chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 25-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-APR-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route from her primary care physician for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient developed nerve pain on the left side of her body and a painful rash along her midsection. In response to these complaints, the patient presented to a rheumatology physician's office with complaints of shoulder pain and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Administration Error. Vaccine was potential diluted with wrong diluent (sterile water) not the required diluent.
Rotarix not reconstituted; Diluent given without reconstitution; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ) for prophylaxis.   On 09-FEB-2023, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 09-FEB-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Rotarix not reconstituted) and inappropriate dose of vaccine administered (Verbatim: Diluent given without reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-Mar-2023 The reporter stated that, when performing the vaccine count it was noted there was 1 more vial of the live virus vial than the diluent syringe.  The reporter stated three patients had received doses so it was unclear if this patient received the correct dose. The case was linked with case US2023034036 and US2023AMR047918, reported by same reporter for different patients. The patient received diluent portion of Rotarix without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023AMR047918:Same reporter US-GSK-US2023034036:Same reporter US-GSK-US2023034036:Same reporter
Numbness and pain in left jaw line; Numbness and pain in left jaw line; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration at the left arm on 18Dec2020 at 11:15 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no medical history and no known allergies (no allergies to medications, food, or other products). Concomitant medication (other medications in two weeks) included cephalexin (CEPHALEXIN) stopped 1 week prior, and fish oil. The patient experienced numbness and pain in left jaw line on 18Dec2020 at 11:45 AM. The patient did not receive treatment for these events. The clinical outcome of the events was not recovered. The report was reported as non-serious.
Swelling of face & rash on face & neck, after 15 mo shots on 12/3/99. On 12/7/99, had fever of 103, seizure & was seen in the ER. Was dx w/ear infection while in the ER on 12/7/99.
Upper left arm/shoulder pain.  Also reported 36 hours of low grade fever and body aches after injection   Left arm at deltoid felt somewhat warm to touch, very mild erythema, tender to palpation.   Pt sent to Urgent care for evaluation
8 days post injection awoke to find  appropriate 3? diameter red, raised, hard lump, covered with raised, pinpoint rash that was extremely itchy.  Lump was warm to the touch and moderately painful. Had a mild headache that day.  Next day, I experienced mild nausea in addition to other symptoms. Day 3 after this site reaction started, other symptoms disappeared but there was atypical lethargy, and sleepiness. Rash on arm is still very itchy, but less redness and hardness.  Treating w/ Benadryl topical cream, with moderate relief.
Whelp like rash around injection site. Fever; patient said went up to 101). Arm swelling near injection site. Achy muscular.
I got the shot and about a year later got shingles\suspected Vaccination failure; I got the shot and about a year later got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 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 was provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient got shingles vaccine and about a year later got shingles. This case was considered as suspected vaccination failure, as information about Shingrix dose number, laboratory test confirmation for shingles infection were unknown.
Information has been received from a pharmacist concerning a 26 year old male pt who was vaccinated IM with two prior doses of varicella vaccine. On 11/30/1999 a varicella titer was drawn and the result was negative. Unspecified medical attention was sought. An additional pt had a similar experience. Follow-up information reported that the pt has "recovered."
Information has been received from a health professional concerning a 31 year old male who was vaccinated, on an undisclosed date, with varicella virus vaccine live (Oka/Merck) and three weeks later the patient developed a rash and pustules. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to the vax;
On approximately 08/21/2000, it was reported that the patient developed chickenpox. The patient sought unspecified medical attention, however it was reported that the child was not seen by the physician. It was reported that a sibling had a similar experience following exposure to varicella virus vaccine live. It was also reported that another sibling in the patient's household has leukemia. Additional information has been requested.
Large round red, swollen, warm, and sore area on my arm. It?s just right and below of the injection site though and more on the outside facing portion of my bicep.
