chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7FEB91 recvd DTP/HBOC; devel constipation & blood in stool; 3APR mild motor delays, slow weight gain; seen by MD; neurologist dx: hypotonic; JUN91 hospitalized for bowel biopsy;
Headache, Myalgia, sob on exertion, chills Narrative: Employee stated received 2nd vaccine on 1/12/21 and this morning was having migraine, bodyaches, sob on exertion, chills
Pt recv vax on 3/10/99; on 3/12/99 pt exp erythema/ pain/ swelling of rt arm
Pt complains of rash and saw primary care prescriber and was given acyclovir for viral rash or shingles.
Extreme fatigue, chills/fever, exhaustion, headache, no appetite, lasted approximately 2.5 days. Hit suddenly and quickly.
Tightness in throat; Swelling in arm; High fever; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): (Novavax).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "Tightness in throat"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swelling in arm"; PYREXIA (non-serious), outcome "unknown", described as "High fever".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Anthrax lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time.  Report submitted per authority direction.
This spontaneous report was received from a nurse refers to an unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX which had lot # M000997 with expiry date: 07-JAN-2018, lot # M003441 with expiry date: 19-JAN-2018, lot # M009764 with expiry date: 23-FEB-2018 and lot # M017290 with expiry date: 07-APR-2018, (dosing details not provided). The vaccines were exposed to a temperature of 26.6 Celsius Fahrenheit for 1 hour 36 minutes. The call was because of data logger. No adverse effects reported. No further information provided. This is one of two cases received from the same reporter. Additional information has been requested.
Developed left facial palsy approximately 48 hours after injection. Presented to local ER on 3-21-21 and diagnosed with Bells Palsy
Urticarial rash scalp, posterior/anterior neck, and anterior chest 8 to 10 days post primary smallpox vaccination.  Patient also noted to have mild bilateral upper eyelid edema.  He also complains of myalgias, HA, and nausea.
No additional AE; HCP called regarding PROQUAD. Caller reports that PROQUAD was inadvertently administered at the same time as VARIVAX. HCP denies patient reported signs/symptoms of adverse effects. Permission to contact HCP was given. No additional AE/PQC.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 27-JUL-2023, the patient was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) injection, (2nd dose, lot #W034211, expiration date: 24-APR-2024, (strength and route of administration were not provided) for prophylaxis at the same time as varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose description, lot #, expiry date, and route of administration were not provided) for prophylaxis (Accidental overdose).  The reporter denied the patient reported signs/symptoms of adverse effects. No additional adverse event (AE).
aching pain in lt arm, lt shoulder & lt jaw following shot; pain got worse @ noc & p/1 month has gotten better but not gone & lt shoulder ROM limited due to pain;
bilateral Facial swelling; eyes looked pretty swollen; This is a spontaneous report from a contactable pharmacist (patient's son). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 23Feb2021 at 13:40 (at the age of 78 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (positive by a COVID-19 Virus nasal swab test) from Nov2020 to an unknown date; coronary artery bypass and coronary arterial stent placement, MI (myocardial infarction) and stroke - all from an unknown date. The reporter clarified he was younger when the patient had either the MI (myocardial infarction) or stroke in the past, so he does not have any further information. The patient's concomitant medications were not reported. The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021, the patient had facial swelling. The reporter clarified that the patient had bilateral facial swelling. The reporter had "face-timed" with the patient on the morning of the report and the patient's eyes looked pretty swollen, too. The reporter said that the patient had no itching nor shortness of breath. The events did not require visit to emergency room nor a physician office visit. The reporter believed that the patient may have self-medicated with a paracetamol (TYLENOL 500mg tablet) in response to the events. The patient did not recover from both events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within approximately 2 minutes of receiving the vaccine, patient passed out. He was given an ice pack and responded to gentle stimuli within 1-2 minutes.  Patient then verbalized he felt like he might vomit, mom reports he did not eat breakfast this morning. He was given crackers and a sprite and was monitored for an additional 20 minutes. Patient fully recovered.
On 04/23/2021 the next day after the vaccine. I felt pain in my left arm, but in my right arm the pain was worse. I have pain in my whole body. I talked to my family doctor and mentioned that I feel very bad after the vaccination. They said to continue with my medication. They couldn't do anything.  Last week I had an appointment with my doctor  about my pain in my shoulder and they are going to send me to get an X-ray, but they have not given me a date.
HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced headache. Laboratory data (dates unspecified) included: CT (Computerised tomogram) scan (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
8 hours after receiving the shot, I had fever, chills, shaking, fatigue & headache. Stayed in bed 24 hours.
Febrile seizure 2 days after administration. Developed worsening febrile seizures. Was put on phenobarbital and eventually died from complications of TENS. Received D/C summary which revealed final dx: TENS, septicemia, cardiopulmonary arrest, DIC, ARDS, right femoral artery thrombosis.  Developed TENS after receiveing Pb & augmentin for febrile sz & had anaphylaxis to IVIG given for atypical Kawasaki dx w/50% total body desquamation.
