chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stomach spasms; loose stools; This is a spontaneous report from contactable consumer (patient) via medical information team. A 73-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 10Apr2021 at 10:50 (at the age of 73-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/Lot Number: EN6206) on 20Mar2021 (at the age of 73-years-old) for COVID-19 immunization. The patient received vaccine within 4 weeks prior to the next dose of vaccine. On 10Apr2021 at 23:30 the next night, she started to have "stomach spasms" that lasted all night and into the morning. She also reports some loose stools, but did not classify them as diarrhea. She reports that she is "still having terrible spasms". After she came home, she was ok, but then she was up all night going to the bathroom with severe stomach spasms. Patient reported severe stomach spasms and diarrhea and took Bentyl, Diarrhea medicine, Gaviscon, nothing seems to be working. A visit to emergency room and physician office not required for events. She should have went somewhere but she did not. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1st time for seasonal flu vaccine. No reported allergies. After waiting 15 min after injection, complained of tightness in throat - light headed, cold sweat. Given BENADRYL 4tsp. PHN called her later and she was fine.
This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020 / FH8029) via an unspecified route of administration in the left arm on 12Nov2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 vaccination. Concomitant medications included topiramate (TOPAMAX) and duloxetine hydrochloride (CYMBALTA), both for an unknown indication from an unknown date and unknown if ongoing. On 12Nov2021 at 11:00, immediately after the shot, the patient experienced dizzy, lightheaded, stabbing in her left eye, left arm was numb and left side of face had pain. From 13Nov2021, for the next 3 days, the patient had extreme joint pain, nausea, stomach ache, exhaustion, headache, lethargic, fever and rapid heart rate, with all the listed possibilities of side effects. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, lightheaded, stabbing in her left eye, left arm was numb, left side of face had pain, extreme joint pain, nausea, stomach ache, exhaustion, headache, lethargic, fever and rapid heart rate were not resolved at the time of this report.
about 10 hours after receiving the vaccine, a lymph node under my arm swelled up. it was the arm that i received the vaccine in. then i became tired and developed a headache, fever and sore throat. that lasted a few days and has since resolved. i was tested for covid after to make sure i did not contract the virus at my place of employment. it was negative.
This spontaneous report as received from a licensed practical nurse refers to 3 unspecified patients. The patients were vaccinated with ZOSTAVAX (lot number, route, dose, site not reported) in early June 2012. No other co-suspects or concomitant medications were reported. Subsequently the patients developed injection site reactions described as swelling and redness, and varying in size, from 4 inches in diameter to near what another patient also reported by the nurse experienced (the arm turned red and swelled from elbow to shoulder). No treatment information was reported. The outcome of the events was unknown. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
she lost her taste and smell and it stayed gone up until that first shot and then everything began to come back; she lost her taste and smell and it stayed gone up until that first shot and then everything began to come back; she lost her taste and smell; she lost her taste and smell; This is a spontaneous report from a contactable consumer (patient) and physician. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EL9262, Expiry Date: Not Reported), via an unspecified route of administration on 28Jan2021 (at the age of 68-year-old) as dose 1, single for COVID-19 immunisation. There was no medical history, no concomitant medications, and no investigation assessment. The patient had taken a COVID test many times. It was last year she had gone to the store; she wore her mask, but her niece did not. She told her doctor she lost her taste and smell and it stayed gone up until that first shot and then everything began to come back, and she was happy. Everyone was saying how do you feel some, she knows some of her friends and family had problems, but she got her taste and smell back. She clarifies she has not been tested for COVID since it the taste and smell came back, she will see at her doctors appointment next month, what was going on. Outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from an office manager  referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 19-AUG-2016, The patient received an expired dose of M-M-R II injection,by subcutaneous,lot number:k011188,expiration date:12-AUG-2016(Strength,dose were not reported). There was no concomitant medications reported. No adverse events were reported and no product quality complain was involved. Additional information is not expected as the reporter did not consent for new follow up attempts.
7MAY93 mom reported screaming type crying w/fever of 102 APA suppos states began 5MAY93 in evening;
PT BECAME HYPOTENSIVE, DIZZY. BP: 90/62, HR WEAK 58-60. HYDRATED WITH WATER 16 OZ, LYING SUPINE. AFTER 10 MINUES, BP 110/60. COLOR RETURNED. DIZZINESS GONE. SENT HOME
severe headache; Fever to 103 Fahrenheit; myalgias; chills; This is a spontaneous report from a contactable Physician (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 Intramuscular at single dose on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020. The patient experienced Fever to 103 Fahrenheit, severe headache, chills, myalgias on 05Jan2021. No treatment was received for all events. There was no covid prior vaccination. There was no covid tested post vaccination. He had no Allergies to medications, food, or other products. The outcome of all events was resolved.  information on the lot/batch number has been requested.
