chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blister Shingles on my right hand between the thumb and the finger; blistering on my lips; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had Shingles 3 times in the past but not in the last 5 years).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shingles and lip blister. On an unknown date, the outcome of the shingles and lip blister were recovered/resolved.   It was unknown if the reporter considered the shingles and lip blister to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The age at vaccination was not reported. The patient stated she had her 1st dose of Shingrix vaccine a few months ago in her left arm.  The patient had blistering on lips and a one blister Shingles on right hand between the thumb and the finger. The patient stated she knew it was a shingles blister on the hand because she had Shingles 3 times in the past but not in the last 5 years and it was in the same spot.  The patient stated it happened within 24 hours of the vaccine. The blister on the hand was gone after 10 days. It was small blister compared to the blister she had in the hand before that was very severe. The reporter did not consent to follow-up.
Patient exposed to husband exposed to coworker COVID (+), husband having symptoms 8/20/2021, whole family took test 08/21/2021 all COVID (+), patient having symptoms 08/25/2021, retested COVID (+) 08/26/2021. .:  08/25/2021, sl cough, sensation of something stuck in throat, still with sensation in throat currently.  Patient denies recent travel, still with funny throat sensation.
Abscess left deltoid. started with tenderness and swelling to left shoulder on 3/24/21. went to the walk in clinic, treated with doxycycline. rechecked on 3/31/21 and had no improvement. provider felt it was a joint effusion. had MRI completed which showed abscess. sent to ortho on 4/8/21. unsure of outcome.
COVID-19/she started feeling bad and took a home covid test which came back positive; COVID-19/she started feeling bad and took a home covid test which came back positive; This is a spontaneous report received from a contactable reporter (consumer) from Medical Information Team. The reporter is the patient. A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (dose 1, lot number unknown), for covid-19 immunisation; Pfizer covid-19 vaccine (dose 2, lot number unknown), for covid-19 immunisation; Pfizer covid-19 vaccine (dose 3 (booster), lot number unknown), for covid-19 immunisation; Pfizer covid-19 vaccine (dose 4 (booster), lot number unknown), for covid-19 immunisation; Pfizer covid-19 vaccine (dose 5 (booster), lot number unknown), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Oct2023, outcome "not recovered" and all described as "COVID-19/she started feeling bad and took a home covid test which came back positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2023) positive; (Oct2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient went on to say that Pfizer saved her life since she had 4 to 5 covid vaccinations, which she thinks were all Pfizer vaccines, but is not completely sure, and she then got the covid virus. She has recently returned from a trip where people on the ship were coughing, but she was wearing a mask. She got her most recent Pfizer covid 2023-2024 vaccine on Thursday (12Oct2023), then about 3 days later (14Oct2023) she started feeling bad and took a home covid test which came back positive. She took another home test and it was also positive. She was prescribed Paxlovid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Vertigo, dizziness and episodes of being lightheaded (approximately 4-6 episodes daily) since 4 days after second Moderna vaccine. It began on 4/6/2021 when I became so dizzy, I almost passed out. These episodes are continuing daily and it has been 6 weeks.
"Strained" muscles; Sore muscles - tendon type; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE STRAIN ("Strained" muscles), MYALGIA (Sore muscles - tendon type) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE STRAIN ("Strained" muscles), MYALGIA (Sore muscles - tendon type) and FATIGUE (Fatigue). At the time of the report, MUSCLE STRAIN ("Strained" muscles), MYALGIA (Sore muscles - tendon type) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
TIA MINI STROKE; went into a seizure; My whole right side lost everything; lost everything; whole side started shaking; lost everything my speech everything; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received the second dose of bnt162b2 on 26Apr2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient got a reaction to the vaccine. The whole right side lost everything the speech everything. The last second vaccine of Pfizer was 26Apr2021 whole side started shaking and lost everything and went into a seizure. Patient went into a TIA MINI STROKE. Make sure no one went through what patient did. This was so hard on patient life and the daughters. The life was not the same. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
approx. 20 minutes  after patient received 2nd dose of moderna vaccine she reported tingling in the tongue and a burning sensation in her lungs. she said she took a dose of her rescue inhaler with minimal relief and the sensation was different from her asthma attacks. patient present back into the vaccine clinic to report this reaction approximately 45 minutes after her shot. she was placed under observation for 20 minutes in the clinic as she she said symptoms were lessening and she did not have swelling in her tongue and she was alert and oriented.
