chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed erythema, swelling in the site of injection approximately 10 cm (RA) in diameter, itching, no fever, no other symptoms.  Symptoms developed within 24 hours of receiving administration.
pt recvd vax & pt noted to have red, swollen face RTC 1/2 hr later; urticaria generalized over body; edema of face especially eyelids; SOB noted; vitals t98.2 ax, P140, RR36; given Epi, DPH; sent home on DPH, Pred;
This spontaneous report was received from a 65-year-old male patient, who was referring to himself (directly and also via Pfizer). The patient's medical history included two doses of elasomeran (COVID-19 VACCINE MODERNA) and one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). His concomitant therapies included unspecified cholesterol medication and a booster dose of tonzinameran (PFIZER BIONTECH COVID-19 VACCINE). He did not have any known drug reactions or allergies. On 28-DEC-2021, around 8:15 a.m., the patient was administered a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in his right arm (formulation, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis (reported as "immunizations" and "routine vaccination and age"). On 29-DEC-2021, around 3 a.m., the patient woke up feeling dizzy along with nausea and vomiting symptoms. Everything was spinning around and he felt like he could vomit but could not. On 30-DEC-2021, around 4 a.m., the events came back. The patient reported that it was ok when he was up, but when he laid down, it (dizziness) came back and that he thought that he had a side effect. The patient did not seek medical attention, no relevant laboratory diagnostics or studies were performed and no treatment was given for the events. At the time of reporting, the patient had not recovered from the events(discrepant information, also reported as recovering/resolving). The causal relationship between feeling dizzy, nausea and vomiting symptoms and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
I contracted COVID-19 on 12/13/2021. I went to a drive thru testing center and received positive results. I had symptoms of fever, chills, body aches, and nasal congestion. The fever lasted 3 days and the other symptoms lasted approximately 6 days. I did a telehealth visit and did the antibodies treatment.
Patient reported redness of her arm from site of vaccination to her elbow. She stated the redness was itchy, not painful. This redness has been on her arm from the day after vaccination and is still red 10 days later. She has been taking prednisone 20mg tablets for 3 days and has 2 more days to take. No resolution with the Prednisone.
patient received a 5th dose/ patient obtained 4th dose at a local pharmacy and did not make my staff aware of that info.  She did not present us with her vaccine card.  It was after her vaccine that the staff realized she had a 4 th dose 2 months earlier. patient was monitored for any side effects
The patient developed unknown symptoms on 26Oct2019 and was diagnosed with Steven Johnson's syndrome; Initial information and follow-up information received on 05-Nov-2019 regarding an unsolicited valid serious case received from a Pharmacist.  This case involves a 69 years old female patient who experienced developed unknown symptoms and was diagnosed with Steven Johnson's syndrome (Stevens-Johnson syndrome ), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Ongoing medical condition included Postmenopausal.   Concomitant medications included LISINOPRIL (LISINOPRIL) 20mg daily by mouth each night a bedtime that was started on 09-Oct-2019 and ATORVASTATIN (ATORVASTATIN)  unknown dosage/frequency that was started on 17-Oct-2019.  On 18-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number QSAA1928 expiry date 30 June 2020 via intramuscular route in left deltoid.  On 26-Oct-2019, 8 days post vaccination, patient developed unknown symptoms (not reported) and on 30-Oct-2019 the patient was diagnosed with Steven Johnson's syndrome (Stevens-Johnson syndrome),12 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Patient went to ED and Primary Care Physician due to the events.  This event was assessed as medically significant.  Treatment included stopping all medications Lisinopril 20 mg daily by mouth that was started on 09-Oct-2019 and atorvastatin unknown dosage/frequency that was started on 17-Oct-2019. diagnosed Thrust anti fungal treatment.   (Other relevant tests included No lab data.)  Final diagnosis was Steven Johnson's syndrome.  The patient outcome is reported as Unknown for Steven Johnson syndrome.
