chrisvoncsefalvay/vaers-outcomes huggingface dataset:
did not feel good; headache, chills, dizzy and weak; headache, chills, dizzy and weak; threw up; headache, chills, dizzy and weak; headache, chills, dizzy and weak; sick all day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (headache, chills, dizzy and weak), ASTHENIA (headache, chills, dizzy and weak), ILLNESS (sick all day), FEELING ABNORMAL (did not feel good) and CHILLS (headache, chills, dizzy and weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (headache, chills, dizzy and weak), ASTHENIA (headache, chills, dizzy and weak), ILLNESS (sick all day), CHILLS (headache, chills, dizzy and weak), HEADACHE (headache, chills, dizzy and weak) and VOMITING (threw up). On 14-Feb-2021, the patient experienced FEELING ABNORMAL (did not feel good). The patient was treated with PARACETAMOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (headache, chills, dizzy and weak), ASTHENIA (headache, chills, dizzy and weak), ILLNESS (sick all day), FEELING ABNORMAL (did not feel good), CHILLS (headache, chills, dizzy and weak), HEADACHE (headache, chills, dizzy and weak) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-Significant follow up appended to AER
Pt reports she passed out at home for about 10 seconds (witnessed by boyfriend). Upon awakening, pt felt panic, scared, but was hot. After recovering from passing out, pt reports headache.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that patient received 2nd booster dose. No treatment medications were provided.
Headaches, extreme chills, muscle and body ache, also exhaustion with slight fever.
Pt called in on 11/3 to report her adverse rxn to the influenza vaccine given on 11/2. Pt reported rash, redness, and swelling around the injection site. The area affected was ~8 in by 3 in. Small blisters/bubbles in the skin formed. Pt came into the pharmacy on 11/5, and the skin problems were improved. Skin was still slightly red, especially area around smallpox scar.
she had cold and tested positive on the day she is scheduled for her second; she had cold and tested positive on the day she is scheduled for her second; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. CEP ID: 159558  A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, solution for injection, Lot No unknown), via an unspecified route of administration on 04Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Feb2021 (on the day she is scheduled for her second), patient experienced cold and tested positive. The patient underwent lab test which included SARS-CoV-2 test: Positive on 25Feb2021. The patient stated that stated she came out of quarantine on 06Mar2021 (Saturday). The patient was advised that she was not allowed to take the second dose because of her cold. Patient asked if she could get the second dose now since she no longer has cold. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender with an unspecified allergy to neomycin (manufacturer unknown). On 30-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, indication and lot # were not reported) despite an unspecified allergy to neomycin (manufacturer unknown). Concomitant medication was not reported. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 28-NOV-2015 at time- 00:20, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.3 and 1.8 (units unspecified) for 6 hours 40 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
FLU LIKE SYMPTOMS AFTER BEING VACCINATED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: paliperidone palmitate ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the subject experienced flu like symptoms after being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with paliperidone palmitate was not reported. The outcome of flu like symptoms after being vaccinated was not reported. This report was non-serious.
This spontaneous report was received from a Registered Nurse via a company representative, regarding a female patient of unknown age. Patient's medical history and concomitant conditions were not informed. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route, frequency and lot No. were not provided). Concomitant medications were not described. On an unspecified date, the patient experienced a seizure after her second dose of GARDASIL. The patient sought medical attention as she was in hospital. It was unknown whether the vaccine was GARDASIL or GARDASIL 9. At the time of this report, the outcome of seizure event was unknown. Upon internal review, the event seizure was considered as medically significant. No product quality issue was reported. Additional information has been requested.
Patient diagnosed with Guillain Barre Syndrome 1 month after vaccine administration. Symptoms of muscle weakness 2 weeks prior to admission. Received medical records from hospital which reveal patient was admitted 8/16/05-8/21/05 with diagnosis of post vaccination Guillian Barre Syndrome.  Symptoms included progressive muscle weakness & difficulty walking over about 2 weeks prior to admit.  During hospitalization had some autonomic instability including bradycardia, tachycardia& questionable urinary problems.  Treated for 5 days w/IVIG, PT/OT.  Was to continue PT/OT on outpatient basis for continued but improved muscle weakness & abnormal gait.
