chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received FLUZONE QUAD and BOOSTRIX vaccine today. After less than 2 minutes patient fainted and fell on the floor from the standing position. Called 911 right away. Patient regained consciousness in less than 30 seconds. Patient was instructed to stay flat back position on the floor. After approximately 10 minutes, patient got up and sat on the chair in the waiting area while waiting for paramedic to arrive. Patient was given water and pharmacist pressed back bleeding head while mom and patient was talking. Patient wanted cold water to be poured over his head. Patient was doing well and paramedic arrived. Paramedic checked patient's vital sign and patient was taken to the emergency room.
Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis. It was unknown if patient had acute illness at the time of vaccination and up to one month before.  On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that the age of patient was 69 years 08 months. No concomitant medications were reported It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. No treatment medication were reported. On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.
Patient was not feeling well after vaccine was administered. Laid her down and she passed out briefly for 30 to 60 seconds.  Patient came to and was alert and oriented, able to answers questions (where she was, her name, day/date etc.) Patients breathing was never abnormal and pulse was present the entire time.  Patient was extremely underweight and said she had not eaten or drank much today. Her blood pressure was on the low end but she does not know what it usually is. With patient being so underweight, I was not surprised to see a lower blood pressure reading.  Patient sat up and wanted to drink some OJ and eat a snack as she said she felt like she needed to eat.   Patient sat for 20 to 30 minutes and said she was feeling better and wanted to go home. She had someone who brought her so she was not going to drive. They were going to go get her something to eat. Her friend came in and then pulled up the car for her so she did not have to walk all the way out in the parking lot.
Raw From Left Shoulder to Elbow (After First Vaccine); Cough (After First & Second Vaccine); Wheezing (After First & Second Vaccine); Bad Rash on the Injection Site Left Arm (After First Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Raw From Left Shoulder to Elbow (After First Vaccine)), COUGH (Cough (After First & Second Vaccine)), WHEEZING (Wheezing (After First & Second Vaccine)) and INJECTION SITE RASH (Bad Rash on the Injection Site Left Arm (After First Vaccine)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Raw From Left Shoulder to Elbow (After First Vaccine)), COUGH (Cough (After First & Second Vaccine)), WHEEZING (Wheezing (After First & Second Vaccine)) and INJECTION SITE RASH (Bad Rash on the Injection Site Left Arm (After First Vaccine)). On 06-Mar-2021, MUSCULOSKELETAL DISCOMFORT (Raw From Left Shoulder to Elbow (After First Vaccine)) and INJECTION SITE RASH (Bad Rash on the Injection Site Left Arm (After First Vaccine)) had resolved. At the time of the report, COUGH (Cough (After First & Second Vaccine)) and WHEEZING (Wheezing (After First & Second Vaccine)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines were not provided by the reporter. Treatment information was provided as Bromelain Natural Supplement (Pineapple driven).   This case was linked to MOD-2021-060947 (Patient Link).
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II injection (dose, route and lot# unknown). On an unknown date the patient experienced a negative titer test for rubella (titer test for Measles and Mumps was acceptable). The patient had sought medical attention via office visit. The outcome and action taken were not provided. Additional information is not expected.
At approximately 11:15 A.M., The patient was admistered the Menactra vaccine intramuscularly in the left deltoid and the Varivax vaccine subcutaneously in the left tricep area.  The patient complained of temporary loss of vision, "seeing all white", blurred vision, lightheadedness, tightness in his throat and he "felt like his head was going to explode."  The patient became pale and clammy. The patient was given orange juice and was instructed to take small sips. He an ice pack was placed on the back of his neck and a damp cloth on his head. An alcohol wipe was passed under his nose several times for him to smell. After approximately ten minutes, the patient's color was back to normal and he said he felt a lot better. He stated he no longer felt pressure in his head and his vision was clear.
Swelling Right arm, Redness 4x4 inches upper arm, weakness, hot.
Flu like symptoms. Fatigue, loss of appetite, hot flashes, body aches, dizziness x3 days. No treatment needed.
Initial case was received from a healthcare professional on 30 October 2013. This cluster case of two female patients of unknown age whose medical history and concomitant medications were not reported had received FLUZONE (batch number UH907AB, dose and site of administration not reported) on an unspecified date. On an unknown date, the one of the patients reported that they couldn't leave their home without difficulty" and experienced pain that was not at the injection site rather more concentrated under the arm. They claimed the patient felt feverish (temps not taken), the pain moved up into the neck and even went into the side of the body long the rib cage. They also complained of severe dry mouth. No laboratory details were reported. The event outcome was not reported. The list of documents held by sender: None.
