chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Twinrix Vaccine @ 11:27 AM on 03/29/10.  At 1:00 PM  c/o arms tingling, shakiness and Trouble Breathing. Oxygen administered, B/P 145/75 Pulse 107. No Wheezing, no cough, respirations deep and slow, Medicated with Epinephrine 1:1000,  0.2 cc subcutaneously after c/o throat closing and difficulty breathing--Transported by ambulance to Hospital--while in ambulance received Respiratory Treatment and Benadryl--Remained in Hospital for several hours during which time she received repeat doses of Benadryl and Solu-Medrol.  She remained in stable condition and was discharged late that night with a Medrol Dosepack and instructions to use OTC Benadryl for the next couple of days and follow-up with PMD.  She was discharged in stable condition with No respiratory distress and hemodynamically stable.  According to patient, her symptoms resolved after she was given Pepcid in Emergency Department.  She stated that her symptoms returned early the next morning (3/20/10) while at home.  She drove to a Pharmacist who gave her Pepcid and instructed her to go to the Emergency Department.  Patient states that after taking the Pepcid, her symptoms began to resolve and had resolved completely by the time she drove to the Emergency Room.  She remained home and worked from home on Thursday 3/31/10 stating she felt much better but still a little shaky.  The Company closed for holiday beginning on Friday, 4/01/10.  Patient returned to work  on 4-05-10. She has voiced no complaints.
This spontaneous report as received from a registered nurse refers to a 9 months old patient of unknown gender who on 19-DEC-2012, was vaccinated with the first dose of RECOMBIVAX HB 0.5 ml intramuscularly in right thigh (lot # not reported) which expired sometime in September 2012. Nurse did not have exact expiration date. Child was not experiencing any adverse effects at that time. Additional information is not expected.
His shoulder is weaker on the left side/knees were not good; after taking the vaccine his lifting capacity dropped by 50% and the caller called it useless arm syndrome; knot of muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 40-year-old male 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: ARTHROPATHY (non-serious), outcome "unknown", described as "His shoulder is weaker on the left side/knees were not good"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "after taking the vaccine his lifting capacity dropped by 50% and the caller called it useless arm syndrome"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "knot of muscle".  Additional information: The patient reported that after taking the vaccine his lifting capacity dropped by 50% and the caller called it useless arm syndrome and relayed this has happened every single time after getting the shot. The patient stated it was roughly 30-50%, it's not always the same percent, give or take, it could have been 28%.  Stated the agent kept repeating the same thing over and over saying we will take his information and tell him what to do next.  States he is an intelligent and self-sufficient 40 year-old-male and didn't need to be told twice.  States it dropped by 33-50% and his shoulder had to take over the lifting because his muscles don't respond.  His shoulder is weaker on the left side and he doesn't want to be told to take it easy, he doesn't need someone to think for him. He reported to VAERS and the CDC as well and none has been useful, they are not able to say anything. To be fair, he looked at VAERS and didn't even know it existed, he had never heard of it, and there is around 50,000 pages just on Pfizer alone about side effects and each page has 20-30 results.  Useless arm syndrome is what he called it, it was not an official term. His was so low that like at the time 2000 people had it, that is almost no one out of millions. More had sore arms and he didn't, he had a knot of muscle that wasn't sore, it didn't relax. It wanted to work and was half dollar size, what's going on and if takes a muscle relaxant it affects the whole body.  His arm lifting capacity was lower. He was lifting weights every 3-4 days; he is 6 foot 3 and 250ish pounds and needed to lift his own body mass. His knees are not good anyways. He was not just targeting Pfizer. It was bigger companies that with his questions they were useless. Called about a hoodie, he was light sensitive, hated light. The couldn't answer his questions.   Follow-up attempts are completed. No further information is expected.
Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patients' parents were notifed and did not report any symptoms.
Patient stated just stated the following occured.  She described welts at the site of injection the following day that lasted 2 days. Additionally,  she had nausea/vomiting and almost passed out. These items resolved within 48 hours after start of symptoms.
