chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination complication
Clinical narrative: Did not feel as good today; Chilly; Took the temperature and it was only 100; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel as good today), CHILLS (Chilly), PYREXIA (Took the temperature and it was only 100) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 028L20A and 011120A) for COVID-19 vaccination.     The patient's past medical history included Eye operation (Eye surgery) since July 2021.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced VACCINATION COMPLICATION (Did not feel as good today), CHILLS (Chilly), PYREXIA (Took the temperature and it was only 100) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Did not feel as good today), CHILLS (Chilly), PYREXIA (Took the temperature and it was only 100) and HEADACHE (Headache) had not resolved.            The patient has taken pills (blood thinner).  Treatment medications was not reported.  company comment : This case concerns a  76-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Malaise and the expected non-serious events of Chills, Pyrexia, and Headache . The events occurred on the day of the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier doses were disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-381162 (Patient Link).; Sender's Comments: This case concerns a  76-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Malaise and the expected non-serious events of Chills, Pyrexia, and Headache . The events occurred on the day of the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier doses were disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (noise increased in my left ear/he started to have tinnitus issues/noise never disappeared) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 010A21A) for COVID-19 vaccination. The patient's past medical history included Ear operation in November 1998. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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 TINNITUS (noise increased in my left ear/he started to have tinnitus issues/noise never disappeared). At the time of the report, TINNITUS (noise increased in my left ear/he started to have tinnitus issues/noise never disappeared) had not resolved. Patient went to see the surgeon who operated him and the surgeon said that he believed it was unrelated to the vaccine. Patient said that the noise never disappeared. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-381289 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in her leg) 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 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 THROMBOSIS (Blood clot in her leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in her leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication details were provided.  No Treatment medication details were provided.  Company comment: This case concerns a female patient with uknown age with no reported medical history, who experienced Serious , Unexpected event of Thrombosis , which occurred on  unknown date with an unknown dose number of mRNA-1273 Vaccine ( Moderna Covid 19 Vaccine ) The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Non-significant follow-up document received on 10-Nov-2021, Reporter contact info updated.; Sender's Comments: This case concerns a female patient with uknown age with no reported medical history, who experienced Serious , Unexpected event of Thrombosis , which occurred on  unknown date with an unknown dose number of mRNA-1273 Vaccine ( Moderna Covid 19 Vaccine ) The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: feeling sleepy; This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (feeling sleepy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A.) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SOMNOLENCE (feeling sleepy). At the time of the report, SOMNOLENCE (feeling sleepy) outcome was unknown.        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-2021-380979, MOD-2021-380980 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Dizziness, Incorrect dose administered, Insomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, MALAISE, BACK PAIN, BONE PAIN, and PRURITUS in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07C21B, 003A21A, and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications were provided by the reporter.  Concurrent medical conditions included Arthritis (The patient was taking her medication for arthritis).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced EXTRA DOSE ADMINISTERED. On 06-Nov-2021, the patient experienced DIZZINESS, MALAISE, BACK PAIN, BONE PAIN, PRURITUS, DYSKINESIA, INSOMNIA, VACCINATION SITE PAIN, and NAUSEA. The patient was treated with ONDANSETRON for Sickness, at an unspecified dose and frequency. At the time of the report, DIZZINESS, MALAISE, DYSKINESIA, VACCINATION SITE PAIN, and NAUSEA outcome was unknown, BACK PAIN, BONE PAIN, PRURITUS, and INSOMNIA had not resolved and EXTRA DOSE ADMINISTERED had resolved.            No concomitant medications were provided by the reporter. patient tried hot and cold compresses, and her medication for arthritis, but nothing seems to help. She cannot sleep and feels like somebody was stabbing her in the back.   Patient contacted her doctor, who told her to take Tylenol and alternate hot and cold compresses. The doctor also suggested calamine lotion, but it was not helping.   This case was linked to GB-MODERNATX, INC.-MOD-2021-162562, GB-MODERNATX, INC.-MOD-2021-162563, GB-MODERNATX, INC.-MOD-2021-162519 (E2B Linked Report). GB-MODERNATX, INC.-MOD-2021-162562: Cases crosslinked: MOD21-162562 and MOD21-162563. GB-MODERNATX, INC.