chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Consistent tinnitus / Constant ringing in left ear- tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Consistent tinnitus / Constant ringing in left ear- tinnitus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Consistent tinnitus / Constant ringing in left ear- tinnitus). At the time of the report, TINNITUS (Consistent tinnitus / Constant ringing in left ear- tinnitus) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received on 09-jun-2021 contains patient ethnicity and race information was updated.
Chronic urticaria, pruritus, angioedema unresolved. Cough lasting thru Sept 1, 2022.
Started feeling extreme fatigue, dry eyes to the point to where they would burn, along with joint pain. . After going to the doctor and having bloodwork I was diagnosed with Sjogrens syndrome. I was told that if I needed any meds to call. Started using eye drops type gel for dry eyes.
Pt became dizzy and lightheaded with blurry vision approx. 30 minutes post vaccine. She also reported left sided chest pain. She was taken to ER. Declined steroid injection. EKG and chest xray were normal. Was discharged to home and will follow up with her PCP.
Initial report was received from a consumer, who was also the patient, on 31 October 2013. A 49-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH907AB, on 28 October 2013 and 90 minutes later developed itchy palms, red flush to face and a red rash over the body. She went to the physician's office and received treatment of IV antihistamines. The symptoms were relieved after the IV, but now the patient has malaise since 28 October 2013. The patient had no illness at the time of vaccination and allergies to thimerosal, sulfa drugs, cycline drugs, KEFLEX and AVALOX. Outcome was not recovered. Documents held by sender: None.
Patient started experiencing redness and a little swelling on the mid part around the arm just about the elbow later in the day after receiving the vaccines earlier in the same arm. Advised patient to take some BENADRYL and if no improvement to see a doctor.
The patient, who is my wife, went into preterm labor and delivered at 30 weeks and 3 days. Date of delivery was 2/9/21. EDD was 4/17/21. My wife is a G3P2. She had a very early miscarriage in 2016. She delivered a healthy child at 37 weeks and 3 days in 2018. During this current pregnancy, all prenatal visits, tests, and scans were unremarkable. Based on a gross examination of the placenta and a review of all clinical data by the patient's OBGYN, there was no obvious stimulus for the preterm labor. Fortunately, the baby is doing ok in the NICU at hospital.
Patient felt dizzy about 1-2 minutes after receiving the vaccine.  He was on his way to the chair in the waiting area when he fainted and fell into a Lysol display.
12/2/04 flu vaccine given, 12/04/04, developed hives over body, seen at Pedi office, gave Benadryl, rash test to eggs done 12/6 was negative. 1/10/05 2nd flu vaccine given 1/11 developed hives treated over phone.
TD vaccine given 10/28/03. Presented to ER on 10/30/03 with "redness & hardness" to right deltoid. Treatment: Cool compresses, APAP or Motrin recommended. Return to ER if gets worse. Other info: Temp = 99.2, Blood Pressure= 114/75, R = 18, P =70.
This spontaneous report as received from a registered nurse concerning possibly seven children who on 16-AUG-2012, were vaccinated with a dose of M-M-R II (lot# not provided). The nurse stated that the children might have been vaccinated with improperly stored M-M-R II. M-M-R II was exposed to 68 F for 9 hours and then on Wednesday last week "on 15-AUG-2012", the temperature went to 48F for 1 hour (also reported as exposed to 68 F for more than 6 hours). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
received Shingrix on 29-JAN-2019 and 31-MAR-2019 had shingles/ Suspected vaccination faliure; shingles; painful; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31-MAR-2019, the patient received the 2nd dose of Shingrix. On 29-JAN-2019, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: received Shingrix on 29-JAN-2019 and 31-MAR-2019 had shingles/ Suspected vaccination faliure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: painful). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 07-AUG-2023 The reporter was a patient. The reporter stated that she administered both doses of Shingrix and has had shingles four times since then on her bikini line. The reporter reported that it was usually resolves within five days and her physician prescribes Valacyclovir. The reporter reported that it was the size of a quarter and painful. The reporter stated that it would be okay to follow up with doctor. 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 reporter did consent to follow up.
pt recv vax 5JUL96 & 9DEC96 pt devel a chickenpox rash w/15 lesions;
Itchy skin all over body/Itching/pruritus (Generalized); hives and bumps on my body/ red bumps like the measles on my skin all over at first/ Hives/urticaria (Generalized); Redness/erythema (Generalized); Rash on body/Rash (Generalized); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin all over body/Itching/pruritus (Generalized)), URTICARIA (hives and bumps on my body/ red bumps like the measles on my skin all over at first/ Hives/urticaria (Generalized)), ERYTHEMA (Redness/erythema (Generalized)) and RASH (Rash on body/Rash (Generalized)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (Itchy skin all over body/Itching/pruritus (Generalized)), URTICARIA (hives and bumps on my body/ red bumps like the measles on my skin all over at first/ Hives/urticaria (Generalized)), ERYTHEMA (Redness/erythema (Generalized)) and RASH (Rash on body/Rash (Generalized)). The patient was treated with PREDNISONE at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing from 22-Mar-2021 at a dose of 1 Daily and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from 22-Mar-2021 at a dose of 1 Daily. At the time of the report, PRURITUS (Itchy skin all over body/Itching/pruritus (Generalized)), URTICARIA (hives and bumps on my body/ red bumps like the measles on my skin all over at first/ Hives/urticaria (Generalized)), ERYTHEMA (Redness/erythema (Generalized)) and RASH (Rash on body/Rash (Generalized)) had not resolved.            Concomitant medication of the patient was not reported.  Treatment also include steroid cream.     Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received on 08-Jun-2021 added event, containing the 2 nd dose information On 24-Jul-2021: Patient demographics (height and weight) and additional corrective treatments were added.
