chrisvoncsefalvay/vaers-outcomes huggingface dataset:
welts on her legs, arms and face/hives all over her body/hives on their face/hives on their extremities; Rash/developed body rash mainly on her torso; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welts on her legs, arms and face/hives all over her body/hives on their face/hives on their extremities) and RASH (Rash/developed body rash mainly on her torso) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure management.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Dec-2021, the patient experienced URTICARIA (welts on her legs, arms and face/hives all over her body/hives on their face/hives on their extremities) and RASH (Rash/developed body rash mainly on her torso). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (welts on her legs, arms and face/hives all over her body/hives on their face/hives on their extremities) and RASH (Rash/developed body rash mainly on her torso) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had blood pressure.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Significant follow-up was received and patient demographics, lot number, past medical history, concomitant medication were updated.
This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age. On unknown dates the patients were vaccinated with (Oka/Merck) VARIVAX (lot # and expiration date, route and dose were unknown) which were exposed to unspecified temperatures above 5F on unspecified dates. The specified temperatures and dates of the excursions were not specified, and it was not known whether or not the temperature excursions would be supported. No adverse effects had been reported or observed. This is one of two reports from the same reporter. (there were totally approximately 50 unspecified patient involved in the two reports). Additional information has been requested.
11pm- severe rigors/chills, lasted 2-3 hours until I could fall asleep.  5pm- arm soreness- ongoing
Symptoms of confusion, memory loss began around 8:00 AM on April 22, 2022. The previous night, patient had heartburn but was otherwise okay. Patient's partner drove her to the Emergency Room at a Hospital where she was evaluated by an ER physician for possible stroke or heart attack. Vital signs were taken, blood work was done, a brain CT scan was done, and patient was admitted. Patient was administered Plavix and 81 mg. aspirin. Later testing took place as detailed below. Patient's memory returned after about three hours, but the three hours were never recalled. Diagnosis was Transient Global Amnesia. WE DO NOT KNOW THAT THIS WAS RELATED TO THE VACCINE!!  ER doctor's note at admission: Patient is a 70-year-old female with history of GERD, valvular heart disease, migraine headaches, woke up feeling well except for some heartburn. Her partner noticed her confusion and loss of memory that began around 8 AM on April 22. Specifically he states that she was forgetting what season it was and was forgetting conversations they were having and was having repetitive questioning and seemed confused. Her speech was never slurred and she never had a headache or diplopia or dysarthria or dysphagia or focal weakness or numbness. She never had vertigo or ataxia. Currently her symptoms are resolving and her mental status seems to be at baseline but still has loss of memory for some of the events of this morning.
Pt came in for Covid vaccine and was administered Moderna.  Pt age is 16 years and 3 months so too young.  Pt was observed for 15 minutes with no noted side effects.
killer headache; chills; full body hives; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (killer headache), CHILLS (chills) and URTICARIA (full body hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product sopelapram for an unknown indication.    Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), rasuvastatin and alandronate for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and sopelapram (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (killer headache), CHILLS (chills) and URTICARIA (full body hives). At the time of the report, HEADACHE (killer headache), CHILLS (chills) and URTICARIA (full body hives) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
nausea lack of appetite fever comes and goes coughing muscle aches "not feeling well"
(9/30/14) (11:40AM): Vaccines (HIB) and (PREVNAR) was administered to L antero-lateral thigh area, within 10-15 seconds post, redness and swelling (mild -moderate) noted to L forearm and L lower leg. Dr. immediately assessed client. Client observed 2 hours in clinic (1340) client re-assessed by Dr. No swelling or redness to extremities. Vital signs normal.
Clinic was giving MODERNA COVID 19 Vaccine to first dose recipients. VR was actually on site for Pfizer 2nd dose. Rec. Moderna in error. No adverse reaction noted.
Fever; body aches; chills; sharp leg pains; sore arm; fatigue.
Pt has typical looking injection site reaction. Red slightly raised induration of appx 4". Pt remarked that it was sore, but was not concerned because it was already getting better.
