chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna).    No concomitant medications were provided by the reporter.  It was reported that patient received 4 COVID-19 primary series vaccinations which was three Pfizer and one Moderna vaccine.  No treatment medications were provided by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered >12 hours post puncture,Dose administered after 30-day Use By Date).    No concomitant medications were reported.  It was reported that the vials were first thawed on 20-Sep-2022. Total 2 patient's were administered with the Bivalent vaccine. It was reported that opened individual vials with vial size 2.5 ml The vial was initially stored in the refrigerator on 20-Sep-2022. The vial was first punctured on 17-Oct-2022 at 9:33 AM. The vial was stored in the fridge post punctured. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to Room temperature range was less than a minute.  No treatment details were reported.   This case was linked to MOD-2022-665346 (E2B Linked Report).; Sender's Comments:  MOD-2022-665346:Patient 1
Age: 1.25
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.; was accidentally given 6 yr old dose of 0.5mL; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.), INCORRECT DOSE ADMINISTERED (was accidentally given 6 yr old dose of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 15-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Oct-2022, the patient experienced ACCIDENTAL OVERDOSE (was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.) and INCORRECT DOSE ADMINISTERED (was accidentally given 6 yr old dose of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.), INCORRECT DOSE ADMINISTERED (was accidentally given 6 yr old dose of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL OVERDOSE (was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.) and INCORRECT DOSE ADMINISTERED (was accidentally given 6 yr old dose of 0.5mL).    No concomitant medication were reported.   Reporter stated that they had a 15-month-old patient here on Monday (24Oct2022) that was accidentally given 6 yr old dose of 0.5mL, instead of the 6month old to 5 yr old dose.      No treatment information was provided by the reporter.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead) and NO ADVERSE EVENT (No adverse event) in a 9-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead).    No concomitant drug were reported.  On 26-Oct-2022, a patient came in for their 4th dose, which was supposed to be Moderna Covid-19 Vaccine, Bivalent, but got the monovalent instead. No treatment drug were reported.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date).    No concomitant drug were reported.   It was reported that HCP was transferred to excursions line to discussed HCP mentioned that 5 patients were administered the vaccine after the 30-day beyond use date. It is the same lot number as the previous case however the date of thaw and administration are different.    5 patients were administered the vaccine after 30-day BUD. vial was opened individual vials  Vial size was reported as 2.5ml  On 20-Sep-2022, the vial was initially stored in the refrigerator.   The vial did not undergo any temperature excursion.   Vaccines administered were first boosters for some and second booster for other patients.
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022; No adverse event; given bivalent booster dose which was beyond the 30 day use by datey; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event) in a 92-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022).    No concomitant information provided The vial did not undergo any temperature excursions.  The patient took previously fist dose on 16-Jan-2021,sencod dose on 13-Feb-2021 and first booster 17-Nov-2021 of unknown brand.  No treatment information provided
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Expired product administered, Pyrexia, Vomiting
Clinical narrative: loss of appetite; diarrhea; vomiting; on and off fever; vaccine administered that day was expired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (on and off fever) and EXPIRED PRODUCT ADMINISTERED (vaccine administered that day was expired) in a 12-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered that day was expired). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), VOMITING (vomiting) and PYREXIA (on and off fever). At the time of the report, DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (on and off fever) and EXPIRED PRODUCT ADMINISTERED (vaccine administered that day was expired) outcome was unknown.            Concomitant drugs were not reported. It was reported that patient received expired vaccine but since it was given within the grace period of 30 days it was okay. Patient visited twice to urgent care. Treatment medications were not provided.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.; No adverse event; refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.).    No concomitant medications were reported.  Reported that the vaccine was punctured for the first time then administered to a patient as first dose on 27-Oct-2022. The vial did not undergo any temperature excursions. Patient received the vaccine from red cap, magenta border vial.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2022: Live significant follow-up received patient identifier, indication and case narrative updated received.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. This case is reported for 3rd patient out of 20 patients. No treatment information was provided.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: syncope. patient recovered almost immediately.  denied any further problems.  Patient also received Pfizer Bivalent at the same time.
