chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per patient, within an hour of receiving the vaccine, she had tightness in her throat, a fever, shaking, and general flu like symptoms. Pt states she took a Benadryl and has to go to the emergency room. Pt has received high dose flu shots before and never experienced these symptoms or any sort of adverse events.
PCR confirmed positive for COVID; PCR confirmed positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 13 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 06Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "unknown" and all described as "PCR confirmed positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive.  Additional information: She was asymptomatic but tested because other family members had just tested positive and they were supposed to travel. Patient had 2nd Pfizer vaccine on 06Jun2021 and had breakthrough confirmed COVID 19 via PCR.  The lot number for bnt162b2 was not provided and will be requested during follow up.
VACCINE WITH AN OUT OF RANGE TEMPERATURE EXCURSION  AND WAS ADMINISTERED; DURING TRANSPORT THE REFRIGERATOR HAD A TEMPERATURE EXCURSION OF ONE DEGREE C FOR FIVE MINUTES; vaccine with an out of range temperature excursion  and was administered; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent #dose1 (influenza vaccine live reassort 4v) (batch number PJ3267) (expiration date 26-DEC-2022) once/single administration, via nasal route, on 03-NOV-2022. The patient received Flumist Quadrivalent #dose2 (influenza vaccine live reassort 4v) once/single administration, via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT #DOSE2.   No malfunction has been reported for FLUMIST QUADRIVALENT #DOSE1.    The report described a medication error for Flumist Quadrivalent #dose1. The reported term was vaccine with an out of range temperature excursion  and was administered (Preferred term: Product storage error). The report described a product issue. The reported term was during transport the refrigerator had a temperature excursion of one degree c for five minutes (Preferred term: Product temperature excursion issue).     The outcome of the event(s) of vaccine with an out of range temperature excursion  and was administered and during transport the refrigerator had a temperature excursion of one degree c for five minutes was unknown.     The events were considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent #dose1 and the following event: vaccine with an out of range temperature excursion  and was administered.   The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent #dose2 and the following event: vaccine with an out of range temperature excursion  and was administered.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT #DOSE2  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT #DOSE1  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
the intention was to give patient his 2nd hep B vaccination (started 5/2020). pt was mistakenly given Havrix (hep A ) , potentially 1st dose.
Immediately following administration of 1st Pfizer vaccine pt lost consciousness and began briefly flailing her arms. Pt then regained consciousness and complained of nausea. Pts parents were notified who stated last meal was breakfast at 0900 and that the pt had no prior history of vaccine reaction. Vital signs were taken which showed:   BP 116/72 Heart rate at 48 98% sp02 r/a 96.3° temp  Cooling pack was provided and pt became alert to verbal stimulus. Pt was monitored for 10 minutes and 2nd set of vital signs were taken:   BP 122/72 Heart rate at 62 98% sp02 r/a 97.3° temp  Pt was monitored for an additional 10 minutes until resolution of symptoms final vital signs showed:  BP 128/76 Heart rate at 77 98% sp02 r/a 97.3° temp  Pt was discharged into care of parents, who were instructed to seek emergency medical care if symptoms returned or worsened.
02/02/22 presents to EC ED for "Fatigue". PMHx of "atrial fibrillation on xarelto, complete heart block, lung ca, spinal stenosis status post C1-C4 laminectomy 12/9/21, Guillain Barre syndrome".
After patient received the vaccine she sat in the waiting room.  She began to pass out in the chair she was sitting it.  She came to immediately and was OK.
10 days p/vax pt devel acute confusional state, concentration poor, speech intelligible. did not recognize family,  recent info 6/25/99 rpt neurological status as stable, pt could recognize family but appeared tired w/ poor concentration.
