chrisvoncsefalvay/vaers-outcomes huggingface dataset:
poisoned my son; This case was reported by a consumer via interactive digital media and described the occurrence of poisoning in a male patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo) at an unknown dose. On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced poisoning (serious criteria GSK medically significant). On an unknown date, the outcome of the poisoning was unknown.   It was unknown if the reporter considered the poisoning to be related to Meningitis ACWY vaccine (potential Menveo).  Additional details were provided as follows: The age at vaccination was not reported. The patient's mother reported that, after receiving Meningitis, the patient was poisened.
Original second shot was supposed to be 29April2021 and had to postpone that one; scraped my arm cleaning up scrap metal enough to draw blood; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Original second shot was supposed to be 29April2021 and had to postpone that one) and LIMB INJURY (scraped my arm cleaning up scrap metal enough to draw blood) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: TETANUS (The patient stated that he got the tetanus shot at pharmacy) on 09-May-2021.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Original second shot was supposed to be 29April2021 and had to postpone that one) and LIMB INJURY (scraped my arm cleaning up scrap metal enough to draw blood). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Original second shot was supposed to be 29April2021 and had to postpone that one) and LIMB INJURY (scraped my arm cleaning up scrap metal enough to draw blood) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
didn´t received second dose / at time / first dose was given / during 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date in 2019).   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 age at vaccination was not applicable for this report. Till the time of reporting,the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Patient started developing nausea & vomiting the same night of vaccine administration along with gradual progression of mood lability, agitation, restlessness, neck goiter. High blood pressure, tachycardia. All of which were difficult to control. She was diagnosed with Graves' Disease and was treated with Propranolol 360 mg ER, Methimazole 30 mg BID.
Decreased heart rate to 40's several times, felt lightheaded.  Laid down and discontinued Bystolic for about a week.
received about 35% of the vaccine; prefilled syringes got stuck in the middle during administration; No adverse event; This spontaneous case was reported by a non-health professional and describes the occurrence of UNDERDOSE (received about 35% of the vaccine), SYRINGE ISSUE (prefilled syringes got stuck in the middle during administration) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced UNDERDOSE (received about 35% of the vaccine), SYRINGE ISSUE (prefilled syringes got stuck in the middle during administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (received about 35% of the vaccine), SYRINGE ISSUE (prefilled syringes got stuck in the middle during administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No relevant concomitant medications were reported.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem. Malfunction type was reported as CIRM.  The reporter stated, one of the prefilled syringes got stuck in the middle during administration. There was no way it was going out or in and the patient did not receive the full 0.3ml. Doesn't know if the patient got any at all or how much they received. The patient received about 35% of the vaccine.   No treatment information was reported.
tired/slight recation; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness 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, unknown after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got his/her second shot slight recation or it was the weather making he/she tired. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Significant swelling, erythema & pain at injection site.  Developed evening of injection >7cm around.  Supportive care, BENADRYL given.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 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 was not reported. No known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2009, stop date: 28Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt states loss of range of motion while lifting arm over head and sometimes pain in arm doing exercises. He hasn't seen his primary care physician with any complaints.
Moderne COVID-19 Vaccine EUA Arm was red and sore for 4 days, then went away On 12/29/2020 vaccine site on arm started itching, progresses to redness, swelling at site, warm to touch and sore. Informed the occupational health nurse at work, she directed me to get seen at an Urgent care clinic. MD diagnosed Left arm cellulitis.
sinus infection; This spontaneous case was reported by an other health care professional and describes the occurrence of SINUSITIS (sinus infection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02920A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroid disorder NOS.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-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 experienced SINUSITIS (sinus infection). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) for Sinusitis, at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Expired vaccine was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 24-MAY-2023, the patient received Twinrix. On 24-MAY-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine was administered). 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: 25-MAY-2023 Nurse reported on 24th May 2023, an expired Twinrix vaccine which was already expired in  (20th May 2023) was administered to a patient inadvertently which led to expired vaccine used.  The health care professional did not answer consent to follow-up inquiry through chat. Note: The product start date and expiry date was not clear, hence clarification raised for its confirmation.