This case was reported by a physician via sales rep and described the occurrence of rash in a 57-year-old male patient who received SHINGRIX. On 29th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. The reporter considered the rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 56 years or 57 years. The patient received SHINGRIX in unknown deltoid. In 2018, the patient experienced rash described as non-itchy, relatively mild, and non-disseminated. The rash resolved within 24 hours of presentation. This case has been linked with US2018064601, reported by same reporter.
2nd dose administered to patient from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  No Treatment information was provided.  Patient did not experience any adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Patient demographics, vaccine facility information and dose details like route and anatomical location were updated On 07-Sep-2021: No new information
Fatigue, fever, chills, headache and arm soreness beginning the same day as the vaccination date through to end of the following day
1/12/22 pt brought to Ed via EMS reporting poor oral intake; O2 sats 85% on RA; placed on NRB; decreased responsiveness, diarrhea x 2 days, vomiting 1 x; admitted started on ABX and fluids; found to be positive for COVID; given Remdesivir, Heparin; pt's condition worsened became hypothermic requiring Bair Hugger blanket; severe sepsis; poor prognosis; DNR; in patient hospice where he expired
pt presents to hosp with worsening SOB; had a positive COVID test 3 days before hosp admission; treated with dexamethasone, remdesivir, heparin drip; O2 supplementation (BiPAP); transferred to ICU; DNR/DNI; respiratory status worsened and pt passed away in the hospital
The day after shot I had itching that went away, felt tired a couple of days, today which is one week later I developed a rash and swollen with a itch again
ACHEY; MILD HEADACHE; LIGHT HEADED/DIZZINESS; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204a21a, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced light headed/dizziness. On 21-MAY-2021, the subject experienced achey. On 21-MAY-2021, the subject experienced mild headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from achey, and mild headache on 21-MAY-2021, and was recovering from light headed/dizziness. This report was non-serious.
Right side of head and right ear feel muffled. Feels like right ear needs to pop but it won?t. Sound isn?t as clear for the right ear as it is for the left ear. Never had any hearing issues previously.
Transient small bowel - small bowel intussusception with reduction during abdominal ultrasound. 3 days of increasing episodes of painful crying, drawing up legs.
Patient received adult dose (0.3mls) of undiluted covid19 (pfizer age 5-11) pediatric vaccine on 3/18/22 and as of 3/21/22 states her only symptoms have been a sore arm
Reminds me of my passing from covid he was fully vac with pfizer; Reminds me of my passing from covid he was fully vac with pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), SUSPECTED COVID-19 (death, medically significant), outcome "fatal" and all described as "Reminds me of my passing from covid he was fully vac with Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The patient date of death was unknown. Reported cause of death: "Reminds me of my passing from covid he was fully vac with Pfizer". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Reminds me of my passing from covid he was fully vac with pfizer; Reminds me of my passing from covid he was fully vac with pfizer
No actual adverse reaction at this time, vaccine was administered outside of approved use. Patient is 17 years 10 months, and product is approved for 18+.
J96.00 ACUTE RESPIRATORY FAILURE 3/13/2022 PNEUMONIA R09.02 HYPOXIA 3/13/2022 PNEUMONIA
A non-serious, spontaneous report of administration of FLUMIST to a pregnant female was received from a registered nurse concerning a 32-year-old female patient. The patient's medical and obstetrical history was not provided. The patient received FLUMIST on 03-Oct-2009. There was no adverse event experienced to date. Treatment and reporter/sponsor causality assessment are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the subject experiences any adverse events during the pregnancy.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-AUG-2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-JAN-2012, the patient was treated by a physician at a family medical center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
pt recv vax & devel inj site rxn of swelling,warmth & pain.Pain radiated to shoulder & above elbow. Pt recovered 5 days later. This is 1 of 3 pt to have adverse rxn p/vax w/lot #4968253
Patient felt lightheaded immediately following both vaccinations. Patient tried getting up to leave, but was unable to make it out of the pharmacy before sitting down on the ground. Symptoms: Lightheadedness, dizziness, blurry vision, syncope.
3 days after receiving the second hpv vaccine, my daughter felt very lightheaded, racing heart, tunnel vision, felt like she would pass out.  These symptoms worsened in frequency and severity over the next 6 months and then she was diagnosed with Autonomic Dysfunction and then POTS.
Erythema-moderate, large area (3" diameter) of injection site. Induration-moderate in area of injection site. Pain-above average: required Motrin (400 mg) for 3 days.