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, Injection site discharge, Injection site erythema, Injection site pruritus, Rash macular
Clinical narrative: Large red blotch patch near site of injection approx 3 inches by 2 inches on the left arm, with red 'spot' closest to the site of injections. At time of injection the vaccine had not successfully gone under the skin and liquid had come back out from the injection site and the vaccinating provider chose to attempt a second vaccination which appeared to be successful.  The red blotch patch is extremely itchy and concentrated itch sensation is closest to both injection sites.
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: Large red blotch patch near site of injection approx 3 inches by 2 inches on the left arm, with red 'spot' closest to the site of injections. At time of injection the vaccine had not successfully gone under the skin and liquid had come back out from the injection site and the vaccinating provider chose to attempt a second vaccination which appeared to be successful.  The red blotch patch is extremely itchy and concentrated itch sensation is closest to both injection sites.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vials stored briefly at <2 degrees C during transport to facility. No s/sx of adverse event
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Dizziness, Dizziness postural, Heart rate increased, Tinnitus
Clinical narrative: This the first time I receiving both vaccines at the same time.  Today is the 3 full day of symptoms.   When lying (flat) down at night I get dizzy for a few seconds and when I first get up in the morning I feel light headed (few seconds).  After I get out of bed and during the day when I am stand, sitting upright or resting I do not feel light head or get dizzy.   These durations are starting to be shorter in time.     Ring is both ears has been continuous through the day. Ringing is starting to be not as loud as the first & second day.  Occasionally I get ringing in both ears for short period of time, average 1 day per week.  They normally last 5-15 minutes.  Breathing exercise causes them to stop ringing.     Blood pressure and heart rate is with my normal daily range ( < 140/85, and > 105/65; HR 70-85), Blood O2 is 94-97.  These are taken before I go the sleep and before I get out of bed in the morning.  They both remain within my normal range during the day.  When exercising or performing yard work heart rate goes up but blood pressure & O2 remain within my normal ranges  Both vaccines (Oct 2022) were giving by Pharmacy.  Covid 19 vaccine history: initial series - Pfizer (Feb-Mar 2021), LOT EN6205 & LOT EN6198;    1st booster - (Moderna (Dec 2021), LOT 0669F21A ;   2nd booster - Pfizer (Oct 2022), LOT GJ3275 OR 6J3275
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vials stored briefly at <2 degrees C during transport to facility. No s/sx of adverse event
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Bell's palsy, Cardiac stress test, Echocardiogram
Clinical narrative: Development of heart palpitations (Informed was Atrial Fib with PVC's/PAC's), as well as Bells Palsy of the right side of my face. Was put on Aspirin therapy until further testing was done.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Laboratory test, Palpitations, Supraventricular extrasystoles
Clinical narrative: Development of heart palpitations (Informed was Atrial Fib with PVC's/PAC's), as well as Bells Palsy of the right side of my face. Was put on Aspirin therapy until further testing was done.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Development of heart palpitations (Informed was Atrial Fib with PVC's/PAC's), as well as Bells Palsy of the right side of my face. Was put on Aspirin therapy until further testing was done.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vials stored briefly at <2 degrees C during transport to facility. No s/sx of adverse event
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient given primary Pfizer for dose #2 instead of Moderna.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric dose give to 13yr old.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Gastrooesophageal reflux disease, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: My first symptoms had been like a normal cold. I picked up some over the counter medicine to treat my symptoms. I took a test and it came out inconclusive. I then tested another time and it did come out positive.  The worst of my symptoms came to heavy coughing. I was prescribed Paxlovid, however, I did not start taking it since I was beginning to feel better. As of now I am testing negative, and I still have leftover coughing and congestion. Acid Reflux has also increased as well.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: My first symptoms had been like a normal cold. I picked up some over the counter medicine to treat my symptoms. I took a test and it came out inconclusive. I then tested another time and it did come out positive.  The worst of my symptoms came to heavy coughing. I was prescribed Paxlovid, however, I did not start taking it since I was beginning to feel better. As of now I am testing negative, and I still have leftover coughing and congestion. Acid Reflux has also increased as well.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: STANDARD MODERNA GIVEN NOT BIVALENT BOOSTER.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, General physical condition abnormal, Heart rate increased, Impaired work ability
