chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID-19; A Spontaneous report was received from a consumer concerning an unknown-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid-19.  The patient's medical history, was not provided .The Concomitant medications were not  reported .  On an unknown day , prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (Lot number: Batch number not provided) intramuscularly  in an unknown location for prophylaxis of COVID-19 infection.  On an unknown day, patient developed covid-19 positive. No further information was reported.  The treatment information was not  reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event covid-19 was considered as unknown.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 49-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
3/2/21:   Shot about 7:30 am I. Arm.   2ish feeling tired and sluggish but not too bad.  4pm low grade fever and tired.  6:30 high fever 103 fever chills, shaking from chills.  Lasted about 4 hours.  No meds taken to offset.   About 11 hot and tired.   Hot with  fever about 99-100.5.  Up and down all night from being sore and not able to get comfortable. As well as feeling hot.  Thirsty.  Mental fog.   3/3/21:  very tired.  Wore out by simple tasks.  Slept most of day.   Achy body.   A few slight fever times but not bad.  Slept 18 of 24 hours.  Times awake we?re just sitting.  Mental fog.  Even hearing someone else talk would wear me out.  Went to bed at 6:30 pm.  Was very tired but trouble falling asleep because could not get comfortable so took an Advil pm.   Slept until 5:50 only getting up once to use bathroom.  Did wake up in puddle of sweat when we to bathroom.   3/4/21:  still tired feeling but feel much better.  Mental fog way better.  No fever.   Feel alert and awake.  Not feelingwore out by simple tasks.  Location of injection: and arm response. Vaccine 1 given  was about 2-3 inches down from shoulder joint.  Very sore arm for 5 days.  3 days could raise arm or move without it hurting. Vaccine 2 given was no more than 1 inch down from shoulder joint.   I was asked to pull T-shirt sleeve up further before getting it.  It was much higher in arm than vaccine #1.  2 hours after vaccine arm was very sore.  By 4 hours after arm hurt and not able to move it without pain.   Did not use arm for even small normal tasks like taking a drink.   By time fever broke around 11 pm, Arm felt much better.  Sore but no pain to move it or use it for normal activities.
pt recvd vax 17AUG92 & on 21AUG92 630PM mom noted pts eyes roll to back of head & twitching limbs; would not come out of it; parent called 911; adm to hosp t103.8p MD guessed pt may have had a virus; rash;
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date (reported as recent date), the patient was vaccinated with doses of ZOSTAVAX (dosing details , lot# and expiration date not reported), ADACEL (dosing details not reported) and unknown form of influenza virus vaccine (unspecified) (dosing details not reported). On an unknown date, the patient developed body aches (pain). The patient sought medical attention (unspecified). The outcome of the event was unknown. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter denied consent to be contacted for further information.
Muscle pain/soreness/stiffness. Felt like I had the flu. Lost all energy, hurt very badly to move. Happened after each of the three vacines I received for HPV. Started a little in the night I received the vaccine, peaking one day after I received the vaccine. Lasted about 1-2 days. I told the nurse at the health center, however she told me the vaccine wasn't a live vaccine so I must have gotten sick from some place else.
