chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt attended a community event on 05/01/2021 and requested a Janssen vaccine, which was administered in his right deltoid.  He then returned on Saturday, 06/26/21 and requested a 2nd dose.  Pt stated he lost his vaccination card, but verbalized receiving a dose of Moderna on 05/01.  During input; it was discovered that patient received two different brands of vaccine, resulting in this report.   Pt's first dose was administered on 05/01/2021, Janssen lot # 1808982
Information has been received from a physician concerning a "teenager" patient who on an unspecified date was inadvertently vaccinated with Zostavax (Oka/Merck), instead of receiving a 2nd dose of Varivax (Oka/Merck) (MSD).  There was no AE reported.  There is no product quality complaint involved.  Additional information has been requested.
I had a little bit of a headache and didn't feel right. Took my temp and I had a fever. Took the at home Covid test and it came out positive. Had a fever for the first 2 days. Slight headache for 1 day. Still have a chest cough today. Fever was about 101.3. Doctor put me on laxaderm for 5 days.
Approximately 2 hours after receiving immunizations, pt had a series of episodes of tonus and staring lasting about 30 sec each. This happened off and on, frequenting for about 3 hours.
About 2 minutes after injection, patient began complaining of being dizzy.  She then lost consciousness  in what appeared to be a seizure: body stiffness, eyes rolled back, shallow breathing, lock jaw.  After 30 seconds, she regained consciousness and function.  She was a little light-headed and nauseous.  3 minutes later she vomited and 5 minutes later EMS arrived,   After the incident and prior to EMS arrival, spouse stated that the patient had a history of similar incidents with needle exposure.  Patient left with husband.  We have tried to get in touch with the patient for follow-up and she has yet to return our calls.
Sorry arm, nausea, chills, cough, fatigue, light headed, dizziness
Pt recvd 3 doses of Engerix-B 13MAY, 10JUN, & 23OCT91 & it was determined that pt did not respond; 13JAN92 pt recvd a booster dose of Engerix-B;
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain, muscle pain and chills. On an unknown date, the outcome of the influenza-like symptoms, pain, muscle pain and chills were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, pain, muscle pain and chills to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient reported that, on the same day after vaccination with SHINGRIX, the patient experienced flu-like symptoms, achiness, muscle aches and chills. The events were resolved in one day. The patient had denied permission to contact their physician.
pulled syringe very fast so lots of Moderna vaccine dripping down on his arm; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (pulled syringe very fast so lots of Moderna vaccine dripping down on his arm) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced ACCIDENTAL UNDERDOSE (pulled syringe very fast so lots of Moderna vaccine dripping down on his arm). At the time of the report, ACCIDENTAL UNDERDOSE (pulled syringe very fast so lots of Moderna vaccine dripping down on his arm) outcome was unknown.        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.
Received phone call from pt. Complained of fatigue and nausea since receiving shot on 4/15/04
12 pm felt woozy and mild headache and blood pressure spiked  4 pm nauseous and woozy something not right headache got worse  6pm arm started to hurt, headache got worse and so did nausea  10 pm whole body started to ache and chills with major headache and throwing up 4am next day 17th pain through whole body and headache so bad I was dizzy throw in up still  17th hard to walk from total body pain and headache  18th  and 19 terrible headache pressure on whole head and neck can?t move neck. Eye pressures
This case was reported by a healthcare professional and described the occurrence of influenza in an adult female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On a unspecified date the subject received unspecified dose of Fluarix (unknown). One and a half weeks later after vaccination with Fluarix, the subject experienced influenza and lack of efficacy. At the time of reporting the events were resolved.
Initial report received from a health care professional on 03 December 2009. An unidentified patient (age, gender and date of birth not reported) had received ADACEL (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient developed suspected radial nerve damage and/or possible brachial neuritis. The patient was referred to a neurologist and per the reporter, the patient fully recovered. According to the reporter, this event was reported to VAERS approximately one month ago. No further information was provided at the time of the report. Documents held by sender: None.
Pt recvd 1st dose of vax in 1987; On 08NOV90 accidentally vaxed w/2nd dose of Pneumovax w/out adverse exp;
Case number PHEH2014US005986 is an initial spontaneous report from the consumer received on 24 MAR 2014. This report refers to a 13-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date in JAN 2014. On an unknown date in JAN 2014, after vaccination the patient felt more tired and experienced frequent headaches. It was reported that the reporter was unsure whether vaccine was the cause of the event or if it was because the patient was being a teenager. The final outcome of the events was unknown.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
BODY ACHES; DIARRHEA; FEVER; HEADACHES; NAUSEA; This spontaneous report received from a physician concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The patient was vaccinated at left deltoid. No concomitant medications were reported. On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headaches. On 19-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, diarrhea, fever, headaches, and nausea on 20-MAR-2021.  No Follow up required as reporter declined. This report was non-serious.
