chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Friday, February 26: Received first shot of Moderna COVID-19 vaccine in left arm, vaccination site at a State University  Saturday, February 27: Traveled to spend the week of March 1 providing healthcare support for parent (mother)  Saturday, March 6: Woke up in the morning with acute pain running from the left shoulder/neck area down the left arm to the left hand. Sitting upright in a char and driving a car made the pain worse. Difficulty sleeping due to pain and having to sleep on one side. Soothed the pain temporarily with a menthol rub but the pain would not go away  Sunday, March 7: Pain (burning, stinging, aching, quaking) unbearable to the point that I stayed in bed most of the day but could not sleep. Sitting upright continued to make pain worse. Menthol rub did not make pain go away. Pain intensified throughout the day in left shoulder and neck, shoulder blade, arm, and hand.  Monday, March 8: Appointment with Dr, internal medicine specialist who is my mother's primary care physician. Dr. suspected that I may be suffering from brachial neuritis and recommended that I see a neurologist for further diagnosis. He prescribed Gabapentin (nerve pain medication) and a series of steroid medication (Prednizone) for me to take throughout the week. I asked him how long I would have to take the medication in weeks/months to come. He said as long as I am feeling the pain. That night, when I started taking the medication, the pain flared up deep in my shoulder and down my arm like a fireball!   Tuesday, March 9 - Thursday, March 11: Gabapentin was not effective with reducing extreme pain. Dr. instructed me to increase dosage as needed. A day later, he called in a prescription for -------, a pain medication that he said I could take with Gabapentin to help strengthen relief. Made appointment with Dr, neurologist with Medical Group.   Friday, March 12:  Appointment with Dr. Initial tests suggest to him that my condition could be either brachial neuritis. He ordered MRI and EMG nerve test. I asked if I would be able to drive back to home. He advised against driving at all given my medications and ongoing pain, as well as the need to arrive at a clear diagnosis. I asked him what I should do about getting the second Moderna shot. He told me that I should not get the second shot. I am scheduled to get the second shot on Friday, March 26, at a vaccination site, State University.
A report has been received from a physician concerning a 15 year old, female subject, who had been receiving nasal FLUIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 14-Jan-2014. It was reported by physician that eight patients were received expired FLUMIST QUADRIVALENT on 14-Jan-2014. The outcome of the event of received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
This spontaneous report as received from a pharmacist via company representative refers to a female patient in her 60's. On an unknown date reportedly couple of years ago the patient was vaccinated with a dose of ZOSTAVAX (lot# and dosing regimen unspecified). The pharmacist reported that the patient developed papules at the injection site after administration of ZOSTAVAX a couple of years ago. The patient sought medical attention (contacted pharmacy via phone). The outcome of the event was unknown. Reporter's causality was not provided. Additional information is not expected.
Fever up 102 for 3 days with mild posterior lymph node swelling and one left axilla, and neck tenseness gradually resolved.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and myalgia. On an unknown date, the outcome of the influenza-like symptoms, fever and myalgia were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, the patient experienced flu-like symptoms, myalgia and fever. The reporter did not have any additional information. The medical representative stated that, this event was reported to him by the healthcare professional on 29th August 2018 and he submitted it on Wednesday however, the report was hung in email and he do not believe it went through. The reporter stated that he noticed, that it had not gone through so wanted to call GRC to report the event. This case was one of the 2 cases, reported by the same reporter.
Information has been received from a medical assistant and refers to multiple unknown patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, since 17-MAY-2017, the patients were most likely vaccinated with doses of improperly stored PNEUMOVAX23 lot # M037533 and expiration date of 17-MAY-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 2 hours and a lowest recorded temperature of 30.2 Fahrenheit degrees for two cycles for a cumulative timeframe of 10 minutes).  No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved.  This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001766: US-009507513-1705USA015824: US-009507513-1706USA001765:
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with ROTATEQ lot # M042821, oral for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to  ROTATEQ. Sender's Comments: US-009507513-1708USA013474: US-009507513-1708USA013473: US-009507513-1708USA013475.
