chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my 56 year old husband die a week after he received your vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56-year-old 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: DEATH (death, medically significant), outcome "fatal", described as "my 56 year old husband die a week after he received your vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical information: It was reported that reporter asked why did her 56 year old husband died in a week after he received the vaccine and her 8 year old daughter and she would like an answer and said it was safe for everyone you lied. Event Awareness Date: 20Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: my 56 year old husband die a week after he received your vaccine
Tingling in left arm, hand, leg and foot; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and doxylamine succinate (UNISOM). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 14:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 20:00, the patient experienced tingling in left arm, hand, leg and foot. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event tingling in left arm, hand, leg and foot was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt has the shot on 3-2-20. Called and spoke to Rph on 3-18-20 about her arm being sore for a week and hurt when she tries to raise her hand up. Rph advised pt to seek medical doctor for advice.
Dizziness the following four days after the injection. Headache started the following morning after the injection and has been continuous, I still have it.
I starting serve headache and pain in both shoulder that went up into my neck. I went to the ER. They did EKG, chest x-ray, and blood work, normal result for all but my EKG was a little abnormal. They wanted me to have a stress test. They finally gave me a muscle relaxer that helped. I went to a chiropractor that did ultrasounds treatment to my muscle. It finally went away after a week.
Initial misuse report received from a healthcare professional on 06 February 2014. A patient had received a dose of PENTACEL on an unspecified date. A medical assistant took the ActHIB portion from PENTACEL and reconstituted it with Merck diluent and administered the vaccine. The Dtap-IPV was not administered. No adverse event was reported. List of documents held by sender: none.
Raised red lump at injection site appeared 8 days after first dose injection.  Lump is only mildly painful and warm.
DEATH; SEVERELY INJURED; This spontaneous report received from a consumer concerned multiple patients with unspecified age, gender, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that on an unspecified date multiple patients had died and were severely injured as a direct result of vaccine. The cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severely injured was not reported. This report was serious (Death).; Sender's Comments: V0: 20211057445-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report was received from a medical assistant referring to a 66 year old female patient with depression. Information about pertinent medical history was unknown, the patient's drug reactions/allergies included tetracyclin, augmentin (reported as audmentin), erythromycin (reported as euirthyromycin) and codeine. The patient's concomitant medications included dapagliflozin (FARXIGA), glipizide (GLIPIZIDE), levothyroxine sodium(SYNTHROID), famotidine (FAMOTIDINE), pantoprazole (PANTOPRAZOLE), pramipexole dihydrochloride (MIRAPEX), hydrochlorothiazide, lisinopril (HYDROCHLOROTHIAZIDE (+) LISINOPRIL), cyanocobalamin (CYANOCOBALAMIN), albuterol sulfate (PROAIR (ALBUTEROL SULFATE)), metformin hydrochloride, sitagliptin phosphate (JANUMET XR), fluticasone propionate (FLONASE), insulin glargine (TOUJEO), pregabalin (LYRICA), paroxetine hydrochloride (PAXIL), montelukast sodium (SINGULAIR), pravastatin and dicyclomine. On 07-DEC-2018, the patient was vaccinated with an injection of PNEUMOVAX 23 injection in the medical office (lot # R016638 with expiration date 28-JAN-2020,in the right arm, dose detail and route were not reported) for avoid pneumococcal disease (prophylaxis). On the same day, several hours after injection, the patient called the medical office stated the arm that received the vaccination was swollen, red at the injection site and itching at the injection site. The physician told the patient to put ice on the swollen arm and take unspecified diphenhydramine hydrochloride (BENADRYL) and ibuprofen (ADVIL). The outcome of events were reported as not recovered. The causality assessments between events and PNEUMOVAX 23 were not reported.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician at a healthcare facility/office, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 21-SEP-2014, the patient was treated by the physician at the healthcare facility/office, for a blistering vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
MILD TINGLING AROUND LIPS SYMPTOMS RESOLVED WITHIN A FEW MINS AFTER SHOT WAS GIVEN
localized rash; tender to touch 6mm x 6 mm; area around inject site red & inflammed; given DPH; on Tegretal; NKA;
Nausea if she eats too much "had a few teaspoons of oatmeal today"; Diarrhea, "can barley make it to the toilet, and I had to change my pants 5 times"; Flu like symptoms; I am still sick and very weak; "My head is killing me, it hurts to stand"; 3am Saturday 12Jun2021 I woke up so sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (3am Saturday 12Jun2021 I woke up so sick), DIARRHOEA (Diarrhea, "can barley make it to the toilet, and I had to change my pants 5 times"), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (I am still sick and very weak) and HEADACHE ("My head is killing me, it hurts to stand") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced ILLNESS (3am Saturday 12Jun2021 I woke up so sick), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (I am still sick and very weak) and HEADACHE ("My head is killing me, it hurts to stand"). On 13-Jun-2021, the patient experienced DIARRHOEA (Diarrhea, "can barley make it to the toilet, and I had to change my pants 5 times"). On 14-Jun-2021, the patient experienced NAUSEA (Nausea if she eats too much "had a few teaspoons of oatmeal today"). At the time of the report, ILLNESS (3am Saturday 12Jun2021 I woke up so sick), DIARRHOEA (Diarrhea, "can barley make it to the toilet, and I had to change my pants 5 times"), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (I am still sick and very weak), HEADACHE ("My head is killing me, it hurts to stand") and NAUSEA (Nausea if she eats too much "had a few teaspoons of oatmeal today") outcome was unknown.            No concomitant medications were provided.  The patient stated she lives a very healthy lifestyle, was a vegetarian and does not drink or smoke. Patient did not report pre-existing medical conditions.Patient states she received the first and second dose at different vaccine sites.   The patient only had drinking lemonade and grapefruit, soda, crackers, tried not to take any medications.No treatment medication was provided.
