chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up).    Patient ID was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
high pulse multiple times over several days; intensely racing heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE: MANUFACTURE UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE: MANUFACTURE UNKNOWN), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "high pulse multiple times over several days"; PALPITATIONS (non-serious), outcome "unknown", described as "intensely racing heart". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that his wife received a third dose of the Pfizer COVID vaccination and, in the week that followed, she suffered from an intensely racing heart and high pulse multiple times over several days. She can't say for certain that it was because of the vaccine, but it does seem to be a rare side effect of the vaccination. What can she do to find out of this was a result of the vaccine or not and what to do to make sure she doesn't suffer any permanent damage to her heart.  Follow-up attempts completed. No further information is expected.
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient is experiencing prolonged pain in his left arm and shoulder.  He saw his primary care MD with no resolution. He does not want to pay out of pocket for additional testing or therapy.  Escalating to Risk to coordinate treatment options that will not require the patient to pay out of pocket.
Rash to arm of administered vaccine. Vaccine provided on 11/10/09. No other extremity involved. Patient admitted  to hospital. Call her immediate care for follow up. No change post 24 hour injection.
Diffuse urticarial rash developed on morning after vaccinations. First appeared at umbilical region then spread over body. Treated with Benadryl 5mg/kg for 24 hours.
Localized erythema/swelling over (R) deltoid region. Measuring ----> 3cm diameter 7cm x 5cm started Benadryl/Keflex. Pt rec'd VARIVAX.
Experiencing wake up and go to sleep and , I don't sleep good, wake up I fall asleep; doesn't wish to get second dose; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Experiencing wake up and go to sleep and , I don't sleep good, wake up I fall asleep) and PRODUCT DOSE OMISSION ISSUE (doesn't wish to get second dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04SA21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Prostate tenderness, Atrial fibrillation, Hypertension and COPD.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (Experiencing wake up and go to sleep and , I don't sleep good, wake up I fall asleep) and PRODUCT DOSE OMISSION ISSUE (doesn't wish to get second dose). At the time of the report, SLEEP DISORDER (Experiencing wake up and go to sleep and , I don't sleep good, wake up I fall asleep) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (doesn't wish to get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included prostate medicines, blood thinners, high blood pressure medicines.  Treatment information not provided.; Sender's Comments: This case concerns an 80-year-old male patient who received the first dose of the mRNA-1273 and experienced sleep disorder and doesn't wish to get second dose (product dose omission).  Sleep disorder show temporal association with product administration and causality cannot be excluded.  Product dose omission is assessed as not applicable.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
This spontaneous report was received from an 84-year-old male patient. The patient's medical history included herpes zoster on an unknown date. The patient had no concomitant medications or concurrent conditions. On an unknown date in 2015 (reported as "two years ago"), the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX intramuscular injection in the left arm (lot number and expiration date were not reported). The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, lot number and expiration date were not reported). On an unknown date in 2015, almost immediately after receiving the vaccine, the patient developed a light pain and itching around his upper left arm. Approximately 2 months after the vaccination, his itching progressively got worse and he started to develop a rash that eventually covered most of his body during an unspecified period of time. The rash spread to his arms, chest back, neck, head and legs. The patient stated that the initial light pain he felt immediately after the vaccination had went away, however, the itching and body rash still persisted at the time of the report. He also stated that his rash and itching sometimes got worse at night, which made it difficult and uncomfortable for him to sleep. The patient stated he had seen 5 different physicians for the past 2 years. He was prescribed topical triamcinolone as a treatment and also used several unspecified over-the-counter topical creams and "salve ointments". The patient did not recover from the events of rash and itching at the time of the report. The outcome of itching at injection site and sleeping difficult and uncomfortable was unknown. The relatedness between the events and ZOSTAVAX was not reported.
ARM PAIN AT INJECTION SITE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included diverticulitis, and rectal bleeding, and concurrent conditions included arthropathic psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ustekinumab for arthropathic psoriasis, pneumococcal vaccine conj 13v (crm197) for prophylactic vaccination, amoxicillin, azithromycin, fenofibrate, fluticasone, folic acid, lisinopril, loratadine, metoprolol, omeprazole, rosuvastatin calcium, sulfamethoxazole/trimethoprim, and tamsulosin. On an unspecified date, the subject experienced flu like symptoms, and arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and the outcome of arm pain at injection site was not reported. This report was non-serious.
Pt called RN at clinic on 6/20 stating that he had fever, chills, body aches, "not feeling well all weekend". Was treating symptoms with Advil several times daily.
This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE BRUISING (injection site bruising) and INJECTION SITE BRUISING (Injection site bruising) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. Concurrent medical conditions included Crohn's disease. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) dosage form. In February 2021, the patient experienced INJECTION SITE BRUISING (injection site bruising). On 05-Mar-2021, the patient experienced INJECTION SITE BRUISING (Injection site bruising). At the time of the report, INJECTION SITE BRUISING (injection site bruising) had resolved and INJECTION SITE BRUISING (Injection site bruising) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The co-suspect drug was Humira (solution for injection in pre-filled pen) (Adalimumab), sub-cutaneous route of administration. The reporter assessed the event, injection site bruising, as reasonably possible to Humira. On an unspecified day in February 2021,the patient reported that she experienced silver dollar sized bruise at the injection site, after the first dose of covid-19 vaccine, which faded to yellow and resolved. On 05-Mar-2021,after the administration of second dose of covid-19 vaccine,  the patient experienced a similar, large, dime-sized bruise at the injection site,  which  is resolving. No concomitant medications were reported. No treatment information was reported.
