chrisvoncsefalvay/vaers-outcomes huggingface dataset:
violently ill; nausea; sick; very dizzy with flu symptoms; grogginess and extreme exhaustion; arm got numb; grogginess and extreme exhaustion; arms were getting  weaker and weaker; weak; sweat; dizzy, weak, sweats; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Apr2021 (at 51-year-old) (Batch/Lot number was not reported) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included ongoing chronic back pain (diagnosed for years), and ongoing type 1 diabetes mellitus. The patient's concomitant medication was not reported. After the first dose, date unknown, he got violently ill, stated literally he got ill at the center where he got the vaccine, he was weak, started to sweat, the medical people there were a little concerned they held him there for an additional amount of time for observation after the first vaccine. He was very dizzy. (event weak, sweat and dizzy onset 24Apr2021 03:00 as reported) He went home and he was very nausea and sick, at 23:00 he laid down and slept all day until the next day. He woke up on the third day very dizzy with flu symptoms, but was able to get up and get moving and was getting better, after about a week during the four weeks between the two doses started calling doctor telling them something was wrong, got over the first three days and then the grogginess came back extreme exhaustion, noticed every night in bed if he curled up in bed or brought arms up or like now if he has arm up to his ear on the phone his arm got numb immediately. Arms went within a minute. The doctor and nurse practitioner doubted this was lingering side effects, progressively his arms were getting weaker and weaker, he was getting weaker and weaker as a person. MRI and rheumatology (lymes, MS, lupus) showed negative. The outcome of the events violently ill and arm numb was not resolved; of events weak, sweat, dizzy, nausea, sickness, flu symptoms, exhaustion, groggy and weakness of arms was unknown. The events under second dose referred to case 2021648178.  Information on the lot/batch number has been requested.
Chronic pain, large red spot appeared overnite lasting approximately 6 days.  Went to hospital ER and treated with antibiotics and was unable to work following day due to pain and inflammation of arm.
No additional AE reported; administered ROTATEQ and RECOMBIVAX HB after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 29-DEC-2021, hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion with 35.9 Fahrenheit degrees for 0 hours 20 minutes 0 seconds. There was no previous temperature excursion.  On 04-JAN-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (once, lot # 1742430, expiration date 16-SEP-2022; strength was not reported) orally and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (once, lot # T032918, expiration date 12-NOV-2022; strength, route and anatomical location were not reported), both for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA007167: US-009507513-2202USA006998: US-009507513-2202USA007571: US-009507513-2202USA007032: US-009507513-2202USA007028:
Developed a hot, swollen area 3" x 2" on arm where shot was given. Applied ice to area and by 10/15/04 swelling was gone.
WRONG VACCINE TYPE ADMINISTERED TO PATIENT. HE WAS SUPPOSED TO RECEIVE MENINGITIS B (TRUMEMBA) INSTEAD HE RECEIVED MCV4 (MENACTRA).
Injection site abnormally sore and got a lot worse. By 9:00 pm I basically had the flu -- body aches, chills and shaking, hard to get warmed up and then I got too hot, skin sensitivity and whopping headache. Tried to sleep and had a really bad night. Woke up at 5:00 am and realized that flu symptoms had ended and I was left with headache and feeling like I'd been beaten up. Soreness in arm still beyond normal but subsiding.
Information has been received from a nurse practitioner and a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL.  Shortly after receiving the vaccine the patient experienced syncope.  The patient's outcome was not reported.  This is one of several reports from the same source.  Additional information has been requested.
On the second day after my shot, I noticed a rash on my whole belly (mosquito bite like). I took a medicine called Avapena (Chloropyramine hydrochloride) and Loratadine. The rash completely fade the next night. No other symptoms happened within the first 48 hours. On the fifth day after the shot, I started with flu-like symptoms, which have not yet fade.
Vein under left  eye vibrating; Pinkie and ring finger (bottom half of hand) was numb; Twitches in triceps; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Vein under left  eye vibrating), HYPOAESTHESIA (Pinkie and ring finger (bottom half of hand) was numb) and MUSCLE TWITCHING (Twitches in triceps) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009CUA) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (Vein under left  eye vibrating), HYPOAESTHESIA (Pinkie and ring finger (bottom half of hand) was numb) and MUSCLE TWITCHING (Twitches in triceps). At the time of the report, OCULAR DISCOMFORT (Vein under left  eye vibrating), HYPOAESTHESIA (Pinkie and ring finger (bottom half of hand) was numb) and MUSCLE TWITCHING (Twitches in triceps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 61-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced syncope, feeling unwell and dizziness. On an unknown date, the outcome of the syncope was not recovered/not resolved and the outcome of the feeling unwell and dizziness were unknown. It was unknown if the reporter considered the syncope, feeling unwell and dizziness to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, the patient felt under the weather for a few days after the dose of SHINGRIX. This then led to bouts of syncope that had not resolved. The healthcare professional stated that, he was not sure if it was true syncope by definition of loss of consciousness but rather dizziness. The healthcare professional called to check on post-marketing information and when reporter transferred to a vaccines medical information system (MES) he informed them it was not true syncope by definition but more like dizziness.
Fever: 102.0 degree x 3 days. Malaise. Injection site pain. Outbreak of shingles over RT eye at day 21.
Blurred vision; Dizziness; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), DIZZINESS (Dizziness) and FATIGUE (Very tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VISION BLURRED (Blurred vision), DIZZINESS (Dizziness) and FATIGUE (Very tired). At the time of the report, VISION BLURRED (Blurred vision), DIZZINESS (Dizziness) and FATIGUE (Very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Worst headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 24Aug2022 at 09:30 as dose 1, single (Lot number: PF7140) at the age of 62 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 24Aug2022 at 21:30, outcome "recovered" (27Aug2022); HEADACHE (non-serious) with onset 24Aug2022 at 21:30, outcome "recovered" (27Aug2022), described as "Worst headache". Therapeutic measures were taken as a result of headache, chills. Additional information: No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination, COVID not tested post vaccination. 12 Hours after the shot the patient started having chills and "the worst headache he had ever had". They lasted for about 3 days. The patient was told to take Advil or Tylenol for treatment.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/25/21 (EL9266) Pfizer Dose 2 3/19/21 (EN6204) COVID Positive 10/26/21  10/26/21: Patient is a 91 year old male who lives at home with his daughter at baseline who presented to ED with complaints of bilateral hip pain.  Patient is ambulatory with a cane at home.  History was obtained per the patient and his daughter who is at bedside.  Yesterday, the patient suffered 2 falls.  First fall occurred when he slipped out of bed in the morning. His second fall occurred when he was going to bed last night. He hit his head on his nightstand, denies loc. He is anticoagulated on Eliquis.  His hip pain is worse with standing and ambulating.  He denies any chest pain or shortness of breath.  No recent fevers.  No nausea, vomiting or diarrhea.  Patient has a past medical history significant for atrial fibrillation anticoagulated on Eliquis, history of DVT, CAD status post stenting, PVD, hypertension, hyperlipidemia, GERD, BPH, OSA on CPAP, anxiety/depression and CHF LVEF 55%.  Arrival to ED the patient was febrile 101.3, saturating on room air at 91%.  Laboratory findings were significant for hypocalcemia 8.4.  Anemia HGB 12.1.  Chest x-ray showed new by basilar airspace disease which may represent atelectasis or infiltrates.  Levaquin was initiated in ED and IV hydration was given with NS 0.9% 1 L bolus. X-ray of pelvis showed no acute traumatic injury.  10/29/21: Patient is a 91 year old male who lives at home with his daughter,presented to ED with complaints of bilateral hip pain and falls.  Patient is ambulatory with a cane at home.  He was  feeling fatigued recently tested positive for COVID-19 infection and started on treatment.  Patient saturation okay with desaturation room.  No recent fevers.  No nausea, vomiting or diarrhea. Patient has a past medical history significant for atrial fibrillation anticoagulated on Eliquis, history of DVT, CAD status post stenting, PVD, hypertension, hyperlipidemia, GERD, BPH, OSA on CPAP, anxiety/depression and CHF LVEF 55%.  Chest x-ray showed new by basilar airspace disease which may represent atelectasis or infiltrates from COVID-19 infection.  Patient was initially started on IV levofloxacin  This has been discontinued because of absence of fever, leukocytosis or symptoms  The patient will be discharged to home with family.  He needs to follow with PT/OT as outpatient
Pain in arm, headache, itchy eyes, body aches, sore throat, running nose, tired.
