chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Dose 1=Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Pfizer/BioNTech, Dose 5= Pfizer/BioNTech; Dose 1=Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Pfizer/BioNTech, Dose 5= Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 63 years, in right arm for covid-19 immunization; BNT162b2 (BNT162B2), on 25Feb2022 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 14Jan2021 as dose 1, single (Lot number: 028L20A), in right arm, on 11Feb2021 as dose 2, single (Lot number: 016M20A), in right arm and on 31Aug2021 as dose 3 (booster), single (Lot number: 059EZ14), in right arm for covid-19 immunization. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cimzia, reaction(s): "Allergy_cimzia". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant) all with onset 2022, outcome "unknown" and all described as "Dose 1=Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Pfizer/BioNTech, Dose 5= Pfizer/BioNTech"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Investigation results: The complaint for "Pfizer-BioNTech COVID-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702 and FM0698. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS # concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
This retrospective pregnancy case was reported by a healthcare professional and described the occurrence of autism in a neonate male subject exposed to FLULAVAL (GlaxoSmithKline) transplacentally when his mother was vaccinated. On 17 September 2010, the 33-year-old mother of the subject received a dose of FLULAVAL via intramuscular injection. Her last menstrual period and estimated date of deliver were unknown. The neonate was exposed to FLULAVAL at an unspecified gestation age during the 3rd trimester. On 21 September 2010, at unknown weeks gestation, the neonate was born; method of delivery, weight and Apgar were unknown. At the time of this report, no birth defects were reported. At an unspecified time after vaccination with FLULAVAL, the neonate developed autism. The reporter was inquiring about thimerosol in the multi-dose vial for FLULAVAL and mentioned that a mother was inquiring because her son was diagnosed with Autism. At the time of the report no other information was provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the autism was unresolved.
HYPOXIA 1/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Fever. irritability, malaise and cough beginning within 8 hours of getting 1st flu vax.
crying 1hr p/vax crying constantly-unable to console w/bottle, bathing or massage of leg;given APAP-spit out-did not retry;APAP given 7PM t102R MD told to take to ER;mom stated pt shaking also;seen in ER t99.8R;hematoma;
Swelling from injection site to elbow, redness, warm to touch and taut Pt stated onset in the afternoon after injection.
moderate pain in injection site/upper arm, 36 hours of low grade fever, body aches, chills, insomnia,, fatigue into 3rd day
Patient called indicating that her right arm was swollen, sore.  This is the arm she recieved the pneumonia shot in.....  She applied ice to her right arm.
This spontaneous report as received from a other health professional refers to a 11 years old female patient with no illness at time of vaccination, no adverse events following prior vaccination and no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (669796/0840AA) dose 2 GARDASIL, IM. left deltoid on 21-DEC-2011 at 10:07 AM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. There was no labs diagnostic performed. This is one of several reports from the same source. Additional information is not expected.
Patient presented to the hospital on 4/26/23 with generalized weakness. During his admission, he began to develop fevers and tested positive for COVID on 5/3/23. The patient passed away in the hospital on 5/15/23.
I got single in my face by the right side of my lips; I got single / right side of my lips it burns no only the blisters; it burns no only the blisters but internally/ everything came burning me.; first single shot before the pandemia / dr never call me again for / second dosis; This case was reported by a consumer via an Agency and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, lip blister, burning sensation and incomplete course of vaccination. On an unknown date, the outcome of the shingles, lip blister, burning sensation and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, lip blister and burning sensation to be related to Shingles vaccine.  Additional details was reported as follows: The age at vaccination was not reported. The age group was not reported but captured adult as per vaccine indication. The patient received 1st dose of Shingrix before the pandemic and got shingle on face by the right side of the lips, it burnt, had not only the blisters but internally the patient felt like burning, even when use the toilet everything came burning . Till the reporting patient did not received 2nd dose and the doctor also never called the patient again, which led to incomplete course of vaccination.