Hurting; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HUMIRA solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and HUMIRA (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN. At the time of the report, PAIN outcome was unknown.        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.   Suspect drug is HUMIRA solution for injection in pre-filled pen.  Concomitant drugs not reported.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above included on 28-May-2021.
Pt co lightheadness.  Also complain of hot flashes. 1705 bp 147/71; p 72, rr 20, 02 99 1710  bp 139/64, p 80, rr 20, 02 99; 25 mg Benadryl given po 1712 - c/o lips and tongue tingling 1715 - 135/69, 65, 100% 1715 - tingling improving 1720 - 138/68, 66, 99% 1725 - tingling gone, lightheadness impoving; pt stood by chair without complaints 1730- 125/55, 66, 99%; pt feels better; pt assisted out to car.
Complaint of left arm pain post COVID Vaccine immunization. With this Provider, pt reports pains to the left arm area with movement and reaching x 5 days, however, reports pain is resolved at this time. Further reports maculopapular rash to the chest area x 3 days, denies any itching, pain, irritation to the rash area, states just noticed rash 3 days ago. Denies any other symptoms at this time
Felt like her ear was on fire; Ear turned pure red for an hour; Red circle of redness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Felt like her ear was on fire), ERYTHEMA (Ear turned pure red for an hour) and VACCINATION SITE ERYTHEMA (Red circle of redness on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced EAR PAIN (Felt like her ear was on fire), ERYTHEMA (Ear turned pure red for an hour) and VACCINATION SITE ERYTHEMA (Red circle of redness on her arm). On 09-Mar-2021, EAR PAIN (Felt like her ear was on fire) and ERYTHEMA (Ear turned pure red for an hour) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red circle of redness on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Patient's treatment information included Benadryl to treat her symptoms.
Left arm (flu shot) had walnut sized lump, warm to touch for a week. Now is the size of mosquito bite. Was exhausted and achy for 3 days.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 details were reported.  The box of vials was received on 14-Oct-2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
Patient woke up next morning with headache, fever, chills and fatigue. He took aspirin that resolved the headache. He was still experiencing symptoms when reported around 5:00pm. No reaction at either site of administration. Spouse will monitor and give ibuprofen as needed.
Covid Shot 3/4/21 Sore right arm. 3/14/21 Woke up and found blood on the waistline of the underware.  Cleaned it up and had a pencil eraser size whole in my abdomen near an old suture site.  The last surgery there had been 3 1/2 years ago. #/15/21 Called the plastic surgeon and made an appt for 3/22/21. Saw the Dr.  He didn't know why my abdomen would have opened up after the time lapse of his last surgery.  Told me to keep clean use antiseptic cream and see him again in 3 weeks.   Second Vaccine 4/1/21. Right arm sore, headache for 3 days Chills and Fever. Better 4/421.  On 4/9/21 I developed a cold sore on my upper lip. Last cold sore I had was 51 years ago.  Not a common occurance for me.  On 4/10/21 I noticed more blood on my bandage and also that the opening had gotten worse.  Went into the Surgeons office 4/12/21.  He used silver nitrate on it to see if he could get new tissue to grow together.  When I mentioned to him about the cold sore.  He then put together that the opening was casued by the covid vaccine.
pt recv vax 13OCT95 & 29APR97 pt devel chickenpox w/approx 50 lesions & low grade fever;pt recovered from exp;
Information has been received from a company representative concerning nine children who in 1995 were vaccinated with one dose of varicella vaccine. Three to four years later, the patients experienced "full blown chicken pox, not breakthrough pox." The physician expressed a concern regarding the lot number. The physician noted that the vaccine was stored properly. Medical attention was sought. The records of testing prior to release of this lot have been checked by biological quality assurance and found to be satisfactory. The lot complies with the standards of the center for biologics evaluation and research and was released. Additional patients were reported who had adverse experiences following vaccination with varicella vaccine.
Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022; Vaccine administered 30 days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient had received second booster on 18 Jul 2022.  Number of doses and vials were reported as 6 doses from the same vial 3. The vials were stored in refrigerator on 16 Jun 2022. The vial did not undergo any temperature excursions.  No treatment medication was reported by reporter.
Day 1-3 post injection: subnormal fever 96.5, injection site pain and itching (no visible rash), fatigue Day 7 post injection:  large, very warm, swollen area on left arm at injection site on lasting 13 days, slowly subsiding over the latter 3 or 4 days.  Thick and rough skin changes in that same area (most of left upper outer arm) remains as of today, post injection 31 days Day 8 enlarged, tender breasts, bilateral lasting approximately 7 days
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
10:20 am - client fainted approximately 5 minutes following administration of vaccines. Ammonia 3 inhalant used to restore consciousness. B/P 130/80 assisted client to chair when was feeling better. Gave him a coke to drink. C/O headache. Gave client a cold pack for his head. B/P 116/50 at 11:00am. Notified doctor (mother gave client Ibuprofen 200mg at 10:40am) 11:15am client says he feels better. Instructed him to visit doctor if symptoms return. Left the office at 11:15 am.
I saw the left deltoid on 04/19/2018. The area was swollen and red. 4 inches wide and 4 1/2 inches long was the area of redness and swelling. The left deltoid arm area circumference was 9 1/4 inches. The right deltoid area circumference was 7 3/4 inches.
Noted redness, warmth, swelling (R) arm 5/3/11 in evening. Seen in PCP office 5/4/11. Txed with IM steroid, PO steroid taper, antihistamine.
Patient c/o swelling and itching to vaccination site. Pt was seen by provider on 03/22/18 - oral histamine and cool compress to site.
FEELING WEAK AND DRAINED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch no was not known and has been requested. Concomitant medications included adalimumab for crohn's disease.  On MAR-2021, the subject experienced feeling weak and drained. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from feeling weak and drained. This report was non-serious.
Aches; Fatigue; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches), FATIGUE (Fatigue) and PYREXIA (low grade fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Idiopathic thrombocytopenic purpura (resolved) and Lymphocytic leukemia (Chronic Lymphocytic Leukemia which is in partial remission). Concomitant products included IMMUNOGLOBULINS NOS (IMMUNE GLOBULIN) for Chronic lymphocytic leukemia, PARACETAMOL (TYLENOL), Veoclexta and IBRUTINIB (IMBRUVICA) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Aches), FATIGUE (Fatigue) and PYREXIA (low grade fever). On 27-Feb-2021, MYALGIA (Aches), FATIGUE (Fatigue) and PYREXIA (low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.         Treatment medication use was not provided by the reporter.  The patient got Covid-19 antibody test to check if he developed any antibodies to Covid-19. The results came back negative   The patient's immunologist recommended to get a T-cell specific test to Covid-19. The test was approved by the FDA on 05 Mar 2021. The results came back positive.   This case was linked to MOD-2021-065381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received and lab details were updated.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; 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 during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 71.80.  Concomitant products were not reported.  On 17-Feb-2021, At excursion time 08:00 AM, temperature was 20, total doses given for the day was 62 and at 09:00 AM, temperature was 22, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-Mar-2021.  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 traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
The patient received the Monovalent dose rather than the Bivalent Dose.  The box and vial do not say monovalent, it says use for Booster only.  This product is no longer being used as a Booster and is only being used as a primary series.  The product vial and box do not have that information changed to reflect how it is actually being used.  When consulting the  Moderna COVID-19 Vaccine chart, the picture on the chart shows the word Monovalent .  The actual bottle does not have the word Monovalent on it and does not match the chart.  The Bivalent vial and box do not have ages on them.  It is not indicated on the box to use for pediatrics.
Developed pneumonia. Treated by Dr. and then rushed to Hospital on 10/19/2022.