chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Came down with Evans Syndrome 3/15/09. Seen for irritability 3/7/09.  5/4/09 Received hospital medical records of multiple admits. FINAL DX: thrombocytopenia; Evans syndrome Clinic visit 3/7/09 for crying & tugging at ears.  Noted to have dime size bruise at injection site right thigh.  Ears were clear & dx w/pain/irritability s/p immunizations. RTC 3/15 w/easy bruising x 1 wk worse last 2 days all over body.  Referred to ER for coagulopathy. 3/15-3/21/09 Admit Records reveal patient experienced bruising x 1 wk.   Admitted for Heme & tx w/IV high dose steroids which failed to increase plts.  Tx w/IVIG & improved.  D/C to home on continued steroids w/central line for future IVIG tx.  D/C to home on steroid taper. 4/3-4/4 Admit for IVIG. Plts 35K.  4/6 Seen in clinic for URI & left OM.  Tx w/oral antibiotics 4/7-4/8 Admit for IVIG.  Plts 21K.  4/10-4/17 Admit for vomiting, increased bruising, irritability, blood tinged stool & falling plt ct.  Tx w/IVIG 4/22 Clinic visit for resolved OM.  4/26 Seen in ER for episode of irritability.
weird symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (weird symptoms) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (weird symptoms). At the time of the report, VACCINATION COMPLICATION (weird symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
My daughter came down with COVID three days prior on 28FEB2023 I was very tired the next day I woke with congestion I took a COVID-19 test and it was positive, on day three I noted a very irritating cough that was constant my Doctor prescribed Paxlovid I was better the next day symptoms were gone on the fourth day although I did test positive until day seven.
Horrible  head to toe body aches, photophobia, fever 100.1-102.1, chills, exhaustion lasting about 32 hrs.  By 36 hrs, temp 99-100 F
Sunday 4/4: Low-grade fever; sore arm all the way up to neck; backache; exhaustion; diarrhea; night sweats Monday 4/5: dizziness; sore arm; backache; diarrhea; rash started appearing in the late PM Tuesday 4/6: viral rash (hot / itchy) covering entire upper body - entire neck, chest, stomach, back, groin area; diarrhea; backache
-sore are at site of injection for 2 days; then more generalized shoulder pain, progressing to limited range of motion;  then inability to lay on that side while in bed. -revisited APN at Family Clinic and was referred to Orthopaedic physician.   -Orthopaedic physician injected the shoulder and prescribed Meloxacam along with at home physical therapy. He stated I should get back to 90% functioning.  Two years after flu shot that has occurred.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (confirmed not GARDASIL quadrivalent) (lot#, dose#, dose and route unspecified). No adverse symptoms reported. No product quality complaint was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
left sided burning sensation, blisters, and persistent sharp pain which was diagnosed as shingles; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.   In or around 08-SEP-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).   In October 2017 (reported as "one month after receiving zoster vaccine live (ZOSTAVAX))", the pt suffered a left sided burning sensation, blisters, and persistent sharp pain which was diagnosed as shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using it. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX). Shingles was considered to be a disabling event, due to the pt's permanent and incurable injuries.
Patient with prolonged febrile seizure (20 minutes) within 24 hours of vaccine administration
This spontaneous report as received from a Pharmacist refers to multiple unspecified patients of unknown demography. On an unspecified dates, multiple unspecified patients may have been administered improperly stored PNEUMOVAX 23 syringes. Nurse was not sure at the time of the call if she had PNEUMOVAX 23 syringes included in her temperature excursion so she has no lot number or expiration dates to provide. She states that the PNEUMOVAX 23 syringes may have reached -3.6 degree C for 92 hours and 6 minutes, but is unsure if they were actually involved in the office excursion. No adverse effects have been reported. No additional information provided. No product quality compliant (PQC) involved. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291334 same patient, different drug/event;
Pt received boostrix and gardasil vaccines on april 16th 2007. on 5/9 pt was seen in ED with seizure activity - no prior hx of seizured. Mother called MD office to inquire as to whether vaccines could be responsible for the seizure.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. The patient was vaccinated with PNEUMOVAX 23 (dose, route and site of administration not reported) lot # H014283 and expiration date 17-APR-2014 on 01-MAY-2014. There was no adverse reaction reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was given the 2nd Pfizer vaccine 6 days before the recommended time between the 1st and 2nd dose.
