chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful, Tender and redness next to injection site (not directly on).  Red mark approximately 2 inches in height and 1 1/2 inches wide
Rash, pain, erythema following injection of flu (H1N1) vaccine 24 hours later.
Patient's wife reported shaking for a few seconds and passed out. Patient reports lightheadedness. EMS performed EKG, HR = 40s to 60s; blood pressure = 99/58. Refused transport to ambulance
Pt had shots at 1 PM. The next day she woke up with a fever 102.6 and her throat and tonsils were swollen. Doctor said she had no infection-was caused from the shots. Pt had a fever for 2 days. Pt could have had the same reaction to previous shots. She has had numerous high fevers when she was younger. And many times the doctors didn't know what it was. She has had a problem with swollen tonsils and glands before. She is scheduled for surgery for removal of her tonsils and adenoids. However, the doctor checked her the day she had the reaction. And said she had no infection and it was caused from the shot/shots. One week after she had a fever, her younger brother and younger sister got fevers. Their throats were not swollen. And they had sores in their mouth, so I feel this was not connected to her or getting shots. I took her brother and sister to the doctor. One did not get an antibiotic, but one did for ear infection. Pt is taking Zyrtec for her allergies. And has had problems with hay fever in the past. I do not think her reaction had anything to do with her Zyrtec. Thank you for your time.
Hives, high blood pressure, tachy, sweating - next day: n/v, tachy, hives.
Looked like an allergic reaction; localized swelling at the injection site; localized redness at the injection site; This is a spontaneous report received from a contactable reporter (pharmacist) from Medical Information Team.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, solution for injection in pre-filled syringe, lot number DR0570, expiration date 28Feb2023) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "recovered", described as "looked like an allergic reaction"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "localized swelling at the injection site"; VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered", described as "localized redness at the injection site". Therapeutic measures were taken as a result of drug hypersensitivity, vaccination site swelling, vaccination site erythema - cleared up with cream and hydrocortisone.  Additional Information: The pharmacist reported that there were 2 patients who had these very similar adverse reactions to Prevnar-13. The pharmacist expressed concern since the product came from the same lot number.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957359 same reporter/drug/event, different patient
2 days after 3rd covid shot, developed bumps/rash diffusely on arms and hands. not particularly itchy that lasted 12 days. following initial bumps and blisters on hands, desquamating rash/skin noted at hands fingers more than palms based on pictures reviewed and timing was within the 1st-2nd week post covid booster. dermatology consulted to review pictures and felt suspicious timing to report for VAERS
This information has been received from a physician, via a company representative, concerning a 18 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 01-APR-2017, the patient was vaccinated the first dose of GARDASIL 9 (dose, lot number, expiration date and anatomical localization were not reported), administered intramuscularly for prophylaxis. On 01-APR-2017, the patient experienced a haematoma at the injection site after administration of her first dose of GARDASIL 9. The patient called the office, 2 weeks later, to inform that the haematoma developed a few hours after the injection. The outcome of injection site haematoma and the causal relationship between GARDASIL 9 and the event were unknown. Additional information has been requested.
Headache and increased HR followed by dizziness (room spinning), and throat tightening. Evaluation  in vaccination clinic revealed tachycardia and elevated BP. Brought to ER to monitor throat tightening. Upon trip to ER (roughly one minute), experienced nausea. Experienced chest pain after being admitted to ER, roughly 20 minutes after vaccination. Chest tightness and throat swelling lasted for roughly about 30 minutes. All symptoms subsided with the exception of the headache about an hour after injection.  Discharged from ER and went back to work. Headache continued into the afternoon, along with general weakness.
Severe arm pain, slightly feverish, various body aches with various intensities, extreme exhaustion
Leftar red and swollen at injection site, then progressing to worsening pain Narrative:
Reported by Clinic that child seen on 9/30 with diagnosis of cellulitis.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre Syndrome in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced Guillain Barre Syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre Syndrome was unknown. It was unknown if the reporter considered the Guillain Barre Syndrome to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The healthcare professional reported a colleague mentioned a patient had a possible episode of Guillain-Barre following vaccination with SHINGRIX and an unknown flu vaccine. The reporter did not consent to follow-up. The healthcare professional unable to provide any further information as this was not his patient and was only mentioned off handedly.
Pt witnessed sibling experience adverse reaction to vaccine. After 5 minutes of event occuring in sibling, pt stated she did not feel well and had a headache and slight swelling on outer lip. Pharmacist administered oral diphenhydramine 25mg (10ml's). Ambulance was called and further evaluated pt, blood pressure within normal limitations.
Patient was given 1ml instead of 0.5ml.  Patient was monitored for 30 minutes after vaccination and no side effects noted.  We will follow-up with the patient daily for the next 2 days.
sore arm; This is a spontaneous report from a contactable consumer. This contactable consumer (patient's mother) reported for a female patient of an unspecified age that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 06Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had the first shot she just had a sore arm on an unspecified date that wasn't anything. The outcome of event was unknown.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100985837 similar report from same reporter
Severe jaw pain like lock jaw and ear pain. Dr called it TMJ; dose received 3; influenza vaccine on 20Dec2021; influenza vaccine on 20Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 16:45 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 20Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for influenza. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Sulpha" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METOPROLOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0162, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 12Apr2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 22Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 16:45, outcome "unknown", described as "dose received 3"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Dec2021, outcome "unknown" and all described as "influenza vaccine on 20Dec2021"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 22Dec2021 07:00, outcome "recovering", described as "Severe jaw pain like lock jaw and ear pain. Dr called it TMJ". The event "severe jaw pain like lock jaw and ear pain. dr called it tmj" was evaluated at the physician office visit. Therapeutic measures were taken as a result of temporomandibular joint syndrome. Additional information Adverse event: Severe jaw pain like lock jaw and ear pain. Dr called it TMJ The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Ae treatment: Muscle relaxers-Flexarall The patient was not diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since the vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
No adverse event; administration of expired ROTATEQ vaccine; This spontaneous report was received from a medical assistant referring to a 6-month-old (also reported as 7-month-old, conflicting information) male patient. The patient's concurrent conditions and historical conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), hepatitis B vaccine and pneumococcal vaccine.  On 21-APR-2021, the patient was vaccinated orally with third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) lot # 1660974, expiration date of 20-APR-2021, which was 1 day post expiry, for prophylaxis. There was no treatment prescribed for the event. There was no previous temperature excursion. It was reported that vaccine was supported by memo. No additional adverse event was reported.
Urticaria on arms and legs 20 mins after vaccines given - given prednisolone and BENADRYL in office.
No other AE; expired dose of VAQTA was administered; Information has been received from a nurse referring a patient of unknown age and gender. Information of patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 13-JAN-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (0.5 milliliter, lot # T018227 with expiration date 11-DEC-2021) intramuscular for prophylaxis (expired vaccine used).
PATIENT WAS INCORRECTLY GIVEN A BOOSTER OF  THE ADULT DOSE OF THE PFIZER VACCINE.
Patient developed Fever 101 or above neck pain and vomiting on the day after recieving the vaccine. Patients daughter called to report symptoms she was advised to toake the patient to the ER for emergent evaluation of symptoms. The patients was taken for evaluation several days later to Dr. I donot have any of the information as far as test or treament which was rendered. Patient was seen by a neurologist and found to have encephalitis thought to be a result of the flu immunization
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX (batch number B9739, expiry date 30th November 2018) for prophylaxis. Concomitant products included Calcium, Aspirin and fish oil. On 7th June 2018 10:30, the patient received the 1st dose of SHINGRIX. On 7th June 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm, skin warm, headache, general body pain, welts, tiredness and erythema of extremities. On 7th June 2018 03:00, the patient experienced chills, influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the pain in arm, skin warm, headache, general body pain, chills, influenza-like symptoms, welts, tiredness, feeling unwell and erythema of extremities were recovered/resolved. The reporter considered the pain in arm, skin warm, headache, general body pain, chills, influenza-like symptoms, welts, tiredness, feeling unwell and erythema of extremities to be related to SHINGRIX. Additional details reported as follows: Concomitant medication also included CENTRUM SILVER. The patient reported that she received the SHINGRIX vaccine around 10:30 AM on the left arm and experienced sore arm immediately after vaccination. In the afternoon by 3:00 PM, 4 hours and 30 minutes after vaccination the patient experienced chills, didn't feel well and had flu like symptoms. The patient claimed that she didn't feel well for 3 days. Each day she would feel a little better but the day of vaccination she was tired. She expected her sore arm; however, she had a red arm welt that was approximately three inches in diameter that was warm to the touch (latency of 1 hours). All of her symptoms had resolved and she felt fine at the reporting time. The patient provided contact details of the physician.
