chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first time I felt uncomfortable on my chest, arm, hands, feet, legs ,and my back it was on May 24th 2021. We went to the ER, at first I thought I was having another heart attack but that was not what was found. They were really not sure what was going on but the Dr. knew it wasn?t a heart attack. I was released to be referred to a GI Dr. but that appointment was not to happen until September 8th. But in the month of June, July, August and until now, I?ve had many episodes that?s been waking me up in the middle of the night. At first it was only happening at night, but the last month it has happen first thing in the morning when I first wake up.  It?s really hard to explain the exact feeling I have and I?m really not sure if this is actually an adverse reaction to the vaccine or it has something to do with my gastric. I?m getting tests done between now and the end of October that my GI has scheduled for me. I just wanted to know if there has been any report to this same reaction that I am having. It has been a complete nightmare and very frustrating. I know there is something wrong with me I just don?t know what it is. I?m just hoping I can get some answers.
Period start with some bloody spot; Mild headache.; This is a spontaneous report received from a non-contactable Healthcare Professional. A 55-year-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6204; Dose number: 1st dose), via an unspecified route of administration on her left arm on 11Mar2021 at 16:00 (at the age of 55-year-old) as a single dose for COVID-19 immunization. The Patient's Medical history was not reported. Concomitant medications included Multi-vitamin (Indication - unknown, manufacturer unknown), Calcium (Indication - unknown, manufacturer unknown) from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021, two days after the vaccine the patient experienced period with some bloody spot and mild headache. It was reported that patient did not have period for more than 1 year. The clinical outcomes of the event were period with some bloody spot and mild headache were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
On 9/07, he felt tired and foggy, then woke up on 9/08 with double vision and blurry vision, as well as a new rash at the R flank (described as dark red dots, flat, non-pruritic, non-painful), as well as cognitive fogging. This worsened so he presented to ED on 9/09 for further evaluation. No fevers, abd pain, vomiting, diarrhea, dysuria, headache, focal weakness noted then (did have some nausea, attributed to visual disturbances). He was sent from one ED to another ED for MRI; exam at that time noted horizontal binocular diplopia, perhaps worse when looking at right side, thought suggestive of peripheral vs central deficit. He obtained CTA H/N and MRI which were largely unrevealing except for asymmetric L cerebral peduncle increased T2/FLAIR signal without enhancement. He was discharged with outpt follow up -- he noted that he spent the next few days sleeping a lot, but the diplopia went away after 2-3d, the remainder of symptoms also gradually improved, and the rash dissipated. By the time he saw hospital Neurology on 9/22, he felt he was at his baseline. Neurologic exam at that time was wnl. Overall, Neuro felt the MRI findings were nonspecific especially given lack of enhancement, so could monitor with repeat MRI in 3mos. Unclear cause of his symptoms, which did not clearly correlate with the MRI findings -- likely a peripheral nerve issue, perhaps temporary viral paralysis of a cranial nerve. No recurrence of symptoms as of 9/29.
Pt got mono-valent Pfizer booster instead of Bivalent Booster
Began approx 36 hours after injection.  Extreme chills, threw up > 5 X, Lip Swelled, eyes (1 more than the other).  Did not take a hydrocodone this day.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was unresponsive for 10 seconds then after she became responsive should couldn't remember today's date or where she was for about 30 seconds. Then she was ok. Talkative and could answer all of my questions perfectly. She was very sweaty and thirsty. Patient drank 2 bottles of water and was monitored for 30minutes before she was allowed to leave the store.
2 to 3 days after the patient received her vaccine, she developed a rash on her chest and limbs. The rash was red, and itchy. No respiratory sickness. Localized slowly resolving rash.
ELEVATED BLOOD PRESSURE; SEVERE HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced severe headache. On 10-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced elevated blood pressure. Laboratory data included: On 12/Apr/2021, computerized tomography scan was done to rule out blood clots. computerized tomography scan (CT scan) (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, elevated blood pressure, and fatigue. This report was non-serious.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), on 24Mar2021 at 12:00 as dose 1, single (Lot number: ER8733), in left arm, on 14Apr2021 at 12:00 as dose 2, single (Lot number: ER8735), in left arm and on 14Dec2021 as dose 3 (booster), single (Lot number: Foo809) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "mild emphysema" (unspecified if ongoing); "pelvic neuritis" (unspecified if ongoing); "Known allergies : Shellfish" (unspecified if ongoing); "Known allergies : Bee sting" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies : Aspirin"; Iodine, reaction(s): "known allergies : Iodine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: COVID 19 Treatment; (15Aug2022) Negative, notes: Tested negative; (18Aug2022) Negative, notes: Tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given COVID 19 Treatment (brand: Pfizer, lot number: GD8771) from 07Aug2022 to 12Aug2022; symptoms resolved by end of treatment, tested negative on 15Aug. 16Aug nasal congestion and cough started to return. Cough worsened on 17Aug. Still testing negative on 18Aug. Primary care doc prescribed prednisone for 10 days as cough and wheezing worsened.
