chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Limb discomfort, Neck pain, Pain in extremity
Clinical narrative: I noticed it since the first vaccine; taste of the food doesn't change even if I have fish or barbeque; arms have been very heavy; peculiar taste; it makes me dizzy; once I put them on arm rest, pain up the arm to the back of my neck; once I put them on arm rest, pain up the arm to the back of my neck; the weird taste in my mouth is still there; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (peculiar taste), DIZZINESS (it makes me dizzy), PAIN IN EXTREMITY (once I put them on arm rest, pain up the arm to the back of my neck), NECK PAIN (once I put them on arm rest, pain up the arm to the back of my neck) and TASTE DISORDER (the weird taste in my mouth is still there) in a 79-year-old male 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 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) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced TASTE DISORDER (peculiar taste), DIZZINESS (it makes me dizzy), PAIN IN EXTREMITY (once I put them on arm rest, pain up the arm to the back of my neck), NECK PAIN (once I put them on arm rest, pain up the arm to the back of my neck), TASTE DISORDER (the weird taste in my mouth is still there), FEELING ABNORMAL (I noticed it since the first vaccine), FEELING ABNORMAL (taste of the food doesn't change even if I have fish or barbeque) and LIMB DISCOMFORT (arms have been very heavy). At the time of the report, TASTE DISORDER (peculiar taste), DIZZINESS (it makes me dizzy), PAIN IN EXTREMITY (once I put them on arm rest, pain up the arm to the back of my neck), NECK PAIN (once I put them on arm rest, pain up the arm to the back of my neck), TASTE DISORDER (the weird taste in my mouth is still there), FEELING ABNORMAL (I noticed it since the first vaccine), FEELING ABNORMAL (taste of the food doesn't change even if I have fish or barbeque) and LIMB DISCOMFORT (arms have been very heavy) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant Medications includes Blood pressure, Blood thinner and Cholesterol medication. Treatment Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up added on 23-JUN-2021: contact information updated.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: I noticed it since the first vaccine; taste of the food doesn't change even if I have fish or barbeque; arms have been very heavy; peculiar taste; it makes me dizzy; once I put them on arm rest, pain up the arm to the back of my neck; once I put them on arm rest, pain up the arm to the back of my neck; the weird taste in my mouth is still there; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (peculiar taste), DIZZINESS (it makes me dizzy), PAIN IN EXTREMITY (once I put them on arm rest, pain up the arm to the back of my neck), NECK PAIN (once I put them on arm rest, pain up the arm to the back of my neck) and TASTE DISORDER (the weird taste in my mouth is still there) in a 79-year-old male 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 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) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced TASTE DISORDER (peculiar taste), DIZZINESS (it makes me dizzy), PAIN IN EXTREMITY (once I put them on arm rest, pain up the arm to the back of my neck), NECK PAIN (once I put them on arm rest, pain up the arm to the back of my neck), TASTE DISORDER (the weird taste in my mouth is still there), FEELING ABNORMAL (I noticed it since the first vaccine), FEELING ABNORMAL (taste of the food doesn't change even if I have fish or barbeque) and LIMB DISCOMFORT (arms have been very heavy). At the time of the report, TASTE DISORDER (peculiar taste), DIZZINESS (it makes me dizzy), PAIN IN EXTREMITY (once I put them on arm rest, pain up the arm to the back of my neck), NECK PAIN (once I put them on arm rest, pain up the arm to the back of my neck), TASTE DISORDER (the weird taste in my mouth is still there), FEELING ABNORMAL (I noticed it since the first vaccine), FEELING ABNORMAL (taste of the food doesn't change even if I have fish or barbeque) and LIMB DISCOMFORT (arms have been very heavy) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant Medications includes Blood pressure, Blood thinner and Cholesterol medication. Treatment Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up added on 23-JUN-2021: contact information updated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pyrexia
Clinical narrative: Fatigue; Felling Sick; Slight Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ILLNESS (Felling Sick) and PYREXIA (Slight Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020 and COVID-19 in December 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (Fatigue), ILLNESS (Felling Sick) and PYREXIA (Slight Fever). At the time of the report, FATIGUE (Fatigue), ILLNESS (Felling Sick) and PYREXIA (Slight Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.   The Patient refused to give contact details. un-coperative, thinks it was a scam call and repeatedly disconnected.   This case was linked to MOD-2021-070386, MOD21-071030, MOD21-071138 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR-Follow up received on 26-May-2021 contains no new information-Patient refused to give details.; Sender's Comments:  MOD-2021-070386:Case for second dose MOD21-071030:cross linked case MOD21-071138:cross linked case