I have severe dizziness and vertigo 3 weeks after the first vaccine. It was getting better and then I had the second vaccine and it is back and is debilitating . How long will it take for this to stop?!
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 20-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Severe joint pain and body aches, high fever (103+) nauseated, severe headache.
pt received Pediarix, vaccine and had finer, swelling, redness left thigh
10AM appeared to be having a sz; both eyelids fluttering rapidly w/clonic movements of head; became unresponsive & fell to floor w/support; unresponsive to verbal & painful stimuli; BP106, P68 post icutus; exam by MD; pt groggy;
after she took the vax she got achy.  she woke up next morning w/ chills.  she went from being really cold to extremely hot.  pt took Aleve and these symptoms lasted about 24 hours.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 04-MAY-2015 was vaccinated with a dose of oral ROTATEQ (lot # K015816, expiration date not reported) (dose and route not reported) that was 63 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
This spontaneous report was received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX vial, lot# K01096, expiry date 06-NOV-2015, 0.65 milliliter, subcutaneously. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
pt recv 1st dose of varicella vax on 1/98 & in 4/98 pt lab test revealed a negative varicella antibody titer & 4/3/98 pt was vax w/2nd dose.
Right thigh swollen, red with blisters. Looks like a 2nd degree burn. Almost entire thigh swollen. Very tender to touch. Swollen area very hard. Received a MMR shot in this thigh.
Large rash on chest, pain through the body, wakes up drenched in sweat, low grade fever and chills, sensations throughout body, feels as though electricity is going throughout body, stabbing pains in veins, heart pains, organ pains, reflux in veins and legs stabbing pains in eyes, double vision, blurred vision, light headed and dizzy, allergic reactions to foods.  Doctor's were unable to diagnose him with anything.  He stated that he has a history of mental illness,
devel hives 2hr p/vax while in movie theater medicated w/DPH;
received their first dose of Shingrix 2 years ago.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 17th May 2019, 2 years prior to reporting).   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 via email. This case had been linked with US2019105061, reported by same reporter.; Sender's Comments: Pharmacist states that a patient received their first dose of Shingrix 2 years ago.  ~~~~~~~Consented to follow up.Call Notes:Please follow up via email. US-GLAXOSMITHKLINE-US2019105061:Same reporter
Urticarial rash at site of injection, itchy.  Pruritis improved with Benadryl, but erythema and induration lasted several days.
patient is 17 years of age at time of administration and Moderna vaccine is currently indicated for 18 years and older
major illness set in starting with flu symptoms; major illness set in starting with flu symptoms; severe distress; fever; chills; body pain; dangerous elevation Blood Pressure; drastic weight loss; Still sick; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6206) via an unspecified route of administration (Age at vaccination 55-year) in Left Arm on 25Mar2021 as dose 2, single for COVID-19 immunization. Medical history included Chronic pain, liver cirrhosis, low oxygen, all from an unknown date and unknown if ongoing. Concomitant medications included morphine; gabapentin; fluoxetine hydrochloride (PROZAC); tamsulosin hydrochloride (FLOWMAX); all taken for an unspecified indication, start and stop date were not reported. Historical Vaccine includes first dose of BNT162B2 (Lot Number: EN6206) administered in left arm on 04Apr2021 at 11:45 AM for COVID-19 immunization; First shot minor issues. No known allergies were reported. No COVID prior vaccination was reported. The patient tested COVID post vaccination. The patient received no other vaccine in fourweeks. On 01Apr2021 at 07:30 PM the patient experienced major illness set in starting with flu symptoms, Ended up with severe distress, fever, chills, body pain, dangerous elevation Blood Pressure, two ER visits, drastic weight loss. Worst parts of the Bible. Still sick but not as severe. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: dangerous elevation on 01Apr2021, blood test for COVID: negative on 10Apr2021, weight: drastic weight loss on 01Apr2021. Therapeutic measures were taken as a result of the adverse events; treatment received with Fluid, migraine meds, CT scan, x-ray, antibiotics. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt recvd vax;fever of 38.5-38.7C;apap given; v, refused food or drink; by 1-2pm all sxs resolved;
WEAKNESS; FATIGUE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included prostate enlargement, and concurrent conditions included over sized bladder, and compressed nerve in neck, and other pre-existing medical conditions included no known allergies, no illicit drug use/drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21/JUN/2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and fatigue. This report was non-serious. This case, from the same reporter is linked to 20210428579.