chrisvoncsefalvay/vaers-outcomes huggingface dataset:
25 Year old female suffers pericarditis after her second moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (25 Year old female suffers pericarditis after her second moderna COVID-19 vaccine) in a 25-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (25 Year old female suffers pericarditis after her second moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (25 Year old female suffers pericarditis after her second moderna COVID-19 vaccine) outcome was unknown.            No concomitant medication information was reported. No treatment medication information was reported.  Company comment: This spontaneous case concerns a 25-year-old, female patient, with no reported medical history, who experienced the expected, serious (Medically significant) AESI pericarditis. The event occurred after an unknown time of interval from receiving the second dose of mRNA-1273 vaccine, as nor vaccination or event dates were reported. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 25-year-old, female patient, with no reported medical history, who experienced the expected, serious (Medically significant) AESI pericarditis. The event occurred after an unknown time of interval from receiving the second dose of mRNA-1273 vaccine, as nor vaccination or event dates were reported. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Fever, rigors, myalgia, arthralgia onset 12h post vaccination, resolved 36 h post vaccination, severity grade 3/unable to carry out usual activities
Bell's Palsy; swollen tongue; itchiness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 14:30 (Batch/Lot Number: EL9262) (at the age of 32 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included immunoglobulin g4 related disease (IGG4-RD) and rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took rituximab (RITUXAN) and experienced drug allergy and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686) in the left arm on 07Jan2021 at 02:30 pm for COVID-19 immunization and experienced rash in face and back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 01Apr2021, the patient experienced Bell's Palsy, swollen tongue and itchiness. The events resulted in emergency room/department or urgent care.  The patient was hospitalized for the events for 3 days. The patient received treatment for the reported events. Since the vaccination, it was unknown if patient has been tested for COVID-19. The outcome of the events was recovering.
Initial information received from physician on 11-OCT-2103. 7 month old had one dose of FLUZONE and another 12 days later. No further relevant information reported.
Child was given TDAP, Hep A in Left Deltoid, then given Flu in Right Deltoid.  While administering the additional vaccine (Menveo) in rt deltoid, the child had syncope.  He turned pale and was not breathing.  He was lowered to the floor; his feet were elevated.  Sternal rub started, he began to have seizure like activity and he took a breath.  Episode lasted approximately 20 seconds.  Ambulance was called for the child. No further treatment occurred.
Cluster headaches, pain 3-4/10 beginning approximately seven hours after administration and pain increased to 6-7/10 approximately 12 hours after administration. Pain subsided to 2/10 approximately 24 hours after injection.  Chills, beginning approximately seven hours after injection and continuing for approximately 20 hours. Intermittent uncontrolled, severe shivering with teeth chattering approximately 2-3 times per hour for approximately eight hours.  Bilateral neck pain 4-5/10 and neck stiffness beginning approximately seven hours after administration and continuing for approximately 20 hours.
Localized erythema @ inject site, c/o intense, itching @ site only 15 mins p/vax; ice pack to site; DPH recvd;
5 hours after second injection sever fatigue slept 48 hours with flu symptoms, whole body ache. Massive headache neck pain sever after 2 days the headache and neck pain subsided  I have had since then a monster of a arthritis flare up Prior to vaccine I had a light nuisance arthritis occasionally in rist and hands    Now my body aches 24-7 at times my hands hurt so badly I can't dress eat pickup a cup of coffee or get keys out of pants pocket without real pain. I have pain in knees back neck everywhere  This is all day and night I awake at night in pain repeatedly every night. I deeply regret my vaccination
I tested positive for COVID-19 on 10/5/22. I had a high fever, fatigue, and congestion. I also had brain fog that lasted for about a month. It was hard to concentrate. I contacted my doctor and was prescribed 5 days worth of PAXLOVID. I started feeling better not long after taking PAXLOVID. I was still testing positive on day 10, but the CDC website stated that I was no longer contagious.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 18-NOV-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, lot#, expiration date and route not reported). No adverse effects were reported. Additional information is not expected because the physician could not be contacted.
