chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: mild case of COVID after booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (mild case of COVID after booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (mild case of COVID after booster). At the time of the report, COVID-19 (mild case of COVID after booster) outcome was unknown.            No concomitant medication information were given.  The patient took the Moderna vaccine last year and the first booster in November. She stated that she got a mild case of COVID after a trip. Patient wants to take the second booster, but her doctor said to wait 90 days after she gets well.  No treatment information were given.  Company Comment: This spontaneous case concerns a female patient (age not specified) with history of travelling reported, who experienced the unexpected non-serious AESI of Covid-19 unspecified days after the third dose of mRNA-1273 vaccine. it was reported that patient took the first booster of Moderna in November and got COVID after a trip. The current pandemic situation of COVID-19 may remain as confounder and history of travelling as a risk factor to the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient (age not specified) with history of travelling reported, who experienced the unexpected non-serious AESI of Covid-19 unspecified days after the third dose of mRNA-1273 vaccine. it was reported that patient took the first booster of Moderna in November and got COVID after a trip. The current pandemic situation of COVID-19 may remain as confounder and history of travelling as a risk factor to the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Pruritus, Vaccination site pain
Clinical narrative: itching/itching in the mollero (biceps) and in two fingers; Not being able to sleep; Pain in the injection site; Right hand and elbow gets tired; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching/itching in the mollero (biceps) and in two fingers), INSOMNIA (Not being able to sleep), VACCINATION SITE PAIN (Pain in the injection site) and FATIGUE (Right hand and elbow gets tired) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065r21a and 202521a) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis. Concomitant products included LISINOPRIL for an unknown indication.   On 28-Apr-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient experienced PRURITUS (itching/itching in the mollero (biceps) and in two fingers), INSOMNIA (Not being able to sleep), VACCINATION SITE PAIN (Pain in the injection site) and FATIGUE (Right hand and elbow gets tired). At the time of the report, PRURITUS (itching/itching in the mollero (biceps) and in two fingers), INSOMNIA (Not being able to sleep), VACCINATION SITE PAIN (Pain in the injection site) and FATIGUE (Right hand and elbow gets tired) outcome was unknown.            Concomitant medications were reported as unspecified arthritis and cholesterol medication and pain medication for his arthritis.  Treatment included pain medication- 2 different kinds, icepack ,hot water and cream for the pain   This case was linked to MOD-2022-588250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Translation document attached event verbatim updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Ringing in my ears) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 025A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in my ears). At the time of the report, TINNITUS (Ringing in my ears) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's race was given as private. On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, batch lot number 029X21A, left arm.  On 25-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, batch lot number 049L21A, left arm.  Concomitant medication list was not provided. No treatment was received for the event. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient was treated with a Pfizer product for COVID-19 from 02-Jun-2022 to 07-Jun-2022.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: Joint pain/ shoulders/ hip; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain/ shoulders/ hip) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced ARTHRALGIA (Joint pain/ shoulders/ hip). At the time of the report, ARTHRALGIA (Joint pain/ shoulders/ hip) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications information was reported. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 16 year old accidentally received the Moderna Covid 19 vaccine/ A person younger than 18 years old received the first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old accidentally received the Moderna Covid 19 vaccine/ A person younger than 18 years old received the first dose of the Moderna Covid 19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 prophylaxis.     Patient had no Allergies. The patient had not tested positive for Covid 19.     On 25-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old accidentally received the Moderna Covid 19 vaccine/ A person younger than 18 years old received the first dose of the Moderna Covid 19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old accidentally received the Moderna Covid 19 vaccine/ A person younger than 18 years old received the first dose of the Moderna Covid 19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported.  Reporter did not reported any side effects.  Treatment information was not reported.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Psoriasis, Vaccination site mass
