chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BUMP ON BACK TOP PART OF THE HEAD; SWOLLEN EYES; ITCHING OF THE BUMPS; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported and is requested) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced swollen eyes. On 14-MAR-2021, the subject experienced itching of the bumps. On 15-MAR-2021, the subject experienced bump on back top part of the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes on MAR-2021, had not recovered from bump on back top part of the head, and the outcome of itching of the bumps was not reported. This report was non-serious.
No additional adverse event; Caller confirmed that the consumer was found to be pregnant after the vaccine was administered; This spontaneous report was received from a nurse prescriber regarding a 19-year-old female patient. The patient's concurrent conditions, drug reactions, allergies, and concomitant therapies were not provided. Her medical history include a child birth.   On 19-JAN-2021, the patient received the second dose in the three dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular (lot number S028738 has been verified to be a valid lot number, with expiration date reported and established as 03-MAR-2022) as prophylaxis.  On the same day, after the vaccine administration, it was found that the patient was pregnant by a office positive pregnancy test performed (exposure during pregnancy).Moreover, it was confirmed that the patient last menstrual period was one month ago (19-DEC-2020). The patient's due date was reported as 25-SEP-2021, her gestion period was four weeks, the pregnancy outcome was pending, and the fetal outcome was unknown. Also, a gonorrhea and chlamydia test were performed but result the results were pending. 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: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
temperature; lethargic; didn't eat; Three months between shots. One before he had the first one in August. Not this year but probably 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: the year before he had got the shot. Not severe, had a cold, came home from school. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "Adverse reaction". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "temperature"; LETHARGY (non-serious), outcome "recovered", described as "lethargic"; DECREASED APPETITE (non-serious), outcome "recovered", described as "didn't eat"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Three months between shots. One before he had the first one in August. Not this year but probably 2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was reporting on caller's daughter's oldest son. None of her daughter's family will take another one. Her daughter's oldest son had reactions to both the COVID shots. He had temperature, lethargic, and didn't eat. Was sure with his father he will never get another one either. Daughter's oldest son would have been 11 or 12 at the time. It was known that boys were having heart issues at that age. He was in the part where before guys sprout so a little chubby but not overweight. Reaction to the shot happened with both shots he took. Remembered he had one before he had a fever, lethargic, didn't eat, and that was pretty much it. Both times he had a reaction versus his brother who didn't. Doesn't know if age made a difference. Read something that teenage boys had an issue.  Doesn't know if he has had reactions to other shots that she was aware of. He recovered within 24 to 36 hours.  Dates: Whatever was normal. Three months between shots. One before he had the first one in August. Not this year but probably 2021. Both shots were Pfizer as at that time Pfizer was trusted the most. Dates: Unknown. Full product information for both shots unknown as she does not have her daughter's oldest son's vaccine information.  He was a good healthy kid. He did have COVID once, but she can't remember when. Clarified it was the year before he had got the shot. Not severe, had a cold, came home from school. At that time kids had to be tested to go to school even though it sounded like a cough he was positive and had to stay at home.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
25JUL AM pt started becoming cranky & had dec PO intake & nasal congestion;febrile sz 9 days post vax;
experiencing pain; numbness on right side of shoulder and then going down now the area is expanding; This is a spontaneous report from a contactable consumer (Patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date: was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date: was not reported) via an unspecified route of administration, administered in Deltoid Left on an unspecified date as dose 1, single for COVID-19 immunization and experienced slight fever. The patient experienced experiencing pain, and numbness on right side of shoulder and then going down now the area is expanding on an unspecified date. Consumer stated, he have a problem and it seemed as if it is not only his but he have the vaccine but, he thought this effect will go away and it never went away and first shot he had because he took the Pfizer, the first one on left shoulder and 2nd one was on the second shoulder, he mean on right shoulder and initially he did get any experience any side effect other than just slight fever but now he experiencing pain that never went away, it's just increasing, and increasing, and numbness on right side of shoulder and then going down now the area is expanding and he tried to do some exercises and his wife experiencing the same thing and even other friends that also receive the same vaccine on the same day are also complaining the same thing. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100994049 same reporter/ drug, different AE/ patient;US-PFIZER INC-202100994048 same reporter/ AE/ drug, different patient
Pt received COVID vaccine on Jan. 7. Pt c/o sob on 11 January. Pt states she had an itch near the place of vaccine injection  starting today. Pt able to talk in full sentences w/o stopping. Pt able to take temp w/o issue.
1/11/22/Review of Systems  Constitutional: Positive for chills, fatigue and fever.  HENT: Positive for ear pain, postnasal drip, sinus pressure and sore throat. Negative for congestion and rhinorrhea.   Respiratory: Positive for cough. Negative for shortness of breath.   Musculoskeletal: Positive for myalgias.  Allergic/Immunologic: Negative for environmental allergies.  Neurological: Positive for headaches.  Psychiatric/Behavioral: Negative for confusion.