Initial and follow-up info has been received regarding a case in litigation concerning a male child who, for the first two years of his life, was vaccinated with injections containing the "dangerous and highly toxic" mercury based preservative thimerosal. The alleged result of these vaccinations is that the pt not suffers from, and allegedly in the future will continue to suffer from, the toxic neurological effects of mercury poisoning. It was reported that the pt was vaccinated with haemophilus B conjugate vaccine (Recombivax HB) on 08/06/1998, dose #2 on 10/07/1998, and dose #3 on 02/24/1999. Concomitant therapy included MMR II on 07/06/1999, varicella vaccine on 07/06/1999, haemophilus B conjugate vaccine ActHIB on 08/06/1998, dose #2 10/07/1998, dose #3 on 12/22/1998 and dose #4 on 11/03/1999, Acel0Immune on 08/06/1998, dose #2 on 10/07/1998, dose #3 on 12/22/1998 and IPOL on 08/06/1998 and dose #2 on 10/07/1998. It was also reported that the pt's brother had a similar experience (WAES0201USA00825). Upon internal review toxic neurological effect and mercury poisoning were determined to be other important medical events. No further info is available. It was also reported that the pt's brother had a similar experience (WAES0201USA00825).
COVID-19; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Scleroderma (Limited Scleroderma), Psychiatric symptom and Reynold's syndrome. Concurrent medical conditions included GERD and Asthma (Adult Asthma).   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            Concomitant medications details were not reported.  The patient was the mother of the reporter and reporter was informed at around 11:30 (local time) on 09 Feb 2022.   The patient had underlying health conditions all of which were prior to vaccination. The patient had a mild Covid 19, and was currently quarantined and had not needed hospitalization at that time.  No treatment information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Redness at the injection site for over a week after getting the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site for over a week after getting the first dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site for over a week after getting the first dose). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site for over a week after getting the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sore arm; Hot flashes; Body weakness; Chills; Severe fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HOT FLUSH (Hot flashes), ASTHENIA (Body weakness), CHILLS (Chills) and FATIGUE (Severe fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 antibody test positive (was tested with positive antibodies 5 days before I received my first dose.).    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced FATIGUE (Severe fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HOT FLUSH (Hot flashes), ASTHENIA (Body weakness) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), HOT FLUSH (Hot flashes), ASTHENIA (Body weakness), CHILLS (Chills) and FATIGUE (Severe fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient on day 3 had severe fatigue set in to the point that I had to medicate myself to push through work . The patient slept the entire following weekend again and after 10 days the fatigue finally subsided, although it spurs up every 2-3 days so far again lasting about 6 hours.   This case was linked to MOD-2021-026499 (Patient Link).
19 years patient received an adult dose; 19 years patient received an adult Engerix dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On 4th August 2021, the patient received Engerix B adult. On 4th August 2021, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: Nurse practitioner reported that the patient was currently 19 years old and received an adult dose of Engerix B, which led to overdose and inappropriate age at vaccine administration. Followed by a pediatric Engerix dose on 4th September 2021. The reporter asked should they continue with adult dose. Nurse Practitioner called in to inquire how to proceed with Engerix series. The reporter did not provide vaccine details. The reporter did not consent to follow-up.
he had malaise; had a fever of 103.6; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via Medical Information (Reference number- 00369207) and transmitted to Sanofi on 23-Nov-2020.  This case involves a 72 year old male patient who had a fever of 103.6 (pyrexia) and he had malaise (malaise), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date Thursday about a month and a half ago, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number unknown) via an unknown route in the left arm for prophylactic vaccinations.  On an unknown date, the patient felt bad, no cough and had a fever of 103.6 "for a day or two" (pyrexia) and the fourth day patient was fine. Patient wondered if he had Covid so had he had done 2 test that resulted as negative. Patient also mentioned that he had malaise but it was "financial".   It was not reported if the patient received any corrective treatment.  Event outcome was reported as Unknown for pyrexia.  There will be no information regarding the batch number for the case.
Sudden onset of shortness of breath for an hour or so, then cramping and pain in left upper and lower extremities, followed by numbness in left upper and lower extremities. With pain in back of left knee. Also menstrual spotting for severa days? numbness progressed on 4th day after vaccine
Exacerbation of  MS-spasticity  right leg and arm,  rash below injection site and elbow-right arm.  Spasticity returned to pre-vaccination status  in 48 hours.  Rash still evident 5 days post-vaccination despite decreasing intensity.
administered only the adjuvant component; administered only the adjuvant component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date 7th July 2023) for prophylaxis.   On 14th June 2022, the patient received the 1st dose of Shingrix. On 14th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The reporter stated that, the patient was administered only the adjuvant component of the Shingrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received the Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with case US2022093076, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093076:Same Reporter
?? cellulitis, red, swollen from shot area to elbow, ?? fluid accumulation under skin. Rx with steroids -- improving.