ITCHINESS ON THE ARM; received Pfizer for second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (ITCHINESS ON THE ARM) and INTERCHANGE OF VACCINE PRODUCTS (received Pfizer for second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received Pfizer for second vaccine). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (ITCHINESS ON THE ARM). On 20-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (received Pfizer for second vaccine) had resolved. At the time of the report, VACCINATION SITE PRURITUS (ITCHINESS ON THE ARM) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not received. Concomitant medication not received   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021 and contains significant information. Added one additional event Vaccination site pruritus
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 19-SEP-2011, patient was vaccinated with dose 1 of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 25-SEP-2012, the patient was vaccinated with dose 2 of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 20-MAR-2013, the patient was vaccinated with dose 3 of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
pt has sore arm, was red but redness has gone away on 10/21, looked pinkish.  she has appt  with provider next week and will have him look at it if still any issues
Information has been received from a pharmacist concerning a 62 year old female who on 17-NOV-2007 was vaccinated subcutaneously with ZOSTAVAX.  On 20-NOV-2007 the patient developed a large red raised bump at the injection site, with a "little pain" associated with it.  It was reported that the patient did not seek medical attention, but the patient was told to "take two diphenhydramine hydrochloride (BENADRYL) and come back in two days if the bump did not go away".  The patient did not return to the pharmacy.  There was no product quality complaint.  Additional information has been requested.
Suspected Vaccination failure; diagnosed with shingles. Because I did get the shot it is a much milder case; somewhat painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows The patient reported for him/herself. The age at vaccination was not reported. The patient got the shingles shot less than a year ago and the patient was just diagnosed with shingles.  The patient stated because he or she did get the shot it was a much milder case but still somewhat painful. The patient's doctor said to the patient that the patient was his first breakthrough case. The still patient recommend getting the shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset and laboratory confirmation were not provided.
Mild fever, mild headache, chills,  malaise/low energy.  Tylenol XS taken every 6 hours with rest.  Continue to feel this way this AM (21 hours post vaccine)
EXPIRED;  Hospitalized (10.11.21);  COVID-19 positive (10.11.21);  fully vaccinated  Admission Date: 10/11/2021 Date of Death: 10/16/21 Time of Death:  3:41 AM Preliminary Cause of Death: Acute on chronic systolic CHF (congestive heart failure)  PRESENTING PROBLEM: Congestive heart failure with left ventricular dysfunction HOSPITAL COURSE: The patient expired on comfort care.  For exact date and time of death please refer to nursing staff documentation. a 92 y.o. male who presented with SOB.  in the ER and admitted to the hospital for further management of his medical problems noted below  The patient has a PMHx significant for CKD stage lV, systolic CHF and hypothyroidism.  Below is a list of his medical problems addressed during this hospitalization. Acute CHF exacerbation AKI with CKD stage lV COVID-19  Dysphagia DM ll, diet controlled  BPH Hypothyroidism HPI (10.11.21): HISTORY OF PRESENT ILLNESS a 92 y.o. male who presents today with SOB. The patient has a PMHx significant for CKD stage lV, systolic CHF and hypothyroidism. The patient developed SOB and peripheral edema about two week ago. He has been being followed by his outpatient cardiology office who added metolazone to his regimen. Despite this adjustment he continues to have SOB and productive cough. Associated peripheral edema. His kidney function and BNP have also been worsening so the patient was instructed to go to the ED to be hospitalized so his kidney function could be monitored while trying diuresis. The patient notes he is vaccinated for COVID-19 and has no known contacts. Denies fevers, chills, and N/V/D.  Upon arrival to the ED Na 140. K 3.4. Cr 3.93. BNP 30,280. HsTnT 208>>197. WBC 6.22. Hgb 10.7. CXR shows improvement of mild CHF. The patient was given IV lasix in the ED. The patient has remained hemodynamically stable. The patient is being admitted to SHMG for further management and evaluation
My left arm became red, swollen, and  itchy below the injection site 9 days after the injection.  It is day 4 days after the irritation and there is still slightly red.
Son had fever of 101-103.6 was very irritable could not be consoled. Did not sleep through the night. Sleepless, cranky, skin warm to the touch.
