chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date, the patient experienced injection site pain, injection site swelling and injection site erythema. The outcome of injection site pain, injection site swelling and injection site erythema was reported as not recovered/not resolved. Additional information has been requested.
On 05Oct2021 patient received Fluzone, on 11Nov2021 received Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 48-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 977EN, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)).   On 11th November 2021, the patient received Fluarix Tetra 2020-2021 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 11th November 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix Tetra in the left deltoid. The patient received the Fluzone flu shot, however the patient inadvertently received a second flu shot, Fluarix, which led to extra dose administered. The reporter consented to follow up.
Team member accidentally administered an expired Pneumovax 23 vaccine to patient. Vaccine expired on 10/15/2022. Vaccine was administered on 10/25/2022. Provider, clinical supervisor, nurse lead (reporter), and patient were notified.
This spontaneous report as received from a hospital purchaser via company representative refers to a patient of unknown age and gender. The purchaser reported that, on 29-DEC-2014, the nurse inadvertently administered a dose of GARDASIL lot # K008213, expiration date: 17-DEC-2016 (dose and route of administration were not reported) that had been improperly stored. No adverse effects were reported. Additional information is not expected as there is no consent to follow up contact.
mother reports tonic-clonic seizure x 2 per about a minute each and separated only by a few seconds. Childs had 103.3 at that time. Child recovered quickly and has been fine since then.
The pt began 1 day post vax with pruritis which progressed to erythema and tenderness and induration of approximately 15 x 12 cm area primarily over triceps. It was also hot to the touch. The pt also had similar experiences with prior vaccines. The pt was treated with antibiotics due to possible cellulitis.
Patients vaccinated using old vial from 03/10/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) had resolved.        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 Concomitant medications was reported  No treatment informations was provided  Patient received a dose from aa punctured vial after 12 hour timeframe in the refrigerator   This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548, MOD-2021-258689, MOD-2021-258660 (Patient Link).
has a spot coming on that looks the same and feels the same as the MRSA he had before/red spot/little swollen on the outside/like a pimple; This is a spontaneous report from contactable consumers (patient and patient's wife) reported that a 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on the left arm on 26Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included ongoing blood pressure high, rheumatoid arthritis and diabetes; all from an unknown date and were diagnosed many years ago. The patient had MRSA before 12 years ago (2009). Concomitant medications included prednisone. It was reported that 12 years ago, he had MRSA. He thought he has it again. The patient clarified that he had MRSA about 12 years ago and he doesn't know if there was a chance the COVID-19 triggered the MRSA. He was not positive it was even MRSA. He has a spot coming on that he noticed last night (08Feb2021). The spot he has now looks the same and feels the same as the MRSA he had before. However, it's not the in the same area. It's in the same arm he got the shot in, which he doubted it has anything to do with the COVID-19 vaccine. It just looks and feels the same as it did 12 years ago when he had MRSA. The caller explains the spot was about the size of a dime, maybe a little bit smaller. There was a red spot of course. It shows on the outside, it's a little swollen on the outside, but there was a bigger area on the inside. He explained further there was more of it on the inside. The patient's wife told him it looks like a pimple. The outcome of the event was unknown.
I had the vaccination on 11/18/2021. On 08/28/2022 I had a cough at night. During the day of 08/29/2022 the cough continued and the following days. I tested COVID-19 positive on 08/28/2022. I was prescribed an antibiotic for 5 days. I presently feel fine on 11/23/2022.
Initially pain, same day as vaccine given. Within 24 hours developed redness, tenderness and swelling at site.
Throat  and voice are much worse than yesterday; throat  and voice are much worse than yesterday; Got sick after; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6203) via an unspecified route of administration, administered in arm left on 28Feb2021 (at the age of 51-years-old) as dose 1, single for covid-19 immunization. Patient medical history included blood pressure high (diagnosed about ten years ago) from 2011 to an unknown date. There were no concomitant medications. On 01Mar2021, the patient reported that her throat and voice was worse, got sick after the vaccine and on an unspecified date in 2021, patient was feeling sick. Patient was asking if it is normal to get sick after the vaccine. Patient treated feeling sick with tylenol and Theraflu. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of pruritus (itchy) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 19, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; unknown. On May 19, 2021, patient experienced pruritus (itchy). The patient treated with rubbing alcohol (isopropanol) for itching, at an unspecified dose and frequency. At the time of the report, pruritus (itchy): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use not provided.
This spontaneous report as received from a pharmacist via company representative refers to a male patient in his seventies. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On an unknown date, reported as "a while ago - over a year ago, but less than two years ago", the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose and anatomical location were not reported) subcutaneously to prevent shingles. On an unknown date, an unspecified time after vaccination, the patient experienced a case of the shingles. The treatment was given and included an unspecified pain medication. The reporter also stated that the therapy was continued. The outcome of the event was reported as recovered (on an unknown date). The patient sought medical attention and went to an unspecified physician. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a consumer referring to her daughter, a 12 year old female patient enrolled in a market research. On unknown dates in October 2014 and October 2015 the patient was vaccinated with GARDASIL dose 1 and dose 2 respectively (which were 12 months apart) (inappropriate schedule of drug administration). The outcome was unknown. Additional information is not expected as the reporter was not willing to be contacted.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored VARIVAX subcutaneously, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperatures of excursion were reported as 6 degree F to 14 degree F during a time frame of 1 hour and 15 minutes and 28.5 degree F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009441: US-009507513-1808USA009442: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA009447: US-009507513-1808USA003515.
