chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial for Pfizer 6 months- 4 years of age did not have enough diluent added to the vial- 0.22 mL was added to the vial instead of the correct 2.2 mL. Patient therefore got a higher dose of vaccine. Family was notified, and they report that patient had no adverse effects.
2ND INJECTION     (NO REACTION 1ST VACCINE LEFT ARM) 2ND INJECTION - RIGHT ARM..AROUND 3 I FELT VERY HOT ON THE RIGHT ARM. LATER THAT NIGHT I HAD A LARGE BUMP. THIS WAS  WEDNESDAY 5/12/2021, THIS WENT ON FOR A FEW DAYS. I HAD BROKEN OUT WITH A SORE AROUND THE INJECTION. I CALLED THE ONCOGOLIST OFFICE AND WENT IN ON THE 19TH, MY ONCOGOLOGIST DID NOTE THE  REDNESS, HEAT, AND INFLAMATION. HE PRESCRIBED  CEPHALEXIN 500 MG CAPSULE 1 CAPSULE 3 X A DAY FOR 19 DAYSNONE      THE PILLS APPEARED TO WORK BUT NOW I HAVE  A LOT OD SMALL LOOKING SORES ONLR ON THE RIGHT ARM
Patient came into pharmacy and described a possible allergic reaction after second dose of Pfizer Vaccine. Patient had small bumps on the wrist and thighs. Bumps were described as itchy and patient states she is ,"itchy all over body."
Within 24 hrs of injection patients right arm swelled at injection site, red, and warm to touch. Patient developed headache and malaise.
SWEATING; NIGHT CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was allergic to a unspecified medications. The patient experienced drug allergy when treated with influenza vaccine for drug used for unknown indication. 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 28-JUN-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUN-2021, the subject experienced sweating. On 28-JUN-2021, the subject experienced night chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from night chills, and sweating. This report was non-serious.
She dies on 12/31/08 - clinicians list hypersensitivity myocarditis of unk etiology - I autopsy case 1-14-09 - confirmed an eosinophilic myocarditis, unk etiology but cannot exclude ZOSTAVAX vaccination given around 12-4-08 - unk where, clinician indicate possible delayed hypersensitivity reaction. (She presented --> to ER 12-20-08 with diaphoresis, chest tightness, SOB). 4/27/09-records received-COD Eosinophilic myocarditis, etiology not established.
This spontaneous report was received from the registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 13-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
PT came in with stuffy nose, weakness and low grade fever; Gave her Vitamin C, Zinc, Pantaprazol; Tylenol;  PT is discharged
Clearly demarcated area of redness, warm to touch on left upper arm aprox 5X8 inches.
Extremely tired went to bed at 8:30. At 11:00, tossed and turned until 12:16 a.m. Did not think she could stand up. Walked in the bathroom had pain in stomach, was very hot and freezing at the same time, was shaking. Head hurt was hurting so bad. Tried standing up from toilet, was passed out. Eye, half of face is bruised and swollen , eye shut for two days. More than forty minutes passed before she could call her husband. Does not remember anything because she was passed out. Husband came in and grabbed her, to get her back into bed. she could not stand. Went to ER at  Hospital. Had CT scan, blood work , EKG, chest xray. Was still kind of out of it but was able to communicate with nurses. Face is still black and blue. Last night got up at 4:00 a.m. something was wrong with her throat. Felt like a walnut was in her throat. Went to doctor this morning. They said it was a reaction from the shot. Got an EpiPen, prednisone. Call them in 2 days to let them know how she's doing and also wear a heart monitor because they do not know how to take care of her, Has had vision blurriness in both eyes. Has not felt well at all.