Pt s/sx started at 1200. Pt c/o stomach pain 4/10 on pain scale, throbbing pain in the L arm and needing to vomit. Pt denied chest pain, difficulty breathing, and difficulty swallowing. Pt denied any similar reaction to vaccines. Pt stated that she had not eaten anything that day. Pt was offered EMS. Pt refused EMS. Pt was offered an adult dose of diphenhydramine. Pt agreed to take medication. First dose administered at 1222 by RN, second dose administered by RN at 1223. Pt stated at 1250 "I feel like I need to puke." Pt was offered EMS for a second time. Pt refused EMS. Pt left vaccination site with son at 1305 with a steady gait.
Patient presented to the ED on 1/18/22 for flu like symptoms, tested positive for COVID-19 and was discharged home.  He later returned on 1/25/22 with weakness, lethargy, and fever. He was admitted to the hospital. Severe sepsis with lactic acidosis, leukocytosis, suspected source of infection-lung. UA (+) for mild pyuria but no bacteriuria noted. 2/2 COVID-19 PNA. Date of Admission: 01/25/2022. Currently on Room Air. Patient has bilateral chest infiltrates. Found to have subdural hematoma from frequent falls. Patient continued to deteriorate, NSTEMI, patient discharged to Hospice 2/9/22. Patient previously vaccinated with Moderna 3/17/21 & 4/14/21.
diarrhea; vomiting; has not received 2nd dose. first dose administered 27Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), DIARRHOEA (diarrhea) and PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose. first dose administered 27Mar2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose. first dose administered 27Mar2021). On an unknown date, the patient experienced VOMITING (vomiting) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose. first dose administered 27Mar2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.
Received vaccine and ambulated over to the observation area where she started feeling dizziness and nausea and then felt faint prior to fainting. Treated with ondansetron and IV fluids. Was discharged once symptom free and able to tolerate fluids without vomitting.
Received the Second Dose of HEPLISAV-B (A Year After the First Dose); Received a Dose of HEPLISAV-B and then a dose of ENGERIX-B; Initial Report Received on 16-Nov-2020 and 17-Nov-2020  A pharmacist reported that a 40 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for his first dose of hepatitis B immunization, then ENGERIX-B for his second dose. He was then administered the second dose of HEPLISAV-B a year after the first dose.  No medical history was reported.   No concomitant medications were reported.  On 19-Nov-2019, the patient received the first dose of HEPLISAV-B (Lot # 933837, expiration date 05-May-2021 and NDC # not reported) from a pharmacy.  On 11-Jun-2020, 206 days after receiving the first injection of HEPLISAV-B, the patient was given Engerix-B (Lot # KC57F, expiration date 04-Sep-2021) from another pharmacy.  On 16-Nov-2020, the pharmacist contacted medical information to get information on HEPLISAV-B administration after a dose 2 of Engerix-B.  On an unspecified date after receiving the information, a year after receiving the first dose of HEPLISAV-B, the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) was administered.  At the time of the report, the customer had not reported any adverse events with regards to the vaccinations received.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. No adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Patient presented to the clinic for a nurse visit to recieve immunizations. The vaccines that were due at the time of visit were Td, Measles, Mumps and Rubella, and Varicella. Discussed injections to be given with other nurse. Was discussed that MMR and Varicella should be given separate and in separate arms. Went to prepare vaccines, and a different nurse was consulted about giving the patient MMRV instead of MMR and Varicella separately to avoid the patient getting multiple injections. Was told to give MMRV. Further information about the patient such as her age was not discussed prior to giving the MMRV injection.
nurse inadvertently administered 1ml instead of 0.5ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (nurse inadvertently administered 1ml instead of 0.5ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) 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) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (nurse inadvertently administered 1ml instead of 0.5ml). On 27-Apr-2021, ACCIDENTAL OVERDOSE (nurse inadvertently administered 1ml instead of 0.5ml) had resolved.        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.   No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MODERNATX, INC.-MOD-2021-092190, MOD21-083125 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-092190: MOD21-083125:
little tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 13 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "little tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200132748 same reporter/product/event, different patient
Temperature excursion occurred due to the placement of hand warmers in the insulated bag used to transport vaccine. All 81 persons receiving vaccine in lanes 5 and 6 on 02/15/2021 between 14:00 and 16:45 were notified they received vaccine that was outside of the appropriate temperature range and were recommended to be revaccinated.
68 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose). On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
MMR shot was intended for subcutaneous injection but I injected it into the deltoid muscle. No adverse events otherwise reported at this time.
FLUSHED FACE; ACHINESS THROUGHOUT THE BODY; CHILLS; RASH ON THE INSIDE OF THIGHS; HEADACHE; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a female 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 06-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 flushed face. On APR-2021, the subject experienced achiness throughout the body. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced rash on the inside of thighs. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced tiredness.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, flushed face, rash on the inside of thighs, fever, chills, tiredness and achiness throughout the body was not reported. This report was non-serious.
I had a severe headache, and then a rash over my entire body. I felt feverish and the rash remained for 3 weeks. I did have the fever on and off for 2 weeks. I called the doctors and I was seen but for a concussion because I fell down the stairs on the same evening.