chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Myalgia, Neck pain, Swelling
Clinical narrative: Pain at the injection site/Tenderness at the injection site (left arm); muscle pain; joint pain; headaches; migraine; neck pain "like snapping a rubber band"; a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy; a redness on the muscle area/a red line around the arm; Swelling; fatigue; chills; Feels a very nasty taste when is gargling and brushing the teeth.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches) and MIGRAINE (migraine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches), MIGRAINE (migraine), NECK PAIN (neck pain "like snapping a rubber band"), FACIAL PAIN (a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy), ERYTHEMA (a redness on the muscle area/a red line around the arm), SWELLING (Swelling), FATIGUE (fatigue), CHILLS (chills) and TASTE DISORDER (Feels a very nasty taste when is gargling and brushing the teeth.). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches), MIGRAINE (migraine), NECK PAIN (neck pain "like snapping a rubber band"), FACIAL PAIN (a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy), ERYTHEMA (a redness on the muscle area/a red line around the arm), SWELLING (Swelling), FATIGUE (fatigue), CHILLS (chills) and TASTE DISORDER (Feels a very nasty taste when is gargling and brushing the teeth.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Vaccination site pain
Clinical narrative: Pain at the injection site/Tenderness at the injection site (left arm); muscle pain; joint pain; headaches; migraine; neck pain "like snapping a rubber band"; a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy; a redness on the muscle area/a red line around the arm; Swelling; fatigue; chills; Feels a very nasty taste when is gargling and brushing the teeth.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches) and MIGRAINE (migraine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches), MIGRAINE (migraine), NECK PAIN (neck pain "like snapping a rubber band"), FACIAL PAIN (a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy), ERYTHEMA (a redness on the muscle area/a red line around the arm), SWELLING (Swelling), FATIGUE (fatigue), CHILLS (chills) and TASTE DISORDER (Feels a very nasty taste when is gargling and brushing the teeth.). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches), MIGRAINE (migraine), NECK PAIN (neck pain "like snapping a rubber band"), FACIAL PAIN (a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy), ERYTHEMA (a redness on the muscle area/a red line around the arm), SWELLING (Swelling), FATIGUE (fatigue), CHILLS (chills) and TASTE DISORDER (Feels a very nasty taste when is gargling and brushing the teeth.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Soreness around the injection site; Itchiness around the injection site; Swelling around the injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039a21a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Soreness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        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.   Concomitant medication includes blood pressure medication, cholesterol medication, and supplements.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Headache; Fatigue; Pain in armpit; Sore throat; This spontaneous case was reported by a physician and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), FATIGUE (Fatigue) and AXILLARY PAIN (Pain in armpit) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to Topamax.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and AXILLARY PAIN (Pain in armpit). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), FATIGUE (Fatigue) and AXILLARY PAIN (Pain in armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes Water pill for blood pressure. treatment information includes Cough drops, Lozenges, Took lots of water.
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Dyspnoea, Fatigue
Clinical narrative: Indigestion; tired easily; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Indigestion), FATIGUE (tired easily) and DYSPNOEA (difficulty breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DYSPEPSIA (Indigestion), FATIGUE (tired easily) and DYSPNOEA (difficulty breathing). The patient was treated with CITRIC ACID, SODIUM BICARBONATE (ALKA-SELTZER HEARTBURN RELIEF) from 30-Mar-2021 to 03-Apr-2021 for Indigestion, at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (Indigestion), FATIGUE (tired easily) and DYSPNOEA (difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Alka-Seltzer or Alka-Seltzer plus Concomitants were not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Fever 100.6 degree temperature; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (Shivers) and PYREXIA (Fever 100.6 degree temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced CHILLS (Shivers). On 01-Apr-2021, the patient experienced PYREXIA (Fever 100.6 degree temperature). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (Shivers) and PYREXIA (Fever 100.6 degree temperature) outcome was unknown.        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 details were not reported by the reporter.   