chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loose of vision in one eye; shingles; first dose /December of 2020/not had his second dose; This case was reported by a consumer via call center representative and described the occurrence of loss of vision in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (5 years before the date of reporting) and heart attack. Concurrent medical conditions included bone marrow disorder, coronary stent placement, neuropathy, cancer and pancreatic disorder. Concomitant products included chemotherapy, nos (Chemotherapy).   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the loss of vision, shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the loss of vision and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not applicable for 2nd dose. The patient received first dose of Shingrix and now currently experiencing shingles and had loss of vision in one eye and was seeking care. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to seek guidance, as to when he should receive his second dose of Shingrix. The reporter consented to follow up.
feel a burning sensation on his nose; painfulness; Headache; cheeks and nose are flushed; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (feel a burning sensation on his nose), PAIN (painfulness), HEADACHE (Headache), FLUSHING (cheeks and nose are flushed) and PAIN IN EXTREMITY (arm soreness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (No reported medical history). Concomitant products included RAMIPRIL.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 18-Jan-2021, the patient experienced BURNING SENSATION (feel a burning sensation on his nose), PAIN (painfulness), HEADACHE (Headache) and FLUSHING (cheeks and nose are flushed). At the time of the report, BURNING SENSATION (feel a burning sensation on his nose), PAIN (painfulness), HEADACHE (Headache), FLUSHING (cheeks and nose are flushed) and PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included antibiotic
Eight days after the vaccine, I have developed a red swollen area about 2" in diameter that is sensitive to touch.
1 cm red raised hive at site of DaPT and HIB within 24 hours post vax.  Area measured 4 X 8 cm after injections.
Throbbing headache and golf ball size swollen lymph node after each vaccine.  Swelling had almost disappeared after first vaccine under left arm.  Swelling appeared under right arm the next day after second vaccine.  All day after the second vaccine I was achy and very tired
A 15 month old male received his 1st dose of Prevnar, as well as, his 4th doses of Tripedia and ActHIB on 9/12/00 and within 1 t0 7 days, post vax, he developed fever and an injection site reaction characterized by redness and swelling at the Prevnar injection site.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medications.  Treatment medications included shingles vaccine.
Took vaccine on 12/23/20 no major symptoms, next injection site soreness w/ slight pain. On 1/4/21 had vomited/ major headache at 3:44am.  Continued feeling sick nauseous mild headache brought My blood to be high all day.  On 1/5/20  woke up with headache and diarrhea (6 times for the past13hrs) discomfort of the stomach. Hardly no appetite.  Also noticed today my injection site left arm (slight red and rise bumps almost like a big rash or welts and itchy. That?s what caught my attention to see my arm.    My concern is could this be part of  late reaction of the vaccine?
Immediately after receiving the vaccine she experienced a very strong, pungent and sharp taste and smell, which passed within 5 minutes.  In those 5 minutes the next thing was tingling in her face, cheeks, lips and her sinuses which were not clogged up at the time cleared, which stayed that way until Saturday morning.  She did have tingling and numbness in her fingers, but nothing in her feet, and did not extend beyond her face and cheeks.  Then 20 minutes later at 1:55 PM her tongue became sort of thick and a little numb, but did not swell.   The area between her tongue and mouth tightened and her jaw tightened but nothing swelled.  No itching in the throat.  She had some sort of aching like menstrual cramps but has had a hysterectomy.  She did also have a headache, took a Tylenol at 2:15 and went to sleep.  When she woke up had fatigue, sore arm, and everything else had passed other than the lips feeling prickly and numb.  The tongue was no longer tight or in the jaw.  Just still had the open sinuses and the headache.  The most significant thing was the thickness and lack of feeling of her tongue.   By Saturday she was fine other than the normal side effects, soreness of arm, no red rash, but had been  moving it around.
myalgia, described as muscle aches and muscle pains; fever; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (myalgia, described as muscle aches and muscle pains) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concomitant products included levothlyroxine for an unknown indication.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (myalgia, described as muscle aches and muscle pains) and PYREXIA (fever). At the time of the report, MYALGIA (myalgia, described as muscle aches and muscle pains) and PYREXIA (fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The symptoms have not been treated. The HCP wife of the patient asked can the patient take Tylenol for his symptoms.
Had fever,upset stomach,dizziness,headache. All normal side effects. The adverse reaction was severe shoulder pain(not soreness) limited to no range of motion on right arm. As of today most of pain is gone, soreness is still present. Range of motion almost normal. Still have a tightness in shoulder. Shoulder is constantly popping, just about whenever I move it more than a little.
tiredness; nausea; woozy; pains; muscle pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Apr2021 (Lot number: EW0170) at the age of 69 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Cholesterol" (unspecified if ongoing), notes: Cholesterol; "Sugar" (unspecified if ongoing), notes: Sugar coded as diabetes. Concomitant medication(s) included: DAPAGLIFLOZIN taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; METOPROLOL taken for blood pressure measurement; ATORVASTATIN taken for blood cholesterol; TAMSULOSIN; TELMISARTAN. Vaccination history included: Bnt162b2 (First dose), administration date: 07Apr2021, when the patient was 69 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "tiredness"; NAUSEA (non-serious) with onset Apr2021, outcome "not recovered", described as "nausea"; DIZZINESS (non-serious) with onset Apr2021, outcome "not recovered", described as "woozy"; PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "pains"; MYALGIA (non-serious) with onset Apr2021, outcome "not recovered", described as "muscle pains". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient stated that after 2nd dose he felt nausea and tiredness. And he was stated that I do not know what to take it but I took Tylenol in the beginning.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 30 Mar 2022) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. Patient had no known drug allergy or medication of food allergy. Concurrent medical conditions included Type 2 diabetes mellitus, Hyperglyceridemia, Hypertension, Chest pain and Dorsalgia. Concomitant products included Esomeprazole; Atorvastatin; Amlodipine; Aspirin; Losartan; Metformin; Triamcinolone for an unknown indication. On 30-Mar-2022 at 9:59 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022 at 9:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 30 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 30 Mar 2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had other medication such as Omicron. Dose administered past the 30 day storage on the refrigerator. Number of doses or vials administered 36 doses. Date and time the vial was initially stored in the refrigerator 25 Feb 2022. The vial had not undergone any temperature excursion. Covid positive or negative within last month was reported as N. No treatment medications were reported.
