chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stroke; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Dec2021 13:00 (Lot number: FL3197) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, LOT: EW0183, NDC, EXP: unknown, Route, Anatomical Location: right arm), administration date: 13May2021, for COVID-19 immunization; Bnt162b2 (Dose 2, LOT: EW0191, NDC, EXP: unknown, Route, Anatomical Location: right arm), administration date: 03Jun2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 29Dec2021 13:00, outcome "unknown", described as "Booster"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 01Jan2022 12:23, outcome "unknown", described as "stroke". The patient was hospitalized for cerebrovascular accident (start date: 01Jan2022). The event "stroke" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: The caller was the patients wife, reporting that her 55 years old husband who received the Pfizer covid vaccine Booster shot and 2 days later he had a stroke, he does not have any health issue, he was a very healthy person and doctors do not know the reason for stoke. She was calling to report it as advised by the doctor. She states that on Wednesday, they met with the doctor and they said there is no reason they can prove that this has something to do with her husband or his health. She states that he was perfectly fine and there was nothing wrong. She states that one of her friends who is a doctor, said to report this to Pfizer. Stroke occurred early Saturday morning at 12:23 in the morning. It was in the first few minutes of the new year, 01Jan2022. She states her husband is in critical condition and has been in the ICU since Saturday. He is not responsive and, they are saying his situation is getting very fast. Really bad things that usually go in like 6 days, is taking him hours. Treatment: Clarified that her husband has been in the hospital, in the ICU since 01Jan2022 and was still there now. She states she does not have any information with her regarding any treatments or mediations he has had. No prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Seizure (tonic-clonic) 2-3 minutes within 30 seconds-1 min of vaccination witnessed in office.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 27-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1611USA004113.
Humira was not working; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT INEFFECTIVE (Humira was not working) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe Chronic Plaque Psoriasis). On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen. On an unknown date, the patient experienced THERAPEUTIC PRODUCT INEFFECTIVE (Humira was not working). At the time of the report, THERAPEUTIC PRODUCT INEFFECTIVE (Humira was not working) outcome was unknown.      No relevant concomitant medications were reported. Moderna was reported as 4782589.  No treatment medication reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Opinion was that the causality for the event of Humira was not working with Moderna COVID-19 vaccine (Elasomeran) was not provided.  The reporter's causality for the event(s) of Humira was not working with Adalimumab Solution for Injection was Not Provided The reporter's causality for the event(s) of Humira was not working with Moderna COVID-19 vaccine (Elasomeran) was Reasonable Possibility Opinion was that the causality for the event(s) of Humira was not working with Moderna COVID-19 vaccine (Elasomeran) was Not Provided Opinion was that the causality for the event(s) of Humira was not working with Adalimumab Solution for Injection was Not Provided
starting 48hr p/vax exp nasal congestion, non productive cough, weak;
Monovalent booster given in error. No adverse outcome, Patient  notified that she  may receive the bivalent  booster  2  months after  administration of  monovalent booster
Vaccine 2/9, 3/9. Admit 4/12. Admit for COVID PNA, treated w/antibiotics, steroids, Remdesivir. DC'd to home.
8APR92 pt recvd Engerix-B & 1 wk p/vax pt reported felt drained, felt that energy was taken out of her, felt bad (malaise, fatigue);
Went to ER- ER HPI below 30-year-old female with shortness of breath, tachycardia.  She has a history of HTN, palpitations, anxiety, PCOS and is a non-smoker.  She is currently breast-feeding.  She states she had COVID in early January with similar symptoms. She received Pfizer COVID vaccines and had the booster yesterday around 1430. Before bed she had Temp 100.3, Chills. Took tylenol at 8pm and Motrin at 0200.  She woke around 4 AM with tingling in her bilateral hands and feet, chest tightness with palpitations, feeling lightheaded, nauseous and sweaty.  She checked her HR at home which was 160 bpm. No headache, sore throat, radiating or pleuritic CP, vomiting, stool changes or edema. No cough or hemoptysis. No IVDA. She started OCP 72 hours ago. With the first vaccine she tolerated well, the 2nd she had a fever Tmax 104 with antipyretics, no reported allergic reaction otherwise.
Swelling of lymph nodes in left armpit with sharp pain in lowe inner bicep area with pain radiating from arm pit to sharp pain in bicep.
Around 4 PM on 12/20/2021 I had minimal symptoms. I had severe chills, but I was burning up. I had a couple of rounds of mild vomiting and some general malaise, but nothing respiratory or headaches. I'm not certain, but it's possible that food is a little thin on flavor, but I can certainly taste and smell. I got up Tuesday and was fine all day and I'm fine today. I tested positive on Monday 12/20/2021.
Approximately 2-5 minutes after receiving vaccine patient fainted. Patient was pale, sweaty and unresponsive. Patient regained consciousness shortly after but was still pale and sweaty for some time. Patient was given water, ice pack and closely monitored for 30 minutes. Patient and family with him stated that he does not do well with shots and this is a common occurrence. After approximately 15 minutes color came back to patient and he stated he was fine although monitoring continued until 30 minutes.
Side effects; Nausea; This case was reported by a consumer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event and nausea. On an unknown date, the outcome of the adverse event and nausea were not recovered/not resolved.   It was unknown if the reporter considered the adverse event and nausea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had all but the nausea. The reporter asked how long would the common side effects of Shingrix last.
I have been breaking out in severe hives for approximately 5 months. I have been to the doctor several times and have been given allergy shots and allergy testing, but nothing has helped. My eyes swell completely shut and my lips swell as well, and the hives cover my whole body. This has never happened prior to receiving the vaccine.
Narrative: COVID infection following COVID vaccine series 02/26, Pfizer, dose #1 03/18, Pfizer, dose #2 07/29 Had colonoscopy (private sector) 08/01 pt  cc: cough non-productive, rhinorrhea, sore throat 08/02 seen private sector at clinic given rx z pak and medrol dose pak 08/03 pt cc: cough exposure: unknown 08/03 COVID swab, result: detected 08/05 cough, rhinorrhea, sore throat 08/06 pt cc: "cough and sneezes much better than the Saturday...still a little/slight cough states however feeling better" pt report: T97.5, bp 136/78, sat 98% 08/07 pt cc: rhinorrhea and post nasal drop (IMPROING) 08/08 clinically resolved
After receiving her pneumonia vaccination on her right arm on 11/08, patient noted what she describes as a normal local reaction at the vaccine site. However, after 48 hours, patient noted a significant increase in swelling and erythema surrounding the site which extended from the shoulder to the elbow, and around almost the entire circumference of her upper arm; by the a.m. of 11/11, the swelling and redness had extended almost to the wrist. The patient called the clinic and was told to wait and watch and urged to take an OTC analgesic and anti-inflammatory. The redness and swelling gradually resolved over the next 7 days. The patient describes an aching pain at the vaccine site that started the night of vaccine receipt, which continues today when pressure applied at site. She also reports right upper arm and should pain that started the evening of vaccine receipt and continues today. The pain has decreased to some extent, but worsens with lifting and AROM. The first 2 weeks following vaccine receipt, patient was not able to lift her arm above her head. She denies any numbness or tingling in her upper extremity. She denies any previous trauma or injury to her RUE. ( She received her flu vaccine that same day in her left arm and denies any significant local reactions or pain in her left arm.) She denies problems going to sleep or awakening during the night.
Pt recvd 1st dose of Engerix-B 01AUG91; 4 hrs p/vax pt exp nausea & itching for 2 days;
SMALL FEVER; .This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced small fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of small fever was not reported. This report was non-serious.
About 24hrs after shots given For both shots severe arm pain and swelling. Also severe diareah . And both shots made my period come early, for the second shot it feels as thought I was hit my a truck! Severe chest pains and body aches all  over. Could not go to work can barley move
Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakness in my right hand had become progressively worse since dec 30 or 31 st . Had the second shot on Jan 11 . In last 2 data I am having trouble holding a mug or iPhone in right hand . It feels very numb   From Jan 12 to today my right hand is having trouble gripping pen , hair brush , difficult to open doors .
Right arm swelling 5x5, itchy and red. Ice pack with Tylenol.
Currently hospitalized with undiagnosed several lung issues, admitted to the hospital on 2/6/2022.  Sickness started 3 or 4 weeks prior.  Initially determined double pneumonia but unable to treat with antibiotics.  None of the cultures grow, every test comes back negative.   Unable to treat because it's unknown... treating symptoms broadly but all medical specialist are baffled but admit the condition is rare.  In my research I found 2 case studies that point to interstitial lung disease.  I believe it was drug induced by the vaccine, slow on set triggered over time.  This is why the perceived infection, not confirmed is not consistently reacting to treatment for the last month.  Shortly after being admitted and  placed on a ventilator he had a stroke.  They also can't say what caused that.
