chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: mild case of COVID-19 after the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild case of COVID-19 after the second shot.) in a 69-year-old female patient 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 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. On an unknown date, the patient experienced COVID-19 (mild case of COVID-19 after the second shot.). At the time of the report, COVID-19 (mild case of COVID-19 after the second shot.) outcome was unknown.            Patient's weight was reported to be 130- units not specified.  No concomitant medications were reported. No treatment information was reported.  This case concerns a 69 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI event of COVID-19. The event occurred on an unknown date after the second dose of Moderna COVID-19 vaccine. Information on first dose was not provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-157249, MOD-2021-157264 (Patient Link).; Sender's Comments: This case concerns a 69 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI event of COVID-19. The event occurred on an unknown date after the second dose of Moderna COVID-19 vaccine. Information on first dose was not provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration
Clinical narrative: a little dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (a little dehydrated) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (a little dehydrated). At the time of the report, DEHYDRATION (a little dehydrated) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient did not receive any treatment.   This case was linked to MOD-2021-365126 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site reaction
Clinical narrative: sore muscles in both arms; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) and MYALGIA (sore muscles in both arms) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm) and MYALGIA (sore muscles in both arms). At the time of the report, VACCINATION SITE REACTION (Covid arm) had resolved and MYALGIA (sore muscles in both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-365147 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HEADACHE (headache) and CHILLS (chills). At the time of the report, HEADACHE (headache) and CHILLS (chills) had resolved.            It was also reported that these events /symptoms experienced after second dose were worse than the ones she experienced after the booster shot.  Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-365182 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-364913 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that expired 15OCT2021 was given to some (16) patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that expired 15OCT2021 was given to some (16) patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that expired 15OCT2021 was given to some (16) patients). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that expired 15OCT2021 was given to some (16) patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Fatigue, Loss of personal independence in daily activities
Clinical narrative: heaviness in her chest; "I'm a walker, but I couldn't do that effectively"; whenever she walked, she got very tired and had to stop; thought it looked like asthma but it didn't clear up with medication; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (heaviness in her chest), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I'm a walker, but I couldn't do that effectively"), FATIGUE (whenever she walked, she got very tired and had to stop) and ASTHMA (thought it looked like asthma but it didn't clear up with medication) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Elevated liver enzymes. Concurrent medical conditions included Arthritis, Hypothyroidism and Asthma. Concomitant products included GINGER [ZINGIBER OFFICINALE RHIZOME] and CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +) for Arthritis, OMALIZUMAB (XOLAIR) for Asthma, RAMIPRIL for Hypertension, THYROID (ARMOUR THYROID) for Hypothyroidism, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHEST DISCOMFORT (heaviness in her chest), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I'm a walker, but I couldn't do that effectively"), FATIGUE (whenever she walked, she got very tired and had to stop) and ASTHMA (thought it looked like asthma but it didn't clear up with medication). On 05-Mar-2021, CHEST DISCOMFORT (heaviness in her chest) and ASTHMA (thought it looked like asthma but it didn't clear up with medication) had resolved. On 12-Mar-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I'm a walker, but I couldn't do that effectively") and FATIGUE (whenever she walked, she got very tired and had to stop) 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.   treatment reported was Inhaler   This case was linked to MOD-2021-365222 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pain in the left calf; Muscle pains in thighs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left calf) and MYALGIA (Muscle pains in thighs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 039K20A and 013C20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (infection form dermatological surgery.).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left calf) and MYALGIA (Muscle pains in thighs). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the left calf) and MYALGIA (Muscle pains in thighs) outcome was unknown.            Patient was taking antibiotic as concomitant medication.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Electrocardiogram, Feeling abnormal, Headache
Clinical narrative: headache; fever for 10 to 12 hours; very weak; any time she walked, she felt like she was going to die in the walk; tightness in the chest; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), FEELING ABNORMAL (any time she walked, she felt like she was going to die in the walk), CHEST DISCOMFORT (tightness in the chest), HEADACHE (headache) and PYREXIA (fever for 10 to 12 hours) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Asthma, Hypertension, Arthritis and Allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) and CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for Arthritis, OMALIZUMAB (XOLAIR) for Asthma, RAMIPRIL for Hypertension, THYROID (ARMOUR THYROID) for Hypothyroidism, CALCIUM, VITAMIN D NOS, LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ASTHENIA (very weak), FEELING ABNORMAL (any time she walked, she felt like she was going to die in the walk) and CHEST DISCOMFORT (tightness in the chest). On 25-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever for 10 to 12 hours). On 26-Mar-2021, HEADACHE (headache) and PYREXIA (fever for 10 to 12 hours) had resolved. On 26-Apr-2021, ASTHENIA (very weak), FEELING ABNORMAL (any time she walked, she felt like she was going to die in the walk) and CHEST DISCOMFORT (tightness in the chest) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Electrocardiogram: normal (normal) normal.Symptoms: It was reported that she thought all the symptoms are due to vaccine, she visited to doctor and ER but couldn't find anything wrong, also she visited to heart specialist and by that time all her symptoms were gone, she reported to fear getting booster dose of vaccine. No treatment medications were reported.This case was linked to MOD-2021-365216 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; fever for 10 to 12 hours; very weak; any time she walked, she felt like she was going to die in the walk; tightness in the chest; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), FEELING ABNORMAL (any time she walked, she felt like she was going to die in the walk), CHEST DISCOMFORT (tightness in the chest), HEADACHE (headache) and PYREXIA (fever for 10 to 12 hours) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Asthma, Hypertension, Arthritis and Allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) and CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for Arthritis, OMALIZUMAB (XOLAIR) for Asthma, RAMIPRIL for Hypertension, THYROID (ARMOUR THYROID) for Hypothyroidism, CALCIUM, VITAMIN D NOS, LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ASTHENIA (very weak), FEELING ABNORMAL (any time she walked, she felt like she was going to die in the walk) and CHEST DISCOMFORT (tightness in the chest). On 25-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever for 10 to 12 hours). On 26-Mar-2021, HEADACHE (headache) and PYREXIA (fever for 10 to 12 hours) had resolved. On 26-Apr-2021, ASTHENIA (very weak), FEELING ABNORMAL (any time she walked, she felt like she was going to die in the walk) and CHEST DISCOMFORT (tightness in the chest) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Electrocardiogram: normal (normal) normal.Symptoms: It was reported that she thought all the symptoms are due to vaccine, she visited to doctor and ER but couldn't find anything wrong, also she visited to heart specialist and by that time all her symptoms were gone, she reported to fear getting booster dose of vaccine. No treatment medications were reported.This case was linked to MOD-2021-365216 (Patient Link).
