chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Hypervolaemia, Intensive care, Life support
Clinical narrative: pt brought to hospital with c/o facial swelling; fluid overloaded; positive test result for COVID, although pt is asymptomatic at admission; over time, pt had worsening SOB and increased O2 needs; BiPAP/HFNC; pt became delirious and experienced A Fib with RVR; O2 needs worsened; transferred to ICU and intubated; placed on vasopressors; went into cardiac arrest, after a few rounds of ACLS, family requested stopping; pt died in the hospital
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy, SARS-CoV-2 test positive, Swelling face
Clinical narrative: pt brought to hospital with c/o facial swelling; fluid overloaded; positive test result for COVID, although pt is asymptomatic at admission; over time, pt had worsening SOB and increased O2 needs; BiPAP/HFNC; pt became delirious and experienced A Fib with RVR; O2 needs worsened; transferred to ICU and intubated; placed on vasopressors; went into cardiac arrest, after a few rounds of ACLS, family requested stopping; pt died in the hospital
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient had tested positive on 12/28/2021 for Covid, also had a UTI.  States yes there are symptoms but not specifically identified in the charting. Patient has multiple underlying health conditions:  Chronic lung disease, cardiovascular disease, hypertension an cancer.  Hospitalized for 3 days  01/08-01/10-2022
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Patient had tested positive on 12/28/2021 for Covid, also had a UTI.  States yes there are symptoms but not specifically identified in the charting. Patient has multiple underlying health conditions:  Chronic lung disease, cardiovascular disease, hypertension an cancer.  Hospitalized for 3 days  01/08-01/10-2022
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Vaccinated pt admitted with covid infection
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: He was accidentally given the adult dose of COVID vaccine at Pharmacy on 2/17/2022. This was his second dose for the COVID vaccine. He had some vomiting and a fever after receiving the COVID vaccine, which resolved. He then developed swelling in abdomen and periorbital edema on 2/19-2/20, was seen on 2/24 for these symptoms and found to have proteinuria, eventually diagnosed with nephrotic syndrome on 2/26 and started on prednisone
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Incorrect dose administered, Nephrotic syndrome, Periorbital oedema, Pyrexia
Clinical narrative: He was accidentally given the adult dose of COVID vaccine at Pharmacy on 2/17/2022. This was his second dose for the COVID vaccine. He had some vomiting and a fever after receiving the COVID vaccine, which resolved. He then developed swelling in abdomen and periorbital edema on 2/19-2/20, was seen on 2/24 for these symptoms and found to have proteinuria, eventually diagnosed with nephrotic syndrome on 2/26 and started on prednisone
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: He was accidentally given the adult dose of COVID vaccine at Pharmacy on 2/17/2022. This was his second dose for the COVID vaccine. He had some vomiting and a fever after receiving the COVID vaccine, which resolved. He then developed swelling in abdomen and periorbital edema on 2/19-2/20, was seen on 2/24 for these symptoms and found to have proteinuria, eventually diagnosed with nephrotic syndrome on 2/26 and started on prednisone
Age: 35.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Anxiety, Chest discomfort, Distractibility, Dizziness, Dyspnoea
Clinical narrative: approximately 3min after injection complained of sensation of lip swelling -numbness to the lips -feeling short of breath -some difficulty swallowing -bilateral hand tingling and cramping
Age: 35.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Flushing, Grimacing, Hypersensitivity, Hypoaesthesia, Hypotonia
Clinical narrative: approximately 3min after injection complained of sensation of lip swelling -numbness to the lips -feeling short of breath -some difficulty swallowing -bilateral hand tingling and cramping
Age: 35.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Mouth breathing, Paraesthesia, Paraesthesia oral, Posture abnormal, Respiratory distress
Clinical narrative: approximately 3min after injection complained of sensation of lip swelling -numbness to the lips -feeling short of breath -some difficulty swallowing -bilateral hand tingling and cramping
Age: 35.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Tachypnoea, Use of accessory respiratory muscles
Clinical narrative: approximately 3min after injection complained of sensation of lip swelling -numbness to the lips -feeling short of breath -some difficulty swallowing -bilateral hand tingling and cramping
Age: 35.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Dysphagia, Dyspnoea, Hypoaesthesia oral, Lip swelling, Muscle spasms
Clinical narrative: approximately 3min after injection complained of sensation of lip swelling -numbness to the lips -feeling short of breath -some difficulty swallowing -bilateral hand tingling and cramping
Age: 35.0
Sex: M
Vaccine: COVID19, FLU4, COVID19
Symptoms: Paraesthesia
Clinical narrative: approximately 3min after injection complained of sensation of lip swelling -numbness to the lips -feeling short of breath -some difficulty swallowing -bilateral hand tingling and cramping
