chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMSIT QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 17-Dec-2013. The reporter mentioned that patient had inadvertently given expired doses of FLUMIST on 17-Dec-2013. The outcome of the event of we inadvertently gave expired doses of FLUMIST is unknown. The report was considered to be non-serious.
Tachycardic and anaphylactic shock.  Heart beat over 140 out of the blue while laying on couch, throat felt like something was lodged in it, Voice became very raspy, felt out of breath.
PERSONALITY CHANGED; SICK; SCREAMED TO HIGH HEAVEN FOR 6 HOURS; GOING CRAZY; VERY ANXIOUS; POUNDING HEADACHE; This spontaneous report received from a consumer on 16-JUL-2021 and concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had regular ongoing medical care that she got. she was taking a couple of pills a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 personality changed, sick, screamed to high heaven, going crazy, very anxious, and pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from personality changed, sick, pounding headache, screamed to high heaven, going crazy, and very anxious. This report was non-serious.
This spontaneous report as received from a nurse via Company Representative refers to a 63 year old male patient. Medical history and concurrent conditions were not reported. On 18-MAR-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse reported that a patient received a dose of PNEUMOVAX 23 and was diagnosed with pneumonia on 21-MAR-2014. The outcome of pneumonia was not reported. It was reported that patient sought medical attention. Additional information has been requested.
Has a bad headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Has a bad headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Has a bad headache). At the time of the report, HEADACHE (Has a bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe diarrhea - ER visit; still not better after 4 days; started losing ability to walk or hold things w/hands; ER to Hosp-spent 13 days. Had IVIG treatment and diagnosed w/GBS! Am still in rehab hosp- can't walk.
1 hour after receiving vaccine in (L) arm her arm started hurting. By end of shift couldn't lift arm without "extreme" pain. Lasted 2 days. Next AM had marble sized swollen lymph node (L) side of neck. Neck very stiff. Skin felt tight. A month later still has swollen area, size of small chickpea. Achy for 3-4 days no fever. Arm red at injection site about size of palm of hand.
Patient complaint: left arm pain from shoulder to elbow beginning 11/11/18 after flu shot.
Experienced anaphylaxis after receiving the Pneumovax23; This spontaneous report was received from a pharmacist, via a company representative, referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were unknown by the reporter.   In May 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).         On an unknown date in 2019, the patient experienced anaphylaxis and she visited the physician. It was unknown by the reporter whether the patient received treatment, or if any laboratory tests were carried out.  The outcome of anaphylactic reaction was unknown. Causality assessment was not provided.  Upon internal review, anaphylactic reaction was considered to be a medically significant event.
One day post vax, "non-specific test for hepatitis" was reportedly positive. Additional tests didn't confirm this. Most recent information indicated this was a false positive test.
patient was given a dose of Infanrix in error instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: patient was given a dose of Infanrix in error instead of Boostrix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-AUG-2023 The reporter was a medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a patient was given a dose of Infanrix in error instead of Boostrix, which led to wrong vaccine administered.
This spontaneous report as received from a Registered Nurse refers to a 23 year old female patient. On 27-APR-2015, the patient was vaccinated with the first dose of GARDASIL that had expired on 19-MAR-2015 (0.5 ml, intramuscular in the left deltoid, lot # H013977). No adverse effect was reported. Additional information is not expected as the reporter did not want any follow up correspondence.