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient was administered a 3rd dose being a 0.5 mL Moderna dose on accident instead of the Pfizer booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient was administered a 3rd dose being a 0.5 mL Moderna dose on accident instead of the Pfizer booster) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient was administered a 3rd dose being a 0.5 mL Moderna dose on accident instead of the Pfizer booster). On 23-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient was administered a 3rd dose being a 0.5 mL Moderna dose on accident instead of the Pfizer booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received first two doses of Pfizer vaccine. No side effects reported by pharmacist. First Pfizer dose on 30-Mar-2021 and second dose on 20-Apr-2021.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 24-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml). At the time of the report, ACCIDENTAL OVERDOSE (received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-366705 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 58 patients received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (58 patients received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (58 patients received dose from expired vial). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (58 patients received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  No treatment medication information was reported.   This case was linked to MOD21-157253, MOD-2021-365271 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow-up received on 27-OCT-2021 and updated event details (event verbatim).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Vomiting
Clinical narrative: diarrhea; Aches; started throwing up; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (Aches), VOMITING (started throwing up) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012FZ11A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac valve disease.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced DIARRHOEA (diarrhea), PAIN (Aches), VOMITING (started throwing up) and CHILLS (chills). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. On 26-Oct-2021, VOMITING (started throwing up) and CHILLS (chills) had resolved. At the time of the report, DIARRHOEA (diarrhea) and PAIN (Aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   This case was linked to MOD-2021-365461 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that nine patients were administered expired dose of the Moderna COVID-19 vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: blood pressure spike of 147/89 10 minutes after booster; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure spike of 147/89 10 minutes after booster) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS, NICOTINIC ACID (NIACIN), OMEPRAZOLE, FISH LIVER OIL and PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure spike of 147/89 10 minutes after booster). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure spike of 147/89 10 minutes after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Blood pressure increased: high (High) Patient reports his normal blood pressure reading is 118 to 122/78 to 82. However, now he is getting a blood pressure spike of 147/89..         Patient received the Moderna COVID-19 booster dose. While sitting at the pharmacy 10 minutes after the vaccine, patient took his blood pressure and got very high reading.  Patient reports he took his blood pressure a few more times on the machine and went down after relaxing. He has a manual blood pressure reader at home, so an hour later, he got back and has been relaxing, but his blood pressure was still high.  Patient took Tylenol before got home  and went to bed with no problems for the last 2 doses of the vaccine. He also took Tylenol this morning, as well as his normal medication regimen. Patient reports he has never taken blood pressure medications.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site oedema, Vaccination site swelling
Clinical narrative: I have a sore arm; Sunday evening injection site became raised red swollen with a hot feel to it; Sunday evening injection site became raised red swollen with a hot feel to it; Sunday evening injection site became raised red swollen with a hot feel to it/The area between my collar bone and shoulder is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I have a sore arm), VACCINATION SITE OEDEMA (Sunday evening injection site became raised red swollen with a hot feel to it), VACCINATION SITE ERYTHEMA (Sunday evening injection site became raised red swollen with a hot feel to it) and VACCINATION SITE SWELLING (Sunday evening injection site became raised red swollen with a hot feel to it/The area between my collar bone and shoulder is swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 013L20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CAPTOPRIL, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE + CAPTOPRIL), DICLOFENAC, LOSARTAN and THIAMAZOLE (METHIMAZOLE) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-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 PAIN IN EXTREMITY (I have a sore arm), VACCINATION SITE OEDEMA (Sunday evening injection site became raised red swollen with a hot feel to it), VACCINATION SITE ERYTHEMA (Sunday evening injection site became raised red swollen with a hot feel to it) and VACCINATION SITE SWELLING (Sunday