chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wanted to die because it was soo painful; a little headache; serious pain; convulsing for almost an hour; cramps all over my body\ spasming; muscle weakness; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsing for almost an hour) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus, Rheumatoid arthritis, Fibromyalgia and Spinal fusion. Concomitant products included METHOTREXATE, ETANERCEPT (ENBREL), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced SEIZURE (convulsing for almost an hour) (seriousness criterion medically significant), MUSCLE SPASMS (cramps all over my body\ spasming), MUSCULAR WEAKNESS (muscle weakness) and PAIN (serious pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (wanted to die because it was soo painful) and HEADACHE (a little headache). At the time of the report, SEIZURE (convulsing for almost an hour), MUSCLE SPASMS (cramps all over my body\ spasming), MUSCULAR WEAKNESS (muscle weakness), CONDITION AGGRAVATED (wanted to die because it was soo painful), HEADACHE (a little headache) and PAIN (serious pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine Nurse inadvertantly diluted ActHIB with sterile water diluent instead of included normal saline diluent. Pt's father was immediately notified of the event and the need to repeat vaccine. Father provided consent, vaccine was readministered after appropriate reconstitution with ActHIB diluent. Patient tolerated well.
Severe colic lasting three to four months. Followed by ? problems and fussiness. Later diagnosed with ADHD and PDD. Believed subsequent immunizations exacerbated symptoms. Believe mercury damaged. 60 day follow up states pt has not recovered. ADHD, Pervasive developmental disorder.
Pregnant at the time of vaccination?: Yes Gestation period: 2 weeks; Metallic taste in mouth; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself. A 30-years-old female patient (patient was pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 12Feb2021 (age at vaccination was 30 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included COVID-19 on an unknown date. Concomitant medications included prenatals. The patient previously took naproxen and experienced known allergy to it. The patient's last menstrual date was reported to be 05Jan2021. The gestation period at the time of vaccination was reported as 2 weeks. The patient's expected delivery due date was 12Oct2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient started having a metallic taste in mouth and it had not gone away. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the event metallic taste in mouth. The patient underwent lab work and the result was unknown on an unspecified date. The clinical outcome of the event metallic taste in mouth was not resolved at the time of this report.   The lot number for BNT162B2 was not provided and will be requested during follow up.
About 20 days after first dose of Pfizer vaccine I had an immense acute gout attack, my first ever with no prior history of gout or arthritis. I had the second dose during the attack since at first I thought I had broken my toe the pain was so severe. Thereafter for 8 months I lost mobility of my entire right foot with immense swelling, pain, osseous edema, bony erosion, and stripped me of the ability to walk, wear shoes, drive, and even work without immense swelling at a desk. It did not respond to steroids, anti-inflammatories, and only after an aggressive high dose of allopurinol for 5 months did it subside. Secondary nerve damage occured in same areas of the gouty arthritis outbreak. Since correlation doesn't mean causation each medical team did not think there was a relationship. Later on, a month ago, I got my booster shot since I had recovered from this first vaccine series and arthritis advanced demobilizing flare up, and pretty much 20-25 days after my booster shot the same thing happened now in an opposite foot. Acute debilitating gout attack directly connected and matching my first problem, so figured it was time to file this report since it's clear now.
