chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vaccination site pain
Clinical narrative: pain in arm of injection; dizzy; nausea; headache; tingling down arm into fingers; back pain; fever; pressure on chest; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm of injection), DIZZINESS (dizzy), NAUSEA (nausea  ), HEADACHE (headache  ) and PARAESTHESIA (tingling down arm into fingers) in a 55-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 09-Jun-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) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced DIZZINESS (dizzy), NAUSEA (nausea  ), HEADACHE (headache  ), BACK PAIN (back pain  ), PYREXIA (fever   ) and CHEST DISCOMFORT (pressure on chest). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in arm of injection) and PARAESTHESIA (tingling down arm into fingers). At the time of the report, VACCINATION SITE PAIN (pain in arm of injection), DIZZINESS (dizzy), NAUSEA (nausea  ), HEADACHE (headache  ), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (back pain  ), PYREXIA (fever   ) and CHEST DISCOMFORT (pressure on chest) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-216505, MOD-2021-216360 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Secretion discharge, Vomiting
Clinical narrative: sick; sweating profusely; throwing up this thick mucus; vomiting/holding no food down/throwing up this thick mucus; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), HYPERHIDROSIS (sweating profusely), SECRETION DISCHARGE (throwing up this thick mucus) and VOMITING (vomiting/holding no food down/throwing up this thick mucus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, 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 (sick), HYPERHIDROSIS (sweating profusely), SECRETION DISCHARGE (throwing up this thick mucus) and VOMITING (vomiting/holding no food down/throwing up this thick mucus). At the time of the report, ILLNESS (sick), HYPERHIDROSIS (sweating profusely), SECRETION DISCHARGE (throwing up this thick mucus) and VOMITING (vomiting/holding no food down/throwing up this thick mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the 2nd dose on day 46 ¨; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose on day 46 ¨) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose on day 46 ¨). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose on day 46 ¨) outcome 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. Treatment information was not provided. Lab details were not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Skin odour abnormal, Therapeutic response unexpected
Clinical narrative: Sweating more; Odor on my skin; dont have sensitive teeth and I am not getting those headaches anymore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating more), SKIN ODOUR ABNORMAL (Odor on my skin) and THERAPEUTIC RESPONSE UNEXPECTED (dont have sensitive teeth and I am not getting those headaches anymore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating more), SKIN ODOUR ABNORMAL (Odor on my skin) and THERAPEUTIC RESPONSE UNEXPECTED (dont have sensitive teeth and I am not getting those headaches anymore). At the time of the report, HYPERHIDROSIS (Sweating more), SKIN ODOUR ABNORMAL (Odor on my skin) and THERAPEUTIC RESPONSE UNEXPECTED (dont have sensitive teeth and I am not getting those headaches anymore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Dizziness, Headache, Nausea
Clinical narrative: Dizzy; tingling down arm into fingers; Back pain; pressure on chest; pain in arm of injection; Headache; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (Back pain), CHEST DISCOMFORT (pressure on chest) and VACCINATION SITE PAIN (pain in arm of injection) in a female patient of an unknown age 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 09-Jun-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) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced DIZZINESS (Dizzy), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (Back pain), CHEST DISCOMFORT (pressure on chest), VACCINATION SITE PAIN (pain in arm of injection), HEADACHE (Headache), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, DIZZINESS (Dizzy), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (Back pain), CHEST DISCOMFORT (pressure on chest), VACCINATION SITE PAIN (pain in arm of injection), HEADACHE (Headache), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-216479 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vaccination site pain
Clinical narrative: Dizzy; tingling down arm into fingers; Back pain; pressure on chest; pain in arm of injection; Headache; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (Back pain), CHEST DISCOMFORT (pressure on chest) and VACCINATION SITE PAIN (pain in arm of injection) in a female patient of an unknown age 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 09-Jun-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) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced DIZZINESS (Dizzy), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (Back pain), CHEST DISCOMFORT (pressure on chest), VACCINATION SITE PAIN (pain in arm of injection), HEADACHE (Headache), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, DIZZINESS (Dizzy), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (Back pain), CHEST DISCOMFORT (pressure on chest), VACCINATION SITE PAIN (pain in arm of injection), HEADACHE (Headache), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-216479 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: skin is soft and soaky, skin cleared up from the goosebumps she had since birth; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (skin is soft and soaky, skin cleared up from the goosebumps she had since birth) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (skin is soft and soaky, skin cleared up from the goosebumps she had since birth). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (skin is soft and soaky, skin cleared up from the goosebumps she had since birth) outcome was unknown. Not Provided          No concomitant medications were reported.   This case was linked to MOD-2021-216460 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles). At the time of the report, HERPES ZOSTER (stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment details were not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Periorbital swelling, Swelling face
Clinical narrative: facial swelling; puffy eyes; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), PERIORBITAL SWELLING (puffy eyes) and LYMPHADENOPATHY (Swollen lymph nodes) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 016c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced SWELLING FACE (facial swelling), PERIORBITAL SWELLING (puffy eyes) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, SWELLING FACE (facial swelling), PERIORBITAL SWELLING (puffy eyes) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive.         Concomitant medications were not provided.  Treatment information was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Fatigue, Feeling abnormal, Frustration tolerance decreased
Clinical narrative: "a blotch of red bumps"; "not too comfortable"; frustrated; "I'm not feeling better"; "I don't know my body now"/a lot of strange things are happening"; "a blotch of red bumps"; a little itchy; been itching like crazy;  feel like a junky because I am scratching on one side and scratching on the other side; felt tired; "felt a little weak"; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("felt a little weak"), RASH MACULAR ("a blotch of red bumps"), DISCOMFORT ("not too comfortable"), FRUSTRATION TOLERANCE DECREASED (frustrated) and MALAISE ("I'm not feeling better") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included BIMATOPROST (LUMIGAN) for Glaucoma, VITAMIN C [ASCORBIC ACID] and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced ASTHENIA ("felt a little weak"), PRURITUS (a little itchy; been itching like crazy;  feel like a junky because I am scratching on one side and scratching on the other side) and FATIGUE (felt tired). On 07-Jun-2021, the patient experienced RASH MACULAR ("a blotch of red bumps"), DISCOMFORT ("not too comfortable"), FRUSTRATION TOLERANCE DECREASED (frustrated), MALAISE ("I'm not feeling better"), FEELING ABNORMAL ("I don't know my body now"/a lot of strange things are happening") and RASH ERYTHEMATOUS ("a blotch of red bumps"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ASTHENIA ("felt a little weak"), RASH MACULAR ("a blotch of red bumps"), DISCOMFORT ("not too comfortable"), FRUSTRATION TOLERANCE DECREASED (frustrated), MALAISE ("I'm not feeling better"), RASH ERYTHEMATOUS ("a blotch of red bumps"), PRURITUS (a little itchy; been itching like crazy;  feel like a junky because I am scratching on one side and scratching on the other side) and FATIGUE (felt tired) outcome was unknown and FEELING ABNORMAL ("I don't know my body now"/a lot of strange things are happening") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Blood Builder supplement  as concomitant product. patient took Benadryl to treat her symptoms.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pruritus, Rash erythematous, Rash macular
Clinical narrative: "a blotch of red bumps"; "not too comfortable"; frustrated; "I'm not feeling better"; "I don't know my body now"/a lot of strange things are happening"; "a blotch of red bumps"; a little itchy; been itching like crazy;  feel like a junky because I am scratching on one side and scratching on the other side; felt tired; "felt a little weak"; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("felt a little weak"), RASH MACULAR ("a blotch of red bumps"), DISCOMFORT ("not too comfortable"), FRUSTRATION TOLERANCE DECREASED (frustrated) and MALAISE ("I'm not feeling better") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included BIMATOPROST (LUMIGAN) for Glaucoma, VITAMIN C [ASCORBIC ACID] and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced ASTHENIA ("felt a little weak"), PRURITUS (a little itchy; been itching like crazy;  feel like a junky because I am scratching on one side and scratching on the other side) and FATIGUE (felt tired). On 07-Jun-2021, the patient experienced RASH MACULAR ("a blotch of red bumps"), DISCOMFORT ("not too comfortable"), FRUSTRATION TOLERANCE DECREASED (frustrated), MALAISE ("I'm not feeling better"), FEELING ABNORMAL ("I don't know my body now"/a lot of strange things are happening") and RASH ERYTHEMATOUS ("a blotch of red bumps"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ASTHENIA ("felt a little weak"), RASH MACULAR ("a blotch of red bumps"), DISCOMFORT ("not too comfortable"), FRUSTRATION TOLERANCE DECREASED (frustrated), MALAISE ("I'm not feeling better"), RASH ERYTHEMATOUS ("a blotch of red bumps"), PRURITUS (a little itchy; been itching like crazy;  feel like a junky because I am scratching on one side and scratching on the other side) and FATIGUE (felt tired) outcome was unknown and FEELING ABNORMAL ("I don't know my body now"/a lot of strange things are happening") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Blood Builder supplement  as concomitant product. patient took Benadryl to treat her symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Paralysis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) Unknown. On an unknown date, the patient experienced PARALYSIS (Paralysis). At the time of the report, PARALYSIS (Paralysis) 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 medication and treatment information not reported.  Company Comment: Based on the current case data, this case has been classified as invalid.; Sender's Comments: Based on the current case data, this case has been classified as invalid.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Parosmia, Taste disorder, Visual impairment
