chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 25 year old white female with allergies to vancomycin and latex, and with Hirschsprung's disease and short-bowel syndrome who on October 30, 1995 at ; was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. Concomitant therapy that day included influenza virus split virion 3V vaccine inactivated (Fluzone (influenza virus split virion 3v vaccine inactivated)) (has received in the past). On October 30, 1995 at 3:40 PM, 10 minutes after injection, the patient became quite agitated and developed pain in the throat. It was noted that the patient was scratching her skin vigorously. The patient was given 0.3cc of 1:1000 dilution epinephrine. The symptoms resolved rapidly on October 30, 1995. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. It was also noted that the patient had a reaction to hepatitis B virus vaccine rHBsAg (yeast) (WAES #0601USA01543). No additional information is expected.
Arm swelled up and was hot-then after treatment with antibiotics the swelling and blood moved down arm- lasted more than 10 days.
Sore arm that was not present immediately after the vaccine but presented a couple days later and has lasted over a month at this point. Patient describes it as a sore arm that does not improve but has not significantly worsened.
Red itchy bumps on stomach, then spread to arms, legs, back, genitalia and buttocks
This case was reported by a physician via call center representative and described the occurrence of shingles in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The reporter gathered patient's information. The age at vaccination was not reported for this report. The patient's age group was captured as elderly from the release date of SHINGRIX and date of birth of patient. The patient experienced shingle in close proximity of getting 1st dose of SHINGRIX. The patient had a mild case. The doctor wanted to confirm if there was any relation between the vaccine and getting shingles and if it was safe to receive 2nd dose of SHINGRIX. The patient experienced shingles within a week of receiving 1st dose of SHINGRIX.
increased neuropathic symptoms; trouble in her arms.; tingling and burning sensation from shoulder to wrist; tingling and burning sensation from shoulder to wrist; This is a spontaneous report from a contactable consumer (patient) to a Pfizer-sponsored program. This 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247and expiry date unknown, Solution for injection), via an unknown route on 27Jan2021 at 14:15 (at the age of 72-years-old) at single dose arm for COVID-19 immunization. The patient had relevant history of neuropathy prior to receiving vaccine. Concomitant medications was nor reported. On an unspecified date, the patient mentioned that she experienced increased neuropathic symptoms and fair amount of tingling and burning sensation from shoulder to wrist after receiving the first dose. Especially having trouble in her arms between her wrists and shoulder. The patient also felt like burning, stinging, and pins and needles. The patient was scheduled to receive the second dose. Outcome of the events was unknown.
patient felt a little tired and a little sore arm after received the covid Pfizer shot. No major complains after an hour observational period.
This patient came in requesting a Flu vaccine.  She was administered a Pfizer Covid19 vaccine in error.
Heart palpitations and shortness of breath began to occur about a week after receiving 2nd dose.  Symptoms persisted regularly for about 2-3 weeks. Now symptoms occur intermittently. Bloodwork and EKG were done on 2/19/21. Referred to cardiologist.  EKG on 3/25/21 and holter monitor placed for 5 days.  Ultrasound on heart scheduled for 4/15/21 to check for inflammation of heart muscle and/or other abnormalities.
Itching from being hot or sweaty then became red and hive dermographia, or shin writing
My immune system was completely compromised after the shots. After the first shot, I was counting steps to sit down right after being injected because I felt very dizzy and lightheaded. After second shot, I had muscle pain, swollen face, extreme fatigue, chills, muscle and joint pain all over my body, headache, problems sleeping, 3 days after the 2 nd shot my sever bladder problems started, I was diagnosed with interstitial cystitis, and embedded infection of the lining of my bladder with e-coli, enterococcus and pseudomonas aeruginosa. I am still in treatment. I have severe insomnia.
Vaccine administered 7/2/12, went to MD on 7/5/12 AM 5cm x 5cm angry red hot and raised patch surrounding slight. MD prescribed doxycycline 100mg BID x 7d.
second dose of SHINGRIX 9 months ago, shingles gotten worse; Shingles; Rash; Received her second dose of Shingrix 9 months ago while she had an active shingles rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and drug use for unapproved indication. On an unknown date, the outcome of the vaccination failure, shingles, rash and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix. It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-JUL-2022 Reporters comment: The patient received her second dose of Shingrix 9 months ago while she had an active shingles rash.  The patient stated that since after receiving the second dose her shingles had progressively got worsened.  The patient was provided medical advise disclaimer and referred to Healthcare professional. The patient did not consent to follow-up. Limited information was provided. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received her second dose of Shingrix 9 months ago while she had an active shingles rash which led to drug use for unapproved indication and circumstance or information capable of leading to medication error.
Narrative:  Pt received booster COVID-19 vaccine dose (Pfizer) on 03/11/2022. After the vaccine (exact date/time of sx not reported by pt), pt started to feel headache, dizziness, exhaustion, lack of appetite, and muscle soreness. No treatment given.
