chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021 at 10:08 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 31-Mar-2021, 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.   Age of patient was reported as 69.00 for dose administered on 31-Mar-2021 and 69.58 for dose administered on 27-Oct-2021.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 32 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and beyond use date for the vial was reported as 29-Oct-2021. Product moved to clinic on 27-Oct-2021.   Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
A few hours after receiving vaccine started to itch on face, scalp, arms, hands, legs, feet. Itching continued x 3 days. Took 25 mg Benadryl every 6-8 hours x 3 days. Itching gone after 3 days.
Periorbital swelling and itching of both eyes. Primary care physician thought it looked like an allergic response to something. I have no history of food, drug or environmental allergies. I have never experienced seasonal allergies. I had no nasal symptoms.  swelling was worse in the mornings. I took Benadryl 25mg at bedtime and Zyrtec 10 mg in the morning. Swelling improved over a 4 day period. Vision was not affected at all.
This spontaneous case from the United states, initially received on 05-Oct-2018, reported by other healthcare professional (nurse), concerns a female patient of unspecified age. The patient's current condition included unspecified immune disease (since an unspecified date). On 03-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 03144611A, expiry date: 30-Jun-2019] for active immunization against influenza. On 04-Oct-2018, 1 day after vaccination, the patient developed a red circle of 5 cm. On 05-Oct-2018, 2 days after vaccination, the patient visited emergency room due to the swollen arm and was hospitalized. The patient's discharge details were not available. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as serious (medically significant and hospitalization). Non-significant follow-up information received on 04-Jan-2019: Med Info Number (SEQ18-07143) was added in the additional information tab. No changes were done in the narrative. Follow up received from other health professional on 28-Jan-2019: The reporter's address and county was added in the general tab. It was reported that the patient was hospitalized on 05-Oct-2018. Hence, added hospitalization as a serious criteria with hospitalization details for both the events swollen arm and redness. The outcome of both the events was changed from not recovered to unknown in the event tab. The narrative was amended accordingly.; Reporter's Comments: A female patient of unspecified age experienced erythema one day after vaccination and arm swelling two days after vaccination with AFLURIA QIV. Considering the plausible temporal relationship between vaccination to event onset and absence of alternate aetiologies, the company assessed the causality for all the events as possibly related to suspect vaccine.
3-4 hives along hairline; 5cm area of pruritus at injection site; 5cm area of erythema at injection site; pain at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (3-4 hives along hairline), VACCINATION SITE PRURITUS (5cm area of pruritus at injection site), VACCINATION SITE ERYTHEMA (5cm area of erythema at injection site) and VACCINATION SITE PAIN (pain at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's thyroiditis. Concurrent medical conditions included Psoriatic arthritis. Concomitant products included STEROID DOSE PAK for Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 experienced URTICARIA (3-4 hives along hairline), VACCINATION SITE PRURITUS (5cm area of pruritus at injection site), VACCINATION SITE ERYTHEMA (5cm area of erythema at injection site) and VACCINATION SITE PAIN (pain at the injection site). On 18-Jan-2021, VACCINATION SITE PRURITUS (5cm area of pruritus at injection site) was resolving. At the time of the report, URTICARIA (3-4 hives along hairline) had resolved, VACCINATION SITE ERYTHEMA (5cm area of erythema at injection site) was resolving and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jan-2021: Additional info received on 13-Apr-2021.Second dose and causality of event hives was updated.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 15-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 24-FEB-2017) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 336, 24, 1172, 80, 168 and 416 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest temperatures were 49 (9.444444444 Celsius degrees), 47 (8.333333333 Celsius degrees), 59 (15 Celsius degrees) and 48 (8.888888889 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
21jan91 pt vax w/ MMR + H. flu vax; 01Feb91 devel erythematous rash over trunk + arms. 02Feb91 devel fever + rash worsened which caused swelling of face. Tx w/ Benadryl + APAP.  04Feb91 fever 103F. Pt hosp + 05Feb rash turned purple.
sugar blood level very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1, manufacturer-unknown), for Covid-19 immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "sugar blood level very high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information-Was the product used by the patient-Yes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My 6 month old son appeared to be struggling to breathe, his face turned red and pale, and his lips turned blue/purple.  This lasted for about 15 seconds and then he became really sleepy and fell asleep, this occurred a total of 7 times that day, we took him to the ER and were air lifted to a different hospital.
Get the chills; Coughing; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. An unspecified age of female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, Patient got Covid vaccine yesterday and was told to watch for side effects. She stated about an hour ago that she started to get the chills and was coughing on 03Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
On friday 1/1 around 10 pm I developed some chills. Saturday morning 1/2 I woke up feeling like I was hit by a bus, I had body aches,  muscle aches, fatigue, chills, fever, headache and sore throat. Throughout the day I took 1000mg of tylenol every 8 hours, 2000mcg of vitamin C and Zinc two times per day. My fever got as high as 102.1. Sunday I woke up feeling slightly better, but not much. Fever of 100 throughout the day with same course of treatment. Monday 1/4 I was feeling better, I did not have a fever but still had some fatigue, headache and a sore throat. Tuesday I was feeling improved just had fatigue and no appetite. By wednesday 1/6 I was feeling back to normal.
