chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 8 hours after receiving influenza injection at school clinic developed hives from head to toes and swelling of face, lips and tongue per mother's report.  Was given 2 Benadryl (not sure of dosage), slept all night and was completely recovered 24 hours after the shot.
a fever of 101 degrees F; body aches; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via unspecified route of administration in the left arm on 22Mar2021 at 09:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient was allergic to sulfonamide. The patient did not receive any other medications within two weeks of COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via unspecified route of administration in the left arm on 03Mar2021 at 09:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 19:00, after 10 hours of injection the patient had a fever of 101 degrees F with full body aches and chills which lasted 30 hours. Everything had passed after that and had no effects anymore and felt fine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, body aches and chills were recovered on 24Mar2021.   No follow-up attempts are needed. No further information is expected.
3 year 9 month old male presents to clinic with c/o temp around 100 since recieving vaccine yesterday but temp spike to 103 Oral and pt is not standing or walking on right leg. Pt with tenderness around injection site to right upper leg from vaccinations on 6/7. Minimal erythema, the right upper leg is slightly edematous. Pt will not bear any weight on the right leg. Mom reports pt was acting normal all yesterday afternoon after vaccinations. She reports he was running around and helped build a fort at home without any complaints. Mom reports about 2300 pt was laying in bed and requested assistance up to go to the bathroom as well as reported pain to his right upper leg. Mom reports pt has had a fever today, highest of 100.7. She reports pt has not ambulated at all today and has required assistance to use the restroom as he will not stand alone on his left leg. Follow up tomorrow, 6/9 even if improvement. Discussed exam findings with patient/parent, mom reports she wants to hold off on lab draw (CBC & Sed rate) and will continue to monitor pt's status. She reports she will more diligently alternate IBU/APAP as well as apply cool compresses to the leg. She verbalized her understanding of if patient status worsens to seek treatment at the ER. IBU administered orally while pt in clinic.
16 yr old received both doses of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old received both doses of the vaccine) in a 16-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old received both doses of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old received both doses of the vaccine) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-114566 (Patient Link).   Reporter did not allow further contact
The patient's mother called on 7/5/21 at 6:15pm and said that the patient woke up with a red spot, swelling, and hot to touch at the injection site. She had her second  vaccine on 7/3/21.
Information has been received from a physician concerning an approximately 12 month old male child with no known allergies or pertinent medical history who on 29-MAY-2007 was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  Additional suspect vaccination included PEDVAXHIB (MSD) (Oka/Merck).  Subsequently, the child developed autism.  It was noted that the child started to develop language problems at one year of age and at 15 months was noted as having a delay in language development.  Medical attention was sought.  The child was undergoing testing for autism (results not available).  There were no lab studies performed.  At the time of the report the patient had not recovered.  It was also noted that the child has a twin that did not develop autism.  There was no product quality complaint involved.  The patient went on to receive DTaP (manufacturer unknown) and PREVNAR on 24-AUG-2007.  The physician considered the autism to be disabling.  Additional information has been requested.
At approx 10:15 pm experienced fast pulse, difficulty breathing and swallowing. Called 911 and was taken to Emergency Room. Treated with intravenous saline fluid, oxygen, steroids, Benadryl, anti-nausea due to vomiting, breathing treatment, Tylenol & Motrin for fever. Released at approx 4:30 am. Given prescription for Prednisone 20mg; ciprofloxacin eye drops.
injection site is now a little swollen and itching so bad that she could not sleep; injection site is now a little swollen and itching so bad that she could not sleep; injection site is now a little swollen and itching so bad that she could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (injection site is now a little swollen and itching so bad that she could not sleep), VACCINATION SITE PRURITUS (injection site is now a little swollen and itching so bad that she could not sleep) and VACCINATION SITE SWELLING (injection site is now a little swollen and itching so bad that she could not sleep) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INSOMNIA (injection site is now a little swollen and itching so bad that she could not sleep), VACCINATION SITE PRURITUS (injection site is now a little swollen and itching so bad that she could not sleep) and VACCINATION SITE SWELLING (injection site is now a little swollen and itching so bad that she could not sleep). At the time of the report, INSOMNIA (injection site is now a little swollen and itching so bad that she could not sleep), VACCINATION SITE PRURITUS (injection site is now a little swollen and itching so bad that she could not sleep) and VACCINATION SITE SWELLING (injection site is now a little swollen and itching so bad that she could not sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: increased (High) Blood pressure spiked..         The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Telephone contact report was received as an initial additional document on 25-MAY-2021. Patient stated she does not have email or fax to do follow up. It contains non significant information.
swollen lymph node under armpit on same side as vaccine 48 hours later; Discomfort on side of vaccine site by collarbone the first day; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received an unspecified dose number of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration to the left arm on 18Mar2021 at 0900 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Concomitant medications included lexipro (MANUFACTURER UNKNOWN). On 19Mar2021, the patient experienced discomfort on side of vaccine site by collarbone the first day and swollen lymph node under armpit on the same side as vaccine, on 20MAr2021 reportedly 48 hours later. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of discomfort and axillary lymphadenopathy was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Ear ache; Fluid on her ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR PAIN (Ear ache) and MIDDLE EAR EFFUSION (Fluid on her ears) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced EAR PAIN (Ear ache). In January 2021, the patient experienced MIDDLE EAR EFFUSION (Fluid on her ears). At the time of the report, EAR PAIN (Ear ache) and MIDDLE EAR EFFUSION (Fluid on her ears) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company Comment  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Severe Cold chills, headache,  shortness of breath,  joint an body aches an pain, fatigue.  Used ibuprofen and albuterol,  only lasted a day
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender who on an unknown date was vaccinated with a dose of (Merck) VARIVAX (dose, route and lot number not reported) that was expired. The vaccine expired on 20-JUL-2011. The patient was not experiencing any known symptoms. Additional information has been requested.