This is a case of breakthrough COVID-19 disease that resulted in death.   The individual was vaccinated with the Moderna product on 01/28/2021 and 02/25/2021.   The individual then developed symptoms including fever, chills, cough, and sore throat on 11/08/2021.   The individual had a positive COVID-19 PCR panel from a specimen collected on 11/12/2021.   The individual was hospitalized 11/21/2021 until their death on 11/22/2021.   I do not have death certificate details or underlying medical conditions immediately available to me at this time.
Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 01-Apr-2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 01-Apr-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Diabetes mellitus, Hypertension, Sciatica and Fibromyalgia.    On 01-Apr-2022 at 11:24 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 11:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was on multiple medications. The patient took booster dose. The vial was initially stored in the refrigerator on 25-Feb-2022, its 30 day used by date was 25-Mar-2022. The vial did not underwent any temperature excursions.  It was reported that the patient did not experienced any side effect. No treatment information was reported. The patient not had COVID-19 within last month.
The patient's experience was considered medically important. Information has been received from a physician via a company representative concerning a child (age and gender unspecified) who received a dose of Prevnar on an unspecified date. The child subsequently developed a pneumococcal infection. Laboratory/diagnostic test results were not provided.
1wk p/vax pt had fever 105 & had sz & coma;mom had given APAP & also had urticaria;
About 6 hours after getting the vaccine i noticed the back of my shoulder was very itchy and had hives on, this morning when i awoke the hives spread up my neck to my ear and to the center of my back.
Decedent received a booster dose on 8/18/21 and developed symptoms of not feeling well, which appeared to resolve.  She was found deceased at home the following day on 8/19/21. 1st dose given 1/27/21; 2nd dose given 2/24/21.
Small, Red, rash from head to toe. Some spots are slightly raised. It does itch in spots, but not all over all the time. Skin seems to be somewhat hypersensitive. PO benadryl didn't help
Vasovagal, vitals normal after oral fluids but patient felt weak, flushed nauseated. Drove himself and did not feel comfortable driving home. Asked that we call ambulance
At 12:26 client complained of headache lightheaded beginning 20 minutes after receiving the vaccine she felt warm she has a history of allergy to Levaquin oral medication which causes joint and body pain she reported she was nervous before coming to the vaccine center due to she?s breast-feeding and she felt uncertain if she should get the vaccine she had eaten breakfast but no lunch she denied shortness of breath she had no cough no rash no G.I. symptoms at 1:10 PM she felt better she felt OK to drive home she left at 1:10 stable ambulated independently to the car her vital signs taken at 12:30 the blood pressure was 130/72 temperature 98.1 she was alert and oriented at 12:50 her blood pressure was 132/98 pulse was 72 respirations 16 Her breath sounds were clear and she was alert and oriented at 1:05 PM her blood pressure was 130/110 her pulse was 72 respiration 16 clear breath sounds alert and oriented we referred her to her primary care doctor for follow-up of her blood pressure which is elevated and we referred her to call 911 if she has any symptoms of severe allergic reaction
BAD FLU SYMPTOMS; VOMITING; FEELING STRANGE/JUST WEIRD FEELINGS IN HANDS; FEELING ANXIOUS; FEELING A LITTLE HYPER; INSOMNIA; APPETITE CHANGE; BODY FEELS LIKE ITS STARTING  TO HEAT UP AGAIN; NERVOUS FEELING; ILL FEELING/FEELING SICKER; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bad flu symptoms. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced feeling strange/just weird feelings in hands. On APR-2021, the subject experienced feeling anxious. On APR-2021, the subject experienced feeling a little hyper. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced appetite change. On APR-2021, the subject experienced body feels like its starting to heat up again. On APR-2021, the subject experienced nervous feeling. On APR-2021, the subject experienced ill feeling/feeling sicker. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad flu symptoms, vomiting, feeling strange/just weird feelings in hands, feeling anxious, feeling a little hyper, insomnia, appetite change, ill feeling/feeling sicker, nervous feeling, nausea, fever, and body feels like its starting to heat up again. This report was non-serious.
This spontaneous report was received from a physician via Poison and Drug Center (PDC) regarding a baby unknown age and gender. The patient's medical history, current condition and concomitant medication were not reported. On an unknown date, the staff inadvertently vaccinated an expired (wistar ra 27-3) M-M-R II (strength, dose, frequency, lot number and expiry date were not reported) (expired product administered) for prophylaxis. The patient's relevant lab data was unknown. At the time of report (04-MAY-2018), it was unknown if the baby would continue to receive (wistar ra 27-3) M-M-R II. It was reported that the baby was okay.
