chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 5 decade old male of unknown ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was was 44 years old at the time of his primary vaccination. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 04-FEB-2022) dose was not reported, 1 total, administered on 12-MAR-2021 for an prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received additionally  booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, 1 total administered on 08-NOV-2021 for prophylactic vaccination. Age at time of vaccination 45 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced covid symptoms which include slight nasal congestion with an occasional cough (suspected covid-19 infection) (dose number in series 2). On 10-MAY-2022, the patient tested positive through COVID-19 antigen test (Binax) which led to suspected clinical vaccination failure (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220523971-covid-19 vaccine ad26. cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 17Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 31Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Date of last menstrual period: 19Apr2022. The patient is expected to deliver a baby(s) on 24Jan2023. Concomitant medication(s) included: SERTRALINE, start date: 01Sep2015. Past drug history included: Flonase, reaction(s): "Allergy", notes: Known allergies- Yes, Flonase and dextromethorphan; Dextromethorphan, reaction(s): "Allergy", notes: Known allergies- Yes, Flonase and dextromethorphan. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=13Jun2022, Treatment stop date=18Jun2022, Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The evening of my vaccination, 04/24/2021, I felt run down, my arm hurt. Everything happened with the next 3 days: bad rash at shoulder at the  injection site, bad fever, over 103, bad headache, chills, body aches, and very tired. The Tuesday after the 2nd dose my vision was a little blurry. All those symptoms resolved within 4 days, by 04/28/2021. I did not seek medical care because I thought they were side effects of the vaccine. On 07/02/2021, I had tele-health visit with the doctor because I had a sore throat I wanted to know if it warranted to get a COVID Test because I had to report to work. The doctor recommended a rapid test. I couldn't book an appointment. So I purchased an antigen test at the pharmacy and it was negative. My sore throat resolved after 2-3 days on it's own.
Vomiting, 1-2 times daily for 3 days so far.  Treated with rx antiemetic as an outpatient.
No additional AE reported; patient on a 3-dose schedule of GARDASIL 9 received the 2nd dose 3 weeks after the 1st dose; This spontaneous report was received from a pharmacist referring to a patient to unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On approximately 12-FEB-2021 (reported as 3 weeks before of second dose), the patient was vaccinated with first dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration, anatomical location lot number and expiration date were not reported).   Then on 05-MAR-2021 3 weeks after the first dose, the patient was vaccinated with second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration and anatomical location were not reported; lot number T008152 and expiration date 21-JUN-2022) (inappropriate schedule of product administration). No adverse event was reported.  This is one of two reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001750:
arm where she received the vaccine turned blood red, had a lot of rash, and it was itching; arm where she received the vaccine turned blood red, had a lot of rash, and it was itching; arm where she received the vaccine turned blood red, had a lot of rash, and it was itching; This is a spontaneous report from a contactable consumer (patient). This is report 2 of 2 (for 2nd dose of vaccine). A 71-year-old female patient received BNT162B2 (Solution for injection), dose 2 intramuscular (left arm) on 30Jan2021 at 13:00 (at the age of 71-year-old) (Lot Number: EL1283) at SINGLE DOSE for COVID-19 vaccination. Medical history included allergies, toxemia/ preeclampsia. The patient's concomitant medications were not reported. The patient previously took phenobarbital for toxemia/ preeclampsia and BNT162B2 in left arm on 11Jan2021 (Lot EK9231) (at the age of 71-year-old) for covid-19 vaccination.  It was reported that the patient was looking at the vaccination sheet for the Covid-19 vaccine. She said that she had a bad reaction on the arm where she received the injection. It was reported that the arm where she received the vaccine turned blood red, had a lot of rash, and it was itching on 01Feb2021. She said that it was down to her elbow. The patient had lots of allergies. She had the shingles shot and pneumonia shot with no reaction. She had the Covid vaccine on Saturday 30Jan2021 and went to the doctor on Monday 01Feb2021 and they gave her a steroid cream for it, and it did not help much. She had been taking Allegra and Benadryl instead. It was reported that the dermatologist did not think her symptoms were from the shot itself. She said that the doctor said that she had seen people who received flu shots whose arms looked 10 times worse than hers. The reporter said that her shot was Saturday afternoon 30Jan2021 and she noticed the place on her arm on Monday 01Feb2021 or about a day and a half later. Everyone she spoke too said that they felt like they had the flu and she said that she felt lucky until she had the issue with her arm. She said that the itching was a little better but stated that it was a week later, and she was still itching, and it was driving her nuts. She said that the itching comes worse at night. She said that she only lays under 2 sheets and she thinks it may be the heat making it worse at night. She had no reaction from the first dose, only the second dose. The patient had lots of allergies to lots of medication and has broken out before. The patient had toxemia when she had her daughter 50 years ago. She said that she thinks it is called Preeclampsia now but stated that they gave her Phenobarbital, and she broke out in huge water blisters. The reporter did not have a NDC, Lot, or expiration date. The patient had no prior Vaccinations (within 4 weeks). The outcome of the event vaccination site pruritus was not recovered while for other events was recovering.  No further information provided.
