chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: could hardly talk.; nausea; pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"; weakness in my legs/weakness; I was freezing cold; I thought I might die,given the intensity of the discomfort.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"), FEELING COLD (I was freezing cold), DISCOMFORT (I thought I might die,given the intensity of the discomfort.), ASTHENIA (weakness in my legs/weakness) and SPEECH DISORDER (could hardly talk.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Aortic dissection on 10-Sep-2019. Previously administered products included for an unreported indication: STREPTOCOCCUS PNEUMONIAE and FLU. Concurrent medical conditions included Epilepsy (for 13 years.). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN+HIDROCLOROTIAZIDA) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 05-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced FEELING COLD (I was freezing cold) and DISCOMFORT (I thought I might die,given the intensity of the discomfort.). On 07-May-2021, the patient experienced ABDOMINAL PAIN UPPER (pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"), ASTHENIA (weakness in my legs/weakness) and NAUSEA (nausea). On an unknown date, the patient experienced SPEECH DISORDER (could hardly talk.). The patient was treated with PARACETAMOL (TYLENOL) (oral) on 08-May-2021 for Adverse event, at an unspecified dose and frequency. On 07-May-2021, DISCOMFORT (I thought I might die,given the intensity of the discomfort.) had resolved. On 23-May-2021, ASTHENIA (weakness in my legs/weakness) and NAUSEA (nausea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (pain became extremely intense and terrible to tolerate/"the pain was like some one stabbing in my stomach multiple times"), FEELING COLD (I was freezing cold) and SPEECH DISORDER (could hardly talk.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up includes patient demographics , event outcome updated On 22-Jul-2021: Follow up done. No new information received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Peripheral swelling, Product dose omission issue
Clinical narrative: Left arm became completely red; Its been more than 42 days after the first shot and she has not taken the second shot; Tired; rash in left arm; left arm swollen up; itching; i felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen up), PRURITUS (itching), DIZZINESS (i felt dizzy), ERYTHEMA (Left arm became completely red) and PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days after the first shot and she has not taken the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen up), PRURITUS (itching), DIZZINESS (i felt dizzy) and VACCINATION SITE RASH (rash in left arm). On an unknown date, the patient experienced ERYTHEMA (Left arm became completely red), PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days after the first shot and she has not taken the second shot) and FATIGUE (Tired). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 07-May-2021, PERIPHERAL SWELLING (left arm swollen up), PRURITUS (itching), DIZZINESS (i felt dizzy) and VACCINATION SITE RASH (rash in left arm) had resolved. At the time of the report, ERYTHEMA (Left arm became completely red), PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days after the first shot and she has not taken the second shot) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication Benadryl  for rash.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Significant follow up appended
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: Left arm became completely red; Its been more than 42 days after the first shot and she has not taken the second shot; Tired; rash in left arm; left arm swollen up; itching; i felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen up), PRURITUS (itching), DIZZINESS (i felt dizzy), ERYTHEMA (Left arm became completely red) and PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days after the first shot and she has not taken the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen up), PRURITUS (itching), DIZZINESS (i felt dizzy) and VACCINATION SITE RASH (rash in left arm). On an unknown date, the patient experienced ERYTHEMA (Left arm became completely red), PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days after the first shot and she has not taken the second shot) and FATIGUE (Tired). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 07-May-2021, PERIPHERAL SWELLING (left arm swollen up), PRURITUS (itching), DIZZINESS (i felt dizzy) and VACCINATION SITE RASH (rash in left arm) had resolved. At the time of the report, ERYTHEMA (Left arm became completely red), PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days after the first shot and she has not taken the second shot) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication Benadryl  for rash.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Significant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; 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 RASH (Rash) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Patient wants to receive second dose (>35 days from first dose); This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient wants to receive second dose (>35 days from first dose)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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 16-Feb-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient wants to receive second dose (>35 days from first dose)). On 16-Feb-2021, INTENTIONAL PRODUCT USE ISSUE (Patient wants to receive second dose (>35 days from first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medication and cholesterol medication. Treatment medications were not provided.  Action taken with mRNA-1273 in response to the event, Patient wants to receive second dose (>35 days from first dose), was not applicable.