chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient contracted the covid 19 virus about a week after receiving the vaccine; This is a spontaneous report received from a contactable pharmacist via Medical Information Team. A 17-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20Apr2021 as 1st dose, single dose (at the age of 17-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer BioNtech vaccine on 20Apr2021. On an unspecified date in Apr2021, the patient contracted the covid 19 virus about a week after receiving the vaccine. Patient had not yet received second dose of vaccine. Physician recommended she restart the vaccine series. Pharmacist seeking further recommendations in regard to timing of dosing schedule. Pharmacist confirmed he was calling about the Pfizer Covid-19 Vaccine and that he had a patient who got the first vaccine on 20Apr2021 and for some reason they want her to restart the series. He clarified that a physician wants the patient to restart the series of vaccines. The physician said to restart the vaccine series and pharmacist did not think this is accurate. Description of product complaint was reported as a pharmacist called to report that the patient got her first vaccine, confirmed as Pfizer Covid-19 Vaccine, 20Apr2021 and then caught Covid so she did not receive her second shot.  Now, the physician is asking her to repeat the series of vaccines. The outcome of the event was unknown.   Follow up attempt needed; information about lot/batch number has been requested.
lost the taste and smell; lost the taste and smell; tested positive for the COVID-19 infection; tested positive for the COVID-19 infection; This is a Spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program .   A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on  13Jan2021 for Covid-19 immunisation, as being a dental hygienist.  The patient medical history and concomitant medications were not reported.  on 15Jan2021 the patient lost the taste and smell and then in Jan2021 she was tested positive for the covid-19 infection. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive in Jan2021 tested positive for the COVID-19 infection.  The outcome of events was unknown.  Patient wanted to know if she should receive the second dose of the vaccine if she tested positive for the COVID-19 infection. She already consulted her physician and was instructed to receive the second dose. Patient wanted to know for how long would she be protected after receiving the second dose of the vaccine.  Information on the Lot/Batch Number has been requested.
Patient received GARDASIL 8/17/2010. Limping and complaining of pain in groin area 8/22/10; noticed lump in groin area 8/23/2010. Diagnosed as swollen lymph node. Advised to call if symptoms worsen & to call when symptoms are resolved. Lymph node .5 cm in diameter.
Got shot and it gave shingles/ suspected vaccination failure; Shingles; Awful; 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: Got shot and it gave shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and feels awful (Verbatim: Awful). The outcome of the vaccination failure was unknown and the outcome of the shingles and feels awful were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and it gave him or her shingles and it was awful. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
After getting vaccine, pt. stated; "I feel light headed, my ears are blocked, and i feel sweating and shaking" BP 110/82, SO2:99%, HR:83.After 20 min VS: BP 102/86, SO2 99%, HR:88. At 2:30PM pt states she feels fine. Pt is asymptomatic and left this facility.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-JUN-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but instead the patient contracted a persistent strain of shingles. Subsequently, the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe shingles (onset not provided). As a direct and proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
My Mom and I have been light headed and had some  diarrhea; My Mom and I have been light headed and had some  diarrhea; This is a spontaneous report from a Non-contactable consumer (patient). A male patient of an unknown age reported that he had received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient had experienced diarrhoea and dizziness on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021474462 different patient, same reporter, drug, event
severe dizziness; feels stronger/having the will to get things done; severe tiredness that lasts for 20 minutes to an hour; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness), THERAPEUTIC RESPONSE UNEXPECTED (feels stronger/having the will to get things done), FATIGUE (severe tiredness that lasts for 20 minutes to an hour) and HEADACHE (severe headaches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     Concomitant products included BISOPROLOL, CALCIUM and RISEDRONATE SODIUM (RISEDRONATE) for an unknown indication.   On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (severe dizziness), THERAPEUTIC RESPONSE UNEXPECTED (feels stronger/having the will to get things done), FATIGUE (severe tiredness that lasts for 20 minutes to an hour) and HEADACHE (severe headaches). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (severe dizziness), FATIGUE (severe tiredness that lasts for 20 minutes to an hour) and HEADACHE (severe headaches) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (feels stronger/having the will to get things done) outcome was unknown.            The patient was prescribed Ibuprofen, prednisone and unspecified antihistamines by the health care provider. The patient took ibuprofen for 5-6 days and antihistamines and prednisone did not help with the adverse events. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-211625 (Patient Link).