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Possible incorrect administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Possible incorrect administration of second dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020 and COVID-19 in December 2020.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Possible incorrect administration of second dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Possible incorrect administration of second dose) had resolved. Not Provided          It was reported that instead of the injection being done straight into the deltoid muscle, the administrator pinched the skin on the deltoid and then administered the vaccine.  Concomitant Medications were provided by the reporter. Treatment Medications were Provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-070365, MOD21-071030, MOD21-071138 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070365:Case for first dose MOD21-071030:cross linked case MOD21-071138:cross linked case
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Influenza like illness, Malaise, Pyrexia
Clinical narrative: chills like the flu; felt weak; felt dizzy; swelling on right side of face (between eye and upper cheek area); felt drunk getting out of bed; right eye is slightly closed from the swelling; Fever 102F; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (chills like the flu), ASTHENIA (felt weak), DIZZINESS (felt dizzy), SWELLING FACE (swelling on right side of face (between eye and upper cheek area)) and MALAISE (felt drunk getting out of bed) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (Fever 102F). On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (chills like the flu), ASTHENIA (felt weak), DIZZINESS (felt dizzy), SWELLING FACE (swelling on right side of face (between eye and upper cheek area)), MALAISE (felt drunk getting out of bed) and SWELLING OF EYELID (right eye is slightly closed from the swelling). At the time of the report, INFLUENZA LIKE ILLNESS (chills like the flu), ASTHENIA (felt weak), DIZZINESS (felt dizzy), SWELLING FACE (swelling on right side of face (between eye and upper cheek area)), MALAISE (felt drunk getting out of bed), SWELLING OF EYELID (right eye is slightly closed from the swelling) and PYREXIA (Fever 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: chills like the flu; felt weak; felt dizzy; swelling on right side of face (between eye and upper cheek area); felt drunk getting out of bed; right eye is slightly closed from the swelling; Fever 102F; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (chills like the flu), ASTHENIA (felt weak), DIZZINESS (felt dizzy), SWELLING FACE (swelling on right side of face (between eye and upper cheek area)) and MALAISE (felt drunk getting out of bed) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (Fever 102F). On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (chills like the flu), ASTHENIA (felt weak), DIZZINESS (felt dizzy), SWELLING FACE (swelling on right side of face (between eye and upper cheek area)), MALAISE (felt drunk getting out of bed) and SWELLING OF EYELID (right eye is slightly closed from the swelling). At the time of the report, INFLUENZA LIKE ILLNESS (chills like the flu), ASTHENIA (felt weak), DIZZINESS (felt dizzy), SWELLING FACE (swelling on right side of face (between eye and upper cheek area)), MALAISE (felt drunk getting out of bed), SWELLING OF EYELID (right eye is slightly closed from the swelling) and PYREXIA (Fever 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Gastrointestinal pain, Headache, Hypophagia
Clinical narrative: Stomach ache; Guts hurts; Fatigue; Massive pain; Could not eat; Could not function; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Massive pain), HYPOPHAGIA (Could not eat), IMPAIRED WORK ABILITY (Could not function), ABDOMINAL PAIN UPPER (Stomach ache) and GASTROINTESTINAL PAIN (Guts hurts) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A. and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Arthritis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 11-Mar-2021, the patient experienced PAIN (Massive pain), HYPOPHAGIA (Could not eat), IMPAIRED WORK ABILITY (Could not function) and FATIGUE (Fatigue). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) and GASTROINTESTINAL PAIN (Guts hurts). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. On 18-Feb-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 14-Mar-2021, FATIGUE (Fatigue) had resolved. On 16-Mar-2021, PAIN (Massive pain), HYPOPHAGIA (Could not eat) and IMPAIRED WORK ABILITY (Could not function) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache) and GASTROINTESTINAL PAIN (Guts hurts) outcome was unknown.            Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-067545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067545:Same patient, 1st dose
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pain, Pyrexia
