chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 4-month-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 07-NOV-2022 03:07 PM, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral liquid, lot # 1879861, expiration date: 20-OCT-2023, administered orally for prophylaxis (dose, strength was not provided) after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was 11.4 degrees Celcius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion.  No additional adverse effect (AE) details were provided (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA000032: US-009507513-2212USA000033: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000037: US-009507513-2212USA000038: US-009507513-2211USA004171:
Information has been received from a healthcare professional concerning a 17 year old female with no pertinent medical history, drug reactions/allergies or concomitant medication usage who on 27-NOV-2007 was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of Gardasil (lot#658560/1062U). On 28-NOV-2007, 24 hours post vaccination, the patient felt lightheaded. Two hours later her vision became black and she had a convulsion lasting for 15 seconds with urinary incontinence. On 29-NOV-2007, the patient developed a fever (102F), photophobia and a headache, no stiff neck was reported. The patient was seen by her primary physician and recovered in 5 days. On 21-Dec-2007, the patient was seen by the reporting physician's office with a diagnosis of convulsion vs syncope and questions whether this is related to the Gardasil vaccine. The patient was scheduled for an Electroencephalogram, a halter monitor and an MRI of the head. Upon internal review, the patient's convulsions were considered an other important medical event. Additional information has been requested.
24 hours later, red and hard area. By Monday, injection site getting better (4 days later).
Patient noted Left arm pain and burning/tingling into L hand shortly after receiving vaccine in L deltoid.
Patient received above vaccinations on 11/12/2020. Symptoms of fever began 11/21/2020. Emesis began overnight 11/22-11/23. Went to Emergency department for evaluation where partial septic workup done and empiric therapy with Ceftriaxone begun. Child noted to be lethargic, diminished sensorium and not improving; on 11/24, underwent lumbar puncture. Results demonstrated CSF WBC of 551, consistent with meningoencephalitis; Cultures in blood, urine and  CSF (including enteroviral panel, VZV) all negative. Chest X-ray, stool studies also negative.
Patient received the third rabies vaccine on 06/28/2006. Developed swelling at vaccine site and hives on back 2 hours after injection. Mom gave Benadryl and put in a pool. After 4 hours his temperature went from 101 to 101.5 degrees (F). Ok next day except some irritability for a few days.
I'm having dizziness when I sit up from a lying position; first of all I slept for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I'm having dizziness when I sit up from a lying position) and SOMNOLENCE (first of all I slept for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (I'm having dizziness when I sit up from a lying position) and SOMNOLENCE (first of all I slept for 24 hours). At the time of the report, DIZZINESS (I'm having dizziness when I sit up from a lying position) and SOMNOLENCE (first of all I slept for 24 hours) outcome was unknown. Unknown          No concomitant medications provided. No treatment medication was reported.   Reporter did not allow further contact
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml single in the left arm on an unspecified date in Jul2016. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, nausea, headache and feeling weak on an unspecified date in Jul2016 with outcome of unknown. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
Guest  complained of feeling "woozy" approximately 30 minutes following the administration of the first dose of the  covid vaccine.  The guest was given water and juice. Initially reported that she felt better afterwards but about 6 minutes following  she requested to lay down on the cot.  Patient reported that she has a history of  PTSD.  Guest also reported that she has had similar symptoms with other vaccines. The Medics were called to tend to the guest. Vitals were taken periodically over a 30 minute period. Blood pressure  and pulse slowly decreased. Heart rate remined slightly elevated. O2 sats 98%.  Guest was released to go home with her father who was driving. Guest reported that she felt quite a bit better. Ambulation was steady.
Patient called 12/19/2019 reporting pain in her joints and general achiness throughout her body. Said it began in the evening of day she received vaccine. She said she was not running a fever. Informed her this was a possible reaction to this vaccine and should get better within 2 to 3 days. Called patient 12/21/19 to follow up and she said symptoms have gone away. Did not have reaction with first dose.
This spontaneous report was received from the patient's husband regarding a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date (reported as six years ago), the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In approximately 2015 (reported as a few weeks ago), the patient contracted shingles, there was a severe rash on one shoulder and a slight rash on the other. The patient occasionally wakes up in the middle of the night crying from pain the shoulder with the severe rash. The patient sought medical attention by visiting the physician and she was treated with an unspecified antibiotics. At the time of the report, the outcome of the patient contracted shingles was unknown. Additional information is not expected because no contact details were available.
Medication Error, Pt was given Kinrix out of licensed age range. No negative symptoms presented post injection.
~ 10 hours after vaccination  - Muscle aches, pain at injection sight, join pain, fatigue, rapid heart rate, difficulty breathing, chest pain (especially when inhaling) Triage at ER - BP: 138/84, pulse 108, temp (oral) 98.3, respiratory rate 18, SpO2 100% Given iv fluids and potassium tablets  EKG showed sinus tachycardia
Sweating, chills, feeling super exhausted, joint pain. Lasted a day and I began to feel better. I started feeling the symptoms again any time after I get a UTI or a cold. Symptoms keeps coming and going, it's hard to know if it is attributed to the vaccine or it is my ongoing long standing health conditions.
PATIENT RECEIVED MODERNA VACCINE AT AGE 17. SHOULD HAVE RECEIVED PFIZER. PER CDC DOSE DOESN'T NEED TO BE REPEATED.
Erythematous papular and plaque like lesions - very pruritic on extensor surface of upper and lower extremities. This rash developed 2 weeks after 2nd and 3rd GARDASIL vaccine
Diagnosed with covid after getting pfizer covid bivalent booster/ covid symptomatic; Diagnosed with covid after getting pfizer covid bivalent booster/ covid symptomatic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiac arrhythmia", start date: 1985 (ongoing). Concomitant medication(s) included: ELIQUIS taken for arrhythmia.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jan2023, outcome "unknown" and all described as "Diagnosed with covid after getting pfizer covid bivalent booster/ covid symptomatic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2023) positive, notes: Result: positive; Unit: Not Provided; (16Jan2023) positive, notes: She did her first self test on 16Jan2023 and that was a strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: It was reported that, patient had other medications that are prescribed for other problems. One medication had to be modified since it is an anticoagulant for a cardiac arrhythmia, clarifies the medication is Eliquis. Manufacturers bottle is mainly covered by pharmacy label and unable to provide lot, ndc, or expiration. She has taken Eliquis for several years. Cardiac arrhythmia with any other treatment other than beta blockers which she has been taking since the mid 80s. She had an antigen rapid test this morning, it was self administered, which still shows positive for covid. She is a little spacy here, she became covid symptomatic on Saturday 14Jan2023. On the 06Jan2023 she had the Pfizer bivalent booster. She does not have vaccine card handy to provide further details. She did her first self test on 16Jan2023 and that was a strong positive. Paxlovid was started on 17Jan2023.   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.
Vaccine administered from vial that had been punctured for 24 hours and 30 minutes.
This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (feels cold), FEELING ABNORMAL (feels worse today), PYREXIA (fever reached 101 F) and CHILLS (chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Mar-2021, the patient experienced NASOPHARYNGITIS (feels cold), FEELING ABNORMAL (feels worse today), PYREXIA (fever reached 101 F) and CHILLS (chills). At the time of the report, NASOPHARYNGITIS (feels cold), FEELING ABNORMAL (feels worse today), PYREXIA (fever reached 101 F) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever reached 101 f, fever is starting to come down.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication include stress and hypertension medications. Treatment method include cold compress. Upon follow up it was reported by the patient's friend that the patient was feeling fine and she doesn't knowhis email id and asked us to close the case and no more calls , she also mentioned she had sore arm after the injection but now she is fine and no more calls in future for this one.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: no new information was recieved
Pt received the ADACEL (Tdap) first on (L) deltoid while sitting down and had no problem. Pt stood up and got GARDASIL (R) deltoid. He had a syncopal episode immediately after the vaccine was given.
Information has been received form a physician concerning a 9 year old (also reported as 8 year old) female patient who on 17-DEC-2001 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 19-JUN-2004, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 16-JAN-2010, the patient experienced mumps. The diagnosed date was on 18-JAN-2010. The patient had swelling under left ear, left parotitis, swollen glands and sore throat (unknown if the patient had orchitis). There were no other symptoms. It is unknown if the patient had exposure to others with mumps (sib, classmates) or if there was other case in same household.  There was no third dose of MMR II given. There was a second blood work performed. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
Monday 9/30/19 at 8pm arm was red and swollen, applied cool compresses. Tuesday 10/1/19 at 4pm when the child returned from school arm had increased redness, pain, and swelling.  Applied cool compresses, circled the area to check for increasing redness and swelling, and gave benadryl.  Wednesday 10/3/19 the redness had spread outside the line, brought  to walk-in clinic  and was diagnosed with a reaction to the flu vaccine
Developed Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient received first dose of Covid Vaccine last week, Developed Covid, contacted HCP and was advised that she had to wait 3 months to get second vaccination. Wanted to know what Pfizers stance on this was. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
7cm Red, slightly raised, warm to touch area on right thigh, no treatment at present time, site marked to be monitored for increase in redness.
