chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had a fever, diarrhea, vomiting, once his fever broke, he had a cruddy cough, the fever was low-grade, he was a bit fussy like he was in pain. We were on vacation, so we went to an emergency room they did not run any test, listened to his chest, checked his ears. Asked if he was vaccinated, said they felt it was just a virus, but he was doing fine. He does still have congestion and a cough but is improving every day.
Began approx 24 hours later with Right sided headache, intermittent dizziness. Approx 36-48 hours later, develop progressing right facial droop, difficulty raising right eyebrow, and difficulty closing right eye. No paresthesias and no limb involvement. Presented to ER on 4/19/2021. Worked up for Bells Palsy vs CVA. Rec'd Toradol, Reglan, & Benadryl IV with improvement in headache. Diagnosed with Bells Palsy. Given Prednisone 60 mg daily x 5 days and recommended Neurology follow-up.
She began to have a severe headache with in 36 hours of the second dose. The headache progressively worsened without letting up at all for several days. On the evening of August 4 she began feeling light headed as well as the headache. On August 6 she began to speak oddly and we called emergency services in fear of stroke. The medics said at that time she was not hacing a stroke and she returned to bed. She slept all day Saturday August 7 and on Sunday August 8 she was not thinking clearly or acting right so I took her to the ER where it was discovered that she had suffered a massive stroke in the MCA region of her brain. She now has quite a lot mental and physical impairment. She had a physical one day before the first dose of the vaccine and was in perfect health, NO ISSUES. After the second dose she had this stroke and is imparired permanently.
Really Sore Injection Site (Right Arm); Headache post-injection; This is a spontaneous report received from a contactable consumer (patient himself). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration on 10Feb2021 12:30 to the right arm at single dose for COVID-19 immunization. Patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT). Patient received Zoloft 200mg daily within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (Pfizer COVID 19, Solution for injection, lot number: EL3247 via an unspecified route of administration on 20Jan2021 at 11:00 AM on the right arm as a single dose). Patient did not receive any other vaccine in four weeks. On 10Feb2021 at 13:30 PM, patient had really sore injection site (right arm) and headache post-injection. No treatment was provided for the event. Outcome of the events was reported as recovering.
26YO received pediatric dose; 26YO received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 26-year-old male patient who received HAV (Havrix pediatric) (batch number 3397T, expiry date 30th November 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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: 2-Feb-2023 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product.
I caught Covid a few months after my last Covid booster. I have congestion, cough, sneezing, headache, and fatigue. I am currently experiencing those symptoms. I also had the flu vaccine at the same time as the Covid booster.
Pt woke up in the middle of the night uncomfortable, and she had a slight fever (highest read was 100.0 F). This was about 14-15 hours after her second dose of the vaccine. It was extremely minor, and she went back to sleep after taking some Tylenol.  This is pretty minor and not really worth mentioning, but someone from the CDC called and asked me to submit this report.
Information has been received from a new article via an journalist in a website referring to 32 female patients of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. Overall, 6.2 percent of the reported problems were considered serious. This included 32 deaths among women who received the vaccine. The exact adverse events were not reported. It was unknown if autopsy was done. The cause was death was unknown. It was reported that these types of reports could not determine whether adverse events were caused by the vaccine or just a coincidence. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
No adverse effect; inadvertently administered expired dose of VAQTA; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 07-JUN-2019 patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # R012988 for prophylaxis.       On 07-JUN-2019 the patient experienced expired product administered.  On an unknown date the patient experienced no adverse event.    The outcome of expired product administered and no adverse event is unknown.
2nd dose administered 20days after the first dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 reported as follows: The age at vaccination was not reported. Second dose of Bexsero vaccine administered 20 days after the 1st dose instead of 30 days, which led to shortening of vaccination schedule. The reporter asked if there was any potential side effects that patient should be aware of with early dosing. The reporter did not consent to follow-up.
Patient felt dizzy, hand tingling and numbness in her hands, arms, and feet and legs up to her knees.  She also felt it in her face.  Patient laid down on the ground and we gave her a sip of water.  Her symptoms continued to worsen and we called 911.  After paramedics got here, she started to feel better and was able to sit up in a chair.  The paramedics checked her vital signs and they were all normal.  Patient elected to not go on ambulance.  She sat in the chair for another 15 minutes to 25 minutes and then left under her own power.
pt recv vax;devel anaphylactic rxn approx 45 min p/ vax;sx included hives,swelling of tongue & diff breathing;tx at er w/ epi & adm to hosp;
red dots on the arm below the injection site - left arm; Rash on the arm below the injection site - left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red dots on the arm below the injection site - left arm) and RASH (Rash on the arm below the injection site - left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red dots on the arm below the injection site - left arm) and RASH (Rash on the arm below the injection site - left arm). At the time of the report, ERYTHEMA (red dots on the arm below the injection site - left arm) and RASH (Rash on the arm below the injection site - left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Immune thrombocytopenia: negative (Negative) Her doctor did ITP test which came back negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.; Reporter'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.
Pt reports feeling "dizzy." Denies SOB, chest pain, palpitations, no blurred vision, denies nausea, states, "feel more lightheaded than dizzy." Skin pink warm dry, speaks in clear complete sentences, no redness or swelling to the injection site. No allergic reaction noted. Hx of vertigo, trigeminal neuroma. H- No facial drooping, no deformity noted. E- Pupils equal, denies blurred vision. E- Denies hearing problems or deficit. N-WDL. T-No deviation, no swelling, able to swallow secretions. Lungs CTA. Heart rate, WDL, denies palpitations. Vitals WNLs.
Information has been received from a certified medical assistant (CMA), concerning teenaged patients (gender not specified), who were vaccinated on unknown dates, with a dose of Gardasil (lot # not reported).  The CMA reported that the "every young teenager" that had the vaccine administered complained that the medicine burned (no further details provided).  At the time of this report, it was unknown if the patients recovered.  The CMA reported an additional female patient experienced the "medicine burned" when vaccinated with Gardasil (lot # not reported) (WAES #0708USA00619).  Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation), VACCINATION SITE MASS (little bumps at injection site), VACCINATION SITE WARMTH (warm to the touch at injection site), LYMPH NODE PAIN (painful lymph nodes of neck on right side) and VACCINATION SITE PRURITUS (itching at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ESTRADIOL and LOSARTAN POTASSIUM for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflammation) and VACCINATION SITE PAIN (tenderness at injection site). On 16-Mar-2021, the patient experienced VACCINATION SITE MASS (little bumps at injection site), VACCINATION SITE WARMTH (warm to the touch at injection site), VACCINATION SITE PRURITUS (itching at injection site) and PYREXIA (slight fever). On 17-Mar-2021, the patient experienced LYMPH NODE PAIN (painful lymph nodes of neck on right side) and LYMPHADENOPATHY (swollen lymph nodes of neck on right side). At the time of the report, VACCINATION SITE INFLAMMATION (inflammation), VACCINATION SITE MASS (little bumps at injection site), VACCINATION SITE WARMTH (warm to the touch at injection site), LYMPH NODE PAIN (painful lymph nodes of neck on right side), VACCINATION SITE PRURITUS (itching at injection site), LYMPHADENOPATHY (swollen lymph nodes of neck on right side), VACCINATION SITE PAIN (tenderness at injection site) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  Patient did not treated the symptoms.
Case number PHEH2013US005315 is an initial spontaneous report received from a physician on 02 MAR 2013. This report refers to a 15-months-old male patient. It was report4ed that he was inadvertently administered an intramuscular dose of MENVEO (batch number: not reported) on 02 MAR 2013. No adverse event was reported following the maladministration.
Pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Expired Vaccine was given as booster shot to 500 people.
stored in the fridge and experienced multiple warm excursions; Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (stored in the fridge and experienced multiple warm excursions), PRODUCT STORAGE ERROR (Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F) 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)) (batch no. 046H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    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) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (stored in the fridge and experienced multiple warm excursions), PRODUCT STORAGE ERROR (Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (stored in the fridge and experienced multiple warm excursions), PRODUCT STORAGE ERROR (Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (stored in the fridge and experienced multiple warm excursions) and PRODUCT STORAGE ERROR (Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F).    Concomitant medication was not reported. Moderna (Bivalent vaccine) was delivered on 12/21/2022 and placed in the freezer upon delivery. Lot was relocated to fridge on 1/15/2023. Lot was quarantined on 1/18/2023. This request was for fridge excursion only. Impacted product was possibly used until 1/18/2023.  Treatment drug was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2023: Upon receipt of follow-up information received on 25-Jan-2023, it was identified that case MOD-2023-704414 is a duplicate to an already existing case MOD-2023-705542. All information from case MOD-2023-704414 has been incorporated into case MOD-2023-705542. Hence, case MOD-2023-704414 will be deleted from the safety database. Patient's age group added.
redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On 12th November 2020, the outcome of the injection site erythema was recovered/resolved.   The reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the dose of shingrix and after that experienced redness at the injection site which was lasted for 6 days. The reporter did not consent to follow up.
The Covid19 vaccines have left me with chronic fatigue and brain fog. This continues today,  2 1/2 years later. I have been unable to work due to the severity of the symptoms. I have been to many doctors and none has found any other cause for my sysmtoms. These include: internist, rhuematologist, gastroenterologist, oncologist, cardiologist, and allergist. The onset of my symptoms coincide with the time of the vaccines. There has been absolutely no other possible diagnosis for these symptoms and no one has been able to offer any help in getting over them and living a life again and returning to my career. This continues to devastate my life.
Breakthrough COVID case. This patient completed Pfizer series 2//9/21 and became positive last month.
she felt crummy; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she felt crummy) in a 75-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (3 Pfizers), Pfizer (3 Pfizers) and Pfizer (3 Pfizers). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she felt crummy). At the time of the report, FEELING ABNORMAL (she felt crummy) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient received 3 Pfizers and 1 Moderna. Patient thought that Moderna worked better because patient felt crummy afterwards.  Patient was a pro vaccination individual. It was came to light that Moderna was using the dark blue cap with gray writing on the new bivalent omicron vaccine that was coming out. The patient read last time for adults for the regular vaccines, but that the same dark blue cap was what was used for children 6-11. There was concern that there were going to be confusion and mishandling of these particular vaccines. As a very mature adult at 75, patient was not interested in getting something that would help a 6-11 year old child. Patient did not understood why Moderna would not do something with more common sense involved and had like a purple top for the newest one, or an orange top - something that was absolutely different and nobody could make a mistake. A lot of these people who were administering shots were very busy and stressed, and they might not take a look at what was actually in the vial and grab the wrong one. Patient was reading that the caps on the Pfizer and Moderna weren't completely different. Patient also called Pfizer.   No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Live follow up received quality complaint number added. On 08-Sep-2022: Live follow up received contains no new information.
PATIENT REFERS NUMBNESS, REDNESS, SWOLLEN AND HOT AREA IN THE LEFT ARM WHERE THE VACCINE WAS ADMINISTERED. SHE WENT TO THE DOCTOR AND WAS PRESCRIBED WITH NAPROXEN.
Within 12 hours had uncomfortable muscle aches and nausea, took 200 ibuprofen. By 24 hrs post injection has shivering with fever of 100F. Took another 200 ibuprofen. Lasted until bedtime, 9:00pm. Felt well by 60 hrs post injection.
Patient phoned 4/23/08 to report a welt over Varicella immunization site approximately 1 inch wide and two inches long.