Initial report received from a patients parent who is a health care provider on Oct 19 2005. An 18 year old male patient with a medical history of decreased heart rate, attributed to an athletic history and determined by a cardiologist, received an injection of Meningococcal vaccine identified as Menomune, lot number 41675AA (not a valid lot number), in July 2005. The route and site of administration were not reported. Illness at the time of vaccination was unsure and other medications were none. Around the time of vaccination, the patient experienced headache, dizziness and nausea. At an unspecified time later, the patient experienced elevated blood pressure and decreased heart rate. The patient was seen in an ER two weeks prior to the initial report date and referred to a neurologist for follow up. The patient had an MRI (scheduled for Oct 18 2005) and was seen by a neurologist on Oct 20 2005. Per the reporter, the neurologist did not feel the patients symptoms were related to the vaccine, and the patient continues to be monitored and evaluated. He continues to experience dizziness at times during the day and has occasional headache and nausea. At the time of this report, the patient had not recovered. although the product was reported to have been Menomune, the lot number was not a valid manufacture lot number as indicated above. The lot number provided was very similar to a Menactra lot number and the decision was made to enter the suspect product as Menactra at this time.
Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. family contacted personally by PCP.
Lightheaded and dizzy 5 minutes after vaccination.  Assisted to cot legs elevated.  Ice pack given water given.  Flushed.  After 2 attempts approximately 15 minutes apart of trying to sit/stand with dizziness returning, EMS was called.  Attendee has a history of pre-diabetes.  EMS arrived and Blood Glucose was 311.  Refused EMS transport, husband reported to staff that he was going to take her to the Emergency Room himself.
Racing Heart Rate, Elevated Blood Pressure.  Diagnosed as a severe Panic Attack. Now have palpatations each day. Doctor prescribed Metropolol and it has calmed the palpatations, but they are still present.
Developed welt and itching, enlarged as time went on.  Treated with hydrocortisone cream for a few days then prescription by doctor of Triamcinolone Acetonide Cream. 80 mg.  on 10/28.  Took about 2-3 weeks to disappear completely.
Skin sensitivity and chills increasing the day of vaccination. Skin sensitivity and chills continuing overnight. Oral temperature of 100.7 around 6am the morning after vaccine. Nausea, brief loss of consciousness as fever broke.
Patient reports approximately 12 hours post vaccination, he woke up with fever, sweating and unaware of his surroundings x 3 days.  Patient reports his wife helped him with cares.  Pt reports he was "out of his mind"  for 3 days and cannot remember anything during that time.  Pt reports it was a total of 5 days before he was back to normal.
Diarrhea; Upset stomach; Left arm pain; Red bump at injection site; Headache; This is a spontaneous report from a contactable non-Healthcare professional , the Patient. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: not known) via unspecified route of administration in the left arm on 14Mar2021 at 08:30 am (at the age of 56-years-old) as a single dose for Covid-19 immunisation. Medical history included suspected to COVID-19 (unspecified date and duration). Concomitant medication was reported as vitamins (manufacturer unknown) which were taken within two weeks of vaccination. Patient showed reaction to prednisone and was allergic to shellfish and nuts. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, in morning patient experienced headache and was not able to get up from the bed. On 17Mar2021 patient experienced diarrhoea and the headache was continuing. Patient also experienced upset stomach and pain in left arm. She also has experienced a bump at injection site. Patient did not receive any therapeutic measures for the events. The clinical outcome of headache was reported to be recovering at the time of report. the clinical outcome of the events diarrhoea, upset stomach, pain in left arm and bump at injection site were unknown. It was unknown if the patient had tested positive for COVID-19 since having the vaccine.    No further information is expected. Information about lot number cannot be obtained.
an opened vial of Tubersol was used for a patient's TB test after an excursion for 3 hours at 52.8F; Initial information received on 15-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional via phone.  This case involves a 42 years old female patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], IPV (VERO) [IPOL] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and while treated with 0.1 ml dose of TUBERCULIN TEST [TUBERSOL] (batch number: C5562AA and expiry date: 13-Feb-2021) in left forearm for Tuberculin test on 15-Feb-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to incorrect product storage because an excursion for 3 hours at 52.8F.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.   Documents held by the sender: none.
pretty high fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comment: The patient self-reported the case via interactive digital media. The patient had a pretty high fever the day after second vaccine. The patient wanted to know if it was normal. The reporter consented for follow up.