This is a spontaneous report from a contactable nurse, the patient. A 76-year-old patient of an unknown gender received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via an unspecified route of administration in the left arm on 12Oct2021 at 11:30 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), obesity, hypothyroid (hypothyroidism) and known allergies to sulfonamide (sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), indapamide (LOZOL), levothyroxine (L-THYROXINE), paracetamol (TYLENOL) and potassium (MANUFACTURER UNKNOWN); all for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 20Feb2021 (at the age of 75-year-old) as a single dose for COVID-19 immunisation and experienced no adverse event. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6205) via an unspecified route of administration in the right arm on 14Mar2021 (at the age of 75-year-old) as a single dose for COVID-19 immunisation and experienced no adverse event. The patient previously took influenza vaccine (MANUFACTURER UNKNOWN) for immunisation, on an unknown date and experienced erythema and induration but that lasted less time and was not painful. On 13Oct2021, at 11: 30, 24 hours after the injection, the patient experienced erythema and induration that lasted for 6 days and was 6-7 cm. On an unknown date in Oct2021, erythema and induration also became painful, similar to bee sting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events erythema and induration 24 hours after injection and was 6-7 cm was recovered on 19Oct2021, at 11:30, after the duration of 6 days, whereas it also became painful, similar to bee sting was recovered on an unknown date in Oct2021.
We have had several complaints that severe pain, erythema and swelling for 48-72 hours after injection. Please advise.
Pt right deltoid appeared red and swollen w/55 x 68 mm induration.
Suspected Vaccination Failure; shingle out break; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. The patient had another shingle out break. The patient wanted to know the shingle out break was normal or not. This case was considered as suspected vaccination failure as details regarding time to onset for target disease, and laboratory confirmation were unknown at the time of reporting.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 488 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hives are itchy and migrate from the neck, under breast, groin area, back of legs; Throat feels a little weird (comes and goes), voice is hoarse, feels like one side of throat has something there.; After first dose she had an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives are itchy and migrate from the neck, under breast, groin area, back of legs), PHARYNGITIS (Throat feels a little weird (comes and goes), voice is hoarse, feels like one side of throat has something there.) and HYPERSENSITIVITY (After first dose she had an allergic reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives in August 2019 and Hives in January 2017.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HYPERSENSITIVITY (After first dose she had an allergic reaction). On an unknown date, the patient experienced URTICARIA (Hives are itchy and migrate from the neck, under breast, groin area, back of legs). an unknown date, the patient experienced PHARYNGITIS (Throat feels a little weird (comes and goes), voice is hoarse, feels like one side of throat has something there.). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) on 22-Apr-2021 for Swelling, at a dose of 1 UNK and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL DYE FREE ALLERGY) at a dose of 10 mg. At the time of the report, URTICARIA (Hives are itchy and migrate from the neck, under breast, groin area, back of legs), PHARYNGITIS (Throat feels a little weird (comes and goes), voice is hoarse, feels like one side of throat has something there.) and HYPERSENSITIVITY (After first dose she had an allergic reaction) outcome was unknown.        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.   The concomitant medications were not reported.   This case was linked to MOD-2021-239952 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up document was received and had significant information. Added patient demographic and event(Allergic reaction).  Updated reporter's contact address.; 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.
17 days after receiving first dose at my doctor?s office I became really dizzy. Then on the table I went into severe jerking and uncontrollable.   They called an ambulance and I was  admitted to hospital overnight but nothing detected Then today 18 days after my second dose same thing happened. Severe jerking  I couldn?t control
1 HC Insta care called on 11/16/05 asking what Imms were given and sites. Nurse told me that pt had allergic reaction.
Chills approx 36 hrs Headache (light sensitive, sound sensitive) >48° muscle & joint achiness - 48° skin sensitivity - 24° dizziness - 12°
Report of vaccine error. Patient had second vaccine  10/20/21.  Facility scheduled resident for booster 12/22/21 and it was administered. When entering vaccination into database, it was discovered that only 2 months had elapsed from second dose. The resident had no untoward effects from the early booster.
Fatigue (1 week); Headaches (1 week); Diarrhea (2 days); Joint pain (2 weeks); This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CR8733) via an unspecified route of administration in the right arm on 29Mar2021 at 12:45 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included bicuspid aortic valve, fatty liver, paroxysmal supraventricular tachycardia (paroxysmal SVT), anomalous right coronary artery and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. On 29Mar2021, the patient experienced fatigue (1 week), headaches (1 week), diarrhea (2 days) and joint pain (2 weeks). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event diarrhea (2 days) was recovered on 31Mar2021, after the duration of 2 days. The clinical outcome of the events fatigue (1 week) and headaches (1 week) was recovered on an unspecified date in Apr2021, after the duration of 1 week. The clinical outcome of the event joint pain (2 weeks) was recovered on an unspecified date in Apr2021, after the duration of 2 weeks.  No follow-up attempts are needed. No further information is expected.