~15mins post vaccination pt c/o swelling in the lower eyelid and palpitations (fast HR). Vitals @ 10:10 BP 167/95, HR 122, RR 18 -- > @10:12 137/93, 98, 18.  NO SOB, No c/p Pt monitored and provided water Pt condition improved and in stable condition.  Pt released from vaccination site, ED precautions discussed.
Since my vaccination I have been having pain in my left leg muscles.  The pain is worse if I bend my leg very much.  It has been over two weeks since the vaccination and the pain is not getting better.  I contacted my doctor and he suggested that I report the incident.
On 09/13/2000 the patient developed 15 lesions with a fever of 103F. The patient sought unspecified medical attention. Additional information has been requested.
DEATH; This spontaneous report received from a consumer via a company representative concerned a 55 year old female of unspecified race and ethnicity. Initial information was processed along with the additional information received on 14-JAN-2022. 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, and batch number were not reported) dose number in series was 1, 1 total, dose and start therapy date were not reported administered 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 an unspecified date, the patient experienced death (dose number in series was 1). The cause of death was not reported. It was unspecified whether an autopsy was performed. The consumer reported as "My 55 year old friend took the vaccine, died within 2 weeks. It is listed as her cause of death on death certificate". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220126211, 20220126582, 20220126614, 20220126701, 20220126708, 20220126177 and 20220126174.; Sender's Comments: V0: 20220126450-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Mom reported c/o numbness and feeling like both legs were going to sleep, also cramping which started on Thurs. 8/21/2008. At this time has not seen MD.
REACTIVATION OF ARTHRITIS WITH FOOT PAIN KNEE EFFUSION, CHILLS FEVER, MYALGIAS, ABDOMINAL PAIN, WEIGHT LOSS.  HOSPITALIZED 9/1/15 WITH ABDOMINAL PAIN OVERNIGHT.  SEEING RHEUMATOLOGY AND KNEE EFFFUSION DRAINED.  HAD INITIAL JOINT PROBLEMS WITH SIMILAR SYMPTOMS WHEN 4 YEARS OLD STARTING ABOUT 10 DAYS AFTER DTAP GIVEN 7/22/08.  RESOLVED AFTER ABOUT 4-6 MONTHS AND NO PROBLEMS IN BETWEEN.
Instant headache, sore neck and shoulders! Severe chest pain and breathing problems, especially at night, enough to wake me up and have to go to the ER! It?s been a week since my second dose and still can not sleep throughout night, due to sever chest pain and thinking I?m having a heart attack!
Painful soreness in neck; Painful soreness in shoulder opposite side of injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Painful soreness in neck) and ARTHRALGIA (Painful soreness in shoulder opposite side of injection site) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Painful soreness in neck) and ARTHRALGIA (Painful soreness in shoulder opposite side of injection site). At the time of the report, NECK PAIN (Painful soreness in neck) and ARTHRALGIA (Painful soreness in shoulder opposite side of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Give FLUMIST vaccine 10-23-14 at 9am, 920 am c/o weakness and headache. Vitals within normal limits no respiratory distress. Monitored for one hour.
Developed 6x8 cm area of erythema and swelling in left thigh 24 hours post vaccine.
Per MD, 1415-Subacute onset of nausea and dry heaves. After completing fifteen minutes of observation after Moderna 042L20A vaccine. 1420-v/s 138/85, 98%, 98.8 F, P 62. 1430-v/s 130/98, 98%, P 58, 98.7 F. PMH- Gastric bypass & Borderline HTN, & DM after Gastric Bypas. COVID screening questions: Negative. Pt skin tepid- warm, no acute distress. HEEN- WNL, chest- ABD unremarkable, Vasovagal symptoms after vaccine, symptomd resolved. Stable for discharge home.
Local redness/swelling, R elbow pain/redness/swelling, R fingers swelling in DIP'S, red rash on hand, axillary adenopathy.
chills and can't stop shaking; neck and rib cage is so sore; chills and can't stop shaking; can't relax my body; neck and rib cage is so sore; arm was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was pretty sore), CHILLS (chills and can't stop shaking), FATIGUE (can't relax my body), NECK PAIN (neck and rib cage is so sore) and TREMOR (chills and can't stop shaking) in a patient of an unknown age and gender 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 information was reported.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (arm was pretty sore). On 28-May-2021, the patient experienced CHILLS (chills and can't stop shaking), FATIGUE (can't relax my body) and NECK PAIN (neck and rib cage is so sore). On an unknown date, the patient experienced TREMOR (chills and can't stop shaking) and MUSCULOSKELETAL CHEST PAIN (neck and rib cage is so sore). At the time of the report, MYALGIA (arm was pretty sore), CHILLS (chills and can't stop shaking), FATIGUE (can't relax my body), NECK PAIN (neck and rib cage is so sore), TREMOR (chills and can't stop shaking) and MUSCULOSKELETAL CHEST PAIN (neck and rib cage is so sore) outcome was unknown.            No concomitant medication provided by the reporter no treatment information reported by the reporter
A few days after vaccines, my son had two huge lumps in his thigh, then he developed an ear infection, a cold that lasted two weeks, bruising, and a fungal rash only to find out on June 14,2018 he had an aggressive form of blood cancer, Acute Myeloid Luekemia .
A spontaneous report has been received from a Physician concerning a 05 years male patient. The physician reported for three patients. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving FLUMIST (Intranasal) started during Sep-2013. Patient developed fever, cough. They tested positive for Influenza. Physician did not know the date each patient developed the symptoms, but her said it was 3 months after receiving FLUMIST. Patient was treated with TAMIFLU and recovered. The reporter considered the event influenza as non-serious.
sick; tested positive for Covid after first dose of vaccine; This is a spontaneous report from a contactable Nurse. This 49-year-old female nurse reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EJ1685) on 21Dec2020 at left arm for Covid vaccine. Medical history included hypertension diagnosed 20 years ago and asthma diagnosed all her life. Concomitant products were not provided. She was scheduled to get the second dose but she tested positive for COVID on 28Dec2020. She got sick with the first dose so she was scared about getting the second dose.  She was still positive for Covid as of 21Jan2021 and still symptomatic with a cough, no smell or taste. She did not know when she can get the second vaccine. The outcome of Covid was not resolved, of other event was unknown.
Slight itching with red rash starting at top of shoulder running down to elbow. Redder closer to injection site.  It is the Moderna vaccine. I had Covid December 4th. I have severe allergies and asthma. I had the injection February 25th and the slight itching started about 3 days later. I didn't look for rash until today so not sure when it started. My arm was extremely sore after shot and still very  tender to touch but better.
Since covid vaccination I developed A-Fib. My family practice Dr as well as the cardiologist I recently saw both believe that there could be a link between the Johnson & Johnson vaccine and possible inflammation that could be causing me to be having A-Fib.
Pt and grandmother contacted the after hours phone number due to patient stating he was having an itchy throat, and pain, redness and swelling at the site of injection in his right arm. After hours provider instructed guardian to take pt to the ER. Grandmother called 911 and pt was monitored and released and grandmother did not take pt to the ER. She gave pt Benadryl instead as discovered in follow up phone call.
Patient received second dose of Pfizer vaccine on 5/12/2021 at 09:47am.  Medication had a manufacturer's expiration date of 8/2021.  Dose expired on 5/12/2021 at expired at 09:30 am on 5/12/2021.  No adverse reactions.  MD made aware.
Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Fever, shaking, body rash, headache, swollen face, nosebleeds, runny nose, vomiting.
I started getting symptoms of sinus congestion and sore throat. I have migraines and thought I was getting a migraine but the headache was getting worse with no relief from medications. I did an at home COVID-19 test that was positive. I became very nauseous and loss of appetite. Most of my symptoms lasted 11 days. I have GI issues even to this day as well as a migraine.
This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients of unknown ages with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with an improperly stored VARIVAX (Merck) (route, anatomical location, lot# and expiration date were not reported). There was not concomitant therapy reported. The nurse stated that there were no adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.