full body rash; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 25 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 11Feb2022 14:00 (Lot number: FL3198, Expiration Date: 20Apr2022) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D2. The following information was reported: RASH (non-serious) with onset 12Feb2022, outcome "recovered" (Feb2022), described as "full body rash". The event "full body rash" was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of rash.  Additional information: The report was related to a study or programme. She stated a female patient that received the 1st dose of the Comirnaty vaccine on 11Feb2022 developed a full body rash 30 hours after receiving the dose and went to the ER. Reporter mentioned that 3 days after the event, the rash was completely gone with no residual effects. Reporter asked if there was any information on whether she could receive or not the second dose and if there were any studies about it. The patient also mentioned to them the time when she got it, that would be 2 PM and after 24 hours the patient got body rashes and the health care provider also mentioned the covid 19 vaccine that they provide that would be grey cap. Pharmacist stated, "20Apr2022, that was the best use date, pharmacist thought instead of expiration date." (Further clarification unknown). Pharmacist mentioned that the patient had marked no for prior to vaccination within 4 weeks. Pharmacist wanted to know if Pfizer had any data on whether or not she should take the second shot as she had body rash."  No follow-up attempts are possible. No further information is expected.
inc temp approx 6hrs p/vax given w/shaking-taken to Er given fever suppository-adm APAP q 4-6 hr-PRN
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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. There was no other medication in 2weeks. Symptoms rebound/return to positive covid test after stopping Paxlovid. There was no known allergies. There was no other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to unspecified multiple patients. There was no information about the patients' concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, multiple unspecified patients were vaccinated with improperly stored PEDVAXHIB lot # N001348 with expiration date of 31-OCT-2019, lot # N012120 with expiration date of 30-JAN-2020, lot # N012920 with expiration date of 07-FEB-2020, and lot # N007752 with expiration date of 01-DEC-2019; for prophylaxis (dose, route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 0°C to 1°C degrees for 4 hours and 20 minutes. Data logger was not involved. There were previous excursions of 0°C to 1°C for 51 hours (6 cycles). No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009564: US-009507513-1709USA009565: US-009507513-1709USA009566.
2 weeks after his 2nd moderna vaccine he developed neuropathic pains in legs and arms. mostly at night.
SHIVERING/CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 20-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, Laboratory data included: Body temperature (NR: not provided) Fever of 102 degree F. On 20-MAR-2021 22:00, the patient experienced shivering/chills fever and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering/chills on 20-MAR-2021, and had not recovered from fever, and headache. The reporter consider related causality between covid-19 vaccine ad26.cov2.s and event shivering/chills fever, and headache. company causality between  covid-19 vaccine ad26.cov2.s and event shivering/chills fever, and headache was possible.   This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Two hours after the injection  both of my leg seized. The muscles so tight that I was unable to walk (like a spasm). There was no twitch the a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body) .   I also had bilateral jaw pain  (not sure if its was because I was in so much pain in the legs that I was clenching my teeth) I also  had slight numbness on by left face and by the evening I had redness on my left cheek but it went away.   My face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw.
1) Injection site soreness, intensified approximately 3 hours after injection, peak at 24 hours after injection. Resolved approximately 72 hours after injection. 2) Stool consistency was between 5 and 6 on Bristol chart. Bowel movements at 6 times over the course of first day of immunization, approximately once every 1.5 to 2 hours starting close to 3PM (3 hours post-injection). Woke twice from description of bullet point 4 due to bowel movement. Resolved by 24 hours. 3) Muscle pain/tightness in other locations of body, such as upper left thigh, right shoulder, right buttock starting approximately 24 hours after injection.  These were not experienced prior to vaccine, although occasional skeletal related pain in right shoulder from prior injury one year prior is reported. 4) Fatigue began approximately 6 hours after injection, drowsiness following where patient was somnolent 12 hours after injection (4 to 5 hours prior to typical sleep time for patient).
This spontaneous report was received from a pharmacist regarding a 65-year-old female patient. The patient's medical history was not reported and concurrent condition included unspecified pain. The patient had received PREVENAR 13 and unspecified influenza virus vaccine (Manufacturer unknown) on 09-SEP-2015. On 16-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (injection, subcutaneous, lot # K020186, expiry: 27-JAN-2016) dose and frequency unspecified in the arm. Concomitant medications included unspecified pain medication. On 17-SEP-2015, the patient experienced pain at the injection site of ZOSTAVAX. The patient had visited the pharmacist on 19-SEP-2015. The injection site was red, painful and warm to the touch. The pharmacist stated that the "redness encompassed the patient's whole tricep and down onto the elbow of the patient." Pharmacist declined the VZV packet as he stated there was no visible rash outside of the redness on the arm of the patient that was administered with ZOSTAVAX. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the events and ZOSTAVAX, PREVENAR 13 and unspecified influenza virus vaccine (Manufacturer unknown). Additional information has been requested.