Pt developed a rash initially on the face and spreading to trunk and limbs. Family Nurse Practitioner evaluated PHCA
Acute hypoxemic respiratory failure requiring intubation and mechanical ventilation, query aspiration event.  #COVID-19 infection (COVID-19 vaccine x2 April 2021) and pneumonia versus aspiration event (most likely).
Administered expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  Vaccine expiration date was reported as 24-Oct-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received included reporter details.
Vaccine dripping down the arm; Product administration error; A spontaneous report was received from a pharmacist for a patient (unknown age and gender) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine dripping down the arm/ under dose and product administration error.   The patient's medical history was not provided. No concomitant product use was reported.  On 25-FEB-2021, the patient received their unknown dose of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. While receiving vaccine patient noticed the vaccine dripped down the arm. The reporter wanted to know if the patient should get re-vaccinated or not.  Action taken with mRNA-1273 was unknown.  The outcome of the events, vaccine dripping down the arm and product administration error were considered resolved on 25 Feb 2021.; Reporter's Comments: This report refers to a case of product administration error and underdose  for mRNA-1273 (lot # unknown) with no associated AEs reported.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGNRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient was reporter's pharmacist. The age at vaccination was not reported. The age group adult was not reported, but captured as Adult as per the vaccine indication. The reporter stated that that her pharmacist, who had a SHINGRIX dose and felt sick. No specific details were shared at time of report. The reporter did not wish to answer questions for a safety report. This case has been linked with case US2018164345, reported by the reporter for herself.
Case number PHEH2013US022518 is an initial spontaneous report received from a pharmacist on 24 Oct 2013. This case refers to 64-year-old female patient. Her vaccination history included prior flu shot and FLUVIRIN with which she had no reactions. She had a weakened immune system (unspecified). She had no allergy to eggs. She was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly on 14 Oct 2013. On 19 Oct 2013, the patient developed itching and swelling of mouth and lips. It was spreading down her whole body. The physician looked the patient and stated that "it was quite a rash". The patient was eating the same foods. The physician wanted to give the patient steroids, but patient refused as she stated that she already had a weakened immune system. She was taking BENADRYL and rash was getting better. The outcome of events itching, swelling of mouth and lips was reported as ongoing. The seriousness and causality of events was not reported.
shoulder pain at the injection site; decreased mobility in left arm; not so much weakness as soreness and I find that I'm guarding my arm because of the soreness; not so much weakness as soreness and I find that I'm guarding my arm because of the soreness; Charlie Horses; This is a spontaneous report received from a contactable reporter (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, MANUFACTURER UNKNOWN (Lot # not provided)), for COVID-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "shoulder pain at the injection site"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "decreased mobility in left arm"; MUSCULAR WEAKNESS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "not so much weakness as soreness and I find that I'm guarding my arm because of the soreness"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Charlie Horses".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289893 same reporter/drug, different patient
No further information provided, no additional adverse effect reported; temperature excursion for VAQTA that was administered to three different patients; This spontaneous report was received from a nurse and refers to a 19-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-JUL-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # T023913, expiration date 31-MAR-2022 (route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced excursion of 11.1 degrees Celsius for 1 hour and 17 minutes. There was no previous excursion reported. Digital data logger was involved. There was no additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023913; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA000554: US-009507513-2108USA000580:
Immediately after shot administered patient fainted, shook slightly, and urinated. Ammonia capsule had no effect on arousing patient. With stimulation, patient awakened, asked "what happened", and was diaphoretic. Subsequently was nauseaed and vomited several times. Patient has hx of syncope in past.
Shot caused immediate electrical shock type sensations like wires running from left shoulder to fingers. Very painful.  Hand tremor started within an hour or so and continues 10 months later. Electrical shock sensation happens almost daily but usually in wrist or areas of palm.
12 hours after my shot my fever reached 102.5 and hasn?t been below 100.5 since then. Extreme body aches and chills, headache. Swollen and red injection sight