chrisvoncsefalvay/vaers-outcomes huggingface dataset:
worsened eye sight; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "red food dye" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfameth, reaction(s): "known allergies: Sulfameth". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Location of injection: Arm Left), for covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Location of injection: Arm Left), for covid-19 immunisation. The following information was reported: VISUAL ACUITY REDUCED (disability) with onset 01Nov2021 at 12:00, outcome "not recovered", described as "worsened eye sight". The event "worsened eye sight" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of visual acuity reduced. Clinical course: The reporter now needed glasses to see her computer screen. It was not much of a prescription and her ophthalmologist said old age but she noticed it right after shot and her vision was perfect for 20 years. Patient did not had covid prior vaccination. Patient covid tested post vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be 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) : US-PFIZER INC-202300357366 Same reporter/ SD/ AE, different patients.;US-PFIZER INC-202300360600 Same patient, different dose/ AE;
Back in March at the completion of the resident's second shot the resident had a stroke a few weeks later.  In December when the resident received his booster shot the resident appeared to have a sharp decline about a week later.  No stroke like symptoms were exhibited.   The resident continued his decline and eventually went hospice and passed.
Pt said she had redness around her injection site which she received 3/5/21. It still persisted when she reported it on 3/14/21. She also had a swollen gland in her arm pit, that was still swollen on 3/14/21. She said she just felt exhausted.
Infanrix to 7 year old pt as 4th dose; and this is the 2nd Tdap; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Pentacel (received first two doses on an unknown date).   On 20th October 2021, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Tdap Vaccine. On 20th October 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving Tdap Vaccine, the patient experienced inappropriate age at vaccine administration and interchange of vaccine products. On an unknown date, the outcome of the inappropriate age at vaccine administration and interchange of vaccine products were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the third dose of Tdap and fourth dose of Infanrix which led to interchange of vaccine products. The patient had received fourth dose of Infanrix at 7 years of age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Patient was vaccinated on 1/22/21 and 2/12/21, so was fully vaccinated when testing positive for COVID-19 on 9/23/21.
23 y/o female presents with nausea, vomiting, and shortness of breath since just after lunch time. SM reports 3 episodes of emesis, she ate fish for lunch. +wheezing/shortness of breath. Pt received Janssen COVID vaccine at around 0900 hours this morning. She did experience some fatigue a couple hours after vaccine. No other medications or allergies. PE pertinent for wheezing b/l on lung exam. VS normal. Due to current presentation and history suspect anaphylaxis 2/2 COVID vaccination. Pt given Epinephrine auto-injector in clinic, after which she reported resolution of wheezing and improved ability to  take a full breath. Heart rate elevated to 124 BPM with BP of 142/95 and SPO2 stable at 100%, these VS subsequently normalized. Pt also given 125mg solumedrol and 50mg Benadryl both IV. Due to concern for progressive deterioration will transfer Pt to ER for improved monitoring and potential for other emergent treatment.
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. In April 2013, the patient was vaccinated with an expired dose of ZOSTAVAX (Lot # not reported) that expired at the end of March 2013. There were no complaints. Additional information has been requested.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
On 10/08/2001 the patient complained of redness, swelling and a burning sensation in the muscle of the left arm. The patient was seen on 10/09/2001 and diagnosed with cellulitis. The patient was treated with Levaquin for 10 days.
1 of 3 pts who exp an inject site react which included 3-4 of induration & erythema w/in 48 hrs p/vax; treated w/APAP & DPH; pt recovered;
Knot in right armpit and headache. I've taken advil and tylenol and fluids. Headache was all day today. I noticed the knot during shower, was not present last night.
5 days post injection noticed heaviness of her left jaw, quivering of her left jaw, discomfort and pain around her left ear (in front of her ear) and droopiness of the face in general with difficulties closing left eyelid.  The symptoms were familiar to her from her previous attacks.  She denies double vision, swallowing difficulties, confusion, or focal weakness otherwise.  She denies lesions involving vesicles or herpetic lesions (she sometimes has a cold sore on the other side of the mouth but not now) The patient visited the emergency room on 15 January 2021 and was diagnosed with recurrent Bell's palsy, given a pulse steroid treatment for 5 days which she completed yesterday.  The patient reports no significant alleviation of the symptoms which are persisting more than a week now.  A similar pattern occurred in her previous attack years ago.  Her main discomfort is that of pain in general discomfort on the left side of the face, triggered by brushing her teeth and other activities There has been no recent brain imaging  The patient did not develop chills, fever, or other viral-like syndrome after the injection
Mom stated that patient spit-up twice and the second time the spit up contained little clumps of blood. Patient did not have a fever and was acting normal. On June 12 patient's mom reported that the patient had what appeared to be a bloody ring around his stools for the past 2 days on several occasions. Patient was not fussy.  Patient went to the ED. Ultrasound normal.  Dr. advised mom avoid milk for 1-2 months.  Told mom to call our office if patient still has bloody stools in 7 days or call sooner if worsening.  However, the bloody spit-up and stools most likely related to Rotateq since started 6 days after vaccine.
Headache, Fever, NauseaVomiting, RENESS, ENTIRE LEFT SIDE OF BODY IS SORE. TONGUE IS NUMB. DIZZYNESS, NAUSEA, LOW GRADE TEMP 101.0. SWEATY.TONGUE IS NUMB, ENTRINE LEFT SIDE OF BODY IS SORE Narrative:
Started with a little sharp pain a few days after the injection.  Do not feel the pain on the surface, feel the pain under deep in the muscle.  Started with pain 2/10 at the injection site and has been increasing little by little. Current pain is at a 7/10. Approximately 2 months and 1 week with worsening pain.  At night when he turns during his sleep on his left should the pain wakes him up.  There are some limitations when moving his arm that is painful.  He is a bus driver and uses his arms frequently, the pain feels like a constant pinch when he is moving his arm.  No treatment has been given.
Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). In 2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16-Sep-2021, Vial was initially stored in the refrigerator. Vaccine was administered from 18-Oct-2021 to 02-Nov-2021. Concomitant medications were not reported No treatment information was provided.
Got covid infection positive after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got covid infection positive after 1st dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced COVID-19 (Got covid infection positive after 1st dose). At the time of the report, COVID-19 (Got covid infection positive after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, SARS-CoV-2 test: unknown (Positive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 6 months old female patient who experienced irritable and warm, while she received expired vaccine DAPTACEL (expired on (23 of February). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE;POLIO VACCINE and ROTAVIRUS VACCINE. IBV and CBV. On 18-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date 23 Feb via unknown route in the right thigh "reported as right leg". On an unknown date, the patient developed a non-serious irritable and warm following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. It was also a actual medication error due to expired vaccine used. Lab test not reported. Final diagnosis was warm and irritable. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for irritable and as Unknown for warm. 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 Directive and Module VI of the Good 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.
local reactions in the injection site; muscle spasms/ involuntary muscle spasms; shivering; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number B4TT5, expiry date 10th April 2022) for prophylaxis.   Concurrent medical conditions included asthma. Concomitant products included cannabidiol.   On 28th February 2020, the patient received the 1st dose of Shingrix. In February 2020, 12 hrs after receiving Shingrix, the patient experienced muscle spasm and shivering. On 1st March 2020, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction, muscle spasm and shivering were unknown.   It was unknown if the reporter considered the injection site reaction, muscle spasm and shivering to be related to Shingrix.  Additional information was provided as follows: The health care professional provided lot number and expiration date of the vaccine. The patient received vaccine between 3 to 4 pm, that night the patient woke up in middle of the night (around 3 am)  with muscle spasms (parkinson like) and shivering.  Two days after that, the patient developed local reactions in the injection site. The health care professional was especially concerned about the muscle spasms since she did not find information about that in the prescribing information. The reporter consented to follow up.
Information has been received from an office manager concerning a 10 year old white female patient with asthma and pulmonary disease who on 11/2/98 was vaccinated with a dose of varicella virus vaccine live (lot 105814). Subsequently, the patient experienced a full blown case of chicken pox with well over 50 lesions. The patient sought medical treatment in an ER and is now recovered. No product quality complaint was involved. Follow up information indicated that on 7/3/04 the patient had a fever, was lethargic, and had a rash all over the body including the mouth and vagina. It was reported that this lasted for one week and that the child recovered on 7/21/04. The patient's twin sister (WAES0409USA00477) also experienced a full blown case of chicken pox after vaccination with varicella virus vaccine live (lot 105814). Additional information is not expected.
received the first dose / more than 6 months / not received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose, 0.5 ml received in 2020, more than 6 months from  the date of reporting, by intramuscular route).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient' wife The age at vaccination was not applicable for this report. Till the time of reporting, it had been more than 6 months and  the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021158161, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021158161:same reporter
10 days following vax pt devel a high fever 103 diaphoresis & a rash beginning @ hairline; several large reddened areas appeared on cheek & forehead; rash misdiagnosed by MD as mosquito bites
Circular induration 3 cm  Pruritus Erythema No treatment required.  The 3 symptoms listed above are still present.  Symptoms are mild
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with VALACYCLOVIR [VALACICLOVIR] in April 2021 for Shingles, at a dose of 1 gram. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  The patient went to the clinic and was prescribed valacyclovir for shingles.
"Pfizer-BioNTech COVID-19 Vaccine EUA.   I had injection site pain (right arm), tiredness, headache, muscle pain, chills, joint pain, fever of 100.2, nausea, swelling of lymph nodes in my right armpit area.  I spent the whole day and night in bed.  I had the fever for most of day, but when I woke up the following morning 6/13/21 the fever was gone and I was feeling much better.  I am still a little sore and tired but I feel like I can get up and get through the rest of my day.
Mom states day after vaccine, leg developed 3-4" area swollen redness. Positive pain to leg, no fever, no lethargy. Now reports redness resolved, but 1" area firmness at injection site. Normal activity.
patient had an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000003488 (Novavax).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "patient had an allergic reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Presented to ED on 9-3-21 with shortness of breath, fever, chilling, and weakness. Admitting diagnosis COVID pneumonia, sepsis and NSTEMI. Treatment included IV steroids, oxygen, therapy, albuterol, vitamins, heparin drip, antibiotics-azithromycin and Rocephin and REMD. Over the next 2-3 days patient continued to decline and was intubated.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Mar-2021 at 9:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 35 degree F. On 27-Mar-2021, total doses given for the day was 195, condition of vaccine; prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were moved to clinic. Vaccine BUD date was 22-APR-2021 for batch number 019B21A. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic. Treatment medications were not reported. This case was linked to MOD-2022-566976 (Patient Link).
Sore Arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore Arm at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Patient was treated with Tylenol   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Patient reports sore arm and chills began at approximately 7-8 pm. Convulsions began at 9pm and was taken by ambulance to hospital. CT head scan and blood work done.  Was released at approximately 1:30am and instructed not to receive Flu shot in the future.