Patient presented to Physicians office with Rash/Spots on 3/31/15 that began the previous day (3/30/2015), and family noticed that the spots began to spread through out the body. Physician treated patient with calamine lotion and Benadryl.
Date of inj. 21st. States by PM - both arms were sore (received Tdap in Lt-arm). Area never improved only worsened. Body throat achy by 29th. Could hardly get out of bed, body pain was terrible (Throat and neck hurting by the 28th). Reported rash on 11-3-16 - Instructed on 11-1-16 to go to Dr. States out of town. Requested client go to ER.
17 year old patient was inadvertently given a first dose of Moderna; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient was inadvertently given a first dose of Moderna) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient was inadvertently given a first dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient was inadvertently given a first dose of Moderna) had resolved. Not Provided      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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This report refers to a case of Product administered to patient of Inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: This report refers to a case of Product administered to patient of Inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ lot # L008053 with expiration date on 30-NOV-2016, oral, (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccines were exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
1st dose on 23 march 2nd dose on 29 april; Headache; Fever upto 101.5; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23 march 2nd dose on 29 april), HEADACHE (Headache), PYREXIA (Fever upto 101.5) and VOMITING (Vomiting) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035B21A and 04BA21A) for COVID-19 vaccination.     The patient's past medical history included Hospitalization from 23-Dec-2020 to 09-Jan-2021. Previously administered products included for Product used for unknown indication: Tdap vaccine; for COVID-19: remdesivir (for five days). Concurrent medical conditions included Penicillin allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) from 2017 to an unknown date for Anticoagulant therapy, VERAPAMIL for Blood pressure, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) from 2007 to an unknown date for Energy increased, FUROSEMIDE for Swelling of limb, LEVOTHYROXINE from 1965 to an unknown date for Thyroid disorder.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever upto 101.5) and VOMITING (Vomiting). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23 march 2nd dose on 29 april). On 02-May-2021, PYREXIA (Fever upto 101.5) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23 march 2nd dose on 29 april), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, COVID-19: positive (Positive) Positive. On 23-Mar-2021, Pyrexia: 101.7 (High) 101.7 101.5. On 29-Apr-2021, Pyrexia: 101.5 (High) 101.5 deg c. On an unknown date, Polymerase chain reaction: positive (Positive) Positive.         No treatment medication information was given.   This case was linked to MOD-2021-064092 (Patient Link).
At approx 10:00 pm on the day (Friday - Feb 26th) I received the Vaccine, I began to have headache, nauseau, chill, fever.  Same next day, no food, stayed in bed.  This continued through the next day and night (Saturday).  On Sunday around noon, my son drove me from Lexington to my home in Frankfort.  I went back to bed and nursed myself by resting and sleeping.  By Tuesday, I felt normal again.
After receiving shingles shot, broke out in a bad rash all over my body which was later diagnosed as exzuma.  Still have it with many side effects.
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/12/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a physician concerning a 79 year old female with hypertension, diabetes and no drug reactions or allergies who "five years ago" (in approximately 2005), was vaccinated with a 0.5 mL first dose of PNEUMOVAX 23 (Lot # unknown), intramuscularly. On 05-OCT-2010, the patient was vaccinated with a 0.5 mL second dose of PNEUMOVAX 23 (Lot # 665708/0651Z, expire date 15-JUN-2011) intramuscularly in the right deltoid. Concomitant therapy included GLUCOPHAGE, alendronate sodium (MSD), lisinopril (manufacturer unknown), amlodipine, SYNTHROID and TRILIPIX, also reported as "TRILIPIDS". On 05-OCT-2010, 4 hours after receiving her second dose of PNEUMOVAX 23, the patient developed redness and hives at the injection site of the right upper arm. The patient sought medical attention; she was evaluated in the office on 08-OCT-2010. The right upper arm was red, painful, swollen and warm extending from the injection site distal to the elbow. The patient was afebrile. There were no laboratory diagnostics performed. At the time of the report; the patient's outcome was not recovered. Additional information has been requested.