This case was linked to MOD-2021-066171 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). On 02-Apr-2021, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment products information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: sore arm; feeling sick; very nauseous/queasy feeling; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (feeling sick), NAUSEA (very nauseous/queasy feeling) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (feeling sick), NAUSEA (very nauseous/queasy feeling) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (feeling sick), NAUSEA (very nauseous/queasy feeling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: injection site area was itching really bad; red splotchiness; injection site red splotchiness; feverish; injection site was firm; injection site pain; headache; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PRURITUS (injection site area was itching really bad) and VACCINATION SITE RASH (red splotchiness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ETODOLAC and CANNABIDIOL, CANNABIS SATIVA SEED OIL, MEDIUM-CHAIN TRIGLYCERIDES (CBD CANNABIDIOL HANFOEL EXTRAKT) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site pain), HEADACHE (headache) and FATIGUE (fatigue). On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (injection site area was itching really bad), VACCINATION SITE RASH (red splotchiness), VACCINATION SITE ERYTHEMA (injection site red splotchiness), PYREXIA (feverish) and VACCINATION SITE SWELLING (injection site was firm). At the time of the report, VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PRURITUS (injection site area was itching really bad), VACCINATION SITE RASH (red splotchiness), VACCINATION SITE ERYTHEMA (injection site red splotchiness), PYREXIA (feverish) and VACCINATION SITE SWELLING (injection site was firm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: injection site area was itching really bad; red splotchiness; injection site red splotchiness; feverish; injection site was firm; injection site pain; headache; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PRURITUS (injection site area was itching really bad) and VACCINATION SITE RASH (red splotchiness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ETODOLAC and CANNABIDIOL, CANNABIS SATIVA SEED OIL, MEDIUM-CHAIN TRIGLYCERIDES (CBD CANNABIDIOL HANFOEL EXTRAKT) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site pain), HEADACHE (headache) and FATIGUE (fatigue). On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (injection site area was itching really bad), VACCINATION SITE RASH (red splotchiness), VACCINATION SITE ERYTHEMA (injection site red splotchiness), PYREXIA (feverish) and VACCINATION SITE SWELLING (injection site was firm). At the time of the report, VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PRURITUS (injection site area was itching really bad), VACCINATION SITE RASH (red splotchiness), VACCINATION SITE ERYTHEMA (injection site red splotchiness), PYREXIA (feverish) and VACCINATION SITE SWELLING (injection site was firm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Vaccination site erythema
Clinical narrative: Difficulty  breathing; multiple red, hot, itchy lumps at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty  breathing) and VACCINATION SITE ERYTHEMA (multiple red, hot, itchy lumps at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included WARFARIN, ATORVASTATIN, METOPROLOL and PARACETAMOL (TYLENOL) 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) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced DYSPNOEA (Difficulty  breathing) and VACCINATION SITE ERYTHEMA (multiple red, hot, itchy lumps at the injection site). At the time of the report, DYSPNOEA (Difficulty  breathing) and VACCINATION SITE ERYTHEMA (multiple red, hot, itchy lumps at the injection site) was resolving.            Concomitant medications taken were Heart medication No treatment medications were reported Action taken with mRNA-1273 in response to the events were Not Applicable
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Warm Transferred from Moderna Customer Care Case No.00135704. HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered to 63 Patients. She provided all requested information of patients who received the effected Vaccine.   This case was linked to MOD21-068792, MOD21-068791, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068788, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068786, MOD21-068717, MOD21-068718, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068785, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068773, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781, MOD21-068782, MOD21-068783, MOD21-068784 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-068792: MOD21-068791: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068788: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068786: MOD21-068717: MOD21-068718: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068785: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068773: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782: MOD21-068783: MOD21-068784:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Skin burning sensation, Vaccination site pain
Clinical narrative: burning sensation over the skin in lower extremities on both sides; pain in extremity; Vaccination site pain; burning sensation over the skin underneath both arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in extremity), VACCINATION SITE PAIN (Vaccination site pain), SKIN BURNING SENSATION (burning sensation over the skin underneath both arms) and BURNING SENSATION (burning sensation over the skin in lower extremities on both sides) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in extremity), VACCINATION SITE PAIN (Vaccination site pain) and SKIN BURNING SENSATION (burning sensation over the skin underneath both arms). On an unknown date, the patient experienced BURNING SENSATION (burning sensation over the skin in lower extremities on both sides). On 08-Mar-2021, PAIN IN EXTREMITY (pain in extremity) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. At the time of the report, SKIN BURNING SENSATION (burning sensation over the skin underneath both arms) and BURNING SENSATION (burning sensation over the skin in lower extremities on both sides) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant  medications  provided  was Atorvastatin,blood pressure medication Treatment information  provided was Tylenol.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Eating disorder, Fatigue, Headache
