chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report was received from the patient's husband referring to his wife a 35 year old patient. There was no pertinent medical history or drug allergies/drug reactions. On approximately 24-JUL-2015 reported as "two weeks ago", the patient was vaccinated with PROQUAD (Merck), subcutaneous injection (dose, lot# and expiration date not provided). There was no concomitant medication described. The reporter stated that, it was recently confirmed (unspecified date) that the patient was pregnant which was considered as an exposure during pregnancy. Last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. No adverse effects were reported. At the time of the report, the outcome of exposure during pregnancy was unknown. Additional information is not expected as no reporter details were provided.
Patient reported itchy eyes within 30 mins of administration. She was advised to try Benadryl and follow up with Dr. if symptoms worsened. This was a flu shot clinic held at her place of employment.  I was not notified of the more serious adverse event until 12/2/14, more that 30 days after.  She went to Urgent Care about 4-5 days after vaccine because of swelling in face (angioedema) and received a steroid pak. After completing that and not seeing improvement, she went to her primary care Dr. He prescribed a longer dosed steroid as well as Ranitidine, Loratadine. Her PCP has referred her to an allergist for further testing.  She states she is not 100% better and is still dealing with the aftermath.
UPPER RESPIRATORY INFECTION; This spontaneous case (PVX2019-783) was received from nurse on 01-Apr-2019. It describes a 59-year-old male consumer who had upper respiratory infection, while being on Vivotif for an unknown indication.   Case report: The consumer took only three doses of Vivotif in the last week. His last dose was due on 31-Mar-2019, which he missed to take as on the same day he started experiencing upper respiratory infection. He was prescribed azithromycin by his physician. The reporter was unsure of the dosing regimen of the azithromycin, but she stated that she believed it was a Z-pack with 500 mg on the first day and then 250 mg for three more days.  He did not take any concomitant medication at the time of event and he had no remarkable medical history.   Action taken with Vivotif with respect to the event upper respiratory infection was vaccine discontinued.   The consumer had not recovered from the event upper respiratory infection.  Company's Comment: In this case a 54-year-old male consumer experienced upper respiratory infection following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. However, the event upper respiratory infection is an infectious condition with commonly viral or bacterial etiology. Hence, the causality of the event chest infection is assessed as unlikely with Vivotif vaccine.; Sender's Comments: Company's Comment: In this case a 54-year-old male  consumer experienced upper respiratory infection following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event . However, the event  upper respiratory infection is an infectious condition with commonly viral or bacterial etiology.Hence, the causality of the event chest infection is assessed as unlikely with Vivotif vaccine.
Patient had TDAP injection administered to right arm in subcutaneous tissue. area is reddenned, warm to touch. no complaints of pain. has some swelling.
Tinnitus onset hours after receiving vaccine. Ringing has remained consistent since vaccine date with no improvement (approx. 4 months).
Approximately 5 minutes after administering the vaccine, he was waiting in his car with a friend, He became unresponsive and appeared to have lost consciousness.  Upon arrival to the vehicle he looked to be having a seizure.  Did not respond to verbal commands but did respond to sternal rub.  EMS called.  BP 118/58 and pulse 60.  He was diaphoretic and pale.   EMS arrived and during their interview he had another more intense and longer seizure.  Transported to the Emergency Room.
I ask what vaccine he was receiving Pfizer, and he said yes. Then I proceeded to give him Pfizer vaccine. It was later that he came back to complain that he had received Moderna vaccine for his first dose. He was monitored for 30 minutes and there was no adverse reaction noted.
Chills, headache, slight fever (100.6 degrees), starting 3.5 hours after the vaccination and gradually lessening over the next 48 hours.
Got the shot got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the most of the people he or she know that they received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient is a 72 y.o. male patient of, CNP with history of COPD, asthma, ataxia, hypertension, hypothyroidism, BPH, seizure disorder,  presented to Hospital with shortness of breath found to have pneumonia at outside facility and transferred for further work-up and management Covid Pneumonia Acute exacerbation Asthma  Acute hypoxic respiratory failure Covid-19 Virus Infection Leukocytosis  Date of onset of symptoms: 3/27/23 Symptoms present on admission: Fever, shortness of breath, cough  Date of covid positive test: 4/3/23 Vaccination status: vaccinated Imaging: Chest x-ray reveals ill-defined hazy nodular opacities, concern for bronchopneumonia Oxygen requirements on admission: 6 L Covid Pneumonia Acute exacerbation Asthma  Acute hypoxic respiratory failure Covid-19 Virus Infection Leukocytosis  Date of onset of symptoms: 3/27/23 Symptoms present on admission: Fever, shortness of breath, cough  Date of covid positive test: 4/3/23 Vaccination status: vaccinated Imaging: Chest x-ray reveals ill-defined hazy nodular opacities, concern for bronchopneumonia Oxygen requirements on admission: 6 L Current oxygen requirements: Room air  Medical therapy: steroids, Remdesivir  Consultants following: ID Anticipated special isolation end date: 4/13/23 Initial lactate was normal Respiratory panel positive for COVID  Chest CT showing diffuse patchy airspace disease throughout the left lung concerning for multifocal PNA  Oxygen per protocol, wean as appropriate, does not wear oxygen at home  S/p  IV Azithromycin, completed  Rocephin for 5 day course, s/p oral Azithromycin  Blood cultures showing Coagulase negative staph, likely contaminate, Repeat cultures negative  Continue on bronchodilators and DuoNebs Sputum Culture showing Yeast    Hypertension BNP was normal Continue Lasix 20 mg daily, Diamox  500 mg daily  S/P IV hydration  ECHO to be done outpatient-discussed with Cardiology who recommends outpatient  Blood pressure stable, elevated at times but appropriate for age, recommending close monitoring on discharge    Hyperlipidemia Hold statin for elevated liver enzymes    Hypothyroidism Continue Synthroid
Pt had Pneumococcal 23 on 6/9/16 at 2:18 p.m., ran fever during night then developed rash all over his body and itching was sent home but returned again to ER with urticaria.
