chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a 5 year old patient of an unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 21-AUG-2017, at 12:30, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # M021729, expiry date 29-OCT-2017, 0.5 ml, subcutaneously, in the left thigh for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion at -14 Celsius degrees to -10 Celsius degrees, during a time frame of 4 hours and 30 minutes. There was no previous temperature excursion. No adverse events were reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1708USA010724: US-009507513-1710USA011619:
Per pt mom. Pt has n/v ? diarrhea. He does NOT have pain at injection site.
arm was red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of   in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information provided. Treatment included Ice
This male subject was enrolled in a prophylactic observer blind study. On 06 November 2009, he received either a dose of FLULAVAL co-administered with saline placebo or H1N1 pandemic influenza vaccine 3.75 mcg adjuvanted with AS03A or H1N1 15 mcg without adjuvant, either saline placebo co-administered with H1N1 pandemic influenza vaccine 3.75 mcg adjuvanted with AS03A or H1N1 15 mcg without adjuvant. On 24 November 2009, he received a dose of H1N1 pandemic influenza vaccine 3.75 mcg adjuvanted with AS03A or H1N1 15 mcg without adjuvant. This subject received FLULAVAL, placebo and Pandemic vaccine H1N1 15 mcg. On 30 November 2009, six days after the 2nd dose of pandemic vaccine h1n1 without adjuvant, this 39-year-old subject developed elevated alanine aminotransferase. The event was clinically significant (or requiring intervention). The event resolved on 05 January 2010. The investigator considered that there was a reasonable possibility that the elevated alanine aminotransferase may have been caused by FLULAVAL, investigational product and Pandemic vaccine H1N1 15 mcg and that the event was possibly due to the concomitant medication, hydrocodone. Subsequent study vaccine administration was discontinued. 1FEB2010: Per PI, pt. follow up ongoing, elevation of LFT's resolved 1/5/2010. Day 28 labs received. Out of range values of ASAT of 155 reported normal range is 0-42. Elevated ALAT of 309 reported normal, rang is 0-48. ALAT is 5x the upper limit and considered SAE per protocol. Contacted the subject and instructed subject to stop Acetaminophen and reports he stopped that on 01DEC2009. Subject instructed to stop Hydrocodone states it was stopped on 30NOV2009 also stopped Orajel and Excedrine migraine which reports Orajel stopped on 30NOV2009 and Excedrine migraine stopped 29NOV2009. Subject scheduled to come in for redrams per protocol. This a protocol specified SAE. 22DEC2009 update per PI-the lab elevation of LFT's noted 12/09/09 continue to improve. Patient was not vaccinated. Vaccine vs Acetaminophen exposure cannot be definitively defined. However, Acetaminophen dose was felt to be less than 4 grams total. 27JAN2010: All lab levels have returned to normal and event is considered resolved. Doctor still feels that causality is related. A determination between vaccine and medication causing the event cannot be determined. 1FEB2010: Per PI, patient follow up ongoing, elevation of LFT's resolved 1/5/2010.
Information has been received from a pharmacist concerning a female who in 2008 was vaccinated with a dose of GARDASIL. The patient experienced seizure after receiving the GARDASIL. At the time of this report the patient had recovered. Upon internal review seizure was determined to be an other important medical event. Additional information has been requested.
Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided. This case was reported for patient 17 out of 17.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
(R) deltoid showed large area of well demarcated edema/erythema. No systemic signs/sx. This would have been site of varicella and Hep A.
Approximately 20+ minutes after the vaccination , little twinges like electric points all over.  Very mild and then they went away in about 8 minutes.  After that light fatigue and slight headache.  When woke up this a.m. just had a sore arm.  Everything else is fine.
Heart blockage in 3 arteries.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 01Oct2021 (at the age of 61-years-old) at dose 2, single for COVID-19 immunisation. Medical history included COVID prior vaccination and diabetes. Concomitant medications were not reported. The patient received the first dose of BNT162b2 on an unspecified date for COVID-19 immunisation. No other vaccine received in four weeks; no other medications in two weeks. The patient experienced heart blockage in 3 arteries on 02Oct2021. The event resulted in hospitalization in Oct2021 and was treated with open heart surgery. The patient underwent lab tests and procedures, which included COVID tested post vaccination on 09Oct2021 via nasal swab: negative. The patient was recovering from the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient expressed to Clinical Site RN that she was feeling nausea and flushing 15 minutes after administration of COVID vaccine. Upon assessment, patient's blood pressure was 187/110. Patient began to develop rash across chest and arms. Mobile response called and patient was escorted to ED.
Information has been received from a registered nurse concerning her 20 year old daughter with no medical history or allergies, who on 18-DEC-2006 was vaccinated IM with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. On 18-DEC-2006, the patient experienced throbbing pain in her arm.  Unspecified medical attention was sought. No diagnostic studies were performed.  At the time of this report, the patient's pain was subsiding. No product quality complaint was involved.  Additional information has been requested.
