chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 52-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis.   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)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate Free. In 2022, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown. Concomitant medications were not reported. It was unknown if patient was enrolled in COVID-19 Vaccine trial.   The reporter's causality for the event(s) of COVID with Adalimumab Solution for Injection was Not Provided. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes under her arm and the side of her neck were swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     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 LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling). At the time of the report, LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling) was resolving.      No relevant concomitant medications were reported.   It was reported that a patient started treatment on an unspecified date with Moderna COVID-19 Vaccine as a booster for COVID-19 immunisation. The patient reported her lymph nodes under her arm and the side of her neck were swelling and it took 6 weeks to go down. No further follow-up is anticipated.  No treatment information was provided. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     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 LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling). At the time of the report, LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling) was resolving.      No relevant concomitant medications were reported.   It was reported that a patient started treatment on an unspecified date with Moderna COVID-19 Vaccine as a booster for COVID-19 immunisation. The patient reported her lymph nodes under her arm and the side of her neck were swelling and it took 6 weeks to go down. No further follow-up is anticipated.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hidradenitis
Clinical narrative: Hidradenitis Suppurativa flareup; Hidradenitis Suppurativa flareup; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis Suppurativa flareup) and CONDITION AGGRAVATED (Hidradenitis Suppurativa flareup) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    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)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis Suppurativa flareup) and CONDITION AGGRAVATED (Hidradenitis Suppurativa flareup). At the time of the report, HIDRADENITIS (Hidradenitis Suppurativa flareup) and CONDITION AGGRAVATED (Hidradenitis Suppurativa flareup) had resolved.            Concomitant medications were not reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the event of Hidradenitis Suppurativa flareup with Adalimumab Solution for Injection was Not Provided.  Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: pain on both sides of the torso; rash and aggravated skin with pain and swelling when injected; rash and aggravated skin with pain and swelling when injected; rash and aggravated skin with pain and swelling when injected; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain on both sides of the torso), INJECTION SITE RASH (rash and aggravated skin with pain and swelling when injected), INJECTION SITE SWELLING (rash and aggravated skin with pain and swelling when injected) and INJECTION SITE PAIN (rash and aggravated skin with pain and swelling when injected) 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 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and UPADACITINIB (RINVOQ) for an unknown indication.    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)) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (pain on both sides of the torso), INJECTION SITE RASH (rash and aggravated skin with pain and swelling when injected), INJECTION SITE SWELLING (rash and aggravated skin with pain and swelling when injected) and INJECTION SITE PAIN (rash and aggravated skin with pain and swelling when injected). At the time of the report, PAIN (pain on both sides of the torso), INJECTION SITE RASH (rash and aggravated skin with pain and swelling when injected), INJECTION SITE SWELLING (rash and aggravated skin with pain and swelling when injected) and INJECTION SITE PAIN (rash and aggravated skin with pain and swelling when injected) was resolving.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Malaise, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: achy in his legs; feels off for a day; fever; soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (achy in his legs), MALAISE (feels off for a day), VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (fever) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and ADULT MULTIVITAMIN for an unknown indication.    On 25-Nov-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 25-Nov-2022, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 26-Nov-2022, the patient experienced PAIN IN EXTREMITY (achy in his legs), MALAISE (feels off for a day) and PYREXIA (fever). On 26-Nov-2022, MALAISE (feels off for a day) had resolved. At the time of the report, PAIN IN EXTREMITY (achy in his legs), VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (fever) outcome was unknown.            The patient reports that his experience with the Moderna vaccines had generally been a positive one.  No treatment information was provided.   This case was linked to MOD-2022-669831, MOD-2022-669169 (Patient Link).