Patient presented today 8/31/21 and reported that since getting vaccine he had experienced soreness and pain in arm and limited ROM since vaccine.  Has seen ortho, had MRI, intraarticular steroid injection and medrol dose pack taper
Patient was diagnosed with Pneumonia; This spontaneous report was received from an 81-year-old female patient who was reporting on herself. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Historical drugs included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) received around June - August 2021. She stated she was in good health and never had pneumonia or lung issues in her life.  On 08-SEP-2022, the patient received one dose of booster vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, frequency, route of administration, lot number and expiration date were not reported) as prophylaxis.  On 19-SEP-2022 (also reported as 11 days after the vaccination), she became very sick and had a fever. She stated that she had never been so sick like this. On 21-SEP-2022, the patient was admitted to the hospital due to the event. White blood cell count level was 12,000 (unit not provided). A computerized tomography (CT) of the chest with contrast was performed, and the patient was diagnosed with pneumonia and placed on intravenous (IV) medications. IV medications brought their white blood cell count to normal levels. The patient stated that she hoped to be discharged on 23-SEP-2022 (reported as tomorrow) and sent home with oral medications. She stated that she found it 'very fishy' that less than two weeks after receiving the vaccine, she was diagnosed with pneumonia. At the reporting time, the outcome of the event was recovering as the patient stated that she was doing better, but not completely well.  The causality between the event of pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 was not reported.  Upon internal review, the event of pneumonia was considered to be medically significant.
Lip swelling 07/29/21, mother treated with Benadryl and Prednison 10 mg. Was seen by Dr via Telemedicine 08/02/21 given Prednisone 10 mg x 5 more days and has Epi Pen prn
Received DTaP, IPV, Comvax & Prevnar 07/28/04. Mom noticed fever near 105 degrees with increased irritability that PM. Went to ER on 07/30/04 with high fever, irritability and body rash (per mom). Mom reported ER visit to PCP 08/25/04.
3 cm x 3 cm circular wheal of erythema, warmth, tenderness at injection site (R) deltoid. Advised cool compresses, BENADRYL and MOTRIN prn. Return for worsening or no improvement.
This spontaneous case, initially received from other non-health professional (consumer) on 19-Oct-2018, concerns a male patient of unspecified age (under age 65 years as reported). The patient's current condition included asthma (reported as medical history). The patient's concomitant medication included montelukast. On an unspecified date (couple of weeks ago as reported), the patient (under 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250798 and expiry date: 31-May-2018] (explicitly coded as inappropriate age at vaccine administration). The patient had not experienced any adverse events after the vaccination. The reporter assessed the case as non-serious. This case was linked to 201804741 due to same reporter. Follow-up received from other non-health professional on 20-Nov-2018: The batch number: 250798 and expiry date: 31-May-2018 were added in product tab. It was confirmed that, patient had not experienced any adverse events after the vaccination. The narrative was amended accordingly.
Pt is 50 yo male s/p full Pfizer COVID vaccination: dose 1 on 3/12 and dose 2 on 4/2. On 8/9, reports new onset chills, cough, fatigue, muscle/body aches, sore throat, congestion/runny nose. Denies known exposure to COVID-19. Pt takes emtricitab-rilpivir-tenofovir for asymptomatic HIV infection. COVID PCR resulted positive on 8/9. Pt received casirivimab/imdevimab infusion on 8/14.
