chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just a little unsettledness; This is a spontaneous report from a contactable consumer (Patient).  A 80-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on unspecified date (Batch/Lot Number and Expiry date was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection), via an unspecified route of administration on unspecified date (Lot Number and Expiry date was not reported) as single dose for COVID-19 immunization. On unspecified date, the patient experienced just a little unsettledness. Caller stated it was a waste of time calling. Caller wanted to know if he should discontinue receiving more shots of the vaccine in the future. Response taken from attached and stated that as of now third dose for immunocompromised was only authorized. Referred caller to HCP then provided disclaimer on not providing recommendation. Request Name: REQ-493932 and Report Number: 8JOQ731D. Caller is a consumer who received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago. Caller wants to know if it is safe for him to get a haircut. Caller stated that during the first shot, it took one month before he was safe. Caller said that during the first two inoculation, he has no adverse event and just a little unsettledness. In his third inoculation, his resting heartbeat went below 60 and below 90 and he also experienced shortness of breath for 1 week after the shot and it started after couple of days after the shot. Caller also wants to know what it means and if he should discontinue more shots in the future. Response taken from attached. Offered to give link for agency website but declined since he only has phone. The outcome for the event little unsettledness was unknown.  No follow-up attempts are possible. No further information is expected.
this spontaneous report as received from a pharmacist refers to a 36 year old female patient with hospitalization and with a medical history of excision of styloid (January 2013). In January 2013, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, subcutaneous (Lot # H012972, exp: on 09-MAR-2014) for prevention of pneumococcal disease. Concomitant therapy included vaccination given at the same time included a dose of FLUZONE. The reporter stated that the patient was hospitalized for excision of styloid at an unspecified time in the last 2 months and received PNEUMOVAX 23 as part of vaccine protocol in the hospital. At an unspecified time after vaccination in 2013, the patient was diagnosed with cellulitis at the injection site. The outcome of excision of styloid and cellulitis at injection site was unknown. The causality for cellulitis at injection site was unknown. Additional information has been requested.
Patient presented to Facility MD Experiencing Flushing, HA, elevated BP, Faint with Rapid HRT Beat. She was given water, Juice and laid down. After 30-40 minutes sxs subsided. Spoke to pt said she was Feeling much Better. Spoke to nurse at Rehab center. Pt reported she was Feeling much better By 5pm on 1-12-21.
Mother states that temperature rose to 104. Giving Tylenol and Motrin. Mother states pt had a febrile convulsion. No treatment given as we were not aware until 04/14. High temperature lasted for 8 days.
Reported reaction to Health Department on 10/27/05.  Upper right arm (site of PPV23) swollen and warm to touch - 2 elongated areas of redness - advised to take Tylenol and apply cool compresses.  11/02/05:  Patient was called by health department for follow-up at which time patient reported arm much improved.
c/o of pain, swelling, & stiffness in lt arm on 31JAN91 to mom; no tx done except rubbed in alcohol. Seen by MD lt arm swollen & not able to extend fully; Dx as adverse rxn.
pain at the injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site left arm). On 02-Apr-2021, VACCINATION SITE PAIN (pain at the injection site left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was provided.  As per client, MI error in DOB capture as 1-JAN-1900
Anxiety, fever 101.4, lightheaded, dizzy, nausea and vomiting, sensitivity of hands and feet, headache, body aches.  Lasted about 24 hours. Tylenol relieved headache.
This case was reported by a pharmacist via call center representative and described the occurrence of viral infection in a female patient who received Shingrix for prophylaxis. The patient's past medical history included viral infection (frequently experienced viral infections for a long time). On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced viral infection, tingling, back pain, viral rash, shoulder pain, abdominal pain, off label use and drug use for unapproved indication. On an unknown date, the outcome of the viral infection, tingling, back pain, viral rash, shoulder pain, abdominal pain, off label use and drug use for unapproved indication were unknown. It was unknown if the reporter considered the viral infection, tingling, back pain, viral rash, shoulder pain and abdominal pain to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced a flare up of viral infection after vaccination. The patient experienced more intense viral sensations such as rash, tingling, and pain on the back, shoulder and abdomen. The patient had frequently experienced viral infections for a long time in the past too, but te symptoms seemed to be worse after vaccination with Shingrix. The patient's doctor had prescribed Shingrix to decrease the frequency of viral infections, which led to off label use and drug use for unapproved indication. The patient was vaccinated with Shingrix at a different location.
THIS PATIENT WAS GIVEN H1N1 FLU MIST AT VACCINATION CLINIC STAFFED WITH PHYSICIAN ASSISTANT STUDENTS.
