chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body Aches; Rash; This is a spontaneous report from a contactable other HCP (patient). A 70-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9264), via an unspecified route of administration, administrated in Right arm, on 11Feb2021 10:00 (age at the time of vaccination 70-years-old) as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EJ3302), via an unspecified route of administration, administrated in Right arm, on 18Jan2021 10:00 (age at the time of vaccination 70-years-old) as a single dose for COVID-19 immunization. The patient's medical history included hypertension and diabetic. The patient's concomitant medications included Diabetic Medicine. Patient had no known allergies. On 13Feb2021 08:00, the patient experienced Body Aches, and Rash. Treatment was received as a result of adverse events was unknown. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Fever of 100°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100°F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048U(Y)21A and 077CZ1B) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Fever of 100°F). At the time of the report, PYREXIA (Fever of 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 100 (High) Fever of 100°F.         No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-389187 (Patient Link).
Pt is experiencing muscle pain and states he had a fever for first few nights. His arm is tender and red.
5 y.o. male experienced a seizure while asleep 10 hours after 2nd vaccine administration. No patient or family history of seizure conditions. Child was unresponsive for 1-3 minutes with eyes open and fixed, mouth open, arms and legs extended and muscles rigid and twitching. Seizure ended and child became responsive and alert. Child was able to go back to sleep. Lethargic and fatigued  the following morning.
Information has been received from a physician concerning a female patient who was vaccinated with a complete series of GARDASIL. It was reported that the patient now tested positive from atypical squamous changes and HPV. They were negative before beginning the vaccination series. The patient's are being treated with boric acid. At the time of reporting the patient had not recovered. Additional information has been requested.
Pt developed redness/soreness/swelling to left deltoid on 9/5/20.  Pt c/o hard lump at injection sites.
Hep A #2 given IM-RT, Varicella #2 given SQ-back of RT-Mother noted golf ball size-red hard swelling at back of RT on 2-11-15.
Pt vax w/ 1st hepta B; exp pain on entire rt side of body.  No rx.
chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US179395_NS.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 10Aug2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6/11/18 Pt has rash on chest and then to arms, legs, thighs, is painful, itchy, and left wasn't painful.
large area of erythema and mild swelling measuring 26 cm x 28 cm affecting the left upper arm which is where the injection was located (left deltoid is where the injection occurred).  Itching noted.  No pain, no induration.  No systemic symptoms, angioedema, or shortness of breath.  I advised use of a non-sedating antihistamine and gave her a prescription for topical triamcinolone.
Patient contracted COVID after being fully vaccinated. Patient has received first two COVID-19 Vaccines as well.  Pfizer Dose #1 2/9/2021: IM - Left Deltoid - EN5318 Pfizer Dose #2: 3/5/2021: IM - Left Deltoid - EN6199
I received my Covid-19 vaccine on 10/14/2022. On the Morning of 12/07/2022 I woke up and tested positive for Covid-19. I had cold symptoms and nasal congestion with sore throat. Symptoms lasted a few days.
Pt recv vax on 3/17/98; on 3/24/98 pt exp pruritic rash on lower legs w/ swelling, erythema, swollen/warm/macular erythematous rash on shins, tender elbow & left hand w/ swelling
generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Glucose 73; elevated CSF protein to 79, CSF Glucose 73; severe headache; confused; This is a spontaneous report from a contactable physician. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER COVID 19 VACCINE), intramuscular on 22Apr2021 09:30 (Batch/Lot number was not reported) at age of 47 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19. On Friday 23Apr2021, patient woke up with severe headache, per wife was confused. Then had a generalized convulsion. Presented to the ED, had a second seizure witnessed by medical staff. Workup with MRI, CTA and LP were notable for an elevated CSF protein to 79, CSF Glucose 73, otherwise no structural abnormality was identifed. Patient was clinically improving after being treated with seizure medications as of 26Apr2021. The adverse event result in Emergency room/department or urgent care, hospitalization. Covid 19 pcr nasal swab on 24Apr2021 was negative. Outcome of events was unknown.  Follow-up needed. Information about batch/lot number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event seizures, CSF glucose increased, CSF protein increased, headache, confusional state cannot be completely excluded.  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.
achy; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy) and HEADACHE (severe headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ANTIHYPERTENSIVES for Blood pressure abnormal, THYROID THERAPY for Thyroid function abnormal.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (achy) and HEADACHE (severe headache). At the time of the report, PAIN (achy) and HEADACHE (severe headache) had not resolved. Not Provided
Moderna COVID 19 Monovalent Vaccine EUA Pt had a baby boy. Infant was diagnosed with transposition of the great vessels.
Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseous. Didn't last long. Wiped my face and upper body with washcloth soaked in cool water for relief. Messaged my cardiologist and internist but haven't gotten response yet.
Nose bleed; Painful arm; Headache; Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 21-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 in the left arm on 16Jun2021 at 11:30 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included carbamazepine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), Montelukast sodium (SINGULAIR) and medroxyprogesterone acetate (DEPOPROVERA); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 27May2021 at 13:30 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. The patient previously took fluoxetine hydrochloride (PROZAC) and clonidine (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 17Jun2021 at 07:30, the patient experienced nose bleed, painful arm, headache, body aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nose bleed, painful arm, headache, body aches and fatigue were resolving at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No adverse event; Patients was given the Moderna pediatric dose instead of the bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients was given the Moderna pediatric dose instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patients was given the Moderna pediatric dose instead of the bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients was given the Moderna pediatric dose instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients was given the Moderna pediatric dose instead of the bivalent booster dose).    Concomitant medication was not reported.  It was reported by HCP that patient received Moderna pediatric dose instead of the bivalent booster dose. Treatment medication was not reported. No adverse event observed for patient.  This case contains information for the 1st of 16 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697907, MODERNATX, INC.-MOD-2023-697934, MODERNATX, INC.-MOD-2023-697960, MODERNATX, INC.-MOD-2023-697981, MODERNATX, INC.-MOD-2023-698005, MODERNATX, INC.-MOD-2023-698021, MODERNATX, INC.-MOD-2023-698029, MODERNATX, INC.-MOD-2023-698031, MODERNATX, INC.-MOD-2023-698045, MODERNATX, INC.-MOD-2023-698059, MODERNATX, INC.-MOD-2023-698062, MODERNATX, INC.-MOD-2023-698064, MODERNATX, INC.-MOD-2023-698073, MODERNATX, INC.-MOD-2023-698078, MODERNATX, INC.-MOD-2023-698039 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-697907:2 of 16 case MODERNATX, INC.-MOD-2023-697934:3 of 16 case MODERNATX, INC.-MOD-2023-698021:7 of 16 case MODERNATX, INC.-MOD-2023-697960:4 of 16 case MODERNATX, INC.-MOD-2023-698005:6 of 16 case MODERNATX, INC.-MOD-2023-697981:5 of 16 case MODERNATX, INC.-MOD-2023-698031:9 of 16 case MODERNATX, INC.-MOD-2023-698078:16 of 16 case MODERNATX, INC.-MOD-2023-698073:15 of 16 case MODERNATX, INC.-MOD-2023-698062:13 of 16 case MODERNATX, INC.-MOD-2023-698059:12 of 16 case MODERNATX, INC.-MOD-2023-698029:8 of 16 case MODERNATX, INC.-MOD-2023-698045:11 of 16 case MODERNATX, INC.-MOD-2023-698064:14 of 16 case MODERNATX, INC.-MOD-2023-698039:10 of 16 case
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Oct2021 (Lot number: FF3389) at the age of 32 years as dose 3 (booster), single, administration date 08Feb2021 (Lot number: EL3247) as dose 2, single and administration date 20Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunization at workplace clinic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Feb2022, outcome "recovered" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient took no other vaccine in four weeks. No covid prior vaccination  Follow-up attempts are completed. No further information is expected.
SEIZURE; FLU LIKE SYMPTOMS (CHILLS, HIGH TEMPERATURE, FEELS HOT,STUFFY NOSE); This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported.  On MAR-2021,On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which is subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine, including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0: 20210322863-Covid-19 Vaccine Ad26.Cov2.S-Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Seasonal flu vaccine: experienced fever, headache, chills, body ache, insomnia, sweating, shivering for 26 hours
Severe, itchy, skin rash has developed over a large part of my upper body.  It continues to worsen.  It is still spreading, and has not been correctly diagnosed despite three visits to medical facilities.  The latest facility to see me, a Dermatologist, suggested this may well be an adverse reaction, and to submit this report.  I can send pictures of the condition if that would help.
Currently experiencing a slight headache.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Apr2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Mar2021 for covid-19 immunisation. The patient currently experiencing a slight headache on an unspecified date with outcome of unknown. The patient wants to know if he can take pain relievers.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Severe Irritable bowel symptoms lasting longer than a month, diarrhea and abdominal cramping. Extreme fatigue.