Patient felt faint, dizziness, monitored and examined by pediatrician, discharge with no other problems
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; COUGH; CHILLS THE DAY AFTER RECEIVING THE VACCINE; DRAINED/TIRED; HIGH FEVER; RUNNY NOSE; BODY ACHE; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included: no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number series 1) (suspension for injection, intramuscular, batch number: 204A21A and expiry: unknown) dose was not reported, 1 total, administered on 19-AUG-2021 right arm for prophylactic vaccination. No concomitant medications were reported.  On 19-AUG-2021, the patient experienced high fever 104.5 F (Fahrenheit) body ache, runny nose after receiving the vaccine, she was also drained and tired. On 20-AUG-2021, the patient experienced chills  and cough (lasted about a week). On 17-DEC-2021, the patient started getting cough. On 18-DEC-2021, the patients body was sore, had chills and a temperature of 102.8 F. On 19-DEC-2021, the patient tested positive for Covid-19 rapid test (suspected covid-19 infection, suspected clinical vaccination failure) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills the day after receiving the vaccine, and high fever on 22-AUG-2021, cough on 01-SEP-2021, and runny nose, and drained/tired on 21-AUG-2021, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207849. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20211245389- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Wife and Husband got booster shots at the same time.  I injected husband and then the wife.   I mistakenly shot the wife with the used needle from the husband.    The syringe was empty so I realized my error.  Patient was  ok with the mistake.  Husband does not have any illness that could be transferred.
Narrative:  Patient is a 91 yo male who developed COVID-19 PNA after his first dose of the vaccine. Recovered after treatment (supportive care) during hospital admission.
Lyme disease - symptoms started during first week after vaccine. Diagnosed 01/02. Flu-like symptoms, joint pain/swelling, fatigue were initial immediate symptoms.
Patient arrived to receive the Pfizer 12+ vivalent booster vaccine. Patient instead received the Pfizer monovalent vaccine. No noted adverse reactions. Patient's Primary Care Provider is in the process of being notified, and outreach to the patient will take place soon thereafter.
Day after receiving immunizations patient had 3 episodes of syncope, one of which having post ictal like state.  Patient has also experienced stuttering and word finding episodes. 02/27/07-records received and reviewed for DOS 2/15/07- Assessment:3 episodes of syncope followed by 12 hour period of neurologic deficits consisting of word finding and stuttering. Differential diagnosis is board, concerned about a cardiac arrhythmia versus some sort of neurologic event. Shortness of breath is a concern for a cardiac origin or may be due to her asthma. To see cardiologist.  Previous fainting spell six month ago. Day after vaccines fainted 3 times, nauseated prior to fainting, sat a table not responding then fainted again, face white, lips blue.   C/O shortness of breath on exertion over past several months and now short of breath climbing stairs.
9/11/2021: Right facial droop. Emergency room visit diagnosis: Bell's palsy. Dose 1: Exp. 08/09/2021. Dose 2: Exp. 9/6/2021.
Swetted down; Fever; vomiting; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Swetted down), DIARRHOEA (Diarrhoea), PYREXIA (Fever) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021 at 9:30 AM, the patient experienced DIARRHOEA (Diarrhoea). On 18-Jan-2021 at 10:30 AM, the patient experienced VOMITING (vomiting). On an unknown date, the patient experienced HYPERHIDROSIS (Swetted down) and PYREXIA (Fever). On 19-Jan-2021, DIARRHOEA (Diarrhoea) and VOMITING (vomiting) had resolved. At the time of the report, HYPERHIDROSIS (Swetted down) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No information regarding concomitant medication was provided. No information regarding treatment medication was provided.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 12-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
No treatment - had cold sores, fever blisters for 6 weeks after vaccinations. None since.
