chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected shingles; blistered rash on her face; painful, blistered rash on her face; This case was reported by a physician via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced shingles, blistery rash and painful rash. On an unknown date, the outcome of the shingles, blistery rash and painful rash were unknown.   It was unknown if the reporter considered the shingles, blistery rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The patient had painful, blistered rash on her face. When asked if HCP believes that the rash was shingles. It sounds that way based on her description, but waiting for pictures (Coded as suspected shingles). At the time of reporting, no vaccine details (lot, expiry date) nor event details (timing of rash). The reporter consented to follow up.
slight temp; fatigue; insomnia; chills; This is a spontaneous report from a contactable female consumer reported for her son. A 16-years-old male patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 10Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced fatigue, insomnia, chills, slight temp (99.7 F) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient missed second dose; Case reference number US-BN-2021-000072 is a spontaneous case report initially received from pharmacist via agency (reference number USBAV21-0062) on 18-Feb-2021, and concerns a 64-year-old male patient.  The patient's medical history was not provided.  The patient's concomitant medication included Iviglob-ex (imunnoglobulin human normal).  On 13-Feb-2021, the patient received the first dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at an one vial dose, unknown route of administration and for post-exposure prophylaxis.   It was reported that the patient then missed vaccine dose for day 3 (product dose omission issue ).    It was not reported if the patient experienced any adverse events due to RabAvert.  No further information was provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient missed the second dose of RabAvert vaccine which was scheduled on day 3 after the first received dose, that is considered to be product dose omission issue. No adverse events were reported. Product dose omission issue is not related to the suspect product but to human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient missed the second dose of RabAvert vaccine which was scheduled on day 3 after the first received dose, that is considered to be product dose omission issue. No adverse events were reported. Product dose omission issue is not related to the suspect product but to human action.
administered only the diluent portion of Shingrix; administered only the diluent portion of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2022, the patient received Shingrix. On 13th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's Comments: The pharmacist reported that the patient received only the diluent portion of Shingrix. The reporter consented to follow up. Additional Supportive Information: The pharmacist reported that the patient received only the diluent portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Painful, itchy rash on her lower back; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or about February 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy as recommended for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as soon after receiving the vaccine), the patient began experiencing a painful, itchy rash on her lower back. Initially, she felt that the rash could be poison oak and she treated the rash with medications at home. The patient's rash seemed to improve with home treatment and then would reoccur almost immediately. Therefore, she spoke to her primary care provider regarding the recurring rash and she was instructed to return to the office immediately during the next rash outbreak. In or around July 2013, the patient visited the physician and was immediately diagnosed with shingles (herpes zoster). During an outbreak, the patient's shingles rash would last several weeks and causes severe pain, suffering and mental anguish. At the reporting time, the patient continued to have shingles outbreaks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, she had incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of herpes zoster was not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster was considered a disabling event by the reporter.
Patient was given Pfizer COVID-19 Bivalent booster ages 5-11yo. Vaccine order was for Pfizer COVID-19 Bivalent booster 12+. Wrong vaccine given.
My throat hurts a lot. I feel two balls so tight there. I feel my glands swollen. My head hurts constantly. My body hurts. This started 10 days after having the first dose of the vaccine. Take a COVID test and it came back negative.
inadvertently receiving 3 doses of Shingrix; This case was reported by a pharmacist via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date) and Shingrix with an associated reaction of no adverse event (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient inadvertently received 3 doses of Shingrix, which led to extra dose administered.  Health care professional stated that patient did not had any problems with the injection and inquired about long-term effects.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 13-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK STERILE DILUENT). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA001303:Original Case : 1805USA001303 US-009507513-1809USA011187: Original Case : 1809USA010671 US-009507513-1809USA011189: Original Case : 1809USA010671 US-009507513-1809USA011190: Original Case : 1809USA010671 US-009507513-1809USA011186: Original Case : 1809USA010671 US-009507513-1809USA010671: Original Case : 1809USA010671 US-009507513-1809USA011184: Original Case : 1809USA010671 US-009507513-1809USA011188: Original Case : 1809USA010671.
Pt immediately  passed out  in   chair. We moved  pt to floor and raised legs. Pt was very pale.  We immediately called 911. She was slow   to  respond.  Fire & Rescue responded 15 min after vaccine. They obtained  vitals and  made sure Pt  was responsive.  Caregiver with the pt.  did not want an ambulance.
