chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via out of hour services and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received SHINGRIX. In September 2018, less than a week after receiving Shingrix, the patient experienced muscle pain and erythema. The patient was treated with MOTRIN. On an unknown date, the outcome of the muscle pain and erythema were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had the vaccination last week and ever since, she had bad muscle pain and her arm was still red. It seems to be getting worse. She was taking MOTRIN every few hours. The information was left on a voice mail so no additional information or explanation was available.
29-year-old female presented to the ED with complaints of nausea, vomiting, and fever. She received the COVID-19 vaccine yesterday. Initially, she felt well but around midnight she started having chills, fevers, and nausea/vomiting. She also complains of a headache with associated photophobia, with a headache described as a diffuse constant ache. She denies any abdominal pain or diarrhea. She denies any cough or cold symptoms. Prior to the onset of her symptoms around midnight, she felt fine.
Suspected vaccination failure; blister at the injection site/painful blisters.; chills; fever; painful rash/rash with blisters/on various parts of their body/ the thigh, lips, buttocks, sides, and arms/always occurs on one side at a time; painful rash/painful blisters.; tingling pins and needles type sensation; outbreaks of what they suspect is Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced recurring outbreaks of what they suspect is shingles since receiving the second dose of shingrix). Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), injection site blisters, chills, fever, rash, pain, tingling and shingles. Rechallenge with Shingrix was negative. On an unknown date, the outcome of the vaccination failure, injection site blisters and shingles were unknown and the outcome of the chills was recovered/resolved and the outcome of the fever, rash, pain and tingling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, injection site blisters, chills, fever, rash, pain, tingling and shingles to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. Patient herself is the reporter. The patient received the 2nd dose of shingrix approximately 2 years ago and experienced fever,chills,painful rash with blisters on the left side within 24 hours of receiving the dose. The patient also experienced blister at injection site. Patient reported had never experienced a shingles outbreak prior to receiving the shingrix vaccine. Patient reported that she did not experienced any symptoms after first dose of shingrix. Patient reported that she had experienced recurring outbreaks of what they suspect is Shingles since receiving the second dose of shingrix. Patient reported that rash typically begun with a tingling pins and needles type sensation before the development of the painful blisters. Patient reported that since receiving the second dose of the Shingrix vaccine, she had experienced rashes on various parts of their body including the thigh, lips, buttocks, sides, and arms. Patient reported that rash always occured on one side at a time (either the right or the left side). Reporter did not consented to follow-up. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Left upper leg large area of erythema (14x12cm) Warm and firm to touch. Treated with Keflex for 7 days
First 3 days injection site red tender swollen and itchy. On day seven woke up to teeth chattering chills and severe vomiting  and rapid heart rate followed by 4 days of headaches and face tender to touch. Injection site still red fever swollen and itchy on day 13. Went to Emergency Room.
Shot stung going into arm. "Woke up during night (R) arm hurt". Sent to occupational health - red raised welt 23 mm - arm is sore - injection site is too low (over tendon) - visited with RN who gave shot. Dr checked site next 2 days - healed fine.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-05-31.
2 hrs after immz HPV #1 pt c/o HA, no fever, pt stated he is feeling better today.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella virus vaccine (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient was hospitalized to rule out meningitis. the outcome of the event was unknown. the relatedness between vaccination with measles, mumps, and rubella virus vaccine, (manufacturer unknown) and the event was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no contact details to the physician.
