chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the injection arm swelled; red blotch; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL). The patient had a history of allergy (unspecified). Concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on an unspecified date in Feb2021 at 17:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, patient had not been tested for COVID-19. On 25Mar2021 at 09:30, six days after vaccination the patient had experienced swelling in the injected arm and a red blotch which was not at injection site. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events the injection arm swelled and red blotches was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Pt. says 1 hr post vaccine developed a headache with sharp pains including Lt facial area from jawline to temple and continues for 2 weeks. Pt also c/o having blurred vision in Rt eye intermittently.
stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  Clinical course: Enjoy your billions while patient had a well documented stroke from the second shot. Disgraceful.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient fainted couple of minutes after giving the flu shot. Pharmacist assessed breathing and called 911. Patient was unconscious for couple of seconds then responded but not fully. Pharmacist gave him liquid glucose to raise his sugar level b/c of history of diabetes.
Severe migraine, fever, chills, couldn't open left eye without extreme pain to the point of almost passing out.
Approximately two minutes after hep A injection pt fainted. After approx. 3 minutes pt was fully oriented to time, place, person, situation. Pt stated he felt like he was in a "fog" v/x taken  juice and granola bar given.
Case number PHEH2014US009109, is an initial spontaneous report received from a nurse on 02 May 2014 with a follow-up received on 12 Jun 2014. This report refers to 13 year old female patient. Her vaccination history was up to date. Nurse reported that the patient received only the Men CYW-135 liquid component of MENVEO (batch number: M13017) intramuscularly into left arm on 30 April 2014 at 4 pm. On the same day, the patient was also vaccinated with 0.5 ml dose of HARIX (batch number: 3996J) intramuscularly. No adverse event was reported. No further information was provided. Upon follow-up the nurse reported that the patient returned to repeat the shot on 20 Jun 2014. Follow-up received from a nurse received on 12 Jun 2014: Site of vaccination, time of vaccination, concomitant vaccination and narrative updated. Follow-up received from the nurse on 20 Jun 2014: Updated information on repeat vaccination of the patient.
1 month later spotting on my cycle, cycles stared to be 2 weeks longer than normal
soreness in arm at injection site that worsened the next day, heavier than usual period, scalp extremely itchy for a few hours after vaccination, elevated blood pressure, headaches
Started feeling cold but tolerable after 24 hours then around 630PM,  approx 27/28 hours later feeling feeling extremely cold. Around 745PM, I couldn't focus because of how cold I had gotten. Took warm shower, raised heat to 80, took Tylenol, and covered up in bed. After hour I was better, still cold but tolerable. Hear remained at 80 degrees till next morning.  Coldness went down completely by 12PM following day.
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: PATIENT DEVELOPED BLISTERS AND SORES IN MOUTH APPROXIMATELY 1 WEEK AFTER RECEIVING VACCINATION. WENT TO PRIMARY CARE DOCTOR WHO DID BLOOD WORK WHICH SHOWED A PLATELET LEVEL UNDER 2000. PATIENT WAS HOSPITALIZED AND GIVEN STEROIDS BUT HAS SINCE RECOVERED.
Medical Assistant reporting administration of improperly stored VARIVAX; No additional adverse events reported; This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U025791 with expiration date on 19-AUG-2023; lot# U020239 with expiration date on 28-JUN-2023; lot# U016063 with expiration date on 20-MAY-2023) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) which experienced a temperature excursion of 5.4°C Celsius degrees during a time frame of 2 hours 42 minutes. No previous temperature excursions were reported.
Menstrual change. My period is always on time and lasts 3/4 days. Period has been spotty Monday and Tuesday but wasn't supposed to start until Saturday which is highly unusual for me.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion 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 (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion 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.   Age of patient was reported as 59.71 for dose administered on 03-Apr-2021. No concomitant medications were reported.  Batch number 030B21A administered on 03-Apr-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period 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.  No treatment medications were reported.
Pt reports itchy, tingling on hands, elbows going up the arms without any physical rash. Pt has been using BENADRYL. Pt states no new perfume, detergents not any new OTC or Rx meds.