Had a traumatic heart episode 32 days after vaccine and was rushed to hospital after feeling intense chest pains. Later diagnosed with Myocarditis.
Information was received from a physician's assistant regarding a 4-week-old infant of unknown gender who on 21-AUG-2017 inadvertently received a first dose of ROTATEQ, vial 2 ml orally (lot and expiration unknown) for prophylaxis. Medical history and concomitant medication were not reported . No adverse effect was reported. Additional information has been requested.
Approximately three hours after receiving the vaccine I was violently puking and nauseous. I never had a fever, but I had uncontrollable shaking and chills.
Patient experienced a rash that started below her breasts and continued up her chest and to her neck.  rash described as looking and feeling like a sunburn. Rash  Very dry and itchy and tender. Rash began on 4/28/21.  Also experienced severe dizziness, headache, muscle aches and joint pain, nausea so severe it kept her from eating. Left knee swelled up.
Erythema multiforme to injection site 2 days post-vaccine. Treated with topical steroid and oral BENADRYL.
Vaccinee was given a series of 3 Engerix-B vaccinations on 4DEC89, 9JAN90 & 5JUN90. Serology testing on 29AUG90 showed that vaccinee failed to seroconvert. Vaccinee was one of six pt who failed to convert out of a group of 52 vaccinees.
Within 24 hours of vaccine administration, the patient's right arm developed diffuse erythema, warmth and swelling involving most of the arm.
A physician reported that a 9 month old male received his 1st dose of Prevnar (approx. 1 month ago) and subsequently, experienced muscle spasms in both of his lower extremities. The physician indicated that the pt's mother called and reported that her son hand "no fever, no irritability, just pulling up of his legs".
site problem; large area of redness that has grown; started about 7 or 8 days after the vaccine was given; continued to grow from about 2 inches in diameter to 4; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ABSCESS (site problem), VACCINATION SITE ERYTHEMA (large area of redness that has grown), VACCINATION SITE ERYTHEMA (started about 7 or 8 days after the vaccine was given) and VACCINATION SITE ERYTHEMA (continued to grow from about 2 inches in diameter to 4) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ABSCESS (site problem), VACCINATION SITE ERYTHEMA (large area of redness that has grown), VACCINATION SITE ERYTHEMA (started about 7 or 8 days after the vaccine was given) and VACCINATION SITE ERYTHEMA (continued to grow from about 2 inches in diameter to 4). At the time of the report, VACCINATION SITE ABSCESS (site problem), VACCINATION SITE ERYTHEMA (large area of redness that has grown), VACCINATION SITE ERYTHEMA (started about 7 or 8 days after the vaccine was given) and VACCINATION SITE ERYTHEMA (continued to grow from about 2 inches in diameter to 4) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Antibiotics were taken as treatment drugs
This spontaneous report as received from a registered nurse refers to a 66 year old female patient. Pertinent medical history and drug reactions/allergies were not reported. On 11-JUN-2013, the patient was vaccinated with PNEUMOVAX23 (lot # H015780, expiration date 11-JUN-2014) 0.5 ml, intramuscular. Concomitant therapy was not reported. On 12-JUN-2013, the patient experienced injection site reactions after receiving PNEUMOVAX23, redness and swelling at the injection site. The patient did not receive treatment. The patient called the office and the office informed to monitor the injection site and to call back in 24 hours to follow up with the condition of her arm. It was reported that therapy with PNEUMOVAX23 was continued. At the time of the report the patient was recovering.  This is one of two cases from the same source. Additional information has been requested.
Diffuse swelling of arm that received the vaccine from the deltoid muscle, extending down to the axilla and left side of the upper chest. No weakness or immobility. 3/4cm swollen lymph node in the left axilla.
My left knee developed acute pain the day after I received the booster. I had never had knee pain before and was very active-walking about 4 miles each day without any pain. I went to my doctor on  the third day of the pain and she ordered an x-ray of my knee. The x-ray revealed no trauma to the knee so she issued me a Prednisone for 6 days. She also told me to use the arthritis cream Voltaren
31 y.o. female with reported PMH of asthma who presents for SARS-CoV-2 vaccination Pfizer Dose #1. Ten minutes after receiving the vaccination, the patient began to experience itching and hives. The patient was brought back to the monitoring area and vital signs were checked and stable. The patient reports eating lunch before the vaccine appointment. The patient was given bottled water.    Patient's hives and itching worsened, spreading to her chest, mouth, and arms. She was given dexamethasone 8mg IV, benadryl 50mg IV and famotidine 40mg PO. Symptoms persisted and she was transported to the ED.
