chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, single, lot number unknown), administration date: 06Jan2021, when the patient was 54-year-old, for Covid-19 Immunization; BNT162B2 (Dose 2, single, lot number unknown), administration date: 27Jan2021, when the patient was 54-year-old, for Covid-19 Immunization; BNT162B2 (Dose 3 (booster), single, LOT# FF2587), administration date: 05Oct2022, when the patient was 56-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown". The event "tinnitus" required physician office visit. Additional information: the reporter (patient, Registered Nurse) stated, "I guess I wanted to report to you something so, my husband and I both had four of the Pfizer COVID-19 Vaccination, Immunizations and I have been a very big vaccine protonate. I am registered nurse and I really believe in them and I have to tell you that in January my husband started complaining of Tinnitus and I ended up developing tinnitus. We both have, I mean we no way related it to the immunization at first. I mean the drug in our history we looked at what we are eating, no caffeine we did everything and that we are showing doctor and somebody when I was saying that we had tinnitus, they are like, your you got it from shot, I am like, no. Well, my gosh I did it and apparently there is small percentage of people that are reporting tinnitus which of course they can't say for sure they say maybe it just a correlation but there is nothing else that could happen and I want you all to know that you have got add up too in." The patient specified that dose 3 was administered on 05Oct2022 (the COVID 19 mRNA vaccine LOT# FF2587); dose 4 was administered in October like it was week later then that 2022 and that LOT# was GJ3277.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302191 Same reporter/patient/drug, different dose/AE.;US-PFIZER INC-202300302067 Same reporter/drug/AE, different patient.;
About 3 hours after vaccination, she began having hives and itching all over body.  No difficulty breathinc etc.  She went to ER that noted reaction to vaccine.  She was Administered  Benadryl 50mg PO X1 and Prednisone 60mg .  She also received one dose of Pepcid 20mg PO.   No signs of distress noted in ER.
pt was sleeping on way home from MD office;woke up & w/in a few minutes pt started shaking;eyes were open & staring;EMS called. Was given unk dose of valium by unk route & transported to hosp;dx atypical febrile sz, rt upper lobe pneumonia;
PATIENT REPORTED ARM SWELLING SURROUNDING SITE OF INJECTION. TAKING TYLENOL, COLD COMPRESS AT SWELLING SITE
6 days of fever 103-104 range. Started day 5 after vaccines. Rash-MP type- suggestive of measles. Listless, slept 20hr/day. Recovered about 4/23/04.
Parents noted patient drenched in sweat. Fever of 101.4. Given TYLENOL. Could not reduce fever. Saw pediatrician early AM who referred to ED. Labs/ultrasound confirmed bilateral pyelonephritis. Two IV antibiotics administered.
On 4/30/21 at approximately 7:00pm, exactly 1 week after first dose of vaccine, I began noticing that my arm was itching at injection site. I looked and noticed site was red and I had a small hard knot in the area that was slightly warm. The appearance at that time was similar to a bug bite. By the next morning when I woke up (5/1/21) the area had grown much larger. I now have a large knot on my upper arm at injection site that is red, swollen, raised, hard, very warm to the touch, itchy, has a white pinpoint in the center, and is approximately 3-3.5 inches in diameter at this time currently. It is now 4:00pm on 5/1/21 and these are my current symptoms.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: CALLED EMS PATIENT WAS ATTENDED TO BY EMS
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: Ff8839), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: CT contrast" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the vaccination, she started to have difficulty breathing and chest tightness. No wheezing. Pt had neck and face flushing without hives. Pt tachycardic at 120 bpm. SOB and tachycardia lasted 1.5 hrs. Pt denies anxiety, dizziness or GI symptoms. Pt monitored and advised to avoid 2nd dose of mRNA vaccine; pt declined to see PCP
Fever, body aches, chills, neck ache, fatigue,  swollen lymph node under armpit, sore arm
Generalized urticaria with fever up to 105. Starting 5 days after immunization lasting 4 days. Treated with Benadryl. Hospitalized for 2 days to excluded other causes of fever, rash. Discharge summary states viral exanthum or serum sickness. msv
In the right arm deltoid region where AFLURIA was administered: patient reported a 6-7 inch red swollen area with a 3 inch bulls eye region. It was red, inflamed and warm to touch. Patient medicated with BENADRYL reported no other symptoms. After several follow-up calls patient reported on 10/30/13 reaction had almost completely recovered.