This spontaneous report was received from a healthcare worker refers to a 10 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 27-OCT-2015, the patient was vaccinated with second dose of GARDASIL 9 series (dose: 0.5 ml, lot # L007560, expiry date: 15-JUN-2017) as routine vaccine, via intramuscular route. Patient received the first vaccination dose on 10-AUG-2015. Reporting healthcare worker stated that the patient developed a lump in her left arm pit on an unspecified date, after she received the second GARDASIL 9 dose. No lab tests were performed. No treatment was provided for the event. It was unspecified if the patient required medical attention or not. Outcome of the event was unknown. Reporting healthcare worker did not assess the causality of the event with respect to vaccination GARDASIL 9. Additional information has been requested.
migraine; headache; slurred speech; hands were numb; droopy eyes; couldn't use hands properly; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (slurred speech), HYPOAESTHESIA (hands were numb), ASTHENOPIA (droopy eyes), MUSCULAR WEAKNESS (couldn't use hands properly) and MIGRAINE (migraine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DYSARTHRIA (slurred speech), HYPOAESTHESIA (hands were numb), ASTHENOPIA (droopy eyes), MUSCULAR WEAKNESS (couldn't use hands properly) and HEADACHE (headache). On an unknown date, the patient experienced MIGRAINE (migraine). At the time of the report, DYSARTHRIA (slurred speech), HYPOAESTHESIA (hands were numb), ASTHENOPIA (droopy eyes), MUSCULAR WEAKNESS (couldn't use hands properly), MIGRAINE (migraine) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
12/16 vaccination 12/28 symptoms started to include; low blood sugar, shakiness, severe chills, heart palpitations, low potassium.  2-3 hours symptoms lasted. Went to the ER; Oral potassium, juice to bring blood sugar up.
It was determined there was a preparation error at Facility on 1/19/23. Between 4-5 individuals received Moderna 6 month to 5 years monovalent formulation. Preppers unintentionally prepared 1 vial of the 6 months to 5-year monovalent formulation (with volume of 0.5 ml per dose) and labeled it as a Moderna 12+ years bivalent formulation. There was a total of 14 patients scheduled to receive the Moderna 12+ years bivalent on 1/19/23. Clinic is unable to determine if patient received the correct bivalent dose versus the Moderna 6 month-5 years monovalent formulation.   Information about other Moderna formulation: Moderna 6 months to 5 years monovalent dose, Lot AS1414B, manuf. exp 2/13/23.  Patient has been notified of vaccine error that may have potentially impacted him. No reported signs/symptoms of adverse reaction.
6:00 to 8PM cont crying-no appetite;mom states no fever;started twitching from waist down lasting 30sec;pt fussy during next day;twitching 2nd day;slept on & off during noc
Received the first dose / on 8/30/2018 and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of shingrix received on 30th August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provide are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter preferred not to disclose any information regarding the patients but clarified that there were two patients involved. The reporter had no further information but agreed to contacted for follow-up. The reporter consented to follow-up. This case is linked to the case US2021169814, reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169814:Same reporter
According to mother, pt became limp & non-responsive for several mins.Pt was alert & active upon arrival to the office.
For the next seven days dizziness, fatigue, headache, slight fever. Not treated.
Pt experienced temp of 103.8 at 3am on 12/18/20.  Temp decreased to 100 on 12/19-12/20.  As of 9am on 12/21 temp was 99.3.  On 12/19 pt began experiencing diarrhea, cough and stomach pain.  Cough and stomach pain continued to report of 12/21.  Pt had COVID + test on 10/11/2020.  She stated that it was as if the symptoms she had in October were back.
On July 11, 2012, patient had a 10 minute seizure 1 day after immunizations.
Rash on left arm surrounding injection site. Rash on right arm. Tenderness, swelling and pain at injection site. Fatigue, headache, muscle pain, joint pain, chills, nausea, fever.
