chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PTT's drawn and they have all been elevated; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (COMIRNATY; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 27Jan2021 (at the age of 35-years-old) as DOSE 2, SINGLE for covid-19 immunisation. This report is not related to a study or programme. The patient was taking Pfizer Covid Vaccine for work. Vaccine was not administered at Facility and Vaccine facility information was available. The patient medical history and concomitant medications included none. The patient previously received first dose of BNT162B2 in right arm on 31Dec2021 (at the age of 35-years-old) as dose 1, single for covid-19 immunisation. Additional vaccines administered on same date of the Pfizer Suspect; Prior Vaccinations (within 4 weeks); AE(s) following prior vaccinations; Family Medical History Relevant to AE(s) included none. The patient experienced PTT's drawn, and they have all been elevated in 2021. The patient underwent lab tests and procedures which included PTT: elevated, PTT: elevated on unspecified dates, PTT: elevated on 24Aug2021. Caller has had three PTT's drawn and they have all been elevated with her most recent one being 24Aug2021. Caller stated she had been to the doctor and they couldn't figure out why. She was wondering if this was something that had been reported before after receiving the Pfizer COVID vaccine. Patient had been to so many doctors over it; but they could not figure out why it was elevated. Stated the rest of her labs were normal. Caller denied any other medications, medical conditions, labs, testing, or treatments relevant to events. No information in PI regarding elevated PTT after receiving the Pfizer COVID vaccine. No exact times of event onset provided. AE(s) require a visit to Physician office and not to Emergency Room. Clinical outcome of event was not recovered.  Information about lot/batch number will be obtained during follow-up.
(L) deltoid with erythema & induration. 5.6cm wide x 6.5cm long.
hepatitis B virus vaccine (unspecified) on 10-AUG-2012, 21-SEP-2012 and 24-APR-2013 separately; This spontaneous report was received from a lawyer referring to a 64 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 10-AUG-2012, 21-SEP-2012 and 24-APR-2013, the patient received hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis separately (inappropriate schedule of product administration).      The case was split from a legal case referring the same patient.; Sender's Comments:  US-009507513-1812USA003429:
5 hrs after receiving vaccine, pt experienced large reaction with red itchy raised lesion, followed by generalized itching (esp of scalp), fatigue, unarousable sleep for over 8 hours, hang over in am, Headache, nausea and muscle aches.
After the vaccines lost temperature they were administered; A spontaneous report was received from a nurse concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.   On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 62-year old female patient who received their first of two planned doses of mRNA-1273 (Lot number: 027L20A), from a vial that had reached room temperature.
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. 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: 1687292; expirationdate: 25-AUG-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; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
some pain in between my shoulder blades for two days / YES; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (some pain in between my shoulder blades for two days / YES) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (some pain in between my shoulder blades for two days / YES). At the time of the report, MUSCULOSKELETAL PAIN (some pain in between my shoulder blades for two days / YES) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Medical assistant gave an extra Pentacel, seasonal influenza and Prevnar instead of only the H1N1 which was ordered.
No additional AE; Pt was administered expired Gardasil 9; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.        On 12-SEP-2021 the patient was vaccinated with a expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1621929 that has been verified to be valid for,hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)  expiry date 12-JUN-2021 for prophylaxis (strength, dose, administration route and frequency were not provided) (expired product administered).
Severe weakness, severe fatigue, muscle pain, joint pain, chills, nausea, vomiting
Broke out in rash-Hives lasted until Friday 22nd, itching 3 hrs after Benadryl shot-Benadryl pills
Pt came in on 8/15/17 to report she developed a swollen, itchy arm where injection was given. Vaccine was administered 8/10/17. Pt reports that swelling and itchiness has gone down from initial reaction.
This spontaneous report was received from a physician referring to a 71 year old female patient. The patient had no pertinent medical history, drug reactions/allergies, nor concomitant medications. On an unspecified date in 2015, the patient was vaccinated with a dose of ZOSTAVAX, 19400 Plaque Forming Units, for prophylaxis (route of administration, lot # and expiration date were not reported). On an unknown date, the patient developed shingles lesions on the left side of the gluteus with slight pain. No treatment was given for the adverse events and no diagnostic tests were performed. The patient recovered from herpes zoster 1 and half weeks later. At the time of reporting, the outcome of pain was reported as recovered on an unspecified date. The causality assessment between herpes zoster, and pain with ZOSTAVAX was not provided.