This spontaneous report was received from a registered nurse, concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, strength, lot number, expiration date and route were not reported). The register nurse mentioned an unknown number of patients may have received RECOMBIVAX HB that were improperly stored on an unknown date. No adverse effects reported. The registered nurse also reported current stock of RECOMBIVAX HB (not supported) (supported) in fridge at 34F for 5 months (150 days or 3600 Note: hours) due to a problem with the min and max thermometer not being reset. At the time of the report the outcome was unknown. Additional information has been requested. The case is one (1) of two (2) reports from the same reporter (1404USA012815).
Rash/Hives on Arms and Face, swollen eyelids, excessive salivation, difficulty swallowing.
Initial report received from non-healthcare professional on 27 AUGUST 2013. A 48-year-old male patient had received a dose of FLUZONE (batch number was unknown and dose number, route and anatomical site of administration were not reported) on 21 AUGUST 2013. The patient is allergic to tree pollen. The patient has no medical condition as per reporter with no illness at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccination within 4 weeks of vaccination. IT was reported that on 21 AUGUST 2012, 4 hours after receiving FLUZONE, the patient experienced "throat irritation like cold coming on", sinus congestion , nasal congestion, achiness, sweating and bloodshot eyes. The patient received 3 ADVIL (ibuprofen) and 1 CLARITIN (loratadine) as a corrective treatment and laboratory investigation were not reported. On the next morning, the patient was felt 80 percent better and by later afternoon the day after vaccination all symptoms were resolved and no further symptoms noted. At the time of this report, the outcome was recovered. Documents held by sender: none.
Patient Answered pre-vaccination questions and said that he had not had a previous covid-19 Vaccine. After recieving the Moderna vaccine informed the Nurse that he had the Astra Zeneca vaccine, but after looking up Patient it was noted that he had recieved the 1st dose of Pfizer Vaccine on 12/18/20 and did not return for his second dose. Patient had not told anyone that he recieved he Pfizer vaccine prior to Vaccine Administration on 3-10-21.
Patient was a resident on palliative plan of care after recent readmission from the hospital where he was found septic from urinary source.  Patient had a medical history of CVA, Type 2DM,Tubulo-interstia nephritis with septic shock.  On 11/03/2021 per nursing report the participant aspirated during meal.  Patient stabilized requiring 2 L of Oxygen by nasal cannula.  Chest X-ray revealed left lower lobe pneumonia and labs revealed elevated WBC. Patient started on Levofloxacin. Nurse reports the patient was doing well earlier in the evening.  However, at 9pm participant found with no pulse with pupils dilated. Patient was a DNR. Medical record review identified that High Dose Quadrivalent Flu
tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, 3 to 4 days after receiving the Covid Vaccine, the patient tested positive for COVID-19. The patient wanted to know whether he had to wait furthur to receive the second dose. At the time of this report event outcome was unknown.  Information about lot and batch number has been requested.  Follow-up attempts are completed. No further information is expected.
multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers, and was still under their care at the time of reporting. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The event was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of herpes zoster to be disabling.
8 days post vax, the pt developed a fever of 105 and febrile seizures. She was hospitalized overnight. A follow report received 8/30/2000 adds: Spoke to father of child 8/29/2000 - she was not admitted to hospital for 24 hours or more - non serious event.
states that they had a dose of tenivac which expired 15may2022/states they administered the tenivac to a patient today,with no reported adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional via Physician.  This case involves a 65 years old female elderly patient who states that they had a dose of tenivac which expired 15may2022 states they administered the tenivac to a patient today,with no reported adverse event while receiving vaccine Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac].  The patient's past medical history, medical treatment(s) and family history were not provided. No patient history and risk factors provided. The patient's past vaccination(s) included TDaP in 2007 for Prophylactic vaccination.  Concomitant medications included Pneumococcal Vaccine CONJ 20V (CRM197) (Prevnar 20) for Prophylactic vaccination.  On 17-May-2022, the patient received 0.5 ml (TOTAL) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (lot U6669AA; expiry date: 15-May-2022) (strength, formulation: unknown) via intramuscular route (administration site: Left upper extremity) for Immunization.  On 17-MAY-2022 the patient states that they had a dose of tenivac which expired 15may2022 states they administered the tenivac to a patient today,with no reported adverse event (expired product administered) following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult.  No lab data was reported.   Action taken with Diphtheria and Tetanus Toxoids (Tenivac) was not applicable.  At time of reporting, the outcome was Unknown for the event (expired product administered).  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.