Clinical narrative: diarrhea; little energy, very tired; wants to lie down all the time; can't get a meal down; little energy, very tired; annoying headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ASTHENIA (little energy, very tired), HYPOKINESIA (wants to lie down all the time), EATING DISORDER (can't get a meal down) and FATIGUE (little energy, very tired) in a 66-year-old female patient 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 Cancer since 2014, Chronic obstructive pulmonary disease and Heart disease, unspecified.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (little energy, very tired), HYPOKINESIA (wants to lie down all the time), EATING DISORDER (can't get a meal down), FATIGUE (little energy, very tired) and HEADACHE (annoying headache). At the time of the report, DIARRHOEA (diarrhea), ASTHENIA (little energy, very tired), HYPOKINESIA (wants to lie down all the time), EATING DISORDER (can't get a meal down), FATIGUE (little energy, very tired) and HEADACHE (annoying headache) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia
Clinical narrative: diarrhea; little energy, very tired; wants to lie down all the time; can't get a meal down; little energy, very tired; annoying headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ASTHENIA (little energy, very tired), HYPOKINESIA (wants to lie down all the time), EATING DISORDER (can't get a meal down) and FATIGUE (little energy, very tired) in a 66-year-old female patient 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 Cancer since 2014, Chronic obstructive pulmonary disease and Heart disease, unspecified.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (little energy, very tired), HYPOKINESIA (wants to lie down all the time), EATING DISORDER (can't get a meal down), FATIGUE (little energy, very tired) and HEADACHE (annoying headache). At the time of the report, DIARRHOEA (diarrhea), ASTHENIA (little energy, very tired), HYPOKINESIA (wants to lie down all the time), EATING DISORDER (can't get a meal down), FATIGUE (little energy, very tired) and HEADACHE (annoying headache) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Malaise, Mass
Clinical narrative: achy; just did not feel good; redness and puffiness are still present; It looks like a knot; soreness; redness and puffiness are still present; Swollen, red, and itchy; very itchy; Swollen, red, and itchy; Swollen, red, and itchy; headache; body chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), MALAISE (just did not feel good), SKIN SWELLING (redness and puffiness are still present), MASS (It looks like a knot) and PAIN (soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy and Drug allergy (codeine).    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (achy), MALAISE (just did not feel good), SKIN SWELLING (redness and puffiness are still present), MASS (It looks like a knot), PAIN (soreness), ERYTHEMA (redness and puffiness are still present), ERYTHEMA (Swollen, red, and itchy), PRURITUS (very itchy), PRURITUS (Swollen, red, and itchy), SWELLING (Swollen, red, and itchy), HEADACHE (headache) and CHILLS (body chills). On 28-Mar-2021, PAIN (achy), MALAISE (just did not feel good), HEADACHE (headache) and CHILLS (body chills) had resolved. At the time of the report, SKIN SWELLING (redness and puffiness are still present), MASS (It looks like a knot), PAIN (soreness), ERYTHEMA (redness and puffiness are still present), ERYTHEMA (Swollen, red, and itchy), PRURITUS (very itchy), PRURITUS (Swollen, red, and itchy) and SWELLING (Swollen, red, and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Skin swelling, Swelling
Clinical narrative: achy; just did not feel good; redness and puffiness are still present; It looks like a knot; soreness; redness and puffiness are still present; Swollen, red, and itchy; very itchy; Swollen, red, and itchy; Swollen, red, and itchy; headache; body chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), MALAISE (just did not feel good), SKIN SWELLING (redness and puffiness are still present), MASS (It looks like a knot) and PAIN (soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy and Drug allergy (codeine).    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (achy), MALAISE (just did not feel good), SKIN SWELLING (redness and puffiness are still present), MASS (It looks like a knot), PAIN (soreness), ERYTHEMA (redness and puffiness are still present), ERYTHEMA (Swollen, red, and itchy), PRURITUS (very itchy), PRURITUS (Swollen, red, and itchy), SWELLING (Swollen, red, and itchy), HEADACHE (headache) and CHILLS (body chills). On 28-Mar-2021, PAIN (achy), MALAISE (just did not feel good), HEADACHE (headache) and CHILLS (body chills) had resolved. At the time of the report, SKIN SWELLING (redness and puffiness are still present), MASS (It looks like a knot), PAIN (soreness), ERYTHEMA (redness and puffiness are still present), ERYTHEMA (Swollen, red, and itchy), PRURITUS (very itchy), PRURITUS (Swollen, red, and itchy) and SWELLING (Swollen, red, and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided   This case was linked to MOD21-068791, MOD21-068788, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068786, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068785, MOD21-068717, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068784, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781, MOD21-068782, MOD21-068783 (E2B Linked Report).; Sender's Comments:  MOD21-068791: MOD21-068788: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068786: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068785: MOD21-068717: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068784: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782: MOD21-068783:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (FEVER). At the time of the report, PYREXIA (FEVER) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Relevant concomitant medications included, Blood pressure medications were reported.   Treatment information was not provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 02 Apr 2021 that they had power outage and vials were in Freezer and Refrigerator where temperature dropped to : Frozen Vaccine 47Minutes  minus 13.79 C Refrigerator 59 Minutes 12 C No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:crosslinked