pt rcvd vax; pt devel elevated bilirubin; MD felt that inc in bilirubin was coincidently discovered after vax but was due to other etiology;
I received my COVID vaccine and then following that I received my flu shot. Right after receiving the COVID vaccine I had a headache for a couple days and pain for about a week. I also had heavy fatigue. I was hospitalized 1 week later due to breathing issues. I had low oxygen saturation down to the high 60s and low 70s range. It was unclear to my neurologist and pulmonologist whether if the combination of those two vaccines worsened my Myasthenia gravis. The treatment I was on for Solaris may not of have been no longer treating me effectively. I had did well during the summer but I had an underline protection from IVIg. I have been having that IVIg infused every 3 weeks for 80grams. I was receiving those from June-August 2021. My doctors are not sure if the vaccine and flu vaccine contributed to my event. They said it was possible that the IVIg had just ran out. I had a n event in November as well and went to the hospital. I had a plasma exchange. They did that for 3 days in a row. They gave me a liter of fresh frozen plasma the last two days. That treatment worked well on me. In the last past week I have started to have lower oxygen levels again. My doctors are concerned that the vaccination caused my Myasthenia gravis to decline.
Pain and edema on the area of application, it started 1 day after the vaccine administration. Pain in legs possible related to vaccine that started 1 hour after application
6 days later developed a cellulitis in Vacination site on Left Deltoid. Treated with Augmentin 875mg BID and warm soaks TID.
This spontaneous report received from a consumer via social media (Johnson and Johnson Corporate) from a company representative concerned 4 adult male patients of an unspecified age, race and ethnic origin. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, "4 adult males who died supposedly of Covid/ died of the gain of function flu, but 3 were fully jabbed " and had suspected clinical vaccination failure. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected Covid 19 infection / died of the gain of function flu on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220126450, 20220126708, 20220126582 and 20220130063. This report was associated with product quality complaint: 90000211848. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Upon review, the following information was corrected: case corrected from invalid to valid and narrative updated accordingly, batch no statement updated as per recent update. Sender's Comments: V1- Upon review, the following information was corrected: case corrected from invalid to valid and narrative updated accordingly, batch no statement updated as per recent update. This updated information does not alter the causality of previously reported events. 20220126174-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Suspected Covid 19 infection/ died of the gain of function flu. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20220126174-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Suspected clinical vaccination failure- This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: DIED SUPPOSEDLY OF COVID/DIED OF THE GAIN OF FUNCTION FLU.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. The patient experienced significant cellulitis at the point of the shot on an unspecified date with outcome of unknown. The doctor attributed the significant cellulitis to PREVNAR 13.
Osteopenia; Have lost lot of height because of the osteoporosis; Had Ibuprofen but I don't take Ibuprofen because it is harder on stomach; Have lost lot of height because of the osteoporosis; Terrible headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number EW176), via an unspecified route of administration on 08Jul2021, 3:00 (age at the vaccination 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included haemorrhoids from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrocortisone acetate (HYDROCORTISONE ACETATE) 25mg, taken for haemorrhoids, start and stop date were not reported. The patient experienced osteopenia on an unspecified date, have lost lot of height because of the osteoporosis on an unspecified date, terrible headache on 09Jul2021. The patient underwent lab tests and procedures which included bone density abnormal: osteoporosis on Jun2021. Therapeutic measures were taken as a result of osteopenia, have lost lot of height because of the osteoporosis. Treatment for Osteoporosis and Osteopenia consumer stated, its Vitamin D and calcium; had Ibuprofen but don't take Ibuprofen because it is harder on stomach. The outcome of events was persisting (not recovered) for Osteoporosis and Osteopenia; lost lot of height and terrible headache was unknown.   Information on the lot/batch number has been requested
This spontaneous report was received from an office manager and refers to a 33-year-old male patient. The patient's pertinent medical history included pneumonia and concomitant medications included prednisone (manufacturer unknown) and doxycycline (reported as "doxycyline"). The patient had no drug reactions or allergies. On 20-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) lot # N025656 with expiration date: 19-APR-2019. On 20-NOV-2017, 3 hours after vaccination, the patient experienced shoulder injury related to vaccine administration (SIRVA) and limited range of motion. The patient called the physician's office on 21-NOV-2017 and the office referred him to "see an unspecified orthopedist". No treatment was provided however it was also reported that the patient received the treatment. The outcome of SIRVA and limited range of motion was reported as not recovered at the time of this report. The event of SIRVA was reported as related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The relatedness between limited range of motion and PNEUMOVAX 23 was not reported.
