chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 5 hours following Pfizer injection her heart beat was rapid and the right half of her tongue was swollen and red.  No other symptoms, resolved without treatment 3 hours later.   She notified her physician who recommended not taking the 2nd dose.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6201), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. No allergies were reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 25Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2022) Positive; (03Oct2022) Negative. Therapeutic measures were taken as a result of covid-19, vaccination failure.
patient received flu vaccine on 9/17/2021 - she called in 3 weeks later (10/12) stating she was having increased pain in this arm with any type of movement.  On 10/14 she was seen in the office for right shoulder pain and a STAT US of shoulder was ordered with Prednisone and Voltaren Gel. She is scheduled in the office again today for the pain and to review US results.
Patient received 3rd COVID vaccine 4 weeks after 2nd dose. Which was too early.
Narrative: COVID infection following COVID vaccine series 07/13, Pfizer, dose #1 08/09, Pfizer, dose #2 08/12 COVID swab, result: detected 08/12 pt cc: cough, fatigue, fever, headache, loss of taste or smell, Myalgias, rhinorrhea, sore throat vomiting, dyspnea exposure: unknown
parents noticed pt looked funny breathing irregular; picked up, noticed hands & feet bluish legs mottled, hands "shakey"; took to urgent care, sx subsided w/in a few mins; t101;
swelling of lower extreeites bilaterally. pt states had facial swelling with flu, associates leg swelling with recent Hep A injection
canker sore (started 5/24/21)-lasted for about a week or two loss of taste and smell, coughing, tiredness (started 5/26/21)-as of 7/27/21 has not regained 100 percent sense of smell yet shooting nerve pain similar to shingles affecting right lower side  back of head (5/28/21-6/1/21) -started taking ibuprofen on 5/28 for pain
Dizziness with Pfizer-BioNTech COVID-19 vaccine second dose 0.3 mL IM in right deltoid.  Called RRT. Obtained vitals, which were stable. After monitoring, patient released without treatment.
Information has been received from a respiratory therapist concerning a female age not provided, who on 11/9/05 was vaccinated IM into the left arm with 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). The patient also received influenza virus vaccine unspecified on the opposite arm. On approximately 11/9/05, the patient developed hot, painful and swelling about size of half dollar at injection site. The physician ordered 50mg of diphenhydramine hydrochloride Benadryl PO and 30 mg prednisone for three days. The patient was reported as recovered. Hot, painful and swollen injection site was considered to be an other important medical event by the reporting respiratory therapist (OMIC). There was no product quality complaint involved. Additional information is not expected.
pain in her arm (injection site); This is a spontaneous report from a contactable consumer received via Medical Information Team.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced pain in her arm (injection site) on an unspecified date. The patient outcome of the event was unknown.    Information on Lot/Batch has been requested.
Pfizer on 2/8 and 3/1. Positive on 9/8 admitted 9/7 to current
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 35-year-old female patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 18th August 2022, the patient received Havrix. On 18th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: The health care professional reported that a patient received Havrix and was expired on 9th August 2022.  The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix on the day of reporting, which led to expired vaccine used.
Extremely puffy upper and lower eyelids (eyelid edema). Still hasn?t gone down weeks later.
limited movement of arm, pain, swelling and bumps in the muscles and surrounding area. stabbing pain from time to time.  Unable to fall asleep to right side and limited motion .
Systemic: Dizziness / Lightheadness-Mild, Systemic: Unilateral pitting edema/swelling of calf+ankle & bruising-Medium, Additional Details: Referred to closest urgent care
Information has been received from a nurse concerning a female who on 17-OCT-2007 was vaccinated with ZOSTAVAX 0.65 mL. Other concomitant vaccines included influenza virus vaccine (unspecified) and PNEUMOVAX. On 17-OCT-2007 the patient experienced pain and a lot of swelling at injections site, fever and loss of appetite. Therapy with ZOSTAVAX was discontinued. The patient's pain injection site and swelling at injection site and fever and loss of appetite persisted. The patient sought unspecified medical attention. Additional information has been requested.
