chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He received his first dose on 27 Oct 2021. He tested tested positive for covid on 28 Oct 2021 but was asymptomatic.; This is a spontaneous report from contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (COMIRNATY, Batch/Lot Number: ER8735; Expiration Date: Oct2021), via an unspecified route of administration on 27Oct2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included stage 3 cirrhosis and wanted information. The patient's concomitant medications were not reported. The patient received his first dose on 27Oct2021, he tested positive for covid on 28Oct2021 but was asymptomatic. Stated this was a lot number that was expired but was given an extended expiration date of 90 days and the expiration date was provided as Oct2021. He is asking what studies have been done on the lot number with the extended expiration dates prior to administration. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
was given 2 dose of the Flulaval; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 32-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2r5k7, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 28th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 28th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, 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: 28-Oct-2022 Reporter's comment: No adverse symptoms were reported. No follow-up was needed. The reporter did not consent to follow-up. Additional supportive information: The patient received 2 doses of Flulaval Quadrivalent  in right arm versus the recommended 1 dose, which led to extra dose administered.
Swelling at first which formed a hard scar tissue lump about the size of a silver dollar. Today pt woke up and the inflammation was much bigger, a red rash covers nearly all of the patients upper bicep. Rash is warm to touch. MD believes this is cellulitis
This case was received from a health professional on 18 July 2007. An 11-year-old patient with no reported medical history received an injection of Menactra (U2338AA) on 17 July 2007. That same day, the patient experienced a headache and stomach ache. Outcome was not reported. Follow-up information received on 20 August 2007 from a health care professional. Menactra was a first dose administered in the "arm." The patient had no illness at the time of vaccination and had no pre-existing medical conditions. Relevant diagnostic testing was none. The patient recovered from the event.
Patient present with left sided chest pain starting several hours after the COVID 19 vaccine. States it continued over several days without improvement
15 days after varicella vaccine pt developed papular and papulo vesicular lesions over trunk, on extremity. Expected to recover.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. No adverse reactions were reported by patient.
Patient came in to the pharmacy on 12/30/17 complaining about low grade fever, pain on injection site, and swelling and redness below injection site to close to her elbow. Patient was referred to urgent care, and was diagnosed with cellulitis, prescribed BACTRIM DS 1bid for 10 days.
Rash on thighs, both legs, knee (moving up) started 2 days after first rash appeared. Rash comes and goes. Rash started 1/10/2022 a few days after booster. Taking Benadryl.
Woke up at 6:30 AM on May 2 with chills and moderate-severe headache, took 2 Ibuprofen at 7:00 AM. Took nap and then stood to speak to my mother, followed by a severe headache for a few seconds and then a seizure lasting less than 1 minute. Hospital released and recommended follow up with PCP for referral to neurologist. No further events as of  May 2nd at 9:15 PM
Pt contacted pharmacy 11/6/13 stating she had experienced "passing out" episodes. Pt wondered if due to PNEUMOVAX -23 received by pt 11/5/13. Pt went to local ER 11/9/13. Pt was admitted to ICU in larger facility 11/9/13. (Symptoms Respiratory Failure).
No adverse events reported or anticipated - adult dose of Hepatitis A vaccine given to 18 yr old/should have been pediatric dose. Error found in reports review 5/24/16.
Local redness and inflammation that spread from left deltoid area to around the left armpit area. The size of the irritation around the armpit was the size of a quarter. It was also red and inflammed in this area.
w/in 2 hrs of vax felt stiff muscles in neck which became a torticollis type problem by the next day; also had lite rash @ site of inject; placed on Tordal meds-to see MD if not better; no fever;
Stroke; This is a solicited report from a contactable consumer, the patient, based on information received by Pfizer from a company (manufacturer control number: 21K-163-4135909-00). This is the second of two reports.  A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 Vaccination; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot Number: 1141058) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis.  The patient medical history was not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient's concomitant medications were not reported.   The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 Vaccination and experienced spinal fusion, spinal osteoarthritis and post procedural complication. The patient experienced stroke on an unspecified date after the second COVID-19 vaccination.  The action taken in response to the event for upadacitinib was unknown. The outcome of the event stroke was unknown.  The reporter's causality for the event stroke after second COVID-19 vaccine with upadacitinib (RINVOQ), was no reasonable possibility.  The reporter considered there was a reasonable possibility that the event stroke after second COVID-19 vaccine was related to the suspect product bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported "stroke" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101489805 Same patient/drug, different dose/AE
Headache Injection site soreness X 3 days Narrative:  Day 1-4 Injection site soreness/apin Day 7 Developed headache.  Other Relevant History:
Feel bad after second shingles shot?; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient felt bad after 2nd Shingrix shot.
Pain and parasthesia radiating down on left arm (in injected arm) in ulner distribution and diffuse pain (with focus) in upper arm.
POSITIVE COVID TEST, SOB, O2 SAT 88%, ON O2 @ 3L/M.
WEAKNESS IN LOWER EXTREMETIES, ASCENDING PARALISIS. CAN'T STAND ON HIS OWN. HEADACHE, DIZZINESS. WILL BE TREATED WITH GAMMAGLOBULINE 25 MG STAT DAILY X 5 DAYS. STILL HOSPITALIZED.  12/10/09 vaccination record DOS 12/04/09 and hospital admission note, physician orders and laboratory tests received for DOS 12/08/09-12/09/09 Dx: Suspected Guillain-Barre Syndrome.  Patient presented with complaint of leg and arm weakness and pain. A spinal tap was performed and the patient was treated with IV Gamma globulin.     12/14/2009 hospital records received for DOS 12/08/2009-12/13/09. Dx: Cerebillitis s/p H1N1 vaccine  Patient experienced leg weakness and pain, ataxia, loss of balance and loss of strength. On discharge, patient could walk with assistance and was alert and orientated with a mild headache.
A report was received from a health care professional on 12/3/03 concerning a 31 ear old male vaccinee who inadvertently received expired Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee was administered 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Blurry vision, dizzy, light headed, chest pain, pain with breathing, abdominal cramping, headache. I became dizzy, light headed, and got blurry vision within the first 5 minutes after my dose. The other symptoms started within the first hour of the vaccine.
Patient while sitting in the post-vaccination are, fainted in her chair. Upon my immediate arrival, I tapped the patient and she was coming to consciousness. Patient upon awakening, felt nauseous and wanted to vomit, but barely did. I gave the patient water and sports drink and the patient was regaining normalcy. Both the patient and her guardian reported that she did not eat or drink anything prior to coming to the vaccine appointment and that she was very nervous and worried prior. Patient denied history of fainting. I recommended to have the patient sit for at least another 15-20 minutes, but the parent stated his daughter was fine and decided to leave.
ear infection; bronchitis; feelings of something pinching her all over; feverish; chills; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (ear infection), BRONCHITIS (bronchitis), SENSORY DISTURBANCE (feelings of something pinching her all over), PYREXIA (feverish) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083821A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS. Concomitant products included METOPROLOL and SPIRONOLACTONE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EAR INFECTION (ear infection), BRONCHITIS (bronchitis), SENSORY DISTURBANCE (feelings of something pinching her all over), PYREXIA (feverish) and CHILLS (chills). At the time of the report, EAR INFECTION (ear infection), BRONCHITIS (bronchitis), SENSORY DISTURBANCE (feelings of something pinching her all over), PYREXIA (feverish) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient's concomitant medication also included an unspecified allergy medication.  Treatment information was not provided.          This case was linked to MOD-2021-276536 (Patient Link).
Fever 103 for 24 hrs. Crying episodes lasting 3-4 hrs, redness and swelling at injection site.
1PM pt started w/crying/screaming this lasted approx 1/2 hr; pt slept 1 1/2 hrs than awoke & started w/crying-painful type; if leg touched cried even more; pt could not be consoled; intermittant cry until 8PM; had had a temp of 102.6;
Shot was given in left arm.  Injection site seemed fine.  Underarm seemed tender. This tenderness increased until I started to feel around under my arm.  Discovered an enlarged, moveable lump right in the underarm area.  As per my research this is called an axillary lymph node.  Googled to see if this was considered a normal reaction.  Saw some information indicating that some other people had complained of this.  Was warned to.
developed Cranial nerve VI palsy double vision right side ( eye ).; Headaches; pain; Coroneal ulcer in her left eye; This is a spontaneous report from a contactable pharmacist.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and the patient's concomitant medications were not reported. The patient had received the first dose of the same vaccine on Feb2021. On 26May2021, the patient developed Cranial nerve VI palsy double vision right side (eye). Headaches and pain. She was hospitalized. She got treated for this with medication and issue got cleared up after two months. Now at the end of Sep2021, she has developed a Coroneal ulcer in her left eye. The outcome of the events was recovered except for the event coroneal ulcer in her left eye n Sep2021 with outcome of unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Chilling, Body Aches, High Fever, Light Headed, Very Tired,  Arm swollen and very red.  Had fever and stayed in bed all day.  Still had fever the next day.   Arm on third day still very red and swollen.
fainted; Initial information received on 19-Nov-2019 regarding an unsolicited valid serious case received from a physician.  This case involves an unknown age male patient who experienced fainted (syncope), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a serious fainted (syncope) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was fainted.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for fainted.  Information on the batch number was requested.; Sender's Comments: This case concerns an unknown age male patient who presented with syncope after vaccination with FLUZONE QIV. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination, previous vaccination history with similar episodes and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Syncope immediately following 3rd vaccination in series, and later developed Postural Orthostatic Tachycardia (POTS), Mast Cell Activation Syndrome (MCAS), and Sjogren's Syndrome.
mom states patient arm red and swollen. Advised to apply ice and can give Tylenol.
