chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid from 12Aug2023 to 16Aug2023 as treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Could not be awakened / taken to the hospital; Diarrhea; Vomiting; felt blah; Felt feverish; This case was reported by a consumer via call center representative and described the occurrence of unconscious in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th July 2020, immediately after receiving Shingrix, the patient experienced fever and malaise. In July 2020, the patient experienced diarrhea and vomiting. On 29th July 2020, the patient experienced unconscious (serious criteria hospitalization and GSK medically significant). In August 2020, the outcome of the unconscious, fever, diarrhea and vomiting were recovered/resolved. On an unknown date, the outcome of the malaise was unknown.   The reporter considered the unconscious, fever, diarrhea, vomiting and malaise to be related to Shingrix.  Additional details were provided as follows: The patient stated immediately after having the 1st shot of Shingrix, the patient felt feverish and blah.  It worsened over the next few days and she started to have diarrhea and vomiting.  On 29th July 2020, she could not be awakened so she was taken to the hospital where she was admitted for two days.  Her doctors determined she had a bad adverse reaction to the Shingrix shot. All symptoms were resolved around mid of August 2020. The reporter consented to follow up. Emergency room visit required.
Employee Reported symptoms debilitating requiring them to use  leave. Did not clarify Symptoms for calling out of work for 2  days. Narrative:
This spontaneous report was received from a physician regarding a 4 year old male patient. There was no information about concurrent condition and  historical medication. On 22-MAR-2016, the patient was vaccinated with M-M-R II, .5 ml, subcutaneous in the right thigh. On 20-JUN-2016, the patient was vaccinated with M-M-R II, .5 ml, subcutaneous in the left upper arm (experienced inappropriate schedule of drug administration). Other suspect therapies included KINRIX, 0.5 ml, left thigh, intramuscular. the outcome of event was unknown. Additional information has been requested.
This spontaneous report as received from a nurse refers to two unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On multiple unspecified dates, the two unspecified patients were each administered improperly stored (Oka/Merck) VARIVAX (lot # K016129, exp. date: 23-SEP-2016) (dose, strength, route and frequency were not reported). No adverse effects were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient "in her 80's". Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneously in the "back part of her arm". Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On an unknown date the patient developed swelling at injection site. The patient sought medical attention. Patient was admitted to unknown hospital on an unknown date and treated and released to home. The outcome of swelling at injection site was reported as recovered (on an unknown date). Additional information has been requested.
painful injection site early in the morning. Got progressively worse as I felt symptom similar to flu and general body ache. measure temp at 100.1 F.
Pt recvd 3 doses of Hep B SEP90, OCT90, & APR91; 3rd dose was w/Engerix-B; Reported indicated that pt "began their series on Recombivax-most had 2 doses Recombivax & poss 1 dose Engerix-B;
High fever - dizziness - headache - felt like I was going to pass out and throw up after 1st day fever went down but low grade for few days. I continue to have headaches never had before.
Significant left arm site pain; Nausea; Pale; Achy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 09:30 (Lot number: EI3247) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROBIOTICS; EFFOX. Vaccination history included: Bnt162b2 (Dose 1, Lot number- EL3247, Administration date- 22Feb2021, Time- 09:30 AM, Location- Left arm), administration date: 22Feb2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Mar2021 22:00, outcome "recovering", described as "Significant left arm site pain"; NAUSEA (non-serious) with onset 15Mar2021 22:00, outcome "recovering", described as "Nausea"; PALLOR (non-serious) with onset 15Mar2021 22:00, outcome "recovering", described as "Pale"; PAIN (non-serious) with onset 15Mar2021 22:00, outcome "recovering", described as "Achy". Therapeutic measures were not taken as a result of pain in extremity, nausea, pallor, pain.  Additional Information: The patient received other medications within two weeks of vaccination: Probiotic, B-Complex, Vitamin D3, Birth Control, Effex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Allergies to medications, food, or other products was no.  No follow-up attempts are needed. No further information is expected.
1 hour after vaccine, developed facial swelling.  went to ER.  Given Benadryl 50 mg.  Next day better.  Continued to take Benadryl and zyrtec for 3 days, controlled.  2 days after stopping, began to have facial swelling around the eyes.  No oral swelling, shortness of breath, or hives.