24 hours of moderate to severe myalgias and low grade temperature (max 99.6F). Erythema around injection site 4 days post vaccination (Covid arm).
This is a spontaneous report received from contactable other HCP/consumer or other non-HCP, for a Pfizer sponsored program (060820). A 52-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included unknown dose number of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunisation. The patient experienced illness (felt sick) and chills (non-serious), with outcome of recovered. Additional information: Patient is taking Ibrance 125mg tablet by mouth daily, skip 4th day for 21 days on and 7 days off in conjunction with anastrozole by mouth as verbally instructed by MD (Nov 2021). Prescription: Ibrance 125mg tablet by mouth daily for 21 days on and 7 days off in conjunction with anastrozole by mouth as prescribed by MD. After the start of therapy, patient received COVID-19 booster vaccine on an unknown date. She felt "sick" and experienced chills (date of onset unknown), causing patient to electively skip one dose of Ibrance due to symptoms. No additional symptoms experienced due to missed dose. Her symptoms have now resolved. MD aware. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
pt recv vax 10APR96&4-5 days later devel an actiniform rash on face,chest,& lt upper arm;
THROMBOSIS WITH THROMBOCYTOPENIA (VENOUS); PULMONARY EMBOLISM; THROMBUS WITHIN THE PROXIMAL PORTION OF THE GREATER SAPHENOUS VEIN; This solicited report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in on JUL-2022 (reported as approximately 6 days ago) for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in JUL-2022, the patient was hospitalized due to headaches, chest pain and back pain which were ongoing six days prior to presentation and developed 1 day after receiving the vaccine. Laboratory data (dates unspecified) included: CT angiography Bilateral small PEs (pulmonary embolism), and Diagnostic ultrasound demonstrated thrombus within the proximal portion of the greater saphenous vein in the left thigh. It was reported that, patient did not present with thrombocytopenia, but there would, of course, be some concern for vaccination related thrombosis. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thrombosis with thrombocytopenia (venous), pulmonary embolism, and thrombus within the proximal portion of the greater saphenous vein. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and thrombosis with thrombocytopenia (venous) as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and pulmonary embolism, and thrombus within the proximal portion of the greater saphenous vein. Company causality between covid-19 vaccine ad26.cov2.s, and pulmonary embolism, and thrombus within the proximal portion of the greater saphenous vein was related.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220754730-covid-19 vaccine ad26.cov2.s - thrombosis with thrombocytopenia , pulmonary embolism, thrombus within the proximal portion of the greater saphenous vein. This event(s) is labeled per Agency and is therefore considered potentially related.
had recent hip surgery (Apr2023); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: HIP SURGERY (medically significant) with onset Apr2023, outcome "unknown", described as "had recent hip surgery (Apr2023)".  Clinical course: It was unknown whether patient has other vaccines in 4 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199220 same patient/drug, different dose/event;
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAY-2021 for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Paresthesia - R arm and R leg, intermittent, present for over 2 weeksCovid21#
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1708USA013519: US-009507513-1708USA013518: US-009507513-1708USA013488: US-009507513-1708USA013517.
Client was administered a Hepatitis A vaccine, instead of Hepatitis B vaccine. Client was immediately notified to return to receive the Hepatitis B vaccine. The client did return and did receive the Hepatitis B vaccine.
Pt reported difficulty breathing, swelling of face and throat, dizziness and weakness, pain, swelling and redness at injection site, sore throat, swollen lymph nodes, pain/tightness in chest, shortness of breath, headache, body aches, muscle aches, upset stomach, nausea, brain fog, fatigue, dizziness, and vertigo for six days after vaccination.
5mins post vaccination pt c/o Flushing/sweating and dizziness. Vitals: 99/57, 70, 20, 100%RA, 97.5F -- > 99/61, 71, 100% Pt stable and released from the vaccination site 18mins post vaccination.
Facial twitching, lip puckering about 1 hour after hepatitis B number 2.
Suspected vaccination failure; Most painful thing I´ve had, after the shot; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Most painful thing I´ve had, after the shot) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported the patient via interactive digital media. The patient stated that most painful thing he/she have ever had. And this was after the shot. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
site became red, swollen & painful-nauseated, flu like sx saw MD 15AUG96;