Half dollar sized rash and swelling at injection site. Patient was told to report back if it hasn't improved in one week.
sore arm; Quite  sick; dizzy/woozy but doesn't fall down; diarrhea; complaint of general weakness; nauseated; feeling tired the night of vaccination; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (Quite  sick), DIZZINESS (dizzy/woozy but doesn't fall down), DIARRHOEA (diarrhea) and ASTHENIA (complaint of general weakness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (Quite  sick), DIZZINESS (dizzy/woozy but doesn't fall down), DIARRHOEA (diarrhea), ASTHENIA (complaint of general weakness), NAUSEA (nauseated) and FATIGUE (feeling tired the night of vaccination). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (Quite  sick), DIZZINESS (dizzy/woozy but doesn't fall down), DIARRHOEA (diarrhea), ASTHENIA (complaint of general weakness), NAUSEA (nauseated) and FATIGUE (feeling tired the night of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 25-JUN-2021, added patient details.
I got COVID-19 on 4/27/22.  Stuffy nose, fever, headache and sore throat. Saw doctor same day and confirmed positive test. Was given antibody medication.
Nose bleed on 03/26 and on 03/29 when waking up in the am.
he was in and out like faint, like he would go in and out and faint out and faint in; Coughing; Confusion; his appetite was poor; he was too sick.; This is a spontaneous report from contactable nurse (Patient's wife). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 69-year-old on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were none. The reporter said that her husband was having coughing, confusion, he was in and out like faint, like he would go in and out and faint out and faint in and his appetite was poor. Inquired for when these began and she states right after he took the COVID vaccine. She thinks that it was serious because before they got this they didn't have that. Inquired if her husband's side effects are still ongoing and she states yes, he was definitely still experiencing some. She said no not anything really but he was just confused and he was sometimes confused with the medicine and maybe a little down. Reporter confirmed and clarified that these were experienced after her husband had the Pfizer COVID vaccine. She stated that she found a card and it said when to get the 2nd dose but it has (withheld) on there with the COVID 19 and a date. Inquired if there was an NDC, lot number or expiry date on that card and she said that all there was # and 26Nov2021 for when he was supposed to get the 2nd dose he hadn't gotten the 2nd dose because he was too sick. The outcome of events was not recovered. Event relatedness was reported as COVID vaccine was related to event "he was in and out like faint, like he would go in and out and faint out and faint in" and "his appetite was poor".  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "syncope" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.   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.
This spontaneous report received from a patient concerned an 84 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, administered on 22-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 84 years old. No concomitant medications were reported. On 2021, the patient experienced blue/petechiae spots on both feet, and swelling in both feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling in both feet, and had not recovered from blue/petechiae spots on both feet. This report was non-serious.
Outbreak of Shingles after first dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F33X, expiry date 11th December 2021) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. On 18th December 2019, 30 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 case details were reported as follows: All patient identifiers were given as well as Batch number and expiration date. The patient received Shingrix and developed an outbreak of Shingles. The reporter consented to follow up.
Got shots just after 9 AM. Left office 930. Eyes itchy, throat scratchy 10-1030. She called office. Reported face swelling. Got to ER 1147 and treated anaphylaxis with angioedema. Left arm swelled.   7/29/09 Hospital ER records DOS 7/22/09. Assessment: Acute Anaphylaxis Patient presents with lips swelling, eyes and throat itching. Redness to eyes. Moderate distress. Mild respiratory distress. Trouble swallowing. Wheezing. Angioedema - facial, pharynx. Skin rash, erythema.  7/29/09 Hospital admission record DOS 7/22/09. Assessment: Allergic Reaction. ICD-9 Codes: 995.0  995.3  786.50
This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of 0.5 ml GARDASIL, lot number was not reported. No concomitant medications were reported. On an unknown date, the patient after getting GARDASIL had a positive pap smear. Treatment information was not reported. Additional information has been requested.
Myalgia flu-like symptoms Per supervisor report [2/13]: "received second dose on Tuesday 2/9/2021-reports muscle fatigue, flu like symptoms"
MAGNETS ARE STICKING TO ARM; This spontaneous report received from a consumer concerned a female of unspecified age. 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, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced magnets are sticking to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of magnets are sticking to arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210601258.
This spontaneous report as received from a pharmacist refers to an 87 year old female patient. On 12-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX, lot # J008432, expiry date 11-OCT-2014, 0.65 ml, subcutaneous. No concomitant medication, pertinent medical history, drug reactions or allergies were reported. On an unknown date in 2014, the patient developed a varicella like rash on her face. The rash was on one side of her face and continued up onto her scalp. She stated that the rash was vesicular, but did not report that it was painful. She told the pharmacist that the lesions had crusted over, and was beginning to heal. He stated that the patient had not seen a physician concerning this rash. No treatment was given for adverse event. The patient called the pharmacist to seek medical attention. No lab diagnostics studies were performed. The action taken of the therapy also reported as continued. Additional information has been requested.
Having redness, swelling and site of injection is warm to the touch still today 2/9 .. 2 days after injection.  Yesterday 2/8 I had flu like symptoms all day including hot flashes followed by cold sweats, body aches all over body and extreme fatigue.
Information has been received from a physician concerning a 5 month old female infant with no known allergies or pertinent medical history who on 05-AUG-2008 was vaccinated orally with a second 2ml dose of ROTATEQ (lot # 660684/0301X). The first dose of ROTATEQ was given on 30-APR-2008. There was no concomitant medication. Subsequently, on 11-AUG-2008 the patient experienced bloody diarrhea and fever. The patient was seen by the physician and hospitalized. The patient had stool cultures, rotavirus screening, guaiac test, CBC and an abdominal ultrasound performed. The results were not reported. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. The reporting physician considered the event to be immediately life-threatening. A lot check has been requested. Additional information has been requested.
Child had a rash all over body; Lasted about 1 wk states mom did not see MD; Felt warm did not check temp;
Patient called into clinic to report symptoms of joint aches, hurt to touch body, nausea, vomiting, fever, chills, headache, sinus drainage, & cough. Pt was bedridden for 4 days per her report.
While I felt tired and fatigued for the past few days.  I went out for a run on New Years 2 days after the vaccine.  I kept it pretty light on NYE since I was around Kids.  I went for a run and my lungs and breathing was a bit labored.  On Jan 8th, I started feeling a pain in my arm.  I worked out and did some exercises basic arm circles and it helped to improve circulation.  The pain then traveled to my elbow.  That has disipated.  Now on Jan.10th my neck constantly feels strained.
blood clothing after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clothing after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clothing after getting the vaccine) (seriousness criteria disability and medically significant). The patient was treated with Surgery (hand amputation) for Thrombosis. At the time of the report, THROMBOSIS (blood clothing after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was reported.  Caller mentioned some local woman got her hand amputated from a blood clothing after getting the vaccine.  No other treatment medications were reported.  Company Comment: This spontaneous case concerns a female patient of unspecified age with no reported medical history, who experienced the unexpected, serious (medically significant, disability) AESI Thrombosis. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course was not provided in the case although the reporter mentioned hand amputation as result of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no reported medical history, who experienced the unexpected, serious (medically significant, disability) AESI Thrombosis. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course was not provided in the case although the reporter mentioned hand amputation as result of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
information has been received from a registered nurse concerning an adult make housekeeper who was in contact with an individual that was vaccinated with a dose of varicella virus vaccine live. The patient subsequently developed shingles. It was unknown if medical attention was sought. A product quality complaint was not involved. Additional information was received from the registered nurse who indicated that the adverse experience was reported by an employee who came in contact with a client/patient who received the varicella virus vaccine live. The employee was determined by the reporter's medical director to be not related. No further information is expected.