Patient started to get a rash around the injection site but then it spread all the up to her jawline. She started to have trouble breathing shortly after. She had an EpiPen on hand and injected herself with it and was fine.
nausea, headache, shakes, high fever 103+, 104+ for Thursday - Saturday,   Health Department dispatched the nurse to inject the vaccine at the facility.  My daughter?s COVID-19 vaccine card clearly states her birthday / age.  Why did the nurse administer the unapproved COVID-19 vaccine, Janssen, to a minor?  According to CDC, only Phfizer vaccine is approved to be administered to someone of age of 17?
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Patient stated "skin was sore" for several days after the vaccine, stated contact was painful, resolved after several days
Covid positive; Covid positive; Is scheduled for the second shot on 03May.; This is a spontaneous report from a contactable consumer. This consumer reported for his 67-year-old patient (wife) that, she received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The Reporter has a question regarding second shot for Covid. He and his wife got the first shot of Pfizer on 28Jan and stated that doctor checked them and found out they were Covid positive. The reporter stated that they were sent to the hospital and infused with monoclonal antibody, now they were fine and relieved. He reported that the nurse said not to have the shot until about 90 days. The reporter wanted to know if they should have shot at 90 days and if have any information about this. Is scheduled for the second shot on 03May. The outcome of the events reported as unknown.   Information on the lot/batch number has been requested.
Upper arm and shoulder extremely painful, radiating up to the neck; unable to move arm at all without debilitating pain; after 3 days, still extremely tender, not able to lift arm very well.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M016193, expiration date: 24-APR-2018, the medical assistant also reported lot # M026306 which was not valid for GARDASIL 9, however, lot # M026306 is valid for GARDASIL, expiration date: 30-APR-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes and a total time out of range of 40 minutes were reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.  Sender's Comments: US-009507513-1612USA012399: US-009507513-1701USA001262: US-009507513-1701USA001263: US-009507513-1701USA001265: US-009507513-1701USA001266: US-009507513-1701USA001267.
I received my second Moderna booster for COVID-19 on 4/18/2022. On 7/12/2022, I started coughing in the early hours of the morning. Later that day, I went to my doctor's office and underwent a PCR test, which yielded a positive result. I was given a 5-day course of Paxlovid. Earlier today, I was also given Guaiatussin AC liquid and benzonatate capsules for my cough. During my bout with COVID-19, I've had a severe cough, runny nose, a little bit of congestion, but no fever. Of all the symptoms I've had, the cough has been by far the worst. So far, the Guaiatussin AC and the benzonatate seem to be relieving it. I've also headaches and body aches, but think they were probably caused by so much coughing.
Hives began 1/29/03 over total body. Face & lips slightly puffy. Began Benadryl Q6. Hives & puffiness relieved after Benadryl. Hives gone by day 2/2/03.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 07-MAR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006953, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
No additional adverse event reported; a dose of improperly stored GARDASIL 9 was administered to a patient; This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-MAY-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route and anatomical location not reported) for prophylaxis (product storage error). Lot number for improperly stored vaccines were reported as R020200 with expiration date of 05-MAY-2021 and R036913 with expiration date of 23-SEP-2021. However, the specific lot number of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered to the patient was unknown. The vaccine was stored at a temperature of 34 Fahrenheit (below 36 Fahrenheit) for 18 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint (PQC) was present. No additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: Instrument, Surgical, Disposable (KDC); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R020200; expirationdate: 05-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No concomitant medications were reported. No medical history was provided. On unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of PROQUAD (dosage schedule was not provided) (lot# L027634, expiration date: 21-JAN-2017; lot# L019994, expiration date: 02-DEC-2016). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports from the same reporter. Additional information has been requested.
fever of greater than 103, chills, riggors, body aches, swollen lymph nodes, nausea, headache
A nurse reported that a pt inadvertently received an expired dose of Tetanus Toxoid Adsorbed, Ultrafined or Tetanus Toxoid Fluid on 11/8/00. The vaccine expired in 1998. On 11/8/00, she experienced blurriness which resolved within 2 hours. As of 11/8/00, no further information was available.
