chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke; went through an inflammation state and since then has been in a fog; can't remember his birthday; doesn't want to eat; bleeding in the brain which they called it second stroke; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CEREBRAL HAEMORRHAGE (bleeding in the brain which they called it second stroke) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip fracture. Concurrent medical conditions included Polycythemia. Concomitant products included IBUPROFEN for Joint pain, SIMVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL and METOPROLOL for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and CEREBRAL HAEMORRHAGE (bleeding in the brain which they called it second stroke) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (went through an inflammation state and since then has been in a fog), AMNESIA (can't remember his birthday) and DECREASED APPETITE (doesn't want to eat). The patient was hospitalized from 30-Mar-2021 to 12-Apr-2021 due to CEREBRAL HAEMORRHAGE and CEREBROVASCULAR ACCIDENT. The patient was treated with Physical therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), CEREBRAL HAEMORRHAGE (bleeding in the brain which they called it second stroke), FEELING ABNORMAL (went through an inflammation state and since then has been in a fog), AMNESIA (can't remember his birthday) and DECREASED APPETITE (doesn't want to eat) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter states that the patient was given a "clot buster" to prevent further damage.   Patient was transferred to a nursing facility on 12 Apr 2021 and is still there.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patients advance age and past medical history of polycythemia may remain a risk factor for this event. Further information has been requested.   This case was linked to MOD-2021-086187 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patients advance age and past medical history of polycythemia may remain a risk factor for this event. Further information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received SHINGRIX. On 30th July 2018, 3 days after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). The patient was treated with antibiotics nos and steroids nos. On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional information received as follows: The case was reported by the registered nurse, clinic manager. On 30th July 2018, the patient noticed reaction. The patient was issued antibiotics and steroid. The reporter agreed to follow up from GlaxoSmithKline.
strong allergic reaction; developed the strongest oedema in the chin; patient had also presented with swelling in other places where they had over the years; developed an urticarial rash on their shins; RN 2345521 and LRN 2346395.  This is a spontaneous report from health care professional.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number were not provided, Expiration date were not provided), via an unspecified route of administration as unknown dose number, single for covid-19 immunisation. The patient's medical history included swelling in other places. Concomitant medication was not reported. On an unspecified date, the patient experienced strong allergic reaction to [the Pfizer COVID-19 vaccine] in places where they had been injected with Juvederm six days after the vaccination. The patient developed the strongest oedema in the chin where they had the most recent Juvederm injection with Juvederm VOLBELLZ with Lidocaine. The patient had also presented with swelling in other places where they had over the years been treated with [unspecified] fillers in the nasolabial line and between the eyes. The patient has now also developed an urticarial rash on their shins. The swelling had got worse throughout the day. The patient received treatment included dose of allergy medications. This record captures events relating to Juvederm VOLBELLA with Lidocaine. Complaint Dermal. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Weakness makes it hard to walk or stand, shaky, Nausea, Chills, Severe body aches, Exhaustion.
Information has been received from a health care worker concerning a 9 week old female patient who on an unspecified date was vaccinated with a dose of ROTATEQ (dose and lot # not reported). The health care worker reported that on an unspecified date, the patient regurgitated almost immediately after receiving a dose of ROTATEQ. No treatment for the adverse event was given. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the health professional concerning a 8 week old female patient who on 12-JUL-2011 at 14:24 was vaccinated at a private doctor's office with the first dose of ROTATEQ (dose not reported) and lot # 668953/1137Z. The healthcare reported that on 12-JUL-2011 at 14:24 the patient vomited right after dose of ROTATEQ was given. At the time of the report, the patient's outcome was unknown. No further information is available.