Her injection was at about 10:55 am.  About 15 minutes after the injection, patient claimed that she is dizzy,  heart is racing.  We get her seated.  She wanted some water and we gave it to her.  Advised her to take her mask off if she wanted.  Then she she claimed that her eyes are sensitive to light and her throat is scratchy.   We offered her lay down in our immunization room.  At 11:45 am, she was laying flat on her back in our immunization room with both legs elevated on chair.  She asked to have the light turn off.  We have one of our staff to check on her every several minutes.  She claimed that her feet were cold.  Her husband came in the room with her and gave her his jacket to put on her feet.  We offered to check her blood pressure and call EMS for her but she was not interested.   At 12:04, she stated that the room is spinning.  At 12:30,  she was comfortable to get up assisted by one of our staff and leave.  We checked on her at 5:25 pm.  Per spouse, she is doing better but sleeping at the moment.
side effect to ZOSTAVAX, bright red around injection, pain, itching, swelling, very hot, went from injection site to elbow.
pt recv vax 16DEC96 & 19DEC96 pt exp varicella-like rash over entire body;
Felt dizzy and lightheaded immediately after vaccination.  As of 2/18/21 - 10:35 am client feels better with no symptoms.
pt recvd vax (1992) & was inadvertently re-vaxed on 29OCT93; also recvd flu vax; pt exp inject site react (PNU-IMUNE site) 9 x 5 cm which included swelling;
The evening of the vaccine the patient developed a fever.  The following morning he had a fever, chills, headache, fatigue, sore throat and cough.  The symptoms have continued into today 01/19/2021.
Patient states she has had increasing soreness in left arm approximately 1 week after vaccination along with decreased range of motion in affected arm. Patient has not sought medical care.
A spontaneous report has been received from a consumer concerning female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. It was reported that FLUMIST QUADRIVALENT (intranasal) via nasal route, on an unknown date. Reporter stated patient had FluMist Quadrivalent in the past and reported its psychologically damaging to have shot and she had cancer start dates and type of cancer are unknown. It was unknown if the patient had FluMist Quadrivalent prior to having cancer. The outcome of had cancer and psychologically damaging to have shot was unknown. The following event was considered serious due to important medical event: had cancer. The following event was considered non-serious: psychologically damaging to have shot.; Sender's Comments: Neoplasm malignant is not listed in the company core data sheet for flumist quadrivalent. Due to limited information on patient's demographics, medical history, exposure to specific risk factors, concomitant drugs, indication, dose and start date of the suspect drug, onset date and details of the event, diagnostic and aetiologic workup it is not possible to make a conclusive assessment of the causal relationship between the event and suspect drug. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.
Fatigue, Headaches, and Congestion or runny nose - clear and also cloudy, head and ear pressure
June 21, 2021 FIRST PFIZER VACCINE LOT NUMBER: EW0181  That first night I couldn't walk. Chills and high ever. My body was hurting. Took Motrin. It lasted 2 days.  Every 3 months I would get the reaction.  Lab work came out abnormal Quantitative level were high 1454 a whole year later. In between the episodes of the 3 months I was getting sick.  nov. 11 2021 estrogen was low and now high, Over 800.  december thyroids went high again Antibodies were very high glands and neck were swallon Feb 2022 - my heart rate started going low in the 50's.  April 3rd Sever Sinus infection -steroids and medications. May 2022 - glands were swallon July 2022 -pneumonia fractured ribs , tested positive for covid  Sep 2022- NOW  I kept getting sick and sick.
really got sick on the 2 shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really got sick on the 2 shot) 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, the patient experienced ILLNESS (really got sick on the 2 shot). At the time of the report, ILLNESS (really got sick on the 2 shot) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment information was provided.  Consumer posted on social media that patient was scared to get booster because patient got really sick after the second shot.
Patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  The date of vaccine refrigeration was reported as 07-May-2021
On 9/18/09 around dinner time, patient's L arm appeared as a small red area at injection site and was tender and a bit swollen.  On 9/19/2009 patient noticed a big lump high on her left shoulder above the inj site area.  Her arm was red from elbow up to her neck, was extremely hot and looked like it had been burned.  Patient called pharmacy on that day 9/19/09 to report reaction & RPN on duty consulted patient to watch closely and if no improvement contact MD.  Patient also took her temperature on 9/19/09 and said it was normal.  On 9/20/09 the lump on the shoulder area appeared smaller, but the swelling seemed increased from the elbow to shoulder.  It felt warm and tight.  On 09/21/09 patient stated she still had some redness and puffiness, but not swollen as it had been.  she feels that it is definitely getting better and feels much better.  Pharmacist had spoke with patient around 4:00 pm on 9/21/09 when this was last reported.
Redness, swelling, pain entire upper left arm. Given diphenhydramine and Tylenol.
ONGOING PAIN AT INJECTION SITE, INTO SHOULDER AND NECK AREA; PAIN HAS NOT SUBSIDED SINCE THE VACCINE WAS ADMINISTERED ON  5/15/18.
