chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of Shingrix more than 2.5 years ago / second dose has not been administered yet; 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received more than 2.5 years ago from the date of 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 had not been administered 2nd dose of Shingrix which led to incomplete course of vaccination. The healthcare professional was in a hurry and did not had time to provide all the details concerning the patient. The reporter did not consent to follow-up.
pain and weakness in the arm; weakness in the arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and weakness of arms. On an unknown date, the outcome of the pain in arm and weakness of arms were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and weakness of arms to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The patient received Shingrix in an unknown arm. At the time of reporting, the patient was still feeling pain and weakness in the arm of injection.
This spontaneous report was received from an office manager and refers to multiple patient of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored VAQTA, lot number M036459, expiration date 18-JAN-2018, (dose, frequency, route, anatomical location were not reported). No other suspect or concomitant therapies were reported. The vaccines were exposed to 34.1 Fahrenheit degrees for 8 hours. A digital data logger was involved and there were no prior excursions. No adverse events were reported. No product quality complain was involved. This is one of two reports from the same reporter. Additional information has been requested.
One of diarrhea, 2-3 days of headache, 3 days of sore throat,  5 days of local redness and tenderness with induration on injection site
pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis.   On 9th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th February 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix in the left arm and experienced pain at injection site. From the pharmacy, the reporter has been contacted for follow up.
The Covid vaccine EXP date as per the labels on the immunization box is01/31/24, but the BUD Expiration date from the pharmacy is 06/07/23. The vaccine was given pass the BUD Expiration date.
Patient states after she left from health department (7/21) her arm felt like it was constricted with a rubber band.  Friday night (7/21), area was red and swollen approximately the size of a golf ball.  Patient states on Saturday (7/22), the area of redness was hot to the touch and had increased in size, approximately the size of a baseball. On Sunday (7/23), painful reddened area improving.  On Monday, July 24th, no redness but firm area noted approximately the size of a quarter.  Vaccination site much improved since Friday, July 21st.
1/22/2021 received 1st dose of MODERNA COVID-19 Vaccine. 2/3/2021 noticed his tongue and lips felt funny. 2/5/2021 Right side of face drooping and no feeling. 2/6/2021 went to prompt care due to right eye dryness. Prompt care transferred him to OSF: ER to rule out stroke. No admission. 2/9/2021 follow up with neurologist, Dr. whom confirmed Bells Palsy.  Prescribed prednisolone, eye drops, and physical therapy.
Post vax, on 05/23/2001 the patient now has symptoms of a sore left arm and fever of 101F. The patient sought unspecified medical attention. Additional information has been requested.
pain in her left arm after the dose; breakout described as breaking out on her left wrist that looked like shingles; outbreak described as two spots; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 occurance prior to receiving Shingrix vaccine).   In February 2020, the patient received the 1st dose of Shingrix. In March 2020, less than 2 months after receiving Shingrix, the patient experienced rash vesicular. In April 2020, the patient experienced rash macular. On 3rd July 2020, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, rash vesicular and rash macular were recovered/resolved.   It was unknown if the reporter considered the pain in arm, rash vesicular and rash macular to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced pain in her left arm.  Sometime after 13th March 2020, the patient reported first breakout described as breaking out on her left wrist that was 3 by 3 in area that looked like shingles but not as painful as shingles although pain was associated with this outbreak.  The patient reported the outbreak was not extended like previous cases of shingles and was localized to the left wrist. Outbreak reportedly lasted approximately 3 weeks.  The patient reported a second outbreak occurred approximately one month later sometime in April 2020.  Second outbreak described as two spots on patient's right thigh that also lasted for approximately three weeks. For the tolerance of 2nd dose, refer linked case US2020AMR127069.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR127069:same patient, 1st dose
Pt received PREVNAR vaccine on Monday and broke out with a rash 3" x 3" on arm - warm to touch and somewhat painful on Tuesday 2/16/16. Also had a headache.
Patient received a Johnson & Johnson vaccine today. Shortly afterwards while waiting in pharmacy area, we were alerted that the patient was unresponsive by his wife. Immediately responded to patient. Code white called and management responded. Tried to get him to wake up, he opened his eyes but immediately closed them again. I attempted to keep him alert and eyes open. This proceeded to go on for several minutes. Ice packs were placed on neck and wrists. Feet elevated. Once patient was alert and oriented, water was provided and patient was instructed to take small sips. Patient was kept in pharmacy area for additional 15 minutes once he was back to normal. Patient stated that when he passed out, he felt tired, couldn't see or hear.
Pain from head to toes and feels like her body is wrap in rubber band and a lot of tingling, sore throat. PCC f/u  s/w caller states she feels better. Before being vaccinated She has had" steroid shots and had some antibiotics" doesn't remember the name of the antibiotics and she was feeling restless before getting the vaccine.   She has had body myalgia but has resolved by now.   Adv: Restlessness unlikely to be related to the vaccine. Myalgia is common to occur within first 24 hours and usually resolves on its on. Call us back with any questions.
STROKE; BLOOD CLOT IN CHEST; DEATH; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on an unspecified date in APR-2022 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 16-MAY-2022, the patient died from unknown cause of death 3 weeks after his first janssen jab. On an unspecified date in 2022, patient had a stroke the day after the jab and a blood clot was found in patient's chest at the hospital. On an unspecified date, the patient was hospitalized for unspecified days. It was unknown whether an autopsy was performed or not. It was reported as, "My grandpa passed May 16, 2022 3 weeks after his first jab. He had a stroke the day after the jab and a blood clot was found in his chest at the hospital. He chose on his own to go home and pass away in peace." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 16-MAY-2022, and the outcome of stroke and blood clot in chest was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20230248250-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20230248250-stroke. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20230248250-Blood clot in chest. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Severe headache, body aches, fever with waves of chills that have continued., generalized weakness
low grade headache; fever; arm got swollen; Initial information received on 22-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who experienced low grade headache, fever and arm got swollen while receiving vaccines RABAVERT and IPV (VERO) [IMOVAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), anti allergy medicine, nasal spray and corticosteroids.  on 22-aug-2022, patient received first dose and On an unknown date, the patient received a  dose 2, 3 and 4 of suspect IPV (VERO) Suspension for injection (strength, dose, route, lot number not reported)  in unknown administration site for immunization and RABAVERT not produced by Sanofi Pasteur (strength, dose, route, lot number not reported)   On an unknown date the patient developed a non-serious low grade headache (headache), fever (pyrexia), arm got swollen (peripheral swelling) (unknown latency) following the administration of IPV (VERO) and (unknown latency) following the administration of RABAVERT.  It was reported with the 1st and 2nd dose the patient had no any side effects.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (headache, pyrexia, peripheral swelling).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the event.
Pfizer vaccines on 4/16, 5/8/21. Tested positive for COVID on 12/13/21 Hospitalized from 12/13-12/15/21 due to ischemic limb. Per hospital dismissal summary: COVID testing was noted to be positive at the time of admission. Given unknown duration of illness, no emergency treatments were recommended.
Facial swelling for several days; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 09Apr2021 at 13:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 15:00, the patient experienced facial swelling for several days and heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with steroid prescription. The clinical outcome of the events facial swelling for several days and heart palpitations were resolving at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site pain, muscle soreness and weakness, extreme sleepiness, chills and goosebumps, headache, mild nausea
Pt. states that after receiving the 1st dose of Phizer 01/11/2022, starting to experience symptoms 01/12/2022 of chest pains. Emergency Room visit 01/12/2022, Blood Work (White = Low 3.9, DDimer 0.83 = High) C reactive Protein = High. Inflammation and shortness of breath continue.
Mild grade fever (101*), body aches, chills, sweating that began the night following vaccination. Symptoms would clear up for the most part during the day, but return at night. On Monday (1/10) however, symptoms stuck harder midday and persisted through Wednesday morning.
10 days after receiving the injection a dime sized bump appeared at the injection site - with slight redness and itching  On day 11 it is not getting any worse and perhaps is slightly less
On 6/22/21 I experienced dizziness and pain under left arm upon waking. It got worse through the morning. I went to Hospital ER.  They said I had elevated troponin levels and thought I was having a heart attack. They started me on Heparin. I was transported by ambulance  to Hospital. Where numerous tests were run.
No adverse event; Expired dose of Rotateq was administered; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 25-JAN-2022, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral (Lot# U007860 and expiration date 14-JAN-2022) (frequency were not reported) as prophylaxis. (expired product administered). No additional adverse event reported, no further information provided.
Fever, chills, shivering/shaking, extreme body aches all over, occasional sharp, stabbing pains in feet and legs from 10:00 pm - 10:00 am. Felt like I had the Flu. Took a very hot shower and went to bed. Did not sleep much. Extreme pain. Up about 8 times to urinate, very unusual. At noon I was able to eat and felt almost fine at 1:00 pm.
Unspecified adverse effect of drug or medicament, initial encounter on 2023-06-09, Unspecified adverse effect of drug or medicament, initial encounter on 2023-06-09, Adverse effect of other vaccines and biological substances, initial encounter on 2023-06-11.
Ongoing crackling in ear and dizziness (vertigo-like), tachycardia (elevated heart rate)  around 36 hours  post vaccine and ongoing symptoms now for 72 hours.
4 HOURS POST VACCINATION, PATIENT STATED THAT SHE BEGAN HAVING "TROUBLE GETTING HER BREATH AND HER HEART WAS RACING" .  WHEN ASKED IF SHE EXPERIENCED ANY OTHER SYMPTOMS OR FACIAL EDEMA , SHE REPLIED THAT "THE MIDDLE OF HER UPPER LIP SEEMED SWOLLEN".   ALL SYMPTOMS RESOLVED AFTER 40 MINUTES.  SHE REPORTED THESE SYMPTOMS AT 2:00PM ON 3/3/2021 TO THE VACCINATING PHARMACY.  SHE IS CONCERNED ABOUT TAKING 2NF MODERNA VACCCINE AND ALLERGIC IMPLICATIONS.
Migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine headache). At the time of the report, MIGRAINE (Migraine headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported. No treatment Drug was reported.
Redness and swelling of (L) arm beginning approximately 16 hrs after vaccine. Redness measured 19 x 22 cm. Arm circumference bigger on (L) by 1 1/2 inches.
VACCINE GIVEN @ 111O AM. APPROXIMATELY 10 MINS POST INJETION PT C/O ITCHING TO FACE.  NO EDEMA, SOB, VERTIGO REPORTED.  50MG PO BENADRYL GIVEN TO PATIENT.  PATIENT KEPT 50 MINUTES FOR OBSERVATION LEFT IN STABLE CONDITION.
Fever, Nausea, Headache, Chills, Pain at injection site for 24 hours.   Itchy bumps developed on right wrist & elbow. Formed into blisters. Shingles developed. Had chickenpox when younger.
This report was received from the investigator on 07 June 2010. A 20 year-old male subject with no significant medical history received the following vaccines on 13 March 2010: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Sixteen days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. On Day 11 (24 March 2010), the subject had an abnormal electrocardiogram. On Day 14 (27 March 2010), the subject had a Troponin I of 1.29 (abnormal). The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Menactra 0.5cc administered at 11:30AM. Pt states approx 2 hrs later began to feel ill. Injection site sore. 3/30/05 c/o temp 99.6, nauseated, body aches, injection site sore and red, pt instr. to use ice on site and ibuprofen or Tylenol. 3/31 pt phoned, states much improved. Only symptom tenderness around injection site.
Having the listed general side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having the listed general side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Having the listed general side effects). At the time of the report, VACCINATION COMPLICATION (Having the listed general side effects) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination.     No medical history provided by Reporter.  The patient's past medical history included Pregnancy (Live, full-term birth) on 11-May-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive (Positive) Positive.         The date of positive pregnancy test was Oct-2020. The patient has an established prenatal care. Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Internal review on 23-Jul-2021 resulted in updates to the pregnancy test, birth type and fetal outcome.
no additional AE; given a dose of VAQTA after the dose was stored improperly; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 02-MAY-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, formulation established as vial, 0.5 milliliter, lot #X003791, expiration date: 01-JUN-2024 (administration site, and route of administration were not provided) administered for prophylaxis. On 02-MAY-2023, the vaccine experienced the temperature excursion of 34 Fahrenheit degrees for 7 hours (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).
1 of 3 pts vaxed who exp inj site rxn;pt devel swelling, erythema & pain from elbow to shoulder;this was pt's 1st pneumococcal vax;no history o pneumococcal infect;
I experienced extreme soreness in the arm that had the injection, a headache that lasted about 8 hours, had fever symptoms and I was very tired, like my whole body ached.
High fevers with rigors and diffuse weakness for 10 straight days and still continuing despite alternating Tylenol and Motrin. My doctor is at a loss and suspects some contamination of flu vaccine because I've never been sick like this in my life.