chrisvoncsefalvay/vaers-outcomes huggingface dataset:
collapsed; seizure; vomited; neurological pain; elevated resting heart rate (around 123); fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of the Pfizer BioNTech vaccine, Event verbatim: neurological pain shooting up her body.), administration date: 22Sep2021, when the patient was 35 years old, for Covid-19 Immunization, reaction(s): "neurological pain"; Bnt162b2 (1st dose of the Pfizer BioNTech vaccine, Event verbatim: pain both sitting or standing.), administration date: 22Sep2021, when the patient was 35 years old, for COVID-19 immunization, reaction(s): "pain both sitting or standing", "Fatigue". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "collapsed"; SEIZURE (medically significant), outcome "unknown", described as "seizure"; VOMITING (non-serious), outcome "unknown", described as "vomited"; NEURALGIA (non-serious), outcome "unknown", described as "neurological pain"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated resting heart rate (around 123)"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) elevated, notes: elevated resting heart rate (around 123); sars-cov-2 antibody test: (16Aug2021) positive.  Clinical course: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Loss of consciousness, Seizure. 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.
Initial misuse report received from a healthcare professional on 24 March 2014. A patient had received an intramuscular dose of YF-Vax on an unspecified date. No adverse events were reported. List of documents held by sender: none.
pt recv vax 23SEP97 & on 24SEP97 pt had an unk exp;f/u info indicated that the vaccine was manufactured by another company (name not provided);
numbness, left feet worsens with position; Tingling in fingers, toes hands and feet; Episodes of shaking legs, shaking, not  seizure, taken to ER; This case was reported by a pharmacist via call center representative and described the occurrence of numbness in a 12-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 72KJ4, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2022 11:00, the patient received FluLaval Quadrivalent 2022-2023 season (intramuscular). On 15th October 2022, the patient started Flulaval Tetra Pre-Filled Syringe Device. On 15th October 2022, 45 min after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced numbness, tingling of extremity and tremor limb. On an unknown date, the outcome of the numbness and tingling of extremity were not recovered/not resolved and the outcome of the tremor limb was recovered/resolved.   It was unknown if the reporter considered the numbness, tingling of extremity and tremor limb to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. 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: 17-OCT-2022 Reporter's comment: The patient's mother reporter this case. Around 11 am, the patient was vaccinated with Flulaval into unknown arm and about 45 minutes later she experienced numbness and tingling in the fingers and toes that spread to her hands and feet (adverse events numbness and tingling were not recovered).  At that time her legs were shaking uncontrollably (adverse event shaking was recovered). She remained alert. The reporter denied it was a seizure.  The patient was taken to the emergency room that day. She had one more episode of shaking legs while in the ER (emergency room). Unknown tests were done and all were normal. The patient still had some numbness in her left foot today which worsens depending on her sitting position.  The reporter had nothing else to report. The reporter stated ER (emergency room) visit required. The reporter consented to follow-up with pediatrician.
I administered dose to patient  and then  he stood up and was going to go to the next station to schedule his second appointment  and he fell straight back and hit his head on concrete  which caused bleeding.  He was conscious and asking what happened  by the time  I could get to him.   He remained alert.   An ambulance was called and he did go to ER to be checked out.
Sore arm; mild fatigue for 24 hours; mild shortness of breath upon exertion (persists); cough began within 1 hour of 2nd vaccination; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3248), via intramuscular route in the right arm on 19Jan2021 16:30 as a single dose for COVID-19 immunization. Historical vaccine data included the first dose of BNT162B2 on 29Dec2020 at 16:30 (at the age of 58-years) via intramuscular route in the right arm. Medical history included rheumatoid arthritis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tofacitinib citrate (XELJANZ XR), methotrexate, atorvastatin (LIPITOR), lansoprazole (PREVACID), and celecoxib (CELEBREX). The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2017 at 17:30, the patient experienced sore arm, cough began within 1 hour of 2nd vaccination and persisted 2 days later, mild shortness of breath upon exertion which persisted, and mild fatigue for 24 hours. The patient did not receive any treatment for the events. The patient was not tested for COVID-19 post vaccination. The clinical outcome of the events sore arm, fatigue, shortness of breath, and cough was reported recovering.   No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of eye muscle weakness in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received at age of 60). On 14th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced eye muscle weakness (serious criteria GSK medically significant), ocular vascular disorder, double vision and eye pain. On an unknown date, the outcome of the eye muscle weakness, ocular vascular disorder, double vision and eye pain were not recovered/not resolved. It was unknown if the reporter considered the eye muscle weakness, ocular vascular disorder, double vision and eye pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. Two weeks later, the patient experienced double vision and pain in his right eye. The patient states that the muscle in his right eye became weak. The patient visited an ophthalmologist 3 times and the physician informed him that these symptoms were a result of a loss of blood flow in the right eye.
No Adverse event; Monovalent vaccine administered instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine administered instead of bivalent booster) and NO ADVERSE EVENT (No Adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022 at 4:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Oct-2022 at 4:24 PM, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine administered instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine administered instead of bivalent booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related and WRONG PRODUCT ADMINISTERED (Monovalent vaccine administered instead of bivalent booster) to have an unknown relationship.    Concomitant products were not provided. Treatment medication were not reported.  The gave Monovalent vaccine instead of bivalent booster to a patient. Patient was informed and they will come back in 2 months to get the correct Moderna Bivalent booster dose.   This case was linked to US-MODERNATX, INC.-MOD-2022-677171, US-MODERNATX, INC.-MOD-2022-662852 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-677171:same reporter, US-MODERNATX, INC.-MOD-2022-662852:
Patient with 3 COVID vaccines who admitted to hospital with complications from COVID in relation to COVID detected PCR.   Provider d/c note:  "Patient came in after a week of weakness, anorexia.  He had a cough for a while and was treated with Zithromax.  The patient was admitted and found to have COVID.  He was clinically stable.  Didn't need steroids or Remdesivir.  Patient had some issues with delirium at first but this has resolved. He continued to be weak and needed SNF admission.  This took a while as he was in isolation.  Isolation was completed.  He received his booster.  He didn't get a repeat COVID test before discharge as there is a high likelihood that it would still be positive."
The patient was brought back to Hospital on 02/26/2022.  The patient previously had a 30-day admission at the facility for PNA, acute diastolic heart failure, and was found to have COVID towards the end of her hospitalization.  She was brought back to the facility for respiratory failure, hypotension, and lethargy.  In the ED the patient was found to be septic and have a new PNA.  The family agreed to perform only comfort measures.  The patient expired on 02/27/2022.
Approximately 8 minutes post injection, mother yelled for help and patient was slumped over in chair. Unresponsive for 5-10 seconds. Mother reports her right arm locked up and was shaking. Patient became alert but remained confused for about 5 minutes. Patient unaware of episode. Patient repots feeling very tired, hot, and sweaty. Patient told RN she "feels weird" 911 called. RN and MOA remained with patient until EMS arrived. Patient was accompanied by her mother. Requested RN to call 911- mother wanted patient to be evaluated in ER.
This spontaneous report was received from a licensed practical nurse referring to one unspecified patient (age and gender unknown). No information regarding the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant therapies was provided. The reporter stated that, on an unspecified date, the patient was vaccinated with an improperly stored dose (incorrect product storage) of injectable VARIVAX (lot# L032391, expiration date 26-AUG-2017) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine dose was exposed to a temperature excursion between -14 and -10 Celsius degrees for 2 hours; digital data logger was involved, but there was not previous temperature excursion. The reporter was not aware about any adverse events. There was no product quality complain (PQC) reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Started Paxlovid on 17Nov2022 until 21Nov2022.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.
Bruising/redness at site of injection.  At its peak the redness went halfway down upper arm and was warm to touch.  She took 25mg diphenhydramine and within an hour or two the reaction seemed much better.  On Monday, August 1st when she showed her arm to me,  The redness was localized at injection site and was the size of a lemon with no significant swelling.  By August 3rd, the redness had resolved.  Patient was instructed to take diphenhydramine  as needed or loratidine 10mg daily.
Started out with about 2 tiny blood spots on Abdomen area, raised blood spots, not itching. Not sure when they initially appeared. Recently, last couple weeks I noticed the number of tiny red blood spots increasing on abdomen area to 10 or 12 and 1 on left breast and 1 near left ear and 2 near left eye. Went to Dermatologist on 28 March 2023 and I was told that they are Hemangiomas & that the number may increase. I have never seen these on my body before and I am 55 yrs old. I have had 5 total Moderna vaccines, each approximately 6 months apart after the initial 2 doses. I think this may be related and would like to know how to stop them from increasing on my body. I am not on any prescribed meds.
Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Dizziness/Weakness; Dizziness/Weakness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that since Saturday at 10AM. Low grade fever (100.9). Tiredness, headaches, muscle pain, chills, joint pain, nasal congestion, Dizziness/Weakness. Scale of 1-10, 10 being the worst= Level 9 on 30Jan2021 at 10:00 AM. The patient not received treatment for the events. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The report considered as a non serious. The outcome of the events was reported as not recovered.
First reaction total loss of hearing in right ear. Returned after 6 hours. Next day partial loss of hearing in left ear. Did not return to normal hearing.