Had employee PE 11/10/08. Received flu vaccine, TB test and Hep B vaccine 11/10/08 during employee PE. Then was sent to health Dept. for Tdap-ADACEL (11/12/08).  Patient states approximately 2 or 3 days after the immunization experienced Myalgia and arthralgia i.e. severe bilateral hip and knee joint pain. Took Tylenol. Went to employee health dept for treatment 11/19/08 due to pain. Was in orientation to work at Hospital as a nurses' assistant. Had difficulty performing her job duties as this required lifting, bending, etc. She was evaluated in the health clinic, Emergency Dept 12/09/2008 and Walk-In clinic. Required Prednisone to control symptoms. Sent to Allergy dept for evaluation. I am sending her to Rheumatology for further eval. due to a positive ANA. Literature review has produced several case reports of reactive arthritis after a tetanus immunization. Most resolved within a few weeks on NSAIDS. But a couple case reports were found with prolonged arthritis symptoms after a tetanus report. Patient continues in pain. Is on NSAIDS, put on "light duty" so was essentially "let go" at the job (was in orientation to be a Nursing assistant).
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a infant female patient who received FLULAVAL Quadrivalent (batch number 4373E, expiry date unknown). In October 2017, the patient received FLULAVAL Quadrivalent. In October 2017, less than a day after receiving FLULAVAL Quadrivalent, the patient experienced hives, generalized rash and rash. The patient was treated with NOS BENADRYL. On an unknown date, the outcome of the hives, generalized rash and rash were recovering/resolving. The reporter considered the hives, generalized rash and rash to be almost certainly related to FLULAVAL Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported, but it could be 20 or 21 months. The healthcare professional reported that, the patient received FLULAVAL Quadrivalent vaccine sometime between 16th October 2017 and 21st October 2017. The patient experienced hives and rash on the face and bumps on the body within 18 hours after receiving the vaccine. The patient received BENADRYL and the symptoms subsided. The HCP was almost certain that, the FLULAVAL Quadrivalent had caused the outbreak. No additional information was given.
Sudden onset of flu symptoms:  chills, fever of 101 to 102 degrees, very ill, needing to lie down, fell asleep rapidly, very cold, difficult to walk to get into car to go to doctor's.  Ibuprofen helped but did not bring down the fever immediately or completely.
None note just received Dose #3 of vaccine. 1st dose Moderna the 2 subsequent Pfizer doses at appropriate time spacing levels
Patient had a small, itchy rash that started 2 days after the shot.  It lasted for 2-3 days then cleared.
Client verbalized feeling itchy throat after receiving the vaccine.  Client was evaluated by onsite Fire Rescue.  Client was released to go home at 12pm.  Per Fire Rescue no additional evaluation needed.
No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    No concomitant medication was provided.  The vial was initially stored in refrigerator on 07-Jun-2022.  The vial did not undergo any temperature excursions.  The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022. The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
Arm was sore after second shot and remained so. One small area felt "congested". A month after that shot, I decided to massage the area and "work it out". That night I woke up with deep red hives all around the muscle of the injection site. The itching was terrible. The next day, I went to the pharmacy to get benedryl. Talked to pharmacist who suggeted this might be "covid arm." I confirmed with my doctor. Took benedryl to sleep. Used ice packs and avena bath to reduce itching. The affected area expanded to include a rash (more pimply, not  large welts like the hives) which extended down to my elbow, under my arm, and across my chest under my breast.  A week later, the hives are fading as is most of the rash, though there are a few new isolated red itchy spots that have developed.
Patient received Covid19 booster shot (Moderna) given 1 month early, second Covid19 (Moderna) vaccine received 05/28/2021, patient remained in clinic for 15 minutes for observation, no adverse reaction noted or complaints from patient.
12/12/22 presents to ED for  "SOB". PMHx of "CHF on lasix 40 mg po daily, CVA r/t carotid dsease on aggrenox, HTN on emetoprolol"
did fall and hit head as part of fainting; did fall and hit head as part of fainting; This spontaneous report was received from a nurse via a company representative and refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On an unknown date (reported as within last few months), the patient was vaccinated with an unspecified dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # and expiration date, strength and dose were not reported) administered intramuscularly for human papillomavirus (HPV) prevention. The patient fainted after the administered dose and was observed in the office after fainting. Treatment for fainting was not specified. It was also reported that the patient might have fallen and hit head as part of fainting. The office called 9-1-1 and patient was taken to unspecified medical facility (not believed to be a hospital) for an unspecified treatment and release. It was unknown if any laboratory tests were performed for the events. The outcome of faint was reported as recovered. The outcome of head injury was not provided.   The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, faint was determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA008572:
Child had VZV/MMR/HAV vaccines on 9/22/14. On 9/27/14 mom noted several red spots on lower back. On 9/29/14, he had developed band like distribution rash on lower bk (L2 dermatome) with erythematous papules, vesicles and crusting.