developed first COVID symptoms (fever, headache, chills, cough on Tuesday 28Jun/Both COVID PCR and rapid antigen tests were positive on 30Jun); developed first COVID symptoms (fever, headache, chills, cough on Tuesday 28Jun/Both COVID PCR and rapid antigen tests were positive on 30Jun); This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: FH3219) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "gastroesopheageal reflux" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE; HYDROCHLOROTHIAZIDE; SIMVASTATIN; AMLODIPINE; RABEPRAZOLE. There were no Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "not recovered" and all described as "developed first COVID symptoms (fever, headache, chills, cough on Tuesday 28Jun/Both COVID PCR and rapid antigen tests were positive on 30Jun)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive, notes: strongly positive; (30Jun2022) Positive; (06Jul2022) Negative; (07Jul2022) Negative; (08Jul2022) Negative; (30Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti-viral Treatment Paxlovid for COVID 19 from 30Jun2022 to 04Jul2022, approximately 40 hours after symptom onset. The patient completed the 5 day course and had rapid resolution of symptoms. By day 5 of treatment the patient was completely asymptomatic except for a very mild residual cough and had negative COVID rapid antigen tests on 06Jul2022, 07Jul20222 and 08Jul2022. However, on Thursday 07Jul2022, he noted recurrence of nasal congestion and mild cough and on 09Jul2022 his COVID Ag test turned strongly positive. The patient reported this as a likely case of COVID rebound.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Information has been received from a medical assistant /office manager concerning a 6 month old female who on 14-NOV-2008 was inadvertently vaccinated with 0.5 ml dose of PNEUMOVAX. IM in the thigh. This was a human error. No adverse effects reported. The patient sought medical attention at the office. Additional information has been requested.
Patient reports shivering, diarrhea, and tactile fever within 5 hours of getting vaccines. Overnight had temp up to 102, shaking/shivering, complaining of  headaches and just laying in bed, not even wanting to open eyes
Nausea, Stomach cramps, Fatigue, Sleeplessness, Body aches, Headache, Injection site pain -all  the same or slightly better 16 hours after onset.
Fever; headache; nausea; chills; diarrhea; hives; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an intramuscular route of administration in left arm on 10Apr2021(at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history included bronchial asthma and the patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 11Apr2021, the patient experienced fever, headache, nausea, chills, diarrhea and hives. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included PCR (polymerase chain reaction) test on 10Apr2021 and tested negative. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse events which included treatment with antihistaminic medication. The clinical outcome of the events fever, headache, nausea, chills, diarrhea and hives was recovering at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
1 of 3 pts immunized from the same lot exp a react; pt had local react which was 10 x 2 cm in diameter; pt also had arthralgias & low grade fever; sx resolving @ time report;
Information has been received from a physician's assistant and refers to unspecified multiple patients of unknown ages and genders. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PNEUMOVAX23 (lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored at a  recorded temperature of 34.84 Farenheit (1.57 Celsius) for 19 hours. It was unknown by the reporter if there was previous temperature excursion.  No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Patient has not reported an adverse event - this is being reported as an administration error. It is believed that patient received a Janssen vaccination at the age of 16 years old. An incident report has been filed, the manufacturer and the patient (mother) have been notified.
Child received varicella vaccine on 9/17/12. Broke out in varicella like rash 10/2/12. Prompting dr. appt.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-DEC-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength and dose were not reported) (lot # R018931 and expiry date: 02-JUL-2020), via subcutaneous for prophylaxis (product storage error). The vaccine vas reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degrees Celsius (C) to -10 C(14 C) for 27 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This report is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1812USA011983: US-009507513-1812USA011984: US-009507513-1812USA011985:
This spontaneous case reported by a consumer, describes the occurrence of neck pain (pain passed up to her neck), arthralgia (pain in her right shoulder/pain went into her joint) and headache (pain back of the head) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 10, 2021, patient experienced neck pain (pain passed up to her neck), arthralgia (pain in her right shoulder/pain went into her joint) and headache (pain back of the head). The patient treated with Advil (ibuprofen) for pain relief, at an unspecified dose and frequency. At the time of the report, neck pain (pain passed up to her neck), arthralgia (pain in her right shoulder/pain went into her joint) and headache (pain back of the head) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medications reported.
Patient was administered the Bivalent by MA. Patient was due for the second dose in initial series.
Headache started within 15 minutes of receiving vaccine and remained for 24 hours.  Tylenol did work to reduce pain. Swollen lymph node in left armpit causing pain and tenderness at site of lymph node.  Discomfort in armpit started around 28 hours after vaccine administered. True pain in armpit started 30 hours after vaccine administered. Pain and slight numbness is occurring in left elbow and hand once lymph node became painful too. Swollen lymph node is about the size of a large pea.  Tylenol and warm compress are sufficient to reduce pain down to a discomfort.  No other symptoms are occurring at this time, it is 39 hours after vaccine administration.