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 an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 11:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 11:02 AM, 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.   The age of patient was provided as 82.46 years. No concomitant medications were reported. Batch number 016M20A underwent temperature excursion on 08-Feb-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and at 11:00 AM with temperature 35 degrees Fahrenheit. The vial was initially moved to the fridge on 02-Feb-2021 and proposed beyond use date was 04-Mar-2021. Product moved to clinic on 08-Feb-2021. 3 vials were sent to clinic. 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 Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician concerning her daughter who in January 2000, was vaccinated with a 0.5 mL dose of varicella virus vaccine live. There was no concomitant therapy. The physician reported that her daughter subsequently developed full blown breakthrough varicella. It was unknown if medical attention was sought, but no prescription drug treatment was required. Subsequently, the physician's daughter recovered. The physician also reported that two of her other children developed mild breakthrough varicella after being vaccinated with varicella virus vaccine live. Additional information has been requested.
2 weeks following the vaccination, I started to develop a prominent burning at the tip of my tongue In the first week of April 2021, I started noticing that the taste buds on my tongue were inflamed and I started developing red lesions along the top of my mouth along the soft palate I have not had any reprieve from these symptoms and now my tongue constantly feels like I burned it on a hot drink and the oil glands in my eyes have reduced significantly
Seven-eight days following vaccine I experienced ptosis in my right eye.  It has been diagnosed as either Ocular Myasthenia or Myasthenia Gravis. First, I was examined by an opthalmologist. He referred me for CT scans of the head and neck. They were negative.  Second, I was examined by a neuro opthalmologist. He prescribed a blood test which was positive for Myasthenia Gravis. Third, I was examined by a neurologist. We will follow up in two months to note progress of the disease. I am currently scheduled for a chest CT scan to rule out thymoma.
Patient felt dizzy and possibly fainted for about 2-3 seconds after vaccine was administered. patient recovered and was in sound mind after a few seconds recovered. Patient was given a glass of orange juice and water to drink. Patient refused additional medical attention and was monitored  in pharmacy for 30 minutes before he left. Upon leaving patient di not experience any additional symptoms.
The day after the injection there was swelling and redness below the injection site and the injection site was red and bruised.  I had the redness and bruising at the injection site for 5 days with the redness almost gone on the 5th day.  On the sixth day I woke up to find the redness was back very red and larger.  I went to the doctor and she said it wasn't cellulitis and I should report it to you.
fingers that are numb; muscle pain in her forearms; tingling in the fingers; This is a spontaneous report from a contactable consumer (patient, self-reported). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, she developed fingers that were numb except for her pinkies, and a section of her palm by the thumb that was numb and painful. She also had muscle pain in her forearms. It wakes her up it hurts so badly, and she delivered two children with no epidural, so she feels like she's pretty tough. She felt these side effects were getting worse. The tingling in the fingers usually subsides throughout the day but the soreness/pain in the forearms is lasting all day now. The symptoms she believes started the next day but initially thought it might be due to sleeping on it wrong or from doing yard work. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Change of personality, regression in development acting the way she did at 1 week old instead of normal current behavior, not recognizing familiar objects, lack of interest in things that normally interest her, extreme lethargy non responsive to stimulus, blank stares, loss of desire to track favorite objects and people.
Arm ached for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2023, the patient received the 2nd dose of Shingles vaccine. In February 2023, unknown after receiving Shingles vaccine, the patient experienced pain in arm. In February 2023, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the second shot this week. The patient's arm ached for 3 days. Additional Supportive Information: The follow up would not possible as no contact details were available.
Information has been received from a pharmacist concerning a female patient who on an unspecified date a few years ago, was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported). Subsequently the patient experienced hives. At the time of this report, the patient had recovered from hives. No further information is available.
Information has been received from a physician concerning a 6 year old female with no medical history who, at 12 months of age, in approximately 2001, was vaccinated SC with a 0.5 mL dose of Varivax. On 31-MAY-2006, the patient experienced shingles down her right arm. Unspecified medical attention was sought and the patient was given acyclovir and acetaminophen (+) codeine phosphate (TYLENOL WITH CODEINE). No diagnostic laboratory tests were performed. At the time of the report, the patient was getting better. A product quality complaint was not involved.  Follow-up information was received from the physician who reported that she did not believe that this event was an "adverse event." Additional information has been requested.
