chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a heart attack (non-ST elevated myocardial infarction). Was at Lakewood ranch medical center and started to get the chills, which progressed to rigors and then to something that resembled convulsions. Was treated in the ER and admitted with elevated triponin levels that continued to rise.
Fever (101.1), body aches and chills, extreme fatigue, headache.
This spontaneous report as received from a pharmacist refers to a 53 year old female patient with no drug allergies. The patients pertinent medical history was none. On 15-JUL-2014 the patient was vaccinated with ZOSTAVAX (Dose/Frequency: single dose, Therapy route: subcutaneous (SQ), Lot # and expiry date were not reported). Concomitant medications were none. On 16-JUL-2014, the patient developed redness, tenderness, warmth and itching at injection site. The patient sought medical attention (reported as came in to pharmacy) and was self treated with BENADRYL. Lab tests were none. The outcome of redness, tenderness, warmth, and itching at injection site was reported as not recovered. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Pt. states that after receiving the 1st dose of Moderna 07/17/2021, starting experiencing symptoms 07/17/2021 that evening of tongue swelling, speech difficulty, and confusion. Primary visit 07/18/2021 resulting in Blood Work and recommendations for Allergy Medications and Prednisone. Still continuing to experience symptoms.
Greater than 35 days between Covid-19 vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Covid-19 vaccination) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 001A21A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Covid-19 vaccination). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Covid-19 vaccination) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Swollen and sore armpit and lower left side of neck (suspected swollen lymph nodes)
PATIENT PRESENTED WITH SMALL,  UNIFORMED, RED,  CIRCULAR POX-LIKE RASH ON LEFT ARM THAT APPEARED APPROXIMATELY 2 DAYS AFTER HER SECOND SHINGRIX SHOT. SHE REPORTED NO ITCHING, NO FEVER, OR BODY ACHES OR PAINS.
Fever , Headache , Joint pain , Body aches , Chills , Fatigue , thirst. Took 4 low dose aspirin. Symptoms were gone in a little less than 48 hours.
Patient is fully vaccinated.  COVID positive on 3/12/2022.  ED visit on 3/14.62-year-old male presents the ER complaining of worsening shortness of breath. Positive for chest pain. Imaging: no evidence of acute cardiopulmonary disease.  Medications: fluid, nitrogycerin, asprin. EKG IBM:  NSR at 70; NL intervals;  LAD; No ST elevations. Discharged home.
Chillness; Achiness of the right arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Chillness) and MYALGIA (Achiness of the right arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced FEELING COLD (Chillness) and MYALGIA (Achiness of the right arm). At the time of the report, FEELING COLD (Chillness) and MYALGIA (Achiness of the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  Treatment information was not provided.
This spontaneous report was received from a healthcare student concerning a 20 year old female patient with no pertinent medical history or drug reaction/allergies. On 04-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number not reported) lot #K000996, expiration date 13-MAR-2015, 0.65ml in the left upper arm. Other suspect therapies included PNEUMOVAX23 on left upper arm and FLUVIRIN on right upper arm. Patient sought medical attention at the pharmacy on 10-SEP-2014 for an injection site reaction at the site of ZOSTAVAX administration. A description of the injection site reaction was unspecified. At the time of the report the outcome was reported as not recovered. Patient did not received treatment or performed any lab diagnostics studies for the adverse event. Additional information has been requested.
The caller and his wife got fully vaccinated and after their second vaccine they both tested positive for covid.; The caller and his wife got fully vaccinated and after their second vaccine they both tested positive for covid.; This is a spontaneous report from a Pfizer sponsored Program . This consumer reported similar events for 2 patients. This is 2nd of two reports. This consumer (patient's husband) reported for a 24-year-old female patient that she received the second of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 09Feb2021 (Batch/Lot Number: EN5318) 0.3 ML, SINGLE for COVID-19 immunization. She received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 19Jan2021 (Batch/Lot Number: EL8982) as DOSE 1, 0.3 ML, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that he and his wife got fully vaccinated and after their second vaccine they both tested positive for COVID. leading to vaccination failure on 19Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Jul2021 with outcome of unknown. The clinical outcome for the events unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100918542 same reporter/product/event, different patient
pt recvd vax; 23jan95 returns to ofc, shaking,stating she was cold; T 100.3; 24jan95 returns to ofc w/ MOM,states T was 103 & when apap given, T 98.5 in ofc;
Extreme chills, nausea, headache, muscle aches throughout body, sore arm (injection site, dizzyness
High fever 106-107 oral w/hallucination especially @ noc; since the day of vax;
TAILBONE SORENESS; BODY ACHES; ANKLE SORENESS; SLIGHT TEMPERATURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced tailbone soreness. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced ankle soreness. On APR-2021, the subject experienced slight temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight temperature, ankle soreness, tailbone soreness and body aches was not reported. This report was non-serious.
