chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low grade fever; chills; body aches; This is a spontaneous report from a Non contactable Consumer. This consumer reported for a 22-Years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration on 03Feb2021 (at age of 22-Years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient had not other medical history. Patient had not known allergies. There was no any other vaccine in four weeks. Patient had not COVID prior vaccination. The patient experienced low grade fever, chills and body aches on 03Feb2021. Patient did not receive any treatment for AEs. Patient had not COVID tested post the vaccination. The outcome of all events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
the shot is causing herpes in other people, like cold sores; This spontaneous case was reported by a patient and describes the occurrence of HERPES DERMATITIS (the shot is causing herpes in other people, like cold sores) 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 No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced HERPES DERMATITIS (the shot is causing herpes in other people, like cold sores). At the time of the report, HERPES DERMATITIS (the shot is causing herpes in other people, like cold sores) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to -MODERNATX, INC.-MOD-2021-083076 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-083076:First dose
PT WAS GIVEN 4 IMMUNIZATIONS: DTaPC DTaP-INFANRIX; IPV POLIO VACCINE, INJECTABLE; MMR, HER 2ND DOSE; AND VAR (VARICELLA).  THEY WERE GIVEN IN HER LEFT AND RIGHT ARMS, BUT I DO NOT KNOW WHICH SHOTS IN WHICH ARM.  I DO NOT HAVE ALL OF THE INFORMATION REQUESTED IN ITEM 13. THE LOT NUMBER IS NOT LISTED ON THE IMMUNIZATION RECORD THAT I RECEIVED 6/19/2002. THAT VERY SAME DAY SHE STARTED URINATING VERY FREQUENTLY.  THE SAME THING HAPPENED ON THURSDAY.  SHE WENT TO STAY WITH HER GRANDMOTHER THURSDAY EVENING UNTIL SATURDAY, AND SHE TOLD ME PT HAS CONTINUOUSLY BEEN WETTING HERSELF ALSO.  I'M CONCERNED BECAUSE THIS IS NOT NORMAL FOR HER.  WE ALSO NOTICED THE URINE HAS A VERY STRONG SMELL. SHE HAS BEEN EATING (EXCEPT SHE'S BEEN DRINKING A LOT OF  MILK) & PLAYING NORMALLY AND TODAY, JUNE 22, SHE'S NOT WETTING HERSELF AS FREQUENTLY BUT THE ODOR IS STILL VERY STRONG. HER LAST VACCINES WERE IN 1998: DTAP; OPV; MMR; AND HIBA.  NO ADVERSE SYMPTOMS WERE NOTICED AT THAT TIME; BUT SHE WAS STILL WEARING A DIAPER THEN.
Generalized trunkal rash - macular, red raised - not vesicular; blanching with pressure.  No mucous membrane involvement.
Case previously recorded as MA2009-6266. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
trouble breathing-  feeling like she "had yawn or having to take a deep breath; legs felt super heavy when I tried to walk; fatigue; Numbness and tingling in L-arm (opposite from vaccine given) which lasted for 20 minutes, then tingling went to feet up to thigh (5-10 min)/Tingling sensation continued to her tongue (3 minutes) then to her R-arm and to the top of her head; Numbness and tingling in L-arm; This is a spontaneous report from a contactable Other-HCP. This Other HCP reported for self that the female patient of unknown age who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Arm right on 30Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient reports that she got the vaccine 30Dec2020 2 days after felt great, day 3 and 4 fatigue (fatigue on days 3 and 4 after dose). Then 06Jan2021 reports trouble breathing-feeling like she "had yawn or having to take a deep breath,". She reports having Sars-Cov-2 infection previous to this experience. She was tested for Sars-Cov-2 infection, had Covid in the past and had a chest X-ray, both negative. Numbness and tingling in L-arm (opposite from vaccine given) which lasted for 20 minutes, then tingling went to feet up to thigh (Didn't last long 5-10 min) then reported her "legs felt super heavy when I tried to walk". Tingling sensation continued to her tongue (3 minutes) then to her R-arm tingly and to the top of her head. She states she is "getting better" and is "fine now" but wanted to know if this is a reported AE and how long it might last. She is asking for guidance on getting the second dose after her experience. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Swollen, hot, red skin 8 cm in diameter covering most of child's anterior thigh from proximal thigh to just above knee; no fever
Sore arm; Swollen face that gets tight and hot which is ongoing; Swollen face that gets tight and hot which is ongoing; Swollen face that gets tight and hot which is ongoing; Chills; Fever, a temperature of 105; Swollen lymph notes; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SKIN TIGHTNESS (Swollen face that gets tight and hot which is ongoing), FEELING HOT (Swollen face that gets tight and hot which is ongoing), CHILLS (Chills) and PYREXIA (Fever, a temperature of 105) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-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 experienced PAIN IN EXTREMITY (Sore arm), SKIN TIGHTNESS (Swollen face that gets tight and hot which is ongoing), FEELING HOT (Swollen face that gets tight and hot which is ongoing), CHILLS (Chills), PYREXIA (Fever, a temperature of 105), LYMPHADENOPATHY (Swollen lymph notes), SWELLING FACE (Swollen face that gets tight and hot which is ongoing), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever, a temperature of 105), LYMPHADENOPATHY (Swollen lymph notes), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and SKIN TIGHTNESS (Swollen face that gets tight and hot which is ongoing), FEELING HOT (Swollen face that gets tight and hot which is ongoing) and SWELLING FACE (Swollen face that gets tight and hot which is ongoing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105 (Inconclusive) Patient's body temperature was 105..