Fever (101.7 ~22 hours after injection) Body aches, chills, headache
medium size red circle on arm-- with lump.  Lump grape size/circle bigger than a plum.  Tender to touch.  No itchiness
Swollen arm, red raised spot bigger than quarter size at injection site. Red spot warm to the touch. Knot under the red injection site
Sore arm (not too bad). Extreme body aches, lethargy, I felt extremely cold all over. This was on the day after I got the second dose. I took the day after that off from work.  Fully recovered by day three
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. Approximately in 2016 (reported as from 24-MAR-2016 to 01-APR-2016) multiple unspecified patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # L042257, expiry: 17-AUG-2018 (dosing details and route of administration were not reported). The patients sought medical attention. It was reported that the vaccines were exposed to maximum temperature of 9.9C and minimum temperature of 0.8C during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effect was reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Immunization given 5/3/13 10 AM. Pt reported inj site on 5/4/13 reaction of raised, red, warm about 5 inches by 3 inches around site. 5/5/13 symptoms remained with addition of itchiness. 5/6 pt consulted physician who stated to contact if worsens, otherwise the symptoms were improving. Pt purchased cetirizine 10 mg to take 5/6/13.
still not eating full meals; had nausea after receiving the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DECREASED APPETITE (still not eating full meals) and NAUSEA (had nausea after receiving the first dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (still not eating full meals) and NAUSEA (had nausea after receiving the first dose). At the time of the report, DECREASED APPETITE (still not eating full meals) outcome was unknown and NAUSEA (had nausea after receiving the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Rheumatoid arthritis; Injection site itching; Injection site redness; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4223121-00 (Abbvie).  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Jun2021 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single and intramuscular, administration date 15May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Rheumatoid arthritis"; INJECTION SITE PRURITUS (non-serious) with onset 2021, outcome "recovered", described as "Injection site itching"; INJECTION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovered", described as "Injection site redness". The action taken for adalimumab was dosage not changed.  Causality for Humira (ADALIMUMAB): Causality for the events Injection site itching, Injection site redness was not reported by the reporter. Causality for the event Rheumatoid Arthritis was not related as per reporter.  Causality for Pfizer BioNTech COVID-19 Vaccine: Causality for the events Injection site itching, Injection site redness was not reported by the reporter. Causality for the event Rheumatoid Arthritis was reported as possible by the reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the possible contributory role of suspect product BNT162B2 to the development of events rheumatoid arthritis, injection site pruritus, injection site redness cannot be totally excluded. The case will be reassessed when additional information available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient called back to the pharmacy approximately 2 hours after receiving vaccine stating  that she had broken out with an itchy rash on her face and neck
This medically confirmed spontaneous report (initial receipt: 26-Feb 2016) concerns a 47 year-old female patient. On 09-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Information has been received from a nurse concerning a female patient who was vaccinated with "all three doses" of GARDASIL. The nurse reported that she saw on local news channel that the mother of the patient experienced seizures after receiving three doses of GARDASIL. The nurse stated that the patient's seizures were linked to GARDASIL vaccine. The patient was diagnosed with a seizure disorder. The nurse did not know the patient's recovery status and did not know the patient's identifiers. Upon internal review, seizures was considered an other important medical event. Additional information is not expected.
Information has been received from a physician concerning an 18 month old "healthy" patient who on 03/17/2005, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot 644981/1235M). There was no concomitant medication. On 03/18/2005, the patient developed a measles like rash. Unspecified medical attention was sought, and the patient was treated with diphenhydramine HCL (Benadryl). Subsequently, the patient recovered. Additional information has been requested.
Expired use beyond date from when removed from freezer which was on 11/16/21 under 18 years of age No adverse S/S, no treatment needed  Patient weighs 241.6 lbs,   Height: 5'11"
pt recv vax 2DEC97 d/t scratch on finger on following day approx 32hr p/vax noticed knot under collar bone on same side of body as immun site;saw MD on 5DEC97 w/dx of infected lymph node probably secondary to sinusitis;
I had pain right foot that seemed to be getting better but all of a sudden I had to go to the ER. Around midnight it started hurting and I had to go see a doctor. The pain was so bad that it woke me up out of my sleep the leg in question was visibly red and very swollen. I couldn't bear weight or even wear shoes because the pain was so bad.
Felt week, trembling, felt like passing out, palpitations, bp 144/98, pulse 96
Information has been received from a 25 year old female with no medical history who on 15-SEP-2008 was vaccinated IM with the first dose of GARDASIL vaccine. Concomitant therapy included YAZ, within a week of getting the vaccine, patient experienced "a hard bump the size of a dime" at the injection site. At the time of this report, the patient was recovered. the reporter did not remember the date of recovery. Unspecified medical attention was sought. Additional information has been requested.