flu like symptoms/fever/ headache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms/fever/ headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, Prostatic specific antigen: 4.43 Elevated to 4.43. On 14-May-2022, Prostatic specific antigen: 3.73 Result:3.73. On 10-Jun-2022, Prostatic specific antigen: 4.64 measured at 4.64.         Concomitant medications details were not reported by the reporter.  Reportedly, the symptoms occurred the same day as the injection, but much later in the day around 8-9 PM. It was stated that these symptoms that had experienced were typical to what he had reading on all the websites.   Additionally, the patient had been going to receive PSA tests for his prostate for the past 10 years and over the past 2-3 years he had been going to receive these tests more often and was scheduled to had this test at the beginning of MAY. The patient had discussed these findings with his urologist who recommended to received an MRI of his prostate and also had been following the research of another urologist online who had been seeing similar trends in patients after vaccination.   Patient had not taken any medications or treatments for any of his symptoms.   This case was linked to MOD-2022-588193, MOD-2022-588201, MOD-2022-588203 (Patient Link).
Pain where shot was given, pain and swelling where shot was given, chills and sore joints and body aches, lump where shot was given, has resolved.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced shingles after dose one of Shingrix.  No additional details were provided.
The following Monday ,in the evening ,my arm began to hurt and itch.  It has a bumpy rash around it. Its Tuesday now,and hard at the injection site.  Like something is stuck inside.
Initial report received from health care professional on 25 Aug 2010: On 23 Aug 2010, this child received a intramuscular dose of only the MenCWY liquid conjugate component of MENVEO (batch number 090701) without being reconstituted with the MenA conjugate component. No adverse reaction had occurred following this administration. Follow up report received from physician on 07 Sep 2010: It was reported that the child received 0.5 ml dose of only the MenCWY liquid conjugate component of MENVEO on right arm and the physician will repeat the MENVEO in one or two months.
Vaccine expired on 13-OCT-2021 and placed in refrigerator on 29-OCT-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 29-OCT-2021) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 29-OCT-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 29-OCT-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The health care professional reported that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response code was scanned. Date vaccine was placed in refrigerator is 29Oct2021. Vaccine did not undergo any temperature excursion and patient had not experienced any adverse event. No treatment medications were reported.
I never had any sort of reaction to flu shots the past 40+ years. Hot flashes (sweating) 2 hrs after shot. Blisters (itchy) on left hand.
Significant chest pain in heart area 6 days after first shot, especially if I took a deep breath. I don't think it was even that bad when I suspect I first got Covid 1 year ago. Got mostly better by the next day.
This spontaneous report was received from a nurse refers to a multiple unknown patients of unknown age and gender. The multiple patients' pertinent medical history, Drug Reactions/Allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M041080 with expiry date:06-OCT-2018, lot#M039317 with expiry date:20-SEP-2018, lot# M028552 with expiry date:07-JUN-2018 and lot#M024702 with expiry date:18-MAY-2018) for prophylaxis along with properly stored doses of sterile diluent (lot and expiration date unknown by the reporter). The vaccine was exposed to temperature excursion of 6 Degrees Fahrenheit (°F) to 14 °F for 5 hours. There were no previous temperature excursion reported. The call was not due to data logger. No adverse effects were reported. No product quality complaint was filed. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA001926: US-009507513-1708USA013329.
raised rash; This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced raised rash. On an unknown date, the outcome of the raised rash was recovered/resolved.   It was unknown if the reporter considered the raised rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-NOV-2022 Reporter's Comment: The reporter reported that patient experienced a rash after dose one of Shingrix. Health care professional did not have time to complete safety report and did not provide patient demographics, lot number, or expiration date.  Health care professional described the rash as raised.  Health care professional noted the rash lasted for a couple of weeks, no exact dates provided, after dose one was received. The reporter consented to follow up.
Had temp of about 100 on 7-30-07. Denies cough, diarrhea, fever, rhinnorhea and vomiting.
Chills; Headache; weakness; hot left arm; sore left arm; This case was reported by a consumer via call center representative and described the occurrence of chills in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, less than an hour after receiving Shingrix, the patient experienced chills, headache, weakness, extremities hot feeling of and pain in arm. On an unknown date, the outcome of the chills, headache, weakness, extremities hot feeling of and pain in arm were recovered/resolved.   It was unknown if the reporter considered the chills, headache, weakness, extremities hot feeling of and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient reported that the received Shingrix vaccine and within hour experienced chills, headache, weakness and lasted for a day. The patient also had a hot and sore arm within minutes after getting Shingrix and lasted for week. Referred to health care professional. The reporter did not give consent for follow-up.