Patient received MCV4 vaccine at approximately 2:15pm. At about 2:20pm, she had a seizure and urinated on the floor. Paramedics accessed the patient and she was still not coherent. She was then transported to Hospital.
Itching all over causing to have scabs because of it. Scratched head so much that I took most skin off.
Chills, Fever, Shakes, Aches & Headache after vaccination. almost 2 months later severe joint/muscle pain in calves.
Acute edema in all muscles. Inability to move legs after waking from overnight sleep. Abnormal restriction of bodily movement.
I got my booster shot the morning of 11/23. The night of 11/24 I developed severe body aches/joint pain. I was hot and cold all night like with a. Fever. I woke up on 11/25 with severe pain near the injection site and swollen/inflamed lymph nodes under my left arm. The chills and body aches went away after about 24 hours, but the swollen lymph nodes and sore are have continued until this morning, 11/29. The swelling has now gone down but the area is still a little sore and tender. I did not visit a doctor in relation to these side effects
May 10 started to experience numbness and tingling in both hands and feet. May 20 got in to see a neurologist symptoms worsened became difficult to walk. May 20 admitted into hospital.
I had my first dose yesterday afternoon and at first just experienced mild body aches. Around 1:30am, body aches got pretty bad and suddenly I got really nauseous. I began having whatI believe was an endometriosis flareup, which involves cramps, cold sweats, feeling like I?ll vomit / pass out, diarrhea, numb extremities. It lasted 20-30 min. I feel okay now. Just a bit sore all over. I am confident without a doubt that the vaccine triggered an immune response that flared my endometriosis. I dont get these flares often (maybe a couple times a year, can be triggered by new meds). I believe it?s imperative women with endometriosis know that the vaccine can cause flare ups. It was not pleasant. Please contact me for any details you need. Thank you.
This spontaneous prospective pregnancy report has been received from a medical assistant concerning a 16 year old female patient as a part of Child Protective Services intake. The patient's concurrent condition included depression. There was no information about drug reactions. Concomitant medication was unknown. Prior to administer the vaccine, the patient was given a urine test to determine pregnancy (date unspecified). It was then that the pregnancy test came back positive. The patient refused a blood test, but the patient's medical records indicated a last menstrual cycle as April 2016. On 17-JUN-2016, the patient was administered a first dose of GARDASIL 9 vaccine (lot# and dose not provided, Intramuscular) for prevention of human papillomavirus infection (HPV) (Exposure during pregnancy). On the same day, the patient experienced an adverse event. No treatment was given for the pregnancy.The outcome of the Exposure during pregnancy and adverse event was not reported. Causality assessment was not provided. Follow up information was received from the medical assistant on 29-JAN-2018. It was reported that, unfortunately they work for foster kids often do not have follow up. Report previously followed up with the case worker on this patient who was in the foster system. The case worker told the reporter, the girl had a baby (recovered) but case was closed in the foster system so there was no way to obtain additional information about the pregnancy, delivery or child that was born. No further information is available.
20 YO ENLISTED SOLDIER EXPERIENCED CHEST PAIN 2 WEEKS S/P SMALLPOX VACCENATION. DIAGNOSED AS PERICARDITS BY SYMPTOMS. PTS SYMPTOMS RESOLVED WITH NSAIDS
A day after receiving my second anthrax vaccination, I began to have daily headaches and sharp piercing pains in my head, running down to my face and neck.  I also began to feel slightly light-headed.  I have an odd spacy feeling at times also.  The headaches have continued for every day since the vaccination.  After receiving my first anthrax vaccination I began having sharp pains in my head, but no sustained headaches.  Since receiving my second anthrax vaccination, the intensity of the sharp pains has increased and the headaches are a daily occurrence.  I received my first anthrax vaccination on May 19.  The lot number was FAV083.
4/8/2021 - felt very winded, dizzy  and out of breath during physical exertion.  Temporary chill developed.  Went away over night.   4/12/2021 - same symptoms during physical exertion.  Chills and fever developed shortly after and stayed for 2 weeks ranging from 99.5 to 102.  Fever, fatigue, dizziness, headache, sore muscles and joints, rapid heart beat, tingling and burning sensation in hands and feet and increased tinnitus lasted for 3 weeks.   Ongoing - sore muscles, joints and tendons, tingling/burning sensation in hands and feet, cold hands and feet, muscle fatigue and tiredness since 4/12/2021 and ongoing today.