death/Passed away at home after having a COVID shot; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP).  An 80-year-old female patient received BNT162b2 (BNT162B2 NOS), on 04Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; treprostinil sodium (TYVASO), since 03Nov2022 (Lot number: 000321P, Expiration Date: 30Apr2024) at 64 ug 4x/day, nasal for pulmonary arterial hypertension; treprostinil (TREPROSTINIL), first regimen (Batch/Lot number: unknown) at 64 ug 4x/day and second regimen since 03Nov2022 (Batch/Lot number: unknown), all nasal for pulmonary arterial hypertension. The patient's relevant medical history included: "Pulmonary arterial hypertension" (ongoing), notes: Current Condition. Concomitant medication(s) included: OPSUMIT. The following information was reported: DEATH (death, medically significant) with onset 2023, outcome "fatal", described as "death/Passed away at home after having a COVID shot". The patient date of death was 2023. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: Report received from a consumer's spouse from a patient support program via (pharmacy name). Passed away at home after having a COVID shot.  The reporter did not provide causality for the event of death. Case Comment/Senders Comment: The company has assessed the serious adverse event of death as not related to treprostinil inhalation powder and Tyvaso DPI inhaler. The event was likely due to progressive and life limiting nature of underlying PAH (Pulmonary hypertension).  The reporter's assessment of the causal relationship of "death/passed away at home after having a covid shot" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information the causal role of suspect product cannot be excluded for reported event. Case will be reviewed on receipt of FU information The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death
Patient reports being fully vaccinated with Pfizer COVID19 vaccination on 12/21/20 and 2nd dose on 1/12/21.  Patient reports COVID symptoms of cough, nausea, body aches, loss of taste, loss of smell, headache, eye pain, dizziness, scratchy throat, congestion  starting 8/17/21 and tested COVID positive via antigen test on 8/19/21. Patient remains symptomatic and unable to work as of 8/23/21.
Child after 15 minutes of receiving immunization c/o headaches (in between eyes). BP: 121/82, reexamined child, fundi disc sharp, BV normal, child received a popsicle-> and waited=15 minutes later. BP: 110/69, P 80: Headache resolving, TYLENOL 1 gram given PO after eating lunch.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 24-SEP-2017, the patient was inoculated with ZOSTAVAX at a family physician's office for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-NOV-"2012" (note this is prior to vaccination date), the patient was treated by a dermatologist for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. She was prescribed VALTREX, gabapentin, and TYLENOL for management of her painful symptoms. On or about 06-DEC-2012, the patient sought subsequent treatment by another Dermatologist for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster.  She was prescribed VALTREX and gabapentin. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
As soon as ENGERIX-B given (4th immunization for today, client suddenly fell from her chair to the floor, facing the floor. Her upper and lower extremities were shaking. Client got up on her own and sat on the chair. Client's face was ashen and pale. Client complained of being dizzy and not feeling well. Client  was helped to the bed and asked to lie down. Vital signs at 1:35 p.m. were BP =120/78, HR=64. Client's legs were elevated and approximately 90 cc of juice given. Client was orientated to her name, date of birth, and was able to name family members who accompanied her to the clinic. Client reportedly ate last at 8:00 a.m. There was no reported history of any preexisting medical conditions. 18 year old sister revealed client had similar episode at a previous vaccination. Screening questionnaire revealed no concerns. 1:45 p.m. Client reported dizziness and not feeling well. comfortable position was supine for the client. EMT was activated at 1:45 p.m. Vital signs at 1:50 p.m. were BP=150/88, RR=22. Client given approximately 90cc of juice again. Client continues to complain of dizziness. Client's color has returned to pre-episode color. At 1:55 p.m., Fire Department arrives and client is assessed. Between 2:00-2:05 p.m. EMT arrives and assess client. Decision is made to transport client to nearest Emergency Department. Vital signs prior to departure were BP=140/80, HR=120. client transported to Medical Center. Ambulance departed at approx. 2:18 p.m.
Pt had gastric upset, feeling tired, nausea, no rash, pt given Benadryl prior to last vaccine 9/29. Pt had these symptoms after 9/15 vaccines was given.
I experienced a fever 102.4, headache and extreme muscle pain and aches throughout my entire body.. The adverse events lasted approximately 36 to 48 hours.
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 20-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half dose was discarded by the person administering the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Patient received the covid vaccine 5/14/2021 around 220pm and was waiting post vaccination for observation. About 2-3minutes after receiving the vaccine the patient lost consciousness and fell out of the chair on to the floor. The patient stated she lost consciousness and was very anxious.
Patient had a positive COVID test on 1/27/22; 2/3/22 patient to ED with syncopal type episode; O2 sats 97% on RA; doctor states patient already on treatment for COVID from 1/27/22 (no specific treatment in the medical records); patient was DC'd to home where he passed away.
Experienced common site reaction pain, swelling.  However over the next 48 hours experienced dizziness, nausea body aches and severe headache.  One episode of LOC resulting in severe facial bruising and swelling, bilateral knee bruising and swelling.
Patient had a few red splotches on the arm and red at site of injection. Only on right arm.
Severe piercing pain rippling from left side of pelvis to right side occurring 5 minutes after vaccination (Flu) to left deltoid muscle.
Had Fluzone/pneumonia vaccine 11/19/2004(AM). That evening started feeling achy(lower back) temp went up to 103 degrees by late PM. Temp went down to 101 degrees but lasted all week-end. Did not seek medical care. On 11/22/04 red blotchy area appeared on right arm near the injection site. Client states feeling much better, but feels weak.