Woke up with subconjunctival hemorrhage in left eye; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198), via an unspecified route of administration into the left arm on 26Feb2021 09:15 at a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient's concomitant medications were not reported. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN9581), via an unspecified route of administration into the left arm on 05Feb2021 09:30 at a single dose for COVID-19 immunization. The patient woke up with subconjunctival hemorrhage in left eye on 28Feb2021 06:00. The patient did not receive treatment for the event reported. Outcome of event was not recovered.
His wife awoke to the patient moving around in distress in the bed at about 6:30am. She called emergency and started CPR and continued until the paramedics arrived and they took over. Paramedics performed CPR both manual and mechanical and used paddles to try and restart a normal sinus rhythm.  The paramedics also gave the patient 2 shots of Epinephrine. They were unsuccessful and declared the patient dead after about 50 minutes of trying to revive the patient.
Extreme nausea started at 11:10PM on same day the vaccine was given. Next day very fast and pounding heartbeat and nausea  Extreme nausea for the next 6 days
Pt. has a history of seizure disorder. Pt. has a small seizure about 15 mins following flu shot. Recovered and went home.
COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program COVAX US support received from a contactable consumer (patient) via medical information team. A 25-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date of Apr2021 (three weeks ago) (Lot number: not reported) as SINGLE DOSE, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of Apr2021, 1 day after the vaccination, the patient was tested positive for COVID 19.  The patient underwent lab tests and procedures which included COVID-19 test with result positive on an unspecified date of Apr2021. The outcome was reported as unknown at the time of reporting. The reporter was going to get his second dose of the product tomorrow and had some questions whether it was fine for him to go ahead and get his next dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Narrative:  Patient is a 73 year old male with PMH significant for dementia. Per 12/19/20 Nursing Inpt Noteat02:17: Pt was found to have tachycardia to 166 on routine vital check 12/19/20 at00:50. Resident also noted to beusing diaphragmatic muscles to breathe. When EKG performed, HR down to 100 and in sinus rhythm. Pt was sent to ER but no interventions were taken. ED workup reported unremarkable and patient was sent back to community living center. 12/19/20 Nursing Inpt Note at14:50: at0810 V/S taken and recorded, P- 88,02 sat 94%. No further tachycardia episodes noted.
Patient is a 75 year old male with past medical history significant for CKD status post recipient of live donor kidney from his wife approximately 10 years ago on mycophenolate and tacrolimus, unused 8-year-old left AV fistula as result of end-stage renal disease (unused as he received a kidney), left nephrectomy as result of traumatic injury at age 14, anxiety insomnia originally presented to emergency department with concern for dyspnea and generalized weakness after testing positive for COVID on 12/31.  At that time, initial laboratory results demonstrated a sodium measured at 128, potassium at 4.2, CO2 less than 10, BUN of 148, and creatinine is 7.17.  Imaging revealed a relatively normal chest x-ra
Patient presented to the pharmacy on 1-26-18 with a swollen and red arm. He said the symptoms started on the evening of the 24th. He said the swelling has went down. He is going to put ice on it and then let us know if it gets worse.
A report was received from a health care professional on 6 November 2003 concerning a 25 year old female vaccinee who experienced redness and warmth at the injection site 1 day after receiving Fluvirin on 5 November 2003. On 6 November 2003 the vaccinee experienced redness and warmth at the injection site. The vaccinee had not recovered at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301012.
Information has been received from a registered nurse concerning a 73 year old male with no allergies and diverticulitis, back pain, hypergonadism, gastroesophageal reflux disease, and hyperlipidaemia, who on 01 Nov 2006 was vaccinated IM with a 0.65 ml dose of varicella zoster virus vaccine live (lot 652946/102F). Concomitant therapy included ANDROGEL, aspirin, FLOMAX, VIAGRA, and CELEBREX. On 02 Nov 2006, within 24 hours of vaccinations, the patient experienced an increased sensitivity in the top of his head. He called the physician's office on 06 Nov 2006 to report the event. Unspecified medical attention was sought and the physician did not feel it was related to the vaccine and was possibly occipital neuralgia. The patient currently had less sensitivity in the area and at the time of the report, was recovering. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. 6/17/10 Additional information indicated that the patient complained of a brief episode of occiptal neuraliga on 05-NOV-2006 (also reported as 02-NOV-2006). The physician felt it was totally unrelated to his vaccination 4 days prior to the symptoms. This occiptal neuralgia resolved on 05-NOV-2006 without incident or treatment. No office visit was necessary. No further information is available.
ANGIOEDEMA, INIT ANGIOEDEMA, SUBSEQ ANGIOEDEMA, SEQUELA
I started having a severe headache, chills and I thought I had fever I was feeling hot but I did not have fever, I had nausea ,  then after 3 hours of the above symptoms I vomited. From then I fully recover just I had light headache for a few hours.
Celiac deisease; gas with stool; Mucus with stool; This serious case was reported by a consumer and described the occurrence of celiac disease in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included cardiac disorder. Concomitant products included bisoprolol.   On 13-SEP-2023, the patient received RSV vaccine. On 14-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced celiac disease (Verbatim: Celiac deisease) (serious criteria GSK medically significant), flatulence (Verbatim: gas with stool) and mucus stools (Verbatim: Mucus with stool).  On 20-SEP-2023, the outcome of the celiac disease was resolved and the outcome of the flatulence and mucus stools were resolved (duration 6 days).   It was unknown if the reporter considered the celiac disease, flatulence and mucus stools to be related to RSV vaccine.     It was unknown if the company considered the celiac disease, flatulence and mucus stools to be related to RSV vaccine.   Additional Information: GSK receipt date: 21-Sept-2023 No symptoms were treated. The reporter consented to follow-up.
PATIENT DEVELOPED FEVER, CHILLS THAT BEGAN ON THURSDAY 10/15/15 AND CONTINUED THROUGH FRIDAY PM 10/16/15.  SHE ALSO DEVELOPED EXTREME SORENESS, PAIN, INFLAMMATION AND SWELL AT THE INJECTION SITE.  THE INFLAMMATION AND SWELLING RADIATED DOWN HER ARM AND CAUSED HER MUSCLES TO HURT AND BE TENDER TO TOUCH (ESP. IN THE BICEP MUSCLE REGION).  THE PATIENT TOOK TYLENOL AND BENADRYL FOR THE ALLERGIC SYMPTOMS AND PAIN.  WHEN THE PATIENT CONTACTED OUR PHARMACY THE INJECTION SITE WAS STILL RED AND SWOLLEN BUT APPEARED TO BE GETTING BETTER ACCORDING TO THE CUSTOMER.
This spontaneous case, initially received on 27-Mar-2018, was reported by a physician and concerns a 74-year-old, elderly, male patient. The patient's current condition included anemia (since an unspecified date). The concomitant medication included VICODIN, magnesium, vitamin D3 for unknown indications. Since 22-Dec-2017, the patient was taking non-company suspect product JAKAFI (dose: 5 mg, route of administration: oral, frequency: qd (daily once), batch number, expiry date: not reported). On 05-Jan-2018, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 06-Jan-2018, the next day of vaccination, the patient experienced pain in the same shoulder (described as miserable for next 2 days). The patient consulted medical doctor and was prescribed with unspecified pain medication, which relieved the pain. On an unspecified date, during a follow-up, it was reported that, the patient was off from JAKAFI regimen for an unspecified reason. Later, JAKAFI 5 mg bid (twice-a-day) was included in the care plan. On an unspecified date, JAKAFI 10 mg bid was initiated. On 16-Jan-2018, the patient had recovered from the event shoulder pain. On 06-Feb-2018, the patient underwent unspecified blood tests, biopsy and chemotherapy. The reporter assessed this case as non-serious and the causality of the event (shoulder pain) was considered as related to the flu shot.
pt recvd vax; 21dec mom noted rash on back, chest area; t 102.2 22dec R & red;
Patient received Td 2/07/08 in emergency room.  Presented to our office 2/08/08 with redness, swelling and pain in vaccine site.  Seen again 2/11/08 with cellulitis left arm where vaccine was given.
sore arm; afib; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE and BUPROPION for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath). On 31-Mar-2021, the patient experienced MYALGIA (sore arm). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at a dose of 1 dosage form; AMIODARONE at a dose of 1 dosage form and APIXABAN (ELIQUIS) at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (afib), DYSPNOEA (shortness of breath) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient is wearing a life vest with a wearable defibrillator.  Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
skin rash; Severe hive rash around waist; A spontaneous report  was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events skin rash/ Rash, Severe hive rash around waist/ Urticaria.  The patient do not have any medical history. Concomitant medications  were not reported.  On 13/Jan/2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On  20/Jan/2021, the patient experienced the events Severe hive rash around waist. Nurse stated that about a week later patient had severe hive rash around her waist and saw a family doctor and was put on a dose pack.  Case for patient #1- Crosslinked to other 5 AEs reported Dose pack treatment  was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) skin rash/ Rash, Severe hive rash around waist/ Urticaria was unknown.
Information has been received from a registered nurse concerning a 6 year old white female with no medical history who on 19AUG1997 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 22APR2003 the patient was seen in the doctor's office with papule lesions on the face, chest and back. The number of lesions were unknown and they were in various stages. The reporter indicated that it was considered to be a mild case of chickenpox. No treatment was provided. Follow up information was received from a consumer which indicated that on 22APR2003 the patient had vesicles and papules consistent with varicella. It was unknown if the patient had recovered. Additional information has been requested.