Left extremity numbness (arm, leg, side) to present. Also, headache urticaria on arms and legs.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Received Tetanus & Diphtheria Toxoids Absborbed for Adult Use-Decavac on 12/7/06 at about 11:00 AM in my left shoulder.  At approximately 1:30 PM, I noticed that my left ear began to ache and throb.  At about 3:00 PM, my left jaw area began to ache and I noticed that it was becoming painful to open and close my mouth.  It felt as if my jaw was locking.  At 5:00 PM, I began to have increased pain in my left ear and the left side of my jaw.  I contacted the doctors office to discuss with the nurse.  At 7:00 PM, I ate dinner and had difficulty chewing my food.  It was very painful due to my jaw locking and not being able to bite down fully.  No medication was taken.  On 12/8/06, I awoke without pain in my ear or jaw.  I could open my mouth normally without any pain.
Dizziness, Vertigo starting 1.16.21 after getting up and causing vomiting.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The reporter stated that a patient was administered an expired dose of VARIVAX (Merck) (0.5 ml, lot # 1881AA, exp. date: 30-NOV-2013) on 13-DEC-2013. No adverse effects were reported. Additional information has been requested.
EVERY TIME I GOT THE SHOT I GOT SICK.; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case received from a patient via social media.  This case involves patient (unknown demographics) who every time when got the shot, got sick (illness) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that every time when the patient got the shot, he/she got sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Action taken with suspect drug was unknown.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.
Narrative:  Patient admitted for pneumonia due to coronavirus disease 2019; other specified sepsis; acute respiratory failure with hypoxia
Patient presented to the ED and was subsequently hospitalized for STEMI within 6 weeks of receiving covid booster vaccination.
Fever, intense body aches, headache, sweats, extreme arm pain, swollen lymph nodes on neck.
migraine; intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine) and HEADACHE (intense headaches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bone marrow depression.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HEADACHE (intense headaches). On an unknown date, the patient experienced MIGRAINE (migraine). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature, at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine) and HEADACHE (intense headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Body temperature: 102.4 (Inconclusive) temperature of 102.4°F after the second shot.. In November 2020, White blood cell count: 17000 High.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-017346 (Patient Link).
Within 20 min child became red, had difficulty swallowing (clearing throat), diff breathing (wheeze), she was given O2, epinephrine, Xopenex neb treatment, Orapred, and Zyrtec. She was observed for several hours in office and by time of discharge had recovered.
Significant axillary lymphadenopathy within 36 hours. Took several weeks c/o improve. Remains unresolved & enlarged lymph nodes. Remain at 3 months out.
ESRD (end stage renal disease) - Patient was started on hemodialysis.  Social worker was consulted and arrange for outpatient dialysis. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pain on the knees (both of them); When he tries to stand up the has lots of pain; Started a more severe pain in back of the knees and it's extended to his ankle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Started a more severe pain in back of the knees and it's extended to his ankle), ARTHRALGIA (Pain on the knees (both of them)) and MYALGIA (When he tries to stand up the has lots of pain) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Acid reflux (esophageal). Concomitant products included VITAMIN D NOS for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Started a more severe pain in back of the knees and it's extended to his ankle) and MYALGIA (When he tries to stand up the has lots of pain). On an unknown date, the patient experienced ARTHRALGIA (Pain on the knees (both of them)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Started a more severe pain in back of the knees and it's extended to his ankle), ARTHRALGIA (Pain on the knees (both of them)) and MYALGIA (When he tries to stand up the has lots of pain) outcome was unknown.            Concomitant medications included drugs for Acid Reflux , Unknown drugs for high blood pressure and Thyroid medication .  No Treatment information was provided.
arms are still sore; fever; chills; extreme head ache; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional (patient) via public post on the flu shot campaign via social media.   This case involves patient of unknown demographics whose stated that his/her arms are still sore (pain in extremity), fever (pyrexia), chills and extreme head ache (headache), while he/she received vaccines PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) and dose of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious adverse events as his/her arms are still sore (pain in extremity), fever (pyrexia), chills and extreme head ache (headache) on an unknown latency following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Case details: Patient stated that he/she  just has his/her flu shot and a pneumonia shot and his/her arms are still sore after three days and had fever and chills and extreme head ache. He/she was  just now able to eat something light. Patient further stated that this was the worst reaction he/she have ever had.   Details of laboratory data were not reported.    It was not reported if the patient received a corrective treatment.  The patient was not Recovered from the event of  pain in extremity and outcome was unknown for other events.  There will be no information available on the batch number for this case.
Pt came to the clinic and received MMR vaccine on 6/9/23.  She was then seen for a new OB pt on 7/11/23. Pt became pregnant within 1 month of receiving MMR.
pt recv vax 12MAR96 & on 25JAN97 pt exp chickenpox;9 other pt were reported as well (WAES 97030174, 97030176-97030177, & 97030179-97030184);
Bell's Palsy right occurred 24 hours after injection of Gardasil. Previously healthy. MR received revealing an 18 yr. old in for well-woman exam with only c/o some discomfort in the mastoid area behind her right ear x2 days. The following day she presented with right-sided facial droop. HPI: Pt awoke morning following Gardasil vax. and had difficulty with spitting out her toothpaste. No pain or visual loss. No extremity weakness or paresthesias. Most obvious upon smiling.  Able to wrinkle forehead and puff cheeks. Good sensation. Txd with Famvir, Solu-medrol and Refresh Tears.  Assessment:  Bell's Palsy.
Chills, teeth chattering for approximately two hours, then overheated with sweating for another two hours, insomnia,  fatigue and muscle aches x2 days
pain in lt arm-shoulder blade to chest area;under arm-down to wrist-aches like a tooth ache x 2wk;
I just have a fluttering in my chest located where my heart is. It happens at different times of the day even when I'm not doing any activities. It comes off and on. It feels like my heart is changing a beat or fluttering. It doesn't hurt, but it just catches me off guard. It may not come for a few weeks then it'll come for a while on and off. When I went to the doctor they said that I have been having heart palpitations. I'm still having them.
Patient received expired dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired dose).    No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.
This spontaneous case report was received from a pharmacist regarding a 66-year-old male patient. Patient had no pertinent medical history and no drug reactions/allergies. On 04-JAN-2016, the patient was vaccinated with PNEUMOVAX 23 (lot number L022262, expiry date 05-NOV-2016) 0.5 ml, intramuscularly in the upper right deltoid muscle. Concomitant therapy included FLOMAX. On 05-JAN-2016, the patient had an 'irritated', big red rash on his forearm. Patient sought medical attention-he contacted the pharmacist. No treatment was given for the events. No laboratory tests were done. The outcome of both the events was unknown. Causality assessment was not provided. No product quality complaint was reported. Additional information has been requested.
Headache, fever 101-102 within 24 hours of administration, loss of appetite, no vomiting, no cough.
Sore arm; headache; slight nausea; body ache; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the right arm on 25Mar2021 at 10:45 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. Medical history included gluten sensitivity. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and psyllium hydrophilic mucilloid (METAMUCIL); all from unknown dates for unspecified indications. The patient did not receive other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021, the patient experienced sore arm, headache, slight nausea and body ache which lasted approximately 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events sore arm, headache, slight nausea and body ache. The clinical outcome of the events sore arm, headache, slight nausea and body ache was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Swelling redness, pruritus, hot deltoid (L) s/p TDAP 16 x 9 cm confluent lesion. Tx: KEFLEX, Hydrocortisone cream PRN ice pack, NSAID or TYLENOL OTC. Cellulitis avoid hot shower/bath.
A month after the second Pfizer vaccine came down with shingles.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG198) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included norethisterone acetate, ethinylestradiol, ferrous fumarate (LARIN FE) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 24Feb2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, a month after the second Pfizer vaccine, the patient came down with shingles. This was the first time the patient had shingles. The patient was not sure if they're connected, but thought it was best to report it. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with unspecified medication. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.