chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 64-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation.  Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at the age of 63, Jan 2020, single dose, for immunization. The patient experienced laziness, with outcome of recovered. Additional information: Patient got her second dose (date unspecified) and experienced mild side effects like laziness for 1 day. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This spontaneous report as received from a registered nurse (RN) refers to an unspecified number of patients (age and gender not reported). The R.N. reported that a "sister office" on an unknown date vaccinated the patients with the first dose of VAQTA (Lot number, dose and route not reported) and in less than 6 months they received the second dose of VAQTA (Lot number, dose ans route not reported). Concomitant therapy was not reported. NO symptoms reported. Additional information has been requested.
7/12/22 Covid Pfizer booster shot allergic effects: tingling electric prickly and cooling numbness feeling. Shortness of breath, red blotches, redness in arms, blister on index finger, swollen lips and cheek, and broken capillaries. Allergic reaction started happening about 4 minutes after injection. Pharmacist gave me a Benadryl at time of allergic reaction. He followed up by phone call several hours later and asked how I was doing. I told him I had to go to local Urgent Care and told me I should have eaten something before the injection, next time just eat something. Again, I did have to get treatment at the Urgent Care. They gave me an EpiPen injection, IV of Benadryl and another  anti-histamine, and a prescription high dosage of prednisone to take for the next couple of days.
slight rash about 2 inches below the injection site, rash probably the size of a half a coffee cup; redness; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (slight rash about 2 inches below the injection site, rash probably the size of a half a coffee cup) and VACCINATION SITE ERYTHEMA (redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (slight rash about 2 inches below the injection site, rash probably the size of a half a coffee cup) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (slight rash about 2 inches below the injection site, rash probably the size of a half a coffee cup) and VACCINATION SITE ERYTHEMA (redness) was resolving.            No concomitant medications provided.   This case was linked to MOD-2021-034925 (Patient Link).
pt recv vax 3/21/98 & 3/30/98 pt devel rash, irritability & a fever of 103;4/2/98 pt recovered;
Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. One week after vaccination, the patient experienced broke out with Shingles.  The patient visited the urgent care and was treated by her physician for Shingles. No further details were provided.
Patient states she noticed erythema at injection site and thought she has an infection on Sunday Oct 7th. She went to the emergency room where the doctor circles area of erythema about 2.5 inches radius and prescribed her antibiotics doxycycline. At observation on Oct 9th 2018 the erythema has reduced from circled area down to size of quarter. She states that she has not picked up or taken the antibiotics and reports no fever or any other size adverse effects other than achiness. She states she has be icing the area with ice packs since Friday. We recommended her to stop the ice and use arm normally.
VACCINATED TWICE; This spontaneous report received from a health care professional concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031/043A21A expiry: UNKNOWN/05-AUG-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-JUL-2021, the subject experienced vaccinated twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccinated twice was not reported. This report was non-serious.
paxlovid start on 09Apr2022 Treatment of COVID-19; paxlovid start on 09Apr2022 Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: Unknown), in left arm, in Jan2021 as dose 2, single (Lot number: Unknown), in left arm and in Sep2021 as dose 3 (booster), single (Lot number: Unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "copd" (unspecified if ongoing); "gerd" (unspecified if ongoing); "mold" (unspecified if ongoing); "grass" (unspecified if ongoing); "dust" (unspecified if ongoing). Concomitant medication(s) (also reported as patient received other medication in 2weeks) included: ALBUTEROL HFA, start date: Jan2015, stop date: Apr2022; SINGULAIR, start date: Jan2010, stop date: 18Apr2022; ALLEGRA, start date: Jan2010, stop date: Apr2022; SYMBICORT, start date: Jan2020, stop date: Apr2022; PREVACID, start date: Jan2008; GABAPENTIN, start date: May2021, stop date: Apr2022; MELATONIN, start date: May2021, stop date: Apr2022. Past drug history included: Sulfa drugs, reaction(s): "Allergy".   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "paxlovid start on 09Apr2022 Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti-viral paxlovid (lot number=FX4465) started on 09Apr2022 to 11Apr2022. Reported that, with paxlovid, on 10Apr2022 at 15:00, Patient experienced double vision. patient could close one eye and see fine. With both eyes open, most but not all things were double vision. No treatment received for the event and it was recovered on 12Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 53-year-old male patient who received SHINGRIX for prophylaxis. On 12th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 12th January 2019, immediately after receiving SHINGRIX, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The caller reported that just after injection, he experienced tingling in his left hand which was the same arm where he received the injection. The reporter did not give consent to follow up. The caller had not notified his physician and therefore denies GlaxoSmithKline to follow up with his doctor.
After my se one dose I began having abnormal blood clotting during my period beginning on 5/8/2021. Each cycle has gotten progressively worse- cycles shorter and irregular, and very heavy menstrual flow with significant clotting. Culminated with event on Aug 1. Began my period on Sunday 25th, light bleeding, then stopped, and period began again on July 31st with heavy bleeding on August 1st I was bleeding through super tampons and pads every time I would stand. Went through tampons every 30min. Contacted my physician and she called in prescription and advised I go to ER if bleeding continued, it continued with very large clots and so went to ER on 8/1 at 15:56 PM.  Indicated possible fibroid and have never had issues with fibroids. Follow up appointment in process of being scheduled with my OB/GYN for further testing.
I didn't wake up until 2 days later after I was in the ICU. I had a Subdural Hematoma on the left side and before they operated, I had developed Paralysis on the left side. I was found unconscious by my mother on 11/08/2021. The EMT took me to a HCF. 4 hours later after they did a CT Scan, they realized that I was having a neurological event and the doctor transferred me over to a local Hospital and the Dr. opened my skull and found an older bleed and new bleed together which had been leaking for at least a week. I have no memory of such event. The week prior to that, my mother claimed I was slurring my words, but again I have no clue. And after that, I spent a week in the hospital and a week in rehab for walking, talking. I had trouble talking at first and then I woke up and things slowly came back. The only side effect that I've noticed is a very slight tremor in my left hand. I have no memory of falling down, I've never had falls before. If I did, it probably would've been during the night time. Not sure of correlation. Local HCF for PT. Sore head right now. In process of recovering.
symptomatic for COVID-19; short of breath; This case was reported by a consumer via call center representative and described the occurrence of suspected covid-19 in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included endoscopy.   In August 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In February 2020, between 6 and 7 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced suspected covid-19 and shortness of breath. On an unknown date, the outcome of the suspected covid-19 and shortness of breath were unknown.   It was unknown if the reporter considered the suspected covid-19 and shortness of breath to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received vaccine not confirmed as Fluarix or Flulaval in August.  The patient was in another country in February and symptomatic for COVID-19.  The patient experienced short of breath. The reporter did not consent to follow-up.
Initially patient had fever of 100.7, chills, malaise, symptoms have resolved Patient took Advil now symptoms have resolved
Lungs became inflammatory within 3 days. X-rays were taken 3 weeks prior to the vaccination and no inflammation was there. Vaccine triggered lupus flare up. Shortness of breath. Radiant pain from chest to back
skin was itchy both arms, arms to waist, back, legs; like sting sunburn, kept on scratching; could not think clearly; rash over the trunk, under breasts; a lot of red dots on upper arms and upper legs; bad flu; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash over the trunk, under breasts), ERYTHEMA (a lot of red dots on upper arms and upper legs), PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching) and THINKING ABNORMAL (could not think clearly) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (bad flu). On 24-Apr-2021, the patient experienced RASH (rash over the trunk, under breasts) and ERYTHEMA (a lot of red dots on upper arms and upper legs). On 26-Apr-2021, the patient experienced PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching) and THINKING ABNORMAL (could not think clearly). On 25-Apr-2021, RASH (rash over the trunk, under breasts) and ERYTHEMA (a lot of red dots on upper arms and upper legs) had resolved. At the time of the report, PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching), THINKING ABNORMAL (could not think clearly) and INFLUENZA LIKE ILLNESS (bad flu) outcome was unknown.            Other concomitant medications include Hormone Replacement gel from France and Hormone Replacement take daily.  No treatment medications were provided.  Action taken with mRNA-1273 in response to the events was  not applicable.    This case was linked to MOD-2021-090646 (Patient Link).
Information has been received from a office manager concerning a 22 year old female who on 02-APR-2008 was vaccinated IM with the first dose of GARDASIL (Lot #0151X). Concomitant therapy included hormonal contraceptives (unspecified). On 03-APR-2008, the patient experienced numbness in both of her hands and went away over the weekend (approximately 05-APR-2008). The numbness recurred on 07-APR-2008. Medical attention was sought through a call to the office. Patient outcome was unknown. No product quality complaint was involved. Additional information was received from a health care professional indicating that on 03-APR-2008 the patient experienced numbness in both hands that lasted 2 days. The numbness went away over the weekend but has since returned as of 07-APR-2008.  Additional information has been requested. 02/17/2010 Additional information was received from a health acre professional indicating that there has been no further communictaion from the patient to the office. This is in follow-up to report[s] previously submitted on 5/14/2008. Additional information was received from a health care professional indicating that there has been no further communication from the patient to the office.
Red; Next day it was more swollen; little itchy at injection site; Patient's arm was swollen 8 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Patient's arm was swollen 8 days after receiving 1st dose), ERYTHEMA (Red), SWELLING (Next day it was more swollen) and VACCINATION SITE PRURITUS (little itchy at injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Apr-2021, the patient experienced PERIPHERAL SWELLING (Patient's arm was swollen 8 days after receiving 1st dose). On 06-Apr-2021, the patient experienced ERYTHEMA (Red), SWELLING (Next day it was more swollen) and VACCINATION SITE PRURITUS (little itchy at injection site). At the time of the report, PERIPHERAL SWELLING (Patient's arm was swollen 8 days after receiving 1st dose), ERYTHEMA (Red), SWELLING (Next day it was more swollen) and VACCINATION SITE PRURITUS (little itchy at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  Upon internal review on 04-AUG-2021, the age was corrected to 35 years and event onset dates were updated.
Shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be unrelated to Shingrix.  Additional details were provided as follows: The age vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix and had shingles between 1st and 2nd dose. The physician understand that shingles was not associated with vaccine but to patient compliance with second dose.
10/25/2021, 1st Moderna Vaccine Shot: About 19 hr after 1st shot, started feeling hot, then okay for a few hours, then feeling extremely cold, and sever shivering for several hours with 5 blankets, but no temperature.  At 48 hr after 1st shot, started having missing heart beats, Premature ventricular contractions. Went to ER, for blood tests, xrays and EKG. Followed up with Cardiologist a week later, PVC's had stopped for a few day and were not occurring during Dr Appointment. PVC's started again shortly after.  Got a a heart ECHO, all good other than still having Premature ventricular contractions.   11/22/2021, 2nd Moderna Vaccine shot:  10 hours after shot, extreme shivering, needed 5 blankets to feel worm. Still having Premature ventricular contractions.   My Heart was perfect until until I got the Moderna Vaccine!  Had ZERO issues prior to Moderna vaccine.
Swelling, redness, induration left thigh noted 24 hours post IPV dose Rx; Duricef PO + Antibiotic cream
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2018, reported as on an unspecified date since 09-JUL-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot # N024570 with expiration date: 01-MAY-2020) or (lot# N024571 with expiration date: 01-MAY-2020) intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 47 to 77 degrees Fahrenheit (F) (57 degrees Fahrenheit (F)) for 14 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1808USA006189:
temperature would drop below range and then come back into range on and off and minimum temperature overall was reported to be 31F with no reported adverse event; administration post excursion with no reported event; Initial information received on 17-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient for whom reported reported temperature drop below range for  meningococcal a-c-y-w135 (d conj) vaccine [Menactra] and then came back into range on and off and minimum temperature overall was reported to be 31f with no reported adverse event and administration post excursion with no reported event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (with an unknown strength, dose, frequency, route, expiry date, batch number, administration site) for prophylactic vaccination.   On an unknown date the temperature dropped below range and then came back into range on and off and minimum temperature overall was reported to be 31f with no reported adverse event (product storage error) and administration post excursion with no reported event (poor quality product administered) (unknown latency).  Reportedly, Excursion started on 1Aug2022 due to a unit malfunction.  Action taken was not applicable.   Outcome was Unknown for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
p/vax pt devel constant crying & swelling @ the site;inj site swelling persisted;
About 8 days after the vaccine, I had sinus and headache. Aches in the back of my eyes. I felt sinus congestion.
Patient presented to the paramedic in the observation room with red and itchy small patches at each elbow.  Approx 20-25 minutes after shot.  Given 25mg liquid po Benadryl and observed another 30 minutes.  Symptoms resolved and went home with instructions to seek medical help if symptoms return or progress.
Patient received her first COVID-vaccine (Pfizer vaccine) on 1/21/22, and within 10 minutes had difficulty breathing and wheezing. She was taken to ER via EMS and was treated with dexamethasone, diphenhydraime, and adult EpiPen prior to ER arrival. Pt reported improvement of SOB with treatment. Patient discharged from ED w/ rx for EpiPen and prednisone. Patient returned to ED on 1/22/22 with complaints of productive cough w/ small amounts of blood and expiratory wheezing that had worsened since the previous day. CXR clear. Treated with duoneb and albuterol nebs and prednisone. Patient discharged home.
Information has been received from a medical assistant referring to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L001456, expiration date: 22-OCT-2016, route and dose were unknown), by an unspecified physician. No adverse reaction was reported. Additional information is not expected as there was no reporter's contact information.
02/02/2001, Redness and swelling at injection site on left deltoid. Seen in hospital ER on 2/3/01. Treated with Keflex and warm compresses.
Chills and 100 degree temperature beginning about 10 hours after shot.  Temperature returned to normal by the next morning with no chills.