chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the patient received two vaccinations, Comirnaty and Flublok. The patient fainted while still in the vaccination chair. I aroused the patient back to consciousness. I walked him to another chair then he fainted again. I aroused him again then laid him on the floor for 15 minutes. Had him stand slowly; he said he was fine; he appeared to be fine. He left the pharmacy.
Developed daily fever of between 99-102 beginning on 6/22/2022 thru 7/5/2022. Out patient chest x-ray on 6/30/2022 showed no significant changes. Placed on amoxicillin. Increased cough began on 7/2/2022. Seen in urgent care on 7/5/2022 for worsening cough and no resolution of cough and fever. Patient hospitalized on 7/5/2022 for hypoxia. Fever resolved on 7/5/2022. Patient started on oxygen on 7/5/2022. CAT Scan on 7/5/2022 showed worsening lung infiltrates. Bronchoscopy performed on 7/7/2022. To date no identifiable bacteria, virus, or fungus.  Placed on high dose IV steroids and IV antibiotics. During hospitalization required 2-6L of O2 at rest and up to 15L on exertion. Discharged on 7/ 17/2022 with home oxygen and oral steroids (tapering down from 40mg to 10 mg). Diagnosis - ?? Exacerbation of ILD? Currently requires 2L at rest and  6-8L on exertion.
Exp. Date 6/30/2021. Unable to lift my left arm higher than my shoulder, swelling of upper left arm, tiredness.
Patient received immunization around 11:57AM and during waiting period came up to the counter stating she did not feel well. She stated she felt "funny" and hot. I had the patient sit down and take some deep breaths and gave her water. She asked if she could have some diphenhydramine just as a precaution. I made sure her airways were clear with no signs of swelling and administered 10mls of liquid diphenhydramine 12.5MG/5ML. Patient sat around for additional 20 minutes and stated she felt fine and was ready to leave. I told her to report any other ADRs to the pharmacy and I will follow up with a call tomorrow
Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves three patients of unknown demographics who were vaccinated erroneously with a dose of FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that the three children received FLUZONE HIGH DOSE this past season by mistake. It was reported that the patients did not experience any side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Extensive bruising and redness near injection site. Red rash moving down injection arm. Recommended 50 mg BENADRYL every 4-5 h as needed.
Information has been received from a licensed visiting nurse concerning a 22 week old female who on 10-MAY-2007 and 15-AUG-2007 was vaccinated with the first and second dose of Rotateq. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
some diarrhea; feeling very weak; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (some diarrhea), ASTHENIA (feeling very weak), HEADACHE (headache) and FATIGUE (tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 33B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema and Breast cancer.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced DIARRHEA (some diarrhea), ASTHENIA (feeling very weak), HEADACHE (headache) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIARRHEA (some diarrhea), ASTHENIA (feeling very weak), HEADACHE (headache) and FATIGUE (tired) had resolved.
High and low temperature excursion; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. Information regarding patient's medical history, concomitant medication, drug allergies or reactions was not provided.  On 03-DEC-2020, the patient was vaccinated with a improperly stored  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T032003 expiration date 08-MAY-2022, 0.5 milliliter for prophylaxis (administration route and dose number were not provided). The vaccine suffer a high and low temperature excursion one day previous administration , to a temperature above 47 Fahrenheit degree for a time frame of 85 hours, no digital data logger was involved, and none previous temperature excursion was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T032003; expirationdate: 08-MAY-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2012USA002405:
More than 35 days since the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 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 PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
12/31/2020 6 pm diarrhea resolved after 3 episodes. 1/12020 loss of smell and taste.
Shortly before 6 am, patient was found down by friends convulsing. Seizure reported to last nearly 6 minutes from time she was found down, patient unable to respond for an additional 3 minutes after convulsions stopped. Upper lip cut, unsure if bit or related to fall. Patient was taken to ER via ambulance for tests, observation, and discharged on seizure medication, driving privileges revoked.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient received an expired Menactra vaccine; Initial information received on 01-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U5866BC and Exp. Date 22-May-2019) via unknown route in unknown administration site on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Constant mild to severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 17:00 (Lot number: FK5127) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 02Dec2021 22:00, outcome "recovered" (Dec2021), described as "Constant mild to severe headache". The event "constant mild to severe headache" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional information: List of any other medications the patient received within 2 weeks of vaccination: Multivitamin- Fluoride 1mg Tab Chewable. Constant mild to severe headache lasting nearly three weeks, starting the night of the injection. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date was on 30Dec2021. Treatment medication included Tylenol or motrin every six hours.
during injection she had pain in left side of neck. about 1 hours after, she developed blurry vision in left eye and numbness to left jaw and cheek area. took 50mg benadryl and used ice pack. in the morning she noticed swollen left side of face and continued numbness, tingling, which includes some near her eye. some flushed skin to area. Denies facial paralysis or weakness. Her eye no longer has blurry vision.
