chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac arrest, Death
Clinical narrative: Got all vaccinations, gone within a year...cardiac arrest; This case was reported by a consumer via interactive digital media and described the occurrence of cardiac arrest in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced cardiac arrest (serious criteria death and GSK medically significant). On an unknown date, the outcome of the cardiac arrest was fatal. The reported cause of death was cardiac arrest.   It was unknown if the reporter considered the cardiac arrest to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-NOV-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient was the reporter's husband. The reporter said she was not an anti-vaxxer. The reporter mentioned as she received all her vaccinations.  Her husband, who had no heart issues received his as well.  Within a year he was gone due to cardiac arrest.  The reporter was just concerned, not radical. Additional supportive information:  This is one of 2 link cases reported by same reporter. Follow up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR163337:Same reporter. Reporter's case.; Reported Cause(s) of Death: Cardiac arrest
Sex: U
Vaccine: VARZOS
Symptoms: Blood test normal, Fatigue, Headache, Pyrexia
Clinical narrative: Running a fever, temp is back; Extreme fatigue; Headaches, went to urgent care; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th October 2022, the patient received the 1st dose of Shingles vaccine. On 28th October 2022, less than a day after receiving Shingles vaccine, the patient experienced fever, fatigue and headache. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The reporter was told typically, people have a reaction to the second one. The patient received dose of Shingles vaccine on a Friday morning and by the afternoon was running a fever, extreme fatigue and headaches.  This lasted ten days before he/she went to urgent care where she ran blood work, all normal. The patient was put on a steroid. Later that day his/her fever broke and he/she was feeling better.  The patient took his/her last steroid two days ago and the temperature was back. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR157870, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR157870:Same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Myalgia
Clinical narrative: muscle pain/ muscle aches/muscle pain in her leg; weakness; Muscle pain in lower back; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 28th October 2022, the patient received the 1st dose of Shingrix. On 21st October 2022, the patient received Flu vaccine. On 29th October 2022, 1 days after receiving Shingrix and 8 days after receiving Flu vaccine, the patient experienced muscle pain, weakness and muscular back pain. On an unknown date, the outcome of the muscle pain, weakness and muscular back pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, weakness and muscular back pain to be related to Shingrix and Flu vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comments: The patient reported receiving first Shingrix dose and the next day, she started to experienced weakness as well as muscle aches and muscle pain in her leg and lower back. The patient said the weakness and muscle aches and pain were still present.  The patient said she received the flu vaccine on 21st October 2022.  No other information reported to the agent by the patient.  The reporter did not consent to follow-up.  The reporter declined consent for HCP follow-up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Malaise, Migraine, Pain in extremity
Clinical narrative: SORE ARM; MIGRAINE; FELT A BIT CRAPPY; WARM FOR LIKE 15 MINUTES; This spontaneous report received from a patient via other company concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications were reported as patient was taking antidepressant and sleeping pills. On an unspecified date, the patient experienced sore arm (Dose number in series 1). The patient received dose 2 with Non-company suspect Moderna covid-19 vaccine (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported, for covid-19 prophylaxis. On an unspecified date, the patient experienced again sore arm (Dose number in series 2). The patient received dose 3 with Non-company suspect Moderna covid-19 vaccine (elasomeran), (Dose number in series 3), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on morning of 27-OCT-2022 for covid-19 prophylaxis.  On 28-OCT-2022, the patient experienced warm for like 15 minutes, and felt a little bit crappy (Dose number in series 3) and was perfect during the same weekend. On 31-OCT-2022, the patient experienced migraine for 12 hours (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and elasomeran was not applicable. The patient recovered from warm for like 15 minutes on 28-OCT-2022, migraine on 31-OCT-2022, and felt a bit crappy on OCT-2022, and the outcome of sore arm was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Encephalitis, Tachycardia
