chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00772, 2012-00773, 2012-00774, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, route and site of administration not reported) and an unspecified amount of time later experienced "chest feeling heavy, achy for a couple of days and right arm soreness." It was unknown if the patient had any illness at the time of vaccination. The patient had a medical history of asthma and was concomitantly using an unspecified inhaler. The patient had a severe reaction years ago following prior vaccination (vaccine not specified). No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Pt reported injection site to be red, puffy, swollen, hot to touch 24 hours post injection. Advised Tylenol or Motrin, OTC Benadryl and cool compresses call if worsening. Symptoms reported by pt.
Lower body paresthesia and numbness in saddle area, extending to bilateral legs, thigh and trunk. Followed up. Transverse myelitis after MRI with T4 dorsal lesion. Doctor documented possible post vaccine.
No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine 26-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine 26-Jul-2022) and NO ADVERSE EVENT (No Adverse event) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A and 001A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine 26-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine 26-Jul-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13-Jul-2022 Date(s) of administration of vaccine 26-Jul-2022).    No concomitant medications were reported.  A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022. On 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose) and 30Sep2022 (1 dose) vaccine were administered.   No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report). This case was linked to MOD-2023-704343 (Patient Link).; Sender's Comments:  MODERNATX, INC.-MOD-2023-704260:Master case
feel very tired; Since the second vaccine I've experienced, on a daily basis, a temperature rise of one degree when I awaken to 98.6 which rises to 99.7 in the late afternoon and reverts back to 98.6 at bed time.; Tylenol is going to wreck my Liver; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported that a 65-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 17:45 as 2ND DOSE, SINGLE for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included asthma; high blood pressure and high cholesterol. Patient had allergies to medications, food, or other products includes Penicillin. Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); montelukast sodium (MONTELUKAST SODIUM) and atorvastatin (ATORVASTATIN). On an unknown date in Apr2021, the patient experienced tylenol is going to wreck my liver; On 06Apr2021 16:00, since the second vaccine i've experienced, on a daily basis, a temperature rise of one degree when i awaken to 98.6 which rises to 99.7 in the late afternoon and reverts back to 98.6 at bed time; On an unknown date, feel very tired. The patient underwent lab tests and procedures which included body temperature:100.8 on 06Apr2021 went up to 100.8 then the next day it went down to 100.1, then the day after went down to 100 , body temperature: 100.1 on 07Apr2021 the next day it went down to 100.1 , body temperature: 100 on 07Apr2021 then the day after went down to 100 , body temperature: 99.7 on 08Apr2021 then on the 4th day, it went down to 99.7. It was reported that consumer stated since patient second shot of Pfizer COVID 19 vaccine I had on April 5th, I feel very tired and my temperature, I woke up with my temperature of 99.7 and on 11 O' clock at night it goes down to 98.6 and my normal is 97.6. So I feel like it was going on for so long. So was that normal. Consumer stated she want to report this because her doctor said to take Tylenol and Tylenol is going to wreck my Liver, I can't take it every day. She don't go outside the house because she don't know what was going on. Consumer stated she took something for high cholesterol, high blood pressure and asthma. The clinical outcome of event Tylenol is going to wreck my Liver; feel very tired was unknown; while other was not recovered.  Follow-up attempts completed. No further information expected.
3 mini Strockes; Atrial flutter; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (3 mini Strockes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2022, the patient experienced CEREBROVASCULAR ACCIDENT (3 mini Strockes) (seriousness criterion medically significant) and ATRIAL FLUTTER (Atrial flutter). At the time of the report, CEREBROVASCULAR ACCIDENT (3 mini Strockes) and ATRIAL FLUTTER (Atrial flutter) outcome was unknown.            Concomitant medication not reported. Treatment medication not reported.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, adverse event of special interest of Cerebrovascular Accident and the unexpected, non-serious, adverse event of special interest Atrial Flutter. The events occurred approximately 5 months after receiving a dose of mRNA-1273 Original Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The reported outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Original Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, adverse event of special interest of Cerebrovascular Accident and the unexpected, non-serious, adverse event of special interest Atrial Flutter. The events occurred approximately 5 months after receiving a dose of mRNA-1273 Original Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The reported outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Original Vaccine is not affected by this report.
