chrisvoncsefalvay/vaers-outcomes huggingface dataset:
skin hypersensitivity; High fever; severe body aches; severe headache; Large, painful, swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 45-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021 at 08:30 (at the age of 45-years-old) in left arm as a single dose for covid-19 immunization. The patient's medical history was reported as none and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. He had no known allergies. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date in Jan2021 at 10:00 in right arm for covid-19 immunization. The patient experienced high fever that took 3-4 hours to break with alternating Tylenol and Motrin, severe body aches, skin hypersensitivity, severe headache, and large, painful, swollen lymph nodes on 09Feb2021 at 16:30. The patient was treated with Tylenol and Motrin for high fever and did not received any treatment for other events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a male consumer in his 80's years of age concerning himself. The patient's medical history included prostate cancer in approximately 2004 (reported as 10 years ago), the patient had no drug reaction or allergies. On an unspecified date in approximately 2012 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (manufacturer unknown), (strength, dose, route, anatomical location, lot number and expiration date were not reported) in the physician's office, the patient was not able to identify if the vaccine was ZOSTAVAX or another vaccine. Concomitant therapies included steroids unspecified and tramadol hydrochloride. On an unknown date soon after the patient developed a case of shingles from which he was still experiencing nerve pain. The patient seek medical attention through office visit, the patient was given gabapentin as treatment for the event. Quarterly unspecified lab test were performed. No further information was provided. The outcome of shingles and nerve pain was reported as not recovered/not resolved. Additional information has been requested.
Aluminum intoxication; POTS; CFS; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 13-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), chronic fatigue syndrome (CFS) and aluminum intoxication. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of aluminum intoxication was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Injection site got bruised; Injection site got red; Injection site tender to the touch; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Injection site got bruised), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Injection site got red) and VACCINATION SITE PAIN (Injection site tender to the touch) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Injection site got bruised), VACCINATION SITE ERYTHEMA (Injection site got red) and VACCINATION SITE PAIN (Injection site tender to the touch). On 30-Mar-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE BRUISING (Injection site got bruised), VACCINATION SITE ERYTHEMA (Injection site got red) and VACCINATION SITE PAIN (Injection site tender to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included Anti-histamines and Antacid.  Treatment information was not provided.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 07-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 13-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
BLOOD CLOT IN BRAIN; This spontaneous report received from a consumer 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: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in brain was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210453717.; Sender's Comments: V0:20210454254-covid-19 vaccine ad26.cov2.s-blood clot in brain. This event(s) is considered related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Very painful and swollen chest/under arm lymphnode - left side; Very painful and swollen chest/under arm lymphnode - left side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via COVAES. The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 12:00 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma allergies neuropathy; "Neuropathy" (unspecified if ongoing), notes: Asthma allergies neuropathy; "Allergy" (unspecified if ongoing), notes: Allergy with unspecified drug. Concomitant medication(s) included: RELPAX; ALLEGRA D. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 23Feb2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details Location of injection: Arm Left Vaccine Administration Time: 02:00 PM), administration date: 16Mar2021, when the patient was 53 years old, for COVID-19 Immunization.  The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 14Nov2021 04:00, outcome "not recovered" and all described as "Very painful and swollen chest/under arm lymphnode - left side". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included: Relpax, Allegra d as needed. No hospitalization prolonged. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  .  Follow-up attempts completed. No further information is expected.
I am a citizen of which for other motives I visited the and having the opportunity I was vaccinated. I was vaccinated Thursday May 20, this day I did not have any type of symptom and the following Sunday May 23, I began very strongly to tremble in my legs and hands, additionally Monday while trembling a strong loss of strength and tingling and numbness in my hands and feet. Never before have I had this type of trembling. To this date, the trembling continues, the loss of strength and I have with exercise been able to recover a little of it, the trembling continues. I visited the neurologist who is checking blood work, I am taking Topiramate 25mg from 8AM  8PM; but the symptoms are not improving
PATIENT EXPERIENCING SWELLING IN THE RIGHT DELTOID AND SWELLING HAS BEGUN TO MOVED  DOWN HIS ARM.  HE HAS BEEN TAKING TYLENOL AND ROTATING BETWEEN ICE AND HEAT TO REDUCE SWELLING AND INCREASE BLOOD FLOW.  PATIENT STATED CAN NOT TOLERATE BENADRYL TO HELP IF ALLERGIC REACTION SO RECOMMENDED CETIRIZINE WHICH HAS ON HAND.  RECOMMENDED HE BE EVALUATED ON SUNDAY 09/06/20 DUE TO SWELLING HAS MOVED PAST HIS ELBOW.
Patient's initial vaccine dose was Pfizer. Given Moderna second dose instead of Pfizer.
The day after the shot, I developed a fever of 102.4.  During the night, I developed a headache so bad I couldn't sleep.  When I got up to take Tylenol, I fainted on the bedroom floor.
Severe flu like symptoms within 4-6 hrs with chills high fever nausea injection site pain rating 8-10 symptoms lasting 4 days confined to bed.
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
I contracted COVID-19 while visiting another area on 05/28/2022 with symptoms of cough, runny nose, difficulty breathing, loss of smell. I was prescribed fluticasone, LEVOPRONT, tamsulosin, chamomile peppermint spray, SYNCOL, vitamin C, doxycycline, azithromycin, and viral medications on 06/08/2022. My symptoms began to resolve after two days of taking medications. I am fully fully recovered with no lingering symptoms.