This case was reported by a pharmacist and described the occurrence of tremor in a 11-year-old subject of unspecified gender who was vaccinated with DTaP (unspecified manufacturer). On an unspecified date the subject received unspecified dose of DTaP. At an unspecified time after vaccination with DTaP, the subject experienced tremor and was hospitalized. At the time of reporting the outcome of the event was unspecified. No additional information was reported.
ADVISED TO GO TO ER BECAUSE HE WAS PT HAVING UPPER ABDOMINAL PAIN.  PT GIVEN 5X ADULT DOSE (1/9/11) INSTRUCTIONS IN COMPLIANCE WITH DR. (POISON CONTROL) ADVICE FROM CASE #4570825.  PT WENT TO HOSPITAL FOR TREATMENT.
1/13/2021 7pm: nausea headache  runny nose  730pm-7am: throwing up  headache  runny nose  1/14/2021 8am -3pm nausea, minor headace,stuffy/runny nose 4pm-7pm throwing up, headache sore throat runny nose exhaustion loss of apatite trouble breathing
Very sore reaction; Red reaction; Swollen reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles shot with an associated reaction of no adverse event (received first shot on an unknown date and had no trouble whatsoever).   In MAR-2023, the patient received the 2nd dose of Shingles vaccine. In MAR-2023, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain (Verbatim: Very sore reaction), erythema (Verbatim: Red reaction) and swelling (Verbatim: Swollen reaction). The outcome of the pain, erythema and swelling were not reported.   It was unknown if the reporter considered the pain, erythema and swelling to be related to Shingles vaccine.     It was unknown if the company considered the pain, erythema and swelling to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient just got his or her second shingles shot Tuesday and have had a very sore and red swollen reaction to it. The follow-up could not be possible as no contact details were available.
TIGHTNESS IN THROAT Narrative: Patient C/O some tightness in throat a few minutes after 1st Pfizer covid vaccine. No problems breathing or swallowing. No hx of anaphylaxis. NAD, calm, conversing with east. BP 133/91, P92, RR 18, PO2 99% Patient released after completing 30 minutes of observation in stable condition with instructions to seek medical care if symptoms worsen.
Patient inadvertently received the Moderna vaccine as initial vaccine. According to his age he should have received the Pfizer vaccine as first dose.
fatigue; chills; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 25Mar2021 at 12:00  the patient experienced fatigue, chills and muscle aches. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, chills and muscle aches were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Sore arm; Stiffness but not disabling; Just a feeling of a shot from flu virus; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Stiffness but not disabling), INFLUENZA LIKE ILLNESS (Just a feeling of a shot from flu virus) and FATIGUE (Tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Stiffness but not disabling) and INFLUENZA LIKE ILLNESS (Just a feeling of a shot from flu virus). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Stiffness but not disabling), INFLUENZA LIKE ILLNESS (Just a feeling of a shot from flu virus) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Follow-up information received on 26-Mar-2021 contains non-significant information.
PATIENT'S HUSBAND CALLED CLINIC TODAY, 10/12/2021 AT 12:50 AND STATED THAT HIS WIFE CAME TO MEDICAL CENTER YESTERDAY FOR HER PFIZER COVID BOOSTER SHOT. HE STATES THAT HE JUST WENT INTO THE KITCHEN WHERE HIS WIFE "ABOUT PASSED OUT". HE STATES HE SAT HER IN A CHAIR. HE REPORTS HER BLOOD PRESSURE IS 140/86, PULSE IS 119, AND HER BLOOD GLUCOSE  IS 110. INSTRUCTED  PATIENT'S HUSBAND TO EITHER CALL PATIENT'S PCP OR CALL 911 FOR EVALUATION. I CALLED PATIENT TO CHECK ON HER AT 1:40 AND NO ANSER, I LEFT VOICEMAIL THAT I WAS CHECKING ON HER STATUS. AT 2:41 PATIENT'S SPOUSE  CALLED BACK AND STATES HE CALLED 911 AND PATIENT WAS TRANSPORTED TO MEDICAL CENTER ER IN IN A NDIFFERENT CITY. HE STATES THE DOCTOR HAS SAID HE THINKS THE PATIENT LIKELY HAS VERTIGO. PATIENT'S HUSBAND STATES HAS HAD VERTIGO IN THE PAST.
Injection site reactions:  pain, redness, and swelling, hot skin lasting longer than 6 days     General reactions:  Headache, fever, nausea, stiffness of the neck, muscle aches, fatigue, fast heart rate, dizziness
Rash and swelling at injection site 8 days after vaccine. Swelling of the throat, light headedness, then tiny rash bumps all over hands and forearms and some amounts on stomach.
administered Havrix that was activated the night before; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 9-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2021 09:30, the patient received Havrix. On 31st August 2021, the patient started Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Health care professional reported that the patient was inadvertently administered Havrix in left arm, which was activated (needle attached) the night before at 04:20 pm on 30th August 2021, which led to incorrect storage of drug. The reporter consented to follow-up.
Sand paper like rash on torso, back, chest, neck, upper arm. Pt states it started the weekend after the injection. Date of onset is not exact as he did not tell his parents immediately.