I received the vaccine on 8/23/2021.  My period had ended the day before my vaccine.  After I  received the Tdap vaccine my period started on 8/26/2021. The bleeding lasted for 6 days. My period has always been regular since I was 13. I have never had two periods in the same month.  I spoke to Dr. about it and she said it was a possibility that the tdap vaccine could've started my period.
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 1:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:55 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 71.52.  No concomitant medication was reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. Vial was moved to fridge on 30-Mar-2021 and moved to clinic on 31-Mar-2021. Vial was punctured right before administration. Vial best before use date was 29-Apr-2021. Vial was undergone temperature excursion at 09:00 AM with 32 degree Fahrenheit. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
About 2 weeks after receiving the J&J one dose vaccine, I started getting sever neuropathy pain in my feet that quickly moved up my legs, hands, face and my vision started to go. I ended up getting diagnosed with a GBS variant: Acute Sensory Ataxic Neuropathy. I?m still severely affected to this day and am now legally blind.
REALLY HARD TO CHEW AND NOT REALLY TO TALK BUT TO CHEW FOOD; EARACHE ON THE RIGHT SIDE OF MY FACE; PUFFY FACE; JAW PAIN; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced headache. On 05-MAY-2021, the subject experienced jaw pain. On 05-MAY-2021, the subject experienced earache on the right side of my face. On 05-MAY-2021, the subject experienced puffy face. On an unspecified date, the subject experienced really hard to chew and not really to talk but to chew food. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache on 05-MAY-2021, had not recovered from jaw pain, earache on the right side of my face, and puffy face, and the outcome of really hard to chew and not really to talk but to chew food was not reported. This report was non-serious.
Missed menstrual cycle: one week as of reporting Swallon gland on left clavicle: causes serve pain and sensation of restricted breathing pathway
He died suddenly in his sleep; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jun2021 10:00 (Lot number: EWD198) at the age of 17 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 (Dose Number: 1, Batch/Lot No: EW0211, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 05Jun2021, when the patient was 17 years old, for Covid-19 immunization. The following information was reported: SUDDEN DEATH (death) with onset 24Jan2022 09:00, outcome "fatal", described as "He died suddenly in his sleep". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of death. The patient date of death was 24Jan2022. The cause of death was unknown. The autopsy was performed, and results were not provided. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: "He died suddenly in his sleep" occurred almost 6 months after vaccination are unrelated to bnt162b2 (BNT162B2). The case will be reassessed once more information become available. 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.; Reported Cause(s) of Death: He died suddenly in his sleep
Passed away; Severe hypotension; Hemodialysis shunt bleeding; A spontaneous report was received from other health professional concerning a 72 years old, male patient who experienced hypotension, removal and replacement of hemodialysis shunt (procedure), hemodialysis shunt bleeding and death.   The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    On 29-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Batch number [LOT/BATCH: 039K208] intramuscularly in the right arm for prophylaxis of COVID-19 infection.      The patient was hospitalized for severe hypotension and Removal and Replacement of hemodialysis shunt from 17-JAN-2021 to 21-Jan-2021. On 26-01-2021 the patient was sent to hospital due to his hemodialysis shunt bleeding. On 27-01-2021, the patient passed away at the hospital . Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 27 Jan 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
patient was administered two dose of Fluzone High-Dose / no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 80 years old female patient who received two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17 Sep 2019, patient received dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (vaccination details regarding dose, route, site, batch, exp date was not reported)  On 19 Sep 2019, Patient received 05 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ253AB (Expiry date 06-May-2020) via unknown route in unknown in the left deltoid   It was an actual medication error case due to extra dose administered.   At a time of vaccination no adverse events were reported.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Right side upper arm ache spread to right side of neck and into headache at back and top of skull.  Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day.  Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights.  Headache off and on for 10 days.  Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose.  On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.
Very large local reaction to vaccine. No fever. Reaction around DTaP site (right deltoid). No intervention needed.
Product Complaint; Arm sore; Arm warm to the touch; Underdose; Small drops ran down the patient's arm; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 18th October 2019, the patient received the 2nd dose of Shingrix. On 18th October 2019, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On 19th October 2019, the patient experienced pain in arm and skin warm. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the pain in arm, skin warm, accidental underdose, inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the pain in arm and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and during the injection, 3 small drops came out of the syringe and ran down the patient's arm, which led to underdose, inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint. The following day the patient's arm was sore and warm to the touch. The reporter consented to follow up. The health care professional stated the needle was secure and that the leakage was due to a malfunction of the syringe.