Developed an 8 x 3 inch wide red itchy rash. Increased in severity through 8/1/ 20
7SEP95 mom reports p/pt's 6mos vax had limpness & fever 103;
mom did not report adverse event returned to clinic on 11MAY94 for 3rd immun; states that approx 1 wk p/vax noticed pt devel a twitch (tic) all over body for no apparent reason;
Hives breakout all over face and arms - I've been taking Benadryl but still present,  swelling on eyelids so I could barely open eyes - Been taking benadryl,  Fever of 105.3 degrees - Been taking tylenol for 2 days but still have fever,  Sore arm and body aches,  Overall weakness feeling
headache; fever; shakes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. Relevant medical history included: "allergy to nuts" (unspecified if ongoing), notes: Just as a note, (name-withheld) has an allergy to nuts, including peanut and coconuts.; "including peanut" (unspecified if ongoing), notes: Just as a note, (name-withheld) has an allergy to nuts, including peanut and coconuts.; "coconuts" (unspecified if ongoing), notes: Just as a note, (name-withheld) has an allergy to nuts, including peanut and coconuts. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; PYREXIA (non-serious), outcome "unknown", described as "fever"; TREMOR (non-serious), outcome "unknown", described as "shakes".  Additional Information: It was unknown whether patient had any other medical history or known allergies. It was unknown whether patient tested for COVID-19 prior and post the vaccination. It was unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine and also unknown if patient had received any other medications in two weeks. It was unknown whether patient tested for COVID-19 prior and post the vaccination. Patient believe was getting their booster shot today. There was a discussion regarding vaccine side effects, and they said that they agreed that they had a similar experience to (Name withheld) reported in (not sure for which dose(s)). Specifically, the headache, fever, shakes (or scenario described for the 1st dose or 3rd dose, whichever was the one actually described. Not sure which vaccine has gotten or timeframe. Believe today was getting booster, so believe has had the first two shots.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient came in to receive both the seasonal flu vaccine and the pfizer bivalent booster. seconds later she feld lightheaded and then she slid down the chair and had a seizure. parametics were called and she was evaluated. they recommended she go with them but she refused.
Intense body and joint aches all over my body. Fever hovering between 100.3 and 101.2
Patient reports after 2 weeks her injection site is still red, sore and she has a rash all over her body. She is very itchy.
I started to have hot flashes. Two days afterwards my mouth turn purple and my mouth started to bleed. Sore throat
About 4 hours later, started getting an intense pain in stomach. At night had cold sweats, vomited once, severe diarrhea, low temp, blacked out, but did not go to the ER. Arm soreness and swollen. Stopped around 1:00 the next day. Monday felt a little froggy. Feeling better now.
Onset of very painful left arm in bicep area on day 2 & 3. I applied ice several times a day & took Tylenol & Advil. Pain lessened on day 4, BUT my concern is the pain still persists in bicep area with all movement. Pain level NOW is 6-8. Continue needing Tylenol but must limit Advil as I?m on Clopidogrel.
This spontaneous report refers to herself: a 64 year old female patient. There was no pertinent medical history, drug reactions/allergies included codeine. On an unknown date in April 2012 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous for prevention of shingles. There was no concomitant medication. On an unknown date in October 2012 the patient developed "a mild case of shingles". The rash was mostly limited to the right side of her face. Then on 23-JUN-2013 she broke out in a new shingles rash which developed on both sides of her face and neck as well as both arms and legs. The patient had not recovered from this rash. She stated it was a much more severe case and very painful. There were no lab diagnostics studies performed. The patient sought unspecified medical attention. Patient's doctor prescribed valacyclovir for the symptoms.  Additional information has been requested.
