chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pruritus, Pyrexia, Rash
Clinical narrative: Itchy all over; Redness; Itching at the site of the injection; Fatigue/Feeling tired; Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face; Muscle pain at the site of the injection/It was very sore; did feel the chills as the temperature had gone up a bit; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy all over), ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the site of the injection), FATIGUE (Fatigue/Feeling tired) and RASH (Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 030H21B, 044B21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Stays away from Ibuprofen but in past got a red rash from ibuprofen in past).   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-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 (Itchy all over), ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the site of the injection), FATIGUE (Fatigue/Feeling tired), RASH (Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face), VACCINATION SITE PAIN (Muscle pain at the site of the injection/It was very sore) and PYREXIA (did feel the chills as the temperature had gone up a bit). At the time of the report, PRURITUS (Itchy all over), VACCINATION SITE PRURITUS (Itching at the site of the injection), FATIGUE (Fatigue/Feeling tired), RASH (Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face), VACCINATION SITE PAIN (Muscle pain at the site of the injection/It was very sore) and PYREXIA (did feel the chills as the temperature had gone up a bit) outcome was unknown and ERYTHEMA (Redness) was resolving.            No concomitant medication reported.  No treatment medication was reported only reported that patient rested, drinking water, eating minimal.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy all over; Redness; Itching at the site of the injection; Fatigue/Feeling tired; Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face; Muscle pain at the site of the injection/It was very sore; did feel the chills as the temperature had gone up a bit; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy all over), ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the site of the injection), FATIGUE (Fatigue/Feeling tired) and RASH (Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 030H21B, 044B21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Stays away from Ibuprofen but in past got a red rash from ibuprofen in past).   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-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 (Itchy all over), ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the site of the injection), FATIGUE (Fatigue/Feeling tired), RASH (Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face), VACCINATION SITE PAIN (Muscle pain at the site of the injection/It was very sore) and PYREXIA (did feel the chills as the temperature had gone up a bit). At the time of the report, PRURITUS (Itchy all over), VACCINATION SITE PRURITUS (Itching at the site of the injection), FATIGUE (Fatigue/Feeling tired), RASH (Rash was all over the torso of the body (front and back torso) slightly on the neck but not on the face), VACCINATION SITE PAIN (Muscle pain at the site of the injection/It was very sore) and PYREXIA (did feel the chills as the temperature had gone up a bit) outcome was unknown and ERYTHEMA (Redness) was resolving.            No concomitant medication reported.  No treatment medication was reported only reported that patient rested, drinking water, eating minimal.
Sex: U
Vaccine: COVID19
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  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (unknown drug).   On 15-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021 at 11:00 AM, received second 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 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Treatment details was not reported by the reporter.  It was reported that patient has taken Pfizer on 19 May 2022 for the treatment of COVID-19 and experienced the event- Metallic taste after taking the first dose ,on 19 May 2022 12:00  and the outcome was unknown.  The device date was reported as 20-May-2022.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the second dose of mRNA-1273 vaccine. It was reported that patient has taken Pfizer on 19 May 2022 for the treatment of COVID-19 and experienced Metallic taste after taking the first dose of Pfizer. 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 patient of an unknown age and gender with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the second dose mRNA-1273 vaccine. It was reported that patient has taken Pfizer on 19 May 2022 for the treatment of COVID-19 and experienced Metallic taste after taking the first dose of Pfizer. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired Moderna COVID Vaccine as a second booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired Moderna COVID Vaccine as a second booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 15-Mar-2021, Hyperlipidemia since 15-Mar-2021, Diabetes since 15-Mar-2021 and Urinary retention since 15-Mar-2021.   On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired Moderna COVID Vaccine as a second booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired Moderna COVID Vaccine as a second booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. It was reported that patient did not experience any other adverse event. No treatment were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain, Vaccination site rash, Vomiting