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site). At the time of the report, INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        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.   Treatment medication was reported by the reporter.
After the vaccine I was very sick for about four days. I tested positive for COVID on January 3,2021.
Sudden rapid heartbeat and breathlessness, followed by shaking and nauseousness. Symptoms are similar to a panic attack.
Case number PHEH2014US018225, is an initial spontaneous report received from a medical assistant on 09 Sep 2014. This report refers to a 12 years old male patient. His medical history and concomitant medications were not reported. It was reported that MENVEO vaccine was at 47 F for 10 minutes on 29 Aug 2014. On 04 Sep 2014, the patient was vaccinated with 0.5 ml intramuscular MENVEO (batch number: not reported) which underwent temperature excursion. No adverse event was reported following this administration error.
BODY ACHES, CHILLS, LOW GRADE FEVER 99.5-100.0
BUD date 04/07/2022 administered on 4/12/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended revaccination
VERY ACHY AS THE DAY WENT GOT WORSE; CHILLS AS THE DAY WENT GOT WORSE (CURRENTLY COVERED WITH BLANKETS); HEADACHES AS THE DAY WENT GOT WORSE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 213D21A expiry: UNKNOWN) dose was not reported, administered on 12-JAN-2022 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-JAN-2022, the patient experienced very achy as the day went got worse, chills as the day went got worse (currently covered with blankets), and headaches as the day went got worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very achy as the day went got worse, chills as the day went got worse (currently covered with blankets), and headaches as the day went got worse. This report was non-serious.
PARTIAL DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced partial dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose of vaccine administered was not reported. This report was non-serious.
fatigue, fainting, dizziness and seizures starting in 10/08 and lasting until seizure were under control in 3/09 while taking trileptal. There were a few fainting spells and over twenty different seizures during the five month period.   Seizures started again after second dose of gardasil given in 6/09.  9/15/09 Neurology consult records received DOS 6/10/09. Assessment: Complex partial epilepsy. Patient had episode of loss of consciousness. Passed out 7-8 min w/o postictal period. Recurrent episode with whole body jerking following by 30 min postictal period. Continued recurrent seizures. Episodes are preceeded by chest pain.
SEVERE NEUROLOGICAL AFFECTS, PAIN, LOSS OF MOBILITY - ENCEPHALOPATHY
nausea, vomiting, fainted, fell down twice from weakness, fever 102.2 for 3 days and fever 5 days total, swelling and pain at injection arm that continues, no appetite, extreme chills 3 days and shaking, extreme fatigue
Fever 12 hours after vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: 33025BD) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL. Past drug history included: Keflex, reaction(s): "known allergies: keflex", notes: known allergies: keflex. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: ER9727), administration date: 24Mar2021, when the patient was 41 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Lot No: ER8737), administration date: 14Apr2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2022, outcome "recovered" (Jan2022), described as "Fever 12 hours after vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient received other medications within 2 weeks of vaccination are fish oil, mutli vitamin The patient did not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination.  Follow-Up (19Jan2022): Follow-up attempts are completed. No further information is expected.
BODYACHE; COUGHING; CHILLS; FEVER; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced coughing. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, coughing, chills, fever, headache, nausea, and fatigue on 11-APR-2021. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications reported. No treatment information was provided.
FEEL ABIT UNDER THE WEATHER; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (FEEL ABIT UNDER THE WEATHER) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (FEEL ABIT UNDER THE WEATHER). At the time of the report, ILLNESS (FEEL ABIT UNDER THE WEATHER) outcome was unknown.            No concomitant medications were reported. Treatment information was unknown.
STILL LOSE BREATH MORE EASILY 3 MONTHS LATER; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced still lose breath more easily 3 months later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of still lose my breath more easily 3 months later was not reported. This report was non-serious.