Clinical narrative: When I went to work I had to leave a meeting because I was coughing so bad.  My job sent me home because they said I looked bad. The coughing got worse by Wednesday. I started having shortness of breath on Friday. I was grocery shopping and my coughing cut my breath off. I went to the hospital and they ran test on me and they came back negative. I was on oxygen since the 10/24/2022. They wouldn't let me go home because my heart rate was so high. They gave me several medications.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test negative, Laboratory test normal, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: When I went to work I had to leave a meeting because I was coughing so bad.  My job sent me home because they said I looked bad. The coughing got worse by Wednesday. I started having shortness of breath on Friday. I was grocery shopping and my coughing cut my breath off. I went to the hospital and they ran test on me and they came back negative. I was on oxygen since the 10/24/2022. They wouldn't let me go home because my heart rate was so high. They gave me several medications.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: We found the first Moderna primary shot was given on 10/22/22 while it was 4 days passed after Beyond Use Date 10/18/22 by a pharmacist. I checked the patient if he had any adverse effect but he only had usual side effects of headache, body aches, tiredness, sore arm. After taking Ibuprofen he felt fine next day. I reported to Moderna and they performed activity test on the very lot (083B22A) and concluded the activity has been maintained to protect the patient from Covid 19. We concluded this patient doesn't need any additional vaccination and just need to complete the 2nd shot for the primary series.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Anal fissure, Chest pain, Colonoscopy normal, Diarrhoea
Clinical narrative: The patient presents with his partner today to discuss ongoing unexplained symptoms of anemia, lymphadenopathy, gastric varices, and diarrhea which began shortly after his first series of COVID vaccination.  He explains 1.5 years ago he moved with his partner and later discovered the home may have had mold in it. The home also had a rat infestation. He has since been seen by ID who has done reported work up and did not feel potential mold exposure is related to current symptoms. They lived in the home for 1 year and during that time he received his COVID vaccines. He received the COVID Moderna vaccine first dose in May of 2021 followed by second dose in June of 2021.  Following the first dose he had no adverse reactions or unusual symptoms. Three days following the second dose he developed "left hand locked like a claw" which lasted for several days. Two weeks thereafter his "lymph nodes exploded" with associated chest pain.  He was seen by his primary who provided reassurance.  He later developed loose stools that resulted in an anal fissure and hemorrhoids. He was seen in the ER in August of 2021 due to "feeling horrific, dizzy, extreme fatigue, ongoing diarrhea" where he was found to have anemia.  He has since been diagnosed with hemolytic anemia and has undergone 40 blood transfusions by report. He was referred to the hospital heme/onc. He was seen by ENT for LAD.  He has been seen by rheumatology with all evaluation thus far being reassuring by report. He has been seen by GI for gastric varices, chronic diarrhea, and transaminitis with reassuring EGD, colonoscopy but abnormalities on HIDA scan.    He denies any adverse reaction within 24 hours of vaccine administration including hives, swelling, shortness of breath, wheezing, vomiting or diarrhea. First symptom was locked hand 3 days post second dose administration.  He has no previous history of adverse vaccine reactions.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Full blood count, Gastric varices
