chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very cold; fatigue; body aches; Severe tremors and shaking lasting one and a half hour.; Chills; fever of 102.1; This is a spontaneous report received from a contactable consumer, the patient. A 74-year-old non-pregnant female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6200, via unspecified route of administration in the right arm on an 19Feb2021 at 18:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patients past medical history was not provided. The concomitant medications included amlodipine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), esomeprazole (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN). The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EP7534), via unspecified route of administration in right arm on an 14Mar2021 at 11:30 as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since having the vaccine. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 12:30, the patient experienced severe tremors and shaking which lasted for one and a half hour. After that, chills and fever of 102.1. On 16Mar2021, the following day, the patient felt very cold, experienced fatigue and some body aches. No treatment was received for these events and the events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tremors, chills, fever, cold, fatigue and body aches were recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
BLOOD SUGAR INCREASED; This spontaneous report received from a patient concerned an 83 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 22-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-MAR-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 173.  On 22-MAR-2021, the subject experienced blood sugar increased. Laboratory data included: Blood sugar abnormal (NR: not provided) 140, 200.  On 23-MAR-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 148.  On 24-MAR-2021, Laboratory data included: Blood sugar abnormal (NR: not provided) 159. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood sugar increased was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Information has been received from a physician concerning a female patient who on vaccinated with the three doses of GARDASIL. Shortly after the third dose she developed an abnormal pap smear. The patient sought unspecified medical attention. Additional information has been requested.
her husband experienced only some sore arm.; This is a spontaneous report from a contactable consumer (wife). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267; Expiration Date: 31May2021) via unknown route of administration in right arm on 13Feb2021 as single dose for COVID-19 immunization. Medical history and Concomitant medication were not reported. It was reported that the patient experienced only some sore arm on 14Feb2021. The outcome of event was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Follow up information has been received from a nurse concerning an 84 year old white male patient, with history of immunisation and no known drug reactions/allergies, who on Oct 14 2005 was vaccinated intramuscularly in the right deltoid with a second dose 0.5cc pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). It was reported that the patient received a first dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown) 5 years ago with no adverse evens. On Oct 15 2005, after the injection 1 day later, the patients arm stiffened up and the pain was very severe. He was unable to lift his right arm. He took 50 mg diphenhydramine hydrochloride (Benadryl) and it did not help. It was reported that the arm was hot, swollen greatly. The patient also developed redness from the shoulder down to the wrist which lasted 4 days. It was previously reported that on Oct 17 2005 the patient called and was seen by the physician, complaining of injection site itching, swelling, redness of entire arm, and hot to touch. No product quality complaint was involved. On Oct 23 2005 the patient recovered. It was reported that the adverse events resulted in persistent or significant disability/ incapacity. No further information is available.
This spontaneous case reported by a physician, describes the occurrence of vaccination site erythema (red), vaccination site swelling (swollen), vaccination site warmth (warm) and vaccination site pruritus (itchy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 020B21A) for COVID-19 immunization. No medical history reported. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 3, 2021, patient experienced vaccination site erythema (red), vaccination site swelling (swollen), vaccination site warmth (warm) and vaccination site pruritus (itchy). After the injection, patient treated with Tylenol (paracetamol) May 1, 2021, at an unspecified dose and frequency. At the time of the report, vaccination site erythema (red), vaccination site swelling (swollen), vaccination site warmth (warm) and vaccination site pruritus (itchy) outcome: unknown. The reporter did not provide any causality assessments or concomitant medications.
caught rare form of covid 11/2020 brain fog 1 week after 1st dose, fatigue, difficulty concentrating
Information has been received from a health professional concerning a 12 month old female who on 22Oct2003 was vaccinated with a dose of varicella virus vaccine live. On 24Oct2003 the pt vomited and as of 27Oct2003 has continued vomit once a day. Unspecified medical attention was sought and it was indicated that prescription drugs were not required. A product quality complaint was not involved. Follow up information from the medical assistant indicated that the pt recovered in about one week. The reporter also indicated that another pt had a similar experience following exposure to varicella virus vaccine live. No further information is expected.