Tired; Moody; psychotic with dark thoughts; psychotic with dark thoughts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "Known allergies: sulpha drugs" (unspecified if ongoing). Concomitant medication(s) included: PROZAC. The following information was reported: FATIGUE (non-serious) with onset 18Apr2021 09:00, outcome "not recovered", described as "Tired"; MOOD ALTERED (non-serious) with onset 18Apr2021 09:00, outcome "not recovered", described as "Moody"; PSYCHOTIC DISORDER (non-serious), THINKING ABNORMAL (non-serious) all with onset 18Apr2021 09:00, outcome "not recovered" and all described as "psychotic with dark thoughts". Therapeutic measures were not taken as a result of fatigue, mood altered, psychotic disorder, thinking abnormal. Additional information: The patient had no other vaccine in four weeks. The patient was had no covid prior vaccination and was not tested for covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of sweating in a 58-year-old female patient who received TWINRIX adult (batch number HZ9Z9, expiry date 13th March 2017). Previously administered products included TWINRIX adult with an associated reaction of back pain (1st dose received on 7th September 2015, see case US2015148849). On 9th October 2015, the patient received the 2nd dose of TWINRIX adult .5 ml. On 10th October 2015, 1 days after receiving TWINRIX adult, the patient experienced sweating. On an unknown date, the outcome of the sweating was recovered/resolved. The reporter considered the swelling to be almost certainly related to TWINRIX adult. Additional details were provided as follows: This case was previously reported to a doctor. The reported injection site was left deltoid. The reported batch number (HZ929) of TWINRIX adult did not exist and was updated to HZ9Z9 as per sales database.
Patient, mother, and father each separately gave pts DOB as xx/xx/xxxx, meaning the child would be 12. CDC Vaccination record presented with same DOB and record of previous vaccination. It was not until entering the vaccine into the Database that it was discovered the patients actual DOB was xx/xx/xxxx making her 11 years old. Her record in database had the same mothers 1st name, same middle initial, and same date and location of 1st dose of COVID vaccine. Attempted to follow up with mother over the phone, the line picked up but there was no response when writer identified self. Patient had ill effects at the time of vaccination. Stated only a sore arm with the first dose and no other side effects.
3/14/22@1600 Patient and siblings presented to clinic for scheduled immunizations and COVID vaccine. 3/15/22 RN notified clinic administrator the wrong vaccine had been administered. The patient received Pfizer gray cap for 12 years and older.
got her first shingrix shot Novemember 2019 and due to the pandemic got her second shot yesterday; fever; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in november 2019).   On 1st June 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2021, 1 day after receiving Shingrix, the patient experienced fever, headache and nausea. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the fever, headache and nausea were not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the fever, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received the 2nd dose of Shingrix on unknown arm , due to pandemic it was received late. It was stated that one day after the vaccination the patient experienced fever, headache and nausea. The reporter did not consent to follow up.
Migranes, hot flashes, dizziness, nausea, stomach upset, pin pain heart, swollen tonsils, pin pain gallbladder, pin pain area liver,  pin pain area pancreas, chemical taste,  sore throat, pain both side of ovaries.
Rash started on trunk then spread to face, arms, & groin, days 7/11/19 thru 7/22/19 Apt. Fever 7/18/19 thru 7/21/19.
Pt recvd vax & 2 days p/dose exp localized rash on trunk, arms & back; pt was not treated; outcome: fully reocvered; The rash was considered to be unrelated to the Engerix-B vax;
Vaccine given IM instead of SQ, no symptoms reported, patient was instructed to call pharmacy if any issues arose.
Information has been received from an investigator regarding a 76 year old male who received a dose of Influenza virus vaccine trivalent, types A & B, live cold-adapted (frozen formulation) on 11/10/98 as a part of the study, a Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Efficacy of Protection From Natural Influenza Virus Infection of Influenza Virus Vaccine Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) and Inactivated Influenza Virus Vaccine in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Field Trial". On 11/16/98, the patient developed an exacerbation of chronic obstructive pulmonary disease. He recovered by 12/01/98. The investigator considered the exacerbation of chronic obstructive pulmonary disease (unexpected per the investigator brochure) to be medically important and "possibly" related to study vaccine administration. The medical monitor's assessment was unknown.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2020 as dose 1, single (Lot number: EL0142), in left arm and on 22Jan2020 as dose 2, single (Lot number: EL3302) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SERVENT. Other medication patient received in 2weeks of vaccination included product: Servent, brand: GlaxoSmithKine, lot number: 10 c59c.Known allergies: None.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date:05May2022, Treatment Stop date:06May2022, Lot number: FY0461, Indication: Treatment of COVID-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded
Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breathe and chest pain.
Extreme pain, unable to move arm for 2 days - limited arm function for several days with pain. Full arm functions after 7 days and still sore. Profuse sweating; decreased energy.
Neck Pain; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. This case was reported for reporter's wife. The patient received Shingrix and experinced neck pain. The reporter did not want to provide any additional details on adverse events.
morning after receiving the Pneumovax vaccine, red & splotchy rash on upper arm away from injection site, pain, tenderness, warm skin.  Next day redness had spread: called and visited doctor on 9/3/09 who diagnosed cellulitis and prescribed Clindamycin for 7 days.  Indicated situation would be serious if infection reached the elbow or shoulder joint.  Experienced patches of warm, red, itchy areas that would come and go only at the site of the cellulitis on day 2 of antibiotic.  That resolved in 24 hours.  Finished antibiotic 3 days ago, and SO FAR recovery OK and no apparent sequelae from Clindamycin to date.
pain on hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on hand) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 636A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain on hand). At the time of the report, PAIN IN EXTREMITY (pain on hand) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication details include diabetes medication. No treatment medication details was reported.
The vaccine leaked during administration/She is unsure how much the patient received; She had a defective needle; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The vaccine leaked during administration/She is unsure how much the patient received) and DEVICE CONNECTION ISSUE (She had a defective needle) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-May-2021, the patient experienced UNDERDOSE (The vaccine leaked during administration/She is unsure how much the patient received) and DEVICE CONNECTION ISSUE (She had a defective needle). On 03-May-2021, UNDERDOSE (The vaccine leaked during administration/She is unsure how much the patient received) and DEVICE CONNECTION ISSUE (She had a defective needle) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported There were no adverse effect on patient and was under supervision for 20 min after vaccine was administered.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Additional information received and reporter details, Start and stop date of vaccine administration was updated. On 18-Nov-2021: Follow up received and contains no new information On 18-Nov-2021: Patient demographics were updated. Suspect product details (start date updated from 02-Nov-2021 to 04-Nov-2021)
Received vaccinations. Left clinic room about 3-5 minutes later.  Client noted to have passed out @ front window of health department.  Mother stated that she didn't sustain any injury, but fell against her and her sister before she went to the floor.  Profuse sweating, very pale.  2 nurses assisted with elevating legs and placing ice pack on nape of neck.  Remained there for more than 5 minutes.  Sips of water offered when she was alert.  Then placed in a chair in waiting room with ice pack in place for about 10 minutes.  Walked out of the office without assistance.
Took two doses of Vivotif on consecutive days; Spontaneous report received on 08AUG2020.  A pharmacist reported that a male consumer "took two doses of Vivotif on consecutive days" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. On an unknown date, the consumer started Vivotif. He took two doses of Vivotif on two consecutive days. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer took two doses of Vivotif on consecutive days (inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer took two doses of Vivotif on consecutive days (inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.
Circular red patch around the vaccination site (about 2 inches in diameter), itchy & hot to the touch. Mildly painful on contact. It has been 3 days since the vaccination & the patch shows no sign of getting better.
Itchy rash on hand, stomach, and leg which lasted for about an hour; Patient did not receive second dose; Pain in extremity; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on hand, stomach, and leg which lasted for about an hour.), OFF LABEL USE (Patient did not receive second dose) and VACCINATION SITE PAIN (sorearm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash on hand, stomach, and leg which lasted for about an hour.), OFF LABEL USE (Patient did not receive second dose) and VACCINATION SITE PAIN (sorearm). At the time of the report, RASH PRURITIC (Itchy rash on hand, stomach, and leg which lasted for about an hour.), OFF LABEL USE (Patient did not receive second dose) and VACCINATION SITE PAIN (sorearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided No treatment was reported  The consumer reported that, had not received the second vaccine because the company advised to do so.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Non significant FU, narrative updated