Clinical narrative: The patient presents with his partner today to discuss ongoing unexplained symptoms of anemia, lymphadenopathy, gastric varices, and diarrhea which began shortly after his first series of COVID vaccination.  He explains 1.5 years ago he moved with his partner and later discovered the home may have had mold in it. The home also had a rat infestation. He has since been seen by ID who has done reported work up and did not feel potential mold exposure is related to current symptoms. They lived in the home for 1 year and during that time he received his COVID vaccines. He received the COVID Moderna vaccine first dose in May of 2021 followed by second dose in June of 2021.  Following the first dose he had no adverse reactions or unusual symptoms. Three days following the second dose he developed "left hand locked like a claw" which lasted for several days. Two weeks thereafter his "lymph nodes exploded" with associated chest pain.  He was seen by his primary who provided reassurance.  He later developed loose stools that resulted in an anal fissure and hemorrhoids. He was seen in the ER in August of 2021 due to "feeling horrific, dizzy, extreme fatigue, ongoing diarrhea" where he was found to have anemia.  He has since been diagnosed with hemolytic anemia and has undergone 40 blood transfusions by report. He was referred to the hospital heme/onc. He was seen by ENT for LAD.  He has been seen by rheumatology with all evaluation thus far being reassuring by report. He has been seen by GI for gastric varices, chronic diarrhea, and transaminitis with reassuring EGD, colonoscopy but abnormalities on HIDA scan.    He denies any adverse reaction within 24 hours of vaccine administration including hives, swelling, shortness of breath, wheezing, vomiting or diarrhea. First symptom was locked hand 3 days post second dose administration.  He has no previous history of adverse vaccine reactions.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Haemolytic anaemia, Haemorrhoids, Hepatobiliary scan, Hypertransaminasaemia
Clinical narrative: The patient presents with his partner today to discuss ongoing unexplained symptoms of anemia, lymphadenopathy, gastric varices, and diarrhea which began shortly after his first series of COVID vaccination.  He explains 1.5 years ago he moved with his partner and later discovered the home may have had mold in it. The home also had a rat infestation. He has since been seen by ID who has done reported work up and did not feel potential mold exposure is related to current symptoms. They lived in the home for 1 year and during that time he received his COVID vaccines. He received the COVID Moderna vaccine first dose in May of 2021 followed by second dose in June of 2021.  Following the first dose he had no adverse reactions or unusual symptoms. Three days following the second dose he developed "left hand locked like a claw" which lasted for several days. Two weeks thereafter his "lymph nodes exploded" with associated chest pain.  He was seen by his primary who provided reassurance.  He later developed loose stools that resulted in an anal fissure and hemorrhoids. He was seen in the ER in August of 2021 due to "feeling horrific, dizzy, extreme fatigue, ongoing diarrhea" where he was found to have anemia.  He has since been diagnosed with hemolytic anemia and has undergone 40 blood transfusions by report. He was referred to the hospital heme/onc. He was seen by ENT for LAD.  He has been seen by rheumatology with all evaluation thus far being reassuring by report. He has been seen by GI for gastric varices, chronic diarrhea, and transaminitis with reassuring EGD, colonoscopy but abnormalities on HIDA scan.    He denies any adverse reaction within 24 hours of vaccine administration including hives, swelling, shortness of breath, wheezing, vomiting or diarrhea. First symptom was locked hand 3 days post second dose administration.  He has no previous history of adverse vaccine reactions.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Joint contracture, Lymphadenopathy, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased
Clinical narrative: The patient presents with his partner today to discuss ongoing unexplained symptoms of anemia, lymphadenopathy, gastric varices, and diarrhea which began shortly after his first series of COVID vaccination.  He explains 1.5 years ago he moved with his partner and later discovered the home may have had mold in it. The home also had a rat infestation. He has since been seen by ID who has done reported work up and did not feel potential mold exposure is related to current symptoms. They lived in the home for 1 year and during that time he received his COVID vaccines. He received the COVID Moderna vaccine first dose in May of 2021 followed by second dose in June of 2021.  Following the first dose he had no adverse reactions or unusual symptoms. Three days following the second dose he developed "left hand locked like a claw" which lasted for several days. Two weeks thereafter his "lymph nodes exploded" with associated chest pain.  He was seen by his primary who provided reassurance.  He later developed loose stools that resulted in an anal fissure and hemorrhoids. He was seen in the ER in August of 2021 due to "feeling horrific, dizzy, extreme fatigue, ongoing diarrhea" where he was found to have anemia.  