chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COLD; SINUS INFECTION; This spontaneous case (PVX2019-1469) was received from a physician on 07-Jun-2019. It describes a female consumer who experienced cold and sinus infection, while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer experienced cold and sinus infection on 06-Jun-2019, while taking Vivotif. Her last dose was due on 08-Jun-2019.  The consumer's medical history included cold and sinus infection.  The consumer's past medication included Augmentin (amoxicillin) for cold and sinus infection.  The consumer was not taking any other medication.  Action taken with Vivotif was unknown.  The clinical outcome of the events was unknown.  The reporter considered the events unrelated to vaccine.  Company's Comment: In this case, the consumer experienced cold and sinus infection while taking Vivotif. Since cold and sinus infection are infectious in etiology, the causality of the events is assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, the consumer experienced cold and sinus infection while taking Vivotif. Since cold and sinus infection are infectious in etiology, the causality of the events is assessed as unlikely with Vivotif.
This spontaneous report was received from a Nurse Practitioner (NP) via a filed representative concerning her daughter who was between the ages of 13 and 17. Medical history and concomitant medications were not provided. On an unspecified date but "within the last year", the female patient (pt) completed GARDASIL series. The pt experienced irregular menstruation after completing the series. She had a follow-up visit with the OB/GYB who did an "extensive work-up" but the doctor could not determine the root cause of the pt's adverse experience. The NP did mention that her daughter had been under a lot of stress which may have contributed to the irregular menstruation. The event resolved. Additional information is not expected as there was no contact information available.
Patient started taking oral vaccine on Friday, 9/1/23 starting with the first dose. on 97/23, patient started having diarrhea. Patient denies having experienced any other symptoms but still continues to have diarrhea . Patient saw medical care on 09/26/23 in which the medical provider recommended Imodium which helped improve symptoms however, patient is still experiencing symptoms today.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 8th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever and product supply issue. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever over 102 degree F. The patient had denied permission to contact their physician.
pain in left arm in vacinity of shot - 2+ days; vertigo starting 24 hours after shot and continuing 1+ days
Moderate to severe reaction at site, (R) FA. 2x2.5 cm knot at site, with induration, redness extending 7x6 cm around inj. site. Cool compresses TID, BENADRYL PRN.
Acute myocarditis presenting with chest pain and elevated troponin I. Admitted toi the PICU at Hospital on 6/2/21 (previously had been in the ER on 6/1/21 at the start of chest pain).
The pt experienced an immediate red urticaria like appearance. Called the pt's home 2 hour later and the baby's father states the child is fine.
Fever day of vacc. Loss of speech, diminished eye-contact, loss of previously acquired skills, loss of interest in previously interesting activities, diagnosed later as Autistic. Developmentally delays when he was meeting milestones prior to vaccination. Records rec'd 10/21/2005, box 7 complete. Information from 60 day follow-up report states: fever, residual symptoms are: lost all speech gained autistic behaviors diagnosed w/autism 4/04. Patient now has a life long disability as a direct result of vaccines that contained mercury/thimerosol a known neuro-toxin since the 1930's. 12/31/09 Lost all previously acquired speech and sitll hasn't regained. Also began exhibiting autisitc behaviors shortly after losing speech. Has not and will not receive any more vaccinations to prevent further damage.
Dizzy; Nausea; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced DIZZINESS (Dizzy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizzy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Client reports that she had a reaction to the vaccine about 1 hour after the vaccine.  Stated she was working at the hospital became diaphoretic, had shortness of breath, all most passed out, had pain in her throat. Stated hospital staff started an IV gave her benadryl.  Reported that her blood pressure was low and that she had rigors for a hour after.  Stated she was monitored at the hospital then released home where she is doing okay at this time.
Approx 4 hours post receiving vaccine - malaise, fatigue, and fever set in. Soon severe burning and redness of both eyes, severe headache. Periorbital swelling and mouth swelling, facial numbness and tingling also manifested. Seen by provider. Reversed effect - IM 50 mg of Benadryl. 12/19/08-records received-10/10/08 allergic reaction to flu shot with oral edema and numbness.