Tachycardia, elevated blood pressure, feeling faint, clammy skin.  Called 911 and help arrived.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were administered an unspecified number of improperly stored doses of PNEUMOVAX 23 lot # K020215, expiration date 15-MAY-2016 (dose and route of administration were not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Received vaccines on 7/25/01 at 16:15. Tylenol was given prior to shots at 15:15. At about 18:45 pt became tired, arms hurt and legs were tired. He felt warm. Tylenol was given at bedtime. On 7/26/01, he went to Daycare and his only complaint was sore arms. At the end of the day (15:30) he was congested and with cold symptoms. Tylenol given at bedtime. On 7/27/01, later in the day, he developed a dry cough. On 7/28/01, he slept on and off throughout the day with a bad productive cough. In the middle of the night, acted differently. Sleeping and complaining of having a hard time breathing. He was taken to ER. No fever. Oxygen at 88%. He will be followed-up with pulmonary functional test. He was given Bioxin, Prednisone, Nebulizer and O2 in the hospital and discharged on 7/30/01 with O2 sats at 93% and lungs sounded better. Per doc 204160, 60 day follow up, patient has subsequently been diagnosed with Athsma.
Initial information for this unsolicited case was received from a patient on 12-Oct-2016. This case concerns a 67-year-old female patient who experienced MS to flare up and flu-like symptoms unknown duration after administration of Aubagio and influenza vaccine. Concomitant medications included simvastatin, ampyra, ramipril, Vitamin B12, Vitamin C3, calcium/Vitamin D. no relevant medical history or past drugs were reported. On an unknown date, the patient started therapy with influenza vaccine (dosing details, lot number and expiry date; unknown) and with oral teriflunomide tablet (strength; 14 mg) at a dose of 14 mg once daily for multiple sclerosis (lot number and expiry date; unknown). The patient had a flu shot was had flu like symptoms (onset and latency; unknown) which was causing her multiple sclerosis to flare up (onset and latency; unknown) but she felt like she was getting better since the flu like symptoms were getting better. Action taken; unknown Corrective treatment; not reported. Outcome; resolving. Reporter causality; not reported. Sender's Comments: Sanofi company comment dated 21-10-16- This case concerns a 67-year-old female patient who experienced multiple sclerosis flare while on influenza vaccine. Although the causal role of the vaccine with the event cannot be assessed due to lack of adequate information about patient's past medical history, concomitant medications and underlying medical conditions.
Immunized 4/17 Tdap & MCV (R) deltoid about 12 hours later awoke with severe pain/spasm (R) trapezius/deltoid - to ER for eval & treatment.
Itching; pimple-like hives; pimple like rash; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included biopsy (had biopsies done which had not revealed any information). Previously administered products included Shingrix with an associated reaction of pruritus (1st dose received in March 2021, refer case US2022021678).   In May 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pruritus, hives and pimple-like rash. The patient was treated with prednisone and dupilumab (Dupixent). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pruritus, hives and pimple-like rash were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, hives and pimple-like rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022021678  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in her left arm and experienced hives, rash and itching. Since receiving Shingrix, she had continued with the pimple-like hives, rash and itching the areas of her body that are currently affected by the itching, rash and pimple like hives include both legs, under both arms, and down both her sides of her torso. The patient had been to an allergist, her primary care physician, and a dermatologist.  The patient had been treated with prednisone which helps clear it up, but the hives and itching subsequently comes back, she had recently started on Dupixant by her dermatologist to treat her itching and hives. Spoke per package insert (PI). Gave Medical Information phone number for her to provide to HCP to call on her behalf.  The patient was given medical advice disclaimer and was referred to HCP.  The reporter consented to follow-up with HCP (Pharmacy).; Sender's Comments:  US-GLAXOSMITHKLINE-US2022021678:Same patient, different dose
Shingles L3 dermatome. No pain. Minimal discomfort. Photo available - call with or e-mail & I will send. It is impressive!