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Headache, Pyrexia, Vaccination site pain
Clinical narrative: "little stabbing pain" in his heart; Swelling in the armpit up to his nipple area; Sore Injection Site; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN ("little stabbing pain" in his heart), PYREXIA (Fever), HEADACHE (Headache), AXILLARY PAIN (Swelling in the armpit up to his nipple area) and VACCINATION SITE PAIN (Sore Injection Site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore Injection Site). On 03-Apr-2021, the patient experienced CHEST PAIN ("little stabbing pain" in his heart) and AXILLARY PAIN (Swelling in the armpit up to his nipple area). At the time of the report, CHEST PAIN ("little stabbing pain" in his heart), PYREXIA (Fever), HEADACHE (Headache), AXILLARY PAIN (Swelling in the armpit up to his nipple area) and VACCINATION SITE PAIN (Sore Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Influenza like illness, Movement disorder, Myalgia
Clinical narrative: patient cannot move; flu like symptoms; chest pain; scratchy throat; nausea; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat) and NAUSEA (nausea) in a 59-year-old female patient 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 Lupus syndrome (the patient has lupus.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle ache). At the time of the report, MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.7 (Inconclusive) fever of 101.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. List of concomitant medication were not given.   This case was linked to MOD-2021-118963 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Throat irritation
Clinical narrative: patient cannot move; flu like symptoms; chest pain; scratchy throat; nausea; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat) and NAUSEA (nausea) in a 59-year-old female patient 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 Lupus syndrome (the patient has lupus.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle ache). At the time of the report, MOVEMENT DISORDER (patient cannot move), INFLUENZA LIKE ILLNESS (flu like symptoms), CHEST PAIN (chest pain), THROAT IRRITATION (scratchy throat), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.7 (Inconclusive) fever of 101.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. List of concomitant medication were not given.   This case was linked to MOD-2021-118963 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Rash at injection site rash; Injection site redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash at injection site rash) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at injection site rash) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE RASH (Rash at injection site rash) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included Ibuprofen, aspirin and applied cool packs on the injections site.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pain, Injection site swelling, Oral discomfort, Paraesthesia oral
Clinical narrative: Tingling lips; Burning lips; Swelling of injection site; Tenderness of injection site; Burning sensation; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (Burning sensation), PARAESTHESIA ORAL (Tingling lips), ORAL DISCOMFORT (Burning lips), INJECTION SITE SWELLING (Swelling of injection site) and INJECTION SITE PAIN (Tenderness of injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Premature atrial contraction, Post concussion syndrome, Chronic migraine, Tendinitis (around right ankle), Drug allergy (codeine (suicidal ideation)), Topical adhesive allergy (rash) and Contrast media allergy (generalized delayed rash).    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced BURNING SENSATION (Burning sensation), ORAL DISCOMFORT (Burning lips), INJECTION SITE SWELLING (Swelling of injection site) and INJECTION SITE PAIN (Tenderness of injection site). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling lips). At the time of the report, BURNING SENSATION (Burning sensation), PARAESTHESIA ORAL (Tingling lips) and ORAL DISCOMFORT (Burning lips) was resolving and INJECTION SITE SWELLING (Swelling of injection site) and INJECTION SITE PAIN (Tenderness of injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: No additional AEs; a 7-year-old female patient was mistakenly mixed up with an older female patient that had similar names and was administered GARDASIL 9 in error; a 7-year-old female patient was mistakenly mixed up with an older female patient that had similar names and was administered GARDASIL 9 in error; This spontaneous report was received from a healthcare business professional (described also as an administrator) via a Company representative and refers to a 7-year-old female patient. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On 19-AUG-2021, the patient was mistakenly mixed up with an older female patient that had similar names and was inadvertently vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 time dose (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration, wrong patient received product). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC's reported; excursions vaccine was administered to patients; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # T002847, expiration date23-JAN-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (13.5 F) for the time frame of 57 minutes, and between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (7.3 F) for  the time frame of 15 minutes. There was no previous temperature excursion. No adverse event was reported.  This is one of two reports from the same source.; Sender's Comments:  US-009507513-2108USA006421: