chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face; This is a spontaneous report from a contactable other HCP. A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration in left arm on 29Dec2020 11:00 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included Scleroderma, Interstitial Lung Disease, and Raynaud's. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tadalafil (ADCIRCA), amlodipine, pentoxifylline, ASA, and fish oil. The patient experienced diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face that started around 03Jan2021 and was at its worst on 04Jan2021. The patient went to the doctor's office on 05Jan2021. The outcome of the event was recovering. The event was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.
pt c/o t103.6, h/a, aches all over;wheezing (has asthma) was listened to by mom employer-foot doctor later took to MD;pt may h ave been misdiagnosed prev-early age instead of asthma may have had pneumonia;
swelling in my arm, area of swelling is a golf ball size; pain (not throbbing pain; it's constant pain); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in my arm, area of swelling is a golf ball size) and PAIN (pain (not throbbing pain; it's constant pain)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling in my arm, area of swelling is a golf ball size) and PAIN (pain (not throbbing pain; it's constant pain)). At the time of the report, PERIPHERAL SWELLING (swelling in my arm, area of swelling is a golf ball size) and PAIN (pain (not throbbing pain; it's constant pain)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Bells Palsy, numbness and paralysis on left side of face, unable to close left eye, use left side of mouth, smile, wrinkle forehead, blink, wink, pain in left ear and down neck, started at about 10 am with a watery eye then numbness then inablity to move left side of face.  occurred in about 30 min.  have appointment with neurologist to determine treatment on dec 28th
Minor's dad states that she general achiness and sniffles next am. Symptoms progressed to cold-like symptoms ie. cough, fever
Patient was given Kinrix at months 2 and 4; Patient was given Kinrix at months 2 and 4; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pediatric patient was given Kinrix as an infant at the age of 2 and 4 months, which led to inappropriate age at vaccine administration and extra dose administered. The reporter consented to follow up.
She got her vaccine, she had a little bit of a sore arm, but took Tylenol and that was no issue.  On Saturday morning she woke up all of a sudden got very clammy and dizzy.  She sat down in the dining room chair and all of a sudden she passed out and woke up on the floor on the shoulder with a chair on top of her.  She started to get a migraine and took Tylenol, but her arm was very very sore and was unable to lift it.  She put ice on it and pulsating water on it, and did some stretching.  Today she can lift her arm up with the assistance of the arm to raise it .  She called her doctor and notified her what had happened.  She did call the pharmacy who informed her that she had a reaction to the vaccine.    She went to her chiropractor today who told her she had minimal damage and manipulated her back and shoulder.
This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. The patient's concurrent conditions included diabetes mellitus, hypertension and hypercholesterolaemia. The patient's concomitant therapies included metformin, unspecified medication for hypertension and hypercholesterolaemia. There were no drug reactions or allergies. The patient's medical history was not reported. On 06-MAY-2017, the patient was vaccinated with a single dose of ZOSTAVAX subcutaneously in the right arm, which had a lot # of M040146, expiration date of 26-DEC-2017 (concentration and dose were not provided), for prophylaxis, which was reconstituted with sterile diluent with a lot # of M046369 and an expiration date of 07-JUN-2019. On the same day, the patient also was vaccinated with PNEUMOVAX 23 in the left arm (dose, route and concentration were not provided), which had a lot# of N004564 and an expiration date of 22-OCT-2018, for prophylaxis. Approximately in May 2017, the patient experienced a red rash at the injection site of the right arm and the right side of her back. Therefore, on 09-MAY-2017, the patient came into the pharmacy and the pharmacist gave the patient diphenhydramine hydrochloride (BENADRYL) and an unspecified hydrocortisone cream to apply to the rash. At the time of reporting, the patient did not recover from injection site rash, injection site erythema and rash erythematous. The reporter did not provide a causality assessment between ZOSTAVAX, PNEUMOVAX 23, sterile diluent, injection site rash, injection site erythema and rash erythematous. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Medium, Additional Details: numb tongue. bp was 117/85 however  hr was elevated trended down from 150 to 134 to 114. pt stopped complaining of numb tongue and heart rate issues after emergency emt arrived.  after assessment with emt she left on her own accord pretty quickly, with no complaints
Pt reports fever of 102 in the morning 8/16 around 9 am. Pt rested, and took aspirin. Her fever was 100 8/17 in the am, and by the afternoon had resolved.
Initial and follow-up information has been received through the Merck pregnancy registry from a 25 year old female, who in approximately April 2007, was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient became pregnant. The patient's last menstrual period was 09-Jul-2007, with an estimated date of delivery was 14-Apr-2008. Subsequently, on an unspecified date, the patient had a miscarriage at 10 weeks. Upon internal review, miscarriage was considered to be an other important medical event. Additional information is not expected.
17SEP90 high pitched cry (6PM) constant 2 hrs-slight fever. 0 reddness & swelling at site-managed pain w/tylenol. MD advised that it was rxn to Pertussis & DT given 27Nov90
Received vaccine on 10/27/16 approx. 11am. By 2am 10/29 raised, red, hot, increased BP, itchy and hard. Painful to move arm. TX in ED with steroids.
This case was reported by a pharmacist via other manufacturer and described the occurrence of ascites in a female patient who received HAVRIX for prophylaxis. In June 2018, the patient received HAVRIX. On an unknown date, less than a year after receiving HAVRIX, the patient experienced ascites (serious criteria hospitalization and GSK medically significant), renal disorder (serious criteria hospitalization), liver disorder (serious criteria hospitalization), confusion and difficulty breathing. On an unknown date, the outcome of the ascites, renal disorder, liver disorder, confusion and difficulty breathing were unknown. It was unknown if the reporter considered the ascites, renal disorder, liver disorder, confusion and difficulty breathing to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received Havrix (unknown lot, unknown expiration date). On an unspecified date, the patient developed severe ascites, confusion, had trouble breathing and needed a liver and kidney transplant. The pharmacist also stated that the patient was hospitalized at an unspecified hospital on unspecified dates for unspecified reason. No additional information was provided.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Was given Prevnar 13 at 11 AM.  Fever of 101.6 at 1:15 PM gave Tylenol. Lethargic. At 6:25 PM had fever of 103.5 - gave more Tylenol.  At 7:50 PM started coughing and vomited.  At 1:30 AM 1/13/13 had 103.2 fever gave Advil.  At 6:40 AM started coughing and vomited.  Called doctor at 9:30 AM.  Still out of sorts and will see if fever comes back. Info I wanted was what does the high fever mean - not handling vaccine well?  Only said did not have to give any more doses - but this was his last one in series.
Information has been received from a 69 year old female consumer with allergy to codeine. Concomitant medications included blood pressure medication (unspecified), calcium, vitamins and vitamin D. On Thursday, 27-SEP-2012 the consumer was vaccinated with a dose of ZOSTAVAX in her left arm. A day later on 28-SEP-2012 the consumer had a high fever and a tingling sensation on her stomach. By Monday, 01-OCT-2012 she had red spots on her stomach. The consumer sought medical attention. Her doctor advised her it was a minor case of the "virus that causes the chicken pox." Treatments was not given. No further information was provided. Additional information is not expected.
PMH:  CHF, TAVR, HTN, MDD, peripheral neuropathy; admitted to hosp with c/o SOB, cough, lethargy; positive for COVID; started on dexamethasone, redesivir; O2 supplementation, BiPAP; increased work of breathing; condition continued to deteriorate; moved to comfort measures; pt died in the hosp
vegetable in all muscles; was in bed/ no strength in body; could not lift; nauseous; sick to stomach; sick all day; arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm got sore), ABDOMINAL DISCOMFORT (sick to stomach), ILLNESS (sick all day), MUSCLE DISCOMFORT (vegetable in all muscles) and ASTHENIA (was in bed/ no strength in body) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Prostate cancer stage IV (prostate cancer 11 years Ago) and Coronary artery bypass graft (heart bypass surgery 11 years ago). Concomitant products included METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) and ATORVASTATIN CALCIUM (AVASTATIN) for an unknown indication.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced PAIN IN EXTREMITY (arm got sore). On 29-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach), ILLNESS (sick all day) and NAUSEA (nauseous). On 31-Oct-2021, the patient experienced MUSCLE DISCOMFORT (vegetable in all muscles), ASTHENIA (was in bed/ no strength in body) and MOBILITY DECREASED (could not lift). At the time of the report, PAIN IN EXTREMITY (arm got sore), ABDOMINAL DISCOMFORT (sick to stomach), ILLNESS (sick all day), MUSCLE DISCOMFORT (vegetable in all muscles), ASTHENIA (was in bed/ no strength in body), MOBILITY DECREASED (could not lift) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications was not specified   This case was linked to MOD-2021-370242 (Patient Link).
This spontaneous report has been received from a nurse practitioner via a company representative referring to an 11 year old female patient. There was no pertinent medical history. The patient was allergic to amoxicillin. On 14-AUG-2017, the patient was vaccinated with the first dose of GARDASIL 9, 0.5 ml (lot # and expiration date were not reported) intramuscularly for prevention of Human Papilloma Virus (HPV). The nurse practitioner reported that the patient did concomitantly receive diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) and MENACTRA vaccine during the same office visit but the vaccines were given in a different arm than GARDASIL 9. On the same day, the patient experienced light headed, and the patient's head rolled but she did not lose consciousness. The patient was given "orange juice and cookies for this event". No lab diagnostics were performed. On an unknown date in August 2017, the patient was recovered from the event. The causality between the event and GARDASIL 9 was unknown.
FOUR DAYS OF SEVERE FLU LIKE SYMPTOMS INCLUDING SEVERE HEADACHE, BODY ACHES, LOSS OF APPETITE, CHILLS, FEVER.
Following second vaccine, about 12 hours after vaccine. Sever levels of fatigue, nerve pain, joint and muscle throbbing, convulsions, fever of 102.4
Left arm pain, significant decreased range of motion beginning about 2 days after the vaccine and continuing 8 days after the vaccine.
He developed temperature greater than 102, body aches, headache and chest pain.  He was seen in the Emergency room and was felt to have a reaction to the vaccine.  He continued to run a fever the following day with same symptoms.  The second day, his fever seems to be resolving as well as the symptoms.
The day after receiving my arm was extremely sore on day 4-1/6/21 I noted swollen mandibular lymph nodes tender to the touch These were resolves 1/12/21 On 1/11/21 I noted a red patch with a few small bumps approx. 3"x1" at inj. site.  I had my husband take a picture on 1/12/21. This continues to be red and I continue to have arm pain and it is hard to use arm. I am doing ROM several times a day. Have used ice and ibuprofen for pain.
Patient felt faint within minutes of getting immunization and was under constant supervision of pharmacist and tech. Thready pulse and started having mini convulsions. Pharmacy contacted 911 and paged code white. Pt stable after several minutes and started feeling normal. EMT came to monitor vitals and patient declined hospital visit to get checked out. We monitored patient for additional 30 min and then had him call someone to drive him home.
early menstuation within 48 hours and extremely heavy, extreme fatigue, extreme swelling around eyes, joints and face, pain in joints and back. symptoms subsided after 60 days
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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IPF" (unspecified if ongoing); "COPD" (unspecified if ongoing); "HIV" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid Treatment from 01Jul2023 to 06Jul2023. Patient got COVID rebound about 5 days after she felt fine and finished Paxlovid. Patient had no Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251669 same patient, different drug/AE.;
My head started aching and wouldn't stop which is still aching today, my PCP increased my Clonidine med to 0.3 mg twice a day, had a MRI because of the extreme head pain and elevated hypertension  systolic rates near 300 and diastolic in the 100's, results is white matter disease in the small blood vessels of the brain and I'm still hurting, DUE FOR NEXT SHOT  MAY 6TH
Child became dizzy & c/o (L) arm pain where flu injection has given. Monitored vital sings. When dizziness gone sent child to Health Room for further monitoring.
Patient completed her 15 minute wait time after vaccine and states she walked out of the facility and the "cold wind" made her cough and vomit. Her friend came back into the facility to notify staff and ask for assistance. Writer then proceeded out to the parking lot and found patient crouching with a bag actively vomiting and coughing up bright red blood and blood clots. Blood was also seen coming from her nose. Interpreter was utilized to ask questions. She denied headache, nausea, dizziness, pain, heartburn, or black stools. She states she felt well after the vaccine and that the wind was what made her start coughing/vomiting.  She states that in February a similar occurrence happened but there was not as much blood. At that time she sought care and was referred to pulmonology and states that "nothing was wrong". She has not had another occurrence until today. She was unable to discuss medications currently taking and pre-existing conditions. She was alert and oriented. Paramedics were called and took the patient at 01:32 PM.
Received HPV #3 on 5-19-15. On 5-20-15 at night patient noticed rash on arm she received immunization. On 5-21-15 rash to arm, neck, face and back. Mom reports looks like "hives" like "Heat Rash".
Patient was given 0.25mcg Moderna Bivalent Booster not 0.5mcg, patient was given wrong dose.
Patient went home after vaccination and started experiencing chills, fever, and eventually passed out the next day.
Dizziness, Joint pain, Swollen lymph nodes, Nausea, Vomiting, Fever of 101F.
10-12 hours, post vax, pt developed full body hives, lethargy and anorexia. Two hours, post vax, pt developed a fever which was not reported to the Health Dept until 2/8/02. Seen in ER. No treatment given and resolved in 72 hours. Pt had a Hep-B vaccine on 9/30/01 with no reaction.
Muscular Pain like someone is shooting arrow through muscle. Pain in waistline and thighs. Had to crawl to bathroom couldn't stand up.
4 month-old patient was given the FLUZONE QUAD (prefilled) by mistake with no reported adverse event; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case received from other health professional (Inquiry number: 00560052).  It was reported that INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: UJ559AC, expiry date not reported) (Suspension For Injection) was administered to a four month old female patient via an unknown route for prophylactic vaccination (product administered to patient of inappropriate age).  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
got covid arm now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (got covid arm now) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced VACCINATION SITE REACTION (got covid arm now). At the time of the report, VACCINATION SITE REACTION (got covid arm now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
BODY ACHES; SLIGHT FEVER; SUPER TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, slight fever, and super tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever, body aches, and super tired. This report was non-serious.