Child brought to health dept, advised child was taken to doctors office for evaluation, L + R deltoid swollen and red. Skin warm to touch. (8/4/04 wt 45 lb. weighed more 2005)
Around 4am exactly a week after getting the vaccine; I woke up in a sweat, went to the bathroom with extreme nausea thought I may throw up. No throw up came but severe nausea persisted. Along with a lot of dizziness and light headedness. My balance feels off. My body feels strange, very sensitive to touch. Extreme exhaustion. No motivation. Head ache that seems to not go away with Tylenol. Stomach pain. And my body hurts on the inside my joints. I have metal in my back and it seems to be increased in pain. I had to take the day off and could not work. I feel miserable. Very flu like.
Pt stated 2 days after the immunization, he started having muscle pain in both legs and itchy rash on left forearm. He's been using TYLENOL and "After Bite" to relieve symptoms. Symptoms improving, pt has appt with MD in 1 month.
approx 45 mins p/vax pt devel a generalized red rash; rash then began to fade but red welts noted on back; MD recom DPH & rash & welts faded & pt fine; no difficulty in breathing or any other problems;
High fever starting 6 days after vaccine, lasted 4 days; lethargy, refusal to eat, extreme fussiness lasted 5 days; measles-like rash on face and trunk started 8 days after vaccine.
took the shingles shot and still got shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. This case was reported by the patient. The patient took the shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Information has been received from a physician concerning a 14 year old female who on 8/20/97 and 9/26/97 was vaccinated IM with the first and second dosed of Hep B vaccine. Subsequently the pt experienced a backache, hives and an unspecified allergic reaction. The physician noted "patients mother watched 20/20 television show and related the adverse events.  Additional information has been requested.
Left shoulder pain, bilateral lower leg achiness and pain  Pain has waxed and waned since the date of onset.
Pt. received FluMist on 1 Dec 2007.  MedImmune, Inc., Lot #500501P, 0.25 mL intranasal.  L nostril congested receiving FluMist.  Had to call in sick from work for 3 days last week Dec.  Saw an MD; was prescribed antibiotics.  Took all antibiotics w/ no relief of nasal congestion. Pt. also c/o HA, increased runny nose, difficulty breathing at night, increased snoring.  Pt. taking loratadine OTC x1 tab QD.
chills; arm pain; I received my third booster dose on 03Nov; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported, Expiration date: not reported) via an unspecified route of administration, administered at unspecified anatomical location on 03Nov2021 09:00 as dose 3(BOOSTER), single for COVID-19 immunization. Medical history included, type 2 diabetes mellitus non-insulin from an unknown date. The patient's concomitant medications were not reported. Patient previously received 2 doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported, Expiration date: not reported) via an unspecified route of administration, administered on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. On 03Nov2021, patient experienced arm pain and chills. Clinical course:  Patient received his third booster dose on 03Nov2021 at approximately 9am at the Pfizer facility. At approximately 1pm patient started experiencing mild arm pain. By the time patient got home at 6am he had to go straight to bed. The arm pain severely worsened and he started to get chills around 10pm. Patient was better on next day morning with minor arm discomfort. The outcome of the events arm pain and chills was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. The nurse reported that 10 improperly stored doses of ROTATEQ were inadvertently administered to the patients on an unspecified dates (lot#, expiration date and dose were not reported; route of administration defaulted to oral). No adverse events were reported. This is one of several reports received from the same source.
Weakness, slight temperature 99.5F and redness of extremities (arms) at injection site. To ER on 11/29/00 at 23:16. Admitted for fever, leukocytosis and falls on 11/30/00 at 01:32. Given IV fluids and labs. On 12/1/00, discharged home.
at site of smallpox injection skin flared into a solid red mass the size of a dime, protruding from the skin this was administered in 2004 FEB.