Bleeding at injection site upon injection.  The arm was painful all night, and it made sleeping difficult.  Bruising all around injection site the size of an egg.  Halfway down my arm between the injection site and the elbow is an area about 4 inches across by 2 inches high on my arm that is hot to the touch and red in appearance.  Arm pain is not as bad as first day.
ACUTE STROKE DUE TO OCCLUSION OF LEFT CEREBELLAR ARTERY 3/31/2021 ACUTE DVT OF RIGHT INTERNAL JUGULAR VEIN  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/31/2021 ACUTE DVT OF RIGHT INTERNAL JUGULAR VEIN  ACUTE STROKE DUE TO OCCLUSION OF LEFT CEREBELLAR ARTERY 3/31/2021 HYPERKALEMIA  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/31/2021 HYPERKALEMIA  ACUTE STROKE DUE TO OCCLUSION OF LEFT CEREBELLAR ARTERY 3/31/2021 ACUTE STROKE DUE TO OCCLUSION OF LEFT CEREBELLAR ARTERY  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/31/2021 ACUTE STROKE DUE TO OCCLUSION OF LEFT CEREBELLAR ARTERY
Painful joints, lasted 1 week after 1st and 2nd shot.  Eczema on palms of both hands which I have never had before which started after 1st shot. Lasted over 2 months. Painful joints in both hands similar to arthritis, which I never had before at all...pain still persists.
Itching all over, whole body. Still itching after one week. Using oral BENADRYL and BENADRYL gel. After one week still itching some when the BENADRYL wears off.
Received shot on 12/05; On 12/09/02, had nasal congestion, thick green drainage from nose; No fever (Mother reports she had an URI also) slight cough, On 12/13 had fever of 102, Mom treated with tepid bath. On Morning of 12/04 had temp of 101; Mother again gave tepid bath ; No other fever noted. Yesterday morning was acting clingy, wanted to be held; No fever; Mother noted child had broke out with chicken pox all over his body, Head to toe; Some places appear to still be "under the skin" other places look like chicken pox.
Sick to stomach; Fatigue; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6200) via an unspecified route of administration in the left arm on 26Feb2021 at 15:00 (at the age of 80-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 COVID-19 vaccine. The concomitant medication included vitamins (unspecified) for an unknown indication from an unknown date and unknown if ongoing. On 26Feb2021 at 21:00, the patient experienced sick to stomach and fatigue. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sick to stomach and fatigue was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via sales rep and described the occurrence of mobility decreased in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced mobility decreased and feeling abnormal. On an unknown date, the outcome of the mobility decreased and feeling abnormal were recovered/resolved. It was unknown if the reporter considered the mobility decreased abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After injection of SHINGRIX, the patient reported she could not move her arms. The reporter said she was almost in a coma like state. The patient went to bed, and mobility returned in the next morning.
dry cough/ coughing; not feeling well; booster shot; too strong for her body; physically weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 24Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "wife's immune is kind of slower" (unspecified if ongoing), notes: States his wife's immune is kind of slower. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Dec2021, outcome "unknown", described as "booster shot"; COUGH (non-serious) with onset 26Dec2021, outcome "not recovered", described as "dry cough/ coughing"; MALAISE (non-serious) with onset 26Dec2021, outcome "not recovered", described as "not feeling well"; ASTHENIA (non-serious) with onset Dec2021, outcome "not recovered", described as "physically weak"; DRUG INTOLERANCE (non-serious) with onset 24Dec2021, outcome "unknown", described as "too strong for her body".  The lot number for bnt162b2 was not provided and will be requested during follow up.
MIGRAINE FOR 3 DAYS; BODY ACHES ESPECIALLY IN LEGS; CHILLS; ACHES IN INJECTED ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced migraine for 3 days, body aches especially in legs, chills, and aches in injected arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from migraine for 3 days, body aches especially in legs, chills, and aches in injected arm. This report was non-serious.
Pt was hospitalized with severe sepsis and septic shock with hypotension,  hypothermia, bradycardia, AKI, pancytopenia requiring pressors on 3/11/21. This was 14d after the initial vaccine. He received his second vaccine on 4/2 and was hospitalized with severe sepsis again on 4/27/21 with similar symptoms. First episode c/o diarrhea but no pathogen identified. Second episode with bilateral multifocal pneumonia but no pathogen identified.