April 11 - Out of cycle uterine cramping;April 12 - Uterine cramping/heavy spotting;April 13 - Uterine cramping/spotting April 14 - Uterine cramping/spotting  All are out of cycle.
Mom states that approximately 48 hours after immunization the child had a blank stare, arched her back, held her breath, and had a "frothy' saliva from mouth. This lasted just a few seconds.
Rash noted around injection site 6 days post injection site -- U shaped area 2.5 cm thick with 3 cm area of unaffected area around injection site.
red circle around the injection site; itching at the injection site; injection site swollen; injection site burning; having a rash, like a red circle around the injection site; pain on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain on her arm), VACCINATION SITE RASH (having a rash, like a red circle around the injection site), VACCINATION SITE ERYTHEMA (red circle around the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (injection site swollen) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN (pain on her arm). On 06-Feb-2021, the patient experienced VACCINATION SITE RASH (having a rash, like a red circle around the injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE PAIN (injection site burning). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red circle around the injection site). On 01-Feb-2021, PAIN (pain on her arm) had resolved. At the time of the report, VACCINATION SITE RASH (having a rash, like a red circle around the injection site), VACCINATION SITE ERYTHEMA (red circle around the injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE PAIN (injection site burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
Narrative:  Patient reports he had seizure 2 days after receiving COVID vaccine. Patient's friend who witness the seizure states he was shaking, drooling, and eyes were rolled up, seizure lasted 20 minutes, which occurred while he was asleep. Patient followed up with neurology and EEG shows left temporal epileptiform discharged and was started on lamotrigine.
Tinnitus. There is constant high pitch ringing in my ears. The only variable throughout each day is the intensity of the ringing.
No adverse event.  The Janssen SARS-CoV-2 vaccine was administered when she was 17 years old.
This is a spontaneous report from a noncontactable other HCP (patient). A 28-year-old (non-pregnant) female received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN5318), at the vaccination age of 28, via an unspecified route of administration, left arm, on Jan 15, 2021, at 13:00, single dose, for COVID-19 immunization. The patient has a medical history of acne, eczema, anxiety and ADHD (attention deficit hyperactivity disorder). Concomitant medications included spironolactone 150 mg, sertraline hydrochloride 200mg and Adzenys XR 18.8 mg. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and tested for COVID post vaccination. On Jan 15, 2021, patient experienced itchy rash (similar to hives but more mild), with only a few spots on arms and torso. Patient first noticed night of first vaccine around 11 pm or so. Unsure if related. Lasted about 2-3 days. The patient did not receive any treatment for the events. Patient underwent lab test and procedure, which included SARS-CoV-2 test: Negative on Jan 15, 2021 and SARS-CoV-2 test: Negative on Jan 29, 2021. Outcome of the event: recovered Jan 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a 26 months old patient. The patient was vaccinated accidentally with a 0.5 ml dose of AFLURIA (Lot # was not reported) IM on 12-JAN-2013. The patient was not experiencing any known symptoms. Follow up information was received from the medical assistant who reported that the 16 month old (also reported as 26 months previously) patient was vaccinated the fourth dose of RECOMBIVAX HB (lot # 0958AA is an invalid lot number for RECOMBIVAX HB) on thigh intramuscularly on 05-APR-2012 06:35 PM, the second dose of AFLURIA (lot # 07149211 is an invalid lot number for AFLURIA but lot 07149221A is valid) on thigh intramuscularly on 12-JAN-2013 01:06 PM, the first dose of MMR II (lot # 1023AA) on thigh Intramuscularly on 05-APR-2012 06:36 PM. Additional information is not expected.
Develop redness swelling and itchiness with some tenderness at the injection site.  Patient denies any fever no chills and she has full function and strength of her left arm.  No medication taken.  No shortness of breath no throat swelling no fatigue or generalized myalgia.  Patient describes symptoms as moderate. Prescribed on 2/15/17 with triamcinolone cream, hydroxyzine oral tablets and Bactrim DS x 10 days.
One hour after the injection the itching started in the scalp are and progressed to the face and jaw line.  By the second hour the itching progressed to the chest and bra line area.  I also started to experience a dull headache which did not go away.  Took 2 Benadryl but this did not help.  Took another round of Benadryl 6 hours later and went to bed.  The next day (3-24-21) I woke with no itching, but the dull headache remains.
Has not had monthly period in the 3 months after receiving Gardasil. Had been regular for 1yr prior.