I have a brain injury; I had a Covid Booster yesterday and shortly after, I had numbness in my head; my lips were tingling; I have been dizzy, after a couple of hours it went away but I still feel dizzy.; I couldn't like move my eyes and the right side; I can't understand accents; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose number unknown (booster), single (Lot number: GH9703) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: BRAIN INJURY (medically significant), outcome "unknown", described as "I have a brain injury"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "I had a Covid Booster yesterday and shortly after, I had numbness in my head"; PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "my lips were tingling"; DIZZINESS (non-serious), outcome "unknown", described as "I have been dizzy, after a couple of hours it went away but I still feel dizzy."; EYE MOVEMENT DISORDER (non-serious), outcome "unknown", described as "I couldn't like move my eyes and the right side"; AUDITORY DISORDER (non-serious), outcome "unknown", described as "I can't understand accents".   Clinical course: Concern: Consumer stated, "I can't understand anything. Is there somebody that I could talk to that I can understand better? I can't understand you." Consumer stated, "I had a Covid Booster (Clarified as: Pfizer Covid-19 Vaccine) yesterday and shortly after, I had numbness in my head and my lips were tingling, they weren't swollen but they were tingling and it went away. I have been dizzy, after a couple of hours it went away but I still feel dizzy. I am reporting that, after I had the vaccine, I had numbness in my head. I couldn't like move my eyes and the right side, the side that, I had the vaccine (Pfizer Covid-19 Vaccine) on. That's all." Consumer was informed about the role of Pfizer drug safety and when probed to proceed with the questions: Consumer stated, "I have a brain injury and I can't understand accents, So, I heard part of that but I don't, you said is that okay, I don't know what you are asking about? I do not know what you said after file a safety report, after that I don't get what you said, 8 to 10 more minutes? Is that what you said? For what? You have an accent, I am not understanding anything what you are saying. I would rather have somebody call me tomorrow or later." When probed for the Expiration date of Pfizer Covid-19 Vaccine: Consumer stated, "No." Further probing could not be done as consumer was unwilling to complete the report Hence, Limited information was available over the call.  No follow-up attempts are possible. No further information is expected.
Itching; Red rash in upper body; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash in upper body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001176) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash in upper body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash in upper body) outcome was unknown. Not Provided      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.
Pt recvd 1st dose of Engerix-B & devel diarrhea, vomiting, upset stomach, soreness all over & t103; events began p/24 hrs & became more severe p/3 days; pt severely ill w/n/v/d;
An improperly stored dose of GARDASIL9 was administered to the patient on an unknown date; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N022952 with expiration date 14-JUN-2020, dose detail and route were not reported) for prophylaxis.  The vaccine experienced improperly stored and was stored below 36 Fahrenheit degrees (F) and was stored at 32.1 F for 8 hours. There was no previous temperature excursion. The call was because of a data logger involved. No adverse effects were reported.
the spot where they gave the shot was sore like it was with the 1st dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Aug2021 11:20 (Lot number: EW0168) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Pertinent Details: Take a 12.5 mg tablet of Hydrochlorothiazide Daily.; "Cholesterol" (ongoing), notes: Pertinent Details: Take a 40 mg tablet of Pravastatin Daily. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LOSARTAN; PRAVASTATIN; VITAMIN D NOS. Vaccination history included: Flu shot, for Vaccination site pain; Flu shot, for Appetite lost; Flu shot, for Woozy. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the spot where they gave the shot was sore like it was with the 1st dose".  Additional information: The spot where they gave the shot was sore like it was with the 1st dose but she was feeling ok. Caller stated she had nothing like this with the 1st her arm was sore the next day and she did not walk anywhere. Patient had no prior vaccinations (within 4 weeks). Relevant Tests: None. Vaccine administered at a facility: No. Vaccination facility type: Other. No test were given for adverse effect experienced after receiving second Covid-19 vaccine. Patient took a 25 mg tablet of Losartan Daily. Patient took blood pressure medication, cholesterol medication and over the counter Vitamin D. Investigation Assessment: No.  No follow-up attempts are possible. No further information is expected.