Clinical narrative: I lost partial hearing for about a month and when it came back it didn't come back fully.  My eyesite changed for worst within 2 days of shot.   I have a pungent taste and odor I smell all the time.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Loss of consciousness, Pain, Seizure
Clinical narrative: Dizziness, lightheaded, headache, body ache, seizure or loss of consciousness with odd vocal noise.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vocal cord disorder
Clinical narrative: Dizziness, lightheaded, headache, body ache, seizure or loss of consciousness with odd vocal noise.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: 8/21- felt light headed, brain fog, headache starting around 8:00 pm; 8/22- woke up with 100.7 degree fever, severe headache, fatigue, malaise, brain fog, dizziness, swelling in lymph node under left arm, highest measured fever 102.4 around 4:00 pm, 101.8 fever around 8:00 pm; 8/23- temp down between 100.5 around 7:00 am to 99.0 around 8:00 pm, all other symptoms from 8/22 present; 8/24- woke up around 2:00 am with swelling, warmth, and rash at injection site that is tender to the touch and tender when left elbow or shoulder are moved, continued swelling of lymph node, mild headache, fatigue, temp down to 98.1 around 5:00 am
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Lymphadenopathy, Malaise
Clinical narrative: 8/21- felt light headed, brain fog, headache starting around 8:00 pm; 8/22- woke up with 100.7 degree fever, severe headache, fatigue, malaise, brain fog, dizziness, swelling in lymph node under left arm, highest measured fever 102.4 around 4:00 pm, 101.8 fever around 8:00 pm; 8/23- temp down between 100.5 around 7:00 am to 99.0 around 8:00 pm, all other symptoms from 8/22 present; 8/24- woke up around 2:00 am with swelling, warmth, and rash at injection site that is tender to the touch and tender when left elbow or shoulder are moved, continued swelling of lymph node, mild headache, fatigue, temp down to 98.1 around 5:00 am
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness
Clinical narrative: 8/21- felt light headed, brain fog, headache starting around 8:00 pm; 8/22- woke up with 100.7 degree fever, severe headache, fatigue, malaise, brain fog, dizziness, swelling in lymph node under left arm, highest measured fever 102.4 around 4:00 pm, 101.8 fever around 8:00 pm; 8/23- temp down between 100.5 around 7:00 am to 99.0 around 8:00 pm, all other symptoms from 8/22 present; 8/24- woke up around 2:00 am with swelling, warmth, and rash at injection site that is tender to the touch and tender when left elbow or shoulder are moved, continued swelling of lymph node, mild headache, fatigue, temp down to 98.1 around 5:00 am
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia, Skin burning sensation, Testicular pain
Clinical narrative: Numbness in my left leg  thigh,  the area of the Rectus Femorus and  the Vastus Lateralis muscles, mild pain in that area and the pain  traveling to my left testicle,   constant sharp  tingling and burn like sensation to the touch of the skin
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Rash
Clinical narrative: losing her hair; started in the crown of her head and now she is starting to lose her hair in the front; used a hairbrush and her hair started coming out; little bumps on the scalp; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing her hair; started in the crown of her head and now she is starting to lose her hair in the front; used a hairbrush and her hair started coming out) and RASH (little bumps on the scalp) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L10A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS, Hypercholesterolemia and Thyroid disorder NOS. Concomitant products included FAMOTIDINE for Allergy, ATORVASTATIN and EZETIMIBE (ZETIA) for Hypercholesterolemia, LEVOTHYROXINE for Thyroid disorder NOS.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ALOPECIA (losing her hair; started in the crown of her head and now she is starting to lose her hair in the front; used a hairbrush and her hair started coming out) and RASH (little bumps on the scalp). At the time of the report, ALOPECIA (losing her hair; started in the crown of her head and now she is starting to lose her hair in the front; used a hairbrush and her hair started coming out) and RASH (little bumps on the scalp) outcome was unknown.             Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow Up received on 20-JUL-2021 contains non significant information. Contact information (email address) for the reporter was updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Low grade fever; Body ache/ Pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and MYALGIA (Body ache/ Pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (Low grade fever) and MYALGIA (Body ache/ Pain). The patient was treated with PREDNISONE for Pain burning, at a dose of 1 dosage form; DULOXETINE at a dose of 20 milligram and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 19-Feb-2021, PYREXIA (Low grade fever) and MYALGIA (Body ache/ Pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: (High) 102 degree Fahrenheit on first day and (High) 100 degree Fahrenheit on second day. In March 2021, SARS-CoV-2 test: negative (Negative) negative.     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.   This case was linked to MOD-2021-216580 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient identifiers obtained; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) 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.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Very tired). At the time of the report, FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Body temperature, Chills, Fatigue
Clinical narrative: Hurting legs; Back pain; Fever/ low grade fever everyday; Chills; Fatigue; Periods of significant pain / lot of burning pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Periods of significant pain / lot of burning pain), PAIN IN EXTREMITY (Hurting legs), BACK PAIN (Back pain), PYREXIA (Fever/ low grade fever everyday) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back disorder NOS (Patient reported to have pre-existing back problem).   On 13-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Periods of significant pain / lot of burning pain), PYREXIA (Fever/ low grade fever everyday), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurting legs) and BACK PAIN (Back pain). The patient was treated with PREDNISONE for Pain burning, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and DULOXETINE at a dose of 20 mg. At the time of the report, PAIN (Periods of significant pain / lot of burning pain), PAIN IN EXTREMITY (Hurting legs), BACK PAIN (Back pain), PYREXIA (Fever/ low grade fever everyday), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 102 (High) Reported as 102 Fahrenheit.. On 15-Mar-2021, Body temperature: 100 (High) Reported as 100 Fahrenheit.. On an unknown date, Blood test: inconclusive (Inconclusive) 7 rounds of blood work up was performed and results were not reported.. On an unknown date, SARS-CoV-2 test: negative (Negative) Tested negative.         No concomitant medications were reported. Initially the patient was prescribed with 4 mg of Duloxetine, but later physician increased to 20mg.  The patient noticed fever going up during the day, down during evening but had fever for every single day without fail for last three months. The patient reported that she can't receive vaccine on right side as the region was affected in past for infusion and mentioned that her physician had all the records of tests and results that were performed even the historical records. She had been evaluated by physician, infectious specialist, immunologist but body had no clue of events. The reporter mentioned that the doctors had even researched all the available literature to diagnose the cause of getting low grade fever on daily basis and these were affecting her work.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-216565 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Hurting legs; Back pain; Fever/ low grade fever everyday; Chills; Fatigue; Periods of significant pain / lot of burning pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Periods of significant pain / lot of burning pain), PAIN IN EXTREMITY (Hurting legs), BACK PAIN (Back pain), PYREXIA (Fever/ low grade fever everyday) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back disorder NOS (Patient reported to have pre-existing back problem).   On 13-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Periods of significant pain / lot of burning pain), PYREXIA (Fever/ low grade fever everyday), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurting legs) and BACK PAIN (Back pain). The patient was treated with PREDNISONE for Pain burning, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and DULOXETINE at a dose of 20 mg. At the time of the report, PAIN (Periods of significant pain / lot of burning pain), PAIN IN EXTREMITY (Hurting legs), BACK PAIN (Back pain), PYREXIA (Fever/ low grade fever everyday), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 102 (High) Reported as 102 Fahrenheit.. On 15-Mar-2021, Body temperature: 100 (High) Reported as 100 Fahrenheit.. On an unknown date, Blood test: inconclusive (Inconclusive) 7 rounds of blood work up was performed and results were not reported.. On an unknown date, SARS-CoV-2 test: negative (Negative) Tested negative.         No concomitant medications were reported. Initially the patient was prescribed with 4 mg of Duloxetine, but later physician increased to 20mg.  The patient noticed fever going up during the day, down during evening but had fever for every single day without fail for last three months. The patient reported that she can't receive vaccine on right side as the region was affected in past for infusion and mentioned that her physician had all the records of tests and results that were performed even the historical records. She had been evaluated by physician, infectious specialist, immunologist but body had no clue of events. The reporter mentioned that the doctors had even researched all the available literature to diagnose the cause of getting low grade fever on daily basis and these were affecting her work.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-216565 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore Arm; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus and Hypertension. Concomitant products included AMLODIPINE and METFORMIN HYDROCHLORIDE (METFORMIN ER) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-114315 (Patient Link).   Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient identifiers obtained; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) outcome 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.   ?patient's lab test data not reported. No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Vaccination site pain