Clinical narrative: Stomach ache; Guts hurts; Fatigue; Massive pain; Could not eat; Could not function; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Massive pain), HYPOPHAGIA (Could not eat), IMPAIRED WORK ABILITY (Could not function), ABDOMINAL PAIN UPPER (Stomach ache) and GASTROINTESTINAL PAIN (Guts hurts) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A. and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Arthritis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 11-Mar-2021, the patient experienced PAIN (Massive pain), HYPOPHAGIA (Could not eat), IMPAIRED WORK ABILITY (Could not function) and FATIGUE (Fatigue). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) and GASTROINTESTINAL PAIN (Guts hurts). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. On 18-Feb-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 14-Mar-2021, FATIGUE (Fatigue) had resolved. On 16-Mar-2021, PAIN (Massive pain), HYPOPHAGIA (Could not eat) and IMPAIRED WORK ABILITY (Could not function) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache) and GASTROINTESTINAL PAIN (Guts hurts) outcome was unknown.            Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-067545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067545:Same patient, 1st dose
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Not sure if her husband received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Not sure if her husband received the first dose) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Not sure if her husband received the first dose). At the time of the report, ACCIDENTAL UNDERDOSE (Not sure if her husband received the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reporter by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red arm; 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 ERYTHEMA (Red arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red arm). At the time of the report, ERYTHEMA (Red arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash erythematous, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of erythematous rash (site of injection developed a red rash), vaccination site warmth (site of injection is warm), vaccination site pruritus (site of injection is itchy), vaccination site pain (site of injection is sore) and fatigue in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025B21A) for COVID-19 immunization. No medical history reported. On Apr 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 6, 2021, patient experienced erythematous rash (site of injection developed a red rash), vaccination site warmth (site of injection is warm), vaccination site pruritus (site of injection is itchy) and vaccination site pain (site of injection is sore). On an unknown date, patient experienced fatigue. At the time of the report,  erythematous rash (site of injection developed a red rash), vaccination site warmth (site of injection is warm), vaccination site pruritus (site of injection is itchy), vaccination site pain (site of injection is sore) and fatigue outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information provided. Reporter did not allow further contact.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle pain in the legs; muscle stiffness; muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (muscle stiffness), MUSCLE SPASMS (muscle spasms) and MYALGIA (Muscle pain in the legs) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 13A2A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (condition improved) since 27-Mar-1967.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-Mar-2021, the patient experienced MUSCLE SPASMS (muscle spasms). On 06-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (muscle stiffness). On 07-Apr-2021, the patient experienced MYALGIA (Muscle pain in the legs). The patient was treated with IBUPROFEN ongoing from 03-May-2021 for Muscle pain, at a dose of 200 milligram. At the time of the report, MUSCULOSKELETAL STIFFNESS (muscle stiffness) and MUSCLE SPASMS (muscle spasms) had not resolved and MYALGIA (Muscle pain in the legs) outcome was unknown.            No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable.     Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information was received on 18 May 2021 wherein patient demographics, dose details and events were added.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Injection site mass, Malaise
Clinical narrative: Injection site lump; minty/metal taste in my mouth; I feel weird; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Injection site lump), DYSGEUSIA (minty/metal taste in my mouth) and MALAISE (I feel weird) 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 INJECTION SITE MASS (Injection site lump), DYSGEUSIA (minty/metal taste in my mouth) and MALAISE (I feel weird). At the time of the report, INJECTION SITE MASS (Injection site lump), DYSGEUSIA (minty/metal taste in my mouth) and MALAISE (I feel weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Dizziness; Bad Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Bad Headache) and NAUSEA (Nausea) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Bad Headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Bad Headache) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications included for birth control. Treatment details was not reported by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) 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 07-Apr-2021, the patient experienced HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: two different doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (two different doses) 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 INTERCHANGE OF VACCINE PRODUCTS (two different doses). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (two different doses) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received two different doses (one Pfizer 4 weeks) and Moderna vaccine.Safety consent for follow-up. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Lethargy, Nausea, Pyrexia