Clinical narrative: Fatigue; quite sore; Left arm 5 inch circumference rash that went down underneath my arm; violent case of chills; vomiting; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (quite sore), VACCINATION SITE RASH (Left arm 5 inch circumference rash that went down underneath my arm), CHILLS (violent case of chills) and VOMITING (vomiting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 019F21A, 002A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (quite sore), VACCINATION SITE RASH (Left arm 5 inch circumference rash that went down underneath my arm), CHILLS (violent case of chills) and VOMITING (vomiting). On 20-May-2022, CHILLS (violent case of chills) and VOMITING (vomiting) had resolved. At the time of the report, FATIGUE (Fatigue) had not resolved, VACCINATION SITE PAIN (quite sore) outcome was unknown and VACCINATION SITE RASH (Left arm 5 inch circumference rash that went down underneath my arm) was resolving.     No concomitant medications was provided by the reporter. Reporter stated 6 hours after vaccine, experienced violent case of chills, vomiting. Wrapped up in a bunch of blankets, drank hot water. Left arm 5-inch circumference rash that went down underneath my arm, no knot at the site. Rash, it's all going away. Chills lasted for about 1 hour. Vomiting's lasted for about an hour; vomiting started half hour after chills started. Chills started to go away when vomiting was increasing. No treatment medications was provided by the reporter.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Adverse drug reaction, Fatigue, Hot flush, Tinnitus
Clinical narrative: Tinnitus; Hot flashes; Drug side effect; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), HOT FLUSH (Hot flashes), ADVERSE DRUG REACTION (Drug side effect) and FATIGUE (Tiredness) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LEUPRORELIN ACETATE (LUPRON DEPOT) injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and LEUPRORELIN ACETATE (LUPRON DEPOT) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (Tinnitus), HOT FLUSH (Hot flashes), ADVERSE DRUG REACTION (Drug side effect) and FATIGUE (Tiredness). At the time of the report, TINNITUS (Tinnitus), HOT FLUSH (Hot flashes), ADVERSE DRUG REACTION (Drug side effect) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were reported. Causality for reported drug Lupron depot was not reported for event Tinnitus, hot flash, drug side effect, and tiredness. No treatment information were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypersensitivity, Immunisation reaction, Infection
Clinical narrative: Hotness; not being able to sleep; lethargy; neck pain; amount swelled either infected or allergic reaction; infected; Itchiness / itching at the injection site; Arm swelled; Redness; joint pain; headache; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain) and IMMUNISATION REACTION (amount swelled either infected or allergic reaction) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031m20a and 025l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION, MILNACIPRAN HYDROCHLORIDE (SAVELLA), LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain), IMMUNISATION REACTION (amount swelled either infected or allergic reaction), INFECTION (infected), VACCINATION SITE PRURITUS (Itchiness / itching at the injection site), VACCINATION SITE SWELLING (Arm swelled), VACCINATION SITE ERYTHEMA (Redness), ARTHRALGIA (joint pain), HEADACHE (headache) and HYPERSENSITIVITY (allergic reaction). At the time of the report, VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain), IMMUNISATION REACTION (amount swelled either infected or allergic reaction), INFECTION (infected), VACCINATION SITE PRURITUS (Itchiness / itching at the injection site), VACCINATION SITE SWELLING (Arm swelled), VACCINATION SITE ERYTHEMA (Redness), ARTHRALGIA (joint pain), HEADACHE (headache) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            No treatment medications were provided by the reporter.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Neck pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Hotness; not being able to sleep; lethargy; neck pain; amount swelled either infected or allergic reaction; infected; Itchiness / itching at the injection site; Arm swelled; Redness; joint pain; headache; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain) and IMMUNISATION REACTION (amount swelled either infected or allergic reaction) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031m20a and 025l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION, MILNACIPRAN HYDROCHLORIDE (SAVELLA), LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain), IMMUNISATION REACTION (amount swelled either infected or allergic reaction), INFECTION (infected), VACCINATION SITE PRURITUS (Itchiness / itching at the injection site), VACCINATION SITE SWELLING (Arm swelled), VACCINATION SITE ERYTHEMA (Redness), ARTHRALGIA (joint pain), HEADACHE (headache) and HYPERSENSITIVITY (allergic reaction). At the time of the report, VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain), IMMUNISATION REACTION (amount swelled either infected or allergic reaction), INFECTION (infected), VACCINATION SITE PRURITUS (Itchiness / itching at the injection site), VACCINATION SITE SWELLING (Arm swelled), VACCINATION SITE ERYTHEMA (Redness), ARTHRALGIA (joint pain), HEADACHE (headache) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            No treatment medications were provided by the reporter.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hotness; not being able to sleep; lethargy; neck pain; amount swelled either infected or allergic reaction; infected; Itchiness / itching at the injection site; Arm swelled; Redness; joint pain; headache; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain) and IMMUNISATION REACTION (amount swelled either infected or allergic reaction) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031m20a and 025l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION, MILNACIPRAN HYDROCHLORIDE (SAVELLA), LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain), IMMUNISATION REACTION (amount swelled either infected or allergic reaction), INFECTION (infected), VACCINATION SITE PRURITUS (Itchiness / itching at the injection site), VACCINATION SITE SWELLING (Arm swelled), VACCINATION SITE ERYTHEMA (Redness), ARTHRALGIA (joint pain), HEADACHE (headache) and HYPERSENSITIVITY (allergic reaction). At the time of the report, VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain), IMMUNISATION REACTION (amount swelled either infected or allergic reaction), INFECTION (infected), VACCINATION SITE PRURITUS (Itchiness / itching at the injection site), VACCINATION SITE SWELLING (Arm swelled), VACCINATION SITE ERYTHEMA (Redness), ARTHRALGIA (joint pain), HEADACHE (headache) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            No treatment medications were provided by the reporter.   Reporter did not allow further contact