Stroke; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a stroke.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 Mar 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On 16 Mar 2021, approximately 8 days after vaccination, the patient experienced a stroke. The event is life-threatening.     Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event a stroke was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
A report was received from a health care professional on 12/15/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin vaccine on 12/13/03. On 12/13/03, the vaccinee was administered Fluvirin. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 2/23/04: Further information was received from a health care professional indicating that the mother of the vaccinee stated that the vaccinee had no adverse reaction or side effects. No follow up pending. All information received.
red marks on body; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received Shingrix. On 8th September 2021, 7 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's niece.   The age at vaccination was not reported. The reporter reported that the patient got the Shingrix vaccine and a week later developed red marks on her body. The patient was still experiencing these red marks. It was unknown if this was the first or second dose. The reporter did not consent to follow up. There was no additional information known about this report.
Pt was in rehab unit recovering from a tibial plateau fracture.  Was exposed to COVID and found to be COVID positive.   Found to be mildly encephalopathic.
Headache; Left arm pain; Back pain; Vaginal pain; Hot flashes; Lack of appetite; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse, allergy to nuts (tree nuts), allergy (poppy seeds) and sulfonamide allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) taken for unknown indication on unknown date and unknown if ongoing. The patient previously took cefdinir (OMNICEF) and tobramycin (TOBREX); both on unknown dates for unspecified indications and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 09:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. On 23Apr2021 at 05:30, the patient experienced headache, left arm pain, back pain, vaginal pain, hot flashes and lack of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with Tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, left arm pain, back pain, vaginal pain, hot flashes and lack of appetite were resolved on 23Apr2021.    No follow-up attempts are possible. No further information is expected.
Broke out in an itchy rash that produced hives across the chest and travelling up the throat externally. Administered oral benadryl 50mg as one dose.
Greetings, I am a long time (many years) blood donor, the donor organization here in my state, routinely tests my donated blood. My donation was rejected in the past few months due to a positive syphilis test and I had another sample taken recently to confirm if that test was positive. It also came back positive. I have donated for years and have not had a positive syphilis test in the past, but I did recently have the three shot regimen of Modena's COVID vaccines. I looked at the internet and found that the you have recently sent an advisory about a cross reaction between the COVID vaccine and an PRP syphilis test. I believe that this may also occur with the test under my blood (syphilis treponemal antibody test (MHA-TP). I was negative for the Captia syphilis G EIA. I thought you should be aware of this issue and may want to investigate. Blood donor organizations may be turning away acceptable donors due to cross-reactivity in the syphilis tests. If you would like more information or would like to discuss this more, feel free to contact me. All the best.
pain from her neck to her arm; unable to sleep; feels down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain from her neck to her arm), SLEEP DISORDER (unable to sleep) and DEPRESSED MOOD (feels down) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0136204) for COVID-19 vaccination.     Concomitant products included THYROID, MULTIVITAMINS, PLAIN and FOLIC ACID for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (pain from her neck to her arm), SLEEP DISORDER (unable to sleep) and DEPRESSED MOOD (feels down). At the time of the report, PAIN (pain from her neck to her arm), SLEEP DISORDER (unable to sleep) and DEPRESSED MOOD (feels down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Case number PHEH2013US006920 is an initial spontaneous report received from a nurse on 21 Mar 2013 and a follow up report from the nurse received on 23 Apr 2013. This case refers to a 18-year-old male patient. Concomitant vaccinations included Oral Typhoid (batch number: 3000326), Hepatitis B (batch number: AHBVC142AA) and influenza vaccine (batch number: U4545EF) on 21 Mar 2013. On the same date, he was vaccinated with MENVEO (batch number: M12026) via subcutaneous route. No adverse event was reported following this maladministration. The nurse inquired whether to repeat the vaccine and due to information found on CDC general recommendations under non standard vaccine practices, the MENVEO vaccine was not repeated. No other information was available. Follow up report from a nurse received on 23 Apr 2013: The age of the patient was changed from 88 years to 18 years (deleted the event inappropriate age of vaccine administration). Concomitant vaccines were added and information from nurse related to the immunisation was updated.
Next evening pt. C/O warmth, redness at site, no fever. On 11/1/17, pt. was here in office. Site red and swollen, and warm to touch redness was 15 cm x 14 cm. Since then swelling has resolved.
Hurts; Swelling; Red patch; Bug bite; Itching; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching/pruritus, looked like a bug bite/arthropod bite, hurts/pain, feels like a bump inside/swelling, red patch/rash.  The patient's medical history included diabetes mellitus type-2, hip replacement. Concomitant medications reported were Metformin, Spironolactone, Lipitor, Micardis, Amoxicillin for drug use for unknown indication.  On 24 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the events itching/pruritus, looked like a bug bite/arthropod bite, hurts/pain, red patch/rash. On 4 Mar 2021, the patient experienced the event feels like a bump inside/swelling. Treatment details included Cortisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itching/pruritus, looked like a bug bite/arthropod bite, hurts/pain,feels like a bump inside/swelling, red patch/rash were considered not resolved.