Bell's Palsy/facial paralysis; Bell's Palsy/facial paralysis; This is a spontaneous report received from a consumer (patient's husband). A 78-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 78 years, administered in right bicep on 16Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Patient's medical history includes bells palsy from 1997, lower right lobe of her lung removed in 2016, and removed for carcinoid tumor on an unspecified date. Patient did not have prior vaccinations in 4 weeks. Concomitant medications were none. There were no other vaccines administered on the same date as the suspect. Patient previously too quite a few medications but she hasn't been taking for years or that would affect it. It was reported that patient and the reporter received first dose on 16Mar2021 at 09:00 AM in the right bicep as recommended by the pulmonologist and oncologist.  It was reported that on 29Mar2021, also reported as "13 days later from vaccination", facial paralysis started around noon. At the time of report, patient was experiencing Bell's Palsy from 29Mar2021 and asking for recommendation for second dose. Patient was also officially diagnosed with Bell's Palsy when she went to the ER on 31Mar2021. Patient has seen the doctor and been to the ER and the doctor refused to comment saying he had no opinion, they had asked him if she should do the second dose and he said he had no opinion. Reporter relayed that on the website there is no specific notable balance in the numerical groups to suggest a causal relationship to the vaccine. Reporter was asking if the second dose was prohibited, stating patient was scheduled for 06Apr2021 which is 21 days after her first dose. Patient's husband spoke from the FDA's briefing document that "Bell's palsy was reported by four vaccine participants and none in the placebo group. These cases occurred at 3, 9, 37, and 48 days after vaccination," and mentioned that  there have been 4 reports of Bell's Palsy during the study and 1 of those was after the first dose and 3 were after the second dose. They wanted to know if it is allowed should she get it or could it be rescheduled to a later date. For tests, no testing was done they just did a visual exam on an unspecified date. Vaccine was not administered at Facility. The outcome was unknown.  Information about lot/batch number is requested.
Pt had J&J Covid vax and  2 Moderna Boosters.  Next day after 2nd booster she felt very tired.  Her Blood Pressure dropped very low.  It was 67/37 which is very low for her.  It was about half hour before she was able to contact a nurse regarding her symptoms.  She was told to go to the ER.  Pt waited to see how she if she felt better before going.   After several hours it was went to 110/60, so she was able to function in a normal capacity.  The following day BP was back to normal.  She states it is a very acute reaction and has not had this issue again.
Mild allergic response; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was taken as an adult as per vaccine indication. The patient received 1 dose of Shingrix without the second dose and experienced a mild allergic response and wanted to have an informed discussion regarding risks and benefits of having a second dose. The reporter consented to follow up.
starting having a funny taste in her mouth; injection site really bruised; really sore like you would get the flu; cough; rash real red; arm itching; felt like sleeping all day; sore all over/ muscle aches; fatigue; fever at 102.0; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough) and RASH ERYTHEMATOUS (rash real red) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough), RASH ERYTHEMATOUS (rash real red), PRURITUS (arm itching), SOMNOLENCE (felt like sleeping all day), MYALGIA (sore all over/ muscle aches), FATIGUE (fatigue) and PYREXIA (fever at 102.0). At the time of the report, DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough), RASH ERYTHEMATOUS (rash real red), PRURITUS (arm itching), SOMNOLENCE (felt like sleeping all day), MYALGIA (sore all over/ muscle aches), FATIGUE (fatigue) and PYREXIA (fever at 102.0) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 102 (High) units not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received provided event onset date.
No additional adverse events reported; The patient was accidentally given a second dose of PNEUMOVAX23; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient was vaccinated with a dose of pneumococcal 13v conj vaccine (crm197)(PREVENAR 13) on 11-SEP-2017. There was no information regarding the patient's concurrent conditions, concomitant medications or drug reactions/allergies.  On 08-OCT-2019, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not provided). On 09-JAN-2020, the patient was accidentally vaccinated with a second dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), because the office got a new computer system and the first dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not carried over to the new database.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received SHINGRIX. On 6th February 2019, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: Nurse Practitioner on the line stated that the patient went to her pharmacy to receive SHINGRIX on Monday and then on Wednesday started to have shingles. The reporter had two other providers confirm the patient's shingles as well. The reporter not gave the product, she believes it was given at a pharmacy. She did not have that information to provide. Also, cannot confirm placement of product, but she would assume they administered the product as recommended. The reporter did not have lot number or expiration date to provide.
Temperature, chilled, fever top 102 degrees, from knees down to ankles pain symptoms came back 2 weeks later.