Age: 87.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator and first punctured on 23-Nov-2022, administered on 25-nov-2022; No Adverse Event; A patient was given an expired dose of Moderna Covid-19 Vaccine, Bivalent that was beyond 12 hrs; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was given an expired dose of Moderna Covid-19 Vaccine, Bivalent that was beyond 12 hrs), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator and first punctured on 23-Nov-2022, administered on 25-nov-2022) and NO ADVERSE EVENT (No Adverse Event) in an 87-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022 at 8:26 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 25-Nov-2022 at 8:26 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was given an expired dose of Moderna Covid-19 Vaccine, Bivalent that was beyond 12 hrs). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator and first punctured on 23-Nov-2022, administered on 25-nov-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was given an expired dose of Moderna Covid-19 Vaccine, Bivalent that was beyond 12 hrs), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator and first punctured on 23-Nov-2022, administered on 25-nov-2022) 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 (A patient was given an expired dose of Moderna Covid-19 Vaccine, Bivalent that was beyond 12 hrs) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator and first punctured on 23-Nov-2022, administered on 25-nov-2022).    No concomitant medications were provided. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 23-Nov-2022. The vial was first punctured on 23-Nov-2022. The vaccine was administered on 25-Nov-2022 at 8:26a The vial was stored post puncture at room temperature. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C= 46 degree to 77 degree F): Over 24 hrs No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. Patient received a 0.5 ml dose of a monovalent vaccine instead of the bivalent vaccine. Reporter was unsure of batch number. He was unsure if it was 067140C or 057140C. No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Potential administration error: patient was concern that maybe she received primary series dose instead of a booster; Potential administration error: patient was concern that maybe she received primary series dose instead of a booster; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster), WRONG PRODUCT ADMINISTERED (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster) and WRONG PRODUCT ADMINISTERED (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster), WRONG PRODUCT ADMINISTERED (Potential administration error: patient was concern that maybe she received primary series dose instead of a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The patient asked for booster shot on 25-Nov-2022 but when received the vaccine with a new vaccination card, it was unclear whether received a booster dose or a 1st dose of the primary series. When asked the same to the pharmacist, unable to clarify the patient. The information was unknown whether the patient had any adverse events or any treatment provided for the same.  No concomitant medication was reported. The patient received previously the first series of doses (dose 1 and 2) and booster too.   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction
Clinical narrative: negative reaction from covid shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (negative reaction from covid shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In October 2022, the patient experienced IMMUNISATION REACTION (negative reaction from covid shot). At the time of the report, IMMUNISATION REACTION (negative reaction from covid shot) outcome was unknown.            No concomitant medication was reported. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment medication was reported.   This case was linked to MOD-2022-679861 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Ache; with the 5th dose just a little tired; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Ache), FATIGUE (with the 5th dose just a little tired) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot (Had Pneumonia 1 day after flu shot). Past adverse reactions to the above products included Pneumonia with Flu shot. On 07-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 an unknown date, the patient experienced PAIN (Ache), FATIGUE (with the 5th dose just a little tired) and CHILLS (Chills). At the time of the report, PAIN (Ache), FATIGUE (with the 5th dose just a little tired) and CHILLS (Chills) outcome was unknown. Patient previously had Moderna vaccines as 1st Dose on 11-Mar-2021, 2nd Dose on 08-Apr-2021 with lot number 030B21A, 3rd Dose on 29-Oct-2021 with lot number 047C21A and Dose 4 on 08-Apr-2022 with lot number 046L21A. It was reported that patient received Dose 5 which was recorded as Moderna Bivalent on patient's record card, However, the state registry information on patient's record list was stated as Monovalent. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-679862, MOD-2022-679857 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: He woke up with severe pain in his neck; He woke up with severe pain in his knees and shoulder; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NECK PAIN (He woke up with severe pain in his neck) and ARTHRALGIA (He woke up with severe pain in his knees and shoulder) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-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 28-Nov-2022, the patient experienced NECK PAIN (He woke up with severe pain in his neck) and ARTHRALGIA (He woke up with severe pain in his knees and shoulder). At the time of the report, NECK PAIN (He woke up with severe pain in his neck) and ARTHRALGIA (He woke up with severe pain in his knees and shoulder) outcome was unknown.    The concomitant medication was not reported by reporter.  On 10-Jan-2021, patient received Moderna Covid-19 Vaccine first dose lot number 012L20A. On 07-Feb-2021, patient received Moderna Covid-19 Vaccine second dose lot number 016M20A. On 05-Nov-2021, patient received Moderna Covid-19 Vaccine first booster lot number 058F21A.  On 23-Nov-2022, on Wednesday patient got the Moderna Covid-19 Vaccine, Bivalent. On 28-Nov-2022 patient woke up with severe pain in his neck, knees, and shoulder.  The treatment medication was not reported by reporter.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.) and NO ADVERSE EVENT (No Adverse event) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.) 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 WRONG PRODUCT ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.).    Concomitant medication was not reported.  Patient took Covid-19 Vaccine (Monovalent) instead of the Moderna Covid-19 Vaccine Bivalent.  Treatment information was not reported.   This case was linked to MODERNATX, INC.-MOD-2022-679882 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-679882:same reporter
