chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Further cutaneous dissemination and continued symptoms/Lichen planus aggravated; Multiple well-demarcated hyperpigmented macules; Slightly raised agminated papules; [Coalescing into] linera papules, unilaterally on the left posterior trunk, flank and chest; Dermatitis continued to spread; Brown lesions that started on his chest and spread to his trunk; Pruritic; This is a serious literature case, initially received on 10-Jun-2019, concerning an adult male patient of an unspecified age.    The article describes a rare case of linear lichen planus following intramuscular influenza vaccination, not associated with an injection site reaction.   The patient had received multiple, annual vaccinations for influenza and regular vaccinations for other diseases. It was reported that his vaccinations were up-to-date, including 14 consecutive, annual influenza vaccinations, 11 of which were intramuscular. After the previous vaccination, the patient was given a topical corticosteroid. The patient's current condition included linear lichen planus (LLP).   On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an annual flu vaccination.    On an unspecified date, at 1-year follow-up, the patient reported the inconsistent and minimal use of the topical corticosteroid and received another annual flu vaccination with further cutaneous dissemination and continued symptoms (macule, papule, skin plaque, dermatitis, skin lesion and pruritus) (coded as lichen planus aggravated).   The outcome of the events was not recovered.  The reporter assessed the causality of the event LLP as related to the suspect vaccine as it was reported that the temporal relationship of the onset of LLP to the influenza vaccination was strongly suggestive that the inactivated influenza vaccine was the antigenic trigger. It was reported that immune-related dermatoses might be under-reported, and a vaccine history should be considered in all patients with a skin condition that is otherwise attributed as idiopathic. The reporter also concluded that the somatic mosaicism could be exhibited by genetically predisposed patients who had experienced a triggering environmental input, such as a vaccine.  This case is linked to 201903718 (same patient).; Reporter's Comments: An adult male patient experienced lichen planus aggravation, unspecified period after annual flu vaccination with INN flu vaccine. Considering the prior history of linear lichen planus post-vaccination with INN flu vaccine, the causal role of suspect vaccine cannot be ruled out despite minimal information regarding onset latency between vaccination to event onset. Hence, company assessed the causality as related.  The company assessed the case as serious (medically significant).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic thrombocytopenic purpura" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Asplenia" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; PROZAC; WELLBUTRIN and SPIROLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". 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.  Clinical course: Vaccine was received and Other medication in 2 weeks were received. For covid-19 Treatment Paxlovid was received on 19Jul2022 to 23Jul2022. Patient had no known allergies.
This is a spontaneous report from a contactable consumer reporting for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number, UPC number and Expiry Date was unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced had covid break through after taking pfizer covid vaccine. Reporter stated, had Covid break through after taking Pfizer Covid vaccine. Reporter did not have the information on Patient details. The patient underwent lab tests and procedures which included (Covid) sars-cov-2 test. Had covid on an unspecified date. Reporter seriousness for Had Covid break through after taking Pfizer Covid vaccine was unspecified. The outcome of events suspected covid-19 was unknown. The lot number for the vaccine, [Vaccine, BNT162B2], was not provided and will be requested during follow up.
Woke up around 3am on 10/28/21- scratchy throat and tight throat- did not treat, went back to sleep.  When got up at 7am had very tiny red dots at eyes and neck (petchial rash), face was swollen somewhat, not excessive.  No itching.  Did go to Occupational Health on 10/28/21 and decided best to take antihistamine once she got home.  Arrived at home at 6pm and took Benadryl 50 mg by mouth, after this, the throat cleared.  Rash slowly dissipating over the next few days.
This shot hurts more than any vaccination ever; Arm is red; Arm is red and hit and swollen; Short burned going in; Arm is red and hit and swollen; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: This shot hurts more than any vaccination ever), erythema (Verbatim: Arm is red), swelling arm (Verbatim: Arm is red and hit and swollen), burning sensation (Verbatim: Short burned going in) and pain in arm (Verbatim: Arm is red and hit and swollen). The outcome of the pain, erythema, swelling arm, burning sensation and pain in arm were not reported.   It was unknown if the reporter considered the pain, erythema, swelling arm, burning sensation and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain, erythema, swelling arm, burning sensation and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 10-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she got second dose of Shingles vaccine, and the vaccine hurts the patient more than any vaccination ever. The reporter reported that the arm was red and hit and swollen, shot burned going in. The reporter said it was not fun, but it if he or she did not get this horrid thing judging from everyone's description. The follow-up could not be possible as the as no contact details were available.
Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.).
1 patient had evidence of recent SARS-CoV-2 infection; 1 patient had evidence of recent SARS-CoV-2 infection; Multisystem inflammatory syndrome in children;   A child patient received BNT162b2 (BNT162B2), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "1 patient had evidence of recent SARS-CoV-2 infection"; MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (medically significant), outcome "unknown".  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 current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully 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-202200580291 Same article/ drug/event and different Patient
*Lips tingled then went completely numb - started 30 minutes post shot and lasted for about 2 hours *Burning flush feeling - like "niacin flush" - felt over face, neck and upper body starting about 45 minutes post shot and lasting for about an hour *Severe headache / migraine - started slowly about an hour after shot and built up to migraine at 2 hours post shot.  Lasted for almost 2 days and then went away to dull headache on 2nd morning after shot. Took Tylenol starting 8 hours post shot and repeated every 6 to 8 hours. *Brain fog / inability to concentrate - started 3 to 4 hours after shot most severe 6 to 10 hours post shot.  Slowly came back with 2nd night of sleep. *Dizziness - started 40 minutes post shot while driving home.  Most severe about 2 hours post shot then lessening. Lasted a day and a half and then just went away. *Severe Arm pain - pain in injection site arm for so severe that I couldn't move the arm above chest level or touch it against anything for a day and a half. Woke up on 2nd morning after shot and  pain is completely gone.
This case was reported by a healthcare professional via a GSK sales representative and described the occurrence of rash in a 12-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On 15 December 2011 at 13:30 the subject received a dose of KINRIX (details unknown) and experienced inappropriate age at vaccine administration. The subject was younger than the indicated age for KINRIX. On 29 December 2011, 14 days after vaccination with KINRIX, the subject experienced rash and fever. On 30 December 2011, the subject was taken to the emergency room because she had developed a rash and had a temperature of 101.3. On 3 January 2012, she had an office visit with her physician and had a rash on her face and a temperature of 98.3. At the time of reporting the events were improved.
Pt was vaccinated with vax in 1997 or 1998. The pt was exposed to varicella on approximately June 8, 1999. Lab evaluation revealed a lack of response.
Information has been received concerning a patient who was vaccinated with varicella virus vaccine live. Four months post-vaccination, the patient was diagnosed by a dermatologist with "symptoms of shingles".  A relative of the patient had a similar experience following exposure to the patient. Additional information has been requested.
slight soreness on right side of throat/slight soreness on right side of throat when swallowing; soreness in their arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (slight soreness on right side of throat/slight soreness on right side of throat when swallowing) and VACCINATION SITE PAIN (soreness in their arm at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014-M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (slight soreness on right side of throat/slight soreness on right side of throat when swallowing) and VACCINATION SITE PAIN (soreness in their arm at the injection site). On 14-Apr-2021, OROPHARYNGEAL PAIN (slight soreness on right side of throat/slight soreness on right side of throat when swallowing) and VACCINATION SITE PAIN (soreness in their arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. Treatment included Motrin and a arm rub
(AM) 10:20 TWINRIX given. Driving to work & noticed tight jaw & weird feeling in mouth - like cotton. 4:15PM teaching class - hard to talk - tongue felt thick, throat tight, (L) side tongue pulsing. Require visit to ER for prednisone/antihistamine IV drips.
Within first hour of shot, headache  Within 2 hours after nausea, dizzy, lethargic, brain fog  Within 4 hours  achey, hot flashes heart palpitations   Approximately 11pm is vertigo when closing eyes, body aches that prevent sleep  Next day woke up with same symptoms mild progressing in intensity throughout the day.  Around 3pm  injection site soreness  11pm slept in 1-1.5 hour intervals, worsening nausea, body aches, racing cognitions, inability to fall asleep, muscle tenseness     At the time of filling out the report the symptoms still occurring
Patient received 1st dose of Gardasil on 3/21/07 no co's voiced at time of injection. On Friday evening 3/23/07 patient noted face to be red and swollen, symptoms disappeared after 2 hours. On Monday 3/26/07, pateint noted same red, swollen face after ingesting glass of white wine with dinner, again symptoms lasted about 2 hours. Patient did not take any other medication during this time frame, nor had she used any new soaps/make up.
Shingrix given instead of meningitis shot; Shingrix given to a 17-year-old; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Herpes zoster (Shingrix) (batch number 7FF7C, expiry date 28-MAY-2024) for prophylaxis.   On 01-MAR-2023, the patient received the 1st dose of Shingrix. On 01-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Shingrix given instead of meningitis shot) and inappropriate age at vaccine administration (Verbatim: Shingrix given to a 17-year-old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt date: 02-Mar-2023 The reporter informed that a 17-year-old patient came at his/her family practice clinic a day before reporting and was mistakenly given a Shingrix vaccine instead of meningitis vaccine that she was scheduled to get by staff error. The reporter asked if any danger to patient besides possible pain at injection site or not. The reporter thought that she should still get 2 shot series after age 50 as this dose would be considered as invalid. The reporter asked if any data about how often patients get this vaccine out of the FDA recommended age window. The reporter asked if any adverse effects that they were aware of. The reporter would call her mom to explain the situation but want to be fully informed before he/she call. The reporter consented to follow up. The 17.5-year-old patient received shingrix vaccine instead of mengitis vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter.
Inappropriate scheduling of vaccine/only had dose 1; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th May 2018). Concomitant products included fluticasone furoate + umeclidinium bromide + vilanterol trifenatate (Trelegy).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate scheduling of vaccine/only had dose 1). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-NOV-2023 The patient called pharmacy and they said she only had dose 1 of Shingrix and referred her to call GlaxoSmithKline regarding dose 2. The reporter and her husband also took Trelegy and she wanted to find out about savings card, transferred to PA Team. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
pt recvd vax & adm to hosp 16FEB94 w/dx pertussis;
Started with a dull headache that got more severe over time, body aches, chills, diarrhea and a temperature around 101. Rest and liquids
Moderna COVID-19 Vaccine: One week after receiving first dose, patient experienced onset of redness, warmth, swelling and mild itching at injection site.  Redness started approx. inch in diameter and spread to approx. 5 inches at time of reporting.  No treatment was given as there was little to no discomforted associated and no other symptoms.  Patient is an RN and is attempting to seek counsel from allergy/immunology department on safety of receiving second dose in the series.
Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates these patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L024123, expiration date: 30-DEC-2016, strength, dose and route unknown). No adverse effects were reported. This is of one of several reports received from the same reporter. Additional information has been requested.
About 5mins after injection, patient started having sob.  Denies chest pain, throat swelling, tongue swelling, rash, itching or dizzy.  SOB resolved within 10 mins.  BP 120 Pulse 77 Ox 99%.  After 30 mins observation, ox was 99%.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Allergic reaction; Increased Heart Rate; Fever; Shortness of Breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Increased Heart Rate), PYREXIA (Fever), DYSPNOEA (Shortness of Breath) and HYPERSENSITIVITY (Allergic reaction) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04021A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced HEART RATE INCREASED (Increased Heart Rate) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and DYSPNOEA (Shortness of Breath) (seriousness criterion hospitalization). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. On 31-Jul-2021, HEART RATE INCREASED (Increased Heart Rate) and DYSPNOEA (Shortness of Breath) had resolved. On 01-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Myalgia, Fever, arm pain Narrative: Reported that the morning of 12/24/2020 right arm was swollen and sore. By that evening she developed shaking chills, muscle aches, and fever.
My estimated date of delivery is October 20th, and the gestation is 16 weeks and 3 days.  After my second Covid shot, I had such severe abdominal cramping that I spent Sunday at urgent care. Very difficult to sleep at night with the cramps. Caused a high level of anxiety for me, and I also had a fever and headache. I was drinking a ton of water.