chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like he may have walking Pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 15May2021 as dose  2, single (Lot number: ER9449) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD - was a smoker and gave that up 9 years ago; "He had Pneumonia", start date: Dec2019 (unspecified if ongoing); "Had open heart surgery", start date: Mar2020 (unspecified if ongoing); "Smoker" (unspecified if ongoing), notes: was a smoker and gave that up 9 years ago; "Hospitalization" (unspecified if ongoing), notes: Almost 3 years ago, he was hospitalized with Pneumonia. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: ER9449), administration date: 24Apr2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "Pneumonia", "Feels like he has walking pneumonia". The following information was reported: ATYPICAL PNEUMONIA (medically significant), outcome "unknown", described as "felt like he may have walking Pneumonia".  Clinical course The patient was hospitalized due to Pneumonia and was trying to find some info about Prevnar 13. Initially was asking about Prevnar 20 from a US commercial. The patient received dose 1 as on 24Apr2021 lot ER9449 and dose 2 on 15May2021 as lot ER9449. He had Pneumonia twice and has a history of COPD. He did not receive Prevnar 20. He got the Moderna COVID-19 vaccine booster as dose 3 on 23Dec2021. He confirmed that he never received the Prevnar 13. Almost 3 years ago, he was hospitalized with Pneumonia and 2 years and 2 months ago hospitalized with Pneumonia. He got a feeling he has walking pneumonia now. He is trying to wait until end of school year, end of Nov2022, to see if he needs to get into the hospital again. He was interested in the 20. He had Pneumonia in Dec2019, Prior to getting Pfizer COVID Vaccine. He had open heart surgery in Mar2020. He had pneumonia before COVID even started and was in the hospital with it. He had not going to blame it on the vaccine. When Pharmacist first answered at Pfizer Medical Information, he was trying to find out if Prevnar 20 and she could not find out. He wanted to ask her if it was something good for him and was it available, but she couldn't find out. Few weeks ago is when he felt like he may have walking Pneumonia. He confirmed he has not received any medical treatment. Outcome not provided. COPD - was a smoker and gave that up 9 years ago. He was diagnosed when 2 year ago, prior to getting the vaccines. COVID has done a number on him for dates. He feels like he lost 3 years of his life.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201236849 similar report from same reporter;
SEVERE HEADACHE, LOCAL SWELLING AND INDURATION, NAUSEA WITH VOMITING, DIARRHEA, WEAKNESS, FEVER.
Caller reported that she have a friend who was fully vaccinated and ended up in the hospital still with COVID diagnosis.; Caller reported that she have a friend who was fully vaccinated and ended up in the hospital still with COVID diagnosis.; This is a spontaneous report from a non-contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller reported that she have a friend who was fully vaccinated and ended up in the hospital still with COVID diagnosis. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gout Flared up; It been hurting badly Saturday and Sunday; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout Flared up) and PAIN (It been hurting badly Saturday and Sunday) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gout.    On 25-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 GOUT (Gout Flared up) and PAIN (It been hurting badly Saturday and Sunday). At the time of the report, GOUT (Gout Flared up) and PAIN (It been hurting badly Saturday and Sunday) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Colchicine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Patient's underlying gout is considered a risk factor.
No other AE  reported; Administration of an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age (reported as 7 (units not provided)). The patient pertinent medical history, concurrent conditions and concomitant therapies were not reported.    On 21-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # T018275, expiration date: 23-NOV-2021) 0.5 ml dose, one time for prophylaxis. No other adverse event was reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported.         The albumin status for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) has been verified to be rHA (recombinant human albumin).
I began feeling very tired (9 PM). This progressed to significant chills (9:30 PM) and severe muscle pain and nausea (entire night of 2/8/2021 and 2/9/2021. I remained in bed all day on 2/9/2021, getting up only to use bathroom and get water/little bit of food. Still dizzy and weak on 2/10/2021, though feeling like had turned corner
Thursday night she had headache and vomiting. She had fever of 101 on Saturday. On Sunday she had chest pain. On Monday she was better and did not have any symptoms.
Significant bruising and hematoma in muscle measuring 3x3 cm present 9 days after administration.
States blurry vision started day after receiving vaccine, states feels like he is going cross eyed. Advised him to go to his health department, PCP, or ER.
This spontaneous report was received from a registered nurse referring to a patient of currently 11 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt stood up was standing with her father and she felt hot and fainted, falling to the floor, no one witnessed her hitting her head, she was asked about her head and said she didnt hit it, we offered cold packs but she said she was fine, sat in chair for another 15 minutes felt fine and went home.  Next day she had to go to ER twice for migraines/headaches.
