chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Dizziness, ringing in ears" per patient. Treatment: Patient laid down for 15-20 minutes, sx's resolved. Vital signs were stable before, during and after sx's.
Post vax, the pt developed a 12 cm cellulitis at injection site. The site was red, hot, and hard for 48 hours.
pt recv vax 11AM 11JUL95 & 1PM pt devel general urticaria & diff breathing; Adrenalin given sx relieved w/in 10mins; DPH given also;signs & sx returned and went to ER;
On Feb 14 developed Covid arm rash on left arm below site of injection. Rash spread over the course of 2 weeks and was red and hot to the touch. March 2nd left hand was achy and couldn?t open and close the left hand. March 4 rash spread to RIGHT upper forearm and is symmetrical with left arm. March 6 woke with swollen heel on right foot and painful and tender marking it difficult to walk.
The injection site soreness began (like after the 1st shot)a few hours after vaccination. However, about 11 hours in my entire body began to ache (muscles and joints) and I started have chills.  I ran fever from 99 to  101.5 all night and through the next afternoon.  About 24 hours after onset of reaction (4:00), I began to feel more like myself. The fever finally broke.
We do not believe that the patient's death was an adverse event from the vaccine.  Patient received COVID vaccine from Pfizer Dose #1 12/19/2020 (lot # EK5730) and Dose #2 1/7/2021 (lot # EL1284). No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction.  Patient died 1/10/2021 from chronic respiratory failure and congestive heart failure after recent aspiration pneumonia requiring hospitalization. Death was anticipated and not sudden.  We were told to report his death to VAERS even though his death was anticipated and not related to his vaccination.
Elevated temp, major body aches, fatigue, headache, nausea. All within less than 24 hours after receiving the vaccine.
client c/o having tingling sensation like bugs crawling and bilateral arm & face numbness that lasted 10 minutes. c/o head feeling like it is in a cloud. Called the clinic 2 days later c/o head still feeling like it is in a cloud. client was advised to call her PCP for appointment
December 27th felt itchy here and there throughout the day.  December 28th continued to be itchy and developed hives which have continued since.  On December 29th I started Claritin and had a spot in my throat felt a little weird that night.  Not sore, but different.  On December 30th I woke feeling like I had a pill stuck in my throat.  That feeling progressed into discomfort when swallowing and eventually pain that would come and go at what felt like the top and bottom of my esophagus.  The pain woke me that night multiple times.  At my doctor's recommendation I switched to Zyrtec and started and acid reflux medicine, but I started Omeprazole instead of famotidine.  The esophagus pain went away, but the hives weren't fully controlled.  I did a short course of Prednisone, which improved things, but again didn't fully control the hives and they flared some after tapering off.  Saw and Allergist February 15th and started 2 Zyrtec at night, 1 Famotidine morning and night, and Vitamin D.
A little bit of a sore arm; Fever; received expired Moderna booster; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (A little bit of a sore arm), PYREXIA (Fever) and EXPIRED PRODUCT ADMINISTERED (received expired Moderna booster) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Atrophic vaginitis, Allergy to antibiotic (Bactrim allergy) and Allergy to antibiotic (Bactrim allergy). Concomitant products included ESTRADIOL (VAGIFEM) for Atrophic vaginitis.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna booster). On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received expired Moderna booster) had resolved. At the time of the report, PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) to be related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received expired Moderna booster).    Concomitantly, the patient also took Carem/D orally for osteoporosis and Miltrret orally for health.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-387101 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Suspect drug information, patient information, new event, medical history and concomitant medication were added; outcome was updated. On 16-Nov-2021: Consent for follow up was denied.
Case number PHEH2014US003950 is an initial spontaneous report from the consumer received on 21 FEB 2014. This report refers to a 11-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) as a dose of 0.5 ml intramuscularly on 24 JAN 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Non significant follow up received on 25 MAR 2014: Updated  physician information only.  Following an internal review on 18 AUG 2014 of the data received on 25 MAR 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
arm soreness; This is a spontaneous report received from a contactable consumer (patient's husband). A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 15Apr2021 at 10:30, as single dose for COVID-19 immunisation. Patient's medical history included multiple sclerosis and he had triple bypass surgery three years ago. On 15Apr2021 at 12:00, the patient had soreness. They were sent home with a factsheet for side effects to look out for and to take Tylenol if needed. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient came into pharmacy on 1/22/2020 complaining of long-term pain in his upper left arm/shoulder area. Patient claimed to have no pain in that area until he received a influenza vaccination at the pharmacy on 10/25/19. In the 3 months since the pain in his arm has not improved and patient believes that the pain is the direct result from the influenza vaccination being administered too high in his arm. The patient was advised to be seen by his regular physician in order for the pain to be appropriately evaluated. According to the patient his physician agreed that the pain could be caused from the vaccination and is exploring further diagnostic tests and treatments. Patient is currently controlling pain on Ibuprofen 800mg.