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Peripheral swelling
Clinical narrative: COVID-19; Swelling of hands and fingers, as well as middle of arch of left foot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PERIPHERAL SWELLING (Swelling of hands and fingers, as well as middle of arch of left foot) in a 33-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Kidney stones and Sleep apnea. Previously administered products included for Product used for unknown indication: Azythromyacin. Past adverse reactions to the above products included Allergy with Azythromyacin. Concurrent medical conditions included Gout, Allergy to nuts (Name of drug reported as unknown) and Dairy intolerance (Name of drug reported as unknown). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 24-Apr-2022 to an unknown date for an unknown indication.   On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022 at 1:15 PM, the patient experienced PERIPHERAL SWELLING (Swelling of hands and fingers, as well as middle of arch of left foot). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and PERIPHERAL SWELLING (Swelling of hands and fingers, as well as middle of arch of left foot) was resolving.            No treatment medications were reported.  company comment: This spontaneous case concerns a 33-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 . The event Covid-19 occurred unspecified days after second dose of mRNA-1273 vaccine. Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID-19(18-may-2022 to 20-may-2022) 3 days, pheripheral swelling is noted one day after RITONAVIR (Paxlovid) treatment. 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 33-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 . The event Covid-19 occurred unspecified days after second dose of mRNA-1273 vaccine. Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID-19(18-may-2022 to 20-may-2022) 3 days, pheripheral swelling is noted one day after RITONAVIR (Paxlovid) treatment. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Magnetic resonance imaging, Tendon rupture
Clinical narrative: Biceps tendon rupture; This spontaneous case was reported by a patient and describes the occurrence of TENDON RUPTURE (Biceps tendon rupture) 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 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 TENDON RUPTURE (Biceps tendon rupture). At the time of the report, TENDON RUPTURE (Biceps tendon rupture) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Magnetic resonance imaging: results not reported Results not reported.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Humira, Action taken was unknown, dechallenge was not applicable for event Bicep's tendon rupture. The reporter's causality for co-suspect Humira for the event Biceps tendon rupture was probable.  No concomitant drug reported. No treatment information was provided by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received expired Moderna COVID-19 vaccine for his first booster; The vial was expired on 23-Mar-2022 and stored in refrigerator on 16-May-2022 before administration on 20-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna COVID-19 vaccine for his first booster) and PRODUCT STORAGE ERROR (The vial was expired on 23-Mar-2022 and stored in refrigerator on 16-May-2022 before administration on 20-May-2022) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B and 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression (Immunosuppresssion due to drug therapy).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, the patient experienced PRODUCT STORAGE ERROR (The vial was expired on 23-Mar-2022 and stored in refrigerator on 16-May-2022 before administration on 20-May-2022). On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna COVID-19 vaccine for his first booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired Moderna COVID-19 vaccine for his first booster) and PRODUCT STORAGE ERROR (The vial was expired on 23-Mar-2022 and stored in refrigerator on 16-May-2022 before administration on 20-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter occupation was provided as a pharmacy technician. The patient had received third full Moderna COVID-19 vaccine dose. No concomitant medications were reported. It was reported that the nurse had a lot number of older vaccine and expiration date was 23-Mar-2022. This was inadvertently mixed in with other Moderna COVID-19 vaccines with newer lot numbers and that were still within their manufacturer expiration dates. The vial was initially stored in the refrigerator on 16-May-2022. The vial had not undergone any temperature excursions. No adverse reactions or other side effects were noted.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation reaction, Mobility decreased, Tinnitus
Clinical narrative: bad reaction/Booster was the worst; Three days couldn't get out of bed until third day; Seems like  tinnitus left ear; tired; Headache; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (bad reaction/Booster was the worst), MOBILITY DECREASED (Three days couldn't get out of bed until third day), TINNITUS (Seems like  tinnitus left ear), FATIGUE (tired) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 046B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-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 IMMUNISATION REACTION (bad reaction/Booster was the worst), MOBILITY DECREASED (Three days couldn't get out of bed until third day), TINNITUS (Seems like  tinnitus left ear), FATIGUE (tired) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, IMMUNISATION REACTION (bad reaction/Booster was the worst), MOBILITY DECREASED (Three days couldn't get out of bed until third day), TINNITUS (Seems like  tinnitus left ear), FATIGUE (tired) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were provided by the reporter.   Headache had lingered and patient got it more often. Per report, patient was not sure if it was a good thing to get second booster.   This case was linked to MOD-2021-091871, MOD-2021-091890 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 24Mar2021 and 2nd dose on 14Apr2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 24Mar2021 and 2nd dose on 14Apr2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Motor vehicle accident (Car accident.), Fibrillation atrial (He had ablation in 2014, which took away the a fib.) and Cardiac ablation.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 24Mar2021 and 2nd dose on 14Apr2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 24Mar2021 and 2nd dose on 14Apr2021) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2022-573333 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Muscular weakness