Arm was swollen and sore for several months after shot and I started to experiance pain that started to get worse as the months went on.  Started to notice arond april 2022 that I could no longer accomplish certain tasks and made a drs appointment that coulnd not be filled until Sept 9, 22 where I saw my family dr.  She scheduled ultrasound for a nodule that can be felt on left sholder that was done on 9/15/22.  impression was "Largely cystic appearing structure corresponds to the patient's palpable complaint as described above. Possible fat necrosis/coil cyst."  I was scheduled for a general surgan consolt for 10/24/22.  PT was also perscribed with dates of 9/28/22, 10/03/22, and 10/5/22.  Pt findings were from chart and stated "Patient is 44 y/o male who was referred to PT with diagnosis of left deltoid/shoulder pain, who complaints of left shoulder pain, states she had tetanus shot in Sept 2021 and her left shoulder got swollen & was told she had a cyst, has pain since then and got worse around April 2022. Has difficulty with reaching overhead, reaching back, reaching for seatbelt and putting on shirt. Patient presented with limited left shoulder AROM all movements, but has comparable PROM to his right shoulder although with pain. Has WNL muscle strength on her left shoulder, elbow and wrist muscles. Has intact sensation on both upper extremities. Positive left shoulder pain with Empty Can test and Yergason's test which suggest possible left rotator cuff and biceps tendinopathy. Patient will benefit for skilled PT to help decrease her left shoulder pain and improve her left shoulder AROM for more ease with ADL function. Patient is scheduled to see an orthopedic specialist tomorrow for further assessment and patient will contact PT if she's instructed to hold therapy, otherwise she will keep her follow up PT appointments."  On 9/28/22  I seen Dr who's notes stated "Attestation signed by MD at 9/29/2022  4:23 PM I independently evaluated and examined the patient and agree with the resident's note.  Her presentation is consistent with shoulder injury related to vaccine administration (SIRVA).  I gave her an article about this for her education.  I recommend continued physical therapy.  I prescribed meloxicam.  In 2 months, if she has not significantly improved, we may consider an MRI before considering steroid injection or other intervention.  I did note that I do not think her pain is coming from the firm nodule in the side of her shoulder, as this is nontender.  I advised her I do not think having surgery to remove that by general surgery is likely going to make anything better." Pt is still scheduled for next 2 months with follow up 11/30/22 and as needed.
Pt recvd 1 dose of Engerix-B 24APR92 & 11MAY92 breaking out on lower  part of leg which moved up body; dermatologist treated this w/steroid & antihistamines; resolved p/ 1 wk;
Severe headaches (entire head not relegated to one lobe of pain; starting at 10:30 pm day of injection), nausea (starting at 11 pm day of injection), severe body aches (starting at 3:30 am day after injection), joint pain, light sensitivity, trouble swallowing fluid, fever, chills, shaking, sweats, extreme heat radiating from injection site, drowsiness, insomnia, discomfort in all positions (needing to change position every few minutes) and loss of appetite.
I did not have a reaction to the vaccine. I do have a history of heart issues. On 11/09/2022, my heart rate dropped to 29 and 36. I went to the emergency room and was admitted for three days. I had a pacemaker on 11/10/2022. On 02/20/2023, I was hospitalized for five days for extreme shortness of breath. On 11/21/2022, pericardial effusion they drained 1.3 liters of fluid off my heart. They created a wall in my heart wall for drainage. As of today, I am feeling much better.