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain in extremity
Clinical narrative: Fingers have pain like arthritis; Pain in her bones that became worse; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Pain in her bones that became worse) and PAIN IN EXTREMITY (Fingers have pain like arthritis) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In November 2022, the patient experienced BONE PAIN (Pain in her bones that became worse). On 29-Nov-2022, the patient experienced PAIN IN EXTREMITY (Fingers have pain like arthritis). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BONE PAIN (Pain in her bones that became worse) and PAIN IN EXTREMITY (Fingers have pain like arthritis) had not resolved.     No concomitant medications were provided. The patient had her first dose, second dose and third dose of Moderna COVID-19 vaccines by intramuscular injection on 17-Feb-2021 (lot number 0320A), 17-Mar-2021 (lot number 640A21A) and 11-Jul-2022 (lot number 002M21A) respectively. After the most recent dose of the Moderna COVID-19 vaccine she experienced pain in her bones that became worse yesterday. Today her fingers have pain like arthritis. She had taken Tylenol for her symptoms.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No Adverse event; We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.) and NO ADVERSE EVENT (No Adverse event) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced INCORRECT DOSE ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.) 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 INCORRECT DOSE ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.). No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679877 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679877:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching occasionally; Patient had a rash off and on since receiving the most recent dose of the Moderna COVID-19 vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itching occasionally) and RASH (Patient had a rash off and on since receiving the most recent dose of the Moderna COVID-19 vaccines) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 017F21A, 028L20A and 025J20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergic reaction to excipient (Past reaction to polysorbate.) and Epilepsy.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching occasionally) and RASH (Patient had a rash off and on since receiving the most recent dose of the Moderna COVID-19 vaccines). At the time of the report, PRURITUS (Itching occasionally) and RASH (Patient had a rash off and on since receiving the most recent dose of the Moderna COVID-19 vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  She had been taking something to stop the itching occasionally.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired quality of life, Insomnia, Tinnitus
Clinical narrative: tinnitus/so much noise in his left ear/sounds like buzzing in his ear; cannot sleep; screwed up his life; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (tinnitus/so much noise in his left ear/sounds like buzzing in his ear), INSOMNIA (cannot sleep) and IMPAIRED QUALITY OF LIFE (screwed up his life) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B214) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine in October 2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced TINNITUS (tinnitus/so much noise in his left ear/sounds like buzzing in his ear), INSOMNIA (cannot sleep) and IMPAIRED QUALITY OF LIFE (screwed up his life). The patient was treated with QUETIAPINE FUMARATE (SEROQUEL) at a dose of 100 milligram at bedtime. At the time of the report, TINNITUS (tinnitus/so much noise in his left ear/sounds like buzzing in his ear) and INSOMNIA (cannot sleep) had not resolved and IMPAIRED QUALITY OF LIFE (screwed up his life) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       2nd dose - 01-Jun-2021, lot number - 035C21A 3rd dose - 02-Nov-2022, lot number - 051D22A No concomitant medications was reported. 1-2 weeks after the 1st dose of Moderna the patient experienced tinnitus. Patient states that he never had tinnitus in his life nor is it in his family until he got the vaccine. Patient states that he has so much noise in his left ear and it screwed up his life. Patient cannot sleep as it sounds like buzzing in his ear. Patient was taking Seroquel (Quetiapine) 100mg at night so he can sleep. Patient was seen by his primary care physician, an ENT and another specialist who all said that patient is okay.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: Moderna product was stored in the fridge and experienced warm excursions; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna product was stored in the fridge and experienced warm excursions) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna product was stored in the fridge and experienced warm excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna product was stored in the fridge and experienced warm excursions) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna product was stored in the fridge and experienced warm excursions).    No concomitant information provided  Lot 063B22A (Monovalent) was delivered on 9/9 and placed in the freezer upon delivery. Lot was relocated to the fridge on 11/3/2022 and quarantined 8pm 11/20.  No treatment information provided