10 days after my vaccine, I started off with a small blister on my left pinky finger and was very itchy. 11 th day woke up ,having more blisters and hives like rash . on palms and top of hands, bottom and  top of feet. elbow. No  pain extremly itchy .No fevers. Notified employee health and screened if needing Covid test/ was denied because I had no other symptoms. seen by PCP, want really sure what was going on thinking a reaction to the vaccine or some kind of  exzema. , did order triamincolone to areas.   12th day post: blisters worse a at nail beds  and turning a deep red / purple color.again no fever and or pain. severe prutitis. rash now on outer bilateral hips ,abd and 3  on outer naries. None noted on moist mucosa or geniteal/ Called PCP again due to worsening and management.ordered Predisone 40 mg  times 4 doses, along with benedryl 50 mg q 6 hrs. and was  seen on day  13 with derm clinic seen by 3 other dermatologist, Have not seen this rash. feel pcovid vaccine reaction
started during dinner, 6pm, hands and feet cold, chills continued and increasingly worse, shaking, muscle spasms, headache, temp 103, vomited, ache muscles. Tylenol had no notable affect. Next day 3/8/21 chills subsided, groggy, headache #7 on pain scale with light sensitivity. Tylenol little affect. A metal taste in my mouth, food didn't taste right. Next day 3/9/21 felt much better. Please note I had hydrated well previous to getting the vaccine.
Woke this morning to redness, slight swelling, warmth to the touch at the injection site; area is about 2" in diameter. Had no similar symptoms prior to this morning. No pain or itching or irritation. No additional side effects at this time.
This spontaneous report was received from a 64 year old male patient regarding himself. Patient never had chickenpox and had no allergies nor drug reactions. On an unknown date in September 2014 (reported as 1st or 2nd week of September), the patient was vaccinated with ZOSTAVAX, 1 single shot, subcutaneous for prevention of shingles (lot number and expiration date were not reported). Concomitant therapies included CELEBREX and unspecified blood pressure and thyroid medications. On an unknown date in September 2014 (reported as within 2 weeks), the patient felt as though as he was on fire (the feeling of being on fire started on the back of the patient's legs), patient became allergic to many foods like milk, developed nerve damage, rash, hives and blisters. Multiple blood test and lung rays were performed (result not provided). The outcome of nerve damage, became allergic to many foods like milk, felt as though I was on fire, rash, hives and blisters was reported as not recovered. Additional information has been requested.
About 25 minutes after receiving vaccine patient said she had ringing in the ears. She said she has had before but this seemed louder/ higher pitched then before. Patient felt okay otherwise and decided to go some after another 10 minutes. She was informed to follow up with her doctor if it does not go away or gets worse.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4380091-00.  A 24-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2020 as dose 1, single (Batch/Lot number: unknown), on 02Apr2020 as dose 2, single (Batch/Lot number: unknown) and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Lightheadedness/ Felt Faint Required prolonged observation  Supplemental oxygen administered
Chills, mild fever, body aches, headache starting 4/23 9 p.m. ending 4/24 around 12 p.m.;  Moderate vertigo:  one episode a.m. of 4/25, another episode lasting longer, p.m. of 4/25. I have a history of vertigo unknown cause. Went away around 1 a.m. 4/26 after small dose of Dramamine.
First I had strong metallic taste on tongue which lasted about an hour. Then I got a very runny and raw nose. Today 9/8/10 Very runny nose, itchy runny eyes, tired and about 2:00PM started to get a sore throat my teeth also hurt. Just feel sick like a bad cold or allergies with a sore throat.