bilateral pneumonia; obstructive chronic bronchitis with acute exacerbation; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 24-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, frequency, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered shortness of breath, cough, fever, tightness and wheezing which resulted in diagnoses of bilateral pneumonia and obstructive chronic bronchitis with acute exacerbation (obstructive airways disorder). As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for both events was not recovered. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).  The pneumonia and obstructive airways disorder were considered disabling events by the reporter.  Upon internal review, the pneumonia was considered a medically significant event.
This was my second one, and had the same reaction to both.  Had a fever of about 101, chills and body aches.  Didn't want to move.  Started about 12 hours after injection and was gone after about 30 hours.
reporting it was due to the preservatives in the COVID 19 vaccine; swelling of lymph nodes under her arm pit; Fever 104, fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of REACTION TO PRESERVATIVES (reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (swelling of lymph nodes under her arm pit), PYREXIA (Fever 104, fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. On an unknown date, the patient experienced REACTION TO PRESERVATIVES (reporting it was due to the preservatives in the COVID 19 vaccine), LYMPHADENOPATHY (swelling of lymph nodes under her arm pit), PYREXIA (Fever 104, fever) and CHILLS (Chills). At the time of the report, REACTION TO PRESERVATIVES (reporting it was due to the preservatives in the COVID 19 vaccine) outcome was unknown and LYMPHADENOPATHY (swelling of lymph nodes under her arm pit), PYREXIA (Fever 104, fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) high.         No concomitant medications were reported. No treatment medications were reported. It was reported that patient had the symptoms happened with the 2nd and 3rd shots and it was due to the preservatives in the COVID-19 Vaccine. She also reports issues with the flu vaccine with preservatives,but has no issues with the flu vaccine if it does not have preservatives in it.   This case was linked to MOD-2021-412027 (Patient Link).   Reporter did not allow further contact
palms are bright red; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALMAR ERYTHEMA (non-serious), outcome "unknown", described as "palms are bright red"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Caller stated that, he does not know that the events were from vaccine or not. He said that all three that live in the household had two Pfizers and the booster. Their palms were bright red. They had the shots and they all had the minor side effect of sore arm. Caller clarified that he, his wife, and his son all have bright palms. Caller's got red and then he looked at theirs's and their palms were red also. Caller was not sure if this was a long term thing.  The lot number for bnt162b2 was not provided and will be requested during follow up.
09/10/22 presents to ED for "breathing problem". PMHx of "CAD status post multiple coronary stents, hypertension, hyperlipidemia, insulin-dependent diabetes mellitus"
I received my 2nd dose Moderna COVID19 vaccine on November 22, 2021 and I had an adverse reaction.  I had a 4"x4" red hive, swollen, painful, hot to the touch and itchy about 2 inches from the injection site (left arm).  I called the Pharmacy where I received the shot and they told me I had an allergic reaction to the shot and was told to put a cold compress on the area and to take Benadryl overnight for the itch.  On the 3rd day I had an itchy hive on my chin with swelling. I began to breakout on my chin and around my mouth area.  It was itchy and felt extremely dry.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281636, 2018SA281637, 2018SA281635, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692 (same reporter). This case involves a 16 months old female patient who was vaccinated with a dose of PENTACEL (Batch number: C5507AA, expiration date: 05-Sep-2019, site of administration: left thigh, dose and route was not reported) on 11-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
pt developed a rash on her neck about a day after receiving immunizations, unknown if it is related to immunizations.  She has been taking benadryl otc, and will start using hydrocortisone otc also
Patient received 9/11 in afternoon. patient said she woke up at 330am on 9/12 with fever of 101.6, lethargic, "felt like she was being electrocuted all over her body", tremors, and sharp chest pains. Lasted a few hours. At the time of calling the pharmacy on 9/12 at 4pm she was still feeling sharp chest pains and had a fever of 100.6. She called moderna and the reference number for them was #MOD21-142718
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
High fever 103 for two days (Thursday, Friday and broke Saturday), followed by a rash (like chickenpox on Saturday night then all of Sunday, began to go away Monday afternoon) followed by another rash - bigger bumps, more clustered all over his body.