Presented with shortness of breath.  COVID test was positive and admitted for pneumonia management. Tx w/remdesivir, steroids, O2, zinc, abx; weaned to RA, dc'd home
Swollen lymph node in shot arm; General ache; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FF8841) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: EL3247, Route of administration: Intramuscular, Anatomical Location: Arm Left, Dose number: 1), administration date: 20Jan2021, when the patient was 54 years old, for COVID-19 immunisation; Bnt162b2 (Batch/lot number: EL3247, Anatomical Location: Arm Left, Dose number: 2), administration date: 12Feb2021, when the patient was 54 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 16Nov2021 05:00, outcome "recovering", described as "Swollen lymph node in shot arm"; PAIN (non-serious) with onset 16Nov2021 05:00, outcome "recovering", described as "General ache". Therapeutic measures were not taken as a result of lymphadenopathy, pain. Additional information: The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. The patient did not any other medications the patient received within 2 weeks of vaccination. The patient prior to vaccination was not diagnosed with COVID-19. The patient not has been since the vaccination, tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Pain in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 2, single (Lot number: FH8020) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: 30135BA), administration date: 13Oct2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "Pain in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in her arm".  Additional information: COVID vaccine history: All Pfizer First vaccine: given: 13Oct2021 Lot: 30135BA, second vaccine: given 03Nov2021 lot: FH8020.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated an improperly stored doses of M-M-R II (dose and route were not reported, lot # L012480 with expiration date 10-APR-2017 or lot #L020189 with expiration date 03-JUN-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
High pitched screaming for 3 days (more than 3 hours over the course of 3 days), low grade fever - developmentally delayed. 4/28/08-records received-evaluation 3/31/08 13 months of age- Reflux. Assessment: not eligible for early intervention services.  Per family patient screamed after 2, 4 and 6 month immunizations and experienced convulsions.
headache; like a pressure in the frontal lobe of my forehead; mild fever at 99.8°F; chills; was tired/feel tired the rest of the following day; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead), HEADACHE (headache), PYREXIA (mild fever at 99.8°F), CHILLS (chills) and FATIGUE (was tired/feel tired the rest of the following day) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chest pain.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced PYREXIA (mild fever at 99.8°F), CHILLS (chills), FATIGUE (was tired/feel tired the rest of the following day) and MYALGIA (body aches). On 21-Sep-2021, the patient experienced HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Sep-2021, PYREXIA (mild fever at 99.8°F), CHILLS (chills), FATIGUE (was tired/feel tired the rest of the following day) and MYALGIA (body aches) had resolved. At the time of the report, HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2021, Body temperature: 99.8 (High) 99.8 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  The patient was previously diagnosed of potential heart pain.   This case was linked to MOD-2021-334971 (Patient Link).
FEVER OF 102, BODY ACHES, SWOLLEN LYMPH NODES IN NECK, ARM PITS, AND FEMORAL AREAS AND BRUISING IN HER RIGHT ARM.
Joint aches; soreness in arm; stomach cramps; skin sensitivity; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 20Apr2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to food, medication or other products. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the right arm on 30Mar2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 14:30, the patient experienced joint aches, soreness in arm, stomach cramps and skin sensitivity. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event joint aches, soreness in arm, stomach cramps and skin sensitivity were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; No further information is expected.
Body aches, headache, fuzzy mind, sore arm (Day 1 post injection)  Redness, hot to touch, tender arm (Day 2 post)
Information has been received from a nurse concerning a 24 year old female who on 09-APR-2008 was vaccinated IM in the right arm with the first 0.5 ml dose of GARDASIL (Lot # 660387/1967U).  Concomitant therapy included vitamins (unspecified).  On 09-APR-2008 the patient experienced immediate local reaction to the right arm (injection site arm), developed redness up to inches in diameter, increased warmth, pain down arm into chest, heaviness in the right arm and heaviness in chest.  The office has been observing the patient and the redness has begun to lessen.  Patient outcome is unknown.  Medical attention was sought in the office.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/4/2008.  The redness, warmth, and pain down arm and into chest lasted approximately 30 minutes before the symptoms abated.  The patient had no respiratory distress.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  Additional information has been requested.