chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 1, single (Lot number: gj2524) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment start date: 31Aug2023 to 05Sep2023. No known allergies.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300297617 same reporter, patient, and drug, different dose and event;
Delayed redness, large slightly raised patch, and itchiness on upper arm where shot was given
Started feeling very tired the evening after the injection. Couldn't sleep the night after and on Sunday about 48 hrs after shot at had bad chills, fever of 101°, bad joint pain in legs and hips.
This spontaneous report has been received from a nurse practitioner referring to a female patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified date in 2016 (reported as "two years ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, anatomical location, lot number and expiration date were not provided) by intramuscular route for prophylaxis. On 30-APR-2018, the patient was vaccinated with the second dose of GARDASIL 9 (lot # N003703 with expiration date of 29-OCT-2019) dose 2, by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of drug administration). No adverse events were reported.
Within in 2 hours severe headache.   Patient experience dizziness with headache starting 3pm( 6 hours latter) and severe pains in shoulder/neck.   Patient given 900mg motrin and ice pack neck/arm.  Slept 7 hours.   Then experience more severe dizziness and throbbing front lobal headaches overnight and through to 8am.  Patient given 800mg Motrin at 7:30am, sleep more.  Within 30 seconds standing up severe dizziness and headache.   Noon dizziness went away when standing and headache subsided.
became very sick; chills; fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became very sick), CHILLS (chills), PYREXIA (fever) and VOMITING (vomiting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder and Lung disorder.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became very sick), CHILLS (chills), PYREXIA (fever) and VOMITING (vomiting). At the time of the report, ILLNESS (became very sick), CHILLS (chills), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.            Patient mentioned that she had a heart problem and a lung problem and stated that "apparently the vaccine is not safe"  No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021:
Face tingling and numbness; Face tingling and numbness; swelling around mouth; swelling anad itchiness of throat; swelling anad itchiness of throat; This is a spontaneous report from a contactable consumer (Patient, self-reported).   A 36-years-old (non pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Left arm on 04Mar2021 14:45 (At 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unspecified date and unknown if ongoing, known allergies: Penicillin. Concomitant medications taken in two weeks included budesonide, formoterol fumarate (SYMBICORT) (MANYFACTURER UNKNOWN) 160/4.5 from an unspecified date and unknown if ongoing. No other vaccine in four weeks. Patient did not received any vaccine on same date. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19, post vaccination.   On 04Mar2021 15:45, patient experienced Face tingling and numbness, swelling around mouth, swelling and itchiness of throat, very minor and occurred after the 15 minute wait time - about 20 minutes after vaccination, symptoms disappeared approx. 10 minutes after appearing. Patient did not received treatment for adverse events. Events were non-serious. Outcome of the reported events had recovered on 04Mar2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a public health nurse concerning a child who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child experienced a case of chickenpox that was not mild and involved a systemic reaction and malaise. Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. The public health nurse also reported an unspecified number of children who developed breakthrough chickenpox after therapy with varicella virus vaccine live. Additional information has been requested.
Soreness at injection site. Vomiting started at approx. 2 hrs after receiving vaccine. Whole body aches.
tired; flu like symptoms after 2nd dose.  Only lasted for 1 day; This is a spontaneous report from a contactable consumer.   A 46-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported. On an unknown date, the patient received the first dose of BNT162B2 vaccine.  On Jan2021, after 2nd dose, the patient was tired and had flu like symptoms only lasted for 1 day with outcome of recovered.    Lot and batch number has been requested.
temp of 100.0. severe chills and body aches with moderately severe headache.
Local inflammatory reaction consisting of redness/swelling/heat/induration measuring 11 x 12 cm over area of right deltoid/triceps.
pt recv vax 6MAY97 & 25NOV97 pt devel chickenpox (15 lesions);
body aches; arm stiffness & shoulder stiffness; tenderness; warm neck; swollen neck; severe arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck) and SWELLING (swollen neck) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck), SWELLING (swollen neck) and PAIN IN EXTREMITY (severe arm soreness). On 19-Mar-2021, MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck), SWELLING (swollen neck) and PAIN IN EXTREMITY (severe arm soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided No  Concomitant medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-080626 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080626:2nd dose case
She started symptoms on July 23rd with shortness of Birth and she still have symptoms. Unknown exposure. She is admitted in Hospital on July 28th and she is still in the hospital. She got Covid Pneumonia and on Oxygen. She is in Covid Care Unit. She has Rheumatoid Arthritis medical condition. She had her Covid Vaccine in March.  Patient is fully vaccinated.
No additional AE; Nurse reports they had a patient that is 1 year old that has already completed the ROTATEQ series and was administered an additional dose of ROTATEQ today. Nurse does not have patient demographic information at this time and does not give consent to; This spontaneous report has been received from a nurse, concerning to a 1-years-old patient. The patient pertinent medical history, historical drug, concomitant therapies and concurrent conditions were not reported.  On 25-10-2022, the patient received an additional dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot# W011280, expiration date 03-NOV-2023) (strength and dose regimen were not reported. after had completed the series of vaccine scheduled (extradose administered). No additional adverse event was reported.
Severe pain in  injection arm  for 1 day, moderate pain for 2 to 3 more days
Tattoo located at injection site. Several months after injection several bumps have been presented under skin at tattoo site. No itching or redness.
VACCINE INJURY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injury was not reported. This report was non-serious.
Dose dribbled down the arm; Top was not tight; A spontaneous report  was received from a pharmacist for a patient (unspecified age and sex) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dose dribbled down the arm and top was not right (syringe connection issue).  The patient's medical history was not provided. No concomitant product use was reported.  On an unspecified date, the patient received their one of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. While pharmacist giving the shot to the patient the dose dripped down the arm. The pharmacist believe top was not right.  Treatment information was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events, dose dribbled down the arm and top was not right (syringe connection issue) was  resolved on an unknown date.; Reporter's Comments: This report refers to a case of Device connection issue for mRNA-1273  with possible underdose.
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse) on 18-Oct-2017, concerns a patient of an unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown.    Information about lot/batch number has been requested.
Patient Received Pediatric Pfizer dose, will receive appropriate vaccine for age group after 21 days. No adverse reaction noted.
Pain, fever to 103.7 tx - cool compress - PRN Tylenol with Codeine - PRN pain q 4-6 hrs.
F caller wants to know what to treat her current headache and chills, APAP or ASA. Takes both PRN for headaches. She doesn't want to provide any additional information about the shot and doesn't want to be tracked but permission to FU tomorrow to check in tomorrow. Adv can take either one according to OTC recommendations, whichever tends to work better for her headaches if fine, no contraindications for either with the shot. Also adv to keep hydrated. Call back if issues tonight will FU tomorrow.
Body aches for first 36 hours. Sweating, chills, dizziness, vomiting, shakiness, chest tightness, difficulty breathing, hand/arm numbness about 48 hours after receiving shot.
received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Woke with fever at 1AM after receiving the shot at 11AM the previous day (14 hours later). Was moaning from discomfort. Don?t know his exact temperature until the next morning when daughter was called. Fever was 101.1 at 9AM. He was hardly communicative and close to unconscious until 7PM the day after the 2nd dose was administered.  Consistently improved after 7PM.
quite a bit of redness in arm; quite a bit of redness and swelling in arm; stomach problems; fever; malaise; felt bad; achy joint pain; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2019, the patient received the 1st dose of Shingrix. On 3rd August 2019, less than a day after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, gastric disorder, fever, malaise, feeling bad and joint pain. On an unknown date, the outcome of the erythema of extremities, swelling arm, gastric disorder, malaise, feeling bad and joint pain were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, gastric disorder, fever, malaise, feeling bad and joint pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient's physician suggested her to get the vaccine. The patient received her 1st shot on Saturday before the reporting date and had quite a bit of redness and swelling in arm, stomach problems, fever, malaise, felt bad with achy joint pain. The reporter did not consent to follow-up. The health care professional's (HCP) information was not obtained.
Awoke early in the night with uncontrollable chills. Required electric blanket and several other blankets to stop the chills, but had full body aches and intermittent chills for the rest of the night.  By 9am the chills had stopped; by mid-day the aching had mostly subsided.  No fever at the time of the worst chills (but also taking meloxicam 7.5 mg nightly before bed).
felt fatigue, body ache and arm sore 0n 1/8/22. then 1/9/22 am, I passed out in the bathroom. on 1/14/22 started mild urticarial which got worse every day, where my whole body was itching then huge hives develops.  then I started having sore throat, bodyaches, chills and dry coughs. Pcr covid test negative on the onset of respiratory symptoms and 4 days later, repeated again, negative. Dr. is treating the symptoms with 6 day prednisone course, itching is slightly better, cough is worse, stared having wheezing, now taking albuterol as needed.
1157 wife called for help and stated her husband was having a seizure. Wife stated he has had a seizure before but he does not take medication.
patient was given RECOMBIVAX HB that was recalled; Improperly stored vaccine administered; This spontaneous report was received from a nurse referring to a 9-week-old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was not provided.  On 23-OCT-2020, the patient was vaccinated with a recalled and improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (0.5 milliliter, route of administration was unknown, lot # T007984 which has been verified to valid, expiration date reported and validated as 01-NOV-2022) for prophylaxis.         The outcome of recalled product administered and product storage error was unknown.
had both set of shots, shingles/suspected vaccination failure; shingles would be gone forever and that's a lie; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she had both set of Shingles shots, GlaxoSmithKline told him/her shingles would be gone forever and that was a lie. Additional supportive information: This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Received Comvax, MMR, varicella on 2/23/04. Brought to ER 2/24/04 with c/o vomiting, decrease appetite. Was given Tigan supp. Clinical impression: immunization reaction vs. gastroenteritis.