chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hurt in his arm; The hair is falling out on the arm; He doesn't feel like his arm is normal; Before the skin was soft and thin/ it feels thick and rough only on the arm; They are red dots and there is some yellow in the middle; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0158), dose 2 via an unspecified route of administration on 09May2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had the reaction from the first vaccination. He had the first vaccination on 18Apr2021 and the second vaccine was on 09May2021. He had a lot of little dots. They are not pimples. They are dots on the whole arm. They are red dots and there is some yellow in the middle. He mentioned it to the person that gave him the second injection and they said it was normal. He wanted to mention that. He has hurt in his arm and the hair is falling out on the arm. He doesn't feel like his arm is normal. He doesn't feel it as before. Before the skin was soft and thin. Now when he feels it, it feels thick and rough only on the arm. He had the reaction on the first day he had the vaccination. HCP Information: He doesn't have any doctor. He would love anyone to see his arms. He doesn't have medical. Dots on the whole arm: They are going away. Some of them are going away. They are appearing again. He would not say that it has been worse or improving. For example, he can feel a new one there that was going away. They are just coming and going. They appear and disappear. He can feel that his skin is rough and thick. It is not like the arm looks horrible, but it is not either worse or improving. It is both arms.
about 1-1 1/2hrs p/vax pt began high pitched crying which lasted about 4 1/2hrs;no fever;
BIVALENT PFIZER VACCINE INCORRECTLY ADMINISTERED FOR THE  COMPLETION OF THE PRIMARY SERIES; PATIENT SHOULD HAVE RECEIVED A PFIZER MONOVALENT VACCINE AS THE SECOND DOSE TO COMPLETE THE PRIMARY SERIES AND NOT THE BIVALENT PRODUCT.  CALLED AND LEFT A VOICE MESSAGE TO HAVE PATIENT'S PARENT / GUARDIAN RETURN MY CALL.
pt recv vax 9AM & 2PM dec appetite, fatigue, aches, slept 2PM-6Pm-T101 mom rx APAP-n/v;8MAR no complaints-played sports;
Pt. mom reported called 2/8/12 daughter had received HPV4 (3rd dose) and Depo-provera inj (first time receiving) on 2/7/12. Stated pt had lethargy, dizziness, and heart palpitations.  States no previous reaction with prior HPV4 shots.  Advised to call PCP. On 2/15/12 pt mom called back stated daughter had 102*F temp. Stated gave pt ibuprof. 800mg. and pt was feeling better.
Pt woke at approximately 8:30am (8-17-12) with headache, vomiting, dizziness & temp. 105.2.
BP at (+245/+105); Tremors; High heartbeat; Slurred words; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing), notes: Prior to the vac, an episode lasted approx. 20 minutes up to an hour. Concomitant medication(s) included: METOPROLOL SUCCINATE. The following information was reported: HYPERTENSION (medically significant) with onset Jun2021, outcome "recovered" (2021), described as "BP at (+245/+105)"; TREMOR (non-serious) with onset Jun2021, outcome "unknown", described as "Tremors"; HEART RATE INCREASED (non-serious) with onset Jun2021, outcome "unknown", described as "High heartbeat"; DYSARTHRIA (non-serious) with onset Jun2021, outcome "unknown", described as "Slurred words". Patient questioned can Metoprolol Succ. ER (taken 2 hrs prior to vaccine) cause a bad interaction with the Covid vac. Pfizer had my report, last year. Pfizer Vac: 29Jun2021: 1st dose. Within moments of vac, Side Effect included BP at (+245/+105), tremors, high heartbeat, slurred words. EMT was called. Patient decided no hospital. Effects lasted Months after the vac: each High BP episode lasted up to 2-4 hours. Prior to the vac, an episode lasted approx. 20 minutes up to an hour. Doctors, etc. said not to take additional vaccines. The patient underwent the following laboratory tests and procedures: BP: (Jun2021) +245/+105; (Jun2021) high; Heartbeat: (Jun2021) high.  The lot number for bnt162b2 was not provided and will be requested during follow up.
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The reporter's mother and sister (patient) got the shot (Pfizer) a week and half before reporter. /15 family members went to a graduation party and wedding and all 15 got COVID and all but 3 had vaccinations and she couldn't imagine what would be like. A couple family members got COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
9/20/2021: Sudden onset of rapid heart rate in excess of 135 bpm lasting over 24 hours. Hospitalized for four days, received a cardio version on day three which put heart rate back to normal.  Diagnosed as atrial fibrillation.  10/29/2021: Sudden onset of rapid heart rate in excess of 135 bpm lasting over 24 hours. Visited emergency room, where a cardio version was successfully performed. 12/3/2021: Sudden onset of rapid heart rate in excess of 135 bpm lasting over 24 hours. Visited emergency room, where a cardio version was successfully performed. 1/17/2022: Sudden onset of rapid heart rate in excess of 135 bpm lasting over 24 hours. Office visit with electrophysiologist.   Put on high dose medication (Diltiazem) and schedule for a catheter ablation.
