chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fast heart beat; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 02Oct2023 as dose 1, single (Lot number: HG4628) at the age of 79 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "heart attack" (unspecified if ongoing); "breathing problems" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN; METOPROLOL; HYDROCHLOROTHIAZIDE; AMLODIPINE BESYLATE; ATORVASTATIN; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]; PROAIR [SALBUTAMOL SULFATE]. Vaccination history included: Moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset Oct2023, outcome "unknown"; HEART RATE INCREASED (non-serious) with onset Oct2023, outcome "unknown", described as "fast heart beat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, chest pain. Additional information: Patient received Comirnaty 2023-2024 vaccine yesterday (02Oct2023) in which she was experiencing a "fast heart beat and chest pain." Patient also provided that she had previously received a Moderna vaccine, however they were not on the same day. Patient stated she had the shot yesterday (02Oct2023) at the (withheld) and was reading that if she had a fast heart beat and chest pain, she should go to the emergency room. She was now asking what should happen to her and what to do.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
headache; cough; sneezing; difficulty lifting right arm; This is a spontaneous report from a contactable Consumer (Patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Right on 12Feb2021 15:00 as single dose for covid-19 immunization at Pharmacy. Medical history included hypertension, gastroesophageal reflux disease and neoplasm malignant from an unknown date and unknown if ongoing. Concomitant medications included fish oil, omeprazole, lisinopril, methenamine mandelate, methionine (G). On 13Feb2021 10:00, The patient experienced headache, cough, sneezing, difficulty lifting right arm. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.
I came down with COVID; I came down with COVID-asymptomatic; Dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 (Lot number: 30145BA) at the age of 56 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "generalized anxiety disorder" (unspecified if ongoing); "sulfa eye drops" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Reynaud's" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percoset, reaction(s): "Known allergies: percocet". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 07Mar2021, when the patient was 55 years old, for COVID-19 immunization; Flu. The following information was reported: IMMUNISATION (medically significant) with onset 02Oct2021, outcome "unknown", described as "Dose received 3"; VACCINATION FAILURE (medically significant) with onset 10Dec2021, outcome "recovering", described as "I came down with COVID"; COVID-19 (medically significant) with onset 10Dec2021, outcome "recovering", described as "I came down with COVID-asymptomatic". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   Clinical course: Patient did not tested covid prior vaccination. Patient tested positive for Covid post vaccination. It was reported that other vaccine received in 4 weeks was Flu.
Pt experienced dizziness/faintness and developed a rash under injection site 36 hours post vaccination. Pt may visit Dr to be evaluated if dizziness/faintness unresolved. Fasting bg was 126 the am of 7/20 and bp was unknown.
c/o dizziness leaned back in car & seized; eyes open, body shaking; event lasted 10-15 sec; no recurrence; no treatment; contact w/hosp ER:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, lot # L021610, expiry date 10-SEP-2016 (route, anatomical site of injection and frequency were not reported). Information regarding concomitant medications was not reported. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
LOW ELECTRICITY IN HEART/ FLARED AND KICKED INTO GEAR; WEIGHT GAIN; LOW OXYGEN LEVELS; LOW ENERGY LEVELS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid 19, and concurrent conditions included: arthritis, and pre-existing heart condition (15 years prior), and other pre-existing medical conditions included: The patient was health care professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number unknown, expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced low electricity in heart/ flared and kicked into gear, weight gain, low oxygen levels, and low energy levels. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low electricity in heart/ flared and kicked into gear, weight gain, low oxygen levels, and low energy levels. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Numbness, tingling, face hands, feet. Paralysis, face. Weakness, upper & lower extremities
Tingle in tongue immediately after receiving the second dose; Metallic taste in the mouth for about two weeks after receiving the second dose.; Sore arm for a couple of days; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the arm left on 20Mar2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient not had any relevant medical history. Concomitant medications included multivitamin (unspecified) and anxiety medication (unspecified), both are from unknown dates and for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201) via an unspecified route of administration in the arm left on 27Feb2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 20Mar2021 immediately after the vaccination, the patient experienced tingle in tongue, metallic taste in the mouth for about two weeks after receiving the second dose and sore arm for a couple of days. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events sore arm, tingle in tongue were recovered on an unknown date in 2021, while that of metallic taste in mouth was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
patient received expired Daptacel vaccine/ no AE; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143976 and 2019SA143962 (same reporter).  This case involves a 4 years old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, and family history were not provided.  Concomitant medications included IPOL and PROQUAD VACCINE.  On 21-May-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date 16-May-2019,  via intramuscular route in the left thigh.  It was an actual medication error due to expired vaccine used.  It was reported that patient received expired Daptacel vaccine.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Never got the 2nd shot; Chest pain/Felt that after the first 2 hours; Chest pressure; Thought it was heart burn; Back pain/Pain in the back too; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain/Felt that after the first 2 hours), CHEST DISCOMFORT (Chest pressure), DYSPEPSIA (Thought it was heart burn), BACK PAIN (Back pain/Pain in the back too) and PRODUCT DOSE OMISSION ISSUE (Never got the 2nd shot) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included AFib (For 5 years).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced CHEST PAIN (Chest pain/Felt that after the first 2 hours) and CHEST DISCOMFORT (Chest pressure). 17-Feb-2021, the patient experienced DYSPEPSIA (Thought it was heart burn) and BACK PAIN (Back pain/Pain in the back too). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never got the 2nd shot). On 17-Feb-2021, CHEST PAIN (Chest pain/Felt that after the first 2 hours), CHEST DISCOMFORT (Chest pressure), DYSPEPSIA (Thought it was heart burn) and BACK PAIN (Back pain/Pain in the back too) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never got the 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated he is taking lot of concomitant medications but not reported. No treatment medications were reported.  It was reported that the patient laid down and took a nap after experiencing events and the events went away and it did not last longer.