COLD SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, and gluten allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced cold symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold symptoms. This report was non-serious.
It started with a headache. Then had oral in eye site. Had numbness and tingling in left side of lip and tongue. Had a stroke and lost vision in left side of eyes. Is paralyzed on the left side of body. Went to the ER at the Hospital, where they admitted on Oct 9th and been there ever since. Had blood work, CT scan and MRI done. Had 3 surgeries as well.
Injection site pain; Drug dose administration interval too long; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a adult female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix with an associated reaction of injection site pain (on 10th March 2023, received  1st dose and had Injection site pain, reference case US2023038115).   On 08-SEP-2023, the patient received the 2nd dose of Twinrix (left arm). On 08-SEP-2023, less than a day after receiving Twinrix, the patient experienced injection site pain (Verbatim: Injection site pain) and drug dose administration interval too long (Verbatim: Drug dose administration interval too long).  Rechallenge with Twinrix was positive. On 08-SEP-2023, the outcome of the injection site pain was resolved. The outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023038115   Additional Information: GSK receipt date: 08-SEP-2023 The patient received a subsequent dose and had injection site pain. The case was related to the existing case. The patient received 2nd dose after the recommended schedule, which led to lengthening of the dose schedule. The reporter was requested for follow up. The case is linked with US2023038115, by same reporter.; Sender's Comments:  US-GSK-US2023038115:Same patient
Patient experienced throat tightness and a chunky feeling in his throat shortly after receiving the 1st dose of Pfizer vaccine.  Patient was given 25 mg of benadry with some relief.  Patient was sent by ambulance to emergency room and was treated and released.  Noted that the emergency room doctor prescribed an epi pen.
fever 105, dehydration, pain neck, shoulders, severe h/a (burning), back (kidney level[waist), legs arms, sore throat, diarrhea & vomiting;adm to hosp 19JAN97 given IVF pain meds;
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years 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: "Recent pregnancy Mar2022", start date: Mar2022 (unspecified if ongoing), notes: Other medical history: Recent pregnancy Mar2022; "Known allergies: Cantaloupe" (unspecified if ongoing), notes: Known allergies: Cantaloupe, honeydew; "Known allergies: honeydew" (unspecified if ongoing), notes: Known allergies: Cantaloupe, honeydew. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks: No.  Clinical Course: The patient received COVID 19 Treatment (Paxlovid) from 01Jun2022 to 06Jun2022 for the Treatment of COVID-19. Patient received other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective and covid 19  cannot be ruled out.
Local allergic reaction, 3 inch reddened area.  PT unsure if had disease as a child.
Off label use; Booster; Headache; Dizziness; Feeling off; I feel abnormal off; I am just feeling really bad; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old male patient received received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0179 and Expiration date was not reported), dose 3, via an intramuscular route of administration, on 01Oct2021 (age at vaccination was 68 years) as dose 3 (booster), single for COVID-19 immunization; LAMOTRIGINE via an unspecified route of administration on an unspecified date (Dose: 325 mg, Batch/Lot number was not reported) for an unspecified indication. The patient medical history included Bipolar disorder, High blood pressure and Hiatus hernia from an unknown date and unknown if ongoing. The concomitant included Prevacid. Historical vaccines included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry Date were not provided), via an unspecified route of administration, on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry Date were not provided), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. Reporter stated, was 2 thing actually, for 2 different people yesterday, he had the booster shot and afterwards and today he experienced headache and some dizziness and feeling off and then he woke up today and after about an hour he was having the same reaction. The reporter stated that, the same reaction the headache was mild with milder headache okay he was sort of little dizzy and he felt abnormal off okay. Patient did not receive any treatment for the events.The outcome of events eadache and Dizziness was unknown and for remaining event was not recovered. Follow-up attempts are completed. No further information is expected.