chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K008409, with expiration date 04-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced different temperature excursions of 264, 168, 184, 152, 344 and 88 hours. The lowest recorded temperature was 32 F (0 Celsius degrees), 33 F (0.555555556 Celsius degree), 29 F (-1.666666667 Celsius degree), 30 F (-1.111111111 Celsius degree), 31 F (-0.555555556 Celsius degree) and 34 F (1.111111111 Celsius degree) respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
stated that she is still experiencing tachycardia up until now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TACHYCARDIA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "stated that she is still experiencing tachycardia up until now".  Additional information: NDC number of unknown drug was Not Provided. The reason for no lot number of drug was complainant hung up abruptly/transfer incomplete.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had a light fluttering; Heart palpitations, flet like he had butterfiles in his chest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Had a light fluttering) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitations. Concomitant products included GABAPENTIN, MIRTAZAPINE, CLONAZEPAM and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Had a light fluttering) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations, flet like he had butterfiles in his chest). At the time of the report, CARDIAC FLUTTER (Had a light fluttering) and PALPITATIONS (Heart palpitations, flet like he had butterfiles in his chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.  Company Comment: 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; 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
States her arm  has a little knot where the shot was given and her arm is "very sore."  She did go to the MD for one appointment.  Saw provider and was told it should work its way out.  She does get regular massages and was told should work his way out.   States the pain radiates down her arm and to her neck.  It is mainly down the arm.
Fever, chills, myalgias, arthralgias, headache x 30 hours.  Mild-moderate headache persisted x 96+ hours (still present but other symptoms have resolved).  Also after dose #1, developed ipsilateral axillary lymphadenopathy about 5 days after the dose, lasting 2-3 days.
Initial unsolicited report received from a consumer (patient herself) via partner company Pfizer (manufacturer reference Number: 2017083845) on 10-MAR-2017. This case involves a female patient (onset age was unknown) who was vaccinated with dose of TENIVAC and a dose of TETANUS TOXOID (batch number, expiry date, dose and dose in series for both the vaccines were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to tetanus and TENIVAC. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to (Patient Link).
Injection area is red; Swollen; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection area is red), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE WARMTH (Warm to touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection area is red), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE WARMTH (Warm to touch). At the time of the report, VACCINATION SITE ERYTHEMA (Injection area is red), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE WARMTH (Warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information were reported.   Reporter did not allow further contact
Pt recvd 2 doses of Engerix-B & became pregnant p/2nd dose; pt wants com complete series;
After receiving the vaccine, I did not have an adverse reaction. The early morning of 06/18/2023, I had pain in my upper right quadrant. I went to emergency room. I had several tests, and all was within normal range. It was determined to be gastritis. I am taking medication to help with my symptoms. As of today, I have minor symptoms, but I do feel better than before.
She became acute short of breath.  Called EMS.  On their arrival she was nearly unresponsive.  Bagged.  NOT hypotensive.  HYPERCARBIC.  Difficult intubation.  Transferred to our facility on VENT with bilateral pulmonary infiltrates, wheezy with size 6 ETT from outside facility.
Pt received #3 Imovax at 8:30 am on 11/19/99. Went to ER at 2:30 pm w/rash on face & neck, trouble breathing, feeling of constriction in throat & numbness in lips. PE/wnl, lungs CTA. Tx'd w/Prednisone 60mg, Benadryl 50mg, Zantac 50mg/po.
About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-AUG-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, lot # K010465, expiry date 23-MAR-2016 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
It was very itchy; It was bright red; Swollen right arm at injection site/size of palm of the hand around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It was very itchy), VACCINATION SITE ERYTHEMA (It was bright red) and VACCINATION SITE SWELLING (Swollen right arm at injection site/size of palm of the hand around injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (It was very itchy), VACCINATION SITE ERYTHEMA (It was bright red) and VACCINATION SITE SWELLING (Swollen right arm at injection site/size of palm of the hand around injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and TRICLOSAN (CETAPHIL ANTIBACTERIAL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (It was very itchy), VACCINATION SITE ERYTHEMA (It was bright red) and VACCINATION SITE SWELLING (Swollen right arm at injection site/size of palm of the hand around injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   List of concomitant medication were not given.   Reporter did not allow further contact
feels a line over right eye; right side of lip feels swollen; arm stiffness; shoulder stiffness; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (feels a line over right eye), LIP SWELLING (right side of lip feels swollen), MUSCULOSKELETAL STIFFNESS (arm stiffness) and MUSCULOSKELETAL STIFFNESS (shoulder stiffness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Trigeminal neuralgia (Usually side of jaw affected).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (feels a line over right eye), LIP SWELLING (right side of lip feels swollen), MUSCULOSKELETAL STIFFNESS (arm stiffness) and MUSCULOSKELETAL STIFFNESS (shoulder stiffness). At the time of the report, EYE PAIN (feels a line over right eye), LIP SWELLING (right side of lip feels swollen), MUSCULOSKELETAL STIFFNESS (arm stiffness) and MUSCULOSKELETAL STIFFNESS (shoulder stiffness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included cold compress and ointment.