Rash developed on right arm at inside of elbow and right side of midsection.  Just putting on antibiotic and itch creams.
Initially shoulder was sore, difficult lifting arm or abducting shoulder, 4 hours later had mild sore throat, after 6 hrs began having body aches.  During the night (  at least 8hrs after shot) developed a fever 101.2, body aches, especially low back, and mild headache.  Had no appetite the next day, 1/29,21, queasy stomach, temp hovered between 99-100 most of the day, back ache was most problematic, no energy, slept most of the day, mild headache remained.  Symptoms disappeared after 30-36 hours.  Had some digestive distress after this but was probably related to not having eaten for over 24 hours & then resuming.
This was my 2nd dose. Friday morning High fever 103.3 and chills for a day. Mild fever and headache Saturday Sunday woke up with a sore throat....now I have cold and flu like symptoms. Today, March 8 I am finally starting to feel better.
no issues with my first dose, but Feeling fatigued since my 2nd vaccine, and injection site pain, and fingers feel joint soreness, swelling. i still can't get my rings on and has been abnormal for me. fingers feel tight.  facial swelling and edema
after Shingrix, his nerve damage and pain dramatically improved, relieved nerve pains in hands and feet; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included nerve damage and nerve pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR157004   Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. Prior to receiving vaccine, the patient suffered from severe nerve damage and pain from a cervical injury a couple years after the accident.  The patient received the Shingles vaccine in either 2019 or 2020 and it changed his life. The patient stated after receiving Shingles vaccine, almost instantly relieved of nerve pains in hands and feet and nerve damage and associated pain dramatically improved. Although it was short lived for about a week. The patient thought it was a new him, this happened again with second shot and again was short lived. The physician could not able to explain why this occurred.  The reporter did not consent to follow up. No additional details were provided by the reporter. Additional Supportive Information: For tolerance of 2nd dose refer case US2022AMR157004, reported by same reporter. Suspect product was captured as Shingles vaccine instead of Shingrix as per latest follow up information.; Sender's Comments:  US-GSK-US2022AMR157004:Same reporter
Temp 103 degrees. Rash axillary bilat, rash inner aspect left elbow.
Hives developed <24 hrs after Receiving Vaccine; Treated with Benadryl
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant medication was reported.     Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022.  No treatment information was reported.  This case was reported for 9th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-665435, US-MODERNATX, INC.-MOD-2022-665399, US-MODERNATX, INC.-MOD-2022-665436, US-MODERNATX, INC.-MOD-2022-665437, US-MODERNATX, INC.-MOD-2022-665466, US-MODERNATX, INC.-MOD-2022-665472, US-MODERNATX, INC.-MOD-2022-665480, US-MODERNATX, INC.-MOD-2022-665491, US-MODERNATX, INC.-MOD-2022-665504, US-MODERNATX, INC.-MOD-2022-665519, US-MODERNATX, INC.-MOD-2022-665541, US-MODERNATX, INC.-MOD-2022-665611, US-MODERNATX, INC.-MOD-2022-665613, US-MODERNATX, INC.-MOD-2022-665659, US-MODERNATX, INC.-MOD-2022-665669, US-MODERNATX, INC.-MOD-2022-665686, US-MODERNATX, INC.-MOD-2022-665696, US-MODERNATX, INC.-MOD-2022-665704, US-MODERNATX, INC.-MOD-2022-665705 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665435: US-MODERNATX, INC.-MOD-2022-665399: US-MODERNATX, INC.-MOD-2022-665436: US-MODERNATX, INC.-MOD-2022-665437: US-MODERNATX, INC.-MOD-2022-665466: US-MODERNATX, INC.-MOD-2022-665472: US-MODERNATX, INC.-MOD-2022-665480: US-MODERNATX, INC.-MOD-2022-665491: US-MODERNATX, INC.-MOD-2022-665504: US-MODERNATX, INC.-MOD-2022-665519: US-MODERNATX, INC.-MOD-2022-665541: US-MODERNATX, INC.-MOD-2022-665611: US-MODERNATX, INC.-MOD-2022-665613: US-MODERNATX, INC.-MOD-2022-665659: US-MODERNATX, INC.-MOD-2022-665669: US-MODERNATX, INC.-MOD-2022-665686: US-MODERNATX, INC.-MOD-2022-665696: US-MODERNATX, INC.-MOD-2022-665704: US-MODERNATX, INC.-MOD-2022-665705:
Flutter in heart; Metal taste in mouth; Nauseous; diarrhea; Fuzzy head; loss mental focus; Bump appeared on bottom lip; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right on 29Aug2021 13:00 (Lot Number: FD8448) as dose 1, single for COVID-19 immunisation. Medical history included known allergies to Morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. There were no concomitant medications. COVID test (Nasal Swab) on 07May2021 was negative. On 29Aug2021 after 30min of shot (at 13:30), patient experienced a metal taste in mouth; flutter in heart lasted a day; nauseous and diarrhea lasted 4 days; fuzzy head and loss mental focus that lasted 5 days; and a bump appeared on bottom lip. The adverse events result in Doctor or other healthcare professional office/clinic visit. The outcome of the event 'Flutter in heart' was recovered on 30Aug2021 13:30, for 'nauseous and diarrhea' was recovered on 02Sep2021 13:30, for 'Fuzzy head' and 'loss of mental focus' was recovered on 03Sep2021 13:30, for the other events was recovering.   No follow up attempts are possible. No further information is expected.