Family says diffuse arthralgias and myalgias started the day of the vaccine and have continued for the last 3 weeks.
constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (constipation) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Anxiety. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D NOS for an unknown indication.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Feb-2021, the patient experienced CONSTIPATION (constipation). At the time of the report, CONSTIPATION (constipation) had not resolved.            Patient take Thyroid Medication, Antihyperlipidemic Medication, Anti-Anxiety Medication Baby Aspirin and  Vitamin-D as a Concomitant medication.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
--- Wed Mar 17, 2021 @ 19:37 Caller's brother got the vaccination this morning and a little while ago they heard him fall.  When they got to him he his  blood sugar was 174 and his bp 84/60, HR 116.  Now he is starting to get hives.  No treatment at this point    --- Thu Mar 18, 2021 @ 16:04  Follow up: Patient is doing fine and is home now Took him to the ED at hospital yesterday His BP was normal at the hospital so was his HR by the time they got there It was not hives at all- they said it was Shingles- they gave him something for that but he does not remember the name of the medication Was in the ED 6-8 hours, not overnight They did an EKG also  They said it had to be reaction to the covid shot what he experienced They gave him a tetanus shot And sent him home
Crossed eyes, arching back, hand and chin jerking, absent seizures, staring, violent shaking.
This spontaneous report as received from a medical assistant refers to a patient of unknown gender, approximately 23 year old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-DEC-2015, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot # and expiration date were not reported). The patient received second and third dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot # and expiration date were not reported) on 06-SEP-2016 and 20-NOV-2016, respectively. The doses were administered in altered schedule. Additional information has been requested.
I began at 10:45 pm March 9th with fatigue, muscle aches,  nausea and so sleepy.  Chills .  Temp was 98. 2   Ibuprofen helped my pain and I slept all night.  Had more tiredness and achy legs and back through the day but rested.  Used my inhaler .  My arm is not sore or Ted.  H
No adverse event; Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021).    No concomitant medications were reported.  No treatment medication was reported.   This case was linked to MOD-2022-637980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Live follow up received contains no new information
6 days after completing the Paxlovid meds I tested positive for COVID again; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "unknown", described as "6 days after completing the Paxlovid meds I tested positive for COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative; (27Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence..  Clinical information: The patient was reporting about COVID treatment. The patient did not receive other medication within 2 weeks. Patient administered Paxlovid started on 16Aug2022 and stopped on 20Aug2022 for Covid-19 treatment. Patient reported that he took Paxlovid and it helped right away and was tested negative, according to a home test kit, 7 days after starting the meds. But now, 6 days after completing the Paxlovid meds, patient was tested positive for COVID again on 27Aug. it was unknown that patient was recovered. No treatment was reported for AE and there were no known allergies.
Patient came in for 1st COVID vaccine. She did say that she did have anaphylactic reaction in he past but had spoken to her provider before coming in today and he instructed patient to take 75mg of Benadryl prior to coming in. The vaccine was given and about 15 minutes after receiving vaccine patient started to feel itchy in he throat then all over her face. I did get the provider and had him come to assess the patient. Patient was given another 25 mg of Benadryl and observed. After another 15-20 minutes patient was feeling better. We did keep her a little longer before letting her go. She did have a driver and stated that she was feeling a lot better at that time. Patient left. I did follow up with her later in the day and she stated that she was feeling much better. Our provider did instruct her to make sure she makes contact with her provider and let him know what happened and they could advise her if she was to get the 2nd vaccine or not.
Bell's palsy; Lymphadenopathy; This case was received via FDA VAERS (Reference number: 1369999) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and LYMPHADENOPATHY (Lymphadenopathy). At the time of the report, BELL'S PALSY (Bell's palsy) and LYMPHADENOPATHY (Lymphadenopathy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The patient reported Bell's palsy was on right side of face and he was taking an oral steroid. Patient reported swollen lymph node was in left armpit and nothing had changed and he was not treating it. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
COVID Infection breakthrough in fully vaccinated individual. Patient was vaccinated on 1/30/2021 and 2/20/2021. He developed symptoms of COVID on 4/6/2021 (including  fever, stomach ache, chills, nausea, cough, shortness of breath, lightheaded and chest tightness). He presented to the emergency department on 4/7/2021 and has been admitted since then on a medical surgical unit. His maximum oxygenation needs have been 3L.
Severe pain in knee joints, feet and ankles. Chronic fatigue; tingling in face and numb below the waist down and then collapsed and was hospitalized. Severe dehydration and most recently vision is becoming worse and cloudy. Short term confusion; "absence seizure".
Large blisters (50 cent size), arm warm and swollen from shoulder to elbow.
This spontaneous report was received from a medical assistant, concerning a 26 year-old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 10-MAY-2017, the patient was vaccinated with an expired dose of improperly stored PROQUAD injection (dose, frequency and route were not reported) lot # L045678 with expiration date of 09-MAY-2017. The PROQUAD dose was reconstituted with sterile diluent (lot # and expiration date were not reported). The temperature excursion of the PROQUAD was between 6 °F and 14 °F (6.22 F) for a time frame of 5 minutes. No previous temperature excursion was reported. On an unspecified date in May 2017, the patient received a PROQUAD dose in addition to the one received on 10-MAY-2017. No adverse effects were reported. Data logger was involved. Additional information has been requested.
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 about 01-FEB-2015, the patient was inoculated with ZOSTAVAX at a medical office 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. In or about May 2016, the patient was treated at a hospital and was diagnosed with herpes zoster, or shingles.  As a direct and proximate result of the 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.