adult was administered a pediatric dose; adult was administered a pediatric dose; 2nd dose was given; adult was administered a pediatric dose; adult was administered a pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 67-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis.   On 06-AUG-2007, the patient received the 3rd dose of Havrix. On 08-JAN-2007, the patient received the 1st dose of Havrix. On 08-JAN-2007, not applicable after receiving Havrix and an unknown time after receiving Havrix, the patient experienced underdose (Verbatim: adult was administered a pediatric dose) and adult use of a child product (Verbatim: adult was administered a pediatric dose). On 06-AUG-2007, the patient experienced underdose (Verbatim: adult was administered a pediatric dose), adult use of a child product (Verbatim: adult was administered a pediatric dose) and extra dose administered (Verbatim: 2nd dose was given). The outcome of the underdose, adult use of a child product, extra dose administered, underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023AMR047718   Additional Information: GSK receipt date: 29-MAR-2023 A healthcare professional informed that an adult patient had received the two doses of Havrix back in 2007, but that the administered doses were pediatric. The vaccine administration facility was the same as primary reporter. The health care professional (HCP) was not able to provide lot numbers of the products administered. The reporter consented to follow up. An adult patient was administered a dose of pediatrix Havrix, which led to underdose and adult use of child product and also received 3rd dose of pediatrix Havrix, which led to extra dose administered, underdose and adult use of child product.; Sender's Comments:  US-GSK-US2023AMR047718:same reporter
negative pneumococcal, tetanus and diphtheria vaccine titers despite vaccination (Antibody test negative); 13-month old vaccinated with pneumococcal vaccine; This literature marketed report has been received from the authors of a published article titled as stated below concerning a 13-month-old full term male patient. His medical history included reactive airway disease and recurrent infections including multiple bouts of acute otitis media, hand -foot-mouth, and viral upper respiratory illnesses.   On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) as prophylaxis (dose, frequency, lot number, expiration date, route and site of administration was not reported) (inappropriate age at vaccine administration).   On an unknown date, the patient presented to the emergency department with fever and neutropenia with an absolute neutrophil count lower than 100 cells/microL. He was hospitalized and he underwent evaluation for an underlying inborn error of immunity with the following pertinent findings: negative pneumococcal vaccine (manufacturer unknown) titers despite vaccination (antibody test negative). At the time of the report, the outcome of the adverse event was unknown.   The authors considered the event to be related to pneumococcal vaccine (manufacturer unknown).   Literature Report.  A copy of the published article is attached as further documentation of the patient's experience.
Initial small papules on shoulder, which progressed to hive-like lesions and then target lesions over entire body, with no mucosal involvement or fever.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 48-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. Concomitant products included SHINGRIX. On 1st May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st May 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. In May 2018, the patient experienced injection site pain, injection site swelling, injection site erythema and malaise. The patient was treated with ibuprofen and Ice Pack. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and malaise were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the injection site pain, injection site swelling, injection site erythema and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The nurse practitioner came to the pharmacy to inject the vaccine to the patient. The patient received SHINGRIX vaccine at 48 years of age, which led to inappropriate age at vaccination. The patient experienced similar symptoms which were experienced after 1st injection (refer case US2018077569), but it was worse. The patient tried Ibuprofen and placing ice on the injection site, which did not help. This case is also linked to case US2018077566 (husband's case), reported by the same reporter. Follow up was received by the pharmacist on 15th June 2018: The patient's demographic details were updated. The reporter wanted the refund for the cost of the vaccine as the patient experienced pain and suffering. The VAERS details were updated. Sender's Comments: US2018GSK087683: Previous VAERS submission in paper format.
Violent shivering (chills), mid-grade fever, severe headache, mild delirium, chest pain, sweating, malaise, sweating.
Receive vaccination in left deltoid on Saturday 11/15/08. Began having redness and swelling early Monday morning, 11/17/08.  Went to doctor that afternoon to get it checked.
Got COVID Disease 8 months after first booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got COVID Disease 8 months after first booster) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904 and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got COVID Disease 8 months after first booster). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Got COVID Disease 8 months after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Negative) Negative. On 21-Jun-2022, Body temperature: 101.6 101.6 F. On 22-Jun-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  Company comment: This is a spontaneous case concerning a 69-year-old male  patient with no reported medical history, who experienced the serious unexpected event of COVID-19 (AESI), approximately 8 months after receiving the third dose of mRNA-1273 vaccine.  Patient had fever and sickness, SARS-CoV-2 test was performed with positive result and was treated with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-606589 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 69-year-old male  patient with no reported medical history, who experienced the serious unexpected event of COVID-19 (AESI), approximately 8 months after receiving the third dose of mRNA-1273 vaccine.  Patient had fever and sickness, SARS-CoV-2 test was performed with positive result and was treated with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
arm soreness, red and swollen then on 01/18/21 got severely SOB, had muscle aches and very fatigue
Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Hashimoto's disease (Hashimoto's hypothyroidism).    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient stated he was in clinical trials for the Moderna COVID-19 Vaccine back in 2020. The other Moderna vaccines that he took in the trials he had a reaction.  His reactions from the original vaccines consisted of a little temperature and after a day or two it went away.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745290 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745290:Same patient, different vaccine (monovalent)
BLOOD CLOT AND ALMOST DIED; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, (Dose Number in Series: 1), start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Consumer reported that "I personally know one person who got blood clots, and almost died". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot and almost died was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211205693- covid-19 vaccine ad26.cov2.s blood clot and almost died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Moderna vaccine (NDC 80777-0273-98) lot # 039D21A + GTiH 00380777273983 was administered after the beyond of 10/23/2021.  Contacted manufacturer Moderna = no need to repeat dose.