This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 6th July 2018 12:00, the patient received the 2nd dose of SHINGRIX .5 ml. On 6th July 2018, less than a day after receiving SHINGRIX, the patient experienced sleepiness. On 7th July 2018, the patient experienced difficulty thinking (serious criteria GSK medically significant), diarrhea, muscle pain, mental status changes and activities of daily living impaired. On an unknown date, the patient experienced balance difficulty. On an unknown date, the outcome of the difficulty thinking, sleepiness, diarrhea, balance difficulty, muscle pain, mental status changes and activities of daily living impaired were unknown. The reporter considered the difficulty thinking, diarrhea, balance difficulty, mental status changes and activities of daily living impaired to be possibly related to SHINGRIX. The reporter considered the sleepiness and muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 67 or 68 years. The patient received SHINGRIX in left arm. The patient had substantial muscle aches throughout his body. On 7th July 2018, he patient did not feel safe to drive. He would be emailing his experience to Centers for Disease Control and Prevention (CDC), the pharmacy and to GlaxoSmithKline. This case was linked with the case US2018127820, reported for the same patient.
Patient had Pfizer COVID-19 vaccine for Dose # 1, and Moderna COVID-19 vaccine was adm as Dose # 2 today.  Patient did not have vaccine card with her and told nurse she had received Moderna for dose #1.   Verification in system showed patient had in fact received Pfizer for dose # 1 at another clinic but nurse had already adm the Moderna
Started getting a weird headache 3 - 4 days after the second shot - the headache is different - its almost like I hit my head hard. It gets better and then it comes back. I still have it today - 6/2/2021  I got a very slight version of this headache after my first shot but didn't realize it was from the vaccine. I haven't called my doctor yet but will do now.
Came to ER next day (8-24-16), per that documentation: 'Chief Complaint: Left arm pain, swelling, redness. History of Present Illness: A 71-year-old male who got the pneumonia shot yesterday at the primary care office, started last night with left arm pain, swelling and redness. Pain level 9/10. No fever. Patient states there has been improvement in the swelling from yesterday.' Given KENALOG IM 40mg once, and discharged with diphenhydramine, methylprednisolone dosepak, clindamycin. Symptoms: and erythema, injection site pain, swelling. Treatment: diphenhydramine 25 mg PRN, methylprednisolone as instructed on card, clindamycin 300 mg QID.
stated her arm hurt the evening of getting her shot, then on 1-30-21 she noticed a red flat rash  approx 4-5 inches long and approx 1-1.25 wide on the front of her bicep muscle, and  was warm to touch.  On 1-31-21 it was warm to touch and a little tender but itched like fire.  Called her on 2-3-21 stated no itching, not red, warm or even sore.  Totally resolved.
24MAR97 lt upper arm became red-hard black & blue on 24MAR97;no fever uses arm OK;no problem all this day;pt had been wrestling on Sunday;referred to MD 26MAR97;saw MD local rxn;pt OK now;
COVID 19; COVID 19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (15Sep2022) Positive, notes: Rebound 5 days after finishing Paxlovid Return of symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
after administering vaccine patient started to vomit and drop in his pulse, dizzy and bit shakier.  after observation called 911 and paramedic came and after checking everything falls within normal limits and patient went home.
had a heart attack 5 days after taking the Pfizer COVID-19 vaccine; This is a spontaneous report received from a non-contactable consumer from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "had a heart attack 5 days after taking the Pfizer COVID-19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Initial Swelling and redness at the site of injection.  This was felt to be due to poor technique.  It resolved within a week.  Shortly after, I began having intermittent symptoms of an erythematous intermittent rash, intermittent breathing difficulties and tachycardia.  The symptoms occur randomly throughout the week and have been unrelenting since the injection and have been happening for over 3 months.  In addition to the erythematous pruritic rash, I also have developed a rash which occurs with manual contact.  A dermatographic type rash.    I have tried controlling the rash with a 2 week course of steroids and daily antihistamines.   I have used topical steroids to easy the pain and itchyiess of the rash.  But it won't go away.  The respiratory issues and tachycardia are somewhat concerning, particularly when it awakes me at night.  As a physician, this could have been avoided if people would have just understood natural immunity.  If the government hadn't mandated this and the army hadn't mandated this, my life would have been better.  Now I feel I have a debilitating illness that was avoided and no one is accountable.
The pt developed fever of 102-103 deg. F, myalgia, and headache. Within a few weeks, hand and joint pain started. The pt was diagnosed with rheumatoid arthritis on 04/02.
pt recvd vax & about 4-6 hrs after vax; pt screamed suddenly for 1-2 min then became pale & limp & unresponsive; pt was apneic for < 1 min but remained pale & limp for 1 hur; no tx given; home on apnea monitor;