Few minutes after vaccination pt was feeling lightheaded and nausea, a bit hot and thirsty. Parent insisted on calling EMS. Pt was sitting down, told to lie down and elevate legs. Put damp towel on forehead and had a sip of water. EMS came in just over 5 minutes and evaluated and treated her, like checked blood pressure.
pt recv vax 17JUN95 & 25NOV97 pt devel muscle papule spots on back & abd;pt was seen by MD & dx w/chickenpox;pt recovered;
Patient was hospitalized due to vomitus material in mouth, concerns for aspiration pneumonia, decreased alertness, unresponsive verbally, obtunded
Laryngeal edema/spasm, hives, pruritus, wheals, sweaty 1/2-1 hour post Anthrax shot.
Patient came into the clinic on 10/01/18 to report a rash on his left arm. Patient stated the rash started out small, but then continued to spread two days after receiving the PREVNAR-13 vaccine. Patient stated the rash continued to worsen and was warm to the touch.
FEVER OVER 100 DEG F, BODY ACHES BOTH LASTING FOR 24 HOURS
fainted; pt fell to the ground p/standing & hit head; brief LOC, full recovery;
Hives on chest.  Very red irritated,  burning and itching.   Hives starting at armpit down side of body to the hip on both sides.  Very itchy
Approx 24 hrs after receiving vaccination , EE became n/v, upset stomach, dizzy, bp increased, weak,  Had covid approx 4 1/2 months prior and  received antibodies approx 4 months earlier.
Information has been received regarding a case in litigation concerning a male child who, for the first two years of his life, was vaccinated with injections containing the dangerous and highly toxic mercury based preservative thimerosal. The alleged result of these vacciantions is that the patient now suffers from, and allegedly in the future will continue to suffer from, the toxic neurological effects of mercury poisoning. Immunization records were received and indicated that the patient was vaccinated with his first and second doses of hepatitis B vaccine recombinant on 08 APR 1994 was given in the right thigh on 06 JUN 1994 and MMR vaccine live on 07 JUL 1995; a first dose of oral poliovirus vaccine on 06 JUN 1994, and 10 OCT 1994; first dose of diphtheria toxoid, pertussis vaccine, teta given on 06 JUN 1994, diphtheria toxoid, haemophilus B conjugate vaccine, pertussis vaccine tetanus toxoid on 08 AUG 1994 and 10 OCT 1994; a single dose of alum, potassium, diphterhia toxoid, pertussis vaccine, tetanus toxoid on 19 OCT 1995, HIB conjugate vaccine on 06 JUN 1994, HIB conjugate vaccine on 07 JUL 1995; a dose of hepatitis B, recomb given on 10 OCT 1994, and tuberculin purified protein derivative on 14 APR 1995, result negative. Upon internal review, toxic neurological effect and mercury poisoning were determined to be other important medical events. No further information is available. Follow up on 10/31/2003: "This is an amended report.  The primary therapy has been changed from hepatitis B virus vaccine rHBsAg (yeast) (Recombivax) to hepatitis B virus vaccine rHBsAg (yeast) (Recombivax HB).  This report is corrected as amended."
6pm extreme body/ joint pains; teeth chattering chills; fatigue, stomach cramps, brain fog. Not functional until next day, around 24 hours after injection.
4/8/05 the right arm is red, warm to touch, a round to oval five inch raised red area.
pt recvd 2nd dose of Hep B SEP1991; on 18DEC91 pt devel pruritus; no further details were provided;
autism; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an  female patient (pt) (age not provided). The pt's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 14-NOV-2006, the pt received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dosage information, lot # and expiration date were not provided) for its intended purpose: prophylaxis. On unspecified date, after the receipt of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the pt was diagnosed with autism. As a result of the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) the patient was caused and/or in the future will be caused to suffer severe personal injuries, pain, disability, and suffering. At the time of the report, the patient had not recovered from the event. The reporter considered the event to be related to the suspect therapy.   Upon internal review, the event of autism was considered medically significant. The reporter considered the event to be disabling.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2205USA002222:
Left deltoid - redness, pain and itching. Started 2/03/16 at about 5 pm size 3 in in diameter. Recommended cool compresses. Started hydroxyzine 10 mg/5mL 1 teaspoon every 6 to eight hours as needed for 7 days.
Dizziness, stroke on right side of face, Bell's Palsy, erratic heart beat.