Got extremely, unrelentingly cold which was not mitigated by extra clothing and/or blankets.  Shivered and teeth chattered for 8-10 hours.  Finally took acetaminophen which helped but slept most of next day.  Arm hurt.
After the patient received the Rotavirus oral vaccine, the onset of symptoms started within 6 hours. His abdomen was swollen and solid upon touch. His stomach was rumbling with gas bubbles. He cried none stop for more then 3 hours, and did not want to eat. He vomited all his milk that he would drink, because his stomach was filled with so much gas. The hospital did an x-ray and saw his belly full of tightly condense colic gas. These colic episodes lasted for 3-4 days.
no strength to get up; so weak that when he got up to go to another room, after 3 step, collapsed.; They were very very weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no strength to get up), FALL (so weak that when he got up to go to another room, after 3 step, collapsed.) and MUSCULAR WEAKNESS (They were very very weak) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065E21A, 013A21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced ASTHENIA (no strength to get up), FALL (so weak that when he got up to go to another room, after 3 step, collapsed.) and MUSCULAR WEAKNESS (They were very very weak). At the time of the report, ASTHENIA (no strength to get up), FALL (so weak that when he got up to go to another room, after 3 step, collapsed.) and MUSCULAR WEAKNESS (They were very very weak) outcome was unknown.            Concomitant medications was not reported. Treatment medications was not reported The patient had the Moderna booster (lot 065E21A) on 17Nov2021. On 18Nov2021, he had a situation, really scary. His legs from his waist down, they die. They were very very weak, so weak that when he got up to go to another room, after 3 steps, he collapsed. He is 6 feet and 3 inches and weigh 350 pounds. He is 75. He had no strength to get himself up.   This case was linked to MOD-2021-391975 (Patient Link).
Patient received IPV, Comvax, MMR, Varivax, DTaP, and Prevnar on July 30, 2003.  By Sunday, Aug. 3, pt. had developed high fever to 104F and erythema multiforme rash.  On Aug 4, pt. was given Benadryl, without improvement.  On Aug 5, pt. was given Zyrtec without improvement.  On Aug 6, he came to ER (where we saw him) with progression of rash, covering entire body, with raised red areas and flat blue areas.  Fever continued to be 104.  Pt. had tremors of hands and assymetrical Babinski reflex, upgoing on right only.  Rash did not appear to be itchy.
Shingles: Chest began itching slightly the week of May 23, which went away after a few days. Noted dull pain in right breast approx May 28 or 29.  Developed painful itching in a couple of places in the middle and right side of my back on May 30, which I assumed were bug bites. The itching on my back continued to get worse, and the itching on my chest returned with a rash above my right breast on May 2.  I met with a teledoc via clinic virtual visits service on May 3, and based on my description and 4 photos I sent to him, he diagnosed me with Shingles. He prescribed 1GM Valacyclovir for 7 days with Lidocaine patches as needed.
About 13 hours after getting 1st dose of pfizer covid vaccine the patient developed hives like rash on arms and legs. Rash still present, persistent, and worse 6 days later when he was seen in our office. No swelling or respiratory symptoms.  Pt advised to take antihistamine and h2 blocker. Pt was referred to an allergist.
16 year old receiving the Moderna vaccine; A spontaneous report  was received from a consumer concerning a 16-years-old Unknown gender of patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event of 16 year old receiving the moderna vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) 16 year old receiving the Moderna vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), 16 year old receiving the moderna vaccine was unknown.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Unknown) with no associated AEs.