chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stored doses of (Merck) VARIVAX (lot # K021933, expiration date 10-NOV-2016; lot # L037565, expiration date 29-SEP-2017; lot # L045954, expiration date 17-NOV-2017) (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 7 F for 1 hour and 35 minutes. There were no previous excursions. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: patient felt like his throat was itchy and felt flushed and sweating. he had no other apparent symptoms, we gave him a benadryl and he appeared to be fine
injection site pain; puffy face; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain) and SWELLING FACE (puffy face) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 017E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced INJECTION SITE PAIN (injection site pain) and SWELLING FACE (puffy face). At the time of the report, INJECTION SITE PAIN (injection site pain) and SWELLING FACE (puffy face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-319707 (Patient Link).
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and one month after vaccination developed meningococcal meningitis and sepsis, year reported as 2006 (Q 3). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Tinging in hands, feet, and mouth (specifically tounge)  - No treatment as of yet just resting per doctor instructions as of 6/14/2021 Lower back muscular ache/pain - Tyenol every 6 hours or so with food  and laying down resting since contacting Dr. on 6/14/2021 Sore throat - warm liquid (coffee)  Headache/migraine - Tylenol  Joint pain in hands - Tylenol Metallic taste in mouth
seizure 3 days after vaccine; This is a spontaneous report from a contactable other health professional. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included seizure. The patient had known allergies: Risperidone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced seizure 3 days after vaccine on 25Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported seizure cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
2d p/vax,c/o rash, on exam there were vesicular eruptions w/an erythematous base similar to small chickenpox lesions over entire body, sparing face;spoke w/dermatology who agreed was a delayed hypersensitivity reactive to the vaccine;
Extreme fatigue; fever of 101.8 degrees; overall muscle aches; headache; vomiting
complain of tightness in center of chest. no wheezing, no cough. EMS called. going to hospital.
Case number PHEH2013US008331 is an initial spontaneous report received from a medical assistant on 09 APR 2013 with a follow-up0 received on 11 APR 2013. No additional information was added. This report refers to a 10-year-old female patient. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 06 APR 2013. On the same day after vaccination, she had rash on her arm. The reporter stated that rash was a scattered pattern in the deltoid region only and had resolved on an unspecified date. No additional information about seriousness and causality was provided.  Follow-up received from the medical assistant on 11 APR 2013. Updated patient demographics, description of event and outcome.
Diarrhea up to 4 times a day. Am going to a gastroenterologist on 11/11. Nausea, ringing of ears, extreme weakness, confusion, memory loss.
Body hurts everywhere; Muscle spasms in arm and back close to ''my'' spine 5 days after getting the shot.; Acid reflex that is so bad it feels like its pushing on ''my'' heart.; Scratchy throat; Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Aug2021 at 15:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 24Aug2021 at 01:00, the patient experienced, muscle spasms in arm and back close to her spine 5 days after getting the shot. Acid reflex that was so bad it felt like it was pushing on her heart. She also experienced joint pain, scratchy throat and her body hurt everywhere. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of the events. The clinical outcome of the events muscle spasms in arm and back close to her spine 5 days after getting the shot, acid reflex that was so bad it feels like it was pushing on her heart, joint pain, scratchy throat, body hurt everywhere was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine EUA.  There was only a sore arm at injection for a couple of days after the injection. Nine days after the injection, I experienced soreness at the injection site, with redness about the size of a dime, and redness with a lot of itching in a semicircle below the injection site about the size of a fist, also headache, some muscle aching and fatigue. The headache, muscle ache and fatigue only lasted for a day, but the redness on my are and itching are still there.
Area around injection site that is hot; Red area around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area around injection site that is hot) and VACCINATION SITE ERYTHEMA (Red area around injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Area around injection site that is hot) and VACCINATION SITE ERYTHEMA (Red area around injection site). At the time of the report, VACCINATION SITE WARMTH (Area around injection site that is hot) and VACCINATION SITE ERYTHEMA (Red area around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.    Reporter did not allow further contact
Red, swollen, hot to the touch area around injection site.  Large part of upper arm affected.  Sore and tender.
Fever of 102.5F, 2 days, gradually decreased over the next 3-4 days; measles all over for about a week from measles shot required for Nursing School.
general malaise and abdominal discomfort after vaccine,  three days later started with facial rash and fever Treatment: Famotidine, Benadryl
Severe pain in stomach and back on day 2 then on day 3 full blown shingles broke out-rash around entire mid-section and back --raised lesions. tremendous pain
It was reported that a female received Fluzone SV 98-99 USP vaccine on 10/11/98. Reportedly, the pt bled profusely after the injection. Reportedly the next day the pt woke up with the flu.
she had swelling in the legs; This is a spontaneous report from a contactable consumer reported for his wife. A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number, expiration date were not reported) via an unspecified route of administration on 09Jun2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient's husband stated that the patient received the vaccine on 09Jun2021 and she had a problem after 10 days, after 1 week, she had swelling in the legs in Jun2021. The patient's husband wanted treatment. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Patient hospitalized on 4/20/21 for paraesophageal hernia. Patient presented to the ED and was subsequently hospitalized for esophageal hernia on 4/27/2021. These visits are within 6 weeks of receiving COVID vaccination.