This spontaneous report as received from a 67 year old female patient refers to her. On 10-SEP-2014 the patient was vaccinated with ZOSTAVAX, 1 injection (dosage information unknown) at a pharmacy by an unknown pharmacist. Concomitant therapies included DIVANIL reported as DIVAN. On 10-SEP-2014, the patient experienced nausea and belching after vaccination. The following day, on 11-SEP-2014, the patient's head was spinning. On 12-SEP-2014, the patient was still feeling ill and her pulse was also fluctuating. The outcome and casualty of the events were unknown. The patient sought medical attention by calling her physician for medical advice.  A product quality complaint (PQC) was not involved. Additional information has been requested.
Approx 1-3 days post Covid Vaccine @1, patient developed muffled hearing loss  and dizziness.
Felt tired; had a sore injection site arm; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Felt tired) and VACCINATION SITE PAIN (had a sore injection site arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 016B21A and 050C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Felt tired) and VACCINATION SITE PAIN (had a sore injection site arm). At the time of the report, FATIGUE (Felt tired) and VACCINATION SITE PAIN (had a sore injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-336849, MOD-2021-336855 (Patient Link).
sore arm; fever; malaise; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever and malaise. On an unknown date, the outcome of the pain in arm, fever and malaise were unknown.   It was unknown if the reporter considered the pain in arm, fever and malaise to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter stated that her babysitter had an adverse reaction to Shingrix. Permission to follow up denied.
nervous system was freaking out/couldn't stand the TV to be on; couldn't keep anything down; headache; tiredness; freezing; nervous system was freaking out,couldn't stand the TV to be on; Headache; achiness; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing), NERVOUS SYSTEM DISORDER (nervous system was freaking out,couldn't stand the TV to be on), NERVOUS SYSTEM DISORDER (nervous system was freaking out/couldn't stand the TV to be on), VOMITING (couldn't keep anything down) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048b21a and 002b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU (got very sick after the flu shot) in 2001. Concurrent medical conditions included Blood pressure fluctuation and Allergy.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced FEELING COLD (freezing), NERVOUS SYSTEM DISORDER (nervous system was freaking out,couldn't stand the TV to be on), HEADACHE (Headache), MYALGIA (achiness), FATIGUE (Tiredness) and NAUSEA (Nausea). On 19-May-2021, the patient experienced NERVOUS SYSTEM DISORDER (nervous system was freaking out/couldn't stand the TV to be on), VOMITING (couldn't keep anything down), HEADACHE (headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 15-May-2021, FEELING COLD (freezing), NERVOUS SYSTEM DISORDER (nervous system was freaking out,couldn't stand the TV to be on), HEADACHE (Headache), MYALGIA (achiness), FATIGUE (Tiredness) and NAUSEA (Nausea) had resolved. On 25-May-2021, NERVOUS SYSTEM DISORDER (nervous system was freaking out/couldn't stand the TV to be on), VOMITING (couldn't keep anything down), HEADACHE (headache) and FATIGUE (tiredness) had resolved.            Other relevant concomitant medication includes blood pressure medicine.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Within 1-2 minutes complaint of itching at site extending to 2-3 inches below site. Within 10 minutes site became warm. No redness, no rash. No decrease in range of motion. 30 minutes later, slight itching continued.
Information has been received from a pharmacist referring to a 67 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 13-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, subcutaneously (lot# reported as M033219 with expiration date 18-AUG-2017; dose not reported). On an unknown date in October 2016, the patient began experiencing "local irritation, a lump and swelling" at the injection site. The patient did not seek medical attention. There was no treatment given for the events. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The causality was not reported. Additional information has been requested.
PT STATES A LOT OF ITCHING, NOT JUST IN ARM BUT ALL OVER. SHE STATES SHE HAS NO TROUBLE BREATHING, NO TONGUE OR THROAT SWELLING, JUST PERSISTENT ITCHING. PT TOOK BENEDRYL TO HELP THE SYMPTOMS.
She started complaining that her arm and hand hurt and she could not use her hand. She saw Dr at after-hours clinic the next day, Dr 3 days later, then orthopedics specialist and neurology specialist that finally diagnosed Parsonage-Turner Syndrome caused by vaccines. Referred to pediatric rheumatologist for on going treatment.