Client reports receiving a flu and pneumonia shot in the left arm.  A few hours after receiving the injection didn't feel well.  Next morning he had difficulty getting up, took about two hours to get going.  Went to the nurse at work and she gave advice, he decided to go to a doctor; the doctor looked at his arm and sent him to emergency.  Emergency doctor told him he had "cellulitis", prescribed pain medication and antibiotics.  Slowly getting better.  Arm remains red and with some swelling.
Pt vaccinated with Influenza, fainting, BP 56/30, pulse weak thready 96. No redness swelling at site of injection. Given Epinephrine.
Developed hives within 3 days of the vaccine, followed by diffuse joint pain (wrist, hands, knees, elbows, ankles, feet) 2 days afterwards
Numbness in left arm to elbow that resolved in a day. General malaise. Achy joints.
STOMACH ACHE; FEELS DISTORTED; DIZZINESS; BODY SWAYS; ACHES IN  BILATERAL THIGHS AND FRONT/BACK OF CALVES; MUSCLE ACHES; HEADACHES; TIRED; CHEST PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included healthy and not using any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced chest pain. On 28-APR-2021, the subject experienced stomach ache. On 28-APR-2021, the subject experienced feels distorted. On 28-APR-2021, the subject experienced dizziness. On 28-APR-2021, the subject experienced body sways. On 28-APR-2021, the subject experienced aches in bilateral thighs and front/back of calves. On 28-APR-2021, the subject experienced muscle aches. On 28-APR-2021, the subject experienced headaches. On 28-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets and d-dimer were normal, and ECG (NR: not provided) unknown. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 17-APR-2021, had not recovered from muscle aches, headaches, feels distorted, body sways, and stomach ache, and the outcome of tired, aches in bilateral thighs and front/back of calves and dizziness was not reported. This report was non-serious.
Pt recvd MMR vax 6JUL88 & 25FEB91 pt had t103 & pharyngitis; dx of clinical strep; rash, congestion, red eyes, upset stomach & blisters in mouth; dx measles;
Pt was given pediatic dose.  No adverse reaction.  Per pharmacist,  when pt returns in 3 weeks, pt to be given adult dose.
23 year old client received a high dose flu vaccine, contacted facility at 4:00pm and client is doing well.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to an exact time not recorded, noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 08-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
pt recvd vax; 4 hrs after vax; pt began shaking arms & legs & had a high pitched cry; pt given APAP; pt seen by ER, t 100.7;
Patient was given an undiluted COVID-19 vaccine (Pfizer). Medication was given with no diluent to dilute the vaccine vial and 0.3 mL of the vial contents were administered to the patient.
bleed; big black bruise; TThis is a spontaneous report from a Pfizer-sponsored program. A contactable consumer consumer (Patient) reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown)), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bleed and big black bruise. The patient would like to know if the vaccine will still be effective after what happened. The outcome of the events was unknown.   Information on lot/batch number has been requested.
joint pain; sensitive skin; Trouble sleeping; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 41-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA181A, expiry date 30th September 2022) for prophylaxis.   On 14th September 2019, the patient received the 2nd dose of RabAvert. On 15th September 2019, 1 days after receiving RabAvert, the patient experienced joint pain, sensitive skin and difficulty sleeping. On an unknown date, the outcome of the joint pain, sensitive skin and difficulty sleeping were recovering/resolving.   It was unknown if the reporter considered the joint pain, sensitive skin and difficulty sleeping to be related to RabAvert.  Additional details were reported as follows: The reporter stated that, the patient experienced joint pain, sensitive skin and trouble sleeping after the 2nd dose of Rabavert.
Patients coming in read website about premature ovarian failure following Gardasil 9 administration; This spontaneous report as received from a physician and refers to a female patient of unknown age. No information on patients' medical history, concurrent condition and concomitant medication was provided.  On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route of administration, lot# and exp. date were not provided).  On an unknown date the patient experienced premature menopause. The outcome of premature menopause is unknown. Action taken with and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.       The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.; Sender Comments:
Pt had some tenderness at vaccination site later that day. Felt a little dizzy, had very restless night sleep and fell in the am due to feeling dizzy. No loss of conscious no vomiting.
Information has been received from a licensed practical nurse concerning an 18 year old female with a penicillin allergy and allergy to BENADRYL who on 11-FEB-2007 was vaccinated at another practice with a first dose of Gardasil. There was no concomitant medication. On 11-FEB-2007, 30 minutes after the vaccination, the patient "felt lethargic and could not stand on her own". "She looked like she was drunk and she did not make any sense when she spoke". The patient went to an emergency department and was released. She was reported to have no rash or breathing problems. It was also reported that a urinalysis was clear and drug test was normal. She was reported to have recovered 12 hours after the vaccination./ The reporter felt that the patient's symptoms were disabling. Additional information has been requested.