My son had a mild seizure that lasted 1 - 2 minutes. He has never had a seizure before. He then vomited a few minutes after the seizure.
Headache, low grade temperature, nausea, chills from the 14th of Jan. to the 17th of January
About 8 minutes after individual received vaccines, the individual experienced red blotchy areas on his face. Individual did NOT have a systemic reaction or have shortness of breath. Individual examined and assessed by his Health Care Provider (HCP). Per his HCP, given appropriate medication as treatment. Individual then remained in office for a period of time and inspected by a medical professional before leaving to ensure treatment was effective. Individual was doing well and in good health before leaving office.
Pregnant patient was inadvertently administered an expired Fluarix; Pregnant patient was inadvertently administered an expired Fluarix; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 43-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 424R7, expiry date 30-JUN-2023) for prophylaxis.   On 17-OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 17-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: Pregnant patient was inadvertently administered an expired Fluarix). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant patient was inadvertently administered an expired Fluarix). The outcome of the vaccine exposure during pregnancy and expired vaccine used were unknown.   Pregnancy exposure: Gestation time at first exposure (Fluarix Quadrivalent 2022-2023 season): 39 Weeks Pregnancy Exposure (Fluarix Quadrivalent 2022-2023 season): To mother in third trimester Last Menstrual Period Date: 17-JAN-2023 Estimated Delivery/Due date: 27-NOV-2023 Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter reported that the patient inadvertently received an expired dose of Fluarix vaccine, which led to vaccine exposure during pregnancy and expired vaccine used. The reporter did not consent to follow up.
Red papular blanchable rash started at site of injection on day of injection and has spread out to majority of body, sparing palms and soles and mucous membranes. No pain or pruritus. No fever, child acts fine.
swollen face; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient had a swollen face after getting the vaccine. The patient was treated with a shot of diphenhydramine (BENDARYL). The clinical outcome of swollen face was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of  subject product, BNT162B2 vaccine,  cannot be excluded for the reported event of swollen face, based on temporal relationship and the known product safety profile. There is very limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt had rxn to #2 DTP t103; Taken to ER temp brought down; DT given pt fine until 1FEB91 t104.5 AX wouldn't come down w/APAP; To ER Hosp 3 days; RVS virus, ear infect; Mom states pt always fine 'til immun; Had tubes put in ear; Had MMR & HIB
Received 0.5 ml pediatric (NDC 80777-279-05)  Moderna COVID-19 vaccine for the first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 0.5 ml pediatric (NDC 80777-279-05)  Moderna COVID-19 vaccine for the first primary dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS14146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 0.5 ml pediatric (NDC 80777-279-05)  Moderna COVID-19 vaccine for the first primary dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 0.5 ml pediatric (NDC 80777-279-05)  Moderna COVID-19 vaccine for the first primary dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
My Moderna vaccine was given right above where my Smallpox vaccine was given 60 years ago. There has been a red patch which started the evening of March 11, 2021, and is still on my arm this morning, March 18,2021.  It is itchy  intermittently.
t104.5 ax-dropped to 102 p/APAP/bath; seen by MD 21JUN93; MD felt it may or may not be due to vax; maybe viral infectin; no prescription given;
Red spots mostly on left side of body (given in deltoid of left arm) no itching, no pair, no SOB.
Chills; Low fever; Left lymph node under left arm is sore and slightly swollen; Left lymph node under left arm is sore and slightly swollen; Headache; Left lymph node under left arm is sore and slightly swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Oct2021 13:00 (Lot number: FF8839, Expiration Date: 31Dec2021) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 12Oct2021, stop date: 12Oct2021; TDAP, start date: 28Sep2021. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". Vaccination history included: Bnt162b2 (Dose Number: 2, Anatomical site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN0203 Jun2021), administration date: 17Mar2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Anatomical site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN0203 Jun2021), administration date: 25Feb2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Low fever"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 27Oct2021, outcome "recovered" (2021) and all described as "Left lymph node under left arm is sore and slightly swollen"; HEADACHE (non-serious) with onset 27Oct2021, outcome "not recovered", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, lymph node pain, lymphadenopathy, headache, pain in extremity.  Additional information: The patient was not diagnosed with prior vaccination and not tested with covid post vaccination. The patient received birth control within two weeks of vaccination. On 27Oct2021, the patient had chills and low fever. About 12 hours after and still ongoing on two days later, left lymph node under left arm was sore and slightly swollen. The patient continue to have a headache. The issues returned to normal.  No follow-up attempts are possible. No further information is expected.