First dose - Got up with every joint aching in my body, as if I had the flu, along with terrible migraine and extremely tired.  Second dose - had the very same side effects as dose 1, slept many hours the next day.
migraines; nausea; vomiting; pressure around midchest area; feeling of fullness; dehydration; low grade fever; tiredness; lost 38 lbs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0162), via an unspecified route of administration, in arm left, on 12Apr2021 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included sleep apnoea, type 2 diabetes, high blood pressure, high cholesterol, depression from an unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6207), via an unspecified route of administration, in right arm, on 22Mar2021 as single dose for COVID-19 immunisation and reported tiredness. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient has been tested with covid-19. It was reported that on 17Apr2021, 5 days after 2nd dose, the patient had experienced severe migraines (which he never had before this), uncontrollable nausea and vomiting causing 2 ER visits due to dehydration; pressure around midchest area and feeling of fullness after eating a few bites of food; sought gastroenterologist help who suspects gastroparesis, low grade fever, tiredness on 15Apr2021 (3 days after injection) and lost 38 lbs on 13Apr2021. The patient reported that she was scheduled for additional gastrointestinal testing and lost 38 lbs between 13Apr - 1Jul not due to diet or exercise. The events lead to the emergency room and physician office visit. The patient underwent lab tests and procedures which included low grade fever: low on 15Apr2021 and COVID-19 NAT Nasal Swab test: negative on 01Jun2021. Therapeutic measures were taken as a result of dehydration, low grade fever, tiredness, migraines, nausea, vomiting, pressure around midchest area that included medications, IV fluids. The outcome of the events dehydration, low grade fever, tiredness, migraines, pressure around midchest area lost 38 lbs was reported as not resolved and the patient recovered from nausea and vomiting on 01Jul2021.
PER RN REPORT FROM RN:  AT 6:30PM, PATIENT WAS IN WAITING ROOM POST FLU VACCINE AND REPORTED HAVING A STIFF NECK WITH NUMB FEELING RUNNING UP BACK OF HEAD TO TOP OF HEAD. BROUGHT BACK INTO EXAM ROOM TO DO VITALS AND ASSESSMENT. BP 120/76 RA HR 71 SPAO2 98% ROOM AIR, DENIED CHEST PAIN OR DIFFICULTY IN BREATHING.  AFTER 5 MINUTES VITALS RECHECKED BP 138/80 RA HR 78 SPAO2 99% DENIED CP OR DIFFICULTY BREATHING, REPORTS STIFF NECK, NUMBNESS IN BACK IF HEAD TO TOP OF HEAD, NUMBNESS IN NECK.  PATIENT REPORTS SHE HAS A HISTORY OF NECK AND SHOULDER PROBLEMS, LAST SAW PHYSICAL THERAPY LAST WEEK FOR RIGHT SIDE OF NECK/SHOULDER SECONDARY TO RIGHT NECK/SHOULDER INJURY IN AUGUST 2021.  AFTER 5 MINUTES VITALS RECHECKED BP 126/80 HR 72, SPAO2 98%. REPORTS STIFF NECK, NUMBNESS IN BACK OF HEAD, DENIES CHEST PAIN AND DIFFICULTY BREATHING, NO NUMBNESS IN THROAT/NECK.  AS OF 6:45PM PATIENT REPORTS SYMPTOMS SIGNIFICANTLY IMPROVED AND IS NO LONGER EXPERIENCING SYMPTOMS. PATIENT OFFERED EDUCATION REGARDING TYPICAL REACTIONS TO VACCINATION, CRITERIA TO SEEK HIGHER LEVEL OF CARE EMS. PLAN MADE WITH PATIENT TO FOLLOW UP AT A HIGHER LEVEL OF CARE IF SYMPTOMS RETURN.  AT THIS POINT THIS PATIENT WAS RE-EVALUATED BY REPORTER AND WAS DETERMINED TO BE STABLE AND DISCHARGED HOME.
Pt had severe headache and vomiting 40 mins after injection. Followed by facial swelling, dizziness, and petechial rash to face and chest. Pt was treated in ER with iv fluids, toradol and reglan IV.