He has since been diagnosed with hemolytic anemia and has undergone 40 blood transfusions by report. He was referred to the hospital heme/onc. He was seen by ENT for LAD.  He has been seen by rheumatology with all evaluation thus far being reassuring by report. He has been seen by GI for gastric varices, chronic diarrhea, and transaminitis with reassuring EGD, colonoscopy but abnormalities on HIDA scan.    He denies any adverse reaction within 24 hours of vaccine administration including hives, swelling, shortness of breath, wheezing, vomiting or diarrhea. First symptom was locked hand 3 days post second dose administration.  He has no previous history of adverse vaccine reactions.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Mean platelet volume increased, No reaction on previous exposure to drug, Oesophagogastroduodenoscopy, Platelet count normal, Red blood cell count decreased
Clinical narrative: The patient presents with his partner today to discuss ongoing unexplained symptoms of anemia, lymphadenopathy, gastric varices, and diarrhea which began shortly after his first series of COVID vaccination.  He explains 1.5 years ago he moved with his partner and later discovered the home may have had mold in it. The home also had a rat infestation. He has since been seen by ID who has done reported work up and did not feel potential mold exposure is related to current symptoms. They lived in the home for 1 year and during that time he received his COVID vaccines. He received the COVID Moderna vaccine first dose in May of 2021 followed by second dose in June of 2021.  Following the first dose he had no adverse reactions or unusual symptoms. Three days following the second dose he developed "left hand locked like a claw" which lasted for several days. Two weeks thereafter his "lymph nodes exploded" with associated chest pain.  He was seen by his primary who provided reassurance.  He later developed loose stools that resulted in an anal fissure and hemorrhoids. He was seen in the ER in August of 2021 due to "feeling horrific, dizzy, extreme fatigue, ongoing diarrhea" where he was found to have anemia.  He has since been diagnosed with hemolytic anemia and has undergone 40 blood transfusions by report. He was referred to the hospital heme/onc. He was seen by ENT for LAD.  He has been seen by rheumatology with all evaluation thus far being reassuring by report. He has been seen by GI for gastric varices, chronic diarrhea, and transaminitis with reassuring EGD, colonoscopy but abnormalities on HIDA scan.    He denies any adverse reaction within 24 hours of vaccine administration including hives, swelling, shortness of breath, wheezing, vomiting or diarrhea. First symptom was locked hand 3 days post second dose administration.  He has no previous history of adverse vaccine reactions.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Red cell distribution width increased, Transfusion, White blood cell count decreased
Clinical narrative: The patient presents with his partner today to discuss ongoing unexplained symptoms of anemia, lymphadenopathy, gastric varices, and diarrhea which began shortly after his first series of COVID vaccination.  He explains 1.5 years ago he moved with his partner and later discovered the home may have had mold in it. The home also had a rat infestation. He has since been seen by ID who has done reported work up and did not feel potential mold exposure is related to current symptoms. They lived in the home for 1 year and during that time he received his COVID vaccines. He received the COVID Moderna vaccine first dose in May of 2021 followed by second dose in June of 2021.  Following the first dose he had no adverse reactions or unusual symptoms. Three days following the second dose he developed "left hand locked like a claw" which lasted for several days. Two weeks thereafter his "lymph nodes exploded" with associated chest pain.  He was seen by his primary who provided reassurance.  He later developed loose stools that resulted in an anal fissure and hemorrhoids. He was seen in the ER in August of 2021 due to "feeling horrific, dizzy, extreme fatigue, ongoing diarrhea" where he was found to have anemia.  He has since been diagnosed with hemolytic anemia and has undergone 40 blood transfusions by report. He was referred to the hospital heme/onc. He was seen by ENT for LAD.  He has been seen by rheumatology with all evaluation thus far being reassuring by report. He has been seen by GI for gastric varices, chronic diarrhea, and transaminitis with reassuring EGD, colonoscopy but abnormalities on HIDA scan.    He denies any adverse reaction within 24 hours of vaccine administration including hives, swelling, shortness of breath, wheezing, vomiting or diarrhea. First symptom was locked hand 3 days post second dose administration.  He has no previous history of adverse vaccine reactions.
Age: 10.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient presented for her first Covid vaccine dose.  Instead, she received a Bivalent Booster dose for age 5-11.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pt did not have any adverse events, but pt got a 3rd Shingrix shot.  Pt already completed series of 2 shots in 2019 (1st: 5/21/19 and 2nd: 8/05/19).
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID about six weeks after receiving the Moderna booster. Symptoms, fortunately, were relatively mild.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Pharyngeal swelling
Clinical narrative: Patient experienced sharp pains, down left arm throat was feeling a little swollen, fingers numb, Was advised to go to urgent care immediately. 1:00pm
Age: 56.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose was given on 10/14/2022 at 0.25mL (As146B). Other 0.25mL was given on 10/28/2022 (061F22A)
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid 19 on Wednesday October26th.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness postural
Clinical narrative: Dizziness upon standing up too quickly
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Bacterial test negative, Constipation, Culture stool negative, Diarrhoea
Clinical narrative: After taking the vaccine I did have a headache. But then after a day I did notice some mucus in my stools and uneasiness in my stomach. I had urge to defecate a few times. This thing kept on happening for a week and alternating between  Mucus in Stools with passing 3-4 times a day to constipation. But starting 10/12 it became worse. The mucus/slime like liquid started to come out every time I passed gas and my bowel movement increase drastically to 6-7 times a day. So I had to wait 1 more week as I got doctors appointment on 10/19 even then I didnt get any medicine and I had to still go through the same situation. Some Stool test were ordered in which Viral and Bacterial infection came out as negative. I still have the persistent diarrhea with mucus in stools and when I pass gas.  Now I have been asked to get the colonoscopy on 11/4
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Flatulence, Frequent bowel movements, Giardia test negative, Headache, Laboratory test normal
Clinical narrative: After taking the vaccine I did have a headache. But then after a day I did notice some mucus in my stools and uneasiness in my stomach. I had urge to defecate a few times. This thing kept on happening for a week and alternating between  Mucus in Stools with passing 3-4 times a day to constipation. But starting 10/12 it became worse. The mucus/slime like liquid started to come out every time I passed gas and my bowel movement increase drastically to 6-7 times a day. So I had to wait 1 more week as I got doctors appointment on 10/19 even then I didnt get any medicine and I had to still go through the same situation. Some Stool test were ordered in which Viral and Bacterial infection came out as negative. I still have the persistent diarrhea with mucus in stools and when I pass gas.  Now I have been asked to get the colonoscopy on 11/4
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mucous stools, Polymerase chain reaction negative, Viral test negative
Clinical narrative: After taking the vaccine I did have a headache. But then after a day I did notice some mucus in my stools and uneasiness in my stomach. I had urge to defecate a few times. This thing kept on happening for a week and alternating between  Mucus in Stools with passing 3-4 times a day to constipation. But starting 10/12 it became worse. The mucus/slime like liquid started to come out every time I passed gas and my bowel movement increase drastically to 6-7 times a day. So I had to wait 1 more week as I got doctors appointment on 10/19 even then I didnt get any medicine and I had to still go through the same situation. Some Stool test were ordered in which Viral and Bacterial infection came out as negative. I still have the persistent diarrhea with mucus in stools and when I pass gas.  Now I have been asked to get the colonoscopy on 11/4
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: rash started on clt's R upper and lower arm, spreading to the L arm
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was given flu shot twice.  He came into pharmacy to get moderna vaccine and received fluad.  He had previously received the flu shot last month.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient stated after one week of receiving the new Moderna bivalent booster she experienced having itchy, rash all over her body and it continues to spread. She still has it after 2 weeks. Benadryl is not helping.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Erythema, Immediate post-injection reaction, Paraesthesia, Paraesthesia oral
Clinical narrative: Immediately has a fire engine red face, neck, chest and arms; tingling in tongue and fingertips; cough. Went to ED and received IV benedryl and steroids.  Given a script for epi pen. Following IV's skin color returned to normal and discharged home without incident.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Rash
Clinical narrative: that night she started feeling N/V, HA fever and chills.  The next morning she developed a rash and the rash continued for the next 2 weeks
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: that night she started feeling N/V, HA fever and chills.  The next morning she developed a rash and the rash continued for the next 2 weeks
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vials stored briefly at <2 degrees C during transport to facility. No s/sx of adverse event
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blindness unilateral, COVID-19, Cerebrovascular accident, Cough
Clinical narrative: On 9/2/2022, my throat was scratchy, but I also had mucous, I had severe flu-like symptoms, a bad cough, and I was weak, and I was hot and cold. On 9/3/2022, I took a COVID-19 home test and it was positive. My cough got worse that I could not sleep. I called the doctor's nurse; I told her I was very light-headed, and she thought it could be my multiple sclerosis. She advised me to go to the ER and to check my lungs. There was a very long wait at the emergency room, so I did not want to wait, so I went home. I started taking over-the-counter cough medication and doing everything I could think of. I started to feel better a little over a week. I tested negative about 10 or 11 days after I contacted COVID-19.  Then the last week of 9/2022, I could not see out of my left eye. I went to the Emergency room; I waited 36 hours. The ophthalmologist diagnosed me with bleeding in the back of my left eye and inflammation. The ophthalmologist explained to me that I had a stroke in my left eye, for no known reason. I went for a follow up. And the doctor said it was not a cause of my blood pressure and not caused by multiple sclerosis. The doctor thinks that it was due to COVID-19. They think COVID-19 caused a clot in the back of my eye. The doctor said it was not reversible. On 10/31/2022 I have an appointment with ophthalmologist to have an injection in my eye to help with the swelling in my eye.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye haemorrhage, Eye inflammation, Eye swelling, Feeling of body temperature change
Clinical narrative: On 9/2/2022, my throat was scratchy, but I also had mucous, I had severe flu-like symptoms, a bad cough, and I was weak, and I was hot and cold. On 9/3/2022, I took a COVID-19 home test and it was positive. My cough got worse that I could not sleep. I called the doctor's nurse; I told her I was very light-headed, and she thought it could be my multiple sclerosis. She advised me to go to the ER and to check my lungs. There was a very long wait at the emergency room, so I did not want to wait, so I went home. I started taking over-the-counter cough medication and doing everything I could think of. I started to feel better a little over a week. I tested negative about 10 or 11 days after I contacted COVID-19.  Then the last week of 9/2022, I could not see out of my left eye. I went to the Emergency room; I waited 36 hours. The ophthalmologist diagnosed me with bleeding in the back of my left eye and inflammation. The ophthalmologist explained to me that I had a stroke in my left eye, for no known reason. I went for a follow up. And the doctor said it was not a cause of my blood pressure and not caused by multiple sclerosis. The doctor thinks that it was due to COVID-19. They think COVID-19 caused a clot in the back of my eye. The doctor said it was not reversible. On 10/31/2022 I have an appointment with ophthalmologist to have an injection in my eye to help with the swelling in my eye.