Information has been received from a medical assistant referring to a 6 year old male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 15-AUG-2017, the patient inadvertently received an expired vaccination of M-M-R II (lot# L030161, expiration date 11-AUG-2017, dose was unknown) intramuscularly for prophylaxis (incorrect route of drug administration). No adverse effects were reported.
Bloody, mucousy loose stools began 1-11-12. Received vaccinations on 1-10-12.
What is unusual is the dizziness that started last night 12/1 around 9 PM ET.  As of this morning at 6 AM ET on 12/2, I still have dizziness which has me concerned. We will continue to monitor the situation for 24 hours before we seek professional medical assistance. I have no history of low pressure and have no medical history of dizziness or vertigo.  The  side effects that started immediately after the booster dose were consistent with what was provided in fact sheets. On the early morning hours of 11/30 around 1:30 AM EST, I had severe chills and the next day had chills and fever. Managed through this process with Acetaminophen for a day (11/30) and rest the next (12/1).  I?m creating this report for the events in the last 9 hours where I have been feeling dizzy.
Site (L) red - hard - sore - hot - (headaches). Went from 1 1/2 to 2 in to 3" x 5" till I went on Keflex.
pt recv vax;had chills p/ inject;felt tired p/ walking home fr school;T 102.4;HA;apap given; no oth tx;
Swelling under left arm; fever of 100.5; chills; fatigue; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0169) via an unspecified route of administration in the left arm on 01May2021 at 10:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and borderline high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613) via an unspecified route of administration in the left arm on 03Apr2021 at 16:15 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. On 02May2021, the patient experienced swelling under left arm, fever of 100.5 (unspecified units), chills and fatigue. On 02May2021, the patient underwent lab tests and procedures which included body temperature and the fever was 100.5. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events swelling under left arm, fever of 100.5 (unspecified units), chills and fatigue was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
5/4/19 Developed visual disturbance "my eyes don't seem to be working together when I turn my head", while visiting out of state.  Became progressively worse over the next several days ending with double vision in the distance when looking straight ahead and upon turning head to right or left; near and far away.   Upon return to home, on 5/9/19, saw ophthalmologist who diagnosed VII nerve palsy of unknown origin.  Recommended lab work and possible MRI/MRA to Primary Care Physician.  On 5/10/19, diplopia was present near and far regardless of head position.  Seen in PCP office and referred to local emergency room.  As of 5/17/19, vision looking forward is clear; doubles as the day progresses; vision to right and left are double, but overall seem to be improving.  Referred to neuro-ophthalmologist and neurologist, who does not have an available appointment until October.  Has follow up with Ophthalmologist on 5/24/19.  Followed up with PCP on 5/15/19.
scabies; Itching, both hands, legs, thighs, back and head; This case was reported by a consumer via call center representative and described the occurrence of scabies in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unspecified date).   In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a month after receiving Shingrix, the patient experienced scabies and pruritus. On an unknown date, the outcome of the scabies and pruritus were recovering/resolving.   It was unknown if the reporter considered the scabies and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Apr-2022 Reporter's comments: This case was reported by the patient. She received her second dose of Shingrix early in the year. Exact date was unknown. After receiving Shingrix, starting in the last 2 weeks of January, she experienced itching in both hands. The patient also experienced itching on her legs, thighs, back and back of her head. The patient had gone to her doctor where she was diagnosed with scabies. She was also referred to a dermatologist. The patient reported that by 8th April 2022 itching has gotten better but has not fully resolved. The consent to follow up was given.
Severe malaise, muscle pain, headache, nausea and local pain, swelling and itching at injection site lasting 7 days.
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19
dizzy; red spot underneath the shot mark; nausea; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), DIZZINESS (dizzy), RASH MACULAR (red spot underneath the shot mark) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and VITAMINS NOS for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (dizzy), RASH MACULAR (red spot underneath the shot mark) and NAUSEA (nausea). In February 2021, the patient experienced HYPERSENSITIVITY (allergic reaction). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergic reaction), DIZZINESS (dizzy), RASH MACULAR (red spot underneath the shot mark) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient suffered a syncopal episode and confusion while under observation following her booster vaccination. Patient has a history of diabetic related emergencies but this syncope/confusion resolved itself while under the care of on site paramedics. Patient was transported to a hospital of her choosing.