Clinical narrative: "feel bad"; lethargic; Back pain; Fever; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("feel bad"), LETHARGY (lethargic), BACK PAIN (Back pain), PYREXIA (Fever) and NAUSEA (nauseous) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING ABNORMAL ("feel bad"), LETHARGY (lethargic), BACK PAIN (Back pain), PYREXIA (Fever) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL ("feel bad"), LETHARGY (lethargic), BACK PAIN (Back pain), PYREXIA (Fever) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Polymerase chain reaction, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID-19 after 1st dose; Cold like symptoms after 1st dose; Body aches after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID-19 after 1st dose), NASOPHARYNGITIS (Cold like symptoms after 1st dose) and PAIN (Body aches after 1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Allergy to stone fruit) and Penicillin allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 04-Mar-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 SARS-COV-2 TEST POSITIVE (Positive for COVID-19 after 1st dose), NASOPHARYNGITIS (Cold like symptoms after 1st dose) and PAIN (Body aches after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID-19 after 1st dose) outcome was unknown and NASOPHARYNGITIS (Cold like symptoms after 1st dose) and PAIN (Body aches after 1st dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Polymerase chain reaction: positive (Positive) COVID-19 Positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Patient demographic details were updated, relevant medical history was updated, lab data was added, vaccine facility details were added, concomitant medication was added, event outcome for aches updated from unknown to recovered/resolved.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination complication
Clinical narrative: Tested positive for COVID19 Virus; Started feeling really bad; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 Virus) and FEELING ABNORMAL (Started feeling really bad) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (Started feeling really bad). On 15-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 Virus). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 Virus) and FEELING ABNORMAL (Started feeling really bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, based on the mechanism of action mRNA-1273 causal association between the event of COVID-19 Test positive and mRNA-1273 is assessed as not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Hypersomnia since an unknown date. Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (extreme fatigue). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) at an unspecified dose and frequency. On 14-Feb-2021, FATIGUE (extreme fatigue) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-063561 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063561:Dose 1
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus
Clinical narrative: very itchy in those portions; hot all over, mostly the face and top of legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy in those portions) and FEELING HOT (hot all over, mostly the face and top of legs) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very itchy in those portions) and FEELING HOT (hot all over, mostly the face and top of legs). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (very itchy in those portions) and FEELING HOT (hot all over, mostly the face and top of legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Additional information received
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Pain
Clinical narrative: soreness in arm that moved to collar bone; heaviness; as the night went on it was a little heavy and sore and soreness went into collar bone and a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness in arm that moved to collar bone), LIMB DISCOMFORT (heaviness) and FATIGUE (as the night went on it was a little heavy and sore and soreness went into collar bone and a little fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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 08-Mar-2021, the patient experienced PAIN (soreness in arm that moved to collar bone), LIMB DISCOMFORT (heaviness) and FATIGUE (as the night went on it was a little heavy and sore and soreness went into collar bone and a little fatigue). On 10-Mar-2021, PAIN (soreness in arm that moved to collar bone), LIMB DISCOMFORT (heaviness) and FATIGUE (as the night went on it was a little heavy and sore and soreness went into collar bone and a little fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Treatment for the events were not provided   This case was linked to MOD-2021-070615 (Patient Link).
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pruritus, Rash
Clinical narrative: the following day had a rash on the back and legs and it itches; little red bumps appeared and it itches like crazy, severely on the back and top of the tights; the following day had a rash on the back and legs and it itches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (the following day had a rash on the back and legs and it itches), MASS (little red bumps appeared and it itches like crazy, severely on the back and top of the tights) and RASH (the following day had a rash on the back and legs and it itches) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-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) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (the following day had a rash on the back and legs and it itches) and RASH (the following day had a rash on the back and legs and it itches). 05-Mar-2021, the patient experienced MASS (little red bumps appeared and it itches like crazy, severely on the back and top of the tights). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (the following day had a rash on the back and legs and it itches), MASS (little red bumps appeared and it itches like crazy, severely on the back and top of the tights) and RASH (the following day had a rash on the back and legs and it itches) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event were not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable   This case was linked to MOD-2021-036136 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Pyrexia
Clinical narrative: I couldn't eat.; fever; Chills; Headaches; so bad that it was hard to put my head on the pillow. The headaches were the most; Patient wanted us to know that it was the severity of the headache that bothered me.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (I couldn't eat.), PYREXIA (fever), CHILLS (Chills), HEADACHE (Headaches; so bad that it was hard to put my head on the pillow. The headaches were the most) and HEADACHE (Patient wanted us to know that it was the severity of the headache that bothered me.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (I couldn't eat.), PYREXIA (fever), CHILLS (Chills), HEADACHE (Headaches; so bad that it was hard to put my head on the pillow. The headaches were the most) and HEADACHE (Patient wanted us to know that it was the severity of the headache that bothered me.). At the time of the report, DECREASED APPETITE (I couldn't eat.), CHILLS (Chills), HEADACHE (Headaches; so bad that it was hard to put my head on the pillow. The headaches were the most) and HEADACHE (Patient wanted us to know that it was the severity of the headache that bothered me.) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: React badly; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an attorney and describes the occurrence of ADVERSE DRUG REACTION (React badly) in a not specific patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (React badly). At the time of the report, ADVERSE DRUG REACTION (React badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Migraine, Mobility decreased, Neck pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm pain for about 3-4 days), migraine headache, back pain (back pain and neck pain, pretty severe), neck pain (back pain and neck pain, pretty severe) and decreased mobility (she couldn't hardly move) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm pain for about 3-4 days), migraine headache, back pain (back pain and neck pain, pretty severe), neck pain (back pain and neck pain, pretty severe), decreased mobility (she couldn't hardly move), chills (shivers) and pyrexia (mild temperature at 98). At the time of the report, pain in extremity (arm pain for about 3-4 days), migraine headache, back pain (back pain and neck pain, pretty severe), neck pain (back pain and neck pain, pretty severe), decreased mobility (she couldn't hardly move), chills (shivers) and pyrexia (mild temperature at 98) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment details not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm pain for about 3-4 days), migraine headache, back pain (back pain and neck pain, pretty severe), neck pain (back pain and neck pain, pretty severe) and decreased mobility (she couldn't hardly move) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm pain for about 3-4 days), migraine headache, back pain (back pain and neck pain, pretty severe), neck pain (back pain and neck pain, pretty severe), decreased mobility (she couldn't hardly move), chills (shivers) and pyrexia (mild temperature at 98). At the time of the report, pain in extremity (arm pain for about 3-4 days), migraine headache, back pain (back pain and neck pain, pretty severe), neck pain (back pain and neck pain, pretty severe), decreased mobility (she couldn't hardly move), chills (shivers) and pyrexia (mild temperature at 98) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment details not reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oxygen saturation, Pain in extremity, Pyrexia
Clinical narrative: feeling unwell; pain in the legs and feet; oxygen level of 91; fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell), PAIN IN EXTREMITY (pain in the legs and feet), OXYGEN SATURATION (oxygen level of 91) and PYREXIA (fever) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MALAISE (feeling unwell), PAIN IN EXTREMITY (pain in the legs and feet), OXYGEN SATURATION (oxygen level of 91) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form. At the time of the report, MALAISE (feeling unwell), PAIN IN EXTREMITY (pain in the legs and feet), OXYGEN SATURATION (oxygen level of 91) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications are not provided by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant female received Moderna Covid-19 Vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant female received Moderna Covid-19 Vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011B21A) 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) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant female received Moderna Covid-19 Vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 15-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant female received Moderna Covid-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event NOS; This spontaneous case was reported and describes the occurrence of ADVERSE EVENT (Adverse event NOS) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event NOS). At the time of the report, ADVERSE EVENT (Adverse event NOS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported.  No treatment information was reported.   Case was received via email with limited information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; lack of effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) and DRUG INEFFECTIVE (lack of effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In February 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 05-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid) and DRUG INEFFECTIVE (lack of effect). At the time of the report, COVID-19 (Tested positive for Covid) had not resolved and DRUG INEFFECTIVE (lack of effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     Concomitant product use was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Upon internal review on 06-Aug-2021, an event (lack of effect) was added.