This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (really knocked down) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included POTASSIUM CHLORIDE, VALSARTAN, CABERGOLINE, FUROSEMIDE, ALLOPURINOL, PANTOPRAZOLE, APIXABAN, SOTALOL, CARVEDILOL and ROSUVASTATIN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FATIGUE (really knocked down). At the time of the report, FATIGUE (really knocked down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the right upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Patient received 2nd dose of Moderna vaccination in her right deltoid on 3/10/2021 at 1242. On 3/11/2021, patient passed out and landed on face. Patient was taken to hospital in ambulance and received stitches from fall and claimed to have nausea and vomiting. Patient still feels numbness on face.
pt recvd vax 5OCT95 AM; started vomiting 2 times a day 6OCT95 PM x 2 1/2d; seen 9OCT95 w/sinusitis rx'd Ceclor; pt admitted to hosp 9OCT95 PM w/sz;
Patient received Moderna Covid vaccine on 2/17/21 had some pain and itching at site that she used Tylenol and ice for. on 3/2/21 took Humera for psoriasis  and left arm broke out again with the rash and itching after giving herself the Humera
Itchy throat; Slight dry cough; Mild difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Apr2021 at 15:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included emphysema from an unknown date in 2002 and was ongoing, breast cancer, skin cancer, thyroid cancer, hashimoto's disease and allergy to nuts. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously received aspirin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient also previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Mar2021 at 15:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient had no reaction at all to the first dose of vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 04:15, one half hour after the second dose of vaccination, the patient experienced itchy throat, slight dry cough and mild difficulty breathing. The reaction lasted an hour. The patient stated, if the events had continued or worsened she would have gone to the hospital. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as result of the events. The clinical outcome of the events itchy throat, slight dry cough and mild difficulty breathing were resolved on 08Apr2021 at 05:15. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a physician via call center representative and described the occurrence of muscle soreness in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle soreness and fever. On an unknown date, the outcome of the muscle soreness and fever were unknown. It was unknown if the reporter considered the muscle soreness and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that after receiving SHINGRIX, two patients developed sore muscles and fever after receipt of SHINGRIX. The healthcare professional would not give patient's initials or dates of birth did not have vaccine lot or expiry dates. This case has been linked with case US2018154161 and US2018154162, reported by same reporter.
This spontaneous case reported by a consumer, describes the occurrence of fatigue in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included multiple sclerosis (relapsing forms of multiple sclerosis). Concomitant products included ocrelizumab for an unknown indication. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had fatigue. At the time of the report, fatigue resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment information provided.
diarrhea; Doesn't remember an entire day; Altered mental status; Injection site warm to touch; Headache; Swollen red injection site; Swollen red injection site; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL STATUS CHANGES (Altered mental status), DIARRHOEA (diarrhea), MEMORY IMPAIRMENT (Doesn't remember an entire day), VACCINATION SITE WARMTH (Injection site warm to touch) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient reports contracting COVID-19 for 8 days in December) in December 2020. Concomitant products included METFORMIN, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]), FAMOTIDINE, LEVOTHYROXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), HEADACHE (Headache), VACCINATION SITE SWELLING (Swollen red injection site) and VACCINATION SITE ERYTHEMA (Swollen red injection site). On 20-Mar-2021, the patient experienced MENTAL STATUS CHANGES (Altered mental status) and MEMORY IMPAIRMENT (Doesn't remember an entire day). On 21-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 20-Mar-2021, MENTAL STATUS CHANGES (Altered mental status) and MEMORY IMPAIRMENT (Doesn't remember an entire day) had resolved. On 21-Mar-2021, DIARRHOEA (diarrhea) had resolved. On 26-Mar-2021, VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE SWELLING (Swollen red injection site) and VACCINATION SITE ERYTHEMA (Swollen red injection site) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, COVID-19: positive (Positive) Positive. On 18-Jan-2021, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she did not took any treatment for the adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up was received on 06-Apr-2021 which did not update any new information.