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; Caller reports that a four year old patient received the second dose of PROQUAD less than 4 weeks after receiving the first dose of proquad; This spontaneous report was received from nurse referring to 4-year-old patient of unknown gender. There was no information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies.  On 25-JAN-2022, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(recombinant human albumin)) (PROQUAD), 0.5 ml (lot number # was reported as U022722 and expiration date was reported as 16-JAN-2023, route, anatomical location were not reported) and on 18-FEB-2022, the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(recombinant human albumin)) (PROQUAD), 0.5 ml less than four weeks after receiving the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Inappropriate schedule of product administration)(lot number # was reported as U024510 and expiration date was reported as 02-FEB-2023, route, anatomical location were not reported) for prophylaxis.         No additional adverse event was reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP repors no further AE's; Administration of an expired dose of MMR Il; This spontaneous report was received from physician assistant referring to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies.  On 01-MAR-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), 0.5 milliliter one time (Expired product administered) (lot # T007230 was a valid lot number, expiration date was reported and established as 27-FEB-2022; vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis which was reconstituted with sterile diluent, 0.5 milliliter one time(lot# number and expiration date was not reported). There was no temperature excursions reported with this lot# of vaccine.  There was no further adverse event. No PQC. No additional information was reported.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Muscle spasms, Pollakiuria, Thirst, Type 1 diabetes mellitus
Clinical narrative: Approximate 5~6 weeks from my first Pfizer Covid-19 vaccination and 2~3 weeks from my 2nd dose I started having symptoms of excessive thirst and frequent urination. I did not think anything of it at the time and continued on as normal. I did think at the time that maybe it was just some side effect associated with the vaccination; however, these effects did not go away over time. I continued having these side effects for months. During this time, I also started to get cramps in my legs when I slept and lost around 20 pounds. A friend who is an RN suggested I go to the doctor to get checked out because the side effects were worrying. I scheduled an appointment for early February, but it had to be rescheduled to early March due to work. In March I finally proceeded to explain my symptoms to a doctor at Medical Center  and I was told that blood work would be needed to be done as I was showing symptoms of diabetes. These results came back positive for Type 1 diabetes. Before the vaccination I showed no symptoms of diabetes. Before the vaccination, I was a healthy 26 year old male. I exercised more than average and had a healthy diet. There is no history of diabetes in my family. I am reporting this due to the fact that the only abnormal major event leading up to the symptoms was receiving my two doses of the Pfizer Covid-19 vaccine.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Approximate 5~6 weeks from my first Pfizer Covid-19 vaccination and 2~3 weeks from my 2nd dose I started having symptoms of excessive thirst and frequent urination. I did not think anything of it at the time and continued on as normal. I did think at the time that maybe it was just some side effect associated with the vaccination; however, these effects did not go away over time. I continued having these side effects for months. During this time, I also started to get cramps in my legs when I slept and lost around 20 pounds. A friend who is an RN suggested I go to the doctor to get checked out because the side effects were worrying. I scheduled an appointment for early February, but it had to be rescheduled to early March due to work. In March I finally proceeded to explain my symptoms to a doctor at Medical Center  and I was told that blood work would be needed to be done as I was showing symptoms of diabetes. These results came back positive for Type 1 diabetes. Before the vaccination I showed no symptoms of diabetes. Before the vaccination, I was a healthy 26 year old male. I exercised more than average and had a healthy diet. There is no history of diabetes in my family. I am reporting this due to the fact that the only abnormal major event leading up to the symptoms was receiving my two doses of the Pfizer Covid-19 vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Full blood count, Headache, Metabolic function test
Clinical narrative: Developed headache that has been getting progressively worse within 2 days of the vaccination administration
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Pain
Clinical narrative: Left Shoulder Pain 2 hours after Tdap vaccine. Noticeable with overhead motion, sleeping on arm and when moving arm to take on and off clothing. Moderate weakness. No shoulder pain at a resting position or with minimal to moderate palpation. No arm pain at site of injection. No numbness.  Treatment includes medication, hot/cold compresses and exercises. No change in shoulder pain since 3 March 2022.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: broke out with shingles; it won't work again; This spontaneous report was received from a patient of unknown age and gender, referring to themselves via Glaxosmithkline. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 18-SEP-2015, the patient was vaccinated with zoster vaccine live (manufacture unknown) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. On an unknown date in 2016, the patient was vaccinated with varicella zoster vaccine rge (SHINGRIX) (dose, strength, route, indication, lot# and expiration date were not provided).   On an unknown date in 2020, the patient broke out with shingles. They were surprised because they did not think they would have to worry about it. It was very painful just like the commercials say. So should they get another vaccine? They could not afford to pay for it again if there's a chance it won't work again (vaccination failure). The outcome of shingles and vaccination failure was unknown.   The reporter considered vaccination failure to be related to suspect vaccines. The causality assessment between the event of shingles and suspect vaccines was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Post herpetic neuralgia
Clinical narrative: hearing loss; postherpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided), for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia and hearing loss. As a result of these symptoms, she was seen and treated by medical providers and was still under their care. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), her symptoms resulted in physical limitations not present prior to using it. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant. The events of multiple outbreaks of herpes zoster, postherpetic neuralgia and hearing loss were considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Dysphagia, Myasthenia gravis
Clinical narrative: Diagnosed with myasthenia gravis; Difficulty swallowing; This case was reported by a pharmacist via call center representative and described the occurrence of myasthenia gravis in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number C3455, expiry date 3rd February 2023) for prophylaxis.   The patient's past medical history included swallowing difficult (had a history of difficulty swallowing food prior to vaccination with Shingrix).   On 20th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced myasthenia gravis (serious criteria GSK medically significant) and swallowing difficult. On an unknown date, the outcome of the myasthenia gravis and swallowing difficult were unknown.   It was unknown if the reporter considered the myasthenia gravis and swallowing difficult to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient was evaluated on 26th January 2022 for onset of difficulty swallowing and was diagnosed with myasthenia gravis. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2018, never came for second; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received back in 2018, (batch number 4FS5N and expiry date 8th March 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The registered nurse inquired how to proceed with second dose of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received BOOSTRIX, subject to temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24th February 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported.  The reporter did not had patient identifiers of the patient. The health care professional reported that a patient received Boostrix that was subject to temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. The case was linked with case US2022AMR040207 and US2022AMR040208, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR040207:Same reporter US-GLAXOSMITHKLINE-US2022AMR040208:Same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: Hub around the needle leaked and didn't receive full dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number H2PE2, expiry date 19th May 2023) for prophylaxis.   On 2nd March 2022, the patient received Shingrix. On 2nd March 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were reported as follows: The pharmacist reported that the Shingrix dose administered to the patient where the hub around the needle on the syringe leaked and the patient did not receive full dose of Shiingrix, which led to accidental underdose. The reporter consented to follow-up.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: boostrix underwent above temp excur and was administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number n254c, expiry date 23rd November 2023) for prophylaxis.   On 2nd March 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The reporter reported that the Boostrix underwent above temperature excursion with high: 67 F time: 14 days and was administered to the patient, which let to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This was 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040253:Same reporter US-GLAXOSMITHKLINE-US2022040254:Same reporter US-GLAXOSMITHKLINE-US2022040251:Same reporter US-GLAXOSMITHKLINE-US2022040252:Same reporter US-GLAXOSMITHKLINE-US2022040248:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: >35 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days from first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days from first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days from first dose) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2022: Follow-up received contains no new information
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Loss of personal independence in daily activities, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Arm was killing me; It hurts/ Sore; Couldn't even play golf; Discomfort; Been up all morning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was killing me), PAIN (It hurts/ Sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't even play golf), DISCOMFORT (Discomfort) and SLEEP DISORDER (Been up all morning) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.  The patient's past medical history included COVID-19 in September 2021. On 02-Mar-2022 at 10:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Mar-2022, the patient experienced PAIN IN EXTREMITY (Arm was killing me). 03-Mar-2022, the patient experienced PAIN (It hurts/ Sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't even play golf), DISCOMFORT (Discomfort) and SLEEP DISORDER (Been up all morning). At the time of the report, PAIN IN EXTREMITY (Arm was killing me), PAIN (It hurts/ Sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't even play golf), DISCOMFORT (Discomfort) and SLEEP DISORDER (Been up all morning) had not resolved.    The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No Concomitant medication reported. The patient stated that  as a treatment put a hot towel on his arm and his shoulder. Patient had no swelling, no redness. Patient went through some yuck and that kind of stuff, what people go through, Almost passed after about 9-11 days then paitent felt better. There was  some discomfort; it was not severe pain. No Treatment medication reported.   This case was linked to MOD-2022-501358 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials; Frozen vials, removed and transported at refrigerated temperature, re-frozen at time of arrival; Accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at time of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided Total duration of the excursion refrigerated temperature for maximum of 4 hour. On 01Dec2021 Vial was moved to fridge. The facility thought that the vials are received frozen from  Moderna so they had unpacked them and put them back into the facility freezer. They just recently found out that the vials are received in refrigerated temperatures and not frozen. They have been accidentally administering refrozen vials to their patients. Vaccine administered post 30 days from the initial storage at 2 degree C to 8 degree C Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. Not Provided      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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrived at facility. On 06-Oct-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Vials were moved to fridge on 06-Oct-2021.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 06-Oct-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; Patients were administered refrozen vials; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered refrozen vials), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered refrozen vials). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered refrozen vials), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient MRN ID was 07858380.  Concomitant medication list was not provided.  The vials were frozen, shipped in refrigerated temperature and then refrozen for storage once arrive at facility. Further it was reported that vial was moved to fridge on 06-Oct-2021. Both 5.5 ml and 7.5 ml vials were received in partially thawed/liquid condition. Maximum or minimum temperature reached was 8 degree Celsius. Total duration of excursion was 4hrs.  Treatment information was not provided.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Diarrhoea, Erythema, Peripheral swelling, Screaming
Clinical narrative: Entire Leg swelled from hip to knee about 5 hours after the injection.  It  turned bright red, she screamed Inconsolably for an hour.   She had Diarrhea then for a week following the injection.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Injection site bruising, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dryness, skin peeling at sight of injection-Mild, Additional Details: Patient experienced a large bruise, dry skin peeling, and soreness at the site of injection. It has mostly resolved by the date of her second dose.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Skin exfoliation
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dryness, skin peeling at sight of injection-Mild, Additional Details: Patient experienced a large bruise, dry skin peeling, and soreness at the site of injection. It has mostly resolved by the date of her second dose.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Interchange of vaccine products, Nausea, Tinnitus, Vomiting
Clinical narrative: Systemic: Tinnitus-Severe, Additional Details: Pt received Pfzier Booster shot on 11/20/21, and she has experienced tinnitus on her right ear (her left ear was deaf after receiving J&J vaccine on 5/18/2021). She also has dizziness and nausea and vomiting from the vaccination. She said that she experienced tinnitus on her right ear in which she never experienced before. She has not recovered from the tinnitus since
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Immediate post-injection reaction, Pain in extremity, Pyrexia
Clinical narrative: Severe cough after a few days of receiving the booster that has not yet gone away, soreness of the arm that received injection for 2 days after, fever immediately after receiving vaccine and lasted 2 days as well.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after vaccination. Patient was diagnosed with Covid Tylenol Inpatient
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after vaccination. Patient was diagnosed with Covid Tylenol Inpatient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: Pt presented to ED 4/10/21 with a possible allergic reaction to her Covid vaccine. She received it today about 30 minutes afterwards while she was driving home for like her throat was closing. Last for short period of time and seems to resolve. EMS reports stable vital signs in route. She is feels extremely uncomfortable when it occurs. She feels short of breath with it. She will like there is a tightness in her throat and into her chest. She is never had a problem with any vaccines before. Discharged from ED with prescription for prednisone 40 mg daily x 5 days and famotidine 20 mg BID x 7 days.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, Chest X-ray, Chest pain, Electrocardiogram, Fatigue
Clinical narrative: Increased Heart rate, Substernal chest pain, fatugue
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Sinus tachycardia
Clinical narrative: Increased Heart rate, Substernal chest pain, fatugue
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary Embolism
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed with Covid Tylenol Inpatient
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood creatine increased, Bradycardia, COVID-19, COVID-19 pneumonia
Clinical narrative: hpi: arthritis, atrial fibrillation, hypertension, mrsa, sob, bph, ckd stage iii, colon cancer stage 3, contusion of left hand, depression, diabetes, facial contusion, facial laceration, fall, gerd, gout, head injuru without loc, hyperlipidemia, hypothyroidism, migraine, musculoskeletal neck pain, prostate enlargement, skin cancer, sleep apnea.  cause of death listed as respiratory failure due to COVID-19  HOSP COURSE: COVID-19 pneumonia symptoms started on 11/15 with presentation to the hospiatl on 11/19. Acure hypoxemia respiratory failure. acute metabolic encephalopathy secondary to multiple comorbidities; worsening acute on chronic kidney disease stage iii with creatinine going up to 2.57, bradycardia on precedex drip. leukopenia at presentation. outpt with leukemoide type  superimposed bacterial pneumonia with elevated procalitonin
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease, Condition aggravated, Death, Leukopenia, Metabolic encephalopathy
Clinical narrative: hpi: arthritis, atrial fibrillation, hypertension, mrsa, sob, bph, ckd stage iii, colon cancer stage 3, contusion of left hand, depression, diabetes, facial contusion, facial laceration, fall, gerd, gout, head injuru without loc, hyperlipidemia, hypothyroidism, migraine, musculoskeletal neck pain, prostate enlargement, skin cancer, sleep apnea.  cause of death listed as respiratory failure due to COVID-19  HOSP COURSE: COVID-19 pneumonia symptoms started on 11/15 with presentation to the hospiatl on 11/19. Acure hypoxemia respiratory failure. acute metabolic encephalopathy secondary to multiple comorbidities; worsening acute on chronic kidney disease stage iii with creatinine going up to 2.57, bradycardia on precedex drip. leukopenia at presentation. outpt with leukemoide type  superimposed bacterial pneumonia with elevated procalitonin