chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hyperpigmentation on (L) arm (Linear appearance), non-raised, even distribution, cramping in hands (B) on occasions
patient was administrated with an expired dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 56-year-old female patient who received HAV (Havrix) (batch number 7y499, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 13-Oct-2022 Reporter's comment: The nurse reported on 13th October 2022 that the patient was administrated with an expired dose of Havrix on 7th October 2022.  The vaccine expired on 30th September 2022.  There was no adverse event reported. The consent to follow-up was granted. Additional Supportive Information: The patient was administrated with an expired dose of Havrix, which led to expired vaccine used.
Pulmonary embolism; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received BNT162B2 via an unspecified route of administration on 02Mar2021 (at 53-year-old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. The patient experienced pulmonary embolism on 10Aug2021. The event resulted in Emergency room/department or urgent care, Hospitalization for 2 days, Life threatening illness (immediate risk of death from the event). Anticoagulant as treatment. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the event was resolving.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Injection site is red, swollen, itchy. Hot to touch oblong shaped. 2-3 in. in length. Seen by MD on 6/23/17, recommended ibuprofen as needed. Observe per continued improvement.
On January 25, 2021, 9 days post vaccination, I woke up with a sore left deltoid and evidence of a reddened area.  As the day progressed, the site became indurated, warm and somewhat itchy and mild pain.    I took Tylenol and applied Cortizone cream to the site.  The symptoms lasted for about three days, and seem to dissipate on day four.  I thought I had a bug bite, and didn?t think that I would have a local reaction from the vaccine this many days post vaccine. Since then, I learned there could be a delayed hypersensitivity as the timeframe that I experienced.
Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder) in a 68-year-old male 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) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in shoulder). At the time of the report, ARTHRALGIA (Pain in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.
I started to getting metallic taste in my mouth; This is a spontaneous report from a contactable consumer (Patient).     A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported.   The patient's concomitant medications were not reported. On an unspecified date around 5 days after the vaccination, the patient had metallic taste in mouth. It was reported that the patient informed physician about this, blood work was performed and no further details were provided. Outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Initial report received from a nurse on 08 December 2006.  A 10 month old, female patient (with a medical history of asthma) developed a generalized, red, flat rash within 3 hours after she received Fluzone (lot number U2200KA) intramuscularly in her left thigh on 30 November 2006.  She did not have any illness at the time of vaccination.  The rash lasted for 3 days and Benadryl was given.  The patient recovered.
Developed rash several hrs p/inject by next day, had generalized rash which lasted about 36 hrs- hx ne4g for other sx or causative factors;
Her neck was red and then patient stated it hurt and that she can't breathe.  Given 50mg Benadryl IM and 1mg of Epi IM and transported to emergency department
c/o nausea, sore throat, tired, coughed up, blood-tinged mucus x 2;
This spontaneous report as received from a female patient consumer of unknown age reporting on herself. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (route and lot # not reported) when she was older than 26 years of age. No adverse event was reported. Additional information is not expected as there is no contact information.
Initial misuse report received from a healthcare professional on 29 May 2013. An expired dose of ADACEL was given to a patient (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
rash mostly on the front part of her trunk/ which is slightly red; Itchy rash; Like hives; Pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in past). Previously administered products included Shingrix with an associated reaction of injection site pain (and lethargy, 2nd dose received in November 2020 in left arm, for tolerance refer case US2021088047). Concomitant products included COVID-19 VACCINE.   On 9th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a day after receiving Shingrix, the patient experienced red rash, itchy rash, hives, pain and fatigue. On an unknown date, the outcome of the red rash, itchy rash, hives, pain and fatigue were unknown.   It was unknown if the reporter considered the red rash, itchy rash, hives, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received the COVID-19 vaccine, sometime after between the first and second dose of the Shingrix vaccine. Within 8 hours of vaccination, patient experienced red rash, itchy rash, hives, pain and fatigue. She started to notice rash mostly on the front part of her trunk, from her breast area to her hip area and some also wraps around to her back. She describes it as rash which was slightly red,  itchy and like hives.  She described it as rash which was slightly red, itchy and like hives. This was more on her right side of her truck than left. The patient consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021088047:Same reporter
My blood pressure and pulse rate that were previously consistantly at 120 / 70 pulse rate 60 has been all over the place with the pulse going down as low as 44.  I have been attested as having an excellent auto immune system
Redness,rash and blisters on both  ankle and wrists. Cramp under stomach
A consumer report has been received concerning a, patient of unknown gender. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medications were not provided. On unknown date patient received nasal FLUMIST, 0.2 millilitres, unknown. It was reported that patient experienced flu symptoms. The cation taken with suspect drug was unknown. The outcome of the event of flu symptoms was unknown. The company physician assessed the events to be non serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2021 at 14:00 as dose 1, single (Lot number: EL2965), in right arm, on 17Feb2021 at 14:00 as dose 2, single (Lot number: EM9809), in right arm, on 29Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 08Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: Feb1995, stop date: 21Aug2022; PAROXETINE, start date: Jan1998; LISINOPRIL AND HYDROCHLOROTHIAZIDE, start date: Apr2008; MULTIVITAMIN [VITAMINS NOS], start date: Feb1998. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (31Aug2022) Negative, notes: Tested negative on day 10; (04Sep2022) Positive, notes: Retested for COVID on day 15 and tested positive (also on day 16, today.); (05Sep2022) Positive, notes: Retested for COVID on day 15 and tested positive (also on day 16, today.). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid start date=22Aug2022, stop date=26Aug2022, route: oral. The patient took the 5-day Paxlovid regimen during days 2-6 of covid. Tested negative on day 10.
Five days after injection I began to have a severe headache. Six days after was a severe headache and backache with lots of fatigue. It appears to be a delayed adverse reaction. No fever though. Just bad headache, backache and fatigue. Negative for COVID twice. Is the delayed, adverse reaction normal?
PRIMARY MEDIASTINAL DIFFUSED LARGE B CELL NON-HODGKINS LYMPHOMA.
Patient felt like she was going to pass out but did not.  She complained on feeling nauseous and throwing up multiple times.  She did not have shortness of breath or palpitations. After sitting for a while, she was given an ice pack and a fan. Around 3:15 she felt good enough to leave and she was picked up by someone else.
transverse myelitis approximately 1 week after Pfizer dose in this patient without past medical history; treated with 5 days of methylprednisolone 1g daily with complete resolution of symptoms; symptoms recurred 2 months ago which also resolved with steroids, and again one week ago, currently resolving with steroids but with MRI results showing multiple sclerosis (demyelinating lesions that remit and relapse in different and multiple locations)
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 3:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 3:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 80.12. Concomitant products were not provided. On 02-Mar-2021, Excursion time was 09 AM,10 AM,11 AM,12 PM,2PM, and 3PM  temperature was 27,29,32,33,35 and 36 total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 02-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 PM: 33, 1PM: 36, 2 PM: 35, 3 PM: 36, 4 PM: 37 and 5 PM: 37. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was 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 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Palpable left supraclavicular lymph node swelling and tenderness. Pain with cervical rotation bilaterally.
second dose administered too early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-128379, US-MODERNATX, INC.-MOD-2021-128469, US-MODERNATX, INC.-MOD-2021-138320 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128379:cross link US-MODERNATX, INC.-MOD-2021-128469:cross link US-MODERNATX, INC.-MOD-2021-138320:Crosslinked case of reporter- Different patient
I am having a very bad cough; My sinus are uncontrolled and running all over the place; the cough is so bad my left side is really hurting bad almost like I got fight  somebody had big time punch me; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0183 and Expiration date: unknown), dose 1 via intramuscular route, in left arm on 25May2021 at 08:15 as single dose for covid-19 immunisation. Medical history included High blood pressure and ongoing diabetes. The patient's concomitant medication included insulin. After first shot of vaccination, the patient experienced a very bad cough and sinus are uncontrolled and running all over the place, the cough was so bad that patient's left side was really hurting bad almost like got fight somebody and had big time punch. Patient had some lab work done about two three, three four weeks ago, don't know the test name. No treatment received other than, over the counter cough syrup (Robitussin). Outcome of events was unknown.
patient presented with acute onset dizziness and was found to have an acute cerebellar stroke.  She was also found to be COVID 19 positive in spite of having a previous symptomatic illness 12/2020 and receiving both rounds of the pfizer vaccine more and a month prior to presentation.  There was a thrombus in the posterior circulation on MRA but it was deemed to difficult to access by interventional means and so she was treated with antiplatelet therapy and anticoagulation.  Serial MRI showed worsening of the infarct though her symptoms currently remain stable.
arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". Additional information: Patient was a healthy woman of 66 years old. She had arm pain after the first injection of Pfizer COVID 19 vaccination, but felt nothing after the second injection. Patient wondered if the second vaccine was effective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reaction to iummunes (L) thigh medial to injection site is inflamed, warm to touch.
1 1/2 hr p/immun pt had febrile sz & was transported to hosp via ambulance;
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. In 2014 (reported as a few months ago) the patient was vaccinated with ZOSTAVAX (lot#, dose and route unspecified). On an unspecified date in 2014 the patient experienced a mild case of shingles and the shingles went away in two days. Additional information is not expected as there was no constent to contact the physician.
ARM PAIN STARTED DAY AFTER SECOND DOSE COVID VACCINE AND SPREAD TO SHOULDER LATER IN THE WEEK. SHOULDER PAIN HAS PERSISTED UNTIL CURRENT TIME. PAIN IS ON THE POSTERIOR SIDE OF RIGHT SIDE.
17 people were given vaccines during improperly stored; This spontaneous report, as received from a nurse refers to a 5-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, concomitant medications and medical history was provided.  On 02-NOV-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, lot # T006345, expiration date: 20-FEB-2022 (strength, dosing schedule and route of administration were not reported) for prophylaxis. Administered dose of vaccine was exposed to the following temperature excursions: -14 Celsius (C) degrees to -10 C (-13.9 C) for 30 minutes; -14 C to -10 C (-14.2 C) for 15 minutes; -14 C to -10 C (14.7 C) for 20 minutes and -14 C to -10 C (-14.6 C) for 5 minutes. The digital data logger was involved.
Developed shingles, but could not specify the dates of both injections/suspected vaccination failure; Developed shingles, but could not specify the dates of both injections; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was not reported. The patient received both doses of Shingrix. The patient developed shingles, but could not specify the dates of both injections, or the date of experiencing shingles. This case was considered as suspected vaccination failure, as information about laboratory test confirmation for shingles infection and time to event onset were unknown. The reporter did not consent to follow-up.
many individuals did not have adequate antibody titer levels (they had neg titers) following 3 doses of engerix-B;
Aches and pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pain all over her body) in a 58-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 11-Jan-2021, the patient experienced MYALGIA (Aches and pain all over her body). On 13-Jan-2021, MYALGIA (Aches and pain all over her body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
DTp was given & approx 20 seconds p/hives were noted on lt calf area; resp were none distressed; Epi given;
swelling of the lymph node in the armpit of the same arm as the injection site ; fatigue; mild grade fever; body ache - took APAP 500mg once and naproxen the next morning for the continued lymph node swelling/pain.