-MOD-2021-162563, GB-MODERNATX, INC.-MOD-2021-162519.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Movement disorder, Nausea, Pruritus, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, MALAISE, BACK PAIN, BONE PAIN, and PRURITUS in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07C21B, 003A21A, and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications were provided by the reporter.  Concurrent medical conditions included Arthritis (The patient was taking her medication for arthritis).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced EXTRA DOSE ADMINISTERED. On 06-Nov-2021, the patient experienced DIZZINESS, MALAISE, BACK PAIN, BONE PAIN, PRURITUS, DYSKINESIA, INSOMNIA, VACCINATION SITE PAIN, and NAUSEA. The patient was treated with ONDANSETRON for Sickness, at an unspecified dose and frequency. At the time of the report, DIZZINESS, MALAISE, DYSKINESIA, VACCINATION SITE PAIN, and NAUSEA outcome was unknown, BACK PAIN, BONE PAIN, PRURITUS, and INSOMNIA had not resolved and EXTRA DOSE ADMINISTERED had resolved.            No concomitant medications were provided by the reporter. patient tried hot and cold compresses, and her medication for arthritis, but nothing seems to help. She cannot sleep and feels like somebody was stabbing her in the back.   Patient contacted her doctor, who told her to take Tylenol and alternate hot and cold compresses. The doctor also suggested calamine lotion, but it was not helping.   This case was linked to GB-MODERNATX, INC.-MOD-2021-162562, GB-MODERNATX, INC.-MOD-2021-162563, GB-MODERNATX, INC.-MOD-2021-162519 (E2B Linked Report). GB-MODERNATX, INC.-MOD-2021-162562: Cases crosslinked: MOD21-162562 and MOD21-162563. GB-MODERNATX, INC.-MOD-2021-162563, GB-MODERNATX, INC.-MOD-2021-162519.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: pain at the injection site; Shevering; fever of 101; severe body ache (pain levelof 8); This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site), CHILLS (Shevering), PYREXIA (fever of 101) and MYALGIA (severe body ache (pain levelof 8)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site), CHILLS (Shevering), PYREXIA (fever of 101) and MYALGIA (severe body ache (pain levelof 8)). On 01-Feb-2021, VACCINATION SITE PAIN (pain at the injection site), CHILLS (Shevering), PYREXIA (fever of 101) and MYALGIA (severe body ache (pain levelof 8)) 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 information was provided.  Patient stated, event resolved after 28 hours and nothing was lingering after that.   This case was linked to MOD-2021-380951, MOD-2021-380980 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Eyelid irritation, Fatigue
Clinical narrative: head feels heavy; eyelids feel heavy/eyelids feel watery; was in bed all day with profound weakness; fatigue; chills/shivering; headache; fever of 101; This spontaneous case was reported by a nurse and describes the occurrence of HEAD DISCOMFORT (head feels heavy), EYELID IRRITATION (eyelids feel heavy/eyelids feel watery), ASTHENIA (was in bed all day with profound weakness), FATIGUE (fatigue) and CHILLS (chills/shivering) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 025L20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced ASTHENIA (was in bed all day with profound weakness), FATIGUE (fatigue), CHILLS (chills/shivering), HEADACHE (headache) and PYREXIA (fever of 101). On 09-Nov-2021, the patient experienced HEAD DISCOMFORT (head feels heavy) and EYELID IRRITATION (eyelids feel heavy/eyelids feel watery). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date for Adverse event, at a dose of 2 dosage form and IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 600 mg. At the time of the report, HEAD DISCOMFORT (head feels heavy) and EYELID IRRITATION (eyelids feel heavy/eyelids feel watery) outcome was unknown, ASTHENIA (was in bed all day with profound weakness), CHILLS (chills/shivering), HEADACHE (headache) and PYREXIA (fever of 101) was resolving and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 101 (High) fever of 101 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient reported that, after getting the booster shot, on 06-Nov-2021, she had chills, shivering, headache and fever of 101 that started day after booster dose. She stated she was in bed all day with profound weakness. On 07-Nov-2021, she still had the symptoms but to a mild degree, she had burst of energy for 2 hours but felt fatigued after that. She reports having fatigue on and off on 07-Nov-2021. And on 08-Nov-2021, the fatigue was not on and off, only had one incident where she had energy. She stated on 09-Nov-2021, she still has fatigue. She stated headache was not as bad, head feels heavy, eyelids feel heavy and watery. She mentioned her reaction to the booster was not as severe as the second dose.   This case was linked to MOD-2021-380979, MOD-2021-380951 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Pyrexia
Clinical narrative: head feels heavy; eyelids feel heavy/eyelids feel watery; was in bed all day with profound weakness; fatigue; chills/shivering; headache; fever of 101; This spontaneous case was reported by a nurse and describes the occurrence of HEAD DISCOMFORT (head feels heavy), EYELID IRRITATION (eyelids feel heavy/eyelids feel watery), ASTHENIA (was in bed all day with profound weakness), FATIGUE (fatigue) and CHILLS (chills/shivering) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 025L20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced ASTHENIA (was in bed all day with profound weakness), FATIGUE (fatigue), CHILLS (chills/shivering), HEADACHE (headache) and PYREXIA (fever of 101). On 09-Nov-2021, the patient experienced HEAD DISCOMFORT (head feels heavy) and EYELID IRRITATION (eyelids feel heavy/eyelids feel watery). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date for Adverse event, at a dose of 2 dosage form and IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 600 mg. At the time of the report, HEAD DISCOMFORT (head feels heavy) and EYELID IRRITATION (eyelids feel heavy/eyelids feel watery) outcome was unknown, ASTHENIA (was in bed all day with profound weakness), CHILLS (chills/shivering), HEADACHE (headache) and PYREXIA (fever of 101) was resolving and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 101 (High) fever of 101 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient reported that, after getting the booster shot, on 06-Nov-2021, she had chills, shivering, headache and fever of 101 that started day after booster dose. She stated she was in bed all day with profound weakness. On 07-Nov-2021, she still had the symptoms but to a mild degree, she had burst of energy for 2 hours but felt fatigued after that. She reports having fatigue on and off on 07-Nov-2021. And on 08-Nov-2021, the fatigue was not on and off, only had one incident where she had energy. She stated on 09-Nov-2021, she still has fatigue. She stated headache was not as bad, head feels heavy, eyelids feel heavy and watery. She mentioned her reaction to the booster was not as severe as the second dose.   This case was linked to MOD-2021-380979, MOD-2021-380951 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Skin haemorrhage, Vaccination site erythema
Clinical narrative: Itchy; Lighter in color; oval pink spot on her arm/It had a darker blemish inside that was about 4in; Looks like bleeding under the skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Looks like bleeding under the skin), PRURITUS (Itchy), SKIN DISCOLOURATION (Lighter in color) and VACCINATION SITE ERYTHEMA (oval pink spot on her arm/It had a darker blemish inside that was about 4in) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 031L20A and 001B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included WARFARIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced SKIN HAEMORRHAGE (Looks like bleeding under the skin). 06-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (oval pink spot on her arm/It had a darker blemish inside that was about 4in). On 07-Nov-2021, the patient experienced PRURITUS (Itchy) and SKIN DISCOLOURATION (Lighter in color). At the time of the report, SKIN HAEMORRHAGE (Looks like bleeding under the skin) and PRURITUS (Itchy) outcome was unknown and SKIN DISCOLOURATION (Lighter in color) and VACCINATION SITE ERYTHEMA (oval pink spot on her arm/It had a darker blemish inside that was about 4in) was resolving.            No treatment medications were reported Patient provided information that she received flu vaccine the same date in the opposite arm (left).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Contusion, Dry throat, Dyspnoea, Erythema
Clinical narrative: Felt grooves on legs; Has bruises on leg; Bump on hand; Blue dots in palm/blue dots in bum; Hand under the skin from outside got red; Throat got dry; Couldn't breathe; Had 2 pimples on both shoulders; Itchy; Couldn't sleep for 2 weeks; Ringing in left ear - developed tinnitus as side effects; Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Felt grooves on legs), CONTUSION (Has bruises on leg), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum) and ERYTHEMA (Hand under the skin from outside got red) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced LIMB DISCOMFORT (Felt grooves on legs), CONTUSION (Has bruises on leg), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum), ERYTHEMA (Hand under the skin from outside got red), DRY THROAT (Throat got dry), DYSPNOEA (Couldn't breathe), ACNE (Had 2 pimples on both shoulders), PRURITUS (Itchy), INSOMNIA (Couldn't sleep for 2 weeks), TINNITUS (Ringing in left ear - developed tinnitus as side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose). On 06-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose) had resolved. At the time of the report, LIMB DISCOMFORT (Felt grooves on legs), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum), ERYTHEMA (Hand under the skin from outside got red), DRY THROAT (Throat got dry), DYSPNOEA (Couldn't breathe), ACNE (Had 2 pimples on both shoulders), PRURITUS (Itchy) and INSOMNIA (Couldn't sleep for 2 weeks) had resolved and CONTUSION (Has bruises on leg) and TINNITUS (Ringing in left ear - developed tinnitus as side effects) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains no new information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia, Limb discomfort, Pruritus, Swelling
Clinical narrative: Felt grooves on legs; Has bruises on leg; Bump on hand; Blue dots in palm/blue dots in bum; Hand under the skin from outside got red; Throat got dry; Couldn't breathe; Had 2 pimples on both shoulders; Itchy; Couldn't sleep for 2 weeks; Ringing in left ear - developed tinnitus as side effects; Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Felt grooves on legs), CONTUSION (Has bruises on leg), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum) and ERYTHEMA (Hand under the skin from outside got red) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced LIMB DISCOMFORT (Felt grooves on legs), CONTUSION (Has bruises on leg), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum), ERYTHEMA (Hand under the skin from outside got red), DRY THROAT (Throat got dry), DYSPNOEA (Couldn't breathe), ACNE (Had 2 pimples on both shoulders), PRURITUS (Itchy), INSOMNIA (Couldn't sleep for 2 weeks), TINNITUS (Ringing in left ear - developed tinnitus as side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose). On 06-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose) had resolved. At the time of the report, LIMB DISCOMFORT (Felt grooves on legs), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum), ERYTHEMA (Hand under the skin from outside got red), DRY THROAT (Throat got dry), DYSPNOEA (Couldn't breathe), ACNE (Had 2 pimples on both shoulders), PRURITUS (Itchy) and INSOMNIA (Couldn't sleep for 2 weeks) had resolved and CONTUSION (Has bruises on leg) and TINNITUS (Ringing in left ear - developed tinnitus as side effects) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains no new information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: Felt grooves on legs; Has bruises on leg; Bump on hand; Blue dots in palm/blue dots in bum; Hand under the skin from outside got red; Throat got dry; Couldn't breathe; Had 2 pimples on both shoulders; Itchy; Couldn't sleep for 2 weeks; Ringing in left ear - developed tinnitus as side effects; Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Felt grooves on legs), CONTUSION (Has bruises on leg), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum) and ERYTHEMA (Hand under the skin from outside got red) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced LIMB DISCOMFORT (Felt grooves on legs), CONTUSION (Has bruises on leg), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum), ERYTHEMA (Hand under the skin from outside got red), DRY THROAT (Throat got dry), DYSPNOEA (Couldn't breathe), ACNE (Had 2 pimples on both shoulders), PRURITUS (Itchy), INSOMNIA (Couldn't sleep for 2 weeks), TINNITUS (Ringing in left ear - developed tinnitus as side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose). On 06-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 35 days for 2nd dose) had resolved. At the time of the report, LIMB DISCOMFORT (Felt grooves on legs), SWELLING (Bump on hand), VACCINATION COMPLICATION (Blue dots in palm/blue dots in bum), ERYTHEMA (Hand under the skin from outside got red), DRY THROAT (Throat got dry), DYSPNOEA (Couldn't breathe), ACNE (Had 2 pimples on both shoulders), PRURITUS (Itchy) and INSOMNIA (Couldn't sleep for 2 weeks) had resolved and CONTUSION (Has bruises on leg) and TINNITUS (Ringing in left ear - developed tinnitus as side effects) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains no new information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site is sore; Injection site is swollen; Injection site is red; Got the 3rd dose for immunocompromised patients even though he is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and INCORRECT DOSE ADMINISTERED (Got the 3rd dose for immunocompromised patients even though he is not immunocompromised) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot # 07C21B, 010M20A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia and Stroke.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and INCORRECT DOSE ADMINISTERED (Got the 3rd dose for immunocompromised patients even though he is not immunocompromised). On 05-Nov-2021, INCORRECT DOSE ADMINISTERED (Got the 3rd dose for immunocompromised patients even though he is not immunocompromised) had resolved. At the time of the report, VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: Blood clot in the left eye after the 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (Blood clot in the left eye after the 3rd dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Cancer and Immunocompromised.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (Blood clot in the left eye after the 3rd dose) (seriousness criterion medically significant). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (Blood clot in the left eye after the 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  Visited Doctor on 30-Sep-2021.  Company Comment This case concerns a 72 year old female with relevant medical history of Cancer in iummnocompromised state, who experienced, serious , unexpected event of Conjunctival hemorrhage which occurred 1 month and  3 days after vaccination with the 3rd dose of mRNA-1273 Vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since no additional doses will be administered and the outcome of the event is unknown. The benefit - risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.; Sender's Comments: This case concerns a 72 year old female with relevant medical history of Cancer in iummnocompromised state, who experienced, serious , unexpected event of Conjunctival hemorrhage which occurred 1 month and  3 days after vaccination with the 3rd dose of mRNA-1273 Vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since no additional doses will be administered and the outcome of the event is unknown. The benefit - risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving doses from an expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving doses from an expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving doses from an expired vial). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Receiving doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. 26 patients received doses from a vial lot the Moderna COVID19 vaccine with expiration date 07 Nov 2021 on the 09 Nov 2021. HCP mentioned that the boxes didn't have an expiration date and that they were told that the vials expired 6 months after receiving the shipment.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up document received contains No New Information.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: patient suffered a heart attack after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (patient suffered a heart attack after the second dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (patient suffered a heart attack after the second dose) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (patient suffered a heart attack after the second dose) outcome was unknown.      No concomitant medications provided. No treatment medications provided. Patient was not diagnosed with myocarditis or pericarditis. Patient did not get hospitalized for myocarditis and pericarditis previously. Cardiac tests were not reported. Patient did not have history of Covid-19 infection.  Company Comment: This case concerns a 71 year old male with no reported medical history , who experienced Serious, unexpected event of Myocardial Infarction which occurred 21 days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the event occurred after the 2nd dose and no additional doses would be given and also the outcome is unknown . The age of the patient can be considered as a confounder for this case ( Age, risk factor to cardiovascular events and Cardiovascular problems)/ The benefit-risk relationship of  mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.; Sender's Comments: This case concerns a 71 year old male with no reported medical history , who experienced Serious, unexpected event of Myocardial Infarction which occurred 21 days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the event occurred after the 2nd dose and no additional doses would be given and also the outcome is unknown . The age of the patient can be considered as a confounder for this case ( Age, risk factor to cardiovascular events and Cardiovascular problems)/ The benefit-risk relationship of  mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vial refrigerated more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 031B21A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy and Pollen allergy.   On 31-Mar-2021 at 10:16 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021 at 10:23 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  The vials were supposed to remain frozen until 06-Sep-2021 but instead they were immediately put in the refrigerator upon arrival (on 06-Aug-2021). None of the vials underwent any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Added patient initials and date of birth.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick (after 1st dose); This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (got sick (after 1st dose)) 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 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 ILLNESS (got sick (after 1st dose)). At the time of the report, ILLNESS (got sick (after 1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-381139, MOD-2021-381140 (Patient Link).   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to the patient; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to the patient) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to the patient). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to the patient) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  No other adverse event was reported.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurts) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthmatic.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm hurts). At the time of the report, PAIN IN EXTREMITY (left arm hurts) outcome was unknown.            No concomitant information provided, did not want to give the  list of his medications.  No treatment information provided. Patient had completed Moderna primary series, received his booster dose.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: patient started bleeding a lot from the site of vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (patient started bleeding a lot from the site of vaccination.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (patient started bleeding a lot from the site of vaccination.). At the time of the report, VACCINATION SITE HAEMORRHAGE (patient started bleeding a lot from the site of vaccination.) outcome was unknown.            Patient was on concomitant medications like cholesterol pills. Pharmacist had to wipe and wipe with alcohol and had to put double band aid.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: received dose from vial refrigerated more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days). On 10-Sep-2021, PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Significant follow up received: Patient initials and DOB updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient received a double dose of the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received a double dose of the booster) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 09-Nov-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 09-Nov-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient received a double dose of the booster). On 09-Nov-2021, EXTRA DOSE ADMINISTERED (patient received a double dose of the booster) had resolved.        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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired for a day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired for a day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa).   On 06-Apr-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021 at 10:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021 at 10:20 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt tired for a day). On 06-May-2021, FATIGUE (Felt tired for a day) had resolved.            No concomitant medications were reported. No treatment details provided.   This case was linked to MOD-2021-069864 (Patient Link).