chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
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 25Aug2022 and administered on 26Sep2022; No adverse event; beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022) 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 (beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022).    No concomitant medication was reported.  On 25-Aug-2022, the vial was initially stored in the refrigerator. It was reported that one of the vials beyond used date was on 24-Sep-2022 and they used it and made an error yesterday. Four patients were given doses from that vial.   Vial size was reported as 2.5 mL.  The vial did not underwent any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-651820, US-MODERNATX, INC.-MOD-2022-651828, US-MODERNATX, INC.-MOD-2022-651830 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651820:same reporter US-MODERNATX, INC.-MOD-2022-651828:same reporter US-MODERNATX, INC.-MOD-2022-651830:same reporter
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Slight cough; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (Slight cough) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced COUGH (Slight cough). At the time of the report, COUGH (Slight cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient age was reported as 3.5 years.  Concomitant medication information was not provided by the reporter.  Reporter wanted to know if the vaccine can cause a false positive from the antigen test before they give the child the antigen test.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19 after first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for Covid 19 after first dose of the Moderna Covid 19 vaccine) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     The patient had no allergies.     On 31-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for Covid 19 after first dose of the Moderna Covid 19 vaccine). At the time of the report, COVID-19 (Tested positive for Covid 19 after first dose of the Moderna Covid 19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2022, SARS-CoV-2 test: (Positive) Tested positive for Covid 19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. The patients mother reported on 28-Sep-2022, the patient was supposed to receive the second dose of the vaccine.The mother cancelled the appointment, but would like to know how long must her son wait to get his second dose. No treatment medications were provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A214 and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy) and Arthritis. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient concomitant medication included arthritis medication.  No treatment information provided.   This case was linked to MOD-2022-651942, MOD-2022-651944 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: No adverse event; Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A214 and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy) and Arthritis. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient concomitant medication included arthritis medication.  No treatment information provided.   This case was linked to MOD-2022-651942, MOD-2022-651944 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Have you ever tested positive for Covid 19 Yes, 2 months ago.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Have you ever tested positive for Covid 19 Yes, 2 months ago.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033A22A, A4426A, 028A214 and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy) and Arthritis. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Have you ever tested positive for Covid 19 Yes, 2 months ago.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Have you ever tested positive for Covid 19 Yes, 2 months ago.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive, 2 months ago.   Concomitant medication included Arthritis medication.   This case was linked to MOD-2022-651928, MOD-2022-651944 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Have you ever tested positive for Covid 19 Yes, 2 months ago.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Have you ever tested positive for Covid 19 Yes, 2 months ago.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033A22A, A4426A, 028A214 and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy) and Arthritis. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Have you ever tested positive for Covid 19 Yes, 2 months ago.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Have you ever tested positive for Covid 19 Yes, 2 months ago.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive, 2 months ago.   Concomitant medication included Arthritis medication.   This case was linked to MOD-2022-651928, MOD-2022-651944 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022 at 8:40 AM, 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 27-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture) 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 1 patient with the Moderna Covid 19 Bivalent vaccine more than 12 hours after first puncture).    No concomitant medication information was provided.  Vial size was 2.5 mL and the vial was individual vial.  The vial was first punctured on 26-Sep-2022 at 09:00 A.M.  The vial was initially stored in the refrigerator on 26-Sep-2022.  The vial was stored at room temperature post puncture.  The vial did not undergo any temperature excursions.  The total amount of time during which the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) was less than 24 hours.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye swelling, Lip swelling, Rash macular, Rash pruritic, Swelling face
Clinical narrative: bottom lip swelled and then upper lip swelled; cheeks swelled; cheeks swelled and then in went to eyes; developed some spots; itching spots under breast and on leg; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (bottom lip swelled and then upper lip swelled), SWELLING FACE (cheeks swelled), EYE SWELLING (cheeks swelled and then in went to eyes), RASH MACULAR (developed some spots) and RASH PRURITIC (itching spots under breast and on leg) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A9761B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (tested positive for COVID 19 2 months ago) in July 2022. Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy) and Arthritis. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 23-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Sep-2022, the patient experienced LIP SWELLING (bottom lip swelled and then upper lip swelled), SWELLING FACE (cheeks swelled), EYE SWELLING (cheeks swelled and then in went to eyes), RASH MACULAR (developed some spots) and RASH PRURITIC (itching spots under breast and on leg). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (bottom lip swelled and then upper lip swelled), SWELLING FACE (cheeks swelled), EYE SWELLING (cheeks swelled and then in went to eyes), RASH MACULAR (developed some spots) and RASH PRURITIC (itching spots under breast and on leg) outcome was unknown.            Concomitant medication included Arthritis medication. On 19-Mar-2021, patient received first dose of Moderna Lot number. 029A21A, second dose was received on 31-Mar-2021 with Lot number. 028A214, 1st booster dose on 22-Oct-2021 with Lot number. A4426A and 2nd booster dose on 16-May-2022 with Lot number. 033A22A for COVID-19 vaccination.
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
Clinical narrative: a little bit of joint pain; This spontaneous case was reported by a non-health professional and describes the occurrence of ARTHRALGIA (a little bit of joint pain) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (a little bit of joint pain). At the time of the report, ARTHRALGIA (a little bit of joint pain) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was reported. It was stated that patient had no issues, only a little bit of joint pain No treatment medication was reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; adults received 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 27-Sep-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11) outcome was unknown. At the time of the report, 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11).    No concomitant medications were reported.  The pharmacist states they accidentally gave a group of people the wrong dosage of the Moderna booster. They wanted the bivalent booster, but they gave the one intended for ages 6-11 years.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinus disorder
Clinical narrative: sinus not being 100%; tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid) and SINUS DISORDER (sinus not being 100%) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E, 013L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2022, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced SINUS DISORDER (sinus not being 100%). At the time of the report, COVID-19 (tested positive for Covid) and SINUS DISORDER (sinus not being 100%) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Experienced sore arm for a couple of days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Experienced sore arm for a couple of days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 007B21A, 013M20A and 013M20A) for COVID-19 vaccination.     Patient had no allergies reported. Patient had never tested COVID-19 Positive. No other vaccine was given within 1 month prior to Moderna COVID-19 Vaccine.  Concurrent medical conditions included Diabetes (Started 27 years ago), Kidney failure (Started 27 years ago) and Blood pressure high (Started 27 years ago). Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMAN INSULINK) for Diabetes, AMLODIPINE, CLONIDINE, GUANFACINE, PRAVASTATIN, CALCITRIOL, LOSARTAN and SODIUM BICARBONATE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Experienced sore arm for a couple of days). At the time of the report, PAIN IN EXTREMITY (Experienced sore arm for a couple of days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient only had Sore arm for a couple of days after first four shots.  No treatment details were reported.   This case was linked to MODERNATX, INC.-MOD-2022-652241 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-652241:Bivalent booster dose case
Age: 0.5
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: High fever (fever was greater than or equal to 102 degrees); This non-serious spontaneous safety report, with reference number 2022SA294152 was received by a partner on 19-JUL-2022 and forwarded to Agency on 24-AUG-2022 from a physician.   The reporter did not assess the causal relationship between Vaxelis and the reported event of "High fever (fever was greater than or equal to 102 degrees)".  No further information is expected.  NON SIGNIFICANT FOLLOW UP INFORMATION was forwarded to the agency by the partner with reference number: 2022SA354686 on 26-AUG-2022. The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "High fever (fever was greater than or equal to 102 degrees)".   Further information is expected.  For reference purposes, this case is linked to MCM-003947 (same reporter).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Poor quality product administered, Product administration error
Clinical narrative: Muscle ache; Fatigue; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID:   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 11Aug2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 11Aug2022, outcome "unknown" and all described as "The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired."; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; FATIGUE (non-serious), outcome "unknown".  Additional information: Caller was asking about the gray cap vaccine. The vaccine was expired and was administered to 5 patients. Caller mentioned that she was going to report this to VAERS and wants to check on what to do next. She said that this vaccine has an expiration date of 15Jun2022. Caller said at least that helps with one patient and all the patients were similar. No one of the 5 really had adverse reaction to the expired doses though 3 did report they had several days of side effects - so they thought event though expired that the vaccine had some effect on their sometimes muscle aches, fatigue.  Follow-up attempts are completed. No further information is expected.  Follow-up (26Sep2022): This is a spontaneous follow-up report received from the same contactable other HCP. This other HCP reported for the patient in response to HCP letter sent in cross reference case. Updated information included: Reporter middle name and suffix was updated and new events muscle aches and fatigue was added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201070713 Same reporter/drug/event, different patient; PFIZER INC-202201070271 Same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Poor quality product administered, Product administration error
Clinical narrative: muscle ache; fatigue; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID:   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 11Aug2022 as dose number unknown, single (Lot number: FK9894, Expiration Date: 15Jun2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 11Aug2022, outcome "unknown" and all described as "The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired."; MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; FATIGUE (non-serious), outcome "unknown".  Additional information: Caller was asking about the gray cap vaccine. The vaccine was expired and was administered to 5 patients. Caller mentioned that she was going to report this to VAERS and wants to check on what to do next. She said that this vaccine has an expiration date of 15Jun2022. Caller said at least that helps with one patient and all the patients were similar. 3 patient did report they had several days of side effects- so they thought event though expired that the vaccine had some effect on their sometimes muscle ache, fatigue.  Follow-up (18Aug2022): This is a spontaneous follow-up report received from a contactable other HCP. Program ID:  Updated information included: Reporter information, lot number and expiry date, therapy start and stop date, and event onset date.  Follow-up attempts are completed. No further information is expected.  Follow-up (26Sep2022): This is a spontaneous follow-up report received from same contactable Other-HCP. This Other-HCP reported in response to HCP letter sent in cross reference case that included:  Updated information included: Reporter details, new events and additional information added.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201070713 Same reporter/drug/event, different patient; PFIZER INC-202201093830 Same reporter/drug/even, different patient; PFIZER INC-202201070271 Same reporter/drug/even, different patient;
Sex: U
Vaccine: PNC20
Symptoms: Device issue
Clinical narrative: Syringe defective, there was object larger than stopper at end of syringe inside prefilled syringe and it did not dissolve or disintegrate: no patient exposure; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 19Sep2022, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Other HCP and Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2606, Expiration Date: Jul2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "Syringe defective, there was object larger than stopper at end of syringe inside prefilled syringe and it did not dissolve or disintegrate: no patient exposure".  The reporter considered "syringe defective, there was object larger than stopper at end of syringe inside prefilled syringe and it did not dissolve or disintegrate: no patient exposure" associated to pneumococcal 20-val conj vac (dipht CRM197 protein).  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Pain and swelling under left arm next to breast.; Pain and swelling under left arm next to breast.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 3 (booster), single (Lot number: Gh9694) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN; MCT OIL [COCOS NUCIFERA OIL]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ff2593, Location of injection: Arm Left), administration date: 28Nov2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: 30155ba, Location of injection: Arm Right), administration date: 06Nov2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 2022, outcome "recovering" and all described as "Pain and swelling under left arm next to breast.". Therapeutic measures were not taken as a result of axillary pain, swelling.  Additional information: Known allergies reported as no. Other vaccine in fourweeks reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility type vaccine reported as doctor's office/urgent care.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient medical history and known allergies were reported as No. Other medication in 2 weeks was reported as No.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received the vaccine. Patient received Paxlovid treatment (Lot number- GE1613) from 14Sep2022 to 18Sep2022 for treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Aug2022 at 20:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "Post surgical hypothyroidism" (unspecified if ongoing); "Allergy: Sulfa" (unspecified if ongoing), notes: Allergy: Sulfa. Concomitant medication(s) included: LEVOTHYROXINE oral, start date: 01Jan2022, stop date: 26Sep2022. Past drug history included: Levaquin, reaction(s): "Drug allergy", notes: Allergy: Levaquin; Humira, reaction(s): "Drug allergy", notes: Allergy: Humira; Enbrel, reaction(s): "Drug allergy", notes: Allergy: Enbrel. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) positive, notes: positive antigen test on day 12 after first positive PCR test on 14Sep; (14Sep2022) Positive, notes: positive PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received Paxlovid for the treatment of COVID-19 from 16Sep2022 to 22Sep2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162b2 COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity
Clinical narrative: following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore; following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "colonoscopy" (unspecified if ongoing), notes: She used Miralax prior to her last colonoscopy with no issues. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunisation, reaction(s): "Following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore", "Following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore". The following information was reported: PAIN IN EXTREMITY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore".  Additional information: It was reported that the patient was prepping for a colonoscopy and 15 minutes after the Miralax and Gatorade she had the anaphylactic reaction. The colonoscopy was cancelled then rescheduled a month later. The patient tried SuTab tablets, same thing happened but stronger reaction. The patient ended up in the emergency room. The patient was very nervous to get the booster. The only thing that the patient has done differently from the last colonoscopy was the vaccine. She used Miralax prior to her last colonoscopy with no issues. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PV202200071377 same patient, same AE, different dose;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: CLL" (unspecified if ongoing), notes: Other medical history: CLL. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (22Sep2022) Negative, notes: Two days after finishing Paxlovid, I tested negative; (24Sep2022) Positive, notes: 4 days after finishing the Paxlovid, I relapsed with a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After 5 days of Paxlovid, She had a terrible metallic taste in my mouth and diarrhea. Two days after finishing Paxlovid, she tested negative. 4 days after finishing the Paxlovid, She relapsed with a positive test and had sick for the last 3 days with a very stuffy nose and cough.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; LOSARTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Sep2022) Negative; (27Sep2022) Positive, notes: Positive test today (negative yesterday). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment Paxlovid from 18Sep2022 to 22Sep2022 for covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 at 10:00 as dose 2 (booster), single (Lot number: FE3592) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 25May2021 at 09:00 as dose 1, single (Lot number: 1802070), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroid" (unspecified if ongoing); "vitiligo" (unspecified if ongoing); "hx of urticarial vasculitis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Dapsone" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM, start date: 14Mar2019; LEVOTHYROXINE, start date: 18Mar2021, stop date: 27Sep2022; VITAMIN D [VITAMIN D NOS], start date: 12Jul2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (unspecified date) Positive; (20Sep2022) Negative; (21Sep2022) Negative; (22Sep2022) Negative; (23Sep2022) Negative; (24Sep2022) Negative; (25Sep2022) Negative; (26Sep2022) Negative, notes: Became symptomatic; (27Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Drug ineffective, Covid 19 and suspect drug BNT162B2 cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 07Sep2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; DOSE 5 (BOOSTER); DOSE 5 (BOOSTER); DOSE 1,2,3 and 4 as Unknown manufacturer and DOSE 5 (BOOSTER) BNT162b2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 18:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 18:00, outcome "unknown", described as "DOSE 1,2,3 and 4 as Unknown manufacturer and DOSE 5 (BOOSTER) BNT162b2"; OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 09Sep2022 at 18:00, outcome "unknown" and all described as "DOSE 5 (BOOSTER)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound 5 days after testing negative; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as no. Patient started the Paxlovid from 16Sep2022 and stopped on 21Sep2022 for the treatment of COVID-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.