approx 4 hrs post injection, headache and moments of "hot flash" type events.  Looked at numbers on my fit bit, and even though I was sitting at my desk, exerting no excessive energy, my heart rate read 96 bpm (lasted for about 10-15 min).    As the day progressed I began to feel more blah. That evening, I took bandaid off injection site and it was patchy read and raised skin, warm to touch, and the areas where the bandaid was were raised and patchy (I have never had a reaction to bandaids before).  As night progressed, I became excessively chilled and could not get warm.  Would occasionally have a "hot" moment and then return to chilled where I couldn't get warm enough.  Body aches, headache, and chilled through the night. Second day, totally consumed with body aches, chilled, headache, tired and weak feeling. Took Tylenol.  Slept on and off through the day. Second evening  awoke around 8pm and everything still hurt, including my teeth.  Took Tylenol, tried to eat a few crackers- no appetite. Went back to bed. Third morning feeling 90% better. Still have headache. Took Tylenol.
Contracted shingles, fever, fatigue, nauseous, achy, no appetite, chills.  Was not prescribed anything by healthcare professional.
Headache, Myalgia, Arthralgia, Fatigue and elevated temperature of 99.7  Narrative:
Patient complains of extreme shoulder pain that limited range of motion above his head for >3 days. This pain prevented him from completing a round of golf and has impacted his sleep significantly. Patient denies swelling, heat, or redness at the injection site.
minor discomfort on the injection site; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  Medical history included ongoing discomfort on her lower back/back pain (prior to getting the shot).  Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (CRESTOR), ibuprofen (ADVIL) for discomfort on her lower back and naproxen for discomfort on her lower back.  The patient reported that she received her first dose of COVID-19 vaccine on Sunday. The patient experienced minor discomfort on the injection site on 17Jan2021, she barely noticed it. She had no other side effects. She does experience back pain, but this was prior to getting the shot and the pain is still the same as it always has been. She took two Advil on 22Jan2021 and asked if it will have an impact on the efficacy of her vaccination. She usually takes Advil or naproxen, as needed, for discomfort on her lower back (not associated to the COVID-19 vaccine). Prior to the shot he didn't take anything, no Advil or ibuprofen. The patient recovered from the event on 18Jan2021.  Information on the lot/batch number has been requested.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 08-AUG-2017, the patient was vaccinated with the third dose of GARDASIL 9 for prophylaxis (strength, route, Lot # and expiration date were not reported). On an unknown date the patient experienced product use issue and no adverse event.
diarrhea; cough; phlegm; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Sore arm), COUGH (cough) and PRODUCTIVE COUGH (phlegm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU. Concurrent medical conditions included Flu vaccination.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 08-Mar-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (cough) and PRODUCTIVE COUGH (phlegm). On 10-Mar-2021, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Sore arm), COUGH (cough) and PRODUCTIVE COUGH (phlegm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: The patient stated that she got both the shots of vaccine.; 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.
Pfizer-BioNTech COVID-19 Vaccine EUA.   1.5 hours after receiving vaccine (12pm), I felt a flush/warm sensation in my heart area. My heart rate increased, jumping around a lot. I could see my chest moving up & down. I tried to monitor BP & heart rate w/my heart monitor. BP was up to 154/103, pulse 73 at 12:20; BP 150/92, pulse 70 at 1:00pm. My normal pulse is 50-55. Twice the monitor read ERROR.  By 1:30 BP was 128/75, pulse 61 and I felt heart was more calm.  By 10:30pm BP was normal, 116/74, pulse 52. By chance I had appointment with my cardiologist the next day, 1/25/2021. He said it was an episode of atrial fibrillation. I have not had that rapid heart rate issue since the stent implant in December 2011.
During the night after the vaccine my left eyelid became achy and slightly itchy.  The ache remained all the next day and night.  Morning of 3-04 the left eyelid was red and somewhat swollen.  Ache remained.
some lower back pain; mild chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 17:30 (Lot number: ENG205) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scoliosis" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "some lower back pain"; CHILLS (non-serious), outcome "unknown", described as "mild chills". Therapeutic measures were not taken as a result of back pain, chills.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested covid-19. The patient had some lower back pain and mild chills with his First dose. Patient did not take other vaccine in four weeks. Patient took Ibuprofen in two weeks (after 1st dose).  No follow-up attempts are possible. No further information is expected.