chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with 2018SA267442 and 2018SA271669. This case involves a female patient (unknown age) who was exposed to a vaccine FLUZONE HIGH DOSE on an unspecified age. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is a pregnancy case reported that the patient had FLUZONE HD inadvertently given to 3 pregnant patients, increase rate of injection site reaction and FLUZONE HD inadvertently given to several pregnant patients occurred at unknown gestation period. Pregnancy outcome was not reported. List of documents held by sender: none.
This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022. Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly invalid dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY 2014 the patients were vaccinated with RECOMBIVAX. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and RECOMBIVAX was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of RECOMBIVAX was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Hurts to touch; Raised hives; Hard knot below the skin underneath each hive; Area below injection site was rashy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurts to touch), VACCINATION SITE PRURITUS (Raised hives), VACCINATION SITE INDURATION (Hard knot below the skin underneath each hive) and VACCINATION SITE RASH (Area below injection site was rashy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PAIN (Hurts to touch) and VACCINATION SITE RASH (Area below injection site was rashy). 25-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Raised hives) and VACCINATION SITE INDURATION (Hard knot below the skin underneath each hive). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK, qd. At the time of the report, PAIN (Hurts to touch), VACCINATION SITE PRURITUS (Raised hives), VACCINATION SITE INDURATION (Hard knot below the skin underneath each hive) and VACCINATION SITE RASH (Area below injection site was rashy) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a physician concerning a young adult female who was vaccinated with the first dose of GARDASIL (lot number not available) a year ago (in 2008).  One or two weeks after receiving GARDASIL the patient developed systemic allergic reaction in 2008.  She was hospitalized for 7 days (hospital demographic unspecified).  Subsequently, the patient recovered on an unspecified date.  The patient sought unspecified medical attention.  No further information is available.
pt recv vax 22SEP95 & devel a fever of 102.3 24hrs & the fever fell to 99;2OCT95 also devel a vesicular rash on back, trunk, legs & abd;taken to MD same day;
5cm tender, erythematous induration at injection site on right arm with body aches and headache 48 hours after TD immunization.
Began with flu like symptoms, aches, by that pm noticed Pneumovax injection site was red and swollen, tmax of 104.2.  Went to ED next morning on the 13th.  Admitted for IV antibiotics.  Kefzol did not work, starting on cefazolin hopefully will not need to start vancomycin.
Diarrhea with blood in the diaper.  This is the second dose of the vaccine.  The first vaccine had 2 weeks of green diapers.  This time, this is the third green diaper so far.  The green diapers started one week in.  We are waiting though the night for further events to unfold.  No event outcomes to report yet.
14 month old infant given FLUZONE QUAD for 3-18YO - Given 0.5ml instead of the infant flu preservative free 0.25ml.
Started oral Typhoid series 04-14-2004, 8 AM. Ate at 10 AM, then at 11AM, felt cold sensation down center of back, over scapulae down to waist. Cold became numbness, then "pins and needles" lasting about 6 hours, with tachycardia of 120, BP128/76, T98.1.  I spoke with a doctor who had never heard of such a reaction. Pt continued with doses on 04-16, 04-18, and 04-20, and each time experienced similar cold sensation, mid-back, becoming paresthesia, then resolving in a few hours - each time, the reaction lessened, being qiute mild after the last dose, lasting only 3 hours.
PATIENT STARTED OUT BEING NERVOUS ABOUT THE VACCINE. I CALMED HER DOWN  AND ADMINISTERED VACCINE. I INFORMED PATIENT TO WAIT FOR 15 MIN. I CHECKED ON HER IN A FEW MINUTES AND SHE SAID SHE HAD NAUSEA. I GAVE HER A PLASTIC BAG TO BARF IN IF NEEDED AND I RAN TO THE FRONT OF STORE TO GET A BOTTLE OF WATER. MANAGER SENT ME TO BREAK ROOM TO GRAB A BOTTLE OF WATER. AS I WAS RUNNING BACK, I OBSERVED PATIENT PASSED OUT ON THE FLOOR WITH BLOOD AROUND, NOT RESPONDING. I CHECKED PULSE (LOW) AND ASSUMED SHE HAD AN ANAPHYLAXIS REACTION TO THE VACCINE, SO I ADMINISTERED EPIPEN 0.3 MG AND PATIENT WOK UP. SHE HAD BLOOD NEAR HER MOUTH AND BLOOD ON THE FLOOR. WE CALLED 911 AND THEY ARRIVED WITHIN MINUTES AND TOOK HER IN THE AMBULANCE. I HAVE NO FURTHER INFORMATION ON THE PATIENT.
lethargic; had trouble thinking, very confused; slept for three days; dehydrated; high blood pressure; a lot of pressure in my chest; had menstrual cycle right after (before I was due very heavy flow)
I had a sudden burning and abdominal pain in the middle of the night, with some loose bowl movement and vomiting.  It lasted couple of hours than it went down, also ongoing mild abdominal pain daily. I had an endoscopy procedure which was normal, I also had labs including liver, kidney and basic chemistries and a stool test and all were normal. I had a HI duce scan and showed normal gallbladder function, but it did show mild duplication of her symptoms  following a CCK injection.  This indicated that the pain could be coming from the gallbladder.
Could not hold urine; Lost 7 pounds; Vomited; Headache; felt fatigued; Chills; Muscle and joint pain; Muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Could not hold urine), ABNORMAL LOSS OF WEIGHT (Lost 7 pounds), VOMITING (Vomited), HEADACHE (Headache) and FATIGUE (felt fatigued) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (esophageal) and Hypertension. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), CELECOXIB (CELEBREX), ATORVASTATIN, LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced URINARY INCONTINENCE (Could not hold urine), ABNORMAL LOSS OF WEIGHT (Lost 7 pounds), VOMITING (Vomited), HEADACHE (Headache), FATIGUE (felt fatigued), CHILLS (Chills), MYALGIA (Muscle and joint pain) and ARTHRALGIA (Muscle and joint pain). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 3 tablets every 3-4 hours. At the time of the report, URINARY INCONTINENCE (Could not hold urine), ABNORMAL LOSS OF WEIGHT (Lost 7 pounds), VOMITING (Vomited), HEADACHE (Headache), FATIGUE (felt fatigued), CHILLS (Chills), MYALGIA (Muscle and joint pain) and ARTHRALGIA (Muscle and joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Patient was 7 days early for second vaccine. Discussed guidelines. Patient wished to proceed with vaccine.
immunocomprise; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocomprise"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". Clinical course: Caller mentioned that in the beginning of the pandemic, he joined the COVID study where he took the vaccine and was paid for it. He is on social security and pays him using the card. He did two different studies; he wants to get a printout on how he was paid and the time frame. Precautionary AE form created since he has COPD and immunocomprised.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Patient received Tdap vaccine at 1015 AM on 2/11/14. Patient reported to nurse at 1200, patient reported 20-25 minutes after injection that symptoms of tightness in head (front), ringing in both ears and generalized neck pain had began. As patient was talking, voice begin to change to raspy voice and audible wheezing. Wheezing was noted upon auscultation at 1225. PO BENADRYL 25mg administered at 1227. EMS called at 1230, report called to medical director. RN at ED.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Fever of 102 for two days and Rash on stomach/neck/head that started a week after receiving vaccine
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a first dose of GARDASIL (therapy route and lot # not provided). On an unspecified date the patient experienced syncopal episode after the first dose of GARDASIL. Patient sought medical attention by speaking to physician. At the time of reporting, patient's status was not provided. Follow up information has been received from a health care professional who reported they did not know which patient experienced this adverse event. Additional information is not expected.
Stomach cramps; FACILITATED COLLECT  This is a solicited report received from a contactable consumer reported for himself based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-3866546-00).   A 54-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly in 2021 for COVID-19 immunization and adalimumab (HUMIRA) for moderate to severe adult Crohn's Disease via subcutaneous route. In 2016, the patient experienced motorcycle accident and dull ache in foot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, the patient received first dose of COVID-19 Vaccine manufactured by Pfizer. On unknown date in 2021 the patient experienced stomach cramping with outcome of recovering.   AbbVie's opinion is that there is no reasonable possibility that the event of stomach cramping was related to Humira(Adalimumab).  The reporter's assessment of the causal relationship of the event with BNT162b2  was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the current available information, the event Stomach cramps is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Crohn's Disease may provide a plausible explanation for the event.
Four days after given DTaP and Pneumococcal Conjugate child began vomiting and fever of 103, fifth day more vomiting & diarrhea with fever between 99 and 102, sixth was more vomiting with diarrhea, seventh, eighth day after shots more diarrhea and lethargy.
Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and sweaty with a headache and body aches
No additional AE details available. No additional AE reported.; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent.  On 13-FEB-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #W029899, expiration date: 16-MAY-2024), varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #W024335, expiration date: 01-AUG-2024) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #W012118, expiration date: 24-DEC-2023, therapy type: rHA) (all products were administered for prophylaxis, dose was unknown, strength and route of administration were not provided) that were improperly stored (product storage error). The vaccines hepatitis a vaccine, inactivated (VAQTA) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was exposed to above 9 degrees Celsius for 2 hours 32 minutes 0 seconds. No previous excursion. The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to minus 10 degrees Celsius up to 8 degrees Celsius for 1 hour 40 minutes 0 seconds. No previous excursion. No additional adverse event (AE) details were available (no adverse event).
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender 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. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Side effects began around 24 hours after the injection: body aches, marked fatigue, headache and dizziness.  Then at 48 to 72 hours began with vertigo(room spinning with movement) and ataxia.  By  72 hours the body aches and fatigue have lessened but still with slight vertigo, headache and balance issues.
injection site pain; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that patient received first dose wants to know if she can take Tylenol for injection site pain on an unspecified date. The outcome of the event was reported as unknown.   Information on the lot/batch number has been requested.
Immediate severe flushing, mile shortness of breath, and mile dizziness (all within 2-3 seconds of vaccine).  Shortness of breath lasted less than 20 seconds.  Dizziness lasted a few minutes.  Flushing lasted over an hour.
Headache, ringing ears, excessive brain noise, brain zaps, eyes shake, cross-eyes, vertigo, excessive night sweats and chills, neck spasm, Hallucination, hearing voices, seeing visions, cough, dry throat, shortness of breath,  strange smell, confusion, lability, depression. Chest pain/pressure, heart racing/pounding, nausea, diarrhea, twitching, tingling, skin crawling/itchiness,  Shoulder/ elbow/ hip/ ankle (joint) pain, leg/arm cramping, jerking, hands shake, toe curl. The one that really gets me is my hands shaking, the vaccine has entered my brain and causing neurological palsy.
pt w/flushing sl diaphoretic-sl itching of face;saw MD;435PM went back to work no longer flushed;
Headache, Myalgia, Arthralgia, heavy sinus congestion with headache; arm, back, neck soreness Narrative:  OTC Advil and Pseudafed
she is vaccinated, just got Covid; she is vaccinated, just got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EK4176), on 04Feb2021 as dose 2, single (Lot number: EL3302) and on 03Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she is vaccinated, just got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 treatment. Therapeutic measure included Paxlovid, which was taken on 11Aug2022 as a result of vaccination failure, covid-19.
After a week of having the vaccine,  she had a triangle shape about 2 inches at the injection site that was warm to touch. It lasted for approximately 2-3 days started around Saturday or Sunday night, it was gone by Wednesday.
needle gave resistance and only half dose was administered; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 13-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number ZC77G, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 27th September 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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 Information: GSK Receipt Date: 28-Sep-2022 Reporter's comment: The pharmacist called to enquiry that should the dose be repeated.  The registered pharmacist reported the safety feature of the needle which gave resistance and only half Fluarix dose was administered to a 13 year old patient on 27th September 2022.  The registered pharmacist stated that it was not the Prefilled Syringe just the needle that screws on.  The reporter did not consent to follow-up.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
07/16/15 - 4:00pm burning rash warm to touch on left arm looked like bruise at injection site swollen. Urgent care doctor prescribed AUGMENTIN, naproxen and prednisone 2.5.
This spontaneous report was received from a healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 with lot # L043213 and expiration date on 28-AUG-2017 (anatomical route of vaccination was not provided) for prophylaxis. It was stated that, GARDASIL 9, was exposed to a temperature of > 8°C but < 25°C, for a 677 hours time frame. Data logger was involved. Furthermore, GARDASIL 9 was never exposed to previous temperature excursions and a product quality issue was not reported. No adverse effects were suffered. This is one of several reports received from the same reporter. Additional information is not expected as consent to follow up was not provided. Sender's Comments: US-009507513-1702USA006117: US-009507513-1702USA009046: US-009507513-1702USA009047.
Dizziness, light headedness, tachycardia   Patient w/ co dizziness, lightheadedness, and palpitations immediately after receiving her first covid vaccine dose. Hx of hypertension, per patient controlled. Patient immediately brought to medical triage and evaluated by medical personnel.
- several hours post injection, extreme fatigue. Good next day - a few days post injection, a lump/nodule with pain when touched was discovered front left/top shoulder about a finger distance away from injection site. Today 10 days later, nodule still exists and still sensitive to touch. Hard and pea like in size