chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my right  shoulder started to itch; bumps; red patch; This is a spontaneous report from a contactable HCP.  A 62-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL9266 and Expire Date: unknown) on 27Feb2021 at 11:30 via unspecified route of administration as single dose for Covid -19 immunisation. Patient's medical history included Chonic Kidney D and codine allergy from an unspecified date and unknown if ongoing. Concomitant medications were none. No other vaccines were administered within four weeks and medications in two weeks. Patient had not covid prior vaccination and not covid tested post vaccination. After vaccination, she began to notice her right shoulder started to itch. She rubbed it, then felt it bumps, she looked in the mirror and noticed it was red patch on 27Feb2021 at 11:30 AM. She applied rubbing alcohol and then triple antibiotic ointment. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown age and gender. No Medical history or concurrent conditions were reported. On 09-MAY-2014, the unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX, subcutaneous (lot number, dose number and dose not provided). The pharmacist reported that the (Oka/Merck) VARIVAX vaccine reached a -9C. No adverse effects were reported. At the time of the report, the outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.
No reaction after first vaccine other than soreness in injection site.  Day following second vaccine, had chills, fever up to 101, and slight nausea.  Those symptoms were better the next day, but it is now day 3, and I still have redness, swelling, and redness around the injection site.
Left hand cramping, difficulty closing left hand, hard to grasp items with left hand, sporadic pain in left hand-- mistaken for carpal tunnel.
BLOOD CLOT; JOINT PAIN; This spontaneous report received from a patient concerned a 63 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: pseudo gout, moderate to severe chronic plaque psoriasis and arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total (first dose) administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Non-company suspect drugs included: risankizumab (form of admin not reported, subcutaneous, and batch number were not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis.  On an unspecified date, the patient experienced blood clot, and was hospitalized (date unspecified). Number of days of hospitalization was not known. She also had joint pain (dose number in series 1). The patient additionally received Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, administered on JAN-2022 for covid-19 vaccination. It was unknown whether patient had any adverse events following administration of Pfizer vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, and the outcome of blood clot was not reported (dose number in series 1). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220424655 -COVID-19 VACCINE AD26.COV2.S- blood clot.The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
pt recvd vax; devel local rxn described as "cellulitis"manifested by an area of erythema,induration, warmth & itching;tx:keflex & atarax; rxn resolved w/ several days;
On 9-16-09 clients aunt called clinic @ approx 16:30 stated client was c/o "abd. pain & discomfort."  Stated "she was feeling "pukey".  Denied fever.  Advised to go to urgent care or ER.
Extremely cold, shivering, fast hear rate, fatigue, sleepiness, injection site redness.
Patient received 15mo vaccines (Dtap, Hib, PCV) on 3/26/14.  That night, he had a 2 minute generalized tonic clonic seizure at home.  Was seen in the local ER where he was noted to have a fever of 100.4. Rapid flu, rapid strap, and rapid RSV were negative.  CXR showed possible pneumonia, so he was given a dose of Rocephin and prescribed Augmentin (which mom did not fill that night).  Discharged home and around 5am he had another 2 min. generalized tonic clonic seizure.  Returned to the ER where he was noted to have a fever to 103. Lumbar puncture was performed and was negative for meningitis.  He was transferred to another hospital for observation.  He continued to have fevers while we observed him and also developed watery diarrhea.  He was discharged home on 3/28 since he was at his neurologic baseline and was eating/drinking well. Repeat CXR here was negative for pneumonia, so we did not continue antibiotics.
Received vaccine on 1-24-18 and tolerated them well. Through the night, his arm began to get edematous and erythematous. He showed this to the school nurse 1-26-18 and she called his parents.  Started on BENADRYL and prednisone with warm compresses to affected area. Seen again in office on 1-29-18 with area showing much improvement.
Systemic: Dizziness / Lightheadness-Mild, Systemic: fainted immediately awoke-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: fainted but immediately awoke, some vomiting, she said she has passed out while getting blood draws.
Information has been received from a health professional concerning a 23 year old female who was vaccinated with a second dose of Gardasil (date unspecified). Subsequently, one week following the injection, the patient developed a bump at the injection site. It was reported that the patient had no adverse events following the first dose of Gardasil (date unspecified). Additional information has been requested.
This spontaneous report was received from a medical assistant via company representative regarding a 21-year-old female patient. The patient's relevant medical history, current conditions, drug allergies and concomitant medications were not reported. On an unknown date in April 2019, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, frequency, route, lot# and expiry date were unknown) for prophylaxis. On an unknown date in April 2019 (reported as "a day or two ago"), the patient experienced syncope following second dose of GARDASIL 9 and fell. The outcome of the events was unknown. Causality assessment was not reported. There was no product quality complaint (PQC) involved. Upon internal review, syncope was determined to be medically significant.
7/13/10 5 hours after PCV 13 was administered was very fussy, crying, no fever at that time, seen at ER, on 7/14/10 seen at office, baby still not himself, better, fever 101.2 degrees F (R).
Received 4/22/10 - first of series - not certain when itching began - but yesterday 4/27/10 became very uncomfortable with itching/rash over entire body. No difficulty breathing.
Chest pain. Chest pain when breathing. Chest pain that coincided with heart beat. Pressure in chest. Chest pain when laying down.
I had ligament repair surgery on my right ankle on 01/06/2021.  My recovery was going well.  I was walking well without pain and was gaining balance and strength with physical therapy.  I had almost no discomfort at the site of my surgery.  Three days after having my J&J vaccination I woke up to a lot of discomfort in my right ankle, making it difficult for me to walk as I had been able to walk.  I have struggled over the last six days to get back to the mobility I had prior to getting my J&J vaccination.  I spoke with representative from my orthopedic surgeon?s office this morning who confirmed that I am most likely suffering from the side effects of the J&J vaccination, and she suggested that my lack of normal mobility will most likely last another week.
Dizziness, nausea, clamminess after ~15-20 minutes. Patient laid down with feet elevated. Dizziness, nausea went away after 10 minutes of laying down. Patient started to feel cold, had shivers, and complained of heart palpitations or heart feeling like it was skipping a beat.
PATIENT REPORTED A SEISURE INCIDENT AFTER RECEIVING PFIZER COVID VACCINE
he lost 18 pounds; back problem; thought the pain from arthritis increased from his ankles to his neck after first dose; muscle pain for a little over three weeks; Not sleeping; Not eating; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not sleeping), EATING DISORDER (Not eating), WEIGHT DECREASED (he lost 18 pounds), BACK PAIN (back problem) and ARTHRITIS (thought the pain from arthritis increased from his ankles to his neck after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizures (Hasn't had a seizure in ten years while on medication) and Arthritis. Concomitant products included SODIUM CHLORIDE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (Not sleeping). 02-Mar-2021, the patient experienced EATING DISORDER (Not eating). On an unknown date, the patient experienced WEIGHT DECREASED (he lost 18 pounds), BACK PAIN (back problem), ARTHRITIS (thought the pain from arthritis increased from his ankles to his neck after first dose) and MYALGIA (muscle pain for a little over three weeks). The patient was treated with IBUPROFEN (oral) at a dose of unknown and PARACETAMOL (TYLENOL) (oral) at a dose of unknown. At the time of the report, INSOMNIA (Not sleeping), EATING DISORDER (Not eating), WEIGHT DECREASED (he lost 18 pounds), ARTHRITIS (thought the pain from arthritis increased from his ankles to his neck after first dose) and MYALGIA (muscle pain for a little over three weeks) had resolved and BACK PAIN (back problem) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Unspecified concomitant medications for control of high blood pressure, pulse rate, seizures, allergies, itching, temper, and an antacid, were reported.   This case was linked to MOD-2021-046048, MOD-2021-026103 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU contains AE outcome , events added.
PT STATES:  "AFTER FLU SHOT MY BODY WAS WEAK AND I WAS DRAGGING FOR 2 DAYS'. 12/9/2005 PT WENT FOR SONOGRAM M D AND FOUND NO HEARTBEAT OF FETUS.
pt vax 2nd hepta B. pt ex shortness of breath, chills, fever, disorientation, and weakness. pt seen in er.
Started 9-10h after injection. Redness, swelling, pain, itching at site of injection. Continued to grow 41 h after injection (without treatment). At 41 h. initiated BENADRYL, ibuprofen & ice, topical hydrocortisone.
Edematous, red, itchy rash all over body.  It started on my face and bilateral arms and then went to my neck, torso and legs.
Developed shingles about week after taking second shot; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Jun2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history stated that the patient was a thyroid cancer survivor- removed. The patient had no known allergies. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, the patient developed shingles about week after taking second shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event developed shingles about week after taking second shot was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed angioedema of lips and mouth ~60 hours after receiving the booster of Moderna Covid-19 vaccine. The initial concern was ACE inhibitor-induced angioedema, and lisinopril was promptly discontinued. He continued to experience relatively minor episodes of angioedema every few days. Further lab evaluation diagnosed low level beef and pork IgE, and so all red meat was eliminated from his diet, as well as aspirin and other NSAIDs. He has continued to experience intermittent lip swelling, and now urticaria, every few days despite these medication and dietary restrictions. He reports a total of 6 episodes of lip swelling and 4 separate episodes of urticaria since receiving the vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 24Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 01Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FK9896) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "high cholesterol" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "history of respiratory infections" (unspecified if ongoing), notes: history of respiratory infections; "Known allergies: allergic to dust" (unspecified if ongoing), notes: Known allergies: allergic to dust; "ACE inhibitors" (unspecified if ongoing), notes: Known allergies: ACE inhibitors. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Negative, notes: 14Jul & 15Jul Neg Antigen Test; (15Jul2022) Negative, notes: 14Jul & 15Jul Neg Antigen Test; (Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: other medication in 2weeks product Metformin ER 500, Losartan 100 MG, Amlodipine 5 MG, Atorvastatin 40 MG. Anti viral details product COVID 19 Treatment, Paxlovid, treatment start date 08Jul2022 and stop date 13Jul2022, lot number GA8853, Indication for Treatment of COVID-19. COVID19 relapse after Paxlovid treatment. 08Jul-13Jul Paxlovid treatment 14Jul & 15Jul Neg Antigen Test; 16Jul slight sore throat 17Jul (evening) sore throat, runny nose 18Jul fatigue, sore throat, runny nose, cough, Test Positive.  No follow-up attempts are possible. No further information is expected.
Approximately 24 minutes after receiving the vaccine, the patient reported a sharp pain in her head and dizziness.  B/P 145/90, HR 77, O2 Sat. 99%.  She was monitored by one of our RN's for an additional 15 minutes.  At 1030, patient stated she wanted to return to work.  RN advised patient to return if she feels worse during the day.  Patient voiced understanding.
Client passed out and had seizure like activity when getting into the car. No fall or injury. Mother walked to client back to the Health Department at 1420. His color was greenish but client was alert and oriented. Given water and crackers and laid on the exam table for 15 minutes without further incident.
later in day notice arm was red and hot, redness was down to her elbow, iced it and took motrin, unable to move arm mo0nday night and Tuesday.
felt as sick; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (reported for a patient). A 5-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and experienced no adverse event. On an unspecified date, the patient experienced felt as sick. It was reported by the reporter that two people that she knows got their first dose of the Pfizer BioNTech Covid 19 vaccine and were fine, but after their second doses, they said they felt as sick as they did when they had COVID (prior to vaccination). They both recovered Both female, one about 20 years old (college student who lived with her grandparents), one in her 40's. She asked if we could explain why they were that sick, and if they get the booster dose, will they get as sick again. The outcome of the event was reported as resolved on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101224549 same reporter/drug/AE, different patients
This spontaneous report was received from a pharmacist, referring to a male patient of unknown age. The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. His concomitant therapies included Hepatitis A vaccine inact, Hepatitis B vaccine rhbsag (yeast) (TWINRIX) (administered on the same dates as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)). On 22-OCT-2021, he was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, route of administration, lot number and expiration date were not provided). Then, on 29-NOV-2021 (also reported as today), he was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 2 (inappropriate schedule of product administration). No other events were reported by the pharmacist. The outcome of the event was unknown.
aches; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PAIN (aches) and FATIGUE (fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PAIN (aches) and FATIGUE (fatigue). At the time of the report, PAIN (aches) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported   This case was linked to MOD-2021-329558 (Patient Link).
Patient reported continuous headache since vaccine administration (6 days ago) but without leg pain, shortness of breath, or abdominal pain. Patient reports having the occasional headache in the past, but none lasting this long. Advised patient to follow up with primary care provider given prolonged duration of headache.
Within 24 hours I had sore arm and fatigue and a slight headache. The next morning, I had a spot right over the injection spot. I had a swelling in my throat.
Initial report received from a pharmacist on 15 Jan 2010: The patient was vaccinated with FLUVIRIN (batch: 104045P1) 0.5 ml once, intramuscular, stored at temperatures as low as 34 F and 35 F  on an unspecified date. No adverse event was reported.
20SEP95 approx 9AM pt recvd vax & exp mil convuls lasting 2-3mins all extremities jerked for short period of time;reporter felt it was an anxiety attack
Vaccine given on 9/29, and next day awoke with hives on lower back, forearms, and ankles. 10/2/12 - Hives fading. No new ones. Patient has been taking BENADRYL 50mg twice daily.
10/07/21: Patient reports fever (Over 100 degrees F) 10/08/21: Patient calls primary care office and reports swollen throat, headache, swelling of the upper neck area to shoulder. Patient is seen same day by primary care provider. At visit, patient states she felt fine this morning but suddenly noted feeling heart racing and pain in the neck/shoulder area on the right side. Obtained upper extremity venous doppler and confirmed patient has large subclavian vein DVT. Started patient on apixaban 10 mg BID for 7 days then 5 mg BID thereafter. Plan to likely treat for 6 months. Urgent referral placed to vascular surgery same day and appointment made for 10/15/21.