Information has been received from a registered nurse concerning her niece a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who in 2006 was vaccinated with the first and second doses of Gardasil, IM (1st and 2nd dose over a two month period). Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced vomiting and diarrhea after the first and second doses of Gardasil series. The patient sought unspecified medical attention. The nurse reported that the patient does not plan to have the third dose as recommended. Subsequently on an unspecified date, the patient recovered from vomiting and diarrhea. Additional information has been requested.
fever - began at 102 around 4am, dropped to 99.1  after 5 hours, spiked again around 3pm to 101.6, fevers completely gone by 6pm  extreme fatigue - appeared approx. 16 hours after injection. still present extreme body aches/stiffness - appeared approx. 16 hours after injection. still present but beginning to decrease headaches - persistent throbbing headache which has lasted 48 hours, slowly subsiding Nausea/vomiting  - began 16 hours after injection, subsided about 12 hours later
While injecting dose, some spilled out of syringe before administering, therefore pt didn?t get a full dose
A couple weeks after the third dose I developed a cough with a lot of mucus production. My throat is irritated from the postnasal drip that then causes me to cough. My cough now seems to be 50/50 on being dry or productive.
Costochondritis beginning about 10 days after 2nd dose of Moderna. I have never had this condition before.   I also had the usual flu symptoms (fever, chills, fatigue etc.) after both doses 1 and 2, which lasted less than one day.
I experienced some pains in my lymph nodes in my armpit, a fever and fatigue after receiving my third dose. Everything except the lymph nodes subsided. The armpit and lymph nodes are still sensitive today. Three months later, I experienced a heart attack. The only thing that has changed in my life was receiving the booster. I had a stent installed while I was hospitalized, and I will probably need another one.
2 days after the vaccine I became fatigued.  This also occurred after second vaccine but was not reported.
Pt received 0.3ml of undiluted Pfizer vaccine.  Error was not discovered until after the dose had been administered. Patient contacted regarding dosing error and was made aware of possible symptoms to monitor for. No reaction reported by patient.
Information has been received from a health professional concerning a 23 year old white female (70 in., 199 lb.) with no pre-existing allergies, birth defects or medical conditions who on 14-NOV-2007 (at 15:30) was vaccinated with her initial dosage of Gardasil (lot # 659437/1266U), IM, in the left deltoid.  On 14-NOV-2007 (at 15:30) the patient felt lightheaded, got dizzy and passed out.  It was reported the patient recovered from the event on the same day.  It was reported the patient had no illness at the time of vaccination.  Additional information is not expected.
This spontaneous report was received from a 68 years old female consumer, with emphysema and an unspecified allergy, reporting on herself. Consumer noted that she had previously been under the care of a chiropractor for pain unrelated to this event. On 20-AUG-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) injection in the left arm for prevention of shingles. Concomitant medications included unspecified allergy to medications. About three days after receiving ZOSTAVAX vaccine, on approximately 23-AUG-2013, the patient developed a headache which intensified over the following days. This headache was accompanied by overall pain along the patient's right side (torso). The pain was not accompanied by any rash and continued through time of the report. For one week following administration of the vaccine, since approximately 20-AUG-2013, the patient also experienced significant injection site pain and swelling, which has improved. The relationship between ZOSTAVAX and the events was not reported. Patient was treated with two tramadol hydrochloride, 50 mg tablets, every six hours. Patient sought medical attention: two appointments. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (sore arm.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment for event included acetylsalicylic acid.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
first dose on 11/12/2020. Second not yet administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 12th November 2020, batch number was 047FY or 047F4 and expiry date 16th September 2022.).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 2-JUN-2022 Reporter's Comments: Pharmacist reporting Shingrix first dose administered on 12th November 2020. Healthcare professional was unsure if first Shingrix dose lot number was 047FY or 047F4.  Second dose not yet administered. Adverse event report contained all reported information by healthcare professional.  Healthcare professional gave consent for safety team follow up. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Local warmth, swelling, erythema, induration at site of ZOSTAVAX on 11/6/15 at pharmacy.
Persitent lower Back Pain; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 14Apr2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 25Mar2021 (at age of 49-years-old) at 12:00 as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 16:00, the patient experienced persistent lower back pain. The 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 adverse event. The clinical outcome of the event persistent lower back pain was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
administered a dose of Engerix B that had expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 01-SEP-2023, the patient received Engerix B. On 01-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered a dose of Engerix B that had expired).  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: 01-SEP-2023 The medical assistant reported on September 1st 2023 that he administered a dose of Engerix B that had expired on August 11th 2023 which led to expired vaccine used. The reported enquired how to proceed. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.