chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 07Apr2021 at 16:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included ethinylestradiol, etonogestrel (ELURYNG). 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 09Apr2021 at 09:00, one and a half days after the first short, the patient experienced numbness in arms which started in right forearm to pinky. Then both pinkies felt like they were asleep/ tingly for 2 plus hours. It went away for an hour and came back from backs of elbows, went down bottom of both forearms and through tips of both pinkies. 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 a result of the events. The clinical outcome of the event numbness in arms, started in right forearm to pinky, from backs of elbows, went down bottom of both forearms and through tips of both pinkies and the event both pinkies felt like they were asleep/ tingly were unknown, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Booster; booster shot that I had in my left arm affecting my left breast; since I had the immunization my nipple on my left breast is so sensitive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FK9896) at the age of 68 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Aortic valve replacement" (unspecified if ongoing), notes: Medical Condition: Consumer stated, "I have had a aortic valve replacement." (Captured in tab). Concomitant medication(s) included: WARFARIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; NIPPLE PAIN (non-serious), outcome "unknown", described as "booster shot that I had in my left arm affecting my left breast; since I had the immunization my nipple on my left breast is so sensitive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nipple pain. Booster shot that the patient had in left arm affecting the patient's left breast; since the patient had the immunization nipple on patient's left breast was so sensitive.   No follow-up attempts are possible. No further information is expected.
pain that is going into his arm and to his heart; the pain is traveling to the chest; pain in his right arm into his chest; Feverish; running nose and sneezing; running nose and sneezing; This is a spontaneous report from a contactable consumer. This 49-year-old consumer (patient) reported that: A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm right on 29Apr2021 (age at vaccination was 49-year-old) as dose 2, single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0158 and Expiry date was not reported), dose 1 via an unspecified route of administration in right arm on 08Apr2021 (age at vaccination was 49-year-old) as dose 1, single dose for covid-19 immunisation. The call began with the caller's wife. She began to explain her husband's symptoms and stated that her husband had the first dose of the vaccine and didn't feel any symptoms, but he got the second shot on his right arm and is complaining that the pain is traveling to the chest. he had pain that is going into his arm and to his heart. It is on the right arm where he got the vaccine and into the chest. Is this something to be concerned about. The caller wants to know if this is a side effect. The caller looked it up online and didn't see anything about the pain traveling to the chest. This event happened after the second vaccine. No verbal response given to this caller. She passed the phone to her husband, the caller, and he explained further. He stated that the first shot on the left arm was not painful and the pain went away within a day. With the second one he is having pain on his arm that is still hurting and traveling down. He states it is where the collar bone is and is traveling down. After referring him for evaluation for chest pain he stated he doesn't know if it is really chest pain, but it is on top of his breast. He wanted to know if this is a normal side effect and if there is any medication, he can take for it. After the verbal response he stated he will go ahead and call the doctor and continue to monitor this. On 29Apr2021 the patient experienced the pain is traveling to the chest, pain in his right arm into his chest, feverish, running nose and sneezing, on an unspecified date patient experienced pain that is going into his arm and to his heart. pain in his right arm into his chest was reported as worsened. Outcome of the events pain is traveling to the chest and pain in his right arm into his chest was not recovered, pain that is going into his arm and to his heart was unknown and rest of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Beginning at 4:20 on 3/26/2021, the same afternoon when I received my 2nd injection, I have suddenly begun developing pain in multiple joints throughout my body, including shoulders, neck, hips, knees, ankle, feet, headache, and slight throbbing in the arm where the shot was administered. My temperature is normal.  I am taking two Tylenol and resting.
Vaccine given beyond 30 days of refrigeration period; Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Sulfa), Drug allergy (Ultram), Allergy to antibiotic (Bactrim.) and Allergy to antibiotic (Augmentine.).   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.   This case was linked to MOD-2021-313106 (Patient Link).
Patient received Tdap vaccine and had hard lump form at site of injection with red area about 1 inch in diameter form. Very tender to touch.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about concurrent conditions and concomitant medications was reported. The reporter stated that the patient was inadvertently administered ROTATEQ (dose not reported) route oral, on 14-MAY-2014 which had expired on 27-MAR-2014 and no adverse effects reported. It was also reported that vaccine administration was supported as per stability memo. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Lips got numb like Novocain from the dentist; Flu-like symptoms; Aches; Headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Lips got numb like Novocain from the dentist), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (Aches), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HYPOAESTHESIA (Lips got numb like Novocain from the dentist), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (Aches), HEADACHE (Headache) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Lips got numb like Novocain from the dentist), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (Aches), HEADACHE (Headache) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant medication was not provided.
Patient reported feeling dizzy, nauseated and lightheaded Patient provided with water and seen by medical team Patient stated symptoms resolved, refused medical transport and signed AMA form Patient?s family drove him back home
administrated with Pediarix after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9x3t5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix 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 as follows: The physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164784: US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter
Bottom of both feet broke out with blisters and very red and swollen. Tops of my feet itch and burn.
tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) had not resolved. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-068279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068279:Second dose
51 Y/O FEMALE WITH PMH HYPERTENSION, REQUESTING BP CHECK BECAUSE SHE STATED SHE FELT DIZZY.. VS: BP 176/94, HR 107, RR 20, 02 SAT 98% RA. PT REPORTS NORMAL BP IS >200 SBP. PT MONITORED BY MEDICS AND MEDICAL PROVIDER FOR AN ADDITIONAL 30 MINS THEN RELEASED BY MEDICAL PROVIDER WHEN HR <100 AND PT'S SYMPTOMS RESOLVED.
hx of anaphylaxis to MMR. during prolonged observation period developed sensation of heat across chest and into throat, and lip felt numb. had taken Benadryl prior to arriving to clinic. Started to improve but with concern of symptoms worsening once Benadryl wears off, he was directed to the ER by private auto. not permitted to drive himself, wife came and picked him up.
PLAN ONLY COVERS 30 OR 90 DAYS PLAN LIMITATIONS EXCEEDED (PHARMACY HELP DESK.)
Severe pain extremeties- numbness tingling, burning fatigue, developed allergies gluten, sugar, casein, fatigue, irritability, depression, abdominal pain.
dizziness; Injection site pain; extremely tired; migraine (headache); migraine (headache); chills; fever; nauseated; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Aug2021 14:45 (Lot number: EW0168) at the age of 51 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "gurd" (unspecified if ongoing); "Herpes" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN HCTZ; ACYCLOVIR [ACICLOVIR]; SIMVASTATIN; CARVEDILOL. Past drug history included: Sulfamethoxazole, reaction(s): "Known allergies"; Esomeprazole, reaction(s): "Known allergies"; Metronidazole, reaction(s): "Known allergies". The following information was reported: DIZZINESS (non-serious) with onset 28Aug2021, outcome "not recovered", described as "dizziness"; VACCINATION SITE PAIN (non-serious) with onset 28Aug2021, outcome "not recovered", described as "Injection site pain"; FATIGUE (non-serious) with onset 28Aug2021, outcome "not recovered", described as "extremely tired"; MIGRAINE (non-serious), HEADACHE (non-serious) all with onset 28Aug2021, outcome "not recovered" and all described as "migraine (headache)"; CHILLS (non-serious) with onset 28Aug2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "nauseated"; MALAISE (non-serious) with onset 28Aug2021, outcome "not recovered", described as "feeling sick". Therapeutic measures were not taken as a result of dizziness, vaccination site pain, fatigue, migraine, headache, chills, pyrexia, nausea, malaise.  Additional information: The patient was not pregnant at the time of vaccination. The patient race and ethnicity was withheld. The patient was not administered with other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
hasn't had second shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose of Shingrix in left arm intramuscularly on 07th October 2020 with batch number H552g and expiry date 20th September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Jul-2022 Reporter's comment: The pharmacist stated that she had a patient that had not the 2nd dose of Shingrix vaccine. The reporter did not consent to follow-up. Additional supportive information: Till the time reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Itching, redness, swelling (lump about 2 inches across and redness 2x5 inch area). Unsure when it actually started, noticed it about 24 hours after injection.
CHEST PAIN; UNABLE TO SLEEP; FEELING NAUSEOUS; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included nuts allergy, seafood allergy, dog allergy, and cat allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JUL-2021, the subject experienced chest pain. On 22-JUL-2021, the subject experienced unable to sleep. On 22-JUL-2021, the subject experienced feeling nauseous. On 22-JUL-2021, the subject experienced headache. On 22-JUL-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, unable to sleep, feeling nauseous, and fatigue on 23-JUL-2021, and had not recovered from headache. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "generalized anxiety disorder" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was receiving a vaccine for Moderna. While reviewing the paperwork, the patient stated that she has a history of fainting due to fear of needles. After administering the vaccine, the patient was waiting. The patient was walking around because they were feeling ok and then she states she started thinking about the vaccine and she got light headed and dizzy and ended up fainting. The patient was lightheaded for several minutes unable to stand on her own so we called 911 and they came and checked the patient's vitals and blood sugar. After ensuring the patient was feeling better the paramedics left and the patient was allowed to leave. The patient was still considering getting the second shot so we advised the patient to come in with their husband for the second dose since the husband had received his vaccine the day prior.