Patient reported low grade temp of 99.0, chills, HA and nausea after receiving her second Covid 19 vaccine.  She received the BioNTech Pfizer vaccine
tired for several days, sore right arm moving to lymph node in arm pit until day 5, then noticed two red spots that are tender and warm to touch on right arm at and just under the injection site.  the injection site is about 1.5" diameter and the spot just under approx 1" diameter.  these spots were noticed on day  5 after the injection.
4-5 hrs p/vax leg swelled up, turned red & warm, rash around inject site, t102-103 even w/APAP; cried unconsolably for 4-6 hrs even if being held;
I woke up feeling a little nauseated; My back ached slightly; chills; had a fever of 100.8; This is a spontaneous report from a contactable Consumer (Patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 01:30 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing (Multiple Sclerosis asymptomatic for 30 years). Concomitant medication included celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. On 18Feb2021 07:00, the patient reported i woke up feeling a little nauseated, my back ached slightly, chills, had a fever of 100.8. I took Ibuprofin with no alleviation of symptoms. A few hours later I tried Tylenol - with no change. Later in the afternoon I took aspirin. The patient underwent lab tests and procedures which included body temperature: 100.8 on 18Feb2021 (around 100.5 at 4:00 p.m. By 6:00 pm my temp reading was 99.4.). he action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of had a fever of 100.8. The outcome of events was Recovering.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.  No Medical History information was reported.  On 19-Nov-2021 at 5:21 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 5:21 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient was given dose from vial that were stored in an ultracold freezer which was colder than they should have been. The facility had a temperature excursion for the Moderna COVID-19 vaccine and the patient was administered the vaccine underwent temperature excursion.  Excursion duration was 1 month; on 19-Nov-2021, the vial moved from super cold freezer to the refrigerator; 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator; no vaccine state changes were noticed; none of the vials were punctured and no previous temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Started having symptom after 1st dose after having Covid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Started having symptom after 1st dose after having Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Started having symptom after 1st dose after having Covid). At the time of the report, VACCINATION COMPLICATION (Started having symptom after 1st dose after having Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
This spontaneous report was received from a pharmacist referring to a 63 year old male patient with diabetes mellitus, blood cholesterol increased and hypertension. The patient had not drug reactions nor allergies. On 27-SEP-2017, the patient was vaccinated with 0.5 ml of PNEUMOVAX 23 (lot # N019348, expiration date 08-FEB-2019) intramuscularly, for the prevention of pneumococcal disease (prophylaxis). Concomitant medications were not reported. On 28-SEP-2017 (reported as: the morning after receiving the vaccine), the patient reported having swelling at the injection site. Then, it was reported that the patient went to an unspecified clinic and was treated for cellulitis.  At the time of the report, the outcome of cellulitis and injection site swelling was reported as recovering. The relatedness assessment between PNEUMOVAX 23 and cellulitis and injection site swelling was not provided. Upon internal review, cellulitis was considered to be medically significant.
Leg was swollen; Abnormal blood work; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PERIPHERAL SWELLING (Leg was swollen) and BLOOD COUNT ABNORMAL (Abnormal blood work) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Breast cancer), Lymph node biopsy (Cut lymph nodes), Cancer (cancer.) and Immunodeficiency (Immunodeficiency.).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced PERIPHERAL SWELLING (Leg was swollen) and BLOOD COUNT ABNORMAL (Abnormal blood work). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PERIPHERAL SWELLING (Leg was swollen) and BLOOD COUNT ABNORMAL (Abnormal blood work) outcome was unknown.     No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-289568 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Significant Follow up appended on 18-AUG-2021- Patient age & age group updated
Fever for 3 days 103F Nodule in the L arm, Soarness.
I had an allergic reaction to my day 3 vaccine as well but not as severe. Day 7 booster, around 7 minutes after vaccine, my body became warm feeling, it felt as though I was breathing in warm air. My face & chest felt "full", as if I could feel the medicine pulsing through it. I felt like I was going to pass out. It was strong, intense & scary. My blood pressure on the day 3 shot went up to 160; 139 on thr day 7 shot. The next day, I felt the same way & could barely function until afternoon.