chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster vaccine; developed COVID infection with mild flu-like symptoms; developed COVID infection with mild flu-like symptoms; developed COVID infection with mild flu-like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient in their 40's 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 (Dose 1 Manufacturer Unknown), for Covid-19 Immunisation; Covid-19 vaccine (Dose 2 Manufacturer Unknown), for Covid-19 Immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster vaccine"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" and all described as "developed COVID infection with mild flu-like symptoms".Clinical Course: HCP/consumer mentioned that his 2 children (ages and gender not available) received the Comirnaty paediatric vaccine series in Nov2021. Both kids developed COVID symptoms with mild flu-like symptoms around 1 week ago (early Jan2022) and both are almost completely recovered. Both parents ( 40s) had the booster vaccine (unclear which brand) within the past few months and also developed COVID infection with mild flu-like symptoms within the past week. They are almost fully recovered as well. HCP did not mention the type of primary vaccine series that he and his spouse received, or when they received the primary series.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunisation, covid 19, influenza like illness, DRUG INEFFECTIVE and the suspect drug BNT162B2,Linked Report(s) : US-PFIZER INC-202200056556 same vaccine, similar AE, different patient;US-PFIZER INC-202200056557 same vaccine, similar AE, different patient;US-PFIZER INC-202200056555 same vaccine, similar AE, different patient
Body aches that kept me up through the night, low grade fever 100.7, cough, congestion, swollen lymph nodes, extremely tired.
After COVID-19 vaccine shot not feeling well; Tied and pooping; Tied and pooping; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (After COVID-19 vaccine shot not feeling well), DIARRHOEA (Tied and pooping) and FATIGUE (Tied and pooping) in a 28-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.    No Medical History information was reported.   On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced MALAISE (After COVID-19 vaccine shot not feeling well), DIARRHOEA (Tied and pooping) and FATIGUE (Tied and pooping). At the time of the report, MALAISE (After COVID-19 vaccine shot not feeling well), DIARRHOEA (Tied and pooping) and FATIGUE (Tied and pooping) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication provided. No treatment information mentioned.  Patient was not feeling well, tired and pooping after COVID vaccine shot.  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
The patient recieved the vaccine in the left deltoid and the site became red, swollen and tender to touch.
Received Varicella vaccine on June 22, 2009. Was diagnosed with Shingles on August 7, 2009.
pt waiting 15min no problem then return to pharmacy 30 minutes later with facial flushing no other symptoms ask pt to wait longer (gave ice pack) took blood pressure which was elevated and bout 45-1 hr later stilled had flushing and arm seemed bit redder gave 10ml benadryl 12.5/5ml and recheck blood pressure which was still elevated. around 5:45 pm pt said she felt fine and decided to go home. to her to keep eye on symptom and follow with er if got worse.
idiopathic progressive neuropathy; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.   On 21-JAN-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prevention of shingles (herpes zoster). On an unspecified date, shortly after vaccination, the patient suffered numbness, weakness and tingling in both hands with the difficulty of picking things up. The patient was hospitalized and diagnosed with idiopathic progressive neuropathy.  As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to vaccination; the patient had also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. Consequently, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment life, physical impairment and injury.  At the time of the report, the outcome of idiopathic progressive neuropathy was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of idiopathic progressive neuropathy was considered as medically significant. The reporters considered the event to by disabling.
Pt recvd Hep B vax on 18MAR92 & on 15APR92 & lab eval revealed LDH 599, SGOT 316, SGPT 332, serum iron 20 & HGB 9.9; repeat eval on 27APR92 revealed SGOT 48, SFPT 76 & all other studies nl;
Breast tenderness and lower abdominal pain beginning three days after injection. Breast tenderness remains at this time.  Also, my mentrual cycle began on August 16 and it has been unusually light almost more like spotting than an actual cycle.