Information has been received from a consumer concerning her aunt, a female patient with a history of headaches who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot number unknown). The consumer stated that her aunt's headaches became worse after receiving the ZOSTAVAX (Merck) injection. It was unknown if the patient sought medical attention. At the time of report, the patient's outcome was unknown. No further information is available.
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022.  Per FDA (Food and Drug Administration) guidance, Moderna was contacted on May 3, 2022 about the vaccine storage error.  Moderna conducted research on the same lot number and simulated the same conditions noted by Public Health.  Moderna found that the vaccine met the required activity to produce the needed immune response.  This is Moderna Case.  Although Moderna noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them.  Patient has experienced no know adverse events.
PT deferred pending orthopedic evaluation. Unit members vax'd on 6 March. Typical vaccinal reaction first observed on/about 3/27/03. History of "self defense" training in unit on about March 17-18. Denies risk factors, but chart identifies "eczema" in hot weather in groins.
Occurrence of VZV encephalitis s/p new blisters and excoriations, received 2 courses of acyclovir IV (total 24 day tx); patient is currently hospital inpatient
8/29/02 client received MMR, Varivax and Td 7 days later he experienced difficulty breathing and chest pain. Went to ER where he was admitted. All heart tests returned wnl. He was discharged with an order for Previcid. Previcid did not seem to help. By the time he returned to clinic, symptoms subsided. 10/3/02 client returned to clinic for second Varivax. Approx 5-6 days later he again experienced chest pain and dyspnea. 10/10/02 5:45pm client called health dept to report symptoms-wondering if vaccine was involved-referred to private provider. Client was concerned, but did not seem in critical distres.
Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No allergies were reported. Patient never had COVID positive test or diagnosis. It was reported patient had no flu or pneumonia vaccine in 2021.  Concurrent medical conditions included Diabetes and Anxiety. Concomitant products included GLIPIZIDE and LINAGLIPTIN (TRADJENTA) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included unspecified medication for anxiety. Patient had never experienced similar event in the past. No treatment medication were provided.   This case was linked to MOD-2022-669114, MOD-2022-669113 (Patient Link).
Since vaccination, have developed hives/skin rash when consuming foods with MSG/glutamates. Was not allergic prior to vaccination, developed approx. 1-2 weeks following receipt of FLUMIST, progressively getting worse.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 45.05   Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Fever to 101 F deg, headache, and full body muscle pain, for a day.
Information has been received from a consumer concerning her nephew who on an unspecified date was vaccinated with a dose of MMR II.  Subsequently, on an unspecified date the patient developed blood stool a month later received the MMR II.  It was unknown if the patient sought medical attention.  At the time of the report, the patient was 4 years old.  The outcome of the event was unknown.  The patient had a twin sister who experienced an AE post vaccination with MMR II (MSD, WAES # 0911USA01595).  Additional information has been requested.
Really intense dreams - hallucinatory dreams; chills; Fever; headache; Tired, fatigued, kind of "brohl"; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Really intense dreams - hallucinatory dreams), CHILLS (chills), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (Tired, fatigued, kind of "brohl") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 029620A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ABNORMAL DREAMS (Really intense dreams - hallucinatory dreams), CHILLS (chills), PYREXIA (Fever) and HEADACHE (headache). 02-Mar-2021, the patient experienced FATIGUE (Tired, fatigued, kind of "brohl"). On 03-Mar-2021, ABNORMAL DREAMS (Really intense dreams - hallucinatory dreams), CHILLS (chills), PYREXIA (Fever) and HEADACHE (headache) had resolved. On 09-Mar-2021, FATIGUE (Tired, fatigued, kind of "brohl") had resolved.            Concomitant medication was not provided.  Treatment information was not provided.
Information has been received from a 51 year old physician with multiple sclerosis and hypertension who on 12/08/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included interferon bega-la (Avonex), lisinopril (Prinivil) and hydrocodone HC1.  The physician reported that in December 2003, he developed a fever of 102F, myalgia, injection site pain and injection site induration. Unspecified medical attention was sought and the physician was treated with acetaminophen for the fever and pain. At the time of this report, the outcome were unknown. Additional information has been requested.
Had the vaccine and booster and still got shingles/ Suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated he/she received the vaccine and booster and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. No event for booster dose were captured because it was not clearly reported that the patient received both doses and than booster dose. Thus dose no. were also kept blank.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-JAN-2015, the patient was vaccinated with an improperly stored dose of VAQTA 50 U/ 1 ml (lot # K006604, expiration date 21-OCT-2015). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 144, 31 and R; 216, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a vaccine specialist concerning a 12 year old pt who on 05/25/95 was vaccinated with a first dose of varicella virus vaccine live (lot 608320/0405B). It was reported that on 05/17/02 the pt experienced seizure and was taken to a hospital. A physician at the hospital felt that the seizure was related to therapy with varicella virus vaccine live. No other info was available at this time. Upon internal review, the pt's experience was considered an other important medical event. Additional info has been requested.