Clinical narrative: My legs cramped and were so weak; My legs cramped and were so weak; I struggled to get of the toilet.; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (My legs cramped and were so weak), MUSCLE SPASMS (My legs cramped and were so weak) and MOBILITY DECREASED (I struggled to get of the toilet.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (My legs cramped and were so weak), MUSCLE SPASMS (My legs cramped and were so weak) and MOBILITY DECREASED (I struggled to get of the toilet.). At the time of the report, MUSCULAR WEAKNESS (My legs cramped and were so weak), MUSCLE SPASMS (My legs cramped and were so weak) and MOBILITY DECREASED (I struggled to get of the toilet.) outcome was unknown.            No concomitant medication was reported. . It was reported that second Covid vaccine and booster were what  would call severe. Fever, chills so severe, patient had 4 layers plus a winter coat and heating pad. Body pain lasted 48 hours. For the 4th booster, patient switched to Moderna and lost another two days with a worse reaction. Patient legs cramped and were so weak, he/she struggled to get of the toilet. Patient asked If there were no breathing problems, it's all dismissed. It was stated that patient knew another booster would come in the future. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Bad technique used to administer the vaccine/ it was "not really as bad as the first"; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Bad technique used to administer the vaccine/ it was "not really as bad as the first") 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 November 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Bad technique used to administer the vaccine/ it was "not really as bad as the first"). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Bad technique used to administer the vaccine/ it was "not really as bad as the first") outcome was unknown.            No concomitant medications were provided. Patient complained about the bad technique used to administer the vaccine to her for also her first booster and it was not really as bad as the first. Patient mentioned that she received the first booster dose on Nov last year. No treatment medications were reported.   This case was linked to MOD-2021-226740, MOD-2021-025166 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: Patient was immunocomprised but received booster dose on 28-Feb-2022 instead of third dose; Unknown whether third dose was full dose or half dose for immunocompromised patient; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was immunocomprised but received booster dose on 28-Feb-2022 instead of third dose) and ACCIDENTAL UNDERDOSE (Unknown whether third dose was full dose or half dose for immunocompromised patient) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0075212A, 022B21A and 0A0C21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic inflammatory demyelinating polyradiculoneuropathy and Cutaneous lupus erythematosus.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was immunocomprised but received booster dose on 28-Feb-2022 instead of third dose) and ACCIDENTAL UNDERDOSE (Unknown whether third dose was full dose or half dose for immunocompromised patient). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was immunocomprised but received booster dose on 28-Feb-2022 instead of third dose) and ACCIDENTAL UNDERDOSE (Unknown whether third dose was full dose or half dose for immunocompromised patient) outcome was unknown.            No concomitant medications information was not reported.  Patient stated that she was very confused about her personal booster schedule. After she had the second dose of the initial vaccine, she was told that the booster is in 6 months. When she went back, the pharmacist told her she was way overdue. She doesn't know when she was supposed to get the second booster. It was stated that she doesn't know what dosage she received. She received all three doses from the same vaccination facility.   No treatment medications were provided.   This case was linked to MOD-2021-209253 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Low Grade Fever after first shot; Fatigue after first shot; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low Grade Fever after first shot) and FATIGUE (Fatigue after first shot) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease, Atrial fibrillation and GERD. Concomitant products included METOPROLOL SUCCINATE, THIAMAZOLE (METHIMAZOLE) and FAMOTIDINE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Low Grade Fever after first shot) and FATIGUE (Fatigue after first shot). On 01-Mar-2021, PYREXIA (Low Grade Fever after first shot) and FATIGUE (Fatigue after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant products reported as unknown supplements which patient declined to naming them  Patient was back to base line on 01-MAR-2021.  No treatment information was reported.   This case was linked to MOD-2022-573656, MOD-2022-573658, MOD-2022-573657 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Fatigue, Pyrexia
Clinical narrative: Stayed in bed much of the day after 2nd shot; Fever 99.7F after 2nd shot; Fatigue after 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (Stayed in bed much of the day after 2nd shot), PYREXIA (Fever 99.7F after 2nd shot) and FATIGUE (Fatigue after 2nd shot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, GERD and Graves' disease. Concomitant products included METOPROLOL SUCCINATE, METHIMAZOLE and FAMOTIDINE for an unknown indication.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced BEDRIDDEN (Stayed in bed much of the day after 2nd shot), PYREXIA (Fever 99.7F after 2nd shot) and FATIGUE (Fatigue after 2nd shot). On 29-Mar-2021, BEDRIDDEN (Stayed in bed much of the day after 2nd shot), PYREXIA (Fever 99.7F after 2nd shot) and FATIGUE (Fatigue after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 99.7f (High) 99.7F, her baseline temperature is 98F or a little below.         Patient reported of taking unknown supplements and declined for its name. Patient was back to base line on 29 Mar 2021. No treatment medication was reported.   This case was linked to MOD-2022-573655, MOD-2022-573657, MOD-2022-573658 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Hard to function after 2nd booster; Extreme fatigue after 2nd booster/still has Extreme fatigue; Low grade fever after 2nd booster; This spontaneous case was reported by a medical assistant and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard to function after 2nd booster), FATIGUE (Extreme fatigue after 2nd booster/still has Extreme fatigue) and PYREXIA (Low grade fever after 2nd booster) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 013F21A, 026A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, GERD and Graves' disease. Concomitant products included METOPROLOL SUCCINATE, THIAMAZOLE (METHIMAZOLE) and FAMOTIDINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient experienced FATIGUE (Extreme fatigue after 2nd booster/still has Extreme fatigue) and PYREXIA (Low grade fever after 2nd booster). On 21-May-2022, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard to function after 2nd booster). In May 2022, PYREXIA (Low grade fever after 2nd booster) had resolved. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard to function after 2nd booster) outcome was unknown and FATIGUE (Extreme fatigue after 2nd booster/still has Extreme fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported of taking unknown supplements and declined for its name. Patient believed that with 2nd booster shot the side effects progressed more No treatment medications was reported.   This case was linked to MOD-2022-573656, MOD-2022-573658 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rebound effect
Clinical narrative: Rebound symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of REBOUND EFFECT (Rebound symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient had many unspecified medical history or concurrent conditions.  Concurrent medical conditions included Drug allergy (The patient had allergy to unspecified drug.).   On 08-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced REBOUND EFFECT (Rebound symptoms). At the time of the report, REBOUND EFFECT (Rebound symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's race was reported. The patient was taking other unspecified medications/products within 2 weeks of starting COVID-19 treatment. Device Date : 23-May-2022
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Chronic diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Chronic diarrhea) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Chronic diarrhea). At the time of the report, DIARRHOEA (Chronic diarrhea) outcome was unknown.            Concomitant medications includes were blood pressure medication. Treatment medications included were steroids medication. but when they stopped the steroids, the diarrhea started to come back again. Patient had received the 2nd dose in Jul-2021. Patient reported chronic diarrhea, and said had gotten all sorts of tests and everything came out negative. They even had a colonoscopy done.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 1 dose was given past 30 day use by date; 1 dose was given past 30 day use by date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was given past 30 day use by date) and PRODUCT STORAGE ERROR (1 dose was given past 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was given past 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 dose was given past 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose was given past 30 day use by date) and PRODUCT STORAGE ERROR (1 dose was given past 30 day use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 19Apr2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: like a vomiting in the back of her throat; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and  (like a vomiting in the back of her throat) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2020, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). In February 2022, the patient experienced NAUSEA (like a vomiting in the back of her throat). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and NAUSEA (like a vomiting in the back of her throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  On an unspecified date in Feb-2022, the upset stomach was more like it would come back up, like a vomiting in the back of her throat.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I am still experiencing symptoms due to the vaccine,side effects of the Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I am still experiencing symptoms due to the vaccine,side effects of the Moderna Covid vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received 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 (I am still experiencing symptoms due to the vaccine,side effects of the Moderna Covid vaccine). At the time of the report, IMMUNISATION REACTION (I am still experiencing symptoms due to the vaccine,side effects of the Moderna Covid vaccine) had not resolved.            No relevant concomitant medications were reported. It was reported that patient received this vaccine and patient was still experiencing symptoms due to the vaccine until on the day of reporting that was 24-MAY-2022. Treatment medication was not provided by the reporter.