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported arm soreness after receiving an injection of SHINGRIX. The event resolved after one day after the dose. The patient had denied permission to contact their physician. The caller did not wish to participate in an adverse event report, she said it was nothing.
Patient had a reaction on the way to the check out counter. Patient started to develop a rash around his eyes, as well as skin sensitivity and hives. Dr. then assesed him and asked him to go back to the room and we grabbed vitals which all showed stability, and gave him 5mls of Benadryl orally. Patient then was monitored for an additional 15min and had no complications or difficulty breathing or abnormal vitals. Patients hive and rash around the eyes started to disappear. Patient was discharged with Benadryl perscription and educated on sign and symptoms to look out for.
This spontaneous report as received from a healthcare worker refers to a 3 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 01-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
low grade fever; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a patient (age and gender not reported) who experienced low grade fever (pyrexia), while he/she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed low grade fever (pyrexia) (few days) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from fever.  There will be no information available on the batch number for this case.
developed headache, then confusion and neck pain starting one day after booster (previously received 2 Pfizer injections without symptoms).  Admitted to the hospital 1/24/22 - 1/31/22 found to have  superior sagittal sinus thrombosis, nearly occlusive thrombus in the right internal jugular vein, bilateral infarcts in the parietal lobes.  Infectious workup was negative.
missed second dose. First dose received 09/2019; Pharmacist reporting patient missed second dose of Shingrix. First dose received 09/2019. Did not consent to follow-up. Call Notes:Pharmacist reporting patient missed second dose of Shingrix. First dose received 09/2019. HCP disconnected and provided no AE information other than the first dose was received 09/2019. HCP did not give consent for collection of contact information and did not give consent for any follow up.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Additional Details: The patient was kept in observation for 45 minutes. Because she was still experiencing these symptoms after 45 minutes she was dispensed from work and sent home. We will contact her tomorrow to follow up.
Fever, shoulder joint pain, extensive swelling and erythema at injection site and extending to axilla, shoulder and within an inch of elbow. Skin at injeciton site painful to touch.
Needle was loose on syringe and most of dose came out around the connection between needle and syringe.
T - 100.2.  Fussy.  Advised Tylenol, call if no improvement.
The day after the vaccination, I felt down and got a fever (around 9:00 PM) and the next day (Monday) I felt a sore throat and fever and swollen tonsils and on the 4th day I couldn't eat due to inflammation and I felt short of oxygen and hoarse. I went to town, because I don't have insurance, and the doctor gave me an injection and said it was an adverse reaction to the vaccine. That he did not give me the 3rd dose without consulting the doctor and he prescribed intramuscular dexamethasone for three days in a row. He also gave me a Spray (Fluticasone) every 4 hours and an anti-inflammatory Primidone (steroid) of 50 mg. On the third day of taking these medications I felt better.
Patient complained of "feeling sick" about 15 min after injections c/o HA, nausea and dizziness. Vitals: BP 100/60, P 80 observed. Patient at office for about 30 minutes past injections. Vitals again: BP 100/60, P 88 patient also had similar episodes after GARDASIL 1 & 2 which were not reported to our office.
Initial nurse report received on 15 Dec 2009: This patient received one dose of FLUVIRIN (batch no: 102131P1) intramuscularly on 15 Dec 2009. No adverse event was reported. No other information was available.
Employee called nurse line, had COVID vaccine left deltoid 12/23 and began having symptoms of tickle in throat, sinus headache, minor loss of smell and taste, congestion on 12/30/2020. Tested positive for COVID 1/4/2021.