Booster dose 2.5mL administered instead of 0.25mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Medical history was not reported. Concomitant products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for an unknown indication.    On 29-Oct-2021 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 ml. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE. On 29-Oct-2021, ACCIDENTAL OVERDOSE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist stated patient was administered the 2.5 mL dose at 9:45am and left the pharmacy at 10am and did not report any side effects that pharmacist was aware of.
Headache, Sedation, Myalgia, Arthralgia, Fever,  Diarrhea,    Swollen lymph nodes, Stomach cramps, Chills,  Itching @ injection site Narrative:   Other Relevant History:
-Onset of symptoms occurred the day after getting my first Pfizer Covid-19 vaccination. Symptoms include chest pain, palpitations, tremors, left arm pain. -On 9/22/2021 I visited primary care, Dr. for symptoms of chest pain, tremors, heart palpitations that started the day after getting my first Pfizer Covid-19 vaccination. She referred me to neurology and cardiology. Also ordered labs, ran EKG which came back normal. -On 9/26/2021 I went to ER for worsening chest pain, tremors, palpitations. They did a chest Xray, labs, EKG, which came back normal. Gave me IV and Ativan.  -Followed up with cardiologist Dr. 9/28/2021 for chest pain and palpitations. He prescribed Atenolol for heart palpitations. Ran an EKG, came back normal. Ordered an echocardiogram.  -Took new Atenolol prescription 1 time and caused low blood pressure, slow heartbeat, and severe chest pain. Went into ER on 9/29/21 for severe chest pain and lightheadedness. Labs, EKG, X-ray were again normal. They also ran an echocardiogram which showed possibility of mild pericarditis. Was told to take ibuprofen for pain. Was told to stop taking atenolol. -9/30/2021 followed up with cardiologist. Listed Atenolol as an allergy. Dr. reviewed the echocardiogram and confirmed pericarditis. Told me to schedule ibuprofen 400 mg 3 times daily. -Followed up with neurologist Dr. for chest pain, tremors. Prescribed me colchicine, famotidine, and ibuprofen for pericarditis. Ordered chest CT, PFT, and Labs. Labs came back normal. -Went to ER on 10/9/2021 for chest pain. Labs were done and D-dimer was elevated so they ordered a CT angio pulmonary with contrast, which came back normal. XRay and EKG came back normal.  -10/18/21 followed up with primary care for left calf pain which had been persisting for at least 4 days prior, and to discuss my pericarditis symptoms. She ordered a leg ultrasound which came back normal.  -10/28/2021 followed up with Dr. Continued and worsening leg pain, persisting chest pain. GI upset from ibuprofin continues. Ordered left leg ultrasound which came back normal.  -Symptoms of pericarditis persist as of today. Other symptoms like tremors, left leg pain also persists.
On 8/27/02 awakened with swollen lips and cheeks and with red blotching areas on left upper arm. Taken to ER after given Benadryl. ER gave Prelone and prescribed a 5 day course of Prelone. Followed up at clinic on 8/29/02. Slight redness to left upper arm noted.
Itching and slight redness started on 1/21 and is more noticeable today, Friday. One week after receiving the injection. No other symptoms.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age. On 2017 the patients were vaccinated with VARIVAX lot # M010482 (expiration date: 01-MAR-2018), M027347 (expiration date: 01-JUN-2018), M048200 (expiration date: 04-DEC-2018), N007930 (expiration date: 08-MAR-2019) for prophylaxis. Concomitant therapies included sterile diluent. On 08-AUG-2017 was reported incorrect product storage. No adverse event reported. The outcome of incorrect product storage was unknown. The reporter considered incorrect product storage to be not related to VARIVAX. Sender's Comments: US-009507513-1709USA001426.
Got TDAP on 1/13/2011 1/16/11 pt noted pain & redness on injection site arm. Pain increased and she present 1/19/11 to clinic. Arm red, warm, tender in band across left deltoid area pt given BACTRIM DS & BENADRYL.