temperature was higher yesterday; he was very sick also; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY), administration date 13Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization; Bnt162b2 (Second Dose), for Covid-19 Immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 13Jan2022, outcome "unknown", described as "temperature was higher yesterday"; ILLNESS (non-serious) with onset 13Jan2022, outcome "unknown", described as "he was very sick also". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller reported that she and her husband had the first two Pfizer Covid vaccines and they were fine. They got the Pfizer booster dose yesterday and they had severe reactions that were terrible and they still had some residual left today. She was shocked after receiving it because the first two were fine. She stated her husband's temperature was higher yesterday and he was very sick also.  The lot number for bnt162b2 was not provided and will be requested during follow up.
5 days gradual onset partial symmetric numbness starting in both feet gradually ascending to knees, also hypersensitive painful skin paresthesias to abdomen and lower back, but normal sensation to thighs, chest, upper back, and arms except slight numbness right upper arm medial aspect, normal reflexes arms and legs, normal strength and gait, normal speech and swallowing, no shortness of breath, no headache or neck/back pain.
Headache, Myalgia, Arthralgia,  Chills Narrative:
Shortness of breath; fatigue; had reaction to vaccine; decided not to get the second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), FATIGUE (fatigue), VACCINATION COMPLICATION (had reaction to vaccine) and INTENTIONAL PRODUCT USE ISSUE (decided not to get the second vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Heart murmur.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), FATIGUE (fatigue), VACCINATION COMPLICATION (had reaction to vaccine) and INTENTIONAL PRODUCT USE ISSUE (decided not to get the second vaccination). At the time of the report, DYSPNOEA (Shortness of breath), FATIGUE (fatigue), VACCINATION COMPLICATION (had reaction to vaccine) and INTENTIONAL PRODUCT USE ISSUE (decided not to get the second vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Severe abdominal pain, menstrual periods  lasting for up to two weeks, vomiting, diarrhea and extreme fatigue.
Patient presented to the emergency department on 08/07/21 with shortness of breath, wheezing, and cough consistent with previous asthma/COPD exacerbations likely secondary to new RSV infection (COVID negative). Patient was treated with steroids, magnesium, and brochodilators and improved. Patient re-presented to the hospital on 08/11/21 with a recrudescence of her symptoms (SOB, wheezing, cough) which are improving with another course of steroids.
Pt recvd a series of 3 doses of Engerix-B 24DEC90; 25JAN91 & 24JUN91; 30JUL91 tested for Anti-HBS & found to be non-reactive;
Within 10 hours pruritis at head/neck, by 24 hours macular rash with target lesion R chest, spread trunk, extremities, hands, palms. Erythema multiforme.
Mother reports illness lasted approx. (3) days.  PMD seen on 05/14/01.  Soreness to arms -- no discoloration, swelling, warmth Severe headache, dizziness, loss of appetite, nauses.  Temp on day #2 of 103.2 orally.  Motrin (OTC) admin by MO.  PMD order: Do not complete hepatitis series.
This case was reported by other health professional via sales rep and described the occurrence of local swelling in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local swelling and hives. On an unknown date, the outcome of the local swelling and hives were recovered/resolved. The reporter considered the local swelling and hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported his case for herself. The patient received SHINGRIX in an unknown deltoid and experienced swelling from shoulder to elbow and hives on skin. Follow up would be conducted to provide more information.