evening injection site became raised red swollen with a hot feel to it/The area between my collar bone and shoulder is swollen). At the time of the report, PAIN IN EXTREMITY (I have a sore arm), VACCINATION SITE OEDEMA (Sunday evening injection site became raised red swollen with a hot feel to it), VACCINATION SITE ERYTHEMA (Sunday evening injection site became raised red swollen with a hot feel to it) and VACCINATION SITE SWELLING (Sunday evening injection site became raised red swollen with a hot feel to it/The area between my collar bone and shoulder is swollen) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications was not specified No Medical History information was reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: 5 inch rash below the vaccination site; Bump underneath the  vaccination site; Redness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (5 inch rash below the vaccination site), VACCINATION SITE SWELLING (Bump underneath the  vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-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 October 2021, the patient experienced VACCINATION SITE RASH (5 inch rash below the vaccination site), VACCINATION SITE SWELLING (Bump underneath the  vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site). The patient was treated with TRAMADOL for Adverse event, at a dose of 15 mg. At the time of the report, VACCINATION SITE RASH (5 inch rash below the vaccination site), VACCINATION SITE SWELLING (Bump underneath the  vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) outcome was unknown.            Concomitant drugs were not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 1:50 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-366281 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE RECEIVED; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE RECEIVED) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 1:24 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 1:29 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE RECEIVED). On 24-Sep-2021 at 1:29 PM, EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE RECEIVED) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Acne pustular, Defaecation urgency, Diarrhoea, Gastrointestinal pain
Clinical narrative: Diarrhea; Urge to go; Stomach cramps/stomach pain got worse; Gut pain / stomach pain; The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas; Headache; Churning; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DEFAECATION URGENCY (Urge to go), ABDOMINAL PAIN UPPER (Stomach cramps/stomach pain got worse), GASTROINTESTINAL PAIN (Gut pain / stomach pain) and ACNE PUSTULAR (The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (with a very low zero resistance.) and Lung cancer (survivor more than 9 years). Concomitant products included PREDNISONE for COPD.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, 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 DIARRHOEA (Diarrhea), DEFAECATION URGENCY (Urge to go), ABDOMINAL PAIN UPPER (Stomach cramps/stomach pain got worse), GASTROINTESTINAL PAIN (Gut pain / stomach pain), ACNE PUSTULAR (The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas), HEADACHE (Headache) and NAUSEA (Churning). At the time of the report, DIARRHOEA (Diarrhea), DEFAECATION URGENCY (Urge to go), ABDOMINAL PAIN UPPER (Stomach cramps/stomach pain got worse), GASTROINTESTINAL PAIN (Gut pain / stomach pain), HEADACHE (Headache) and NAUSEA (Churning) had not resolved and ACNE PUSTULAR (The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Stomach scan: normal (normal) 2-3 stomach scans and not showing anything.         No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-312685 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received on 27-Oct-2021 and contains no new information .
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Stomach scan
Clinical narrative: Diarrhea; Urge to go; Stomach cramps/stomach pain got worse; Gut pain / stomach pain; The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas; Headache; Churning; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DEFAECATION URGENCY (Urge to go), ABDOMINAL PAIN UPPER (Stomach cramps/stomach pain got worse), GASTROINTESTINAL PAIN (Gut pain / stomach pain) and ACNE PUSTULAR (The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (with a very low zero resistance.) and Lung cancer (survivor more than 9 years). Concomitant products included PREDNISONE for COPD.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, 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 DIARRHOEA (Diarrhea), DEFAECATION URGENCY (Urge to go), ABDOMINAL PAIN UPPER (Stomach cramps/stomach pain got worse), GASTROINTESTINAL PAIN (Gut pain / stomach pain), ACNE PUSTULAR (The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas), HEADACHE (Headache) and NAUSEA (Churning). At the time of the report, DIARRHOEA (Diarrhea), DEFAECATION URGENCY (Urge to go), ABDOMINAL PAIN UPPER (Stomach cramps/stomach pain got worse), GASTROINTESTINAL PAIN (Gut pain / stomach pain), HEADACHE (Headache) and NAUSEA (Churning) had not resolved and ACNE PUSTULAR (The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Stomach scan: normal (normal) 2-3 stomach scans and not showing anything.         No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-312685 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received on 27-Oct-2021 and contains no new information .
