chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Expired First dose of Moderna COVID-19 vaccine; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Expired First dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Expired First dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Expired First dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received Expired First dose of Moderna COVID-19 vaccine).    No concomitant medication was reported. No treatment medication was reported.
Pt went to the ER with tingling pain under arm and short of breath. Dx with swollen lymph nodes. Using cold presses and IBU.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 79-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (and flu like symptoms after receiving 1st dose received on 2nd May 2018, refer case US2018GSK130831). On 13th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth. On 15th July 2018, the patient experienced erythematous rash. On an unknown date, the outcome of the injection site warmth and erythematous rash were unknown. It was unknown if the reporter considered the injection site warmth and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient did not receive any concomitant medications. At 2:30 pm, the patient received SHINGRIX in left deltoid. The pharmacist reported that the patient experienced a hot feeling at the injection site the morning of the day after her injection. In the morning of 15th July 2018, 2 days after vaccination, she also noticed a red, rough rash area along with the hotness from the day before, that began below the injection site that followed the tricep muscle down to her elbow but ended about 1 to 2 inches above her elbow. The whole area was said to be large, about 3 to 5 inches in size. This case has been also linked to case US2018GSK130832 (unspecified number of patients), reported by the same reporter.
saturday 18, woke up very sleepy Sunday 12/19 had fever high as 103.1!  Cough started monday 12/20 Called clinic where i got my shot monday they say they cant help me to go to immediate care, I go to immediate care to test neg for flu, covid and pneumonia only to be told its just a cough. I walked in healthy now so sick.
"Moderna COVID-19 Vaccine EUA"  Woke up to a large red welt about 2 inches below the injection site,
Patient received 2 doses of Pfizer covid vaccine. Dates: 12/29/2020 and 1/15/2021
The pt experienced hive like rash on upper extremities, neck, chest. Given oral Benadryl and then injected Benadryl.
101 degree fever for 2 days Chills, bodyaches Headache for 3 days All food and drink had  "bad" taste. Water was only fluid or solid without impaired flavor. Mild pain at injection site
While mom feeding baby, she started to shake for 5 secs, Fell asleep for while, Was fine after she woke up, A second episode next day while feeding baby lasted 5 secs,Also with shaking.  Follow up: no fever, Dr has no direct connection with vaccines.  Child being evaluated by neurology.  No prescription.
Breakthrough covid case. Patient presented to ER with c/o of cough, sweats, nasal drainage and congestion. Covid exposure. Vaccinated x 3 with Pfizer. DC home
Got a super strong tingle in lip area both lips and above and below; Got a burning sensation that was intense (almost like the feeling get if hands are super cold from snow and as they warm it burns) that lasted about 5 minutes.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 24Apr2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP), obesity and depression. The patient had known allergies to bee stings, lisinopril dihydrate (LISINOPRIL) and pethidine hydrochloride (DEMEROL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN); all from unknown dates for unknown indications and unknown if ongoing. 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 left arm on 31Mar2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 10:00, about 7 minutes after the shot, the patient got a super strong tingle in lip area, both her lips and above and below. It lasted approximately an hour and when it started to go away, the patient got a burning sensation that was intense (almost like the feeling you get if your hands are super cold from snow and as they warm it burns) that lasted about 5 minutes and 4 hours later when she touched her lips, they were odd. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events super strong tingle in lip area, both her lips and above and below, burning sensation that was intense (almost like the feeling you get your hands are super cold from snow and as they warm it burns) was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency, headache, vision changes, loss of appetite, dysphagia and fatigue
Dizziness, Headache, Diarrhea, NauseaVomiting, Tachycardi, chest tightness Narrative:  Shortly after the 2nd vaccination employee noticed scratchy dry  throat, dizziness, nausea, and chest tightness with heart racing. Denied SOB. She couldn't talk because she kept gagging. Patient state prior allergy to hymenoptera envenomation requiring epi, history of asthma, allergic reaction to pepper after first covid vaccination. She was transferred to the ED and found to be tachycardic at 122. She was given epinephrine x 1. She was also treated with Prednisone 40 mg po, Benadryl 25 mg IV, and ondansetron 4 mg IV x 1. She was diagnosed with "reaction to COVID vaccine." She was discharged to home after 5 hours in the ED. Since this incident, she's noticed that she's more SOB with exertion and has chest tightness. This happens off and on randomly. It feels like when she has a severe asthma attack. She continues to have a headache. She ha s an appointment on 1/14 with her PCP. She's taking prednisone for 5 days (last one this morning) and benadryl prn. 1/19 Reports symptoms have improved but is completing prednisone course and is using advair to relieve the SOB. Still has HA which comes and goes. She takes excedrin for it. Still has a scratch voice.
Pt has a local reaction reddened/ warm to touch area 4 1/2 x 4 1/2  inches in Rt thigh she received a DTaP/IPV. Treatment is Benedryl and cool compresses. No complaints of pain.
Injection site Swells up- Softball size and makes me ill; Injection site Swells up- Softball size and makes me ill; Drug Allergies; This is a spontaneous report from a contactable physician. A 49-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced injection site swells up- softball size and made her ill on an unspecified date, and patient also experienced drug allergies with the pneumonia vaccine on an unspecified date. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.
23yo male reported symptoms of lightheadedness, fast heart rate, and dyspnea. Pt was evaluated by medical staff and ems.  Vitals: HR 105 (sinus tach), BP 150s/100s, 99% O2 Symptoms improved after 10mim of observation but vitals remained abnormal. Pt was transfered to local hospital for further evaluation.