Itching behind her ears, head, shoulders, neck, both sides of ribs and top of foot; This is a spontaneous case, initially received from other non-health professional via agency [reference number: SEQ19-07212] on 03-Dec-2019, concerning a 63-year-old, female patient.   The patient's medical history included heart attack. The patient's concomitant medications included Norvasc (amlodipine besilate), Aspirin (acetylsalicylic acid) and Plavix (clopidogrel bisulfate) for heart attack, Crestor (rosuvastatin calcium), Celexa (citalopram hydrobromide) and Nexium (esomeprazole sodium) for unknown indication.   On 25-Nov-2019, the patient was administered Fluclevax (QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right arm, batch number: 262565, expiration date: 30-Jun-2020, route of administration: intramuscular (IM)] for influenza prophylaxis.  On 28-Nov-2019, three days after vaccination, the patient experienced itching behind her ears, on her head, shoulders, neck, both sides of ribs and top of foot. The most intense was around the ears, neck and upper chest area. The patient went to urgent care and they ruled out scabies.   On 01-Dec-2019, the patient received Benadryl (diphenhydramine hydrochloride) and prednisolone as a corrective treatment. Also, it was reported that the patient stooped treatment with Plavix.  At the time of this report, the patient had not recovered from the event.   The reporter assessed the event as non-serious.   The reporter did not provide causality assessment to Flucelvax (QIV).  Company comment: The event of itching is assessed as related to Flucelvax (QIV).; Sender's Comments: The event of itching is assessed as related to Flucelvax (QIV).
Starting 12 hours post Shingrix vaccine #2, severe chills to the point of uncontrollable shaking, no matter how many blankets used to warm me. Severe chills/shaking lasted about 6 hours, followed by severe nausea, dizziness.
Extreme nausea; dizzy; off balance; swollen eyes; red eyes; severe cramps; swollen armpit lymphnode; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FJ1620) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple family members allergy to sulfa" (unspecified if ongoing), notes: Multiple family members allergy to, sulfa. Concomitant medication(s) included: DIFLUCAN; MACROBID [CLARITHROMYCIN]. Past drug history included: Cipro, reaction(s): "Known Allergy: Cipro"; Bactrim for Known Allergy: bactrim; Sulfa antibiotics for Known Allergy: Sulfa antibiotics. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 27Apr2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "Extreme nausea"; DIZZINESS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "dizzy"; BALANCE DISORDER (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "off balance"; EYE SWELLING (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "swollen eyes"; OCULAR HYPERAEMIA (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "red eyes"; MUSCLE SPASMS (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "severe cramps"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021, outcome "recovered with sequelae", described as "swollen armpit lymphnode". Therapeutic measures were not taken as a result of nausea, dizziness, balance disorder, eye swelling, ocular hyperaemia, muscle spasms, lymphadenopathy.  Additional information: The patient had no other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination included birth control, difulcan, Macrobid. Device Date was 22Nov2021.
Upper arm ached around 4-5 pm. Shot administered approximately 12:00pm. Body ached with a fever of 99.1 degrees later in day. Weakness lasted 2 1/2-3 days.
The patient had a rash at the injection site. It was warm to the touch, very tender, and itchy.
Hives; Feeling terrible; Allergic reaction; Rash; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), FEELING ABNORMAL (Feeling terrible), HYPERSENSITIVITY (Allergic reaction), RASH (Rash) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 04821A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced URTICARIA (Hives), FEELING ABNORMAL (Feeling terrible), HYPERSENSITIVITY (Allergic reaction), RASH (Rash) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), FEELING ABNORMAL (Feeling terrible), HYPERSENSITIVITY (Allergic reaction), RASH (Rash) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
SOB, insomnia, chest tightness, dizziness, nausea, weakness, difficulty moving. Sx. began on 2/9/04-ER.
Reaction started 24 hours after  the vaccine was received. Patient stated she was lightheaded, had body aches and fever for 2 days. And had a swollen, red, raised spot, and sore arm for  about 4 days.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 14-JUL-2016, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route, lot number and expiration date were unknown), which experienced temperature excursion. This is one of several reports that received from the same source. Additional information has been requested.
TIRED; SHOULDER STILL HURTS; pain; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Medical information under reference number -00824880).  This case involves a 66-years old female patient who experienced shoulder still hurts (arthralgia), pain and tired (fatigue), after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2021, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  On 23-Sep-2021, the patient developed a non-serious shoulder still hurts (arthralgia), pain on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  On an unknown date, the patient developed a non-serious tired (fatigue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was reported, "her shoulder still hurts almost a month after the vaccination was given. she taken the ibuprophen her dr's nurs recommended but it continues to hurt. she can sleep because of the pain and its hard for her to get dressed. she also states that she's more tired than before the vaccination. she wants to know what to do and if it will be permanent?"  No additional laboratory data was reported.  The patient was treated with IBUPROFEN (IBUPROFEN) for pain.  At time of reporting, the outcome was not recovered for the events arthralgia and pain.  At time of reporting, outcome of the event fatigue was unknown.  There will be no information available on batch number for this case.
Began a few hours after second dose (4-5 hours).  Left Arm pain, headache, and fatigue. 1-2 hours after developed chills, joint pain, weakness/fatigue, muscle aches, as well as the previous symptoms.
Information has been received from a physician concerning a 20 week old patient who on 21-JUL-2011 was given a first dose of ROTATEQ (2ml, orally, Lot# 668359/0982Z). The patient was not experiencing any known symptoms. It was unknown if the patient had sought any medical attention. No further information is available.
Saturday 9/18/10 a.m. stomach ache, dry heaves, headache "all over" used TYLENOL and ice pack with final relief 9-21-10. No fever. "Wonders if swine flu vaccine caused a problem". Started day after flu shot given 9-17-10. Used light-foods and fluids to prevent dehydration. No new medications prescribed by MD before or after flu shot.
Patient started with large, red, swollen left thigh on 04/23/2021 after receiving Kinrix vaccine. The swelling had decreased some at the time of examination but area was still very large. The area on the left thigh measured 10.5 x 11 cm in size slightly tender. The red area is somewhat patchy/heterogenous as opposed to complete redness throughout
loss of hearing in my left ear for 4-6 hours (did not fully return until the next morning); Sensation of heart swelling in chest; Sensation of heart swelling in chest; Under eye bag swelling; general inflammation; migraines; brain fog; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0161), via an unspecified route of administration in the right arm on 16Apr2021 at 11:00 (at the age of 55-year-old), dose 2, single for COVID-19 immunisation. Medical history included likely had COVID. Concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The vaccine was administered at hospital. On 18Apr2021, the patient had sensation of heart swelling in chest, loss of hearing in his left ear for 4-6 hours which did not fully return until the next morning.  The patient also had under eye bag swelling, and general inflammation.  In addition, the patient had migraines, brain fog, some similar to when he believes he likely had COVID during 2020. The patient mentioned he was considered as essential worker and there were several outbreaks at work). The patient received unspecified treatment as he was self-treated since he did not have a doctor or insurance. The patient had not been tested for COVID-19 since vaccination. The outcome of the event loss of hearing in his left ear was recovered on 19Apr2021. The outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.
Information has been received from a physicians assistant concerning a 52 year old female with no medical history and no allergies who on 3/23/06 was vaccianted with a dose of Pneumococcal 23v polysaccharide vaccine 0.5ml (lot 651524/0605R), IM. Concomitant therapy included poliovirus vaccine, hepatitis A vaccine inactive Havrix and typhoid vaccine unspecified. On 3/24/06 the pt experienced redness at the injection site and swelling at the injection site. The pt was seen in the ER of 3/25/06. The pt was treated with antibiotics for possible cellulitis VS immunologic reaction. The pt was to have a follow appointment with an infectious disease specialist. It was reported to be unclear if this was her first vaccination with Pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
A report was received from a health care professional on 12/4/03 concerning a 16 month old female vaccinee who was administered a single dose of Fluvirin vaccine on 12/2/03. On 12/2/03 the vaccinee received Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 2/4/04: A follow up report was received from a health care professional concerning a one and a half year old vaccinee who received Fluvirin on 12/1/03. No adverse events were reported at the time of reporting. No follow up pending, all information received.
Pain / body aches/ pain in her legs; Pain in her legs; Pain in her legs was so bad that it caused her to limp; Pinching in her left shoulder; Difficulty lifting both arms; Muscle stiffness; Muscle spasms/ Knots; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 58-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 30th December 2019, the patient received Boostrix. On 31st December 2019, 1 days after receiving Boostrix, the patient experienced muscle spasm. On an unknown date, the patient experienced muscle stiffness, general body pain, leg pain, limping, shoulder pain and mobility decreased. The patient was treated with non-drug therapy (Acupuncture). On an unknown date, the outcome of the muscle stiffness, muscle spasm, general body pain, leg pain, limping, shoulder pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the muscle stiffness, muscle spasm, general body pain, leg pain, limping, shoulder pain and mobility decreased to be related to Boostrix.  Additional details were received as follows: The patient received Boostrix in upper arm. The patient experienced muscle stiffness, muscle spasms and also experienced knots. The patient stated that the knot started in her left buttock, went down her IT band, then behind her left knee and calves. The knots spread to other leg and was in neck. The knot in buttock was the size of an egg and knots in legs were the size of a walnut. The patient stated that the acupuncture helped reduce the knots, but they return with physical activity. The patient stated that the pain started right away after vaccination and her whole body aches and the pain in her legs was so bad that it caused her to limp. The patient also reported pinching in her left shoulder and difficulty lifting both arms. The patient consented to contact healthcare professional.
no known side effects; an improperly stored (supported) dose of VARlVAX was administered; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's pertinent medical history, concomitant therapies and drug reaction/allergies were not reported.  On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (strength, dose, and route of administration were not reported; lot number T032318 has been verified to be a valid lot number, expiration date was 22-SEP-2022). The vaccine was exposed to minus 12.4 degree Celsius for 1 hour 15 minutes and minus 3.2 degree Celsius for 1 hour 30 minutes, which was detected by a data logger (product storage error). It was reported that the vaccine had a previous temperature excursion at minus 8.6 degree Celsius for 1 hour 40 minutes. No additional adverse events or product quality complaints were reported. No further information was provided.
Vomitting, high fever 102.3,chills,muscle aches,croup rough coughing
After my second shot of MODERNA on March 30, I felt ok for about 10 hours, later in day I started with diarrhea,  I still have it, but if I do not  eat solid food I do not  have to go to bathroom  so bad.  Ongoing now for two days I have had diarrhea. some chills, slight temperature. I just ate an egg and spinach provolone omelette, waiting to see if I am better now  No treatment, just staying home resting, been napping.
face and next rash, app. 15 minutes post injection; heat in face; flat red rash on forehead, cheeks, nose, chin, neck; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6199, expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Mar2021 13:30 (at the age of 58-years-old) as dose 1, single for covid-19 immunization at hospital. The patient medical history included fibromyalgia, hypothyroidism, CFS, osteoarthritis, asthma, known_allergies: morphine, known_allergies: tree pollens, known_allergies: drinking alcohol. The patient was allergic to morphine, tree pollens, drinking alcohol. Concomitant medications included benazepril, zolpidem, fluticasone propionate, salmeterol xinafoate (ADVAIR), levothyroxine, liothyronine (NP THYROID), bupropion hydrochloride (WELLBUTRIN), all taken for unknown indications from an unknown date. List of other medications the patient received within 2 weeks of vaccination included Benazapril, Zolpidem, Advair, NP Thyroid, Wellbutr. Patient was not pregnant at the time of vaccination. 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 not been tested for COVID-19. It was reported that, on 23Mar2021 at 01:45 AM the patient experienced face and next rash, app. 15 minutes post injection, no throat swelling, heat in face, flat red rash on forehead, cheeks, nose, chin, neck. No treatment was received for the adverse event. The reporter assessed the seriousness as non-serious. The outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.