Pt recvd MMR vax 23APR90 & 20MAY91 exp a fever & cough; 24MAY91 hospitalized w/diffuse erythematous maculopapular rash x 2 days; nares & lips were dry & cracked; koplick spot seen; cranky & irritable; dx measles, dehydration & OM;
Patient reported that she has severe body aches, chills, and fever. This is the booster and she stated that it was worse than the other... the next day she felt dizzy and nauseous.
This spontaneous report as received from an other health professional refers to a patient of unknown age. On 08-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live.  Subsequently, the patient experienced breakthrough.  it was noted that the patient was sent back to school with lesions, and now over 10 cases of chickenpox in this school.  Unspecified medical attention was sought.  There was no product quality complaint.  No additional information was available at the time of the report.  Additional information has been requested.
Narrative:  She reports having developed fever to 100.6T and chills about 2 hours after the initial vaccination. Concerns lated for about 2x days (fever treated with acetaminophen). While she had initially answered "throat tightness", upon further query  this was clarifed as tightness emcompassing her entire body related to the chills. She denied difficulty swallowing including eating/drinking or breathing (no wheezing/dyspnea). She also denied swelling, urticaria, flushing, congestion, dizziness, weakness nausea/vomiting/diarrhea/abdominal cramping.
Acute Left knee pain, swelling in joint , unable to walk for weeks , which then became chronic.  It now comes and goes - intermittent
muscle ache at site of injection; very tired; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included seafood allergy. The patient received unspecified medications within two weeks of vaccination. The patient previously took augmentin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. 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 06Apr2021 at 17:00, the patient experienced muscle ache at site of injection which lasted for 2 days and very tired. The patient did not receive any treatment for the reported events. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of injection site muscle pain was recovered on 08Apr2021 while the clinical outcome of tiredness was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient started feeling weak, stomach pain, neck pain, respiratory problems, confusion, low blood pressure which led to death on February 21, 2021, 7 days after the vaccine was given.
Post vax, the pt's left extremity turned red and hard from his thigh down to his toes. Pt cried loudly for 30 minutes. Benadryl was given and the pt recovered within 30 minutes.
Patient received dose #1 of Pfizer vaccine on 6/6/2021 and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 6/24/2021 as recommended. No adverse reactions identified on site.
Arm noted to be slightly swollen, erythematous from deltoid down to elbow, chills and mild pain. Feverish feeling, no temp elevation. Unable to tell between vaccine reaction and cellulitis. Presented to physician office 2/21/08 for treatment.
Tenderness; Feels sleepy all day; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), SOMNOLENCE (Feels sleepy all day) and VACCINATION SITE PAIN (Pain at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026CZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Bee sting (Bee stings) and Drug allergy (Multiple allergies to medications (she don't have a list)). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), SUPER B COMPLEX WITH C, GINKGO BILOBA (GINGKO BILOBA), COLECALCIFEROL, UBIDECARENONE (COQ10 + D3), VITAMIN D3, CENTRUM SILVER +50, GLUCOSAMINE, EMERGEN C, ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +), VITIS VINIFERA EXTRACT (GRAPESEED), METOPROLOL, IRON and LOSARTAN for an unknown indication.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced TENDERNESS (Tenderness), SOMNOLENCE (Feels sleepy all day) and VACCINATION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram once. At the time of the report, TENDERNESS (Tenderness), SOMNOLENCE (Feels sleepy all day) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also reported other concomitant medications that include Garlic capsule, Aller-tec 1 tab once daily.
This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines.    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported.   Patient received supportive care. Patient symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-245527, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Incorrect E2B Company Number was removed. Incorrect reports were generated. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event a causal relationship cannot be excluded.
Body aches/Pain; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix. On 23rd October 2019, less than a day after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and on the same day  experienced Body aches and pain. The reporter did not consent to follow-up. This case was linked with case US2019206668 same reporter different patient.
Diaphoretic - entire body, HTN, body aches, weak, numb, tingle, nausea & vomiting, entire upper arm near injection site red, hot, swollen, tender, painful.
Starting the morning after vaccination (about 24 hours), injection site was warm, swollen, and red. Affected area covered about 2 inches square. Area was itchy and hypersensitive to fabric. General pain  in area and surrounding muscle decreased after about 72 hours,  but pressure applied to injection site still resulted in tenderness and itchiness persisted.
Menses started 2-3 days after first vaccine shot; has continued nonstop since.
Developed headache; progressed to migraines the following week as of today 12/7/15 the headache is still not resolved.