Fever & Chills (about 12 hours after injection and lasted for a few hours), Fatigue/Tired (for 24-48 hours after injection), Brain Fog (for 24-48 hours after injection), Lower back pain (for 2-3 days after injection), Sore Arm (for 4 days after injection)
pneumonia was hospitalized for 3 days,; we can NOT get the 2nd shot; constipation; Diarrhea; difficulty breathing; Chills; fatigue (slept for 5 days); Pain everywhere; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia was hospitalized for 3 days,) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia was hospitalized for 3 days,) (seriousness criteria hospitalization and medically significant), PRODUCT DOSE OMISSION ISSUE (we can NOT get the 2nd shot), CONSTIPATION (constipation), DIARRHOEA (Diarrhea), DYSPNOEA (difficulty breathing), CHILLS (Chills), FATIGUE (fatigue (slept for 5 days)) and MYALGIA (Pain everywhere). The patient was treated with LEVOFLOXACIN for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, PNEUMONIA (pneumonia was hospitalized for 3 days,), PRODUCT DOSE OMISSION ISSUE (we can NOT get the 2nd shot), CONSTIPATION (constipation), DIARRHOEA (Diarrhea), DYSPNOEA (difficulty breathing), CHILLS (Chills), FATIGUE (fatigue (slept for 5 days)) and MYALGIA (Pain everywhere) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided  Patient underwent treatment medication of levofloxacin, ibuprofen and 5 others in hospital.  Patient and her husband were told by Moderna, the state and the local health department that they could not get the 2nd shot and they could not start over.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report also refers to a case of missed dose.   This case was linked to MOD-2021-080331 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up received- Event-missed dose added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report also refers to a case of missed dose.
Patient fully vaccinated (J&J), but not boosted, admitted to the hospital on 6/27/22 with COVID-19 and associated hypoxia. Patient was admitted after Dose 1 of J&J vaccine (received on 4/1/21). Patient was discharged on 7/8/22.
Hives; Itching; Feeling hot; cough; runny nose; heightened sense of smell; phlegm; skin rash; Headache; still have not got my second shot because I still have Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Itching), FEELING HOT (Feeling hot), COUGH (cough) and RHINORRHOEA (runny nose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy since 1996.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), PRURITUS (Itching), FEELING HOT (Feeling hot), COUGH (cough), RHINORRHOEA (runny nose), PAROSMIA (heightened sense of smell), PRODUCTIVE COUGH (phlegm), RASH (skin rash), HEADACHE (Headache) and INTENTIONAL PRODUCT USE ISSUE (still have not got my second shot because I still have Symptoms). At the time of the report, URTICARIA (Hives), PRURITUS (Itching), FEELING HOT (Feeling hot), COUGH (cough), RHINORRHOEA (runny nose), PAROSMIA (heightened sense of smell), PRODUCTIVE COUGH (phlegm), RASH (skin rash) and HEADACHE (Headache) had not resolved and INTENTIONAL PRODUCT USE ISSUE (still have not got my second shot because I still have Symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  information about concomitant and treatment medication was provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received contains information that patient has not received second shot yet because he still has symptoms of first dose, added event - Intentional deviation from dosage regimen, allergic to penicillin.
On the day of vaccination - local discomfort, which later in the day progressed to moderate pain on the outer side of left upper extremity (LUE) till the wirst; severe chills all night Day after vaccination - left upper extremity pain persisted; moderate to severe chills all night Subsequent days - LUE pain became limited to the left upper arm persisted at a mild level. Day 7 post-vaccination - induration covering ~ 3" x 4" area on the outer side of left upper arm, with increased discomfort, increased local temperature and ecchymosis without any preceding local trauma other than the shot a week back,which persisted for 4-5 days. Ongoing symptoms - left upper arm discomfort is persisting and upper arm feels weaker
Pt reported a knot in her arm at injection site, was red and a little swollen. She made a complete recovery, did not seek medical attention.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-MAR-2022; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-MAR-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-MAR-2022) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2022 at 2:49 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Mar-2022 at 2:49 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was reported.  Concomitant medications were not reported by the reporter.   Patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  Treatment medications were not reported by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Rash/hives and itching on arm next to vaccine site that eventually (after about 1 week) bruised and went away.
Extreme itching on dorsal surface of extremities - hands, forearms and lower legs. Extreme irritability, unable to sleep for several days
Night of receiving vaccine I had very intense aching in my lower left back. Felt somewhat like a muscle pulling. I could barely turn. Soon after I began having a pulled muscle pain in my chest. I also have a big, hard lump in my chest. The pain has been going on for over a month. Lower back pain comes and goes but chest muscle pain is always there. None of this was happening prior to the vaccine.
balance problems; herpes zoster; demyelinating disease; postherpetic neuralgia; issues with her vision; Information has been received from a lawyer referring to a patient (pt) of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after zoster vaccine live (ZOSTAVAX) inoculation), the pt suffered from herpes zoster, postherpetic neuralgia, demyelinating disease, issues with her vision and balance problems. The pt was seen and treated by a healthcare provider and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Th pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster, postherpetic neuralgia, demyelinating disease, issues with her vision and balance problems was not recovered.   The reporter considered the events herpes zoster, postherpetic neuralgia, demyelinating disease, issues with her vision and balance problems to be disability.     Upon internal review, the event demyelinating disease was determined to be medically significant.