I Woke up  about 36 hours post vaccine administration with swelling and tenderness mainly under my left eye.  I have a previous history of fillers in my tear trough areas and cheeks, last filler injection was January 2020.  I have some swelling under the right eye too.  I have read about that being caused by an immune reaction to the filler after vaccine administration.   I have not treated the swelling , as I want to see how long it persists.
Gave PNEUMOVAX injection about 1:40 pm and pt was fine. Around 8:30 pm patient called and said the injection site was swollen about the size of an egg & thickness about 1-2 inches. Told pt to put ice & take BENADRYL. If symptom get worse can to go ER.
Information has been received from a physician assistant concerning a patient who on approximately 05-MAY-2007 was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccine administered on the same day included a 0.5mL intramuscular dose of hepatitis B virus vaccine rHBsAg (yeast). Three days post vaccination, on 08-MAY-2007, the patient developed a fever. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pain, burning, stinging and itching at back of shoulder and under armpit of alternate arm to where I had injection. Intense and difficulty sleeping. Began approximately 30 hours after infection
On the day following vaccine administration I developed a temperature of 103 F coupled with body aches, weakness, and extreme fatigue. My arm was in severe pain and I also experienced a complete loss of range of motion. I could not even lift it high enough to brush my teeth. The upper arm also developed swelling the size of a golf ball under the skin. There was also a 4x4 area around the injection site that was red and very hot to the touch. It is now a week later and I continue to have pain, weakness, and swelling in the arm.
PATIENT HAD NO ADVERSE REACTION.  RECEIVED A 3 RD DOSE OF SHINGRIX BY MISTAKE.  HAS SHOWN NO ILL EFFECTS FROM THE 3RD DOSE.
A few hours after receiving 2nd Covid vaccine patient began feeling nauseated then started vomiting. She denies blood in the emesis. She also endorses feeling "chilled to the bone." Triage temp is 103.1. Patient denies chest pain, shortness of breath, cough, numbness, tingling, falls, headache, abdominal pain, diarrhea, constipation, changes in diet, recent travel. No dysuria, hematuria, rashes, bruising or bleeding. She states she has had at least 6 or 7 episodes of emesis and is on her fourth emesis bag in the ER. She states she feels very dehydrated and week.  I was informed that the patient was admitted and was under the care of a hospitalist who I could not reach.
exhausted; headache; Joint pain; Not feeling good; Unable to sleep; Pain in hands; she can't lift herself up; Body ache; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (exhausted), HEADACHE (headache), ARTHRALGIA (Joint pain), PAIN (Body ache) and MALAISE (Not feeling good) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Recurrent UTI, Sjogren's syndrome, Pneumonia and Anaemia. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis, DAILY VITE [COLECALCIFEROL;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RETINOL ACETATE;THIAMINE HYDROCHLORIDE;THIAMINE MONONITRATE;TOCOPHEROL] and PREDNISONE for an unknown indication.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (Body ache). On an unknown date, the patient experienced FATIGUE (exhausted), HEADACHE (headache), ARTHRALGIA (Joint pain), MALAISE (Not feeling good), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Pain in hands) and BEDRIDDEN (she can't lift herself up). At the time of the report, FATIGUE (exhausted), HEADACHE (headache), ARTHRALGIA (Joint pain), PAIN (Body ache), MALAISE (Not feeling good), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Pain in hands) and BEDRIDDEN (she can't lift herself up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.
Patient was administer 1 dose of Janssen Covid-19 vaccine that had an expiration date of 9/19/2021. There were no adverse effects or allergic reactions.
Caller reports that her right arm is black and blue; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient received the second dose of the Covid vaccine on Saturday. Her right arm was black and blue. When she received the first vaccine, she didnot feel anything. When the second vaccine was administered, it felt as they took a dart into her arm or punched her arm. She was unable to utilize her left arm, in which she was unsure if this could have occurred due to having the vaccine in the same arm both times. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2016US023298 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29 year old patient whose gender was not specified. The patient's medical history and concurrent concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 30 Jan 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 10:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 10:11 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.71 No concomitant medications were reported. On 12-Feb-2021 at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit and vial was initially moved to the fridge on 02-Feb-2021 and beyond use date was 03-Mar-2021. Product moved to clinic on 05-Feb-2021, and at 10:00 Am the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 09-Feb-2021 and beyond use date was 10-Mar-2021. Product moved to clinic on 12-Feb-2021, and at 11:00 Am the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 09-Feb-2021 and beyond use date was 10-Mar-2021. Product moved to clinic on 12-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Doses administered to patients 18 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.
Swollen knee right, Difficulty up and down stairs especially up. Initial trouble standing.. Lifting leg to out in pants. Tx: ice, elevate, rest. Water exercise, Tylenol at night.
Rash on the left arm; Severe heartburn; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (SEASONAL INFLUENZA VACCINE)).   On 22nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced rash and heartburn. On an unknown date, the outcome of the rash and heartburn were unknown.   It was unknown if the reporter considered the rash and heartburn to be related to Shingrix.  Additional case details were reported as follows: The healthcare professional declined to leave additional patient demographics. The age at vaccination was not reported. The reporter also noted that the patient received Fluzone in the right arm 15 days prior. The patient received vaccine in her right arm and a rash developed on the left arm. The patient also reported severe heartburn.  The reporter consent to follow up.
Pt presented to ER with altered mental status, 3 grand mal seizures witnessed by staff, required oral endotracheal intubation.