask the entire trip up there and we arrived on Saturday around noon and on Tuesday we were in the car traveling and I started to have quite a bit of coughing and nasal drainage and drainage into lungs which is what I think lead to the coughing. That was late morning and I noticed by 6 PM that evening I was tired and I took a nap and felt crummy. I got up the next morning and didn't feel great but after rest I thought I could function and felt like I had a severe cold and commented that I haven't had a cold since pandemic started because I've been careful. I took Ibuprofen for muscle aches and Zyrtec for the drainage and I stayed pretty steady on those medications until we got home. We got home Friday night and on Saturday morning I took a home test and it was positive and I did another one that was a different brand and it was also positive. At that time I also sent info to my PCP and Monday I got a message back from LPN saying I wasn't a candidate for Paxlovid due to shortages and to take Ibuprofen for the aches and Mucinex and to go to the ER if chest pains occur. They didn't want me to come in and do further testing. I continue, even today, having lots of drainage, coughing, and sneezing. It has improved some but not as much as expected. I will do another home test in a couple of days.
BODY PAIN SPECIFICALLY AT HIPS, NECK, HEAD; FEELING WARM INSIDE; CHILLS, FELT LIKE BLOCKS OF ICE; ARM PAIN AT INJECTION SITE; FEELING LOOPY AND HYPER; SLIGHTLY DIZZY; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, and concurrent conditions included hiv positive, emphysema, chronic obstructive pulmonary disease, sulfa allergy, alcohol user consumes half a cup liquor per week, and cigarette smoker pack a day, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry : UNKNOWN) dose was not reported, administered on 26-MAR-2021 at around14:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced feeling loopy and hyper. On 26-MAR-2021, the subject experienced slightly dizzy. On 27-MAR-2021, the subject experienced body pain specifically at hips, neck, head. On 27-MAR-2021, the subject experienced feeling warm inside. On 27-MAR-2021, the subject experienced chills, felt like blocks of ice. On 27-MAR-2021, the subject experienced arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling loopy and hyper, and slightly dizzy on 26-MAR-2021, and was recovering from chills, felt like blocks of ice, body pain specifically at hips, neck, head, feeling warm inside, and arm pain at injection site. This report was non-serious.
Severe Headache - Sept 25 - Oct 1 Numbness, cramping, and tingling in both arms and legs - Sept 28 through Oct 1 Dizzy - Sept 28-Oct 1 Nausea Sept 28-Oct 1 Faint Sept 28-Oct 1 Muscle Aches Sept 25 - Sept 26 Fatigue/Weakness - Sept 25 - Oct 2
Racing & pounding heart, dizziness, tingling feeling prior to dizziness, then shaking hands. After shaking, heart rate returned to normal. No blood pressure change was noted. Whole event lasted no more than 5-10 minutes.
Information has been received from a patient for GARDASIL, a Pregnancy Registry product, concerning herself, a 24 year old female with penicillin allergy and related family with a history of 4 pregnancies and 2 live births who in 2007 was vaccinated with all the GARDASIL series SQ (Lot # and expiration not reported). Concomitant therapy included "non steroidal inhaler". Consumer reported that she became pregnant after her first dose of GARDASIL in 2007. Nurse administered the second dose of GARDASIL series in July 2007 and then she had a miscarriage between 2nd dose in August 2007 (Lot # and expiration not reported). She was in the hospital for miscarriage (date unspecified) and was unaware of any lab or tests performed. Nurse told the patient it was safe to receive second dose. The consumer received third dose of GARDASIL series (Lot # and expiration not reported she believed in November 2007). The consumer was on birth control for a short time but she had not been taking birth control for the past year (in 2010) and was unable to get pregnant. Also reported that after her miscarriage she had an abnormal PAP (date unspecified) which had never had before receiving GARDASIL series. It was reported that the patient had two live births and two she chose not to keep before receiving the GARDASIL series. The patient sought unspecified medical attention. Additional information has been requested.