2nd Dose: Experienced first symptoms around 6:00pm on June 24, including severe headache and moderate general weakness.  Around 9:00pm experienced mild shortness of breath and moderate lymph node swelling under injection arm armpit which carried into June 25.  This report is being submitted on June 25 and the mild shortness of breath and armpit lymph node swelling is still present.    1st Dose:  Mild to moderate weakness and fatigue day after the first shot (June 3, 2021) with no additional symptoms.  Symptoms completely resolved by June 4.
Janssen vaccine given/documented at another facility. 5 days after vaccine given patient started having left hip pain.  Over the past 5 months this has progressed to involve both hips, both shoulders, wrists, hands, knees, ankles and toes. 10/15/21 - patient started having pain when she swallowed  and swelling in right lateral foot and fingers.  She has progressively lost mobility and needing to use a wheelchair.  She has also experienced bladder spasms and urinary incontinence. Provider Diagnosis of Diffuse Arthralgias
The patient called 3/25/21 to report a rash on the right arm which began the day after the Moderna #2 vaccine on 3/22. The patient developed a rash on the right arm which is red, hot et itchy. Pt states, the rash is super itchy today (3/25). The nurse informed the patient to try Benadryl. If symptom is not better by morning, then visit with PCP for evaluation.   The patient verbally understood.
Acute chest pain diagnose as pericarditis, 15 days following the first COVID vaccine.; This is a spontaneous report received from a contactable physician (patient). A 68 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 68 years old via an unspecified route of administration, administered in Arm Left on 23Dec2020 (Lot Number: EJ1686) as dose 1, single for covid-19 immunisation.  Medical history included hypothyroidism, osteoarthritis. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included levothyroxine; famotidine; rosuvastatin.  The patient experienced acute chest pain diagnose as pericarditis, 15 days following the first covid vaccine on 07Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 1 days. The treatment was received including Colchicine, indomethacin. The outcome was recovered in 2021.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event "Pericarditis" and the administration of the vaccine 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
warmness at the arm of injection; itchiness at the injection arm; Redness at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmness at the arm of injection), VACCINATION SITE PRURITUS (itchiness at the injection arm) and VACCINATION SITE ERYTHEMA (Redness at the injection arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmness at the arm of injection), VACCINATION SITE PRURITUS (itchiness at the injection arm) and VACCINATION SITE ERYTHEMA (Redness at the injection arm). At the time of the report, VACCINATION SITE WARMTH (warmness at the arm of injection), VACCINATION SITE PRURITUS (itchiness at the injection arm) and VACCINATION SITE ERYTHEMA (Redness at the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient reported cheek swelling that began the day after her 2nd dose of Moderna COVID-19 vaccine. Swelling peaked on day 2 and was improving at the time of office visit. She had dermal fillers put in her cheeks about 3 months prior to this event.
Arm is still very sore; Arm is still very inflammed; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and inflammation localized. On an unknown date, the outcome of the pain in arm and inflammation localized were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and inflammation localized to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient had Shingrix vaccination one week ago.  The patient's arm was still very inflamed and sore. Inflammation was about 6 by 4.  The reporter asked if this was normal and what could be done to relieve the inflammation and soreness.
Pt recvd 3 doses of Engerix-B & was not immune when tested p/completion of series 4FEB92;
A couple of hours after had muscle pain in left arm that slowed moved to upper shoulders and back eventually down the back, led to a headache and fever that night that lasted most of the next day.
Child fainted 10 min after immunizations administered. Child was apprehensive during procedure. He conversed with mom & nurses following injection & walked approximately 45 feet from clinic to reception area. At the front counter, he visited briefly, then fainted, falling to the floor. Within 1 minute he was responsive & alert. Comfort measuring reassurance and observation provided for 15 minutes. Child ambulated to vehicle accomp. by mom & RN f/up phone call 5-18-12, mom states no further difficulties encountered.