Moderna vaccine inadvertently administered to person under 18 years of age at nursing home vaccination clinic for residents and staff.    Administration error/deviation from EUA caught on review of consent forms by pharmacist overseeing vaccination clinic.  Nursing home administrator contacted by pharmacist on 11/22/21 (several hours after vaccination) who contacted mother & involved employee regarding error deviation & what potential ADR's to monitor for.  Followed up on 11/24/21 & 12/2/21.   No adverse reactions noted per mother & patient as of 12/1/21 (both employees of nursing home).
I experienced 10 days of severe migraines requiring multiples doses of Sumitriptan every day.  I have a history of migraines which have been under control for years. I take one dose of Topiramate daily and rarely experience a migraine.  When I do, it is mild and only require a single dose 50 mg of Sumitriptan for relief. The migraines I experienced after receiving the first Moderna vaccine were severe and did not remit for 10 days.  No problem after second dose.
This spontaneous report as received from registered nurse refers to multiple unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was unknown. The nurse reported that multiple unspecified patients were administered RECOMBIVAX HB (dose, frequency and route unspecified) that were improperly stored. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reported. Product quality issue was not involved. This case is linked to #1409USA001487, #1409USA001774 and #1409USA001775 via same reporter link. Additional information has been requested.
Patient had potential SIRVA from Fluzone HD.  Being examined by an neurologist now.
p/vax pt had lump on rt leg bigger than 1/2 dollar;very hard, red, hot to touch;is doing ice when pt will let her;massaging the area & giving APAP PRN;
Approx 5 min p/MMR pt became nauseated, pale & weak in the knees; fainted; responded w/in 5-10 sec; Color returned to cheeks; Pt fainted again 10 min later while watching brother receive vax;
after 15 minutes of getting the pediatric Pfizer vaccine the dad and client came to me saying the she is complaining of headache and difficulty breathing I advised the dad to go outside and let her take her mask off and try to breath and I joined them . I asked her if it is better, but she said she is still having difficulty beathing so I asked the dad if he wants me to call ED which I did . the paramedics came and checked her vital and it was normal her blood pressure was 120/70 and they said all her vital normal . they asked the dad if they can take her to the hospital he declined  and he said he lives near a hospital . the patient seemed to improve and I asked if I could give her water and they said yes
fever, chills, mild headache, sweating, fatique & body aches. flu like symptoms. Still symptomatic after 48 hours.
Severe chills approx. 11 hours after injection.  Did not check for fever but had chills, then sweats during Friday.  No appetite, malaise, achy joints through Saturday.  Began to feel normal by Sunday.
Fever of 101 for one day, extreme ongoing, almost incapacitating  fatigue is still continuing almost three weeks and counting
10/30 Pt states started to develop hives at waist/wrists bil and L leg at 0830 24 hours after flu immunization. No local reaction. Benadryl given 1500 10/30/08. On 10/31 Pt states hives spread to most of body then resolved by 11/1.
Metallic taste in her mouth; This is a spontaneous report from contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation and started to receive palbociclib (IBRANCE) via an unspecified route of administration on an unspecified date ("for about five years") to an unspecified date at an unspecified dose and frequency for an unspecified indication. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On an unspecified date the patient experienced metallic taste in her mouth. The patient stated that she had been taking palbociclib for about 5 years and she completed her vaccination series of the Pfizer COVID-19 vaccine on 19Feb2021. She presented with a metallic taste in her mouth that ruined her taste and would not go away. The patient stated that she developed the metallic taste shortly after getting the second Pfizer COVID-19 shot, even though she had been on palbociclib for a long time. She called to inquire whether there were any reports of this reaction with palbociclib. The clinical outcome of the event metallic taste in her mouth was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
vaccine was in refrigerator on 07-FEB-2022 and administered on 20-APR-2022; Vaccine was administered beyond the use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the use date) and PRODUCT STORAGE ERROR (vaccine was in refrigerator on 07-FEB-2022 and administered on 20-APR-2022) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was in refrigerator on 07-FEB-2022 and administered on 20-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the use date) and PRODUCT STORAGE ERROR (vaccine was in refrigerator on 07-FEB-2022 and administered on 20-APR-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Patient had received total three doses. This dose was a booster.  It was reported that as per Moderna lot analysis regarding doses administered on 20-APR-2022 from lot number 083J21A, Moderna cannot guarantee patients received full protection against the Covid-19 virus.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow-up received contains non significant Information. Narrative updated
The patient did not experience any other AE; Expired MMRlI was administered; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.    On 01-MAR-2021, the patient was vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # s005249, expiration date 20-FEB-2021 (dose and route were not reported) for prophylaxis. The vaccine did not have any prior temperature excursions. The patient did not experience any other adverse event.