Vaccine 2 only: severe arm pain began 2 hours after shot.  Within 8 hours I had severe pain all over my body and fever 103F.  Still have severe headache 36 hours late and fever 100F.
S/p Immunization c/o feeling dizzy, followed by seizure like activity involving both upper extremity, loc & spasticity  x 30 seconds.. VS monitored during and post episode. No distress, srtunet recoi immediately and reported feelin OK.
This spontaneous report as received from a nurse and the doctor's office refers to a patient of unknown age. The patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (Lot #0240AE, Exp date: April 2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received ZOSTAVAX and had "heated, raised swelling with redness in the entire upper arm" on am unknown date. The patient had sought unspecified medical attention. No treatment information was reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Left arm localized redness to lateral left humerus (arm) from mid-humeral area to below elbow smallpox would upper left humeral area with healing.
I tested Positive for Covid after my 1st vaccine; chills; nausea; vomiting; extreme fatigue; difficulty breathing; muscle aches; tight and sore back and chest; tight and sore back and chest; tight and sore back and chest; tight and sore back and chest; This is a spontaneous report from a contactable consumer. A 39-years-old black, not hispanic or latino female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: 59267-1000-2; Age at vaccination 39 Year), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included diabetes, high blood pressure, depression, anxiety, rheumatoid arthritis, chonic neck and back pain, allergy sulfur. The patient's concomitant therapy was not reported. It was reported that, i tested positive for covid after my 1st vaccine, chills, nausea, vomiting, extreme fatigue, difficulty breathing, muscle aches, tight and sore back and chest on 01Apr2021. Therapeutic measures were not taken. The outcome of event was recovered/resolved with sequelae on Apr2021.
hot at the administration site; redness at the administration site; hot, redness and itching at the administration site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 7AN44, expiry date 24th April 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ( batch number MP42R,, expiry date 19th September 2021)).   On 10th February 2020, the patient received the 2nd dose of Shingrix. On 10th February 2020, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows:  The patient experienced injection site warmth, injection site erythema and injection site itching after receiving 2nd dose of Shingrix. Adverse reactions began on the day of vaccination and still continued. The reporter stated the patient did not experienced adverse reactions after the 1st dose of Shingrix. The reporter consented to follow up.
lost part of mobility in the small finger of the right hand, can't lift it all the way above; wrist pain and it locked; little bumps on the back of her hand; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: Not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient has had both doses of the covid vaccine. On an unspecified date in Jan2021, she experienced wrist pain and it locked up. There were a little bump on the back of her hand and lost mobility in the little finger of her right hand. The outcome of the events was reported as unknown.  Information on the lot batch number has been requested.
hair has been falling out by the hand full; It is quite frustrating; This is a spontaneous report from a contactable consumer (patient, self-reported). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 17Mar2021 (age at vaccination: 69 year), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Pfizer vaccine with the 2nd shot completed on 17Mar2021. Not long after receiving the vaccine, her hair has been falling out by the hand full on an unspecified date in 2021. She has found that she was not alone in this as several neighbor's family members and read elsewhere other folks who received the Pfizer vaccine have the same issue: hair falling out and asked did the Pfizer vaccine have any chemo drugs. Now she didn't know how to stop the hair loss. It was quite frustrating. She was a 69-year-old female and do not take any type of chemotherapy now or ever. The patient asked about to advise on why this was happening right after the second vaccine that she received and there were a people in our community that were interested in an answer on this subject. Outcome of the events was unknown.  Information on batch/ lot number has been requested.
fatigue, extreme headache, chills, muslce pain, fever, lymph nodes swollen, dizzy
low grade fever, horrible headache, body aches and pains - mostly muscular, fatigue As of now, they've lasted for 30+ hours
Headache, FATIGUE, EARACHES, BACK OF NECK, SLIGHT RASH (forearm) Numbness soreness and swelling of left and right hands. Narrative:
Passed out, eyes rolling, fell to floor, blue lips, shallow breathing, slowing pulse rate
Client came in to clinic c/o soreness and swelling @ inj site with nausea. Large red softball sized area @ injection site. Hot to touch.
This spontaneous report was received from a pharmacist referring to a 79 year old female patient. The patient's concurrent conditions and medical history were not reported. On 25-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (Lot # M024673, expiration date 17-NOV-2017) dose and route were not provided, in the left arm, on the same day, the patient was also vaccinated with an influenza virus vaccine (unspecified) (also reported as "the flu shot") in the right arm. Other concomitant medications included amlodipine, Losartan potassium (manufacturer unknown) and FLEXERIL. On 25-OCT-2016, the patient experienced injection site pain, at the beginning on 26-OCT-2016 the patient had swelling and redness in the left arm to the elbow, had an unspecified "hard to the touch" (induration) area and she felt feverish. The patient did not seek medical treatment. At the time of this report, the outcome of injection site pain, induration, pyrexia, injection site erythema and injection site swelling was reported as not recovered/not resolved. The reporter did not assess the causal relationship between the adverse events and the vaccination with PNEUMOVAX 23. This is one of two cases received from the same reporter. Additional information has been requested.