uncomfortable pain under my arm pit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 23-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (uncomfortable pain under my arm pit) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (uncomfortable pain under my arm pit). At the time of the report, AXILLARY PAIN (uncomfortable pain under my arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided.   Reporter did not allow further contact
About 2 days after I received my first dose of the Pfizer vaccine, I started experiencing chest pain and muscle cramps. On day 6 I experienced it the worst, my chest tensed up and all at once my left side of my body started cramping. Most noticeable of the pain was coming from my heart. It got better as the day ended. Noticed serious muscle cramps for the week after.
Day 3 after shot-Large knot in upper left arm and pain under armpit, and forearm.  Day 6-Chest pain and sweating, nauseous, dizzy. Went to er Day 7, with chest pains and was told after blood work that I had a negative reaction to the covid vaccine.
pt recv vax NOV96 & 1wk later devel numbness in feet;An ER or MD visit was required to treat event;DEC96 sx progressed to gen muscle weakness, optic neuritis & everything you'd expect w/MS;tx w/pred;
Patient was observed experiencing nausea and vomiting with light headedness lasting about 20 mins. Symptoms occurred about 15 mins post vaccine.  Patient was given ice packs, legs elevated, and oral fluids given.  Vital signs taken at 1600 Blood pressure 140/90 heart rate 69 Temperature 98.0F
Low blood sugar at night when sleeping fell to 42. Fever of 100 the day after. Diarrhea for 2 days after.
Blood pressure went down until he died; Couldn't hear his heartbeat; neck was sweating; He was cold; Couldn't get up; Death; Sick; immediately very tired; he was tired; Hands were shaking; Slept for too long; A spontaneous report was received on 18 Feb 2021 from a consumer concerning a 81-years-old, male patient who received Moderna's COVID-19 vaccine and developed immediately very tired, hands were shaking, neck was sweating, was cold, sick, couldn't get up, couldn't hear his heartbeat and blood pressure went down until he died.  Patients' medical history, as provided by patient's spouse, was emergency room(ER) admission in November 2020 because he had a congested chest (he had fluid around his heart). At that time, they gave him pills for kidney function. Other concomitant medication reported was Coumadin, blood thinner. Two weeks before receiving the vaccine, patient's EKG was normal.  On 11 Feb 2021, in the morning, patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 007M20A) probably in the right arm for the prophylaxis of COVID-19 infection.  On 11 Feb 2021, approximately after 15 minutes of receiving vaccine, they left and patient was immediately very tired, his hands were shaking. So, patient's spouse made them down sleep for too long. On Friday, 12 Feb 2021 she tried to pick him up, but he was tired, exhausted, and sick.   On Saturday, 13 Feb 2021, she brought him a coffee and he couldn't hold it because his hands were shaking, so she gave him the coffee and then made him pee on the bed because he couldn't get up. At lunch time she made him eat something and he fell sleep again. His wife was hanging around him all day and around 7:30pm she realized that he was cold, and his neck was sweating, she couldn't hear his heartbeat. So, she called emergency services and when they arrived, her husband's blood pressure went down until he died. Treatment for the events were not provided.  Action taken with mRNA-1273 was not applicable.  Patient was pronounced dead on 13 Feb 2021 20:00. The cause of death was not provided. The plans for an autopsy were not provided.  The events of blood pressure went down until he died and couldn't hear his heartbeat were fatal. The outcome for the remaining events were unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, who experienced a serious event of death among others, 2 days after receiving mRNA- 1273 (Lot# 007M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
The patient received two doses of GARDASIL (4vHPV) when she was in her 20s (unspecified date/lots). Caller is not sure if the patient received the third dose.; The patient received two doses of GARDASIL (4vHPV) when she was in her 20s (unspecified date/lots). Caller is not sure if the patient received the third dose.; No additional AE reported; This spontaneous report was received from an office manager (also reported as healthcare business professional (HBP)) and refers to a 36-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates (reported as "when she was In her 20s"), the patient received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) 0,5 mL (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was unknown whether the patient received the third dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (inappropriate schedule of vaccine administered). No additional adverse event was reported.