Clinical narrative: Malaise; Injection site pain; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), VACCINATION SITE PAIN (Injection site pain), NAUSEA (Nausea) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 030Q21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Left Breast cancer), Premature ventricular contractions and Hysterectomy. Previously administered products included for Breast cancer: Tamoxifen. Family history included Autoimmune disorder since an unknown date.   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-Feb-2021, the patient experienced MALAISE (Malaise), VACCINATION SITE PAIN (Injection site pain), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise), VACCINATION SITE PAIN (Injection site pain), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-216657 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms; Back pain; Headache; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), BACK PAIN (Back pain) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), BACK PAIN (Back pain) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), BACK PAIN (Back pain) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No laboratory data was provided. No concomitant medications reported  No treatment information was provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. No concomitant medication 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.     Treatment medication was not provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Rash
Clinical narrative: small rash on his arm; fever of 101.3; really bad chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (small rash on his arm), PYREXIA (fever of 101.3) and CHILLS (really bad chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (small rash on his arm), PYREXIA (fever of 101.3) and CHILLS (really bad chills). At the time of the report, RASH (small rash on his arm), PYREXIA (fever of 101.3) and CHILLS (really bad chills) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.3 (High) fever of 101.3.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-116421 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pyrexia, Swelling, Vaccination site pain, Vaccination site warmth
Clinical narrative: hotness at the injection site; Severe Swelling,below the shot severe swelling and redness, swelling went all the way down to my elbow, very; redness,below the shot severe swelling and redness, swelling went all the way down to my elbow, very swollen and very uncomfortable; painful area where the shot was, felt like I got stung by a wasp; slight fever, never alarming; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hotness at the injection site), SWELLING (Severe Swelling,below the shot severe swelling and redness, swelling went all the way down to my elbow, very), ERYTHEMA (redness,below the shot severe swelling and redness, swelling went all the way down to my elbow, very swollen and very uncomfortable), VACCINATION SITE PAIN (painful area where the shot was, felt like I got stung by a wasp) and PYREXIA (slight fever, never alarming) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced VACCINATION SITE WARMTH (hotness at the injection site), SWELLING (Severe Swelling,below the shot severe swelling and redness, swelling went all the way down to my elbow, very), ERYTHEMA (redness,below the shot severe swelling and redness, swelling went all the way down to my elbow, very swollen and very uncomfortable), VACCINATION SITE PAIN (painful area where the shot was, felt like I got stung by a wasp) and PYREXIA (slight fever, never alarming). The patient was treated with IBUPROFEN for Swelling, at a dose of 800 mg. On 10-Jun-2021, PYREXIA (slight fever, never alarming) had resolved. On 12-Jun-2021, VACCINATION SITE PAIN (painful area where the shot was, felt like I got stung by a wasp) had resolved. On 13-Jun-2021, VACCINATION SITE WARMTH (hotness at the injection site), SWELLING (Severe Swelling,below the shot severe swelling and redness, swelling went all the way down to my elbow, very) and ERYTHEMA (redness,below the shot severe swelling and redness, swelling went all the way down to my elbow, very swollen and very uncomfortable) had resolved.            Patient has received the first dose on 09-Mar-2021,but has taken the second dose on 07-Jun-2021 according to patient's HCP's suggestion.  No concomitant medication were provided. .       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-Jun-2021 contains significant information including treatment and outcome of the event changed from unknown to recovered. Other information include updated primary reporter and patient details.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness). At the time of the report, MYALGIA (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.