Information regarding PREVNAR 13 was received from a physician regarding a patient who experienced rash. The patient received a dose in 2010. The patient experienced rash in 2010. The outcome is unknown. No additional information was available at the time of this report.
Has no energy; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Has no energy) and FATIGUE (Exhaustion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 19-Feb-2021, the patient experienced ASTHENIA (Has no energy) and FATIGUE (Exhaustion). At the time of the report, ASTHENIA (Has no energy) and FATIGUE (Exhaustion) had not resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, pain and contusion. On an unknown date, the outcome of the fever, chills, pain and contusion were recovered/resolved. It was unknown if the reporter considered the fever, chills, pain and contusion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient had a 103 degree fahrenheit fever, chills, aches and dark bruises that lasted for around four days. The patient was sent to home from work as well. The reporter agreed to be contacted for follow up. Lab Comments: On an unknown date, the patient's body temperature was recorded as 103 degree F.
Information has been received from a female consumer who was vaccinated with ZOSTAVAX (Merck). On an unspecified date, the patient had a reaction to the vaccine. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. No further information is available.
Breast changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Adverse reaction to Pfizer Vaccine first dose 05Apr2022), administration date: 05Apr2021, for Covid-19 immunization. The following information was reported: BREAST DISORDER (non-serious), outcome "unknown", described as "Breast changes". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Breast changes. Previously, in remission 22 years.
10 Grand Mal seizures over 10 days after vaccinations, recurring rash on face. Treatment for seizures with Keppra.
pt recvd vax; swelling of entire arm  fron shoulder to hand, "like a ballon"; some blister around inject site; last dose 5 yrs ago;
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Medical histories and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (route, lot numbers and expiration dates were not provided). No concomitant medications were reported, neither was any adverse effect. This is one of two reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with unspecified number of doses of improperly stored LIQUID PEDVAXHIB, Dose/Frequency: 0.5 ml (dose number, route, lot# not reported). No adverse effects reported. The outcome of event was unknown. Additional information has been requested.
Information has been received from a physician's assistant and a nurse, concerning the nurse's 14 year old daughter, who on 02-FEB-2007, was vaccinated in the right hip, with the first dose, 0.5ml, of Gardasil, and on 04-APR-2007 was vaccinated in the back of her right arm, with the second dose, 0.5ml, of Gardasil. The nurse reported that on 04-APR-2007, the vaccination was administered near her daughter's elbow "in the area of subcutaneous fat," and added that her daughter experienced "injection site soreness" in her right arm. The nurse reported that the arm soreness resolved on the same day, 04-APR-2007. Additional information has been requested.
Light-headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light-headedness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light-headedness). At the time of the report, DIZZINESS (Light-headedness) outcome was unknown.            No concomitant products were reported.  No treatment information was provided.
Systemic and local reaction, fever of 102F, joint pain, body aches, swelling and redness 7x11 cm at injection site.
Patient woke up with arm swollen, hard at site of vaccine administration, numbness.  Patient also described feeling as though her heart was racing.
extreme vertigo; Headache; 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), administration date 25Mar2021 (Lot number: EP7534) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "extreme vertigo"; HEADACHE (non-serious), outcome "unknown", described as "Headache". The events "extreme vertigo" and "headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, headache.  Additional Information: It was reported that patient having extreme vertigo and headache and have gone to Ear nose & throat specialist they advise me to do the Epley maneuver and another one Defat maneuver, Meclizine.   No follow-up attempts are needed. No further information is expected.