Large (approx 7 inches) area of circumferential edema, erythema, and arm discomfort just below where IM was given. Remained like that until 11/08/2010, then slowly decreased until it was resolved by 11/16/2010.  Treatment was ice packs to arm, Tylenol and ibuprofen for comfort.
9/28 1130: Influenza vaccine administered. 1430-1530: Eyes began to itch. Developed body aches/pain, warmth at injection site, hives (raised, reddened areas) on neck and torso. Had fever and chills during night. 09/29 0700: Awoke with facial edema (eyes, cheeks), body aches/ pains, hives. Took BENADRYL. 09/30 Nausea/vomiting, vertigo throughout day. Improved in evening.
Left side of face from cheekbone to chin feeling like novacane  wearing off - warm, tingly, slightly numb.
Patient was given medication Sub-Q instead of Intramuscularly. Patient stated she had a localized reaction at the site of injection that included a small erythema patch and rash. Patient stated that she had no systemic reaction to this injection.
Extreme side effects for 4.5 days - fever, chills, debilitating headache, nausea, vomiting, sore throat. All expected symptoms but very, very extreme levels and lasted much longer than the 24-48 hours others experience.
Pt. at clinic received HPV, MENACTRA, Hep A, Tdap - observed pt. 15 min. after vaccinations. Pt. later reported she couldn't quite hear several hours later at softball practice noted lips swollen (unsure if biting on lip or not). The next morning pt. woke with puffy eyes. Mother reported no respiratory difficulty. Gave BENADRYL with relief.
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Modern a COVID-19 vaccine EUA  Rash all over body from head to toe  Started that night around 7 pm ( I got shot at 1:50 pm)  Rash spreading to leg and then head  It?s very itchy , No fever,
From about 10 at night the day after I received the vaccine to around 5 in the morning, I had a fever of 100.1, chills, and a headache. My arm has been sore since the vaccination but that was expected.
First symptom onset 2-7-2011 @ 7 PM ,described as pain/pressure like sensation located at right retroauricular area ,accompanied with eye irritation .  On Feb 8th presented  one episode of drip/leakage of water out of his mouth while drinking .Eye irritation increased . On Feb 9th consulted @  2 PM with right sided facial droop ,  smile with left deviation  , no closing of right  eye , no whistling , no frowning , no lacrimation
Received 1 year vaccines on 9/21/07.  That night with fever to 102.  9/22/07 with vomiting and low appetite and slight fever (-100).  Vomiting through 9/25, no diarrhea.  Fussy and not acting herself.  9/26 generalized macular/papular rash.
Information has been received from a physician concerning a female 20 years of age or younger with no pertinent medical history who was vaccinated with Gardasil.  There was no concomitant medication.  Subsequently the patient experienced influenza-like symptoms (headache, some nausea, vomiting and myalgia) within 24 hours of receiving her first dose of Gardasil.  The patient possibly had a CPK level that was mildly elevated (values not reported).  The patient was possibly examined in the emergency room but was not admitted.  Subsequently, the patient's symptoms resolved within one to four days.  Unspecified medical attention was sought.  Patient Quality Complaints (PQC) was not involved.  This is one of several reports received from the same source.  Additional information has been requested.
It actually causes spread.My left leg clotted up; Sicker; I will never be able to walk far again in my life because I am vaccinated with Moderna; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (It actually causes spread.My left leg clotted up) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (It actually causes spread.My left leg clotted up) (seriousness criterion medically significant), ILLNESS (Sicker) and WALKING DISABILITY (I will never be able to walk far again in my life because I am vaccinated with Moderna). At the time of the report, THROMBOSIS (It actually causes spread.My left leg clotted up), ILLNESS (Sicker) and WALKING DISABILITY (I will never be able to walk far again in my life because I am vaccinated with Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) unexpected event Leg thrombosis, that occurred on an unknown date after an unspecified dose of mRNA-1273.  It was reported that "my left leg clotted up" and "I will never be able to walk far again in my entire life". Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. Further information is not expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medication were reported.  Patient reported that this is not a vaccine it is a poison.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) unexpected event Leg thrombosis, that occurred on an unknown date after an unspecified dose of mRNA-1273.  It was reported that "my left leg clotted up" and "I will never be able to walk far again in my entire life". Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. Further information is not expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182807 same patient, different product and event;
Fever Tmax 101.6, diffuse body aches, frontal headache, fatigue, malaise; lasted for ~4 hours, until I took 650mg acetaminohen x2; then symptoms improved and continued to improve throughout the rest of the day. In the evening hours, symptoms were pretty much gone. I took 650mg acetaminohen x2 again. On the following day after onset of symptoms, no symptoms were noted. Symptoms, in my opinion, were out of proportion to what has been described as average in the literature and what seem to be the common side effects of peers who have received the same vaccine.