12 hours after the shot I had chills, fever and muscular aches. Went to bed with extra blankets. At 7:00 am Dec. 4 with aches and temp 98.3.
dizziness right after receiving vaccine. 12 hours later severe headache, fever, chills, body aches, slightly elevated heart rate, vomiting.
delayed adverse reaction to vaccine. experiencing severe neuropathy along my left arm. pain is primarily focused around my elbow to wrist area and then less on the upper arm area. Pain is present daily and I feel it most when I'm resting,  relaxing and driving. I also feel pain in the Ulna area when Im typing at my computer at work. I've self medicated with motrin and topical analgesics. cold and hot compresses. give me some relief but pain comes back in a few hrs. I contacted my Doctor on Thursday 2/18/21 and she has recommended PT
Difficulty breathing, extreme pain throughout body especially in joints, sensitive to the touch, confusion, difficulty with memory, numbness & tingling in the arms & legs, fatigue, headaches (migraine-like), balance problems
SORE ARM; 103 FEVER; NAUSEA; BRUISING ON RIGHT FOREARM; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced bruising on right forearm. On 04-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced 103 fever. On 04-MAY-2021, the subject experienced nausea.  Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm, 103 fever, and nausea on 04-MAY-2021, and had not recovered from bruising on right forearm. This report was non-serious.
Patient was initially vaccinated with pfizer vaccination on Sep 2nd 2021.  Initially had slight pain at injection site.  Two days later pt started having extreme leg pain in both legs below the knees.  Both the front of the leg and the calf were experiencing pain.  The adverse event was not initially reported due to tests being conducted (blood tests)  and appointments with Dr.  Advised by Dr to not receive 2nd dose of pfizer until test result came back and constant leg pain subsided.  Nov 8th blood panel came back negative and the leg pain had diminished to uncomfortable instead of extreme pain.  On Nov 20, 2021 pt received his 2nd dose of pfizer.  On 23 November the extreme leg pain returned. Pt is at times unable to walk.  Takes tylenol to deal with pain.  It took almost 10 weeks from initial dose for extreme pain to subside.
could not move their arms/hands; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional This case involves three patients of unknown age and gender, who could not move their arms/hands (mobility decreased), while they received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to the patient.  On 01-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7041MA and expiration date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  On 02-Oct-2020, the patients who could not move their arms/hands (mobility decreased) (non-serious), 1 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event mobility decreased.
Patient came for 2nd HPV in the 2 dose series, and it was administered earlier than recommended time.  This nurse noticed the error had occurred upon preparing for a 3rd dose of HPV.  Parent accompanying minor was notified and agreed to extra dose of Gardasil on 08/15/2023.  No adverse effects noted.  In the future, vaccine schedules will be double checked by this nurse. No symptoms of adverse effects
(L) arm area of vaccine was swollen, swelling went down, but left side hurts when he sleeps on it. Did not have similar reaction w/ the previous GARDASIL vaccine. No tenderness.
Pts bottom lip swelled up approximately 10 minutes after she recieved the singles vaccination. Vitals @ 1319 were B/P- 132/62, HR 63, SpO2 99%, and respirations 14. She was also given a 25mg Benadryl at this time.
He presented to the pharmacy on Monday morning and his left arm and shoulder was swollen and somewhat painful. He was referred to his family physician for further evaluation.
I started having an annaphylaxis reaction a short time after i left. At first it was intense all over body itching that felt like it was from the inside out. By the time i got home i was getting red blotchy patches over my face, neck, and chest. I took benedryl which did nothing to subside the reaction. When my chest started feeling tight i went to the emergency room. My lips were itching and puffy. At the er  i received treatment for annaphylaxis once and about a half hour to forty minutes before i was to be discharge i had a reoccurance of symptoms and was treated for it a second time and admitted to the hospital. This was from the March 31st clinic held at the fire department.
Headache fatigue, itchiness to forehead , soreness to left arm at injection site. Narrative:
The patient's father, present the vaccine and repeatedly told this RN that the patient was 12 nearly 13. The patient received her covid vaccine to the left deltoid. The patient had had no reaction and tolerated well.  The patient's father notified staff after the vaccine was given, the patient was 11 nearly 12 years old and he thought since it was so close to the date of the patient's actual birthday, he thought it was ok for the patient to receive the vaccine. The patient had no adverse reaction while in observation area and left with her father with no issues. The attestation formed was signed.
Pt. developed nausea, 15 minutes after vaccine dose, denied shortness of breath, abdominal pain or other associated symptoms. She had no skin or other changes noted
Awoke 1 day after vaccine administration with nausea, numbness in legs, chest pain, tactile fever and chills, cough, rhinorrhea, left fronto-parietal headache.