Mild "shock" feeling in heart. Sometimes shortness of breath. These were very mild until recently, and I was blaming it on diet until a friend told me of a similar issues discovered to be a side-effect or Miocarditis.
itching/at injection site.; Lump/at injection site.; discoloration (bruise)/at injection site.; This case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date unknown) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 94J24, expiry date unknown) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2019, the patient received FluLaval Tetra 2019-2020 season, Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, less than 2 years after receiving FluLaval Tetra 2019-2020 season, Havrix and Havrix Pre-Filled Syringe Device, the patient experienced injection site itching, injection site lump and injection site discoloration. On an unknown date, the outcome of the injection site itching, injection site lump and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site itching, injection site lump and injection site discoloration to be related to FluLaval Tetra 2019-2020 season, Havrix and Havrix Pre-Filled Syringe Device.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flulaval and Havrix and experienced discoloration (brulse), itching and lump instead of numbness at the injection site. There were no more information. The reporter consented to follow up via an email.
Morning after vaccine had pain and swelling to axilla of the same side he received the vaccine.  that swelling subsided but over the next few days developed swelling to his right chest wall and flank area. No redness or pruritis, does have some pain with movement.  Swelling is improving but not completely gone.
patient back of throat is rough and rigid; Chills; Fatigue; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (patient back of throat is rough and rigid), VOMITING (vomiting), CHILLS (Chills) and FATIGUE (Fatigue) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autistic disorder.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced VOMITING (vomiting). On 22-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (patient back of throat is rough and rigid), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, OROPHARYNGEAL DISCOMFORT (patient back of throat is rough and rigid), VOMITING (vomiting), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            no concomitant medications are provided. treatment to the events not reported. Patient did not have any adverse events from the first dose.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: SHE HAS REDNESS AND ITCHING ALL OVER BODY STARTED 2 DAYS AFTER VACCINES
macular rash, lymphadenopathy-neck, axillary;decadron 8mg IM;
felt as if it had been punched in the arm, sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details provided as follows: The age at vaccination was unknown. The patient had no discomfort with the 1st shot. The 2nd dose felt as if the patient had been punched in the arm. It was very sore for 2 days, but patient hoping it was worth it.  The patient stated that one have to wait 2 months before getting the 2nd one. The follow up was not possible.
disoriented; trouble remembering things; This is a spontaneous report from a contactable consumer (patient's daughter) reported that a 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on 20Dec2020 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient has taken one shot 5 weeks ago. After the shot the mother became disoriented and having trouble remembering things. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from an employee refers to a 28 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient at 28 years of age was vaccinated with GARDASIL 9 (formulation, dose, frequency, route of administration and anatomical location of administration, lot # and expiration date were not reported) for prophylaxis (considered drug administered to patient of inappropriate age). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Never returned for 2nd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16 September 2020).   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 provided as follows: The age at vaccination was not applicable for this report. The patient never returned for 2nd dose after numerous attempts to reach them. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter needed to know if administered 2nd dose or restart series. The reporter consented to follow up. This case was linked with case US2021AMR219304, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR219304:same reporter
Soreness at site of injection, redness at site of injection (2 inches), general malaise. Occurred 2-3 days after administration.
Red, swollen raised, itchy area. Growing over 3 days. Suspected cellulitis - treated with cephalexin.
pt recv vax 22OCT98 & the next morning devel swollen joints in hands  & erythema palmar, lt greater than right;
7hr p/vax pt noted arm itching & felt a bump;mom observed arm then noted hives on entire trunk & all extremities;pt did not seek med care but took DPH & calamine lotion to relieve sx;
Developed rash approximately 4 days after immunizations.  Parents describes as rash that "comes and goes" on trunk, arms and legs.  Pinpoint dots with no welting.  Has one spot that developed white center like whitehead pimple.  Fever up to 101 Ax.  100-101 with Tylenol suppos.  Vomited once 11/23 and once 11/24 AM (parents state he vomits whenever he is sick with anything).  Per phone call 12/11/03, rash and fever resolved within 2 days of clinic visit.
Myalgia, NauseaVomiting, Malaise, fatigue Narrative:  missed work following second dose due to the above symptoms