Patients arm swelled up and she was unable to walk at store(too weak) per her family. They took her to the emergency room to be treated and they said she had cellulitis. They keep her for a couple of days in the hospital. The family stated they said she was dehydrated also. The patients family got her a prescription upon discharge for Keflex 500mg and 1 fluconazole tablet.
felt hot at time; Ache; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot at time), PAIN (Ache), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 058F21A, 038A21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jun-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 experienced FEELING HOT (felt hot at time), PAIN (Ache), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEELING HOT (felt hot at time), PAIN (Ache), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.            Concomitant product use was not provided by the reporter.  Patient received the second booster dose on 27-Jun-2022. It was reported that every time the patient took the vaccine, he had the same side effects. He had chills, headache, nausea, ache and felt hot at time. His symptoms usually lasted 3 days then went away. Patient received the 1st dose, 2nd dose, the 1st and 2nd booster shot of the vaccine in the left arm IM. The expiration dates were not provided. Patient was taking other medication. HCP was not aware of the patient's side effects.  No treatment information was provided.
This spontaneous report as received from a registered nurse refers to a 42-year-old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 30-JAN-2018, the patient was vaccinated with the first dose of VAQTA (exact dose was not reported; lot # N031940 with the expiration date of 23-NOV-2018), intramuscularly for prophylaxis. Concomitant therapies included ATIVAN and SOMA. Since 30-JAN-2018 (also reported as "ever since she was vaccinated"), the patient was experiencing nausea and headache. She sought medical attention for these events in the form of office visit, and received unspecified treatment. No lab diagnostics or studies were performed. The outcome of the events was reported as not recovered at the time of this report. The causality assessment between the events and VAQTA was not reported.
few second p/vax pt exp gen hot flash, gen numbness, palpitations, diaphoresis, cold hands, felt faint;rested in MD ofc for 15-20min went home;not feeling well @ home & mom called amb;ventricular rate of 112;BP 112/78;
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 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: gh9702) at the age of 70 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9269), on 25Feb2021 as dose 2, single (Lot number: en10200), on 26Sep2021 as dose 3 (booster), single (Lot number: fc3184) and on 16Apr2022 as dose 4 (booster), single (Lot number: fp4554) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: z pack, reaction(s): "Known allergies: z pack". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: covid test positive; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 including PAXLOVID given on 01Jan2023 to 06Jan2023. Patient reported that he had no issues with vaccines itself but after 9 days after covid test (positive), it tested (positive) again. Still no symptoms other than some congestion which he usually have in am.
They have remained in a refrigerated state this entire time within the temperature range required to maintain stability.; Expired Vaccine Administration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administration) and PRODUCT STORAGE ERROR (They have remained in a refrigerated state this entire time within the temperature range required to maintain stability.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2022 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Jun-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They have remained in a refrigerated state this entire time within the temperature range required to maintain stability.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administration) and PRODUCT STORAGE ERROR (They have remained in a refrigerated state this entire time within the temperature range required to maintain stability.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had taken booster dose. It was reported that reporter received vaccines on 05-MAY-2022. No treatment medications were reported.
Patient said he had a seizure at  home in his sleep. He said he wetted his pants and his wife told him he had a seizure. He sought medical attention after and his doctor changed his seizure medications. He is now asked by his doctor not to drive for 2 months
Patient walked out of consultation room and was having conversation with family member. Patient passed out and hit her head on the floor. Store managers were called and ambulance was called.  Patient was taken away by ambulance.
The patient's wife called the pharmacy approximately four hours after having recieved his flu shot reporting tingling in his mouth and difficulty breathing. The patient's wife was told that he should go to the hospital right away as he may be having an allergic reaction. Through the phone, the vaccination provider could hear him say he did not want to go the ER. The patient's wife was strongly encouraged to take her husband (the patient) to the ER. She agreed and the conversation was ended.
Information has been received from a pharmacist referring to 3 patients of unknown age and gender. On unknown dates, the patients were vaccinated with 3 doses of improperly stored PNEUMOVAX23 (lot # L014458, expiration date 11-FEB-2017) for prophylaxis. No adverse effects were reported. The outcome of events was unknown. Previous excursion: Temperature: 51F. Time frame: 13 hours and 30 minutes. Present excursion: Temperature: 62F. Time frame: 11 hours. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 11Nov2014; NORTRIPTYLINE, start date: 01May2018. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on day #6; Faint positive, notes: Faint positive on those days; Florid positive, notes: Florid positive test on day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the events Drug ineffective and COVID-19 are assessed as related to BNT162B2, BNT162B2 OMI BA.4-5 administration.