Tingling arm, headache. difficulty breathing, chest felt like it has a 20 pound weight on it, needle like pain when breathing out, coughing
At 5:00a.m. I woke up feeling awful, bad headache and feeling like I was hit by a truck.  By 8:30 I was trying to grab my phone by my night stand to call my kids (who were in the house to get me Ibuprofen).  I could barely talk and I asked them to get me water and Ibuprofen.  I started to get a fever of 103.2.  Then I had the chills so bad.   My head still hurt, I had no appetite, I could not stay awake.  I was in bed for 34 hours.  I kept with the Ibuprofen to try to help.  The next day I developed a rash on my check and stomach.   I have never had a rash before, I am guessing this was a fever rash.  I honestly can say that I don't think I have ever been so sick in my life.
GOUT; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 administration not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the subject experienced gout. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gout was not reported. This report was non-serious. This case, from the same reporter is linked. Sender's Comments: V0:As per standard protocol, comment is not required for non-serious case
Patient under 18 years of age had de vaccine administered (pediatric - special population); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age had de vaccine administered (pediatric - special population)) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age had de vaccine administered (pediatric - special population)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age had de vaccine administered (pediatric - special population)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
10 days after 1st injection, I started having symptoms.  Cough, chest tightness, fever, body aches, chills, etc.12 days after 1st vaccine, I tested Positive for COVID-19.
CRP elevated; This spontaneous case was reported by a nurse and describes the occurrence of C-REACTIVE PROTEIN INCREASED (CRP elevated) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SULFABENZAMIDA for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced C-REACTIVE PROTEIN INCREASED (CRP elevated). At the time of the report, C-REACTIVE PROTEIN INCREASED (CRP elevated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medications were not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Received MMR, Varivax and Prevnar on 2/12/2002. Developed ataxia for 6-9 wks afterwards; 4-5 days rash, 1 day-fever. some nausea, vomiting and diarrhea.
Test positive for COVID-19/have symptoms on 26, 27 and 28Dec2020; Test positive for COVID-19/have symptoms on 26, 27 and 28Dec2020; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient started to receive first dose of BNT162B2 (Batch/lot number: EH9899) intramuscular into left deltoid on 15Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension and the patient was on blood pressure (BP) medications. The patient received no other vaccines on the same day as the COVID Vaccine. The patient received first dose on 15Dec2020 and was exposed to someone with COVID on 24Dec2020 and tested positive for COVID 28Dec2020. The patient stated that he was wondering what the recommendations are for receiving the second dose of the product, if someone contracted COVID-19 after receiving the first dose. He tested Positive for COVID-19 on 28Dec2020 and he does not know if it is ongoing or not, as he does not re-test for COVID-19 until Wednesday (30Dec2020), but he currently has no symptoms. The patient stated that he did have symptoms on 26, 27 and 28Dec2020. The lab tests and included COVID-19 PCR test: positive on 28Dec2020. The outcome of events was unknown.; Sender's Comments: The association between the event lack of effect (COVID-19) with BNT162b2 can not be completely excluded.
Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient)  A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 16Feb2021 (Age at vaccination: 69 years old) as dose 1, single for covid-19 immunization at health department. The patient medical history included: took pneumonia shots for immunization and flu shots for flu prevention on an unspecified date. Concomitant medication(s) included apixaban (ELIQUIS) tablet taken as blood thinner at 5mg twice a day from 2019 and ongoing. Patient did not take additional vaccines on same date of the Pfizer suspect, patient denied any illness at time of vaccination, no family medical history relevant to events of the patient, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021, the patient experienced events, which begins with his first dose of vaccine which he stated gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm. Nausea, diarrhea, gastrointestinal distress, lasted about a day and worn out and sore arm, lasted about three days per patient. Events did not result in a visit to physician office or emergency room. Outcome of events nausea, diarrhea, gastrointestinal distress was recovered on 17Feb2021 and outcome of events worn out and sore arm was recovered on 19Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache; pain in the arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (pain in the arm at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (pain in the arm at the injection site). At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (pain in the arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Outcome of events updated.
Breakthrough COVID infection. Patient fully vaccinated 3/11/21. Patient tested positive for COVID on 7/22/21.
1 week after injection experienced low platelet levels and bruising. Those resolved within another week of time. Patient has also been more tired since vaccine, has been experiencing prolonged sinus issues and has been having sensations of needle pricking all over her body in various places since injection.