started having extreme vertigo type issues feeling like Im rocking back and forth on a boat it is amplified when I am driving. Also start to feel like I m disoriented; Also start to feel like Im disoriented and can keep my eyelids open when the symptoms start; and can keep my eyelids open when the symptoms start; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 12:00 (Lot number: FA6780) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Alpha-gal allergy" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE CIPIONATE; T3. The following information was reported: VERTIGO (non-serious) with onset 03Sep2021 16:30, outcome "not recovered", described as "started having extreme vertigo type issues feeling like Im rocking back and forth on a boat it is amplified when I am driving. Also start to feel like I m disoriented"; DISORIENTATION (non-serious) with onset 03Sep2021 16:30, outcome "not recovered", described as "Also start to feel like Im disoriented and can keep my eyelids open when the symptoms start"; EYE DISORDER (non-serious) with onset 03Sep2021 16:30, outcome "not recovered", described as "and can keep my eyelids open when the symptoms start". Therapeutic measures were not taken as a result of vertigo, disorientation, eye disorder.  Additional information: Additional information: The patient had no other vaccine in four weeks. The patient had other medications in two weeks: T3, testosterone. Adverse event: Approx 2 weeks post injection started having extreme vertigo type issues (feeling like rocking back and forth on a boat) it is amplified when driving. Also start to feel like disoriented and can keep my eyelids open when the symptoms start. The come and go mostly in the morning and late afternoon. No treatment received for the adverse event. The patient was not tested for covid post vaccination. The patient did not had covid prior to the vaccination. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Patient had an afebrile seizure event lasting 2-3 minutes the evening after receiving influenza A and Hepatitis A vaccine at her PMDs on 1/14/09.  She was seen in the ED and sent home.  She had 4 more recurrent seizures, all lasting less than 5 minutes over the next 24 hours.  She was admitted to to the pediatric ward and underwent testing which showed a normal MRI.  She was started on leviteracitam and D/C'd home.  No abnormalities or source of seizures were identified, however, given the timing of the vaccines, a report was submitted. 2/17/09-records received for DOS 1/15/09-C/O fall from chair, hit head, eyes rolled up to back of her head, tonic-clonic movements. Presented to ED . At home had two more seizures the next day, crying hard before each seizure. Seen in ED and observed overnight.
27OCT 10AM dizzy, vomiting, has not seen MD @ this time;
patient received adult dose of pfizer instead of pediatric dose for her second dose, patient is 8 years old and was in line with her 12 year old sibling
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 71 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 20-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 20-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. Flu vaccine was delivered on 20-Sep-2016 at 13:30 to 14:00 and the refrigerator was reading 10 degrees Celsius that afternoon. On 21-Sep-2016, it was 6 degrees Celsius, on the 22nd it was 10 degrees Celsius and on the 23rd (morning), it was 7 degrees Celsius. One dose was given between 21 and 22-Sep-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
This is a spontaneous report from a contactable consumer or other non-HCP (patient wife). A male patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date (reported as in last week), single dose, for COVID-19 immunization. Patient medical history included he has an allergy. The concomitant medications not reported. The patient experienced sensitive skin. The allergy season is just starting, and his skin became itchy after getting the vaccine. He had allergies on an unspecified date. Reporter asked is it ok to take Benadryl for sensitive skin. Reporter clarified he had this allergy before the vaccine, but not this year because the allergy season is just starting. His itchy skin started after getting the vaccine. No treatment received for the event. The outcome of the event: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Initial unsolicited report received from a consumer in the United States on 30 October 2015. This case involves a 42 years-old female patient whose was vaccinated with a dose of Fluzone QIV (batch number, dose, dose number and site were not reported) via intramuscular route on 29 October 2015. Patient's medical history includes allergic to Avalox and concomitant medications were not reported. On 29 October 2015, same day after vaccination patient developed pain at the injection site that radiates to her neck, swollen lymph node about 1 cm in size which is soft, movable, tender to touch and vaccination site reaction. It was reported that patient had received influenza vaccine last year and experienced the same symptoms. No laboratory investigations were performed and corrective treatment was not reported. At the time of this report patient was not recovered from the events. List of documents held by sender: none. Follow-up information received from a consumer on 17 February 2016. It was reported that the patient received FLUZONE QIV in the left arm. Patient's medical history includes seasonal allergies, asthma and allergic reactions due to fluoroquinolones. Vaccines administered within 4 weeks prior to FLUZONE QIV was reported none. Patient's concomitant medication includes yaz, Valtrex, allegra, symbicort and Nasacort. It was reported that symptoms ended ten days after vaccination and no further medical treatment needed. On an unspecified date the patient got recovered.
Red swollen area around injection site - left arm 1 week after administration - Dr. prescribed antibiotic.
heart failure; This spontaneous report has been received on 02-APR-2020 from a lawyer, regarding a case in litigation and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and/or zoster-related conditions as prescribed and/or administered by a pharmacist at a pharmacy. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a physician for heart failure. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of heart failure was not reported. The reporter considered the heart failure to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of heart failure was considered to be medically significant.