Information has been received from an approximately 63 year old male registered respiratory therapist with allergy to UROXATRAL and diabetes and a history of non-hodgkin's lymphoma and premature ventricular contractions who in 2002 was vaccinated with the first dose of PNEUMOVAX 23 (Lot # and expire date not reported), intramuscularly, without incident. On 11-JAN-2011, the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot # and expire date not reported), intramuscularly. Concomitant therapy included metoprolol, lisinopril (manufacturer unknown), FLOVENT, magnesium (unspecified), propafenone HCl, metformin, aspirin and generic simvastatin (manufacturer unknown). Patient stated that he had developed bouts of pneumonia in 2008 and in 2009 that were treated with antibiotics. Patient added that on 11-JAN-2011 within 1 hour of receiving the second dose of PNEUMOVAX 23, he experienced pain and swelling at the site. At 7 pm, patient developed "wretching" shaking, chills and a fever of 103.2 degrees F. On 12-JAN-2011 at 3 am, his chills stopped and his fever dropped to 100 degrees F. Patient indicated he was treated with aspirin and water. The patient sought medical attention by calling physician. At the time of the report, the outcome from pneumonia was unknown and patient was recovering from "wretching" shaking, fever, pain and swelling at the site. On follow up information from a patient who reported that his initial symptoms that were reported resolved quickly, however, patient added that more serious issues happened in the following week. He stated that on approximately 18-JAN-2011, he developed severe headaches with "pain in his left eye socket" which lasted for several days. Patient mentioned that he then contacted a neuro-ophthalmologist, on 18-JAN-2011. Patient stated that by this time, he had a "droopy left eye" and the physician suspected "bleeding of the brain on the left side". Physician sent him to the emergency room and the patient was admitted to the hospital on 18-JAN-2011 (also reported as 18-JAN-2010). Patient said that on an unspecified date a CT scan and an MRI were performed, and though no bleeding was found, an adenoma which had been dormant in his brain for "10 years" was observed to have increased in size. Patient stated that he had had an MRI in early December 2010 which had revealed that the adenoma was unchanged.  Patient said that before he was revaccinated with PNEUMOVAX 23, he had been asymptomatic. Patient was discharged from the hospital on 20-JAN-2011. Patient stated that the "drooping" and headaches had since resolved. Additional information has been requested.
Muscle cramps in left hand/fingers / muscle cramps in both thighs/legs; Temperature regulation; Random chills; Red & raised bump at injection site; Red & raised bump at injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jul2021 at 18:00 (Lot number: EW1077) at the age of 35 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing), notes: General Anxiety Disorder and "Dysthymia" (unspecified if ongoing). Concomitant medication included: DESVENLAFAXINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0183; Anatomical Location: Right arm; Administration Time: 18:00; Route of Administration: Unspecified), administration date: 04Jun2021, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: MUSCLE SPASMS (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", described as "Muscle cramps in left hand/fingers / muscle cramps in both thighs/legs"; TEMPERATURE REGULATION DISORDER (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", described as "Temperature regulation"; CHILLS (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", described as "Random chills"; VACCINATION SITE ERYTHEMA (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", and all described as "Red & raised bump at injection site", VACCINATION SITE SWELLING (non-serious) with onset 03Jul2021, outcome "recovered with sequelae", and all described as "Red & raised bump at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, temperature regulation disorder, chills, vaccination site erythema and vaccination site swelling.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the result was negative (for all the 6 tests). The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
A very itchy red hot rash on my right side of my back.  Very hot red and lasted about 1 hour.  I put Fluocinolone Acetonide topical solution USP 0.01% on my right side from the neck down to bottom of back (only right side).
This patient was administered the vaccine in error - he had already completed the pneumococcal vaccination series, and was not due for another vaccination.
SEVERE ABDOMINAL PAIN FOLLOWED WITH NAUSEA AND VOMITING, FEEL VERY SHAKY PLUS HEADACHY
developed redness on my face, surrounding my eyes (forehead, nose, cheeks).  I assume it's from the vaccine because I hadn't had such a rash ever in the past.
red, swollen at injection site (about 3" diameter) with heat when woke up next morning after shot. about 25 hours after shot the site was more red and swollen with heat and I had severe fatigue, muscle aches, chills. About 48 hours after shot the site is red, swollen (about 7" diameter) with heat and still have fatigue and muscle weakness. Planning  on seeing  family doctor tomorrow.
COVID-19; COVID-19; Knee swelling; Arthropathy aggravated; Knee pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4385646-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis, psoriasis; cortisone (CORTISONE), since 02May2022 (Batch/Lot number: unknown). The patient had no relevant medical history. Patient had no allergies. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. The following information was reported: ARTHROPATHY (non-serious) with onset May2022, outcome "recovering", described as "Arthropathy aggravated"; ARTHRALGIA (non-serious) with onset May2022, outcome "unknown", described as "Knee pain"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; JOINT SWELLING (non-serious), outcome "unknown", described as "Knee swelling". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for adalimumab was dosage not changed; for cortisone was unknown. Clinical course are as follows: Solicited report from the (country) by a consumer of a 69 year old female  with events of non-serious bad flare up/flare up with right knee, knee pain, knee swelling and covid with Humira (Adalimumab).On unknown dates, the patient experienced knee swelling and covid. In May2022, the patient experienced bad flare up/flare up with right knee and knee pain. Cortisone and pfizer biontech covid-19 vaccine (tozinameran) were also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event of covid was not reported while for other events was no reasonable possibility with humira adalimumab).The reporter's causality for the event of Arthropathy aggravated was probable while for other events was not reported with cortisone.  The reporter's assessment of the causal relationship of "covid-19", "arthropathy aggravated", "knee pain" and "knee swelling" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Information has been received from a registered nurse. The nurse reported that one improperly stored dose of PNEUMOVAX 23 (lot number and expiration date not provided) was administered to a patient (age and gender not reported). No adverse effects were reported. No other information was provided. Additional information is not expected.