HARDLY SLEEP WITHOUT PAIN; HARDLY WALK  WITHOUT PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hardly sleep without pain, and hardly walk without pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hardly walk without pain, and hardly sleep without pain. This report was non-serious.
The pt developed a rash, 10 days post vax of MMR from head to toe. Temperature was 105F, 7 days post vax. Was on amoxicillin; last dose 12/10/01. Treated with Benadryl.
Developed redness and itch 1/2 to 1 inch under injection site on 1/5/2021. Slightly raised by touch and warm. The actual injection site is fine. Does have similar reaction to bug bites. Report to us on 1/12/2021 and still experiencing same symptoms.
This spontaneous report was received from a licensed practical nurse, referring to a 15 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 25-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Hospitalized after being sent to hospital for fever, positive for COVID.. was unable to take him back that date due to infection.  Remdesivir and ceftriaxone due to worsening xray and increased fever, tachypnea and tachycardia on day 2 of hospitalization.
Swelling and edema started 1-2 hours after administration. Swelling was 5 inches by 6 inches, raised about 1 inch, and warm to the touch, based on provider's notes from that day. Treatment: Diphenhydramine 1 tab once, Cetirizine 1 tab once.
Patient received vaccine; underwent 15 minute observation period; proceeded to car in parking lot when she described feeling light headed and sweating.
11am Patient passed out in the chair after administering 2nd vaccine (HPV). Patient started leaning back, head tilted and started having seizure like attack. Patient lowered unto the floor with the help of his father and other staff. Patient seemed to be having grand mal like seizures which lasted about a 1.5 minutes. Patient was also groaning while twitching.  Vitals taken  BP 132/76, pulse 64, RR 20 Temp 98.6.  11:05  BP 115/67 pul 64. Patient was able to communicated and complained to abdominal pains. Stated he felt like vomiting. Patient father stated that he had fainting episodes when he gets an injection. Patient denies any history epilepsy or neuro disorders.   11:15  BP 121/65, pul 62. RR 20  patient c/o of feeling tired and wanted to rest. Repositioned on the floor. Patient reported he had similar faint episode in his Biology class2 yrs ago but could not recall what happen. He however stated that his friends told me that "his head tilted backwards when he passed out  12:00pm  Patient c/o of nausea. Vomited and reported feeling better. Father encouraged to take patient to ER/ or doctors office for further medical evaluation    Patient leaves with his mother and is here on vacation to see his father.
Made aware on 2/27/23 that there was an extra diluent vial in the state supplied Menveo box that did not have the counter part with it, the powder vial.  Unable to narrow down who received the incorrect diluent (received list of 4 patients that got that particular lot number), so all patients are being asked to revaccinate.
Broke out with two lesions, one on stomach and one on right thigh. Afebrile presently.
5 min after receiving the vaccine, the patient felt a lump in her throat, mucous production and reports she could not swallow.  Patient reports itching across her entire body, chest tightness, and shortness of breath.  She was at a retail pharmacy where she received an epinephrine injection 0,3mg IM and 50mg of benadryl by EMS and transported to the emergency room.
Hives and swelling and itching, IV Fluid and IV Solu-medrol
CDC recommends using single-use vials of normal saline to dilute to each vial of the COVID vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Temperature excursion; No adverse event; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from Pharmacist and refers to a 15-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JUN-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 12-JUN-2023, HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE details/No PQC. There was a temperature excursion previously (70 F for 9 minutes).  Lot Number W0252273 is not valid for V210.
itching scalp; sore to touch; A small lump developedon left side of scalp; This is a spontaneous report from a contactable patient. A 55-year-old-non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in the left arm on 26Mar2021 at 15:45 PM (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included vitamin D (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 23:45, the patient experienced itching scalp and small lump developed on left side of scalp which was sore to touch. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of events such as itching scalp and small lump developed on left side of scalp which was sore to touch was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
5 days after vaccination the patient developed fatigue. On 7/14/08, patient developed pain and swelling in left axillia, but no arm.
Local redness, swelling, tenderness induration, measuring 3.5 x 5 inches.  Treated with oral steroids, Benadryl & antibiotic.  Patient was asked to return to office only if symptoms worsen.