pain at injection site; heavy breathing; weakness; PAIN IN WHOLE ARM; PAIN IN UPPER SHOULDER; This case was reported by a consumer and described the occurrence of injection site pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 18th December 2021). Concurrent medical conditions included arthritis and swelling.   On 1st April 2022, the patient received the 2nd dose of Shingrix. On 1st April 2022, the dose was an unknown dose. On 1st April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, labored respiration, weakness, pain in arm and shoulder pain. On an unknown date, the outcome of the injection site pain, weakness, pain in arm and shoulder pain were not recovered/not resolved and the outcome of the labored respiration was recovering/resolving.   It was unknown if the reporter considered the injection site pain, labored respiration, weakness, pain in arm and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's comment: The case was reported by the patient's wife. The patient did not have any side effects from first dose of Shingrix. The patient received second dose of Shingrix in left arm and experienced heavy breathing, weakness, pain at injection site, pain in whole arm and upper shoulder of right arm. At the time of reporting heavy breathing was subsiding and all other events were still ongoing. The patient was suffering from arthritis (from before he had the Shingrix vaccine). The reporter consented to follow up. Additional Supportive Information: This case is linked with case US2022058853 and US2022AMR062396 by same reporter for different patient. Note:-As it seems swelling is due to arthritis as it is one of it's symptoms, it is captured as current condition and not event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058853:Wife's case US-GLAXOSMITHKLINE-US2022AMR062396:
Asthma symptoms  - tight chest, shallow breathing - felt better after using albuterol rescue inhaler twice
Information has been received from a registered nurse concerning a 32 year old female pt who was vaccinated with two doses of varicella. Subsequently, the pt failed to seroconvert. Additional information has been requested.
Patient arm from elbow to shoulder turned red and swollen. Patient experienced low blood pressure and dizziness to the point she could not stand. She was taken to the hospital by ambulance. The hospital gave her oral BENADRYL and IV Steroids and after about 20 minutes she began to feel better. The hospital doctor told the patient she was having an allergic reaction to the shot.
Information has been received from the patient's father referring to his 17 year old daughter. The patient had no medical history, concomitant medication or drug reactions/allergies. On 20-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 (dose and route unknown). On 21-AUG-2016, the patient experienced swelling in her throat, had difficulty swallowing, and experienced nausea. The patient had visited the doctor to seek medical attention. No treatment was given for the events and no lab was performed. The patient was fully recovered from the events at present. The causal relationship between the events and GARDASIL 9 was unknown. Additional information has been requested.
GIVEN EXPIRED VACCINE TO THE PATIENT. PATIENT WAS CONTACTED AND WILL COME BACK FOR ANOTHER NEW DOSE
Large, hard bump at injection site, quarter-sized. All-over severe body, joint aches/pain.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  There had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. Were filling out a temperature excursion assessment with the State at the time of report. It was reported that no adverse reactions were reported by any patients. Xyz was reported as AI26 F.   No treatment medication was provided.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients who approximately in August 2012, were vaccinated with improperly stored doses of PEDVAXHIB (doses, routes and lot numbers not provided). It was reported that the vaccines were exposed to 26.8 F over the 4 days in August 2012. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Started with extreme exhaustion 1 hour after vaccination, very loose stools X3 days, extreme joint pain 1 1/2weeks- pain continues until present, headache for 12hours with headache off & on continues, cough x  5 days
I am now a diabetic; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 66-years-old via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:15 (Batch/Lot Number: ER8730) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included Stage 3 Kidney Disease, rheumatoid arthritis and known allergies: penicillin, sulfa from an unknown date. Concomitant medication included etanercept (ENBREL); escitalopram oxalate (LEXAPRO); levothyroxine sodium (SYNTHROID) and rosuvastatin calcium (CRESTOR) all taken for an unspecified indication, start and stop date were not reported.  The patient previously took Macrobid [nitrofurantoin] and experienced allergies (known allergies: Macrobid). The patient reported that she have a healthy diet and had stable glucose her entire life. All of a sudden, last week 10Aug2021, her glucose spiked to 760. She was hospitalized for 3 days and have been sent home on an insulin program. She is now a diabetic since 10Aug2021. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient underwent lab tests and procedures which included blood glucose: spiked to 760 on 10Aug2021, sars-cov-2 antibody test: unknown result on an unspecified date. Therapeutic measures were taken as a result of the events which included an insulin program. The outcome of the events was recovered with sequel.
(09/11/2018, morning) Red, itchy, pain left arm bicep (front part upper arm). Symptoms traveled down bicep until reaching bottom of bicep (09/11/2018, afternoon). As symptoms traveled down arm, upper arm cleared. Also associated with these symptoms was swelling of inner arm. When symptoms reached bottom of bicep swelling was quite pronounced (inner part bulging out at elbow). The symptoms started clearing on 09/13/2018 and as of today, 09/18/2018, the arm looks normal. The afternoon of 09/11/2018, I went back to the pharmacy that administered the vaccine and showed another pharmacist my arm. He said he had never seen that symptom before but he talked to another pharmacist their and she said it would go away.