0800 - Rapid heart rate and SOB. Lasted about 10 sec. 810-0815 - same as above, this cycle continued until around 11:20. Symptoms became milder.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female patient with allergy to codeine who on 23-AUG-2009 was vaccinated intramuscularly with the first 0.5ml GARDASIL (lot # not reported). Fatal ultra sound was performed. The patient was 22 weeks pregnant on 22-Oct-2009. The patient sought medical attention via office visit. Follow up information has been received from a registered nurse concerning a 17 year old female patient with no previous pregnancies who on 12-AUG-2009 (reported as 23-AUG-2009 previously) was vaccinated intramuscularly with a 0.5ml GARDASIL (lot # 662229/1497X). On 12-OCT-2009 ultrasound was performed and it was found the patient was 22+5 weeks pregnant and normal anatomy. The nurse reported the patient's last menstrual period was 04-MAY-2009 and the estimated delivery date was 07-FEB-2010. She also reported that the date of last menstrual period could also be 20-JUN-2009 and the estimated delivery date was 17-MAR-2010. Follow-up information has been received from a medical assistant (MA). The MA pulled the patient's chart and provided pregnancy outcome information. The patient had a cesarean section on 07-FEB-2010, secondary to having a "bony pelvis". She delivered a healthy, 7lb 14oz baby. The MA also added that there was "nothing in the report to indicate there were any problems with the baby." The patient had recovered and didn't have any post operation complications. Upon internal review, cesarean section secondary to having a "bony pelvis" was determined to be an other important medical event. Additional information is not expected.
This spontaneous report as received from a secretary, the Healthcare Worker, refers to a patient of unknown age. In 2007, the patient was vaccinated IM with first 0.5 ml dose of GARDASIL (lot# not reported) and received the second dose (IM, 0.5ml, lot# not reported) in July 2012. The patient reported no adverse effects. The patient sought medical attention via office visit. Additional information has been requested.
Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 72 years old patient who received a dose of MENACTRA batch number not reported via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. A 72 years old patient received MENACTRA. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Rash on left arm around vaccine site. Raised bumps and itching. Developed 10 days after injection.
KILLED; This spontaneous report received from a parent via a social media, via a company representative concerned a 32 year old male of unspecified race and ethnicity. 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, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 32 years old. No concomitant medications were reported.  On an unspecified date, the patient was killed. The patient died from unknown cause of death. It was unknown if an autopsy was performed. It was reported that, "killed my 32 year old stepson in 5 hours". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220624757 -Covid-19 vaccine ad26.cov2.s-Killed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt. rec'ed PCV13 on 7-1-15-she returned to clinic 7-8-15 to ask if this was a reaction. Lt deltoid was red and warm to touch-c/o itching to area-Dr examined the arm-it was a local reaction.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2016, the patient was vaccinated with ZOSTAVAX (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pain and swelling at inj. site for approx. 12-14 hours after vaccine. Body aches into next day.
muscle aches all over my body; chills; Fatigue; a low grade fever of 99.8; headache; mild nausea; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 18Feb2021 14:45 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included asthma and anemia. The patient previously took amoxicillin, ibuprofen and Advil and experienced known allergies. Historical vaccine included: the patient received first dose of bnt162b2 (Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 10:15 as SINGLE DOSE in Arm Left for covid-19 immunization. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks. Concomitant medications included: unspecified birth control medications. On 19Feb2021 at 5:30, the day after second dose of the COVID-19 vaccine, she experienced muscle aches all over my body, chills, fatigue, a low-grade fever of 99.8, a headache, and mild nausea. The patient did not receive any treatment for adverse events. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was recovering.
Test positive for COVID; Test positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL3247), in right arm and on 04Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, start date: 04Nov2021, stop date: 04Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "recovering" and all described as "Test positive for COVID". The event "test positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: Nasal Swab; (08Jun2022) Positive, notes: Nasal Swab; (09Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: The patient took other medications in two weeks birth control pills and multi vitamin.  No follow-up attempts are possible. No further information is expected.
Inital Heart palpatations minor, sweaty, tip of tounge numbness - deep breathing and distraction helped inital responses. Became gassy and had mild GI upset. Took a couple of weeks for the GI upset and gas to alleviate.
About 5 minutes after vaccination patient became dizzy, vision was blurry, very pale.  Patient stated they were thirsty and hadn't eaten anything.  Gave water and crackers and within 5 minutes was back to feeling normal.  Observed for a 30 minutes total.
3Full body tonic clonic seizure, first 20 minutes, followed by another lasting 5 minutes.
Information has been received from a registered nurse concerning a 13 years old female who on 160OCT-1998 was vaccinated with RECOMBIVAX HB vaccine. On approximately 30-OCT-1998 the patient developed hive on the trunk and arms with occasional itching. Additional information has been requested.
Swollen (slight), looks reddish (as if hit by tennis ball on left arm.
A cough. A sore throat. Breathing problems. Runny or stuffy nose. Body aches. A headache. Chills and shakes. Fatigue. Gastrointestinal problems (vomiting and diarrhea) All started two hours after receiving the vaccine. Drove home at  03:00 PM took ibuprofen and went to bed. After worming up symptoms seemed to subside. Had trouble sleeping that night and was forced to take a day off from work because of feeling exhausted.
almost died; Initial information received on 20-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced almost died (ill-defined disorder) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious almost died (ill-defined disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Last time I got a flu shot was 1969. I almost died from it."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.