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:46 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion 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.   Age of patient was reported as 69.25 for dose administered on 3-Mar-2021 and as 69.33 for dose administered on 31-Mar2-021  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 20-Mar-2021 with temperature range of 34 to 51 degrees Fahrenheit from 09:00 AM to 10:00 PM. These vials were moved to fridge on 24-Feb-2021 and beyond use date for the vials was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021.  Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 34 to 51 degrees Fahrenheit from 09:00AM to 10:00 AM. These vials were moved to fridge on 24-Mar-2021 and beyond use date for the vials was reported as 26-Apr-2021. Product moved to clinic on 31-Mar-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period 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. No treatment medications were reported
PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND  BLOOD PRESSURE DROPPING). PT WAS LAYED ON THE FLOOR IN A SUSPINE POSITIION WITH FEET ELEVATED. PT WAS PLACED ON A BLOOD PRESSURE MONITORING MACHINE.  COLD COMPRESSIONS WERE APPLIED TO THE PATIENT'S  BODY.   PT WAS GIVEN A FEW CRACKERS AND SODA TO INCREASE BLOOD SUGAR.  WITHIN MINUTES THE PT BLOOD PRESSURE BEGAN TO RISE AND PT FELT FINE.  PT WANTED TO DRIVE HOME AND WAS ADVISED NOT TO DRIVE. PT CALLED FOR HER PARENTS TO COME AND PICK HER UP.
Upset stomach; Headache; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 032M20A and 024M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine. Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine, ATORVASTATIN, VITAMIN D3, BUTALBITAL, CAFFEINE, PARACETAMOL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) outcome was unknown.        Concomitant medication included OTC women complete multivitamin. No treatment medication were provided.   This case was linked to MOD-2022-623883 (Patient Link).
flu-like sy's: sore  throat, achy, runny nose x 2 days
The patient said that after she was given the shot she couldn't move her arm and it got stiff. She said the next day that she had to get her daughter to move her arm. She lifts freight at work and she says her hand and arm get stiff and there are shooting pains that go down her left arm. The patient is going to make an appointment with her doctor so he can check out her arm.
Parkinson's disease; other serious neurological problems; postherpetic neuralgia; vision problems; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 06-SEP-2012 (at approximately 73 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, postherpetic neuralgia, vision problems, Parkinson's disease and other serious neurological problems. The outcome of the events was unknown. The causality assessment was considered as related by the lawyer.   Upon internal review, Parkinson's disease was considered to be medically significant.
a high fever; extreme fatigue; have allergies; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the second of eight reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine in Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/AE, different patients
Pt. had a syncopal episode immediately following third vaccine. Pt. was assisted to lay down on exam table. Pt. regained consciousness within 3-4 seconds. Pt. was given juice and crackers and continued lying down for 10 minutes after episode. Pt. was assessed by physician. Pt. felt well enough to leave the office.
The pt experienced right anterior thigh redness, swelling over an 8x6cm area.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age and gender. In February 2013 within the last 10 days, the patient was vaccinated with ZOSTAVAX. The pharmacist reported that a physician told him that the patient developed shingles after receiving ZOSTAVAX. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
First  day after first dose.   Achy arm, puffiness in eyes, dizzy feeling, stiffness in neck, feeling bloated. Dehydrated. 2nd day after first dose Intense ringing in ears. Constipated, .feel woozy,  Bones in back and legs feel crickets. Eyes fuzzy. These symptoms continue. Saturday June 19.  Feeling itchy all over.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on an unknown date approximately in June 2012, "one to two weeks ago". No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient needed "an epidural" for an unspecified reason. It was unspecified if the patient had sought medical attention. The outcome of the adverse event was unknown. Additional information has been requested.
expired dose was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAV (Havrix) (batch number Ha9y9, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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: 27-OCT-2022 Reporter's comment: Pharmacist reported that an expired dose of Havrix was administered to the patient. The reporter declined to provide information besides the age and gender of the patient.  Expiration date was from salesforce. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Information has been received from a physician concerning a 5.5 month old male who on 11-SEP-2007 and 27-NOV-2007 received an oral 2 ml first and second dose of ROTATEQ. On 11-SEP-2007 the patient experienced "almost constant diarrhea" that lasted 6 weeks. On 27-NOV-2007, following the second dose, the patient experienced diarrhea that lasted 2 weeks. "After it happened for the second time," the doctor discontinued therapy with ROTATEQ. The patient sought unspecified medical attention. On an unspecified date the patient had a stool culture performed. At the time of the report the patient's status was recovered. A product quality complaint was not involved. Additional information has been requested.
Site: Pain at Injection Site-Medium, Additional Details: Patient describes continued moderate pain months after second injection. She works out every day, has range of motion but pain remains.