Chills Muscle/joint aches Fatigue Dry cough Lasted less than 12 hours
red rash all over her body; This is spontaneous report from a contactable consumer, the patient, via the Pfizer Sponsored Program.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient had a red rash all over her body. The clinical outcome of red rash all over her body was unknown.
Rash on right side, redness & swelling, vesicle like lesions that look dried up. Prescribed VALTREX.
This case was reported by a physician and described the occurrence of cranky in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 13 February 2014 and 28 January 2014 the subject received 3rd dose and 2nd dose of PEDIARIX (unknown). On 28 January 2014, less then one day after vaccination with PEDIARIX, the subject experienced cranky. The physician reported that PEDIARIX was administered on 28 January 2014 was the 2nd dose in the series and the subject received another on 13 February 2014 by mistake. The physician reported the mother of the subject mentioned that the he was a little bit cranky from the PEDIARIX dose he received on 28 January 2014. The physician stated no symptoms occurred with the dose received on 13 February 2014. At the time of reporting the event of cranky was resolved. PEDIARIX is recommended to be administered in three doses at the ages of 2,4 and 6 months.
Patient  was premedicated with Zyrtec 10 mg at 2:15 prior coming to her second appointment. She reported similar symptoms from pfizer Vaccine first dose after 25 minutes of observation for the second vaccine. Reported slight itchiness and facial redness. sightly less than previous dose. The allergist on call was notified, ordered Zyrtec 10mg. Zyrtec 10 mg a/o. Initial BP 176/76 HR 64-sat 100% RA. . BP186/80 - HR 54. HR 60 BP 168/78, Observation 1:1 by RN maintained. BP prior dc 152/79 Hr 58.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 10-MAY-2018 and 24-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N030174 and expiration date 13-JUN-2019) orally for prophylaxis, respectively (Incorrect product storage). The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
I had a real swollen (8-10cm) inflamed area around the injection site of my arm. The doctor wrote local reaction to immunization as well as swollen, redness and pain at the injection site. Doctor visit 02/22/2021.
I tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive for COVID-19) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced COVID-19 (I tested positive for COVID-19). At the time of the report, COVID-19 (I tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: positive (Positive) tested positive for Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported. The patient tested positive for Covid-19, and reported that his daughter caught it from school, and the patient caught it from her.; Sender's Comments: This case concerns a 46-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID 19. The event occurred approximately four and a half months after the second dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the second dose was disclosed. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Large bruise at injection site still visible when patient came by pharmacy 2pm 3/2/17.
Body aches, chills, fever (100.8), headache, sore arm (in order of severity)
Patient's spouse reported patient's arm is slightly red and swollen. Advised to take BENADRYL and TYLENOL and call MD.
This case was reported by a physician's assistant and described the occurrence of an injection site reaction in a 34 year old female patient who received Hep-B.    On 20 OCT 2004 the patient received the second dose of Energix-B in the right arm.  At an unspecified time following the vaccination on 20 OCT 2004 the patient experienced an injection site reaction characterized as red and firm.  The patient was seen at a physician's office.  The immunization series with Energix-B was discontinued.  The injection site reaction had improved as of 02 NOV 2004.  The physician's assistant considered the injection site reaction to possibly be related to vaccination with Energix-B