expired dose of PENTACEL was inadvertently administered to a patient with no reported adverse event; Initial information received on 21-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 1 years old female patient had expired dose of pentacel was inadvertently administered to a patient with no reported adverse event while receiving vaccine Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Immunisation.  On 21-Mar-2022, the patient received a  dose of 0.5 ml (millilitre) suspect Diphtheria/tetanus/5 hybrid ac pertussis/IPV(mrc5)/HIB(PRP/T) vaccine Suspension for injection (strength: unknown)  lot UJ414AAA via intramuscular route in unknown administration site for prophylactic vaccination.  On 21-MAR-2022 the expired dose of pentacel was inadvertently administered to a patient with no reported adverse event (expired product administered) (latency: same day) following the administration of Diphtheria/tetanus/5 hybrid ac pertussis/IPV(mrc5)/HIB(PRP/T) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Crohn's disease flare up; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie Inc. (Manufacturer Report Number: 21K-163-4096483-00).  A 40-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular on 30Apr2021 (Batch/Lot number was not reported) at the age of 40 years old as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous on an unspecified date (Batch/Lot number was not reported), citrate free for Moderate to Severe adult Crohn's disease. Medical history included Moderate to Severe adult Crohn's disease. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) received by the patient on 01Apr2021 (age at first vaccination: 40 years) as dose 1 single, intramuscularly for COVID-19 immunization. Solicited report by a consumer of a 40-year-old female (reported as 39-year-old) with an event of non-serious Crohn's disease flare up with Humira (adalimumab). In 2021, the patient experienced Crohn's disease flare-up. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 30Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech. The patient underwent blood work on an unspecified date with unknown result. Outcome of the event was not recovered. The reporter's causality for the event of Crohn's disease flare-up with the suspect products adalimumab (HUMIRA) and BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE) was not provided.  The reporter's assessment of the causal relationship of the event (Crohn's disease flare-up) with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The company cannot completely rule out a reasonable possibility that bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) caused the reported Crohn's disease flare-up.  The impact of this report on the 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, Ethics Committees and Investigators, as appropriate.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient out of a vial which was punctured for ~21 hours) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient out of a vial which was punctured for ~21 hours). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient out of a vial which was punctured for ~21 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medication details were not provided.Treatment details were not provided. Consumer did not report any adverse events or reactions to the vaccine.Most recent FOLLOW-UP information incorporated above includes:On 16-Nov-2021: Follow up received included non significant information.
Injection area swelled, was itchy and red. Treated with Benadryl and resolved per patient . Talked with patient 2/9/20 after seeing MD office researched last "pnemonia" vaccination approximately 1999.
Patient was vaccinated with this vaccine after the temperature excursion; No adverse event; patient was vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism.    On 03-Oct-2022 at 10:00 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Oct-2022 at 10:00 AM, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was vaccinated with this vaccine after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was vaccinated with this vaccine after the temperature excursion). Concomitant products were not reported. It was unknown if patient was ever diagnosed or tested positive with COVID-19. It was unknown if patient had any acute illness at the time of vaccination and up to one month before. It was reported that moderna bivalent vaccine was administered after a temperature excursion. Patient did not report any adverse events. Treatment medications were not reported.
Mother reported approximately 3x5 inch area of redness and increased warmth at DTaP injection site (left thigh) on 06/15/2000. No other problems until late evening of 06/19 when child was taken to ER with elevated temperature of 105. Dxed with Pneumonia. Prescribed Erythromycin and Albuterol. Saw pediatrician for follow-up on 06/20. On 06/21 had elevated temperature and vomiting and was seen by pediatrician again and was dxed with sinusitis. Antibiotic changed to Augmentin. On 06/23 infant had 104 F after Tylenol and tepid bath and was taken to ER where admitted. Dxed with pneumonia and/or sinusitis. Discharged on 06/25.
After getting first covid shot of Pfizer, I started having severe skin reaction on my arms, back, hip and thighs. I observed them for couple of days but it got verse by each day and now i had marks that looked like small burnt marks. I still have 20-30% visible after taking prescribed medicine by my doctor.
Gradual loss of mental function, mostly short term memory. Started post-vaccine dose 1 and continued through dose 2 until today. Extremely minimal, but unambiguously noticable.
high of 102 degree fever; Sever chills 1-4 am post vaccine; Woke up drenched several times; Muscles felt like she's been shocked with high voltage; Tingling pain in bones and muscles; Tingling pain in bones and muscles; Tingling pain in bones and muscles; Lymph nodes in armpits and legs hurt; Lymph nodes in armpits and legs hurt; Headache approaching migraine; This is a spontaneous report from a contactable consumer (patient) reported that a 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration, administered in arm left on 03Apr2021 16:15 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The vaccine was administered at the school or student health clinic. The patient medical history included occasional migraine headaches from allergies and hormones from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6204), administered in arm left on 13Mar2021 16:15 (at the age of 50-years-old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. On 04Apr2021, the patient experienced sever chills 1-4 am post vaccine. High of 102 degree fever 3:00 pm following day (04Apr2021) until falling asleep around 9. On Apr2021, the patient woke up drenched several times. Muscles felt like she's been shocked with high voltage. Tingling pain in bones and muscles. Lymph nodes in armpits and legs hurt. Headache approaching migraine. No treatments were received for the events. The outcome of the events was recovering.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated intramuscularly with the three series doses of GARDASIL (Lot # and dose not reported) on 22-MAY-2012, 09-AUG-2012 and 21-SEP-2012. No adverse effect was reported. It was not known if the patient sought for medical attention. Additional information has been requested.