fatigue; have muscle soreness though entire body; headache; painful/sensitive skin; sKIN PAIN; This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced generalized muscle aches, headache, sensitive skin and skin pain. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the generalized muscle aches, headache, sensitive skin, skin pain and fatigue were unknown.   It was unknown if the reporter considered the generalized muscle aches, headache, sensitive skin, skin pain and fatigue to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had muscle soreness throughout entire body, headache, painful and sensitive skin and fatigue after vaccination. The primary physician told never had a patient experience side effects so long. The reporter was asking adviced regarding event.
This non-serious spontaneous case, initially received from other non-health professional (patient's sister) on 11-Feb-2018, concerning a female patient of unspecified age. The patient's medical and medication history were not reported. On an unknown date, 30 years ago, the patient was administered with influenza vaccine, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unknown date, the patient experienced tingling in legs and arms. The outcome of the event was not reported. This case was considered as lost to follow-up.
arm was "killing her"; sore arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm injection site) and PAIN IN EXTREMITY (arm was "killing her") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm injection site). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was "killing her"). At the time of the report, VACCINATION SITE PAIN (sore arm injection site) and PAIN IN EXTREMITY (arm was "killing her") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient under 65 received Fluad QIV; Injection site was very sore; Headache; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04838) and concerned a 28-year-old, female patient.   The patient's concurrent conditions included carcinoma (reported as 'CA') and asthma. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unknown date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient's injection site was very sore, and she had a headache. The patient started treatment with Tylenol (paracetamol).  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006090, 202006091, 202006092, 202006095, 202006097, 202006098 (the same reporter).  Company comment: The events of headache and 'vaccination site pain' are assessed as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is assessed as not related.; Sender's Comments: The events of headache and 'vaccination site pain' are assessed as related to Fluad Quadrivalent, while the event of 'Inappropriate age at vaccine administration' is assessed as not related.
This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (patient inadvertently received 0.25 mL dose/Patient that was supposed to be given the 3rd dose was instead administered the booster dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication. On 25-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient inadvertently received 0.25 mL dose/Patient that was supposed to be given the 3rd dose was instead administered the booster dose). On 25-Jan-2022, ACCIDENTAL UNDERDOSE (patient inadvertently received 0.25 mL dose/Patient that was supposed to be given the 3rd dose was instead administered the booster dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information not provided. HCP states that yesterday an immunocompromised patient that was supposed to be given the 3rd dose was instead administered the booster dose 0.25 ml. Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up information received added patient initials.
A non-serious spontaneous report of H1N1 given to seven-month-old female was received from a registered nurse. The patient had no medical history and no concomitant medication was taken by the patient. The patient received H1N1, Intranasal on 28-Oct-2009. The child had no symptoms, no problems, has been doing very well, and was healthy. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved. Additional information was received on 17-Nov-2009 and incorporated in the narrative: Reporter's name changed, concomitant medication and medical history.
allergic urticaria of fingers, palms, arms, legs, abdomen developed 32 hours post 2nd dose of Pfizer vaccine. patient treated in clinic today with Benadryl and systemic corticosteroids
Low-grade fever (99.9), severe headache, chest pain, swelling of armpit (of the injected arm), swelling of injected arm, severe pain of injected arm, itching of injected arm and severe body ache. I saw my doctor on 4/27/2022 and he did an EKG that concerned him. Now I have to go get a  stress test with ECHO.
Redness below injection site; It was hard; Warm; Itchy; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (Redness below injection site), VACCINATION SITE INDURATION (It was hard), VACCINATION SITE WARMTH (Warm) and PRURITUS (Itchy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness below injection site), VACCINATION SITE INDURATION (It was hard), VACCINATION SITE WARMTH (Warm) and PRURITUS (Itchy). The patient was treated with CEFALEXIN (CEPHALEXIN AMEL) ongoing since an unknown date at a dose of 500 mg two times per week. At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved and VACCINATION SITE ERYTHEMA (Redness below injection site), VACCINATION SITE INDURATION (It was hard), VACCINATION SITE WARMTH (Warm) and PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.