Patient received her first dose of Shingrix on 3/29/19, She was given her second dose of Shingrix too early on 4/27/19.  It shouldn't have been given earlier than 5/29.  Patient is experiencing more redness and inflammation at injection site than with first dose.  Most likely due to spacing between first and second shot.  Will continue to monitor patient.
This situation is reported as a medication error due to giving an expired product with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who was treated with YELLOW FEVER VACCINE - [YF-VAX] and it was reported that this situation is reported as a medication error due to giving an expired product with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Aug-2022, the patient received an unknown dose of suspect YELLOW FEVER VACCINE (formulation, strength, route: unknown) lot UJ397AA, expiration date:22-Aug-2022, in unknown administration site as Immunization.  On 24-AUG-2022 this situation is reported as a medication error due to giving an expired product with no reported adverse event (expired product administered) same day following the administration of YELLOW FEVER VACCINE. Nurse manager was calling to find out if an expired dose of YF-VAX was given to a patient would that count as a valid dose? The nurse did not have any patient information available at this time.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (This situation is reported as a medication error due to giving an expired product with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pfizer 1/5/21, 1/26/21, 10/22/21. Positive on 9/21/22
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 14 year old male. 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced product administered to patient of inappropriate age. On 04-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Is a sore throat one of the side effects of the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Is a sore throat one of the side effects of the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Is a sore throat one of the side effects of the 2nd dose). At the time of the report, OROPHARYNGEAL PAIN (Is a sore throat one of the side effects of the 2nd dose) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.
Pt states that her vaccine was placed to low on the arm. A day or 2 after vaccine the arm swelled was arm to touch and painful. Since has resovled.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 65 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2023) Positive, notes: Covid-19 infection treated with Paxlovid on Days 2 - 6 of initial Covid-19 infection (confirmed on Day 0 by rapid test); (30Sep2023) Negative, notes: Day 10: negative COVID-19 infection based on rapid test; (04Oct2023) Positive, notes: Day 14: experienced total loss of taste and smell; rapid test for COVID-19 was very positive (dark red line). Therapeutic measures were taken as a result of vaccination failure, covid-19; patient was treated with PAXLOVID.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Distorted vision,  missing pieces of vision on the right side, colored zigzag lines in right vision.   The doctor said it was an ocular migraine. It passed within 40 minutes. Ibuprofin 600
Information has been received from a nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 06-OCT-2015, the patients were inadvertently administered with improperly stored doses of M-M-R II (therapy type: rHA, lot # L009213, expiration date 17-MAR-2017, strength, dose and route unknown). No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received an improperly stored dose of VARIVAX from lot # N022977 with expiration date 23-AUG-2019 or Lot # N023958 with expiration date 01-SEP-2019, for prophylaxis, (strength, dose, frequency and route of administration were unknown); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature was reported as 6 to 14 degrees Fahrenheit (F) for a time frame of 180 minutes. There was a previous temperature excursion of 6 to 14 degrees Fahrenheit (F) for 222 minutes. Digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1801USA005336: US-009507513-1802USA004552: US-009507513-1802USA004550:
Blurry left eye from approximately 7AM until 4 or 5PM. No treatment other than eye drops, which did not seem to help. Went away on its own.
5:25 pm - Patient pays for ZOSTAVAX prescription and soon receives ZOSTAVAX injection. Patient mentions feeling a little "lightheaded" while conversing with the pharmacist. Pharmacist asks if patient is feeling OK and if still a little lightheaded. Patient says "no". 6:00 pm - Patient says she's feeling OK and leaves pharmacy area / store to go to a store next door. 6:15 pm - Patients returns to pharmacy with visible rash, erythema, generalized itching, very uncomfortable and asks pharmacist for help. 6:20 pm - Patient given 50mg oral diphenhydramine liquid. 6:24 pm - 911 called and one EPIPEN injection administered to right thigh. Patient improving as rash and itch lessen in intensity; patient more at ease. 6:30 pm - EMS arrives and evaluates patient. Patient blood pressure measures 73/51. Patient is not transported to pharmacy; EMS states patient is OK. 6:50 pm - Patient waits for family member to arrive to drive her home. Patient states she's feeling much better. Patient hands are shaking somewhat but patient is not complaining. Pharmacist takes patient's blood pressure - 190/95. 7 pm - Patient's son arrives to drive patient home. Next day 9 AM - Pharmacist calls patient. Patient states she's doing fine/feels fine though she didn't sleep well.