Patient called this morning to report an adverse reaction to her vaccine she received  Thursday evening. She said her throat felt constricted and she took a Benadryl and that resolved that issue but she also has lymph node swelling under her armpit, shoulder and back pain, and a knot at the injection site. She followed up with her doctor who stated she might be allergic and that happens from time to time with the lymph node swelling. Patient has shoulder and back pain still and lymph node swelling .
Narrative: COVID infection following COVID vaccine series 03/16, Pfizer, dose #1 04/06, Pfizer, dose #2 08/20 pt cc: fatigue, fever. myalgias, rhinorrhea, congestion/ sinus pressure pain, chills, cough, nausea exposure; unknown 08/23 COVID swab, result: detected
Experienced shingles with it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "auto immune hypothyroid" (ongoing), notes: current medical condition; "COVID" (unspecified if ongoing), notes: COVID twice and that the last time she got the new variant. The patient's concomitant medications were not reported. Past drug history included: Polysorbate 80, reaction(s): "allergic to polysorbate 80", notes: allergic to polysorbate 80. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: HERPES ZOSTER (non-serious) with onset 2022, outcome "unknown", described as "Experienced shingles with it".  Additional information: Caller asked whether the new flu shot came out this year was from Pfizer. Caller stated that she just got her last booster dose on 13Jul2022 and that she experienced shingles with it. Caller also mentioned that she is allergic to polysorbate 80, so she wanted to make sure if the new formulation has any polysorbate 80 in it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications were not reported. On 02-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU lot # L032184, expiration date 25-NOV-2016 (dose and route were not provided) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Two severe strokes on July 12, 2022. Was hospitalized at Medical Center.  Cannot move left leg and left hand with slurred speech.  Went to acute care and is not in sub-acute rehabilitation.
pregnant patient took fluzone, with no reported adverse event; Initial information received on 07-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 years old female patient who is pregnant and took Influenza Quadrival A-B Vaccine [Fluzone QIV], with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient took fluzone, with no reported adverse event at 17 weeks of pregnancy and the patient was exposed to Influenza Quadrival A-B Vaccine at 17 weeks of pregnancy, during second pregnancy trimester for Influenza Quadrival A-B Vaccine.  The date of last menstrual period was reported as 14-Sep-2022. The estimated due date is 17-Jun-2023.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient had unknown previous pregnancy/ies.   On 06-Jan-2023, the patient received dose 1 of suspect Influenza Quadrival A-B Vaccine Suspension for injection (with an unknown strength, lot number and expiry date) via intramuscular route in unknown administration site for prophylactic vaccination.  On 06-Jan-2023, the pregnant patient took Influenza Quadrival A-B Vaccine, with no reported adverse event (exposure during pregnancy) (Latency: same day).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported Did the mother experience any adverse events: NO. Was the company suspect product inappropriately used as per local Marketing authorization: Unknown  Action taken: not applicable.  Outcome: Unknown   Additionally, at time of reporting, the pregnancy is still ongoing.
HIGH FEVER RANGES BETWEEN 102 DEGREE FAHRENHEIT TO 104 DEGREE FAHRENHEIT.  SHE SEEMED TO BE HAVING A STUFFED NOSE WITHOUT EXISTENCE OF ANY MUCUS.  SOLID HARD AND BLACKISH SUBSTANCES SECRETED FROM EACH NOSE, ONCE.  AFTERWARDS, BREATHING RESUMED AS USUAL WITHOUT SIGNS OF STUFFINESS.
paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chills; fell; This is a spontaneous report from a contactable Physician. A 69-year-old female no pregnant patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 10:30 AM at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included prior spinal cord trauma with rt foot drop. No Known allergies. No COVID prior vaccination. The patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 69-year-old, via an unspecified route of administration at single dose for COVID-19 immunisation. The patient started the next day on 11Mar2021 02:00 PM, after the 2nd shot with headache, fever 101.2 and weakness. Took Tylenol and went to have a nap. She woke up with still fever and chills, when she tried to get up she fell. She was currently in the hospital, paralyzed with no sensation at all in her legs till her waist. AEs resulted in Emergency room/department or urgent care, Hospitalization for 5 days, disability or permanent damage. Lab data included Nasal Swab on 11Mar2021: Negative. No COVID tested post vaccination. Solumedrol 1000mg IV were received. Treatments were received for the events. Outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events cannot be excluded. 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.
Reaction day of injection was mild (queasiness after 40 minutes).  Experienced expected mild injection site soreness days 2-4.  However, more than a week after the vaccine I developed a large, bright red, swollen, very hot to the touch painful welt the size of an adult hand at the injection site.  Tried several times to report it to Montefiore Nyack with no success (no one knew where to transfer the call).  Reaction has been ongoing for 3 days; appears to be waning at this time.