IPOL was given to a patient after the expiration date, with no reported AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00822451).  This case involves a nine-year-old female patient who was vaccinated with the expired dose of suspect IPV (VERO) [IPOL] (expired vaccine used).  Medical history, medical treatment, vaccination and family history were not provided.   Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunisation.  On 20-Oct-2021, the patient received a 0.5 ml first dose of suspect IPV (VERO) (lot R1F971M and expiry date: 03-Oct-2021) (Frequency: Once) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
vomited several times; nauseous; headache; passed out; dizziness; booster; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 09:00 (Lot number: FJ8762) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. There were no concomitant medications. Past drug history included: Allergies: zpack, reaction(s): "Drug allergy". Vaccination history included: Moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: 006C21A, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Apr2021, when the patient was 41 years old, for COVID-19 immunization; Moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: 017B21A, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 25Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 14Dec2021 08:30, outcome "recovering", described as "passed out"; IMMUNISATION (non-serious) with onset 13Dec2021 09:00, outcome "unknown", described as "booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Dec2021 09:00, outcome "unknown", described as "Interchange of vaccine products"; DIZZINESS (non-serious) with onset 14Dec2021 08:30, outcome "recovering", described as "dizziness"; VOMITING (non-serious) with onset 14Dec2021 10:45, outcome "recovering", described as "vomited several times"; NAUSEA (non-serious) with onset 14Dec2021 08:30, outcome "recovering", described as "nauseous"; HEADACHE (non-serious) with onset 14Dec2021 08:30, outcome "recovering", described as "headache". Around 8:30AM on 14Dec2021 during hand PT the patient passed out. Made it home and then around 10:45AM she vomited several times. Still feeling nauseous, headache, and dizziness. Therapeutic measures were taken as a result of loss of consciousness, dizziness, vomiting, nausea, headache, treatment received at PT office which got her legs up and cold compress.  No follow-up attempts are needed. No further information is expected.
Drug allergy; This spontaneous report was received from a physician via Pfizer regarding an elderly female patient of an unknown age. Information on pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot/batch number and expiry date were not reported) for prophylaxis. On an unknown date the patient experienced drug allergy to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (drug hypersensitivity). Outcome of the event was unknown. Causality of the event was related to the suspect therapy.
Redness, swelling and pain started within hours of injection, continued to increase with pain within the next 18hrs and finally started to subside. Now a week later, redness, swelling and itchness has returned (pain gone but itch started). Swelling severe. Redness severe.
Asthma exacerbation, with SOB, chest tightness, decreased PEFR. Sore throat, headache, malaise, cough. Saw PA at clinic 09/26/2014. Missed next week's work. Exacerbation worsened, saw NP at clinic on 09/26/2014. Received 6 day course of prednisone and also Bactrim for lung infection.
This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX. On 26th August 2018, 3 days after receiving SHINGRIX, the patient experienced erythematous rash and raised rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the erythematous rash and raised rash were recovering/resolving. It was unknown if the reporter considered the erythematous rash and raised rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at another pharmacy and not the pharmacy that was reporting about him, so, the batch number and expiry date were not reported. After receiving SHINGRIX, the patient developed a rash that appeared red and raised, spread from his torso to back to stomach. The patient was treated at an urgent care, received BENADRYL which the reporter calling said did help.
Presented dizziness; tight chest; blurry vision; This is a spontaneous report received from a non-contactable consumer. An 18-year-old female patient (unknown if pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jul2021 at 12:00 PM (Lot number: EW0172) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Unknown if covid prior vaccination; unknown if covid tested post vaccination. On 06Jul2021 at 12:00 PM, patient presented dizziness, tight chest, blurry vision; refused EMS. Treatment received for events including first aid, vitals. Outcome of events was unknown.    No follow-up attempts are possible. No further information is expected.