Thursday:  2 pm  - Booster shot in left arm.  Site soreness. Friday:  8 am  - awoke from deep sleep, with headache, body and joint aches, sore throat - difficult to swallow, feeling of diarrhea. Reportedly very pale looking.   Only just conscious.  Bed ridden. Noon:  woke up feeling better.  Got out of bed, wobbly.  Not interested  in food.  Drink ok. Ok from then on.
Information has been received from a licensed practical nurse concerning a colleague's daughter who was vaccinated with a first dose of Gardasil.  Subsequently the patient developed a heavier than normal menstrual period.  A urine pregnancy test was performed before the vaccination, and the patient was not pregnant.  Unspecified medical attention was sought.  At the time of the report the patient's second menstrual cycle returned to normal.  Additional information has been requested.
At 2 am 4/8/2021 started with mild headache, went to bed.  At 3 am headache was migraine strength and was having full body aches (except for arms), extreme lower back and lower abdominal pain (he said it must be like what women experience in labor or during their menstrual cycle).   He got up and took temperature (normal) and blood ox (100 %SpO2 on two fingers).  He got a wet rag for eyes and tried to fall asleep.  He said he felt hot with cover on and cold with cover off.   At 5:50 am his father gave him two Motrin (400mg total), applesauce and a ice pack for his head and back.  I checked on him thru-out day and he seemed restless.  He woke up at 3 pm on 4/8/2021 said headache and major back pain/abdominal pains were gone. He still feels slightly achy, but fine otherwise. as of 8:24 pm.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE), on 02Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 17Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Metronidazole, reaction: "Known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "recovering" and all described as "tested positive for COVID". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive; (01Jul2022) Negative; (04Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid. Clinical course: Using an at-home test patient tested positive for COVID on 23Jun2022 after having symptoms starting on the previous night. Symptoms included fever, headache, sore throat, and severe fatigue. Her symptoms got worse the next day, the headache became much more severe and she also began having a very stuffy nose and earaches. She had a telemedicine call with her doctor on 24Jun2022 and asked for a prescription for Paxlovid. She began taking a 5-day course of Paxlovid in the evening of 24Jan2022. Her symptoms gradually diminished and by 01Jul2022 she tested negative with an at-home test. She still felt tired and had some soreness in the back of her throat. On 04Jul2022 she started feeling worse and again tested positive using an at-home test. She was still recovering from this rebound of the disease. She believed the Paxlovid just put the disease "on hold" for 5 days and then after she finished the medication the virus started replicating again and caused the second bout.
ITCHINESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, 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 number. No concomitant medications were reported.  On an unspecified date, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itchiness was not reported. This report was non-serious.
Initial report received from a consumer who is also patient's husband on 07 May 2012 in mailbox under the inquiry no. 1-376625441. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of Tdap vaccine on an unspecified date, (Manufacturer unknown, lot number, site and route of administration were not reported). The patient's husband had called and reported that his wife had broken out in clusters and had lumps on her head. The patient's outcome was not reported. Documents held by sender: None.
hives, swelling in hands, feet, eyes, lips-voice was affected;went to ER was given Epi & DPH;currently on DPH & Pred
headache; full fever; 101.4 fever; red marks by his ankles, like sunburn; weird rash on his palms, like big dots; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (red marks by his ankles, like sunburn), RASH (weird rash on his palms, like big dots), HEADACHE (headache), PYREXIA (full fever) and PYREXIA (101.4 fever) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (red marks by his ankles, like sunburn) and RASH (weird rash on his palms, like big dots). On 16-Mar-2021, the patient experienced PYREXIA (full fever) and PYREXIA (101.4 fever). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, ERYTHEMA (red marks by his ankles, like sunburn), RASH (weird rash on his palms, like big dots), HEADACHE (headache), PYREXIA (full fever) and PYREXIA (101.4 fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact