chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic seizure; HR 116/ HR 114; HR 56; RR 30; BP of 141/46; This is a spontaneous report from a contactable nurse. An 18-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0170), intramuscular, administered in the right arm on 20Apr2021 at 12:45 as a single dose for COVID-19 immunization.  Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported.  The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks. The patient had not been tested for COVID post vaccination. On 20Apr2021 at 12:45, the patient and her father moved into the waiting area with vehicle. According to the patient's dad, the patient began seizing in the car one minute after the vaccine administration. The dad called out to waiting area monitor. At 12:57 the patient was visibly having tonic clonic seizure and was administered with EpiPen in the right Leg. 911 was called. The patient stopped seizing and was awake and confused. She then became AOx4 (oriented to four spheres; time/place/person/situation). The patient visibly distressed and hyperventilating. At 12:59 the patient had tonic clonic movements and seizure again. The seizure lasted less than 15 seconds. The patient then became AOx4 again, distressed, and became nauseous. Heart rate (HR) was 56 and SpO2 was 98%.  At 13:00 the patient vomited while sitting up. The patient was still distressed and hyperventilating with respiratory rate (RR) of 30. The patient's post vomiting HR was 116 and SpO2 was 97%. The patient moved to a stretcher and moved to the shade. At 13:06 firefighters arrived and the patient had an HR of 114, BP of 141/46, SpO2 of 97%, RR 24 and AOx4. At 13:12 the ambulance arrived and the patient was taken to (Place). The events resulted in a visit to the Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the available information, and on close temporal association, a reasonable possibility cannot be excluded that the suspect drug BNT162B2 (Pfizer-BioNTech COVID-19 vaccine)  contributed to the occurrence of the serious event Generalised tonic-clonic seizure. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient received the flu immunization and then we proceeded over to the register to pick-up prescriptions.  The pharmacist was reveiwing the patients profile and when he looked up the patient was laying on the floor.  The pharmacist came around the counter and the patient was awake and alert.   The pharmacist elevated the patient's feet and had the patient lay on the floor for a few minutes prior to the patient standing up.  The patient did self report that he has fainted in the past and was operating on 3 hours of sleep from the night before.
Pt. Reports nausea, seconds after receiving vaccine. Pt. Reports the same thing happened when she had her 1st dose, but feels more severe this time.  VS- 130/85, O2-98%, HR 104, Resp. 20. Pt. Began hyperventilating, O2 down to 88%. Patient instructed on deep breathing, Resp. Down to 20, O2 back to 96-98%. EMS called, pt. Wheeled to outdoors for EMS assessment and EMS transport to ED. At time of transfer to hospital pt. States that symptoms had subsided, other than ?chills?, which she attributed to being cold.
Within 5 mins of 1/2 dose booster (0.25ml) IM injection, he started having vomiting. About 2-5 min later, reported lower lip numbness. He was given oral benedryl and EMS was notified. He left our unit by 10:40am in stable condition without worsening of symptoms. No rash or facial swelling.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unspecified date in 2008, the patient was vaccinated with the first dose of GARDASIL (lot# and exp date not provided) (dose, route not reported), on an unknown date in 2011 the patient was vaccinated with a second dose of GARDASIL (lot# and exp date not provided) (dose, route not reported) and on 26-MAR-2013 the patient was vaccinated with the third dose of GARDASIL (lot# and exp date not provided) (dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. Additional information has been requested.
Her and her father were shopping in front of the pharmacy and she fainted about 5 minutes after administration.  She regained consciousness in about 30 seconds, slowly.  EMS came to scene, assessed her, and she refused further treatment.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# reported as M017518, expiration date: 11-DEC-2017 (dose was not provided). The vaccine was exposed to temperature below 32 degrees Fahrenheit (0 degrees Celsius), the lowest temperature was minus 40 degrees Fahrenheit for 1 cycle. The vaccine was exposed to incorrect temperature for 6 days 23 hours and 30 minutes. Digital data logger was involved and there was no previous temperature excursion. No adverse effects were reported. Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002783: US-009507513-1701USA011637: US-009507513-1702USA002782:
Tip of fingers in both hands became shriveled and partially insensitive, skin peeled; Tip of fingers in both hands became shriveled and partially insensitive, skin peeled; Tip of fingers in both hands became shriveled and partially insensitive, skin peeled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 18:00 as dose 1, single (Lot number: hg9497) at the age of 61 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "none outside moderate high blood pressure and triglycerides" (unspecified if ongoing), notes: none outside moderate high blood pressure and triglycerides; "none outside moderate high blood pressure and triglycerides" (unspecified if ongoing), notes: none outside moderate high blood pressure and triglycerides. Concomitant medication(s) included: AMLODIPINE BENAZEPRIL; ROSUVASTATIN. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious), SKIN EXFOLIATION (non-serious), DRY SKIN (non-serious) all with onset 03Nov2023, outcome "not recovered" and all described as "Tip of fingers in both hands became shriveled and partially insensitive, skin peeled". Therapeutic measures were not taken as a result of hypoaesthesia, skin exfoliation, dry skin.  Addition information: The most recent COVID-19 vaccine was administered on pharmacy or drug Store. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Impossible to know if caused by the vaccine, but never had this before. Tip of fingers in both hands became shriveled and partially insensitive, skin peeled. Started exactly one week after the vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Pt admitted to Emergency department with inability urinate, dysuria and hematuria urea. Symptoms of Covid have ended pt positive on 12/20
Redness around injection site approximately 1.5 x 2 inches. No pain or fever noted. MD prescribed 3mL Diphenhydramine HCL.
respiratory issue; Diarrhea; headache; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 30Apr2021 as DOSE NUMBER UNKNOWN SINGLE for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced respiratory issue, diarrhea and headache on an unspecified date. It was further stated that "He developed headache and respiratory issue during the 1st day - Diarrhea for 3 days now - He wants to know how long the symptoms usually last - Patient was in a hurry, he was not able to specify if the Pfizer shot that he got was the 1st or the 2nd dose - While confirming the spelling of his name he stopped and mentioned that he will just call again because he needs to answer another phone call". The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Soreness at the site injection,; fatigue; chills; body aches; stomach pains; headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 09:45am (at the age of 43 years) as a single dose for COVID-19 immunisation. Medical history was not reported. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 22Feb2021 at 14:30 as a single dose for COVID-19 immunisation. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received any other medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not have any known allergies to medications, food, or other products at the time of the report. On 16Mar2021, the patient experienced soreness at the site injection (vaccination site pain), fatigue, chills, and body aches, (about 12 hours after receiving the vaccine) and stomach pains and headache. She also had stomach pains and a headache that lasted for about a day and a half. The patient did not receive treatment for the events. The clinical outcome of the events, vaccination site pain, fatigue, chills, body aches, stomach pains and headache were resolved at an unknown date. No follow-up attempts are needed. No further information is expected.
screamed & cried all noc, didn't hardly sleep at all, t103 R;
Headache fatigue, chills, decreases pulse oxygen Narrative:  symptoms lasted 48 hours  Other Relevant History:
He received the 2nd dose of the Moderna shot on 3/10/21. Within the following week he developed an itchy, painful maculopapular rash of both forearms. Patient continued to have the symptoms on 4/2/21--despite trying aveeno lotion and benadryl--at which time at his clinic visit he was prescribed triamcinolone cream for his arms.
severe muscle aches/pain Severe joint pain- unable to get OOB the 2 nd day after being vaccinated Old injury pain- fx Left wrist- Left knee pulled tendon
Swollen sore arm at injection site. 6 days after injection; Swollen sore arm at injection site. 6 days after injection; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 07Mar2021 at 14:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The medical history included diaverticulosus and osteoporosis. 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. The concomitant medications included pantoprazole (PANTOPRAZOL), colecalciferol (VITAMIN D3), alendronate sodium (FOSAMAX) and Multivitamin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPRIN) and experienced drug allergy. On 13Mar2021 at 21:00, 6 days after injection, the patient experienced swollen sore arm at injection site. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen sore arm at injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Dose #1 was 12/30/2020, dose #2 was 1/20/2021. Pt presented with petechiae on legs and headache x 1 day. She had labs drawn that showed platelet level 2 x10^3/uL. She was sent to the ER and hospitalized for management. Was admitted at hospital.
Extreme allergic reaction for 5 days, all over body hives, some several inches wide, extremely itchy. Treated with oral steroids and antihistamines
pt recvd vax 23SEP95 & 2OCT95 exp h/a, crying, dec oral intake, loss of recognition & unaware of things going on around him;same day devel progressive changes in mental status;self-mutilating behavior;choreiform movements;encephalopathy;
- 6 mo old female was walked in for 6mo vaccines, Pediarix #3, PCV#3, influenza #1 and Rotateq #3 were required. Pt had already completed their 6 mo well visit  previously. Staff contacted me approx 15 min after vaccine given and stated that pt was having a localized reaction at the injection site of  the Pediarix vaccine on the L thigh. Exam showed erythema with several wheals grouped around and extending out from injection site. Pt was calm and not in acute distress. mild erythema seen at injection sites on the R thigh but no hives. No edema of leg or feet , no drooling or wheezing. Vitals and wt were immediately obtained. Vital were in normal range. weight verified and a dose of benadryl (3.5 ml ) given orally at 1542 by Nurse given and tolerated well. Pt remained stable and w/o progression of urticarial lesions or other reactions following administration of the benadryl. 20 min after benadryl given hives were resolved and pt doing well. Lungs CTA, HR RRR and normal cap refill and no edema. Pt was observed for 45 min after benadryl given and was able to discharge home . Education regarding allergic reactions d/w parent. If additional hives start in the next 24hrs oral benadryl can be given, s/s of progressing and serious allergic reactions reviewed with parent and instructions to RT ER given to parent. Pt is considered allergic to Pediarix vaccine now and information relayed to mom.
Injection site pain; Tiredness; This is a spontaneous report received from a non-contactable non-healthcare Professional. A female patient of an unspecified age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced injection site pain and tiredness on an unknown date. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of events injection site pain and tiredness was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previous information: Amendment of patient information as Patient's country added.
SWELLING OF WRISTS; HAND/FEET SWELLING/PERIPHERY SWELLING; UNEVALUABLE EVENT/LONG HAULERS SYNDROME; DYSPNOEA/WINDED WITH TALKING OR WALKING; INFLAMMATION; WRIST PAIN; PAIN OF EXTREMITIES/HAND AND FEET PAIN; SUSPECTED COVID 19; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On DEC-2020, the subject experienced suspected covid 19. On an unspecified date, the subject experienced swelling of wrists, hand/feet swelling/periphery swelling, unevaluable event/long haulers syndrome, dyspnoea/winded with talking or walking, inflammation, wrist pain, and pain of extremities/hand and feet pain. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) inflammation in long, Echocardiogram (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of wrists, hand/feet swelling/periphery swelling, wrist pain, and unevaluable event/long haulers syndrome, and the outcome of suspected covid 19, pain of extremities/hand and feet pain, dyspnoea/winded with talking or walking and inflammation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Patient and her husband received the third full dose of 100mcg and are not immunocompromised; had fatigue; left arm was really hurting; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (Patient and her husband received the third full dose of 100mcg and are not immunocompromised), FATIGUE (had fatigue) and VACCINATION SITE PAIN (left arm was really hurting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 04-Oct-2021, the patient experienced OVERDOSE (Patient and her husband received the third full dose of 100mcg and are not immunocompromised), FATIGUE (had fatigue) and VACCINATION SITE PAIN (left arm was really hurting). At the time of the report, OVERDOSE (Patient and her husband received the third full dose of 100mcg and are not immunocompromised), FATIGUE (had fatigue) and VACCINATION SITE PAIN (left arm was really hurting) outcome was unknown.            Treatment details was not reported by the reporter.   This case was linked to MOD-2022-570966, MOD-2022-570982, MOD-2022-571007 (Patient Link).
The next morning, I suffered extreme chest pain, shortness of breath,  heart palpitations.
Local tenderness, swelling, redness. Fever 103F, general malaise, myalgia.
Report received from a paramedic/fire fighter on 05-Nov-2008.  Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise).  One (1) out of the four (4) experienced chest congestion (200914610).  All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008).  As of 05-Nov-2008, all symptoms are milder for all patients.  No patients went to the emergency room.  (See cases 200914591, 200914608, and 200914610).  Several attempts have been made to the reporter to confirm and verify the number of patients involved.  To date, reporter has not provided a response.  Patient outcome is unknown.  No further information is expected.  The manufacturer considered causality possible in relation to the administration of AFLURIA.  Information derived from this ADR report does not change the current safety profile of the product.
Pain in my left arm, not only after the shot, but it still persists today. On August 17th, I was rushed to hospital for heart palpitations after an EKG. While at the hospital, it was concluded that there was nothing wrong with my heart, and they could not pinpoint what was causing my heart to palpitate and cause pain to shoot down my left arm.
Bilateral subcutaneous swelling in each arm that has persisted for 1 month following vaccine (had doses in separate arms and nodules developed after each vaccine)
Headache, Myalgia, Fever, NauseaVomiting, post-injection inflammation, lymphadenopathy Narrative:
Patient reports at 10pm having severe nausea, weakness, dizziness. Difficulty standing.
After recieving the second dose of Pfizer-BioNtech COVID-19 vaccine 48 hours ago; My sensitivity to test and smell has significantly decreased. I still cannot smell food or other scents from a distanc; I cannot taste the food as well as before the vaccination; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 24-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration on Arm Right on 04Feb2021 10:30AM at single dose for COVID-19 immunization. The patient Medical history included patient cannot taste the food before vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies. The patient's concomitant medications were not reported. The Patient did not receive other vaccines in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3248) via an unspecified route of administration on Arm Right on 14Jan2021 05:30 PM at single dose for COVID-19 immunization. On 05Feb2021 09:00AM, after receiving the second dose of pfizer-biontech covid-19 vaccine 48 hours ago; the patient experienced sensitivity to test and smell has significantly decreased and still cannot smell food or other scents from a distance and have to smell up close. Patient cannot taste the food as well as before the vaccination. The patient did not receive any treatment for the events. The Outcome of the events was recovering.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
I became nauseous the next day and started coughing again. I called my Dr. this time and he prescribed prednisone again. I've been taking prednisone after each vaccine because I always start constantly coughing.