PCR test 06Jan and it was positive; PCR test 06Jan and it was positive; occasional cough; Itchy throat; booster; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 40 years as dose 3 (booster), single, administration date 22Mar2021 (Lot number: EL3247) as dose 2, single and administration date 01Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "PCR test 06Jan and it was positive"; IMMUNISATION (medically significant) with onset 12Oct2021, outcome "unknown", described as "booster"; COUGH (non-serious) with onset 05Jan2022, outcome "recovering", described as "occasional cough"; THROAT IRRITATION (non-serious) with onset 05Jan2022, outcome "recovering", described as "Itchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. It was unknown if therapeutic measures were taken as a result of cough, throat irritation.  Clinical information: son sick with COVID first and then sx started 5Jan2022 occasional cough itchy throat describes as mild symptoms  she did a PCR test 06Jan2022 and it was positive she just got the result. Since the vaccination, patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event vaccination failure, COVID-19, immunization, cough, throat irritation and the suspect drug BNT162B2.
Severe headaches had to see private doctor (also noted) vomiting Dr prescribed Maxalt-MH 10 mg tab
Covid sx mild nasal congestion 15Jan and home Ag positive 16Jan; Covid sx mild nasal congestion 15Jan and home Ag positive 16Jan; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (Lot number: FF2588) at the age of 34 years as dose 2, single and administration date 24Aug2021 (Lot number: FC3180) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Covid sx mild nasal congestion 15Jan and home Ag positive 16Jan". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: + covid sx mild nasal congestion 15Jan and home Ag positive 16Jan. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. It was unknown if  patient receive any other vaccines within 4 weeks prior to the COVID vaccine and was the patient diagnosed with COVID-19 Prior to vaccination and has the patient been tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 19-FEB-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Approximately 36 hours after second dose- patient went into late preterm labor of 36w6d. Infant was born weighing 6lbs 3.8oz on 2/21/21. Due date was 3/14/21.
CHILD'S DATE OF BIRTH WRITTEN AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN SYSTEM (#151644920) WITH DIFFERENT DATE OF BIRTH. CHILD TOO YOUNG TO RECEIVE VACCINE IN AUGUST 2021.  SEE VAERS #685192 FOR FIRST DOSE RECEIVED ON 8/05/2021.
Immediately after the vaccination, patient felt faint, started shaking, and eyes rolled in the back of her head. Patient came to and EMS came to assess her,
13 years old (deviation from recommended age group); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old (deviation from recommended age group)) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old (deviation from recommended age group)). On 06-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old (deviation from recommended age group)) had resolved.        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 medical history reported. Concomitant medications were not provided.  Treatment information was not provided.
This case was reported by a nurse and described an adult male patient who did not respond to immunization with hepatitis B recombinant (Engerix-B). Medical history included HIV positive. On unspecified dates, the patient received "two series" of Engerix-B (lot number not provided). Subsequently, on an unspecified date in 2005, a hepatitis B surface antibody titer was "Negative."
Swelling of left lateral upper thigh (11 x 11cm) and redness, warm to touch, slight induration centrally. Seen again 11/12/07 with increase in size to 11 x 16cm.
Her legs and feet became paralyzed and she also became incontinent.; Her legs and feet became paralyzed and she also became incontinent.; Bladder infection; A spontaneous report was received from a consumer concerning a 65-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced legs and feet paralyzed after 2nd shot/diplegia, became incontinent after 2nd shot, blood potassium was low and bladder infection/cystitis.  The patient's medical history was not provided. Concomitant medications were not provided.  On an unmentioned date, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On 08 Mar 2021, prior to the events, the patient received their second of the two planned doses of mRNA-1273 (Batch number: 023m20a) in the left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, 11 hours after the mRNA-1273 shot, her legs and feet became paralyzed and she also became incontinent. The EMT's came twice and she said she ended up in the ER. Bloodwork was done and found her potassium was low and that she had a bladder infection as well. Lab tests mentioned were a CAT scan and nothing significant was found. Events legs and feet paralyzed after 2nd shot and bladder infection were assessed as medically significant as per IME. Treatment information mentions potassium pills and antibiotics.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, legs and feet paralyzed after 2nd shot and became incontinent after 2nd shot was reported resolved on 08 Mar 2021.  The outcome of the events, blood potassium was low and bladder infection/cystitis was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Unable to lift head off pillow Then developed Respiratory problems 19th November admitted to ER twice Pins and needles left Hand On steriods and antibiotics
First 24 hours... dizziness, sore arm, overall malaise...  8 days later... large red, blotchy, itchy rash
Headache; fever; fatigue; chills; injection site bump; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue), CHILLS (chills) and INJECTION SITE INDURATION (injection site bump) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-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 HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue), CHILLS (chills) and INJECTION SITE INDURATION (injection site bump).   At the time of the report, HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue), CHILLS (chills) and INJECTION SITE INDURATION (injection site bump) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Per report from patient's daughter: Patient received 1st dose of Pfizer around 4:30 pm on 2/7/21. Around 4 am the next morning, 2/8/21, he woke up and didn't feel good. Around 12 pm on 2/8/21 he reported feeling "weak" especially on one side of his body. His daughter said she took him to the hospital around 9:30 pm that night, after he continued to feel unwell throughout the day. At Hospital he was diagnosed as having had a stroke. He was admitted to the hospital and kept for observation for 2 days. When his daughter reached out to the patient's PCP to ask if he should get the 2nd Pfizer dose, she was told he should wait at least 3 months and advised to report his stroke to the public health department.
right p/vax pt turned pale somewhat hypotonic & unresponsive;was responsive but not like nl self;appeared drowsy;color returned p/7-10min;somewhat like a vasovagal episode;low grade fever;
Dizziness, CoughWheeze, chills, fatigue, joints ache, muscles weak Narrative:
no adverse effects; the patient received improperly stored dose of Varivax; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 13-MAY-2019, the patient was vaccinated with with  improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # R027989, expiration date 01-OCT-2020; strength, frequency, route of administration was not reported for prophylaxis. The patient's concomitant therapies included properly stored sterile diluent. The temperature of excursion with varicella virus vaccine live (oka/merck) (VARIVAX) was from 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees ) for 3 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported.  This is one of three cases from the same reporter.; Sender's Comments:  US-009507513-1905USA011344: US-009507513-1905USA008600:
sweating - cloths were soaking wet - sweating in bucket; dizzy; so weak; deathly sick; got really really hot; little bit of diarrhea; not really a headache but just pressure; really nauseated; headache; chills; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (sweating - cloths were soaking wet - sweating in bucket), DIZZINESS (dizzy), ASTHENIA (so weak), ILLNESS (deathly sick) and FEELING HOT (got really really hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Apr-2021, the patient experienced HYPERHIDROSIS (sweating - cloths were soaking wet - sweating in bucket), DIZZINESS (dizzy), ASTHENIA (so weak), ILLNESS (deathly sick), FEELING HOT (got really really hot), DIARRHOEA (little bit of diarrhea), HEAD DISCOMFORT (not really a headache but just pressure), NAUSEA (really nauseated), HEADACHE (headache) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweating - cloths were soaking wet - sweating in bucket), DIZZINESS (dizzy), ASTHENIA (so weak), ILLNESS (deathly sick), FEELING HOT (got really really hot), DIARRHOEA (little bit of diarrhea), HEAD DISCOMFORT (not really a headache but just pressure), NAUSEA (really nauseated), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments  No concomitant medications were provided. Treatment medications was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079972 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079972:Crossed linked
Information has been received from a pharmacist via field representative regarding to few patients of unknown ages and genders. On an unspecified date, the patients were vaccinated with, 0.65 ml dose of ZOSTAVAX (route and lot number were not provided), injection. No other co-suspects were reported. No concomitant medications were reported. On an unknown date,  the patients developed cellulitis after got ZOSTAVAX. No rash was reported. Some of these patients visited their doctors because of their adverse event. No treatment information was reported. The patients outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Pt developed blotchy erythema on trunk, extremities, face 20 mins after vaccine given. Resolved 30 min after 18,75mg oral Benadryl.