Needle was not tightly screwed to syringe, therefor as the nurse attempted administer the vaccine it started to leak out. No adverse reaction to patient.
Erythema-silver dollar sized; pruritic, silver dollar sized, Persist > 2w. Still active.
Hospitalization for COVID-19/weakness/acute kidney injury on dates 1/5/23- 1/11/23.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Pt reported a rash on right hand, in between thumb and right index finger. She said it itched and area appeared red, about the size of a quarter in diameter. Pt stayed in store for 20 minutes, symptoms improved and left home. I called her 30 minutes after at home, pt said she was OK.
C/o "One sided sore throat worh lical swelling/red" Symptoms started 2 days ago  There is redness and swelling. Hx of peritonsillar abscess with removal of tonsils following.  Pain is constant. Worse with swallowing. Current pain 2/10. Took Tylenol for relief.  Experiencing otalgia, improved. Had co worker look in ear yesterday d/t constant pain. Reported fluid in ear.  Reports having 2nd dose of Moderna vaccine on 2/14/21 at 1230. Had flu like symptoms afterwards. Fever lasted for about 36 hours. Headache persists.
experienced seizures following the administration / had two seizures 10-15 minutes after being administered; This case was reported by a nurse via sales rep and described the occurrence of seizure in a 23-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   In October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. In October 2020, less than an hour after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: Age at vaccination was not reported. The vaccine was administered to the patient and the patient experienced seizures following the administration. It was reported that the patient had two seizures 10-15 minutes after being administered. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020200826:same reporter
Employee wasn?t able to lift her  head without excruciating pain, it continues throughout the day.  She also had burning in her left arm and aches/pains like a flu SX. Around noon she felt very drowsy and by 6pm  she wasn?t able to function normally due to drowsiness/ cloudy head this continued until 1/21/2021, c/o light headache.
No other adverse events reported; an administered expired VARIVAX dose; This spontaneous report as received from an office manager referring to a 29-year-old male patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 25-APR-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot # T012551, expiration date 10-APR-2022; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine had had never experienced temperature excursion and product supported per article. No other adverse events reported. No product quality complaints.
My booster shot was on the 25Oct2021. The 26th I had my period for 5 weeks.; dose_number=3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 11:00 (Lot number: UNKNOWN) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. Past drug history included: Amoxicillan, reaction(s): "Known allergy: Amoxicillan". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 26Jan2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Immediately after first 2 doses, periods skipped every other month"; Bnt162b2 (Dose 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location:Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 05Jan2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Immediately after first 2 doses, periods skipped every other month". The following information was reported: IMMUNISATION (non-serious) with onset 25Oct2021 11:00, outcome "unknown", described as "dose_number=3"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 26Oct2021, outcome "recovered" (29Nov2021), described as "My booster shot was on the 25Oct2021. The 26th I had my period for 5 weeks.". The event "my booster shot was on the 25oct2021. the 26th i had my period for 5 weeks." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heavy menstrual bleeding.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received treatment with estrogen and progesterone. Prior to vaccination, patient was not diagnosed with COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 3-4 hours after receiving Menactra the patient's scalp got itchy and her hair got markedly thinner (increase hair fall).  She was seen in my office on 12/16/2005. Her exam was normal (negative nail As) without for thinning head hair. Still has hair fall-out when off of treatment.
pain, swelling & fever noted lt deltoid p/vax 2 days prior;pt recv vax 21OCT98;
This spontaneous report was received from a physician via a company representative, and refer to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date of 08-JUL-2016 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 168 hours, with a lowest recorded temperature of 1 F ( also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 96  and 24 hours with lowest recorded temperatures of -1 F (also reported as -1 Celsius degree) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Per CDPH, VAERS reporting is required if a person has COVID after fully vaccinated. This patient was diagnosed with COVID-19 8/4/2021 by the ED physician and required hospital admission for Hypoxemia.  Admitted to Hospital