chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOMITING; FEELING SICK; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, and the outcome of feeling sick was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
devel rash on head & torso rash resolved p/10minutes w/no tx;rash macular;
16 yr. received Moderna dose 1 and 2; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr. received Moderna dose 1 and 2) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr. received Moderna dose 1 and 2). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr. received Moderna dose 1 and 2) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  Reporter queried that if a 16 years old patient received Moderna dose 1 and 2, properly spaced and then received a booster at 17 years of age, does this individual need to repeat any of the doses.   This case was linked to MOD-2022-563490 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Live follow-up document received: Reporter's contact number was reported.
Emergency surgery; Cecal Volvuus; and Ventricular tachycardia (Proxysmal)
pt recv vax 25APR96 & states began running temp in the evening, aching joint * devel a pruritic rash on arms & legs;seen in ER treated w/DPH, hydrocortisone cream & APAP
t102.4, high pitched cry; persistent unconsolable crying for >3hr; vomiting the afternoon & evening of the vax & the next morning treated w/Emetrol, APAP & Motrin
lot of heat in it and it's very raised; lot of heat in it and it's very raised; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (lot of heat in it and it's very raised) and INJECTION SITE SWELLING (lot of heat in it and it's very raised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE WARMTH (lot of heat in it and it's very raised) and INJECTION SITE SWELLING (lot of heat in it and it's very raised). At the time of the report, INJECTION SITE WARMTH (lot of heat in it and it's very raised) and INJECTION SITE SWELLING (lot of heat in it and it's very raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was hospitalized with chest pain and elevated BP. Patient's blood pressure medication regimen was optimized and patient was discharged
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 medical information team. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for COVID-19 treatment, notes: started taking Paxlovid on Thursday morning a little bit before 10 AM,. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
soreness of the arm after getting administered Prevnar 13; This is a spontaneous report from contactable pharmacist. This pharmacist reported same events for three patients. This is 1st of three reports.   A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced soreness of the arm after getting administered the suspected vaccine on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019548927 same reporter/drug/event, different patient;US-PFIZER INC-2019548928 same reporter/drug/event, different patient
Became allergic to poison ivy for the first time in my life.  One of my doctors also told me the same for him.
Erythematous area, ~ 5 cm with 7 cm central redness more pronounced, local tenderness.  No discharge.  No fever.  Treated with clindamycin.
Initially began as low back ache with mild numbness, tingling and cold feeling in feet. On a scale of 1 to 10 I would rate this as a two or three. I called and reported to my doctor and have appointment to see doctor April 16, 2021.
Unable to focus, Cold Chills, sore throat, roof of mouth swollen, left nostril swollen, aches all over and elevated temperature.
Dizziness CTCAE v 4.03 grade 1 as initial symptom similar to dose 1 with also feeling of scalp tightness and with a feeling of electric zaps persistent at this ti; Feeling of electric zaps; Feeling of scalp tightness; Tingling of mild to moderate nature; This is a spontaneous report from a contactable physician, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. The patient was allergic to iodine contrast. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via intramuscular route of administration in the left arm on 14Mar2021 at 16:15 as a single dose for COVID-19 immunisation and experienced dizziness on an unspecified date in 2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 at 10:30, the patient experienced dizziness (Common Terminology Criteria for. Adverse Events, v 4.03) CTCAE grade 1 as initial symptom similar to dose 1 with also feeling of scalp tightness and tingling of mild to moderate nature with a feeling of electric zaps persistent at the time of entry still as of 09Apr2021. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, scalp tightness, tingling and electric zaps was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Mother describes day after vaccination left arm pronounced hard raised edema most severe around injection site, but edema extended from shoulder to elbow of left arm. Also pain extending into neck. Reports limited range of motion in arm during most pronounced edema. Edema lasted for 2 weeks after vaccine administered. Also mother reports her daughter had a headache and vomiting for 3 days after vaccines administered, and a fever that started night after vaccination with a duration of 2 days.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