Felt burning  towards the ears and cheeks and some numbness, reported not having any difficulty breathing but felt like she had to take off her mask to get "air", slight numbness in the arms and felt flushed.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Daughter was diagnosed with Covid. It was a very mild case) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 24-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced COVID-19 (Daughter was diagnosed with Covid. It was a very mild case). At the time of the report, COVID-19 (Daughter was diagnosed with Covid. It was a very mild case) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2022, SARS-CoV-2 test: (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and Treatment medication information was not provided. It was reported that the symptoms improved and had to seek medical care. Allergies and medical history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination were unknown. She did not experience a similar event in the past. It was unknown if patient was given any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Company Comment: This spontaneous case concerns a 2-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 7 days after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient tested positive for SARS-CoV-2 on the same day after receiving the vaccine. After 7 days, the patient was diagnosed with COVID-19. No symptoms were reported, however, the reporter stated that it was a very mild case. The patient was brought for consultation, however, no details were provided. Treatment information was also not provided. However, the event had resolved at the time of the report. The patient's young age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 2-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 7 days after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient tested positive for SARS-CoV-2 on the same day after receiving the vaccine. After 7 days, the patient was diagnosed with COVID-19. No symptoms were reported, however, the reporter stated that it was a very mild case. The patient was brought for consultation, however, no details were provided. Treatment information was also not provided. However, the event had resolved at the time of the report. The patient's young age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
9 days after vaccinaton of the MMR vaccine child had fever of 100.5 and also presented with a rash on trunk and extremities.  Mother called on day 11 describing symptoms to nurse.  Pt does have a hx of egg allergy.
Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and HEADACHE (Headache) had not resolved and PYREXIA (Fever) outcome was unknown. 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.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
on day 8th after vaccine, itching and painful circular area noted at the site (left arm) about 5inch in diameter, swollen and warm to touch, called primary physician who contacted allergist and 5 day course of Prednisolone was prescribed
1Sep92 presentd /w cough-dx URI /w cough.10Sep92 presented /w worse cough-dx RAD, ROM.13Sep92 presented cough until gags-dx bronchitis.17sep92 persistant cough-ordered DFA & cult for pertussis & RSV.21Sep92 cyanosis /w cough adm to hosp
mom reported rash w/edema on face & hands of pt;MD recommended oral DPH;
Mother called today concerned that Avery received his 2nd Hep A vaccine 4/6/21 and that night he developed a stutter.  Mother reports no history of symptoms prior stating "he was very articulate before."
High Fever, Small rash, starting on 7/25. Doctor checked on 7/26, no visable signs of reason for fever. Dr. recomended fever reducers if patient temp over 101.9.
IM influenza vaccine was mistaken for 'FluMist' and administered to the nasal passage as a liquid. Once mistake was determined it was given IM.
Dizzy, faint, joint pain and stiffness, nausea, weakness, fatigue, chills, fever, confusion, headache.
Shot hurt more than usual. Administrator actually told me to breathe because I winced.  I expected some soreness, but this was a pretty quick onset of soreness in the vaccination site.
Accelerated heart rate/irregular heart beat.   Resting HR is normally 80bpm.  At around 1pm RHR went up to 110-120 with SVT
Area redden, hot to touch 15 cm x 10 cm. Patient to follow up 5-18-2018. Patient given BENADRYL 50 mg 5-17-18 IM at 855 am.
Information has been received from a registered nurse concerning a patient (age and gender not reported) who on unspecified dates was vaccinated with 3 doses of Rotateq (Lot #'s were not available). Subsequently the patient tested positive for rotavirus. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.