chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 19:00 as dose 5 (booster), single at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Mar2021 at 09:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Apr2021 at 09:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 22Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 03Mar2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: Blueberries" (unspecified if ongoing); "Known allergies: Eggs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Tetracycline, reaction(s): "Known allergies: Tetracycline"; Lisinopril, reaction(s): "Known allergies: Lisinopril"; Dicyclomine, reaction(s): "Known allergies: Dicyclomine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Child received IPV and KINRIX on same day. No treatment at this time. Parent educated to monitor for adverse reaction including: fever, swelling, redness, nausea, vomiting, difficulty breathing. Informed parent to call or return to office with any concerns.
Numbness in 4th and 5th fingers started five mins after shot. Headache on occipital and top of head. 7m scale 1-10, 7m scale from 1-10, vertigo when closes eyes, and nausea. Pt didn't follow up but was improving on 2nd visit.
Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year).    No concomitant medication reported.  Reporter was asking about a second dose of a Moderna COVID-19 vaccine. She stated that a woman that was not pregnant received the Moderna COVID-19 vaccine first primary series last year and now would like to receive a second dose, but she was currently pregnant and would like to receive the second dose. Pregnant patient was not vaccinated yet. No treatment medication reported.
body aches; Chronic fatigue; light headed feelings; Dose 4: Moderna and dose 5: Comirnaty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interstitial cystitis" (unspecified if ongoing); "BPH" (unspecified if ongoing); "mild high blood pressure" (ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single; ATENOLOL; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; ATORVASTATIN; VITAM [ASCORBIC ACID]. Vaccination history included: coviD-19 vaccine moderna (DOSE 4 (BOOSTER), SINGLE , Lot number: 037A22B, vaccine location: Right arm), administration date: 06Jun2022, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (DOSE  3 (BOOSTER), SINGLE , Lot Number: FG3527, prev dose vaccine location: Left arm), administration date: 23Nov2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE , Lot Number: EW0170, vaccine location: Left arm), administration date: 30Apr2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE , Lot Number: ER0734, vaccine location: Left arm), administration date: 09Apr2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 28Oct2022, outcome "not recovered", described as "Dose 4: Moderna and dose 5: Comirnaty"; FATIGUE (non-serious) with onset 31Oct2022, outcome "not recovered", described as "Chronic fatigue"; PAIN (non-serious) with onset 31Oct2022, outcome "not recovered", described as "body aches"; DIZZINESS (non-serious) with onset 31Oct2022, outcome "not recovered", described as "light headed feelings". The events "body aches", "chronic fatigue" and "light headed feelings" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, fatigue, dizziness.  Additional Information: Other vaccines were taken within 4 weeks. Other medications like antibiotics, atenolol, flomax, atorvastatin, vitamin were taken in 2 weeks. There was no treatment taken for adverse event. No known allergies. No Covid prior to vaccination.
Redness, swelling, tenderness, itchiness, internal feeling of hardness/collection- started 8 days after vaccination. ?cellulitis vs. vaccine reaction
Redness and swelling at injection site.  Tingling in hands and mouth. Swelling increased as the day progressed. Emergency room treatment, area iced Benadryl for swelling and Tylenol 600 administered for pain.
Onset of pain 2 hours post-immunization. No redness or swelling. Pain became severe - pt consulted primary MD. Tried 1 course of prednisone, pain returned. Pt had MRI, results edema and tear of tendon. Pt has lost strength and range of motion.
Redness and itching at injection site. Pt was observed for 30 minutes. 2 BP readings were taken 10 minutes apart reading 140/90 P88 and 139/95 P75.
Extreme pain in arm, fever, when checked, 101.2, usually average 97.6
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 09-MAR-2016 and 06-APR-2017, the patient was vaccinated with VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Started developing redness, warmth, tenderness at site of a sebaceous cyst on my L buttock on 6/29/21. It continued to get worse, went to medical facility on 7/1/21 and was diagnosed with cellulitis and started on keflex 500mg x7d. It continued to get worse rather than better, despite taking the keflex as prescribed- went back to medical facility on 7/6/21. I+D was performed and culture was obtained. Was advised to complete keflex and started on Bactrim DS x10d. The cellulitis was slow to show improvement, but was getting better. The culture came back with Actinomyces as the causative organism. Then I developed itching and a rash on my neck, chest, back, abdomen, upper arms, and upper thighs on July 13- I took benadryl 25mg but it did not help. So I went to ER that evening and was diagnosed with a drug reaction to the Bactrim. I was given solumedrol 125mg IM, pepcid 20mg, clindamycin 300mg in ER. I was discharged home- was told to stop the Bactrim immediately. Antibiotic was switched to clindamycin 300mg x7days. Was also prescribed prednisone 20mg BID x5days. The cellulitis did resolve. I had a follow up appointment with my dermatologist on 8/19/21- the initial sebaceous cyst was no longer present but she was concerned that the underlying infection/ Actinomyces was not completely resolved. She prescribed doxycycline 100mg BID and referred me to infectious disease specialist (appointment is pending).
After the vaccines I did not experience any pain...then mid March of 2023 I lost my sense of smell and taste up to date..
Mild flu like symptoms; Body aches; Fever; Nausea; Vomited; Painful lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV (human immunodeficiency virus) positive and COVID-19 in 2020. The patient was allergic to shellfish. Concomitant medications included emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide fumarate (GENVOYA), cromoglicic acid (CROMOLYN), cetirizine hydrochloride (ZYRTEC) and pea protein. The patient previously took sodium valproate (DEPAKOTE) and experienced specific allergy (drug). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 04:00, the patient experienced mild flu like symptoms, body aches, mild fever, mild nausea, vomited once and the biggest issue was painful lower back pain. The patient had contracted COVID-19 in 2020 ( last year) and it did not bother his lower back but this vaccine really messed with his lower back for a full day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event mild flu like symptoms, body aches, fever, nausea, vomited and painful lower back pain was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
- Got the recommended dose of Shingrix on Jan 2, 2019 and April 19, 2019 - For the week before Oct 9, I had a severe constant headache on the left side of my head. I NEVER get headaches.  - Oct 9 the left side of my nose near my left eye broke out with oozing sores and my face-cheek  swelled up and got red. -Oct 11 I went to MD and diagnosed with shingles - the sores were on my the tip of my nose, and in my head on the left side.started Valtrex 3X/day -Oct 15 my left eye continued to water, and was very red. Went to the ophthalmologist who sent me from his office to the hospital for MRI evaluation of 6th  Nerve Palsy caused by the shingles. (MRI was clear) - I stayed in the hospital for 7 days getting Acyclovir infusion 3X a day and neupogen 2X/day. - My neutrophils were .99 & .3 - I continued with Valtrex for 7 more - shingles  finally healed up, but left my eye with double-vision (so far) and a numb nose where the shingles had been. I shouldn't have gotten shingles - I guess you can count me in the  10%.  I have progressive pictures. Dr thinks the high Ferritin was a result of shingles etc
Patient had not received his 2nd dose since 04MAR2021 and asked should he get the 2nd dose?; Experienced severe tinnitus and ear ringing.; Experienced severe tinnitus and ear ringing.; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of TINNITUS (Experienced severe tinnitus and ear ringing.), the second episode of TINNITUS (Experienced severe tinnitus and ear ringing.) and PRODUCT DOSE OMISSION ISSUE (Patient had not received his 2nd dose since 04MAR2021 and asked should he get the 2nd dose?) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient had not received his 2nd dose since 04MAR2021 and asked should he get the 2nd dose?). In March 2021, the patient experienced the first episode of TINNITUS (Experienced severe tinnitus and ear ringing.) and the second episode of TINNITUS (Experienced severe tinnitus and ear ringing.). On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient had not received his 2nd dose since 04MAR2021 and asked should he get the 2nd dose?) had resolved. In May 2021, last episode of TINNITUS (Experienced severe tinnitus and ear ringing.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.  The patient had been asked to wait at least 9- to 120 days before receiving the second shot.
petechial rash to face, neck, upper chest/back & arms; observed for 1/2 hr in clinic w/o worsening 24 hrs later, rash faded; t98.7 ax;
She accidently gave a 17 year old male his 3rd dose of Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: She accidently gave a 17 year old male his 3rd dose of Bexsero).  The outcome of the extra dose 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: 22-AUG-2023 The healthcare professional was the reporter. The reporter stated she accidently gave a 17 year old male 3rd dose of Bexsero, which led to extra dose administered. The reporter consented to follow up.
ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) HYPOTENSION ACUTE PULMONARY EMBOLISM 1/30/2023  &   1/29/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Body ache; upset stomach; Headache; Chills; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 05Mar2021 at 13:00(at the age of 61-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 00:30, the patient experienced body ache, upset stomach, headache, chills and tiredness. The patient did not receive any treatment for the event. The clinical outcome of the event body ache, upset stomach, headache, chills, tiredness was not resolved.   No follow-up attempts are needed. No further information is expected.
(Rash Lt.deltoid, warm, tender) Treatment: Start sulfamethoxazole  Rx: Suspension (200mg- 40 mg/5mL, 15mL orally every 12 hours x 10 days.
raised reddish patch the size of a tennis ball which was "irritating"; raised reddish patch the size of a tennis ball which was "irritating"; itchiness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (raised reddish patch the size of a tennis ball which was "irritating"), VACCINATION SITE PRURITUS (itchiness on the injection site) and VACCINATION SITE ERYTHEMA (raised reddish patch the size of a tennis ball which was "irritating") 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness on the injection site). On 30-Jan-2021, the patient experienced VACCINATION SITE IRRITATION (raised reddish patch the size of a tennis ball which was "irritating") and VACCINATION SITE ERYTHEMA (raised reddish patch the size of a tennis ball which was "irritating"). At the time of the report, VACCINATION SITE IRRITATION (raised reddish patch the size of a tennis ball which was "irritating"), VACCINATION SITE PRURITUS (itchiness on the injection site) and VACCINATION SITE ERYTHEMA (raised reddish patch the size of a tennis ball which was "irritating") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
it was the shingles vaccine 2nd dose. stared on 01/08/22 with body aches , nose bleed and ear bleed, next day broke out in open sores first in the face and progressed to the body including inside the mouth, continue with aches and and bloody nose. his 2 legs were covered in what looked like goosebumps the color hot pink, also legs were hot to the touch. his back was hurting sooo bad we called the dr on 01/11/22 called dr and prescribed meds. start meds on 1/12/22 as per dr. symptoms to worsen called dr office on 1/17/22 send us to urgentcare they placed him in the hospital on 1/20/22 the ICU then back to the hospital on 1/21/22 as of today he still in the hospital
This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine).    This case contains information for the 13 out of 13 elderly patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  The age group of the patients were mostly over 65.  It was unknown that if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that the 13 patients received an expired Moderna vaccine. The dose administered after manufacturer date of expiry.  The dates of administration of vaccine were reported as 14 April 2022, 21 April 2022, and 28 April 2022.
2nd dose administered beyond 35 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The race of the patient was reported. It was reported that the patient had no known drug and food allergy.  No concomitant information was reported.  It was unknown if the patient had ever tested positive for COVID-19. The patient does not had any acute illness at the time of vaccination and up to 1 month before and not received any vaccine one month prior to moderna COVID-19 vaccine.  No treatment information was reported.   This case was linked to MOD-2022-546730 (Patient Link).
On the evening on Tuesday of his injections, he noticed warmth of his (L) upper arm, at site of PNEUMOVAX injection, redness progressed over next several days & involve axilla & lower arm. Felt "flu-like" with sweats and fever 2 days following injection, treated for cellulitis 3/days after injection.
Information has been received from a consumer concerning her 13 year daughter who on an unreported date was vaccinated with varicella virus vaccine live (Oka/Merck). The patient, at 13 years of age recently (2007) developed a severe case of chickenpox. The patient, along with her older (16) and younger sisters (11), had all been previously immunized. The 11 year old had a breakthrough at the same time as her 13 year old sister. The patient did not develop chickenpox following past exposures to the virus years ago when her oldest sister (16) exhibited a breakthrough case of chickenpox. This is one of several reports from the same. Additional information has been requested.
2nd dose administered too soon (15 days between doses). 1st dose administered 4/26/21.
receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Vial was initially stored in the refrigerator on 31 Aug 2021 and it was reported that the vial did not undergo ay temperature excursion. Treatment medication was not provided by the reporter.
Optic neuritis in the right eye, followed a few weeks by optic neuritis in the left eye, pulsatile tinnitus, numbness in hands face and toes, rapid onset of cataracts requiring surgery, visual disturbances such as floaters in peripheral vision.
Fever to 101.9, resolved within 12 hours.  4 cm local pink, tender right deltoid onset 6-22-08 and persistent for 48 hours.