Shingles. In 1 to 3  dermatome on left shoulder and back side; This case was reported by a physician via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2022, the patient received the 1st dose of Shingrix. On 12th March 2022, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed shingles the same evening.  It started in 1 dermatome to 3 dermatome and location on left shoulder and back side. The reporter consented to follow up by email.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    No concomitant drug was reported. The before use date was 02-Sep-2021. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
not very effective; not very effective; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 11 year-old female patient received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "not very effective". The reporter stated she read an article today that Pfizer covid vaccine for 5-11 years old is not very effective. She stated that article says as of 30Jan, efficacy in 12 years old is 67 % and in 11 y/o is 11%. She stated it was very disturbing. She stated the vaccine her children got was not very effective. She also stated as per the article the vaccine is not effective in preventing hospitalization and protection in general. The reporter wanted to know if there were any booster for these kids, and if Pfizer was going to do some trials or come up with booster dose for this age group (not immunocompromised).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200342154 Same reporter/drug/event, different patient.
Fever of 101.5 degree Fahrenheit; Headache; Flu like symptoms; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Tiredness), PYREXIA (Fever of 101.5 degree Fahrenheit) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, HYDROCHLOROTHIAZIDE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tiredness). On 29-Apr-2021, the patient experienced PYREXIA (Fever of 101.5 degree Fahrenheit) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Tiredness), PYREXIA (Fever of 101.5 degree Fahrenheit) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 101.5 (Inconclusive) 101.5 degree Fahrenheit.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Treatment information included ibuprofen.
Set off extreme fatigue that led to syncope and near-syncope episodes; Set off extreme fatigue that led to syncope and near-syncope episodes; Increased orthostatic intolerance; Increased orthostatic intolerance; Set off extreme fatigue that led to syncope and near-syncope episodes; This is a spontaneous report received from contactable consumer (patient). A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EB8727) via an unspecified route of administration in the right arm on 24Mar2021 11:30 AM (at the age of 21-year-old) as single dose for COVID-19 immunization in school or student health clinic. Medical history included ongoing POTS (Postural orthostatic tachycardia syndrome). Patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included corticosteroids, antihistamine and NSAID (all received within 2 weeks of vaccination). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 03Mar2021 10:00 AM for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 19:30 (reported as within 8hrs of vaccination), the patient experienced set off extreme fatigue that led to syncope and near-syncope episodes. Patient did not have an episode of POTS in months until receiving second dose, the patient experienced increased orthostatic intolerance. The patient did not receive any treatment for the events. The outcome of the events set off extreme fatigue that led to syncope and near-syncope episodes and increased orthostatic intolerance was recovering.  No follow-up attempts are possible. No further information is expected.
fever of varying degree from 15MAY97 thru 25MAY97;on 23MAY97 t100 @ 9PM, sz shortly thereafter;t102.5 915PM, 104.5 930PM in hosp ER;sz in abm;ER MD dx meningeal inflammation d/t vax;
Per patient, he felt dizzy outside of waiting area while making appointment for I 693. He said that he had not slept or eaten prior to coming for his vaccinations. Patient felt clammy to touch. He was aao x 3 and with family. He was assisted to a wheelchair and brought to an exam room and was seen by the clinic Nurse Practitioner. Patient denies any medical history during this time of visit. Patient was offered Ensure to drink and allowed to rest until recovered. He was instructed to go to ER or urgent care when symptoms persist. Vital signs stable. BP 120/79 and HR 80. Patient verbalized understanding of instructions.
Fever, joint pain, malaise. Symptoms resolved approx 10 hours after onset without treatment.
One day after pt  received 1st dose of vaccine,  pt stated, "woke up with high fever 101. Went to meet a friend for coffee. Temperature increased. I stated getting shortness of breath/tightness in my chest  and I felt like I was going to pass out. I had to go home. I then laid down and went to sleep".
Second day my arm felt really heavy 5th day I started getting anxious and my blood pressure elevated
I had a severe case of COVID in October, with over 4 weeks in hospital. After first dose, I experience severe muscle and joint pain for 3 days
Noticeable numbness in right hand beginning ~2 hours after injection at 11:30 on 4/24, ongoing after 10 days. Fever spiking above 101°F, chills, fatigue beginning from 22:30 on 4/24, 9:24 on 4/26.  Headache, onset accompanying fever, which lasted about another 1-2 days after fever.