Clinical narrative: ARM LUMP FROM THE COVID VACCINE; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and VACCINATION SITE MASS (ARM LUMP FROM THE COVID VACCINE) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Plaque psoriasis. Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient received dose of INFLUENZA VACCINE (Intramuscular) at an unspecified dose. On 26-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, the patient experienced VACCINATION SITE MASS (ARM LUMP FROM THE COVID VACCINE). In 2022, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) and VACCINATION SITE MASS (ARM LUMP FROM THE COVID VACCINE) had resolved.            No concomitant medications were reported Patient had been on Skyrizi for two and half a years. Patient got the Flu vaccine on Sep 2021 and got a psoriasis flare up and it resolved. On 2022, patient got Moderna Covid vaccines and had a Covid arm lump from the vaccine a week after patient got it. Patient had psoriasis flare up a few weeks later and it eventually resolved. It happened with Flu vaccine too. It was reported that patient had taken Skyrizi pen on monday 06-Jun-2022. Patient cleansed skin with alcohol swab, had Skyrizi pen with gray cap one pointed up, pulled of the gray cap, held the pen down on her thigh for entire 15 seconds, heard the click after pushing the button and held for another three to five seconds, then saw the yellow and lifted the pen and bunch of medicine leaked out. Patient saw a red dot and mark. Patient had an issue with pen. No treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity, Skin ulcer
Clinical narrative: ulcer in the right leg; VIUOS in her right leg; living with terrible pain in both calves; living with terrible pain in both knees; This spontaneous case was reported by a patient and describes the occurrence of SKIN ULCER (ulcer in the right leg), LIMB DISCOMFORT (VIUOS in her right leg), PAIN IN EXTREMITY (living with terrible pain in both calves) and ARTHRALGIA (living with terrible pain in both knees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 21C21A and 38821A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Hypertension, Cancer since July 2013, Thyroid disorder NOS, Baker's cyst (between the joint of her right knee (before she got the 1st dose of the vaccine)), Neuropathy (in both her feet prior to getting the vaccine) and Tumor (grade tumor on the intermediate lining of the uterus). Concomitant products included LISINOPRIL, LEVOTHYROXINE and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN ULCER (ulcer in the right leg), LIMB DISCOMFORT (VIUOS in her right leg), PAIN IN EXTREMITY (living with terrible pain in both calves) and ARTHRALGIA (living with terrible pain in both knees). At the time of the report, SKIN ULCER (ulcer in the right leg), LIMB DISCOMFORT (VIUOS in her right leg), PAIN IN EXTREMITY (living with terrible pain in both calves) and ARTHRALGIA (living with terrible pain in both knees) had not resolved.            The patient's condition went up and down when abused (abuse in her apartment rental). She had the 1st booster of the vaccine in Jan2022 and after that on an unspecified date had ulcer in her right leg. Currently she was living with terrible pain in both her knees and her calves. Also on a paper from her doctor's office, she mentioned that there was a finding of VIUOS on her right leg. No treatment information was provided.   This case was linked to MOD-2022-588732 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She also experienced pain in the calf of her right leg in Dec2021; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She also experienced pain in the calf of her right leg in Dec2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 21C21A (?) and 38821A (?)) for COVID-19 prophylaxis.     The patient's past medical history included Cancer in July 2013 and Tumor (Grade tumor, intermediate lining of the uterus.). Previously administered products included for Flu: Flu vaccine in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Blood pressure high, Thyroid disorder (Thyroid disease), Baker's cyst (Between the joint of her right knee (before she got the 1st dose of the vaccine)) and Neuropathy (In both her feet prior to getting the vaccine). Concomitant products included LISINOPRIL, LEVOTHYROXINE and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (She also experienced pain in the calf of her right leg in Dec2021). At the time of the report, PAIN IN EXTREMITY (She also experienced pain in the calf of her right leg in Dec2021) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2022-588698 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Hypoacusis, Tinnitus
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HYPOACUSIS (A little hearing loss (Under 10 percent) a couple of weeks after the first booster), ECZEMA (Eczema on both legs and both Arms a couple of weeks after the first booster, Diagnosed with Eczema after the first booster) and TINNITUS (Ringing / Constant buzzing primarily in the right ear a couple of weeks after the first booster) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 024M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced HYPOACUSIS (A little hearing loss (Under 10 percent) a couple of weeks after the first booster), ECZEMA (Eczema on both legs and both Arms a couple of weeks after the first booster, Diagnosed with Eczema after the first booster) and TINNITUS (Ringing / Constant buzzing primarily in the right ear a couple of weeks after the first booster). The patient was treated with TACROLIMUS for Eczema, at an unspecified dose and frequency and BETAMETHASONE for Eczema, at an unspecified dose and frequency. At the time of the report, HYPOACUSIS (A little hearing loss (Under 10 percent) a couple of weeks after the first booster), ECZEMA (Eczema on both legs and both Arms a couple of weeks after the first booster, Diagnosed with Eczema after the first booster) and TINNITUS (Ringing / Constant buzzing primarily in the right ear a couple of weeks after the first booster) had not resolved.            