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 24-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml). On 24-Oct-2021, ACCIDENTAL OVERDOSE (Received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-365290 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were Reported. No Treatments were Reported.  Moderna vaccine was pulled from the freezer on 13-Oct-2021 with a "use by date" of 12-Nov-2021 (30 days storage viability in the fridge).   This case was linked to MOD-2021-364614, MOD-2021-367363, MOD-2021-367372, MOD-2021-367376 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received contains no new information
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received -No new information
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Neck pain, Pain in extremity
Clinical narrative: Second dose. Aching left arm. Aching neck in left side. Sore and swollen lymph nodes left side of face. Shot was in right arm.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: persistent left shoulder pain. Pain noted the day of the shot and has persisted 3 weeks after the shot. No swelling or lump. He has trouble raising his arm up.  Not improving. He has been referred to physical therapy and orthopedics. Unclear at this time if related to vaccine.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Discomfort, Flank pain, Headache, Pain in extremity
Clinical narrative: Headache for both vaccines, some pain in arm for both vaccines. Day 4 after the second vaccine, I started to experience pain in my mid-side/back when I woke up, around 0600. It has now been 2 weeks since this vaccine, and I am still feeling this pain, but only with pressure. If I stretch, I feel discomfort. The area it hurts is not a very large spot. I cannot feel if it is a lump or has taken a shape, where it is located on my back/side, so I cannot tell if this is just my skin or something underneath. I looked in a mirror and it does not appear to have any physical appearance, but it hurts with light pressure.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: low energy, kind of out of it; mild headache/ wasnt too bad; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy, kind of out of it) and HEADACHE (mild headache/ wasnt too bad) in an adult male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (low energy, kind of out of it) and HEADACHE (mild headache/ wasnt too bad). At the time of the report, ASTHENIA (low energy, kind of out of it) and HEADACHE (mild headache/ wasnt too bad) had resolved.            No treatment medication was reported. No Concomitant medication was reported. No lab data was provided. Patient age group is between 25-49.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Affective disorder, Chest discomfort, Depression, Fatigue, Feeling abnormal
Clinical narrative: Headache, sensation of hot and cold, depression, fatigue, mood disorder, brain fog. Most noticeable and reason I am writing is due to heart palpitations felt on and off for almost 3 weeks. These were accompanied by sense of pre panic attack type tightness around solar plexus area and need to take deep breaths almost to try to calm my nervous system and reset my irregular heart Rythm.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Heart rate irregular, Palpitations
Clinical narrative: Headache, sensation of hot and cold, depression, fatigue, mood disorder, brain fog. Most noticeable and reason I am writing is due to heart palpitations felt on and off for almost 3 weeks. These were accompanied by sense of pre panic attack type tightness around solar plexus area and need to take deep breaths almost to try to calm my nervous system and reset my irregular heart Rythm.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Pain, Pyrexia
Clinical narrative: metallic taste in my mouth late last night and this morning; Aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in my mouth late last night and this morning), PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) 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.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. 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. On 25-Oct-2021, the patient experienced DYSGEUSIA (metallic taste in my mouth late last night and this morning), PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, DYSGEUSIA (metallic taste in my mouth late last night and this morning), PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-364243 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Anovulatory cycle, Pregnancy test negative, Stress
Clinical narrative: Received dose one of Moderna covid vaccine on 3/12/21 lot number 001B21A. Received dose two of Moderna covid vaccine on 4/11/21 lot number 037A21B. At the time of vaccine, patient was 31 years old and had a regular menstrual cycle of ~32 days for almost 3 years straight. Since getting vaccinated, all menstrual cycle stages ceased. No ovulation, periods, etc. As of 11/3/21, it is now 7 months from date of second vaccine. Had a full gynecologist visit in February prior to vaccination, with many labs done and every deemed adequate. To add, there is no pregnancy with several tests being administered. Turned 32 in June and while yes, stress and factors do exist, starting to consider this a side effect of the vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 25-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U015689, has been verified to be a valid lot number, expiration date was reported as 13-MAY-2023, but upon internal validation established as 18-MAY-2023, 0.5 milliliter, strength was not reported) subcutaneously (SQ) for prophylaxis.         The vaccine administered after temperature excursion. Administered varicella virus vaccine live (oka/merck) (VARIVAX) were stored at 25.9 degrees Fahrenheit (F) for 1 hour and 30 minutes. There was no previous temperature excursion reported. No other adverse events reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, No adverse event, Underdose
Clinical narrative: No additional AE reported; spit up; This spontaneous report was received from a physician referring to a 2 months old patient of unknown gender.  The patient's concomitant medication, pertinent medical history and drug allergies or reactions were unknown.      On 18-OCT-2021, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, lot# and expiration date were unknown, 2 ml) orally as routine vaccination. During vaccination, the patient split up the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (under dose). It was unsure if the patient received any amount of the vaccine. No additional information and adverse event were provided (no adverse event).