Clinical narrative: ENCEPHALITIS; BLOOD PRESSURE SKYROCKETED; ANXIETY; TACHYCARDIA; This spontaneous report received from a consumer concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total on SEP-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On an unspecified date in 2021, the patient started experiencing weird symptoms shortly after vaccination. There was no exact timeline available as to when the symptoms have started but consumer reported within the first month. Patient was having anxiety, tachycardia, extreme fatigue, paresthesia, tingling, and patient was continuing to have health issues. Patient had encephalitis at one point and was hallucinating. Patient's blood pressure had skyrocketed. Patient was still experiencing these symptoms. Patient went to an urgent care, but not aware if she was admitted or not. Laboratory data (dates unspecified) included: Blood pressure High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, tachycardia, encephalitis, and blood pressure skyrocketed. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221111557- Encephalitis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022 at 12:46 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-Sep-2022 at 12:46 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant products were reported.  Anatomical location for vaccine administration was reported as deltoid. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. No adverse reactions reported for the patient.  No treatment products were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022 at 6:54 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Sep-2022 at 6:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    Concomitant product use was not provided by the reporter.  Dose 4 anatomical site was also reported as deltoid.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation.  No adverse reactions were reported for patient at the time of the report.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022 at 4:40 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 4:40 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    Concomitant medication was not provided.  The patient received previous 3 dose of Moderna vaccine intramuscular in deltoid.  Anatomical location of bivalent vaccine was reported as deltoid.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions identified and vaccine was housed in the units. There were excursions noted. Manufactures were notified and the Regulatory Authority and made aware of the situation. No adverse reactions reported for any patient at the time of report. Date vials moved from freezer to refrigerator was 07-Sep-2022 both monovalent vaccines  Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccines had undergone several temperature excursions and administered to patient; No Adverse Event; Vaccines had undergone several temperature excursions and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No Adverse Event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown whether patient had ever been diagnosed with or tested positive for COVID-19.     On 22-Sep-2022 at 11:26 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022 at 11:26 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient).    No concomitant medications were provided by the reporter.  The patient received 3 primary doses of Moderna vaccine intramuscular in deltoid.  Vaccine 4th dose reported as 0.5 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The Moderna and Bivalent vaccines have undergone several temperature excursions and might got administered to patients.  No adverse reactions reported to any patient.  No treatment medications were provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursion that had occurred in a refrigerator; No Adverse Event; temperature excursions have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator) and NO ADVERSE EVENT (No Adverse Event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 23-Sep-2022 at 10:42 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 10:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator).    Concomitant medication was not reported.  It was unknown if the patient had ever tested or been diagnosed with COVID-19.  The patient received 3 primary doses of Moderna vaccine intramuscular in deltoid.  Vaccine 4th dose reported as 0.5 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; temperature excursions have been administered to patient; temperature excursion that had occurred in a refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator), POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 12:30 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator). On 23-Sep-2022 at 12:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator), POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient).    Concomitant medication was not reported. It was unknown if the patient had ever tested or been diagnosed with COVID-19. The patient received previous 3 dose of vaccine intramuscular in deltoid. Vaccine 4th dose reported as 0.5 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.  Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Conjunctivitis, Lethargy, Pyrexia, Rash
Clinical narrative: Lethargic day 9, fever day 10-12, conjunctivitis day 12-present (13), rash day 12-present (13)
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Confusional state, Dyspnoea, Fatigue
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site lasting at least 12 hours (do not recall any adverse symptoms for doses 1-4)
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Immediate post-injection reaction, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Patient fainted immediately after vaccine and had a convulsion when coming to-Medium
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: gave patient benadryl 25mg capsule and water. after 5 minutes, patient left
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Patient complains about not being able to lift his arm.-Mild, Additional Details: Patient came to the pharmacy complaining about not being able to lift his arm days after getting the flu shot. He specifically said vaccine was given on his deltoid at the correct site, injection site was clean. Patient did not have any visible bruising, inflammation, redness or allergic reaction. When I administered the vaccine I avoided any tattoes and injected the flu shot at a 90 degree angle, around the center and thickest portion of the deltoid muscle, around 3 fingers below the acromion.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Dysstasia, Gait disturbance, Muscle tightness, Pain
Clinical narrative: Approximately 3-4 hours after receiving vaccine, lower back pain began, increasing very rapidly.  I did nothing physical that could have remotely caused this. The pain was in the lower vertebrae and also to the right-it felt like a vise was clamped around my spine and right buttock muscle.  Pain was very bad when attempting to stand up, or walk.  More a severe ache when sitting. 10 on a pain scale of 1-10.  Next morning pain reduced maybe10%; second morning pain reduced maybe 30%.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Sitting disability, Spinal disorder, Spinal pain
Clinical narrative: Approximately 3-4 hours after receiving vaccine, lower back pain began, increasing very rapidly.  I did nothing physical that could have remotely caused this. The pain was in the lower vertebrae and also to the right-it felt like a vise was clamped around my spine and right buttock muscle.  Pain was very bad when attempting to stand up, or walk.  More a severe ache when sitting. 10 on a pain scale of 1-10.  Next morning pain reduced maybe10%; second morning pain reduced maybe 30%.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atelectasis, Bundle branch block right, COVID-19, Chest X-ray abnormal
Clinical narrative: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 11/3/2022 Discharge Date: 11/7/2022 COVID positive Date 11/3/2022 PRESENTING PROBLEM: Generalized weakness [R53.1] History of falling [Z91.81] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 90 y.o. male who presented to the emergency department with weakness.  Patient has a past medical history of asthma, coronary artery disease, hypertension, hyperlipidemia, and GERD. Patient states that over the past 2-3 days, he has developed symptoms of weakness, cough with sputum production, dizziness, sore throat, and diarrhea.  He denies fever, nausea and vomiting, or shortness of breath.  He also states that he has sustained 2 falls due to his weakness.  Patient states that at baseline, he uses a walker for ambulation, however, he has been unable to fully support his weight and fell while ambulating to the bathroom.  He presented to the emergency department for evaluation.  In the emergency department, patient's vital signs were stable.  Complete blood count was unremarkable.  BMP was unremarkable.  Troponin was indeterminate at 59 with a repeat of 53. RSV and influenza were negative.  COVID-19 was positive.  EKG shows presence of right bundle branch block.  CT of the head showed no acute intracranial abnormality.  Chest x-ray shows small pleural effusions with adjacent atelectasis that could have superimposed pneumonia.  Suspect generalized weakness secondary to COVID-19.  Patient has been admitted for further evaluation and management of generalized weakness secondary to COVID-19.  Patient was admitted and remained stable throughout his stay.  He was initially quite deconditioned and weak but Physical therapy Occupational therapy worked with him and were able to stabilize him adequately for discharge home with home health PT OT and nursing.  His markers remained relatively stable and he never developed any respiratory symptoms associated with the COVID.  He was seen on the day of discharge doing well and discharged home to follow-up with his primary care provider.  He was to resume his regular medications as previously ordered.  There were no additions to his regimen.  He could return to diet and activity as tolerated.  He was recommended to complete 10 days of respiratory isolation from the day of his 1st symptoms.  He was to follow up with his primary care provider in the next 7-10 days to ensure complete resolution of his symptoms.  He understood all these instructions and was discharged home with his family in stable condition.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Diarrhoea, Dizziness, Electrocardiogram abnormal, Fall
Clinical narrative: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 11/3/2022 Discharge Date: 11/7/2022 COVID positive Date 11/3/2022 PRESENTING PROBLEM: Generalized weakness [R53.1] History of falling [Z91.81] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 90 y.o. male who presented to the emergency department with weakness.  Patient has a past medical history of asthma, coronary artery disease, hypertension, hyperlipidemia, and GERD. Patient states that over the past 2-3 days, he has developed symptoms of weakness, cough with sputum production, dizziness, sore throat, and diarrhea.  He denies fever, nausea and vomiting, or shortness of breath.  He also states that he has sustained 2 falls due to his weakness.  Patient states that at baseline, he uses a walker for ambulation, however, he has been unable to fully support his weight and fell while ambulating to the bathroom.  He presented to the emergency department for evaluation.  In the emergency department, patient's vital signs were stable.  Complete blood count was unremarkable.  BMP was unremarkable.  Troponin was indeterminate at 59 with a repeat of 53. RSV and influenza were negative.  COVID-19 was positive.  EKG shows presence of right bundle branch block.  CT of the head showed no acute intracranial abnormality.  Chest x-ray shows small pleural effusions with adjacent atelectasis that could have superimposed pneumonia.  Suspect generalized weakness secondary to COVID-19.  Patient has been admitted for further evaluation and management of generalized weakness secondary to COVID-19.  Patient was admitted and remained stable throughout his stay.  He was initially quite deconditioned and weak but Physical therapy Occupational therapy worked with him and were able to stabilize him adequately for discharge home with home health PT OT and nursing.  His markers remained relatively stable and he never developed any respiratory symptoms associated with the COVID.  He was seen on the day of discharge doing well and discharged home to follow-up with his primary care provider.  He was to resume his regular medications as previously ordered.  There were no additions to his regimen.  He could return to diet and activity as tolerated.  He was recommended to complete 10 days of respiratory isolation from the day of his 1st symptoms.  He was to follow up with his primary care provider in the next 7-10 days to ensure complete resolution of his symptoms.  He understood all these instructions and was discharged home with his family in stable condition.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count normal, Influenza virus test negative, Laboratory test, Metabolic function test normal, Oropharyngeal pain
Clinical narrative: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 11/3/2022 Discharge Date: 11/7/2022 COVID positive Date 11/3/2022 PRESENTING PROBLEM: Generalized weakness [R53.1] History of falling [Z91.81] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 90 y.o. male who presented to the emergency department with weakness.  Patient has a past medical history of asthma, coronary artery disease, hypertension, hyperlipidemia, and GERD. Patient states that over the past 2-3 days, he has developed symptoms of weakness, cough with sputum production, dizziness, sore throat, and diarrhea.  He denies fever, nausea and vomiting, or shortness of breath.  He also states that he has sustained 2 falls due to his weakness.  Patient states that at baseline, he uses a walker for ambulation, however, he has been unable to fully support his weight and fell while ambulating to the bathroom.  He presented to the emergency department for evaluation.  In the emergency department, patient's vital signs were stable.  Complete blood count was unremarkable.  BMP was unremarkable.  Troponin was indeterminate at 59 with a repeat of 53. RSV and influenza were negative.  COVID-19 was positive.  EKG shows presence of right bundle branch block.  CT of the head showed no acute intracranial abnormality.  Chest x-ray shows small pleural effusions with adjacent atelectasis that could have superimposed pneumonia.  Suspect generalized weakness secondary to COVID-19.  Patient has been admitted for further evaluation and management of generalized weakness secondary to COVID-19.  Patient was admitted and remained stable throughout his stay.  He was initially quite deconditioned and weak but Physical therapy Occupational therapy worked with him and were able to stabilize him adequately for discharge home with home health PT OT and nursing.  His markers remained relatively stable and he never developed any respiratory symptoms associated with the COVID.  He was seen on the day of discharge doing well and discharged home to follow-up with his primary care provider.  He was to resume his regular medications as previously ordered.  There were no additions to his regimen.  He could return to diet and activity as tolerated.  He was recommended to complete 10 days of respiratory isolation from the day of his 1st symptoms.  He was to follow up with his primary care provider in the next 7-10 days to ensure complete resolution of his symptoms.  He understood all these instructions and was discharged home with his family in stable condition.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Physical deconditioning, Pleural effusion, Productive cough, Respiratory syncytial virus test negative, SARS-CoV-2 test positive
Clinical narrative: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 11/3/2022 Discharge Date: 11/7/2022 COVID positive Date 11/3/2022 PRESENTING PROBLEM: Generalized weakness [R53.1] History of falling [Z91.81] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 90 y.o. male who presented to the emergency department with weakness.  Patient has a past medical history of asthma, coronary artery disease, hypertension, hyperlipidemia, and GERD. Patient states that over the past 2-3 days, he has developed symptoms of weakness, cough with sputum production, dizziness, sore throat, and diarrhea.  He denies fever, nausea and vomiting, or shortness of breath.  He also states that he has sustained 2 falls due to his weakness.  Patient states that at baseline, he uses a walker for ambulation, however, he has been unable to fully support his weight and fell while ambulating to the bathroom.  He presented to the emergency department for evaluation.  In the emergency department, patient's vital signs were stable.  Complete blood count was unremarkable.  BMP was unremarkable.  Troponin was indeterminate at 59 with a repeat of 53. RSV and influenza were negative.  COVID-19 was positive.  EKG shows presence of right bundle branch block.  CT of the head showed no acute intracranial abnormality.  Chest x-ray shows small pleural effusions with adjacent atelectasis that could have superimposed pneumonia.  Suspect generalized weakness secondary to COVID-19.  Patient has been admitted for further evaluation and management of generalized weakness secondary to COVID-19.  Patient was admitted and remained stable throughout his stay.  He was initially quite deconditioned and weak but Physical therapy Occupational therapy worked with him and were able to stabilize him adequately for discharge home with home health PT OT and nursing.  His markers remained relatively stable and he never developed any respiratory symptoms associated with the COVID.  He was seen on the day of discharge doing well and discharged home to follow-up with his primary care provider.  He was to resume his regular medications as previously ordered.  There were no additions to his regimen.  He could return to diet and activity as tolerated.  He was recommended to complete 10 days of respiratory isolation from the day of his 1st symptoms.  He was to follow up with his primary care provider in the next 7-10 days to ensure complete resolution of his symptoms.  He understood all these instructions and was discharged home with his family in stable condition.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased, Weight bearing difficulty
Clinical narrative: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 11/3/2022 Discharge Date: 11/7/2022 COVID positive Date 11/3/2022 PRESENTING PROBLEM: Generalized weakness [R53.1] History of falling [Z91.81] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 90 y.o. male who presented to the emergency department with weakness.  Patient has a past medical history of asthma, coronary artery disease, hypertension, hyperlipidemia, and GERD. Patient states that over the past 2-3 days, he has developed symptoms of weakness, cough with sputum production, dizziness, sore throat, and diarrhea.  He denies fever, nausea and vomiting, or shortness of breath.  He also states that he has sustained 2 falls due to his weakness.  Patient states that at baseline, he uses a walker for ambulation, however, he has been unable to fully support his weight and fell while ambulating to the bathroom.  He presented to the emergency department for evaluation.  In the emergency department, patient's vital signs were stable.  Complete blood count was unremarkable.  BMP was unremarkable.  Troponin was indeterminate at 59 with a repeat of 53. RSV and influenza were negative.  COVID-19 was positive.  EKG shows presence of right bundle branch block.  CT of the head showed no acute intracranial abnormality.  Chest x-ray shows small pleural effusions with adjacent atelectasis that could have superimposed pneumonia.  Suspect generalized weakness secondary to COVID-19.  Patient has been admitted for further evaluation and management of generalized weakness secondary to COVID-19.  Patient was admitted and remained stable throughout his stay.  He was initially quite deconditioned and weak but Physical therapy Occupational therapy worked with him and were able to stabilize him adequately for discharge home with home health PT OT and nursing.  His markers remained relatively stable and he never developed any respiratory symptoms associated with the COVID.  He was seen on the day of discharge doing well and discharged home to follow-up with his primary care provider.  He was to resume his regular medications as previously ordered.  There were no additions to his regimen.  He could return to diet and activity as tolerated.  He was recommended to complete 10 days of respiratory isolation from the day of his 1st symptoms.  He was to follow up with his primary care provider in the next 7-10 days to ensure complete resolution of his symptoms.  He understood all these instructions and was discharged home with his family in stable condition.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given adult dose of Hep A instead of child dose, Patient was 3 years old
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Atrial fibrillation after receiving Pfizer COVID booster
Sex: U
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: on XX/XX/2022, the incorrect patient was called back. MA stated that they verified patient's first name. Patient had visit with provider. Patient was expecting to receive Testosterone injection, but instead received Flu vaccine to left deltoid. Called patient to inform of incorrect medication administration, with no answer. Patient was left 3 voicemails to return call regarding appointment on XX-XX-22. Fluzone Quad Lot # UJ8788AA Exp: 06/30/2023 NDC: 4928-637-78
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: on X/XX/22. 57 y.o. female patient came into the clinic to receive 2nd Moderna Covid 19 booster. 0.25 mL of Moderna covid 19 vaccine was administered to patient's left deltoid. Moderna Covid 19 vaccine 12 and older. Lot #; 083B22A Exp: 11-28-2022 NDC: 80777-273-10
Sex: U
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Patient intended on receiving Shingrix dose #1 and instead received Pfizer Bivalent Vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Dermatitis bullous, Pemphigoid, Scar
Clinical narrative: COVID 19 Moderna Booster Develope severe Bullous pemphigoid patient had 3rd COVID 19 vaccine 3rd shot Booster developed within days Bullous lesions on hands Abdomen Arms with residual scars & needed a Biopsy steroids & Antibodies
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Patient came into the pharmacy today to state that he received a flu shot from our pharmacy last Thursday (11/3/22). He stated that he had a seizure the night of 11/4/22 and that the flu shot is the only change in his life (in his 78 years). His doctor informed him to come to the pharmacy so we could file a report. Patient received Fluzone High Dose.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Cough, Dizziness, Rash, Throat tightness
Clinical narrative: Anaphylaxis after getting a Flu shot. Patient also had her allergy shots. Allergy shots given. Patient waited 30 minutes then received Flu shot. Patient went to ER (10-27/2022) where she was treated for rash, throat tightening, light headedness, and cough.
Age: 7.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine and should have received Bivalent
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 09/14/22 presents to EC ED for "corana virus concern". PMHx of "CKD, Multiple sclerosis, CHF"
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchitis, Cough, Dyspnoea, Feeling abnormal, Malaise
Clinical narrative: Patient stated that she "didn't feel right" several minutes after she got her shot. She said that she "felt sick and was almost going to pass out". She  sat and waited at the pharmacy for awhile as instructed by the immunizer. Eventually she left after she was feeling better, but later in the day she developed a dry cough and was nauseous and had trouble breathing.  She visited a walk-in clinic the next day because her symptoms did not improve. She was diagnosed with bronchitis. She stated that she was given a steroid shot that improved her symptoms immensely. She said that she is feeling much better today and was encouraged to report the adverse event by the doctor.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Presyncope
Clinical narrative: Patient stated that she "didn't feel right" several minutes after she got her shot. She said that she "felt sick and was almost going to pass out". She  sat and waited at the pharmacy for awhile as instructed by the immunizer. Eventually she left after she was feeling better, but later in the day she developed a dry cough and was nauseous and had trouble breathing.  She visited a walk-in clinic the next day because her symptoms did not improve. She was diagnosed with bronchitis. She stated that she was given a steroid shot that improved her symptoms immensely. She said that she is feeling much better today and was encouraged to report the adverse event by the doctor.