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received his first dose of Moderna COVID 19 Vaccine on 23Apr2021 and the second dose on 06May2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID 19 Vaccine on 23Apr2021 and the second dose on 06May2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID 19 Vaccine on 23Apr2021 and the second dose on 06May2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID 19 Vaccine on 23Apr2021 and the second dose on 06May2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Skin discolouration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Felt like something else controlling her body; Pink; itching; burning; Got worse as day went on; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (burning), CONDITION AGGRAVATED (Got worse as day went on), SKIN DISCOLOURATION (Pink) and FEELING ABNORMAL (Felt like something else controlling her body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 002A21A) 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 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (burning) and CONDITION AGGRAVATED (Got worse as day went on). On 07-May-2021, the patient experienced SKIN DISCOLOURATION (Pink). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like something else controlling her body). On 07-May-2021, VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (burning) and CONDITION AGGRAVATED (Got worse as day went on) had resolved. At the time of the report, SKIN DISCOLOURATION (Pink) and FEELING ABNORMAL (Felt like something else controlling her body) outcome was unknown.            Patient stated that she does take CBD oil and smokes pot and is very healthy. No treatment information provided.   This case was linked to MOD-2021-114397 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Muscle twitching, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (feeling tachycardia), INSOMNIA (insomnia), MUSCLE TWITCHING (muscle twitch at night when going into a deep sleep), TREMOR (shakiness) and PYREXIA (fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced TACHYCARDIA (feeling tachycardia). On an unknown date, the patient experienced INSOMNIA (insomnia), MUSCLE TWITCHING (muscle twitch at night when going into a deep sleep), TREMOR (shakiness), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills/chills at night). At the time of the report, TACHYCARDIA (feeling tachycardia), INSOMNIA (insomnia), MUSCLE TWITCHING (muscle twitch at night when going into a deep sleep), TREMOR (shakiness), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills/chills at night) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.No concomitant medication was provided. No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (feeling tachycardia), INSOMNIA (insomnia), MUSCLE TWITCHING (muscle twitch at night when going into a deep sleep), TREMOR (shakiness) and PYREXIA (fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced TACHYCARDIA (feeling tachycardia). On an unknown date, the patient experienced INSOMNIA (insomnia), MUSCLE TWITCHING (muscle twitch at night when going into a deep sleep), TREMOR (shakiness), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills/chills at night). At the time of the report, TACHYCARDIA (feeling tachycardia), INSOMNIA (insomnia), MUSCLE TWITCHING (muscle twitch at night when going into a deep sleep), TREMOR (shakiness), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills/chills at night) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.No concomitant medication was provided. No treatment information was provided.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: She started feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She started feeling dizzy) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced DIZZINESS (She started feeling dizzy). At the time of the report, DIZZINESS (She started feeling dizzy) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had started feeling dizzy and it lasted for quite long.  She said that the reaction happened with lot of her medications also.  Concomitant medication including Sleeping Pills was reported.  Treatment  included therapy and exercise .
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain, Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: hit my blood vessel and I bled a little bit; lingering soreness; nasty looking bruise; immediately had swelling at the injection shot,at least a half inch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (hit my blood vessel and I bled a little bit), PAIN (lingering soreness), CONTUSION (nasty looking bruise) and VACCINATION SITE SWELLING (immediately had swelling at the injection shot,at least a half inch) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-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 VACCINATION SITE HAEMORRHAGE (hit my blood vessel and I bled a little bit), PAIN (lingering soreness), CONTUSION (nasty looking bruise) and VACCINATION SITE SWELLING (immediately had swelling at the injection shot,at least a half inch). At the time of the report, VACCINATION SITE HAEMORRHAGE (hit my blood vessel and I bled a little bit) and PAIN (lingering soreness) outcome was unknown and CONTUSION (nasty looking bruise) and VACCINATION SITE SWELLING (immediately had swelling at the injection shot,at least a half inch) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No Relevant concomitant medications was reported.  Treatment information included ice pack.   This case was linked to MOD-2021-114432 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Insomnia
Clinical narrative: Difficulty breathing,shortness of breath; Coughing; Couldn't sleep; Chest full of congestion; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (Difficulty breathing,shortness of breath), COUGH (Coughing), INSOMNIA (Couldn't sleep) and CHEST DISCOMFORT (Chest full of congestion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing,shortness of breath), COUGH (Coughing), INSOMNIA (Couldn't sleep) and CHEST DISCOMFORT (Chest full of congestion). At the time of the report, DYSPNOEA (Difficulty breathing,shortness of breath), COUGH (Coughing), INSOMNIA (Couldn't sleep) and CHEST DISCOMFORT (Chest full of congestion) outcome was unknown. Not Provided          Treatment provided included steroid inhaler and antibiotics. Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (experienced pain), PRURITUS (Itchiness) and URTICARIA (Hives) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026BNA) for COVID-19 vaccination. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (experienced pain), PRURITUS (Itchiness) and URTICARIA (Hives). At the time of the report, PAIN (experienced pain), PRURITUS (Itchiness) and URTICARIA (Hives) outcome was unknown. 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 12-Apr-2021, DIZZINESS (Dizziness) and HEADACHE (Headache) 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.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: The rash resembles hives; Experience a rash ccine the patient began to experience a rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (The rash resembles hives) and RASH (Experience a rash ccine the patient began to experience a rash) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included VALSARTAN, ATORVASTATIN, DICLOFENAC and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (The rash resembles hives) and RASH (Experience a rash ccine the patient began to experience a rash). The patient was treated with CORTISONE for Adverse event, at a dose of UNK UNK, bid and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY NIGHTTIME) for Adverse event, at a dose of UNK, qhs. At the time of the report, URTICARIA (The rash resembles hives) and RASH (Experience a rash ccine the patient began to experience a rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-255263, MOD-2021-255263 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received - Concomitant medication-Multivitamin and dose-2 info updated
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: Extra pain; Muscle spasms; Stronger pain problems; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extra pain), MUSCLE SPASMS (Muscle spasms) and PAIN (Stronger pain problems) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Myopathy (Patient refers that, on 2004, he was diagnosed with a rare muscle disease (Tubular aggregate myopathy) via biopsy performed at the Hospital. "A problem that type II muscle fibers have when the muscle is under stress." "The disease causes muscle fatigue, weakness, sometimes extreme pain".) in 2004. Concomitant products included Soma                                                            muscle relaxant for Muscle relaxant, MORPHINE, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), DIGOXIN, SOTALOL, OLMESARTAN MEDOXOMIL (BENICAR), EZETIMIBE (ZETIA), ADENOSINE (TRICOR [ADENOSINE]), generic prilosec, Vitamin D supplement, Magnesium tablets, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), LORATADINE and PSEUDOEPHEDRINE for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (Extra pain). 08-Apr-2021, the patient experienced MUSCLE SPASMS (Muscle spasms) and PAIN (Stronger pain problems). At the time of the report, PAIN (Extra pain), MUSCLE SPASMS (Muscle spasms) and PAIN (Stronger pain problems) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-114444 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114444:Original Case : MOD-2021-114419
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was provided.   This case was linked to MOD21-088351, MOD21-088359, MOD21-088361, MOD21-088363, US-MODERNATX, INC.-MOD-2021-114456, US-MODERNATX, INC.-MOD-2021-114834 (E2B Linked Report).; Sender's Comments:  MOD21-088351: MOD21-088359: MOD21-088361: MOD21-088363: US-MODERNATX, INC.-MOD-2021-114456: US-MODERNATX, INC.-MOD-2021-114834:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm (upper left arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm (upper left arm)) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038-A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LIOTHYRONINE for Thyroid disorder.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE REACTION (Covid arm (upper left arm)). On 22-Apr-2021, VACCINATION SITE REACTION (Covid arm (upper left arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-114437 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia
Clinical narrative: Fever; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (A total knee replacement in the left knee in 2015) in 2015.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ARTHRALGIA (Knee pain). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, ARTHRALGIA (Knee pain) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) Fever of 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-114471 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nosebleed that lasted for 3 days on and off; This spontaneous case was reported by a pharmacist and describes the occurrence of EPISTAXIS (nosebleed that lasted for 3 days on and off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-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 EPISTAXIS (nosebleed that lasted for 3 days on and off). At the time of the report, EPISTAXIS (nosebleed that lasted for 3 days on and off) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Muscular weakness, Pyrexia, Syncope
Clinical narrative: fainted - it was very brief; sweating a lot after fainting; felt her legs were very weak; chills \ shivers; fever; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (fainted - it was very brief), HYPERHIDROSIS (sweating a lot after fainting), MUSCULAR WEAKNESS (felt her legs were very weak), CHILLS (chills \ shivers) and PYREXIA (fever) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced CHILLS (chills \ shivers) and PYREXIA (fever). On 07-May-2021, the patient experienced SYNCOPE (fainted - it was very brief), HYPERHIDROSIS (sweating a lot after fainting) and MUSCULAR WEAKNESS (felt her legs were very weak). On 06-May-2021, CHILLS (chills \ shivers) and PYREXIA (fever) had resolved. On 07-May-2021, SYNCOPE (fainted - it was very brief) and MUSCULAR WEAKNESS (felt her legs were very weak) had resolved. At the time of the report, HYPERHIDROSIS (sweating a lot after fainting) outcome was unknown.            Action taken with mRNA-1273 in response to events was not applicable  No concomitant medications were reported.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events syncope, hyperhidrosis, muscle weakness, chills and pyrexia, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events syncope, hyperhidrosis, muscle weakness, chills and pyrexia, a causal relationship cannot be excluded