No concomitant medications were provided by the reporter. It was reported that on 15-Jan-2022, the patient was diagnosed with Eczema.  The doctor prescribed Tacrolimus Ointment (Did not work), then prescribed Betamethasone 5 percent  ointment (did not helped much), Desoximethasone 0.25 percent Ointment (not started using it yet). She states that all side effects are still going on and she does not want to receive a 2nd booster dose of Moderna COVID-19 vaccine.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: May have received 2 doses of Moderna at 9 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (May have received 2 doses of Moderna at 9 years old) in a 9-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (May have received 2 doses of Moderna at 9 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (May have received 2 doses of Moderna at 9 years old) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-588901 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Mild reactions after 2nd primary dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Mild reactions after 2nd primary dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Deep vein thrombosis (10 years ago which resolved).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Mild reactions after 2nd primary dose). At the time of the report, IMMUNISATION REACTION (Mild reactions after 2nd primary dose) outcome was unknown.            It was reported that the patient's age was over 65. Patient did not take Blood thinners anymore. No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-588869, MOD-2022-588877 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Mild reactions after 1st booster dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Mild reactions after 1st booster dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Deep vein thrombosis (10 years ago patient had deep vein thrombosis which was resolved).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Mild reactions after 1st booster dose). At the time of the report, IMMUNISATION REACTION (Mild reactions after 1st booster dose) outcome was unknown.            It was reported that the patient's age was over age of 65. Patient did not take any blood thinner anymore. No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-588869, MOD-2022-588876 (Patient Link).   Reporter did not allow further contact
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (may have received 2 doses of Moderna at 9 years old) in a 9-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.  No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (may have received 2 doses of Moderna at 9 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (may have received 2 doses of Moderna at 9 years old) outcome was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: really sore; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (really sore) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN (really sore). In 2021, PAIN (really sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient had soreness after his 1st dose on 11-Jan-2021. Each time pain lasted 1 day No treatment information was reported.   This case was linked to MOD-2022-589106 (Patient Link).
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine; Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) in a 5-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer in May 2022. Past adverse reactions to the above products included No adverse event with Pfizer.    On 14-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 14-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported Second dose of moderna was supposed to be the 2nd primary Pfizer dose for this patient. No Treatment medication was reported
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthritis, Muscle spasms
Clinical narrative: Cramps in legs; Arthritis; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps in legs), ARTHRITIS (Arthritis) and ABDOMINAL PAIN UPPER (Stomach pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    There was no reported medical history.    On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PANCREATIN (CREON) (Oral) at an unspecified dose. On an unknown date, the patient experienced MUSCLE SPASMS (Cramps in legs), ARTHRITIS (Arthritis) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, MUSCLE SPASMS (Cramps in legs), ARTHRITIS (Arthritis) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in COVID-19 vaccine trial. Concomitant medications were not reported. Treatment medications were not reported.  Company comment: This is a spontaneous case concerning a unknown age, male patient with no medical history reported, who experienced the unexpected non serious events of arthritis, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a unknown age, male patient with no medical history reported, who experienced the unexpected non serious events of arthritis, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Feeling abnormal, Feeling cold, Formication