sore arm; injection site swelling, red about the size of a tennis ball- HCP dx cellulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE CELLULITIS (injection site swelling, red about the size of a tennis ball- HCP dx cellulitis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cellulitis (the patient had symptoms like cellulitis.) on 17-Jan-2021. Concomitant products included ROSUVASTATIN, METOPROLOL and LEVOTHYROXINE for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE CELLULITIS (injection site swelling, red about the size of a tennis ball- HCP dx cellulitis). The patient was treated with NEOMYCIN SULFATE, POLYMYXIN B SULFATE (ANTIBIOTIC [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) (oral) on 17-Jan-2021 for Cellulitis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE CELLULITIS (injection site swelling, red about the size of a tennis ball- HCP dx cellulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
pt recv vax; mom reported pt felt knot & small bumps surrounding knot on lt anterior thigh this am; no redness; swelling; no T' physical recommended; OTC hydrocortisone ointment;
05/31/2013--started with flu-like symptoms; body aches, chills, temp of 101, arm was very sore, red & swollen. For that whole week, body was weak & achy; and site where shot given was very sore, red, swollen, hard & warm to touch. Exactly 1 week following injection (06/06/13); started with a horrible "migraine." Was vomiting, etc... (never had a headache (or vomited with a headache) like this before. Since that headache, haven't been the same; I have continuous ringing in my ears, I often feel dizzy/lightheaded, my neck feels sore/stiff at times, and my eyesight feels (hard to describe) "heavy" and "slow-motioned" and along with that I have a constant light aura which feels as though it's going to trigger another headache. I've made two separate calls to each my PCP, and also my Ob/Gyn (the location I had the vaccination done) since after I've had this shot.
Information has been received from a physician concerning a patient who was vaccinated with RECOMBIVAX HB. Subsequently the patient experienced an adverse event. No further information is available. Additional information has been requested.
Patient received vaccine Wed 4-8-20. She noticed itchiness 4-10-20. The itchiness increased on 4-11-20 & also noticed swelling, rosey red & warm to touch. She called & spoke w/ Dr's office who told her with normal range for now & to take Benadryl & a warm compress. I advised cool compress & to follow up w/MD. Pt reported 6" spreading toward elbow.
tourette syndrome; hallucinations; tenderness in my left arm; sweating; neck twitching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient wrote to complain of the poor service the patient received when the patient became fully vaccinated on 11May2021. The side effects he underwent included tenderness in left arm, sweating, hallucinations and Tourette syndrome on an unspecified date. The patient's tics included neck twitching, a few swear words and one of them is the "K-word". People laugh at the patient's colorful language. The patient is a freshman in college where the patient is viewed as racist, homophobic, ableist and xenophobic due to the shot. The patient said that he/she paid for immunity to COVID-19 and not to get a disease. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Watery nose, chills, and tiredness, fatigue by 10:00 PM. 01/25/2010 dried mouth, minor fever, and tiredness, and running nose with clear mucous at morning.  I taken Theraflu over the counter medicine and slept, until 5 PM. I have ate dinner and feel better, but still running nose and feared about the vaccine.  I wanted to try it, but sort felt that it is not necessary because I have been at home for 2 years without work and not exposed to the public much.
Blotches on the forearm; Rashes on her body, they were itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotches on the forearm) and RASH PRURITIC (Rashes on her body, they were itchy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Blotches on the forearm) and RASH PRURITIC (Rashes on her body, they were itchy). At the time of the report, RASH MACULAR (Blotches on the forearm) and RASH PRURITIC (Rashes on her body, they were itchy) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Slight sore throat; Congestion; Running nose; Coughing; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Slight sore throat), NASAL CONGESTION (Congestion), RHINORRHOEA (Running nose), COUGH (Coughing) and HEADACHE (Headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN and LANSOPRAZOLE (LANSPRO) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Slight sore throat), NASAL CONGESTION (Congestion), RHINORRHOEA (Running nose), COUGH (Coughing) and HEADACHE (Headaches). At the time of the report, OROPHARYNGEAL PAIN (Slight sore throat), NASAL CONGESTION (Congestion), RHINORRHOEA (Running nose), COUGH (Coughing) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
tinnitus has intensified since last week; little soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus has intensified since last week) and PAIN IN EXTREMITY (little soreness on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus (Patient had tinnitus for a long time already and it was tolerable.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus has intensified since last week) and PAIN IN EXTREMITY (little soreness on the arm). At the time of the report, TINNITUS (tinnitus has intensified since last week) outcome was unknown and PAIN IN EXTREMITY (little soreness on the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient confirms of taking daily prescribed medications but none to manage tinnitus. No treatment information was provided.
evening of vax child had low grade temp 100.2x 3-4 days; 11FEB99 pt devel rash in trunk area;child taken to clinic 12FEB99 & 15FEB99;child was placed on ATB;also exp wheezing, runny nose, dec activity, dec PO fluid OK;irritable;viral URI;
Kinrix vaccine that was administered by the MA was expired.  Expiration date: 2/2/2021.  Vaccine was administered on 2/3/2021.  No adverse events reported.