Pt marked he had not received covid vaccine in past. Searched system with no doses showing up. Dose was administered. Pt ended up having had another vaccine out of the country on 6/5/21 and 6/27/21. Dose was changed to booster dose from first dose in the system but noted that the booster was given 11 days early. Pt aware  only one dose could be given.
Gas, severe headache, difficulty breathing, cough stuffy nose no odor, allergy skin with rash and itchy welts, swelling in the face with color. Sore throat, tiredness, pain like gastritis, slight anal bleeding diarrhea at times, pain in the arm, pain in the bones of the other am. kidney discomfort need of water.
Fever, tenderness at injection site, mild reaction headache, achy, heart beating fast. TYLENOL for fever, monitor blood sugars (DM II).
Pt experienced muscle cramping in legs, general malaise. Pt reported a fever of 102.6, back, leg and feet cramps. Pt denies and pain or swelling at injection site.
felt nauseated and sweaty. resolved with observation and orange juice. no resp symptoms, no rash, no hives
This spontaneous report was received from a healthcare worker and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date in August 2015 (reported as "one month ago"), the patient was vaccinated with the first dose of VAQTA, 1 ml, intramuscularly in left arm (lot # and expiration date were not provided). On 11-SEP-2015 (reported as today), the patient was vaccinated with the second dose of VAQTA, 1 ml, intramuscularly in left arm (lot # and expiration date were not provided). No adverse effects were reported at the time of the report. Additional information is not expected as there was no consent to contact physician.
Vaccine taken at 7:15 drove home and slept for work the next day. Woke up for 4:00 am the following day with Chest pains, body/joint pain, cough, throat irradiation sinus pain, headace, 5 days straight as of now.  A severe headace and chills/sweats was preseng for 2 days and subsided pain at injection site with soarness was present from tuesday 2/1/22 through the 2/3/22.
Hardened large grapefruit size raised red area on right arm. Warm and painful to touch.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that an unspecified number of doses of GARDASIL (single dose) (dose, route and lot number were not reported) were administered to patients on unspecified dates after a supported excursion of 20C over a period of 15 hours. No adverse events were reported. This case is linked to cases 1403USA001475, 1403USA002927, 1403USA002928 and 1403USA002929 via same reporter link. Additional information has been requested.
Fainted within 10 minutes, bad nausea for 2 days following the vaccine. Numbness in the left arm and left jaw and cheek area occurred within 30 minutes. By that evening my left leg was numb as well. Numbness and not subsided at all and is on my entire left side of body head to toe including cheek, jaw and teeth.
Patient received both Moderna Bivalent Covid-19 and Fluad 65+ vaccine administered by technician. Once patient stood up to leave immunization room and return to store lobby the patient said she felt dizzy and light headed as well as tingly feeling in her head. Technician immediately reported this to the pharmacist. Pharmacist then spoke to the patient and she mentioned her symptoms and that the dizziness was stopping and that she was feeling normal once again. She declined an ambulance and pharmacist recommended that she waited a total of 30 minutes in order to ensure that symptoms would subside. After the 30 minutes she felt normal and was confident she could drive. She left soon after. No further adverse events were reported
Bilateral joint pain, especially in the wrists, ankles, hands, feet. Swelling at those sites. Fatigue malaise. Loss of range of motion in all extremities.  Started feeling tightness and pain in my calves and tried to stretch them out and could not. This started in March about 5 weeks after 2nd dosage. The pain and loss of motion spread to hands, wrists, shoulders. Lost the ability to wash my own back. Decreased grip strength. Inability to close my hands.  Finally went to doc in October of 2021 and he confirmed my suspicion of rheumatoid arthritis was probably the culprit. Blood was drawn and sent to lab on this day.  On 10/26/2021 I received my 3rd dose of the Moderna Covid 19 vaccine.  At this time I had not thought of a correlation between the vaccine and RA symptoms.
After receiving her vaccine, client stated she started to cough.  Client stated she has a stuffy nose for the past 3 days.
Information has been received from an anonymous consumer. He reported that he experienced a rash on both legs after receiving ZOSTAVAX. No further information was provided as the consumer refused to participate in answering questions. No further information is expected.
1 days after injection pt felt very ill with tightness in chest- myalgias, soreness in arm at site.
I started to itch all on my legs at first and when I would scratch the itch, I would get hives and bumps in that area.  Itching spread to arms, head and back.  I would itch at random times and random spots on my body.  Itching became worse after my second vaccine on 3/2/2021.