Patient is a 35 year old male who received anthrax (AVA) # 2 on 26 Jul 04. Points to outer lateral lower edge of deltoid area of his right arm. He reports that he experienced some soreness, miminal swelling, and burning over his deltoid and inner arm area for the first 2 days, then on day 3 he noticed some tingling on the outer edge of his hand near his pinky. He described this sensation as a constant hitting feeling like that of hitting his funny bone. He reports that he did not think much of this at first and it was just a normal reaction. One week later he noticed that his arm would tighten along the extensor surface of his elbow area when he would throw a basketball, with occassional tingling extending down to his pinky. He reported that he would notice increase tightness and tingling when he would lift an object while flexing his elbow. He saw an allergist 2 wks following when AVA # 3 was due. Since that visit he took some ibuprofen and began to notice some improvement in his range of motion of elbow with now just very slight tightening. The tingling sensation is now minimal. He states he has no other problems and that everthing seems to be improving. He denied any pain or itching
Adult dose to a 4 day-old patient; Adult dose to a 4 day-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 4-day-old female patient who received HBV (Engerix B) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 08-MAY-2023, the patient received Engerix B. On 08-MAY-2023, an unknown time after receiving Engerix B, the patient experienced adult product administered to child (Verbatim: Adult dose to a 4 day-old patient) and overdose (Verbatim: Adult dose to a 4 day-old patient). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 8-MAY-2023. A nurse called in to report the administration of an Engerix adult dose to a 4 day-old patient. The health care professional asked for safety information about  this situation. The reporter consented to follow up. Engerix adult dose administered to a 4 day-old patient which led to adult product administered to child and and overdose.
My entire face swelled up to wear I couldn?t see for about 4 hours. Swelling finally went away after 24 hours.
Patient was ordered to receive Menveo (meningococcal vaccine ACYW), which is a lyophylized powder (containing serogroup A) and a diluent (containing serogroups CYW). The pharmacy erroneously dispensed the lyophylized powder component of Menveo (serogroup A only) and a vial of Menactra (serogroups ACYW). The RN reconstituted the Menveo vial with Menactra and administered this to patient before error was noted.  Patient has not reported any ADRs in past 24 hours. Reviewed with clinic and will not re-administer dose as patient did receive full vaccination but as Manactra rather than Menveo.  The pharmacy does store Menactra and Menveo separate from one another (in different refrigerators in different sections of the pharmacy) but it is suspected that a staff member erroneously returned a dose of Menactra to the Menveo storage location and this wasn't caught during filling. The pharmacist who checked the dose thought the "diluent" vial looked odd, but the Menveo vial said  to reconstituted with the "MenCYW-135 conjugate component" and the Menveo vial said it contained meningicoccal ACY,W and so the pharmacist thought it was correct.
Pt's neighbor reports that pt complain of mild fever, headache, feeling down. Around 1600 or 1700 pt reports having discomfort in the testicles (pain level 4-5). **NOTE** Recommend if the pain in the testicles gets worse to seek medical care asap. Recommend can take Tylenol PRN for mild fever and headache but not to exceed 4,000 mg per day. Also recommend pt to stay hydrated, rest and consume adequate meals. Also recommend if symptoms does no improve by the 4th or 5th day to contact MD.  4/21-Patient feeling much better, symptoms resolved yesterday. No signs and symptoms at this time. Symptoms relieved with  the use of Tylenol as directed.
No adverse reaction.    Reason for this report is the family falsified the minor's birthdate in the Vaccination System, My Turn.  Vaccination age was restricted to 16 and over at the time of vaccination.  By falsifying the minors birthday by 2 years, the family allowed 14 year old to receive vaccination.  This report is to make the system aware of the fraudulent activity.
jaw  start feeling tight , along tingling around lip areas, patient begin to have a wheezing cough
Approx. 3 minutes after HEP A shot was given while walking along the office corridor she suddenly stiffens up fell had jerking  and stretching of the limbs with arching of back and rolled up eyes for about 3-5 secs. Attended to immediately. Vital signs taken was normal serum glucose=112 mg/dl.  Had seizure post vaccination.
4 weeks after, right facial weakness (Bell's palsy-7th cranial nerve right).  steroid rx prednisone  for one week.  on 1-22-2022
A 5th Pneumococcal vaccination was given instead of a 1st Hepatitis A. Incident occured 05/21/09 at 1545.
STOMACH ACHES; CHILLS; SEVERE FEVER; SEVERE HEADACHES; BODY ACHE; BODY SHAKES; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included addison's disease, and other pre-existing medical conditions included patient had not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced body shakes. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe fever. On 08-APR-2021, the subject experienced severe headaches. Laboratory data included: Body temperature (NR: not provided) 103 F. On 09-APR-2021, the subject experienced stomach aches. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body shakes on 09-APR-2021, had not recovered from severe fever, chills, severe headaches, and stomach aches, and the outcome of body ache was not reported. This report was non-serious.
Patient received wrong dose of vaccination in error on 11/2/22. Patient needed Hepatitis B vaccine as patient had a Hepatitis B antibody titer drawn and it was low. Needed another dose of Hepatitis B in order to be in school. Patient recently turned 20 years of age and was given Pediatric/Adolescent Hepatitis B vaccine that has cut off age of 19 years of age. Information regarding this has been sent to patient's primary care provider to determine next steps on re-vaccination and/or re-vaccination and/or titer. Patient will then be notified regarding this and plan of next steps.
Again within a few minutes felt anxious but not as much as after 1st shot. Intensity of gas increased after shot (gassy never went fully away after 1st shot). ate sparingly and made sure I had plenty of liquids. Abdominal pain was moderate at first but kept building. I was very hungry and kept eating but the abdominal pain was increasing and I was sluggish. On May 18,2021  after I work I went to local urgent care. The doctor examined me and found my GI  system needed a jump start. He put me on 3 stool softeners (Lactulose, Miralax, and Senna), Mineral oil, and a liquid diet (bone broth, soups, protein drinks, etc.) for 10 days.  the abdominal pain and hunger went a way slowly but was gone by end of 10 days. However, the belching mild but every time I eat or drink continues.
Patient stated injection stung and she had bruise size of tennis ball for 2 weeks-she didn't seek treatment but came to pharmacy last week to tell team about it. I was on vacation and called her back today. She told me she thinks maybe I hit a blood vessel which caused her bruise. She just wanted us to know to put in her record.
swelling on her arm; dizziness; sleepiness; muscle pain/body aches; feverish; severe headache; patient was "slow"; couldn't remember things; had no hunger; felt something weird on the left side of her head/felt like pression or nostalgic/like she didn't want anything; felt a ball on her neck that started to hurt; soreness in her arm and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm and pain), BRADYKINESIA (patient was "slow"), MEMORY IMPAIRMENT (couldn't remember things), APPETITE DISORDER (had no hunger) and FEELING ABNORMAL (felt something weird on the left side of her head/felt like pression or nostalgic/like she didn't want anything) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm and pain). On 23-Jul-2021, the patient experienced BRADYKINESIA (patient was "slow"), MEMORY IMPAIRMENT (couldn't remember things), APPETITE DISORDER (had no hunger), FEELING ABNORMAL (felt something weird on the left side of her head/felt like pression or nostalgic/like she didn't want anything), NECK PAIN (felt a ball on her neck that started to hurt), MYALGIA (muscle pain/body aches), PYREXIA (feverish) and HEADACHE (severe headache). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling on her arm), DIZZINESS (dizziness) and SOMNOLENCE (sleepiness). On 26-Jul-2021, NECK PAIN (felt a ball on her neck that started to hurt) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in her arm and pain), BRADYKINESIA (patient was "slow"), MEMORY IMPAIRMENT (couldn't remember things), APPETITE DISORDER (had no hunger), FEELING ABNORMAL (felt something weird on the left side of her head/felt like pression or nostalgic/like she didn't want anything), PERIPHERAL SWELLING (swelling on her arm), DIZZINESS (dizziness), SOMNOLENCE (sleepiness) and MYALGIA (muscle pain/body aches) had not resolved and PYREXIA (feverish) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Patient presented to hospital after witnessed sudden syncopal event, found to have ventricular tachycardia requiring EMS activation and treatment with IV amiodarone.  Had episodes of nonsustained VT and intermittent left bundle branch block.  Patient required hospital care, cardiology and electrophysiology consult.  Coronary angiogram, EP study, multimodality imaging.  Prior syncopal spell September 2022 and multiple presyncopal spells for 2 years coinciding with timing of prior Moderna doses received 3/2/2021, 3/30/2021, 10/28/2021 and 5/27/2022