Swollen at site; Pain; Hot to touch; Fatigue; Severe headaches.
Severe, random, quick onset blood pressure spikes and headaches.  Elevated D-dimer.  This has required an urgent care visit, two emergency room visits and a doctor's office visit.  I have never had this happen before.  I am now prescribed Clonidine to bring my blood pressure down quickly when it happens.  None of the healthcare providers have an explanation for it and all have agreed it is most likely from the Moderna vaccine since that is the only thing new or that has changed with my health.
Pt  called 2 days after getting  vaccine  stated  temp was 100. F.  Rash , on arm & arm "on fire "  difficulty  breathing like as than altar  But pt states she does have asthma
pt recvd vax; Rt arm swelling, reddened, blotchy elbow area; red streaks in Rt axilla;
Same day post vax, this pt developed an exacerbation of rheumatoid arthritis with lower back pain in her feet. The prednisone therapy had been discontinued on 10/06/1999. On 12/14/99, her rheumatologist reported that the pt's back and foot pain "slightly better."
Came on very slowly starting with soreness in area of shot, progressing to pain when doing Yoga moves to difficulty dressing and sleeping. By beginning of January, had to completely stop Yoga. Went to orthopedic doctor on January 13, 2015. X-rays showed "frozen shoulder" - no rotator cuff tears. Gave me a cortisone shot and some simple shoulder exercises. Immediately started improving. Was able to return to Yoga classes (with limitations) by beginning of February, 2015. As of now (3/22/2015) shoulder is much better, but not back to normal. Still some pain where shot was given. Still some moves that used to be easy that I can not do with that arm (e.g., eagle arms with left arm on top; triangle pose to the right - left arm will just not go up straight from that position; arm will go behind my back, but can not get hand up at all (used to be able to do reverse namaste. Unfortunately, improvement seems to have stopped in last couple weeks.
Symptoms: Fatigue, dizziness, and shortness of breath Diagnosis:  small blood clots in right upper lung Treatment: Eliquis
Pt. was given shingles shot on Tues. 3/1 and just called to say she has been feeling ill ever since, but woke up with hives on her face today. She stated that she hasn't taken any Benadryl or other medications as she was told to contact the office first is she had any adverse reactions
Lightheaded; heart rate of 165+; unable to read blood pressure twice; sick to stomach; unable to read uncontrollable head shake side to side; numbness in cheeks; tingling in feet; This is a spontaneous report from a contactable consumer or other non hcp. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:00 as dose 1, single (Age at vaccination 43-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included none. Concomitant medication(s) included ibuprofen (IBUPROFEN);ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride(MULTIVITAMINS). Prior to 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. No known allergies. On 13Apr2021 12:00, the patient experienced lightheaded, heart rate of 165+, unable to read blood pressure twice, sick to stomach, unable to read uncontrollable head shake side to side, numbness in cheeks, tingling in feet. The patient underwent lab tests and procedures which included blood pressure measurement was unable to read blood pressure twice on 13Apr2021 and heart rate was 165+ on 13Apr2021. Therapeutic measures were taken as a result of events includes water. The outcome for all events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a other health professional via call center representative and described the occurrence of cramps of lower extremities in a adult female patient who received Herpes zoster (Shingrix) (batch number 5454X, expiry date 25th October 2022) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced cramps of lower extremities, inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the cramps of lower extremities, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the cramps of lower extremities to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. Health Care Provider who was also the patient reported being given the Shingrix diluent without reconstitution with the powder which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The patient reported waiting for a while to take first dose and then received the second dose during the 2 to 6 month window. The patient also reported having leg and feet cramps after receiving the diluent only. The reporter consented to follow up.