The patient was febrile on Sunday 1/31/10 and recently had cough and congestion which became more severe. His fever continued the next day. On Tuesday, feb 2, 2010 he became lethargic. Later that afternoon his mother picked him up from the babysitters at which time he was very lethargic and also had bulging fontanels. He was Taken to the local ER and later transferred to different facility. Upon arrival to the facility the patient had a high fever and developed generalized tonic-clonic seizures.
rapid heartbeat; mild dizziness; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Apr2021 (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation. Patient received the first dose on 23Mar2021. Medical history included lymphoma, blood pressure measurement, and cardiovascular disorder. Concomitant medication included sotalol taken for blood pressure measurement, start and stop date were not reported.  The patient experienced rapid heartbeat and mild dizziness on 13Apr2021. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Body aches; headache; fatigue; This is a spontaneous report from a non-contactable other health professional reporting for himself. A 32-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# el9263), via an unspecified route of administration in the left arm, on 24Jan2021, at single dose, for COVID-19 immunisation. Medical history included penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced body aches, headache and fatigue all on 31Jan2021 at 15:30 with outcome of not recovered. No therapeutic measures were taken as a result of the events. Since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Site: Redness at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium
Dx'd with varicella on trunk area (anterior side) with only 1 dozen vesicular rash present. Chickenpox care instructed. Return in 7 to 10 days. Started 1-2 days prior to 1/4/02 visit. Also dx'd with otitis media and placed on Suprax 100mg po X 10 days.
Severe hives and itching starting 15 days after the booster. All over entire body but most bothersome on palms and soles of feet. After receiving a course of prednisone the itchiness and hives subsided after two weeks but I still suffer from dermatographia several weeks later.
Immediate syncope with brief seizure of few seconds.  Obeserved for 20 minutes then back to normal.  Went home and mom called back later that afternoon stating child was very sleepy, confusional.  Advised to go to ER.  Mom observed at home and stated child had been up late the night prior and felt that was the issue.  She stated she seemed ok.
Noticed on Weds that the site is hard, red and blotchy. This worsened, on thursday she noted a blotchy red rash that has extended down her arm from the injecction site.  This area is now about 2 inches across and 6 inches down her arm.  Is blotchy red, warm to touch and itchy.  Pt advised to take Benadryl OTC.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history was provided. On 19-JAN-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB (strength, dosage, route of administration, lot# and expiration date were not reported). On 13-FEB-2017, the patient received the second dose of RECOMBIVAX HB, which was reported as administered too early. No symptoms were reported. Additional information has been requested.
Patient reports via phone that she developed "blisters in right anterior rib cage; began with a couple area about size of "little finger" on 9-15-07; by next day she noted that they "wrapped around to back in upwards fashion-"some areas look like watery blisters-others drier and scabby-plans to see local MD today-Dr. notified.
pt had a positive COVID test on 1/10/22 at a Hospital; pt received from hospital on 1/21/22 to another HCF; pt with end-stage dementia; DNR; comfort measures only; admitted to a hospice; on O2 supplementation; pt passed away in the facility; death certificate and records sent to info@vaers.org
Fever x 2 days, rash x 1 day, 7/29 developed low grade fever and diarrhea, 7/30 small rash, spread over extremities and trunk, 8/02 presented with rash all over body, no temp.
Fatigue for 36 hours so bad I couldn't keep my eyes open.  Arm sore, mild. Headache, mild.  Rested in bed, took ibuprofen, drank fluids when awake.
Flush, headache, feeling like on fire and all body was red, couldn't breathe, head to Emergency room.
vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022; No adverse event; received doses after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022).    No concomitant medication information was provided. It was reported that Individual vials or unbroken cartons was in the box, Vial size was 2.5ml Date the vial was initially stored in the refrigerator was 03Oct2022. Vial did not undergo any temperature excursions. No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2022-672844, US-MODERNATX, INC.-MOD-2022-673082, US-MODERNATX, INC.-MOD-2022-673093 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2022: Live Follow-up  Significant information accepted: Patient information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672844:Same reporter case US-MODERNATX, INC.-MOD-2022-673082:Same reporter case US-MODERNATX, INC.-MOD-2022-673093:Same reporter case
Up all night long; Heart racing; Shortness of breath; Bed ridden; Delayed the second shot; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), BEDRIDDEN (Bed ridden) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported) and COVID-19.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), BEDRIDDEN (Bed ridden), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) and FATIGUE (Extreme fatigue). At the time of the report, INSOMNIA (Up all night long), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath) and FATIGUE (Extreme fatigue) outcome was unknown and BEDRIDDEN (Bed ridden) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Breakthrough case admission after two vaccines Pfizer 11/23/21 Lot# FH8030;  4/28/22 Pfizer Lot# FK9894