fainted; suffered from a concussion; This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.      On an unknown date (reported as several years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient fainted, fell and hit his head. The patient had to go to the emergency room and suffered from a concussion for a few days following the fall.  It was unknown if treatment was given for the events. The outcome of all events was unknown. The causality assessment between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon interval review, fainted was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA006671:
Fever and chills onset 12 hours after shot. Then chest pain radiating to axilla worsening with exertion with associated orthopnea onset 6/18, aprx two days after shot. Admitted on 6/20/21 with elevated troponin to 16, with suspected covid vaccine related myocarditis. He is getting IVIG and ketorolac. Pt is stable now without any EKG interval changes, EKG sinus tachy with left axis deviation.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
10/29/22 presents to ED for "shortness of breath". PMHx of " CHF, HTN, HLD, PUD, Cerebral palsy, ESRD (MWF), and CAD s/p CABG"
Received my first shot on the 6th of April at or about 1600 (4pm).  No side effects other than general soreness in upper arm/shoulder area.  First major side effect started to kick in around 1700 (5pm) on Thursday April 8 2021.  At that time my voice started cracking, fading in and out with a sore/scratchy throat.  When I woke up on Friday April 9 2021 at 0700 my voice was gone and my throat has a numb feeling to it.
3 hours after the shot I ran a fever,  nausea, vomiting, bone pain, and hives and itching all over my body. The itching and hives lasted over a week.I could not lift my left arm for 4 days. I also experienced palpitations within 48hrs of getting the vaccine that re-occurred for several days.
it's more uncomfortable than usual; been having pains, joint pain, and several head aches; head aches; left knee was really a mess; This spontaneous case was reported by a  and describes the occurrence of DYSPNOEA (it's more uncomfortable than usual), ARTHRALGIA (been having pains, joint pain, and several head aches), HEADACHE (head aches) and ARTHRALGIA (left knee was really a mess) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for an unknown indication.     no medical history was reported.  Concomitant products included COLECALCIFEROL (VITAMIN D 3), DOCUSATE SODIUM (COLACE), PSYLLIUM FIBRE and IBUPROFEN for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (it's more uncomfortable than usual), ARTHRALGIA (been having pains, joint pain, and several head aches), HEADACHE (head aches) and ARTHRALGIA (left knee was really a mess). At the time of the report, ARTHRALGIA (been having pains, joint pain, and several head aches), HEADACHE (head aches) and ARTHRALGIA (left knee was really a mess) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: No specific follow-up information recorded.
Constricted breathing, hard cough, heavy chest, itchy eyes, headache, fainting, nausea, chills, body aches.  Required Benadryl to ease breathing.
From initial information received on 09/13/2004 from a nurse regarding an adverse event occurring in the USA, it was reported that a 4 month old female patient received a second dose of IPOL, lot number W1582-2, administered in the right thigh, a second dose of Tripedia, lot number U1272DB, administered in the left thigh, and a second dose of Pedvax-Hib (Merck), lot number 0995-N administered in the right thigh on 05/04/2004.  Immediately after the doctor visit during the drive home, the patient experienced inconsolable crying, which lasted for 2 hours.  The patient then took a nap and was perfectly fine when she awoke.  The patient recovered from this event.  From additional information received on 12/27/2004 from a healthcare professional, it was reported that no relevant diagnostic tests or laboratory data were obtained.  No other medical information was provided.  No further information is anticipated, this case is considered closed.
Injection not in deltoid muscle much lower. Reactions- sore arm, redness for two days
Pt. was found diaphoretic and disoriented. Pt. expressed feeling dizzy and faint, RN's assisted in laying the pt. on the floor. EMS was contacted and pt. was transported to the hospital by Fire Rescue
Fever, aches and chills, onset 7 hours after vaccine was received. Lasted for approximately 10 hours. Redness at the injection site starting 1 day after and lasting for one week.
Starting 3/14/21, Lightheaded, nausea, diarrhea, exhaustion, pain in back of head, no appetite, short of breath.  These symptoms lasted two weeks.  I still have periods of lightheadedness , pain in back of head and not much appetite.
Received vaccines 10/30/2008 Sudden onset continuous vomiting & 1 liquid stool & listlessness.
Severe headache, sore throat, fever, nausea, aches/pains, diarrhea, dizziness, high blood sugar, high blood pressure,
I was nauseas for 48 hours and threw up non stop.  I also had 103 temp the first 24 hours next 24 hours it went down to 101.  Horrible headache.  3 days later I had swelling all around injection site (around a 10inch by 8inch area)  it was hard and very hot.
Fell asleep almost a hour after getting home and woke up with terrible headache and kept the headache next day. Nausea 2nd day. Took aspirin (6)
CH feels like going to pass out 3:30 PM. Provided with rest. Left with report feeling better, returned to class.
Developed erythema nodosum-type rash on arms/legs w/edematous hands & feet; This was treated w/DPH & cleared w/in 24-36hrs; Exam negative otherwise;
pain at injection site, myalgia, feverish/chills, headache for 2 days, 3rd day nausea