3 minutes after injection pins and needles from head to toe 5 minutes later tongue started to swell up. Lips and tingue were numb as if i had novacane. I went to nurses station ans was observed for 30 minutes. No change but symptoms did not get worse. Vitals were normal. Went to store took benedryl. 2 hours later still numbness of tongue.  Went to ER at hospital and was seen by Doctor. Doctor said it was a side effect of the covid vaccine. I was released.
Redness and circular area around injection point. First occurred on Feb 3 (day of the injection). Red , raised area reappeared Feb 13. Also very itchy and hot to the touch.
I woke up and 4 of my teeth were chipped. I had to go in to have one filed down because it was causing my tongue to bleed. My toenails and fingernails have started chipping and breaking. This has not happened before the vaccine. I also experienced eczema on my right hand and both my elbows as well for which I saw a doctor for as well. I had been treated for eczema in the past. The dermatologist asked if there was anything to triggered this but the only thing, I could think is the vaccine. I was given steroid cream for the eczema which helped after about 14 days of continuous use.
Patient started feeling flu-like symptoms (nausea, diarrhea, extreme exhaustion) on 10/14/11 that lasted 2-3 days. Patient later passed away while playing Squash/handball on 10/19/11.
recieved vaccination at 1:00 pm 12/12/05, at work,then went to break @ 2:00 pm and started having chest pains really bad, this i thought was from having a hiatel hernia. then at 5:00 i went to lunch and had a sore throat and started coughing and could not stop,then within 30 minutes i started getting real dizzy, and then i got the chills so bad i had to leave work, when i got home i took my temp. and it was 101.7. this was around 7:00 pm. my fiance had a prescription for tamiflu and i started taking this. The next morning my fever had broke and was back to normal. I just had the aches and pains and felt lousy the rest of the day and slept pretty much the whole day. I have had to miss 2 days work because of this.
Moderna COVID-19 Vaccine EUA Six days after receiving the first dose of the Moderna vaccine, I noticed a rash on my left arm near the location of the shot. By the next day, the rash had spread to cover most of my upper arm as a large hive that itched badly. As of today, February 26, the large hive has not gone away and the entire area is itchy and painful. I called Dr. who  prescribed Benadryl gel for the itching and recommended that I keep my appointment for the second dose of the vaccine. He said that the reaction was not uncommon.
24JUL1998 pt recv 2nd dose of vax exp measles, sx included fever 104F for 2 days, headache, sore throat, coryza, head to toe rash for 3 days, & lethargy for 1 wk after rash dissipated.
This spontaneous report was received from an unspecified office manager who is also the patient's relative via company representative and refers to a 18-year-old female patient. The patient's pertinent medical history was not reported. Concomitant therapies were not provided. In 2015 and 2016, the patient was vaccinated with all three doses of GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). In 2015, reported as "after the first vaccination ", the patient was getting very sick and had a mushroom allergy. She sought physical attention and went to many unspecified physician. The outcome of the event was reported as recovering. The reporter considered a mushroom allergy to be related to GARDASIL 9. The relatedness between the event of getting very sick and the suspect therapy was not reported.
At about 9:30 pm, 5 hours after getting the shot, I was in the shower with my wife and felt nauseous, then faint. She got my onto the floor right as I fainted. She called the ambulance, my BP was low and I had zero color in my face but felt ok enough to not go in the ambulance. I have never fainted before
Information has been received from a registered nurse concerning an approximate 5-year-old female who on 13-JUN-2003 and 05-JUL-2007 was vaccinated with her first and second dose of varicella virus vaccine live (Oka/Merck) (lot # 657099/0453U 2nd dose). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Confusion; Difficulty speaking; Patient has not received the 2nd dose yet; Super high fever 104; This spontaneous case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (Confusion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-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 CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant), SPEECH DISORDER (Difficulty speaking), PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd dose yet) and PYREXIA (Super high fever 104). At the time of the report, CONFUSIONAL STATE (Confusion), SPEECH DISORDER (Difficulty speaking) and PYREXIA (Super high fever 104) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd dose yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) High fever 104.     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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  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.
Had congestion, slight cough, sore throat and fatigue starting 9/20/21 worsening on 9/21/21.  Tested positive for Covid-19 using rapid antigen test.
2.5 hrs post vaccination, pt had difficulty swallowing, called health department and was encouraged to go to walk in clinic for treatment asap.  ER noted red throat and swollen glands indicating strep throat.
PARENT REPORTED PT HAVING SEVERE SORE ARM WHEN SHE WOKE UP NEXT MORNING ON 10/11/22. ALSO REPORTED GIVING HER IBUPROFEN BEFORE SHE WENT TO SCHOOL
This spontaneous report was received from a nurse refers to a 54 year old male patient. Patient's pertinent medical history included Lyme associated arthritis, elevated triglycerides, thyroid issues, and high blood pressure. The patient had no drug reactions/allergies. Concomitant therapies included a lot of medications (unspecified). On 11-DEC-2017, the blood cholesterol levels was performed. On 15-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, lot number and expiration date were not reported) intramuscularly for prophylaxis (vaccination). On an unknown date in 2018, the patient developed pleural pericarditis (hospitalization, medically significant, disability and life threatening). On 21-JAN-2018, the patient was hospitalized and was discharged on 31-JAN-2018, and was again readmitted on 02-FEB-2018. Currently the patient was hospitalized. The nurse stated that she was not sure whether the pleural pericarditis was related to the PNEUMOVAX 23. The patient received treatment to treat the adverse event. The patient sought medical attention (was hospitalized). The outcome of pleural pericarditis was reported as not recovered/not resolved. The relationship between event pleural pericarditis and PNEUMOVAX 23 was not provided. There was no product quality complaint (PQC) reported. The event pleural pericarditis was considered to be life-threatening by the reporting nurse. Upon internal review, pleural pericarditis was considered to be serious due be medically significant.
my Heart PVCs are close to 50000; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VENTRICULAR EXTRASYSTOLES (medically significant) with onset 2021, outcome "unknown", described as "my Heart PVCs are close to 50000". The patient took Pfizer vaccine one year before. Recently found out that Heart PVCs are close to 50000. They couldn't find any other reason for recent changes so doctor said vaccine could be a reason. The patient underwent the following laboratory tests and procedures: PVC: are close to 50000. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt felt faint, diaphoretic/ pale 1645: BP 110/72, HR 60, O2 95% Laid to floor, feet up, cool rag to head 1655 125/78, HR 91, O2 99% 1700 Up to sitting against wall: 119/97, HR 97, O2 97% 1710 Up to sitting in chair 134/81, HR 83, O2 97% Pt eating nuts, drinking water, no distress
Pt 11 years old and received Pfizer for patients who are 12 and older.
neurological symptoms most consistent with Parsonage-Turner syndrome.; neurological symptoms most consistent with Parsonage-Turner syndrome.; Worsening including increasing pain extending to all the arm; paresthesias throughout arm and hand,; feeling of dislocated scapula; tightening of the lateral aspect of the chest; sharp pain; The injection was incorrectly done too high and too deep into the joint/bursa.  She developed sharp pain; This is a spontaneous report from a contactable physician. A 26-year-old female patient (daughter) (not preganent) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3302 and Expiration Date unknown) via Intramuscular on 18Jan2021 (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EH9899 and Expiration Date unknown) via Intramuscular on 30Dec2020 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as none. The concomitant medications were not reported. No other vaccine in four weeks. The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain and started with neurological symptoms most consistent with Parsonage-Turner syndrome, which includes pain in the brachial plexus with weakness, paresthesia which might never resolve. This is an autoimmune disorder. Patient was worsening including increasing pain extending to all the arm, paresthesias throughout arm and hand, feeling of dislocated scapula, tightening of the lateral aspect of the chest. Onset date for all events was 18Jan2021 and resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with treatment of oral steroids and nonsteroidal anti-inflammatory drugs (NSAID).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the neurological symptoms, Parsonage-Turner syndrome and other reported events in the clinical context of wrong injection technique due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a 74 year old female with Crohn's disease, penicillin and Keflex allergy who on 08-Jan-2009 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included PLAVIX, ZOLOFT, generic pramipexole dihydrochloride and AMBIEN. On 08-Jan-2009, the patient had difficulty sleeping the night after vaccination. She took AMBIEN and was still unable to sleep. She also had pain in her left leg going from her thigh to ankle. The muscles contracted and her veins felt like they were burning. She had calf soreness in her left leg on 09-Jan-2009. At the time of this report, the patient was recovering. The patient spoke to pharmacist for medical attention. Additional information has been requested.
What happens if the second dose is applied for more than a month; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (What happens if the second dose is applied for more than a month) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (What happens if the second dose is applied for more than a month). At the time of the report, UNEVALUABLE EVENT (What happens if the second dose is applied for more than a month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.   Reporter did not allow further contact
Only the liquid component of Menveo was administered; Only the liquid component of Menveo was administered; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that currently the clinic was trying to identify the patient and date of the error. It was unknown which patient only received a partial vaccine dose.  The error was found during an inventory audit.  The clinic was running a report in an attempt to identify the patient. The reporter did not consent to follow-up.
Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild