chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had shingles vaccine and shingles outbreak/Suspected Vaccination Failure; Shingles outbreak; Intense pain; Discomfort; Nerve pain; Rash pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included chickenpox (five children all who had chickenpox ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles vaccine and shingles outbreak/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles outbreak), pain (Verbatim: Intense pain), discomfort (Verbatim: Discomfort), nerve pain (Verbatim: Nerve pain) and painful rash (Verbatim: Rash pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain, discomfort, nerve pain and painful rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, discomfort, nerve pain and painful rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, discomfort, nerve pain and painful rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient's wife interactive digital media. The patient had shingles vaccine a few years back and now he was on his fifth week with shingles outbreak (at the time of reporting). The patient had been in intense pain, more discomfort from nerve pain than rash pain.  The reporter was fortunately seventy years old, went through childhood, and raised five children all who had chickenpox and she never contacted them. The reporter hoped that she would never and I will never get shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Swelling, redness, fever, warmth in arm, but not at the injection site (occurred in the lower arm, just above the elbow, wrapping around the arm on the inner side and to the back of the arm).
Employee had a site reaction on Thursday morning 11-1-18 measuring 1 1/2 inch by 3 inches.  The area was swollen, red & hot.  At 9:00 she noticed her arm was going numb down to her wrist.  At 9:30 it started tingling & burning in the same area.  At. 10:00 it started going numb to her shoulder, across the back & shoulder blades & up the back of her neck with burning & tingling.  She called LPN, at 11:00 that had administered the vaccine.  She called Dr. at 11:30 and he advised her to go to the ER.  She came to the ER at 12:00.  The ER doctor said she was having an allergic reaction to the vaccine.  He ordered Benadryl & Solumedrol IV.  Upon discharge from the ER he gave her a mederol dose pack.   11-5-18 She is still having numbness in the right arm and tingling, burning, & numbness up the neck & the upper back.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Additional Details: Patient was nervous to get her vaccine.  After I administered the vaccine, she stated she didn't feel it and that I was good at administering.  After about 15 seconds patient stated she felt light headed, dizzy, did not feel well and to call emergency.  She said she felt like it was hard to breathe, her heart slowing down and tightening.  She felt like she was going to pass out.  She called her mom on the cell phone, "I knew something like this was going to happen.  I shouldn't have gotten the vaccine
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE lot no EL3247), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE lot no EM9810), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "know since I had the booster shot my knee is hurting, my leg is hurting and my back is hurting". Additional information: LOT# (first & second shot): Consumer stated, "Yes you know what, yes, the first one is EL3247. The second one is EM9810." Treatment: Consumer stated, "No, there is nothing I can take. After this, I am going to take a nap because I am tired. And my booster by the way was the date of my booster was 29Nov2021 (further not clarified)." Date of vaccination for First and Second shot: Consumer stated, "Ok, the first shot was 21Jan2021 (unclear) University. Second shot was 12Feb2021 and the booster was 29Oct2021 (further not clarified)." No prior to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 2/22/99; on 3/5/99 pt exp red, papular rash
I was vaccinated approximately at noon. By 9:30 pm I felt unusually tired. During the night I felt feverish. At 7:30 am the next day I woke up lightheaded and had a fever of 100.6°F. I also had a headache, upset stomach, chills, was nauseous and very tired. I started taking 650 mg. acetaminophen, every 4 hours, for a total of 4 doses, and began to feel better. By the following morning all the symptoms had resolved.
Pt was given SHINGRIX vaccine 7/25/18, Pt came in 7/31/18 ~ 8:30pm reporting left arm redness, swelling, itching and slight fever. She went to walk in clinic where they wanted her to take benadryl and report incident to rx. Pt was given Benadryl otc packet.
First Vaccine: Symptoms of only left arm local errhythemia and itchy, flu like symptoms x 48 hours.  Second Vaccine: Delayed anaphylaxis beginning slowly 20 min after injection with SOB/Wheezing without relief using rescue inhaler 4x in 2 hours. Progressed to full waist, chest, arm, face rash/hives with significant SOB, Progressed to full A-fib. Symptoms self treated at home with Benadryl and Prednisone. No epi-pen used. Continued self treatment on 4/11, 4/12 and had follow up with Asthma/Allergy specialist due to not resolving. Added steroids and anti-histamine for rest of this week.
Snot with blood; Red at injection site; Nose running; Tired; Slight headache; Sore arm at in the injection; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nose running), VACCINATION SITE HAEMATOMA (Snot with blood), VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE PAIN (Sore arm at in the injection) and HEADACHE (Slight headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at in the injection). On 06-Feb-2021, the patient experienced HEADACHE (Slight headache). On 07-Feb-2021, the patient experienced RHINORRHOEA (Nose running) and FATIGUE (Tired). On an unknown date, the patient experienced VACCINATION SITE HAEMATOMA (Snot with blood) and VACCINATION SITE ERYTHEMA (Red at injection site). At the time of the report, RHINORRHOEA (Nose running), VACCINATION SITE HAEMATOMA (Snot with blood), VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE PAIN (Sore arm at in the injection), HEADACHE (Slight headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
Information has been received from a nurse practitioner concerning a 17 year old female who on 07-JAN-2008 was vaccinated with the first dose of GARDASIL (lot number not provided) and on 25-FEB-2008 was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number not provided). Concomitant therapy included ORTHO EVRA. The patient experienced dizziness after receiving her first dose of GARDASIL. The dizziness started 1 hour after vaccination and resolved in 2 hours without requiring treatment. The patient experienced nausea starting 20 minutes after receiving her second dose. The patient vomited twice at home after eating toast. The patient called the office to report the reaction and was advised to increase fluid intake. The nurse practitioner added that the patient, who works in a day care center, had recently been exposed to suspected cases of influenza. Medical attention was sought by phone call to the office. At time of reporting, patient outcome was not recovered. No product quality complaint was involved. Additional information has been requested.
Approx. 20 hours after receiving vaccine, patient developed nausea, vomiting, vertigo, abdominal cramps, and temp. of 102.5. Symptoms lasted approx. 36 hours.
Right upper arm, edema, redness with solid bumps to elbow from top of shoulder, starting 11-18-10. Consulted with MD, via telephone, and was instructed to take oral BENADRYL and apply ice. Signs and symptoms subsided within 5 days.
Had Hep A shot at 9:45-had a seizure at 11 am and another at 2:45 pm (on 2/22/2017) was admitted to hospital after 2nd seizure. No further seizures. She was discharged home 2/23 after negative work-up.
I took Advil the first two days because people had been complaining about a headache, once I stopped my left arm felt strange and the next morning I woke up with swollen lymph glands and it progressively got worse.  Went to the doctors when they opened on Tuesday January 19 and he confirmed I was have an autoimmune response to shot and gave me medication to help with the swelling.  It has been one week and I feel worse every day since the shot not better.
Dose 1 / August 2019 / 1 year and a half later / patient is back to receive dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2019).   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 reported as follows: The age at vaccination was not applicable. The patient received 1st dose of shingrix in August 2019 and 1 and half year later at the time of reporting patient was back to receive the 2nd dose. Till the time of reporting patient did not received 2nd dose of Shingrix which led to incomplete course of vaccination. All patient identifiers were reported. No further clarification made. The reporter consented to follow up.
Fatigue throughout 3/27 with headache and body ache, arm ache which was reduced by 3/28 and gone by 3/29 with a little risidual dizziness that was gone by end of day 3/29. Mostly just slept and avoided strenuous activity, hydrated. Took some advil on 3/28.
A week after the shot, got a large oval rash around shot sight. 6 days after that my TMJ  flared up and had 48hr muscle spasms. 5 days after that got low grade fever, sinus pressure.
Information has been received from a pharmacist referring to a 77 year old female patient. The concurrent condition, medical history and concomitant therapy were not reported. On 16-JUL-2017, the patient was vaccinated with single dose of PNEUMOVAX 23 (lot # N005096 and the expiration date of 22-OCT-2018) intramuscularly for prophylaxis which was recommended by physician. On 17-JUL-2017, the patient experienced pain, tenderness, redness and swelling in her arm at injection site. No lab diagnostics or studies were performed. The patient did not seek medical attention. The patient had received unspecified treatment and was recovering from the events at the reporting time. Action taken with the vaccine was not applicable. The causality between the events and therapy was not reported.
On 3/6/23 he woke up with a fever and was lethargic. He also had a reduced appetite. We took him to urgent care, and they ran a COVID-19 test and RSV test. He tested positive for RSV. We gave him TYLENOL and MOTRIN. No other medications were prescribed. The RSV was resolved in about two days. Then he woke up with a fever again on 3/28/23. He was also lethargic, and no appetite. We took him to the doctor, and he was diagnosed with hands foot mouth. Today his fever is lower but still there. We are giving him MOTRIN and TYLENOL. He has some sores in his mouth, but none on his hands and feet yet. The doctor said that he probably will though.