Pt. started to experience the following symptoms: Throat tightness and difficulty swallowing. Audible wheezing heard bilaterally in lungs. Vitals taken at approximately 1425 and were the following: BP - 140/102, HR - 120, and RR - 25.  50mg (20mL) of Benadryl  orally at 1430. Pt. feeling better, but distressed. Second set of vitals were taken at 1450 and were the following: BP - 123/83, HR - 83, and RR - 13. Pt. was released to go home and given advice on secondary reactions at 1505.
Patient came to pharmacy requesting a COVID vaccine, Pfizer, Moderna, whatever we had. Patient was given Moderna. Hours later daughter calls and states that father had received Pfizer when the vaccine was first available to the public back in January and had received both doses. Stated that father suffers from memory problems.
after having the simplex shots (2) I got shingles/suspected vaccination failure; I got shingles; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the 2 doses of Shingrix shots in 2019 and still got shingles. The patient took gabapentin for 11 months.  The patient asked being under physician's care and 1 being a nerve specialist, how advertisement says the shots would keep us from getting the virus. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Rash on stomach/e rash on face, got worse, moved down chest and neck; Chills; Aches; Headache/ had a severe headachewhenever laying down.; Fatigue; Felt like rash was in mouth, gums; Throat felt tingly.; gums and throat felt tingly; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 10:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included rash on face (Face rash whenever get sick) and seizure (Controlled seizure disorder). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included phenytoin (DILANTIN) and tiagabine hydrochloride (GABITRIL) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 7534) via an unspecified route of administration in the left arm on 05Mar2021 at 10:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. 06Apr2021 at 22:45, the patient experienced chills, aches, headache, fatigue lasting 7 days, but improved a bit each day. Also had rash on stomach 12 hours after vaccine lasting one day. On 08Apr2021 the patient experienced, day 3 after 2nd vaccine had a severe rash on face, got worse, moved down chest and neck day 4. On an unknown date in Apr2021, the patient experienced felt like rash was in mouth, gums and throat felt tingly, took Benadryl and went away around day 6. On 13Apr2021, the patient experienced 8 days following 2nd vaccine had a severe headache whenever laying down lasting entire night, but always went away 25 minutes after being up and about. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events felt like rash was in mouth, gums and throat felt tingly and included treatment with BENADRYL. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021, the patient underwent Saliva (SARS-COV-2 test) and the result was Negative. The clinical outcome of the events chills, aches, headache, fatigue, had a severe rash on face, got worse, moved down chest and neck, had a severe headache whenever laying down (lasting entire night) but always went away 25 minutes after being up and about recovered on an unknown date in Apr2021. The clinical outcome of the event felt like rash was in mouth, gums and throat felt tingly recovered on 11Apr2021.While the clinical outcome of the event had rash on stomach recovered on 07Apr2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown ages and genders. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of MMR II, lot number K016153 expiration date 24-SEP-2016, lot number reported as L001336 expiration date 13-JAN-2017 and lot number K024038 expiration date 26-NOV-2016 (route of administration and anatomical location were not reported). There were not concomitant medications provided. No adverse effects were reported and there was no product quality issue involved. This is one of several cases from the same source. Additional information has been requested.
FEVER, BODY ACHES, HEADACHE, NAUSIA, VOMITING 2 DAYS OF ALL SYMPTOMS
post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 64-year-old male patient. Medical history, concurrent conditions and concomitant medications were not provided.   On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 28-MAY-2015, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration and lot # were not provided). On unknown dates, the patient suffered the following injuries as a result of zoster vaccine live (ZOSTAVAX): herpes zoster and post herpetic neuralgia. The patient claimed damages as a result of: injury to themselves, loss of services and economic losses. The outcome of the events was not provided.   The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX).
Rash erupted on abdomen and chest area following first shot.  Subsided with antihistamine and topical steroids.  More extensive rash/hives erupted approximately 10 days following second shot that covers from pelvic/top of thigh area all the way to the chest area.  Extensive break out of the abdomen and sides that covers to the lower back.  Antihistamines and topical steroids used but the rash lasted longer and did not respond as well to OTC treatment.
Bell Palsy; tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell Palsy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.  Concomitant products included CARVEDILOL (COREG) and RAMIPRIL for an unknown indication.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (tiredness). On 15-May-2021, the patient experienced BELL'S PALSY (Bell Palsy) (seriousness criterion medically significant). On 21-Feb-2021, FATIGUE (tiredness) outcome was unknown. At the time of the report, BELL'S PALSY (Bell Palsy) outcome was unknown.  The patient went to the Emergency Room on 15-May-2021 and was diagnosed with Bell Palsy.  No relevant concomitant medications were reported.  No treatment information was provided.  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.   This case was linked to MOD-2021-137738 (Patient Link).; 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.
Saturday evening (March 3) itching developed at the injection site. By Sunday morning I had developed a large (size of half dollar coin) red rash around the injection site. Each day the rash continued to spread further down and up my left arm. Friday, March 12, I saw my PCP and she measured what she referred to as a hive as being 6" x 7"(Note:  I have had two doses of prednisone and, as of March 13, it has spread a little bit more since yesterday.)