Patient currently hospitalized for choledocholithiasis. She's undergoing an ERCP 2/15. Today 2/16 developed acute abdominal pain severe. CT with ? Blood in abdomen and fluid surrounding GB. Consulted - Recs zosyn and likely surgery tonight. Lipase is negative, s/p ERCP. Yesterday developed worsening abdominal pain CT as above. Taken for surgery 2/16 -lap chole, noted blood in the common duct, sacute cholecystitis secondary to blood in the gallbladder. Recovered in hospital and discharged home. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
This is a spontaneous report from a contactable consumer. This consumer reported for two patients. This is one of the two reports. A patient of unspecified age and gender received a single dose of  PREVNAR 13 , on an unspecified date for immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced cough on an unspecified date with outcome of unknown.  Follow-up attempts completed. No further information expected.
area of administration very big & pink per school hlth nurse;given too low per school nurse lt arm;pt fine now
Seizure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Mar2021 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE and then on 14Apr2021 (Batch/Lot Number: ER8733) as 2ND DOSE, SINGLE; both dose administered via an unspecified route in the right arm for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included pain and inflammation and has a little problem hearing. The patient had no other medical history and no family medical history. Concomitant medication included ongoing etodolac taken for pain and inflammation. The patient was in good health and everything. He got the first shot on 17Mar2021, and 17 days later, he had a seizure on 04Apr2021. He has never had seizures in his whole life. He had the second vaccine on 14Apr2021 and had a second seizure 17 days later on 01May2021. Patient had both seizure in the afternoon. The patient further reported that he was taking a medicine that was supposed to keep him from having another seizure. It was Lev, and he can't read the rest. It looks like pmr, then acetam. He started taking that when he had the first seizure. The patient also mentioned that they did a brain magnetic resonance imaging (MRI) and bloodwork. He doesn't remember the exact date. The patient was taken to the emergency room by an ambulance. He was hospitalized both times. He doesn't remember how long he was in the hospital the first time. The second time he was there for 5 to 6 hours. They cut him loose pretty quick. The patient was first hospitalized from 04Apr2021 to an unknown date and then hospitalized again on 01May2021 for seizure. Therapeutic measures were taken as a result of seizure. The outcome of the event was unknown.
Fell down the stairs; Drowsy; very painful sore arm and hurting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell down the stairs) and SOMNOLENCE (Drowsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (Fell down the stairs) (seriousness criterion hospitalization), SOMNOLENCE (Drowsy) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (very painful sore arm and hurting). At the time of the report, FALL (Fell down the stairs), SOMNOLENCE (Drowsy) and VACCINATION SITE PAIN (very painful sore arm and hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Follow-up received on 30 Mar 2021 included added serious events of fell down the stairs and drowsy.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-032445 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Significant Follow up appended; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Fever, maculo-papular rash X 24 hours, post vax. Self resolved. No treatment.
Cough and Sore Throat progressed to severe Sinus Congestion, fever and Fatigue that lasted 7 days. Symptoms unrelieved with decongestant, anti-inflammatory and Combivent Inhaler so that ER visit was made on the 6th day after Flu vaccine.
A non-serious report of expired FLUMIST administered was received from a registered nurse concerning a 17-year-old female. Neither medical history nor concomitant medications were reported. On 22-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of December 16, 2008. 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Mar-2009 that no delayed adverse events resulted from this error. Additional information was received on 09-Apr-2009: product complaint investigation results.
After immunization, patient came to pharmacy window and stated she did not feel well and asked if we would  check her blood pressure. She stated she felt her BP had bottomed out.  BP was 194/112. She denied SOB or respiratory problems. Husband was called into the room. Her pulse was 81. Checked BP again with a manual device, recorded 192/108. Patient stopped responding to questions. 911 call. 911 dispatcher advised to wait for EMT to arrive and advised to NOT use Epi Pen due to severely escalated blood pressure. Paramedics arrived shortly. BP recorded by EMS was 192/112. Patient had a history of dysautonomia.
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form, qd. At the time of the report, PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported.
This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 27-MAR-2019, the patient was vaccinated with a dose of the pediatric formulation of VAQTA, 25/ 0.5 ml for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects reported. It was also reported that, the patient had received a pediatric dose of HAVRIX vaccine. The outcome of the event product use issue was not reported.