Clinical narrative: weakness; Chilling; felt bad like the flu; anxiety; felt like skin was crawling; felt miserable; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (weakness), FEELING COLD (Chilling), INFLUENZA LIKE ILLNESS (felt bad like the flu), ANXIETY (anxiety) and FORMICATION (felt like skin was crawling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 007M20A and 039K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had never COVID-19 test or diagnosis.  The patient never had reaction to taking the Flu shot.  The patient's past medical history included Breast cancer and Mastectomy (breast cancer removal and repair in 2013) in 2013. Concurrent medical conditions included Penicillin allergy, Drug allergy (Keflex), Stevens-Johnson syndrome and Irritable bowel syndrome. Concomitant products included VITAMINS NOS, FISH OIL, POLYCARBOPHIL CALCIUM (FIBER), CALCIUM, DOCUSATE SODIUM (STOOL SOFTENER) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (weakness). On an unknown date, the patient experienced FEELING COLD (Chilling), INFLUENZA LIKE ILLNESS (felt bad like the flu), ANXIETY (anxiety), FORMICATION (felt like skin was crawling) and FEELING ABNORMAL (felt miserable). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of Benadryl at night. At the time of the report, ASTHENIA (weakness) was resolving and FEELING COLD (Chilling), INFLUENZA LIKE ILLNESS (felt bad like the flu), ANXIETY (anxiety), FORMICATION (felt like skin was crawling) and FEELING ABNORMAL (felt miserable) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2022-588873, MOD-2022-589031, MOD-2022-589045, MOD-2022-589106 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: weakness; Chilling; felt bad like the flu; anxiety; felt like skin was crawling; felt miserable; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (weakness), FEELING COLD (Chilling), INFLUENZA LIKE ILLNESS (felt bad like the flu), ANXIETY (anxiety) and FORMICATION (felt like skin was crawling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 007M20A and 039K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had never COVID-19 test or diagnosis.  The patient never had reaction to taking the Flu shot.  The patient's past medical history included Breast cancer and Mastectomy (breast cancer removal and repair in 2013) in 2013. Concurrent medical conditions included Penicillin allergy, Drug allergy (Keflex), Stevens-Johnson syndrome and Irritable bowel syndrome. Concomitant products included VITAMINS NOS, FISH OIL, POLYCARBOPHIL CALCIUM (FIBER), CALCIUM, DOCUSATE SODIUM (STOOL SOFTENER) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (weakness). On an unknown date, the patient experienced FEELING COLD (Chilling), INFLUENZA LIKE ILLNESS (felt bad like the flu), ANXIETY (anxiety), FORMICATION (felt like skin was crawling) and FEELING ABNORMAL (felt miserable). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of Benadryl at night. At the time of the report, ASTHENIA (weakness) was resolving and FEELING COLD (Chilling), INFLUENZA LIKE ILLNESS (felt bad like the flu), ANXIETY (anxiety), FORMICATION (felt like skin was crawling) and FEELING ABNORMAL (felt miserable) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2022-588873, MOD-2022-589031, MOD-2022-589045, MOD-2022-589106 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received the vaccine after the expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after the expiry date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after the expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after the expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Reporter stated that the date on packing slip that comes with the vaccine was not a correct expiration date and reporter also used the CIR (City Immunization registry) portal, where they store their documentation inventory and find out that the date on the portal is also not accurate, after that reporter used the Look up tool on the Moderna website, the tools told her the vaccine was expired.  Reporter wanted to know the lot number 042J21A have been extended and reporter thought the expiration date was 31-Dec-2069.  The vial didn't undergone temperature excursions.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (ST, runny nose, fatigue starting 6/7/22 then tested + 6/9/22) and HYPERSENSITIVITY (sx of allergies) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067421A) for COVID-19 prophylaxis. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Pfizer (Dose Number: 1 Batch/Lot No: EP6955) on 26-Mar-2021 and Pfizer (Dose Number: 2 Batch/Lot No: EP6955) on 16-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2022, the patient experienced COVID-19 (ST, runny nose, fatigue starting 6/7/22 then tested + 6/9/22) and HYPERSENSITIVITY (sx of allergies). At the time of the report, COVID-19 (ST, runny nose, fatigue starting 6/7/22 then tested + 6/9/22) and HYPERSENSITIVITY (sx of allergies) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive through Nasal Swab and positive (Positive) Positive through Nasal Swab. No concomitant medications were reported. No treatment medications were reported. COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old patient with  medical history of Pfizer covid-19 vaccine (2 doses) without adverse events who experienced the unexpected event of Covid-19 and other expected event 178 days after  3rd. dose of  mRNA-1273 vaccine. On 09-Jun-2022, SARS-CoV-2 test: positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old patient with  medical history of Pfizer covid-19 vaccine (2 doses) without adverse events who experienced the unexpected event of Covid-19 and other expected event 178 days after  3rd. dose of  mRNA-1273 vaccine.  On 09-Jun-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza, Myalgia, Nausea
Clinical narrative: body ache; weakness; Extreme nausea; feels like the flu; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (body ache), ASTHENIA (weakness), NAUSEA (Extreme nausea) and INFLUENZA (feels like the flu) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Stevens-Johnson syndrome and Breast cancer (removal and repair in 2013). Previously administered products included for Product used for unknown indication: Tylenol. Past adverse reactions to the above products included No adverse event with Tylenol. Concurrent medical conditions included Penicillin allergy, Drug allergy (Keflex,Stevens-Johnson syndrome reaction) and Irritable bowel syndrome. Concomitant products included VITAMINS NOS, FISH OIL, POLYCARBOPHIL CALCIUM (FIBER), CALCIUM, DOCUSATE SODIUM (STOOL SOFTENER) and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MYALGIA (body ache), ASTHENIA (weakness), NAUSEA (Extreme nausea) and INFLUENZA (feels like the flu). At the time of the report, MYALGIA (body ache), ASTHENIA (weakness), NAUSEA (Extreme nausea) and INFLUENZA (feels like the flu) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported.   This case was linked to MOD-2022-588873, MOD-2022-589013, MOD-2022-589031, MOD-2022-589106 (Patient Link).
Sex: M
Vaccine: COVID19, UNK
Symptoms: Autoimmune disorder, Off label use
Clinical narrative: Autoimmune reaction; Off label use; This case was received via another Manufacturer (Reference number: 22K-163-4425755-00) on 14-Jun-2022 and was forwarded to Moderna on 14-Jun-2022.    This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune reaction) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune reaction) (seriousness criterion medically significant) and OFF LABEL USE (Off label use). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune reaction) and OFF LABEL USE (Off label use) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  The daily dose of SPIKEVAX was reported as 1 in 1 once.  The reporter's causality for the event of Autoimmune reaction was not provided. The reporter's causality for the event of Off label use with Humira was no reasonable possibility.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning unspecified age male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of autoimmune disorder, which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serious event off label use is also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness is assessed as per regulatory authority's report.; Sender's Comments: This is a spontaneous case concerning unspecified age male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of autoimmune disorder, which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serious event off label use is also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness is assessed as per regulatory authority's report.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medication information was provided.  No treatment medication were provided.  The reporter's causality for COVID-19 event with Humira was reported as no reasonable possibility.  It was unknown if patient was enrolled in COVID-19 vaccine Trial.  Company comment: This spontaneous case concerns a 60 year old female patient with no reported medical history, who experienced the unexpected non serious of COVID-19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The event was resolving. Co-suspect adalimumab and the ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60 year old female patient with no reported medical history, who experienced the unexpected non serious of COVID-19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The event was resolving. Co-suspect adalimumab and the ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Decreased appetite, Weight
Clinical narrative: Less appetite; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DECREASED APPETITE (Less appetite) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 071F21A, 023M20A and 032L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included blood pressure and prostate. Patient never tested positive or diagnosed with COVID-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetic, Drug allergy (Allergies to some medicines), Pain, Stomach discomfort and Short-term memory loss. Concomitant products included AMLODIPINE for Blood pressure, METFORMIN for Diabetes, MELOXICAM for Pain, DONEPEZIL for Short-term memory loss, FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach discomfort, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D3), SIMVASTATIN and FINASTERIDE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-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 DECREASED APPETITE (Less appetite). At the time of the report, DECREASED APPETITE (Less appetite) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Weight: lost 20 pounds lost 20 pounds. In April 2022, Blood glucose: elevated glucose elevated glucose around the time of the second booster dose.         The concomitant medications finasteride was used for the prostate.  It was reported that, the patient was diabetic and had started having an elevated glucose level around the time patient got the second Moderna COVID-19 booster. Now it was going down, but it was still elevated, and it was a normal elevation for the patient. Further it was stated that, patient had less appetite because patient was old and had lost 20 pounds since January. Glucose was still elevated but normal high.  No treatment medications were reported.