Extreme pain at site of Injection, High Fever, Night sweats, Nausea.  Took Advil and put ice pack on my arm
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 16-OCT-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry: 25-FEB-2017 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she has lingering symptoms), MUCOSAL INFLAMMATION (Mucositis), TOOTH DISORDER (block on teeth), NONINFECTIVE GINGIVITIS (Inflammation on her front gum) and GINGIVAL ULCERATION (Ulcer on her right lower gum) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 010A21A) for COVID-19 vaccination. Concomitant products included PANTOPRAZOLE for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced NONINFECTIVE GINGIVITIS (Inflammation on her front gum). In September 2021, the patient experienced MUCOSAL INFLAMMATION (Mucositis). In December 2021, the patient experienced GINGIVAL ULCERATION (Ulcer on her right lower gum). On an unknown date, the patient experienced IMMUNISATION REACTION (she has lingering symptoms) and TOOTH DISORDER (block on teeth). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; CLOBETASOL at a dose of tropical; DOXYCYCLINE at an unspecified dose and frequency and METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (she has lingering symptoms), MUCOSAL INFLAMMATION (Mucositis) and TOOTH DISORDER (block on teeth) outcome was unknown, NONINFECTIVE GINGIVITIS (Inflammation on her front gum) had not resolved and GINGIVAL ULCERATION (Ulcer on her right lower gum) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Biopsy: (Negative) It was just mucositis. It was reported that patient after receiving the second primary dose had inflammation on front gum where she had crowns, dentist prescribed mouth wash to treat it but did not work. Patient was referred to periodontist who gave her dexamethasone which did not work and for this they gave Clobetasol(topical ointment) which too did not work. After biopsy patient was recommended to maintain oral hygiene and dental cleaning. On Dec-2021 she had ulcer on right lower gum and the doctor prescribed doxycycline and Flagyl, the ulcer got better but the inflammation was still the same. This case was linked to MOD-2022-612792 (Patient Link).
Site was slightly red, swollen and warm after receiving vaccine. One week after (1/5/21) I developed a raised hive-like itchy rash- I used over the counter hydrocortisone cream. The next day (1/6/21) my upper arm was very red and swollen- I put Benadryl cream on it over night and it looked much better the next day.  The redness and swelling has gone away, but the site is still slightly warm.
Multiple Sclerosis exacerbation; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Multiple Sclerosis exacerbation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache, Optic neuritis, Pain and Depression. Concurrent medical conditions included Hypertension, Malignant hyperthermia and Multiple sclerosis relapse. Concomitant products included METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL), LORATADINE (LORATAB), METOPROLOL, ZOLPIDEM, MEMANTINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and VENLAFAXINE HCL for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Multiple Sclerosis exacerbation) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Multiple Sclerosis exacerbation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Arm still extremely sore from day one, no improvement. Can?t even lay on it. Also extreme fatigue.
pain at injection site, patient states she flinched due to the extreme pain in left arm x 2 weeks. In addition, pain in both hands x 2weeks. Has taken Tylenol with no relief.  Referred to primary provider
Nausea, dizziness, headache, chills, severe swelling and redness of arm from elbow to top of shoulder and hot to touch, upper left back ache, throbbing pain in arm.  This was given Saturday morning and it is still hot and swollen today Tuesday.
This spontaneous report as received from a medical assistant refers a female patient of unknown age. The reporter stated that the patient previously developed hives after receiving Amoxicillin. In January 1998, the patient was vaccinated with her first dose of PNEUMOVAX23 (dose, route, indication and lot number were not reported). On 26-AUG-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 lot # H022280 and expiration date 16-JUL-2014, (dose, indication and route were not reported). On 27-AUG-2013 the patient experienced fever, redness at the injection site, swelling at the injection site, warmth at the injection site and chills. On unknown date, the patient sought medical attention through call the office. Approximately, in August 2013, the patient received treatment of BENADRYL. The outcome of swelling at the injection site, redness at the injection site, warmth at the injection site, chills and fever was reported as recovering/resolving. This report is the first report of two reports from the same source. The second is 1309USA011510. Additional information has been requested.
Patient had hives at 8 pm on 9/11/23. Given Benadryl. Patient vomited and felt faint when running at school on 9/12/23. Patient had hives at bedtime on 9/14/23. Hives worsened during the night. Given Benadryl. Patient vomited a little and had one episode of loose stool during the morning on 9/13/23. Given Benadryl.
Joint pain in left shoulder, hips, left hand and fingers, left knee, lower back  Steroid injection in hand and shoulder  Physical therapy for left shoulder  Pain medication given
This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX, lot number M033214 with expiration date 13-JUL-2018 and lot M041513 with expiration date 11-OCT-2018, other suspect therapy included sterile diluent which was properly stored, lot number and expiration was not reported (dose, route and anatomical location were not reported for the above described therapies for prophylaxis. There was no previous temperature excursion. The vaccine was exposed to temperatures between 9 Celsius (C) and 25 Celsius (C) during 7 hours and 56 minutes. Data logger was filled. On unknown dates, the patients reported "injection site redness and swelling". At the time of the report, the outcome of the vaccination site swelling and vaccination site erythema was unknown. The relatedness between the events and therapy with VARIVAX was not reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA004607.
Pain in arm; body aches; felt crummy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PAIN (body aches) and FEELING ABNORMAL (felt crummy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Arthritis.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PAIN (body aches) and FEELING ABNORMAL (felt crummy). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PAIN (body aches) and FEELING ABNORMAL (felt crummy) outcome was unknown.