After child received shots, he stood up to leave, stated that he felt faint & slid down the wall to the floor. He did not hit his head or neck or injure himself in any way. He never lost consciousness. He was speaking throughout the event. Additionally, he reported that he had not eaten all day. Vital signs taken and were normal. Heart & lung exam were normal. After juice and crackers, he felt completely fine.
HAVING SYMPTOMS OF COVID AFTER RECEIVING THE JANSSEN COVID 19 VACCINE (SUSPECTED COVID-19 INFECTION); This spontaneous report received from a patient concerned a 43 year old female. 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 not reported, batch number: 204B21A, expiry: 11-DEC-2021) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the patient experienced having symptoms of covid after receiving the janssen covid 19 vaccine (suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having symptoms of covid after receiving the janssen covid 19 vaccine (suspected covid-19 infection) was not reported. This report was non-serious.
pt was given shingrix in left psoterior arm by LVN.  shingrix should have been given IM.  pt wife was getting her second dose of shingrix today and she told him I gave her injection in the muscle, so pt asked me why he was given injection behind arm.  he reported that arm was sore and slightly red.  I looked at arm and indeed left posterior arm slightly erythematous.   He reported after vaccination that night he felt more tired than usual with slight chills. He reported arm was sore" for a few days"  but all s/s have since greatly improved.
This solicited report has been received from an unknown reporter, referring to unspecified patients of unknown age and gender who were enrolled in a marketed research. The patients' medical history, concurrent condition and concomitant therapy were not reported. It was reported the patients were found receiving multiple doses (product use issue) of pneumococcal vaccine, polyvalent (23-valent) (manufacturer, dose and route were unknown) on unspecified dates. It was also reported there was too much uncertainty about who received which vaccine. Additional information has been requested.
Diarrhea - day of vaccination and for two days following, lower abdominal cramping now in my 8th day, profuse intestinal gas/bloating for 7 days, lower back/hip/leg pain for 7 days, somewhat constipated that has included very minimal diarrheal-appearing bowel movements (still ongoing on 8th day). Symptoms seem to be subsiding now 8 days post-vaccination, so referral to medical practitioner has not been sought.
Soreness at site starting at 4/23 increasing to redness and swelling at the site on 4/24.  Headache, diarrhea, nausea, vomiting, anorexia beginning on 4/24.  Fever 101.6 beginning on 4/25.
2nd day headache so severe it caused vomiting for hours; 3rd ti 5tg day severe site soreness and fever; 6th through 9th day exhaustion, and 8th day shoulder pain so severe could not use or move arm as well as such weakness in that hand cannot hold anything in it
VACCINE CAUSED TO FEEL PARALYZED; SUN DAMAGE; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (VACCINE CAUSED TO FEEL PARALYZED) and PHOTOSENSITIVITY REACTION (SUN DAMAGE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HYPOAESTHESIA (VACCINE CAUSED TO FEEL PARALYZED) and PHOTOSENSITIVITY REACTION (SUN DAMAGE). At the time of the report, HYPOAESTHESIA (VACCINE CAUSED TO FEEL PARALYZED) and PHOTOSENSITIVITY REACTION (SUN DAMAGE) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Duration for event numbness was 24 hour. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Inappropriate schedule of vaccine /has not received the second dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 1 year ago of reporting date).   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. The patient had not received the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. At the time of reporting no patient or vaccine data was available. The reporter consented to follow up via email. This is one of five cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021207617:same reporter US-GLAXOSMITHKLINE-US2020173719:same reporter US-GLAXOSMITHKLINE-US2020100162:same reporter US-GLAXOSMITHKLINE-US2020072774:same reporter
This case was reported by a nurse via interactive digital media and described the occurrence of sickness in a female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, several hours after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The nurse reported that Flu shots getting people sick within hours (it happened to her). The reporter also reported increased autism rate. The reporter had been nurse for over 40 years and believed the correlation needs to be investigated.
Itching and rash to both arms and redness on the entire back. Benadryl 25 mg IM given and patient was escorted to urgent care.
Received her first dose Pfizer vaccine (LOT#: EW0179) at 1449 on 4/27/21. At 1510 patient alerted EMT that she felt a prickly feeling on her left hand  with slight pain. Patient stated that her pain was at a 1/10 on the pain scale. EMT alerted. PHN asked patient to stay an extra 30 minutes for further observation. Patient agreed to stay. EMT took patients vital signs at 1515. BP: 116/72, pulse: 80, O2: 100%. EMT reassessed patient at 1540. Patient stated that she was feeling a lot better and that she felt no symptoms. Patient completed her 30 minute observation. Patient left vaccination site with a steady gait at 1542.
Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.; Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.) and PRODUCT AVAILABILITY ISSUE (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.) and PRODUCT AVAILABILITY ISSUE (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.) and PRODUCT AVAILABILITY ISSUE (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.