Had first Pfizer vaccine yesterday 5/31 due to mandate by employer.  This was given in my thigh . Within 5 to 10 minutes I had numbness and tingling down to my toes. Leg is now burning , severe pain and calf pain. Still numbness and tingling. Area around vaccine sight is bruised , red and very inflamed.
had Covid in between doses/tested positive for Covid 19; had Covid in between doses/tested positive for Covid 19; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced had covid in between doses in May2021. It was reported that the patient received the 1st dose of the bnt162b2 and then tested positive for Covid 19. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Client complained of itching of the throat, tightness of chest, shortness of breath after receiving 1st dose of Pfizer.  25mg of Benadryl  was given. 2 doses of epinephrine 0.3ml at 11:35am and 11:45am.  Vitals were monitored. EMS was called . After assessment by EMS client was transported to the hospital.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old female patient with pcn and no previous illness. The patient was vaccinated IM with dose 1 GARDASIL on the right arm on 23-APR-2012. Concomitant therapy included MENACTRA (IM, on the right arm) and FLUZONE (IM, on the right arm) on 23-APR-2012 and BOOSTRIX (IM, dose 1, on the left arm). On 24-APR-2012 the patient experienced fever, syncope at 1215, fever stayed until 0300 on 25-MAR-2012. Rash and raised area 1 cm by 3 cm long at injection site. No treatment information was reported. The outcome of the events were unknown. Additional information is not expected.
got shot and still had singles/Suspected vaccination failure; got shot and still had singles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-July-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient got the shot and still had shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
When administering vaccine, patient was tense, shaking and holding his breathe, was advised to breathe, that he could make himself pass out. Mother advised to sit in office for a few minutes to make sure he was not going to pass out. after patient left room, a few mintues later mom called for help.  Patient was pale, and had voiding himself. Layed patient down and then gave him water and crackers. Several Practioners went in to check and explained to mom about this common event (vaso-vagal) with adolescents and follow up care.
Information has been received from a registered nurse concerning a female with a history of proteinuria who was vaccinated with a first and second of MMR II in 1979 and 1982, respectively. In 1996 the pt's measles titer was positive. In June 2002 the pt was found to have a negative measles titer. It was unknown if the pt sought medical attention. Additional info has been requested.
Report 2001014964-1 described possible vasovagal reaction in a 9-year old female who received hepatitis A vaccine, inactivated (Havrix)  Allergies, medical history, and concomitant medications were not specified.   On 15 June 2001, the vaccines received her first left arm 720 EL. U dose of Havrix via a Tip Lok  syringes with a 5/8 inch 25 gauge needle. The vaccinee fainted within three minutes of receiving the immunization. the reporter stated that "they suspect vasovagal". Emergency care (NOS) was administered at the emergency room. As of 20 June 2001, the patient was "improved"
After individual received a dose of FluMist, she began to sneeze every 3 -4 minutes.  This persisted throughout the day.  Individual contacted her Primary Care Practitioner and was told to take OTC Claritin.  Next day individual noted decrease in frequency of sneezing but every 20 minutes would sneeze 8 - 10 times.  States history of severe seasonal allergies in the past with similar symptoms..none for several years.
Broke out with chicken pox today 06/26/2003: was exposed at daycare had vaccine 09/17/1999
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. "On or" 03-MAR-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a Physician's Assistant and a medical group for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
03/31/2021, 0929. 53 YO F. Syncopal episode. PT was waiting with her father who had received his vaccine today in the observation area. PT received her vaccine yesterday, time unknown. EMS Evaluation, 12-lead. 0939 BP 104/64, HR 80.  Suspected dehydration. IV established L Hand Dorsal. Care transferred to EMS @ 0948. PT transported to hospital.
Frequent Urination began the night of shot, urinating every 1-2 hours for 48 hours. Constant urge to urinate and slight incontinence.
PT DESCRIBES PAIN WHEN MOVING ARM, NO BRUISING OR SWELLING. LIMITED RANGE OF MOTION - PT WILL BE SEEING HER DOCTOR FOR FOLLOW-UP
chest itches; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (chest itches) and RASH (Rash) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052ezia) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced PRURITUS (chest itches). At the time of the report, PRURITUS (chest itches) outcome was unknown and RASH (Rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  Concomitant medications were provided. No Treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow up received and contains: event - chest itches added
Feelings of  air deprivation during am hours, feeling heart "pain", feeling sudden blood pressure in the neck, heavy blood flow during period, often suffering with eye stye, strange rash appearance - random spots, mostly chest area,  bursitis in left elbow;
sweats; mild flu-like symptoms; aching; headaches; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills) had resolved.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient did not have any pre-existing medical conditions. Patient experienced the events for 3 days. Patient did not take any medications for the events.   This case was linked to MOD-2022-577162 (Patient Link).