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Bivalent Booster for first Primary dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent Booster for first Primary dose) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent Booster for first Primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent Booster for first Primary dose) 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 WRONG PRODUCT ADMINISTERED (Received Bivalent Booster for first Primary dose).    No concomitant medications were reported. 22-year-old patient received a Bivalent booster dose instead of the first primary Moderna COVID-19 vaccine. No treatment medications were reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse event; Patient received expired vaccine; 1st dose received on 19-Nov-2021/2nd dose received on 28-Nov-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 19-Nov-2021/2nd dose received on 28-Nov-2022) and NO ADVERSE EVENT (No Adverse event) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 054B22A and 06721A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 19-Nov-2021/2nd dose received on 28-Nov-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 19-Nov-2021/2nd dose received on 28-Nov-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 19-Nov-2021/2nd dose received on 28-Nov-2022).    No concomitant medications were reported.  The patient had not reported any adverse reactions to this dose at this time.  No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Not reported any adverse reactions to the two bivalent doses at this time/ No adverse event; Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day) and NO ADVERSE EVENT (Not reported any adverse reactions to the two bivalent doses at this time/ No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 vaccine (1 booster dose) and Pfizer COVID-19 vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.   On 29-Nov-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 and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day). On an unknown date, the patient experienced NO ADVERSE EVENT (Not reported any adverse reactions to the two bivalent doses at this time/ No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day) and NO ADVERSE EVENT (Not reported any adverse reactions to the two bivalent doses at this time/ 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 (Not reported any adverse reactions to the two bivalent doses at this time/ No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day).    No concomitant medication reported.  The HCP reported that the patient received the Pfizer bivalent vaccine and a few minutes later received a Moderna COVID-19 bivalent vaccine on the same day. Patient had not reported any adverse reactions to the two bivalent doses at the time. The HCP wanted to know if there are any recommendations or guidance that can be provided for the patient.  No treatment medication reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL) and NO ADVERSE EVENT (No adverse event) in an elderly male 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 05-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) .25 milliliter. On 05-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    Concomitant drugs were not reported. It was reported that patient was in 70s and have had 4 doses of Moderna COVID-19 vaccines. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-680188 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680188:Case for Wife
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse reaction; Moderna 1st dose was the incorrect dosing at 0.25 mL vs 0.5 mL; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Moderna 1st dose was the incorrect dosing at 0.25 mL vs 0.5 mL) and NO ADVERSE EVENT (No adverse reaction) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 prophylaxis.     Patient had no known drug allergies. It was unknown that the patient ever been diagnosed with or tested positive for COVID-19. The patient did not have acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions.     On 13-Oct-2022 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 13-Oct-2022 at 12:00 PM, the patient experienced UNDERDOSE (Moderna 1st dose was the incorrect dosing at 0.25 mL vs 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, UNDERDOSE (Moderna 1st dose was the incorrect dosing at 0.25 mL vs 0.5 mL) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for UNDERDOSE (Moderna 1st dose was the incorrect dosing at 0.25 mL vs 0.5 mL).    No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event were reported.   It was reported that upon filed the report it was identified during chart audit the patient was administered with Moderna 1st dose was the incorrect dosing at 0.25 mL instead of 0.5 mL.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-676101 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL) and NO ADVERSE EVENT (No adverse event) 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 05-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) .25 milliliter. On 05-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  No concomitant medications were reported.  The patient in their 70s and had 4 doses of the Moderna COVID-19 vaccines. The most recent was a bivalent Vaccine however, it was administered as a dose of 0.25mL. The vaccination facility recommended they come back into that facility to receive an additional 0.25mL dose.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-680160 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680160:Husband case
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022; No Adverse event; Patient was given vaccine beyound 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event) in a 7-month-old male 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) .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 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 (Patient was given vaccine beyound 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022).    No concomitant medication was reported.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022).  There were unbroken cartons. Vial size for 6 months to 5 year. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after date.  The vial did not undergo any temperature excursions.  No treatment medication was reported.