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Neck pain, Pyrexia
Clinical narrative: Fever; Light headed; Pain in neck; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), DIZZINESS (Light headed) and NECK PAIN (Pain in neck) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Fever), DIZZINESS (Light headed) and NECK PAIN (Pain in neck). On 10-Apr-2021, PYREXIA (Fever) had resolved, DIZZINESS (Light headed) outcome was unknown. On 13-Apr-2021, NECK PAIN (Pain in neck) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.   This case was linked to MOD-2021-114455 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MECLOZINE for an unknown indication.    On 27-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 VERTIGO (Vertigo) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Vertigo) and DIZZINESS (Dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient received the second dose on 27MAR2021and the lot number is 002B21A or 002R21A.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site swelling
Clinical narrative: Intense headache; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Intense headache) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 07-Apr-2021, the patient experienced HEADACHE (Intense headache) and VACCINATION SITE SWELLING (Swelling at the injection site). On 09-Apr-2021, HEADACHE (Intense headache) had resolved. On 10-Apr-2021, VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported to have use Acetaminophen (Tylenol) as treatment.   This case was linked to MOD-2021-114439 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: fatigue; muscle ache; red blotch on her right arm where she was vaccinated; burning sensation; diarrhea on and off.; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea on and off.), FATIGUE (fatigue), MYALGIA (muscle ache), VACCINATION SITE ERYTHEMA (red blotch on her right arm where she was vaccinated) and VACCINATION SITE PAIN (burning sensation) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced DIARRHOEA (diarrhea on and off.). On 28-Apr-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle ache), VACCINATION SITE ERYTHEMA (red blotch on her right arm where she was vaccinated) and VACCINATION SITE PAIN (burning sensation). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at a dose of Ointment. At the time of the report, DIARRHOEA (diarrhea on and off.), FATIGUE (fatigue), MYALGIA (muscle ache), VACCINATION SITE ERYTHEMA (red blotch on her right arm where she was vaccinated) and VACCINATION SITE PAIN (burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Second dose is scheduled > 36 days from the first dose; Second dose is scheduled > 36 days from the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is scheduled > 36 days from the first dose) and PRODUCT DOSE OMISSION ISSUE (Second dose is scheduled > 36 days from the first dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is scheduled > 36 days from the first dose) and PRODUCT DOSE OMISSION ISSUE (Second dose is scheduled > 36 days from the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is scheduled > 36 days from the first dose) and PRODUCT DOSE OMISSION ISSUE (Second dose is scheduled > 36 days from the first dose) 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.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 16 year old male patient received first dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old male patient received first dose of Moderna Covid-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old male patient received first dose of Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old male patient received first dose of Moderna Covid-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment drugs were reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in left heel; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left heel) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in left heel). At the time of the report, PAIN IN EXTREMITY (pain in left heel) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD21-087920, US-MODERNATX, INC.-MOD-2021-114322 (E2B Linked Report).; Sender's Comments:  MOD21-087920:cross linked id US-MODERNATX, INC.-MOD-2021-114322:Wife Case
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Dyspnoea, Fatigue, Lymphadenopathy
Clinical narrative: Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long; Rash; swelling in lymph nodes on side where the injection was; tired; 102.5 fever; mild shortness of breathe which elevating her head with pillows helped; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (mild shortness of breathe which elevating her head with pillows helped), CONTUSION (Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long), RASH (Rash), LYMPHADENOPATHY (swelling in lymph nodes on side where the injection was) and FATIGUE (tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006-T21A and 038-A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LIOTHYRONINE for Thyroid disorder.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced DYSPNOEA (mild shortness of breathe which elevating her head with pillows helped), LYMPHADENOPATHY (swelling in lymph nodes on side where the injection was), FATIGUE (tired) and PYREXIA (102.5 fever). On 07-May-2021, the patient experienced RASH (Rash). On 08-May-2021, the patient experienced CONTUSION (Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (mild shortness of breathe which elevating her head with pillows helped), CONTUSION (Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long), RASH (Rash), LYMPHADENOPATHY (swelling in lymph nodes on side where the injection was), FATIGUE (tired) and PYREXIA (102.5 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Body temperature: 102.5 (abnormal) 102.5 fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114421 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long; Rash; swelling in lymph nodes on side where the injection was; tired; 102.5 fever; mild shortness of breathe which elevating her head with pillows helped; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (mild shortness of breathe which elevating her head with pillows helped), CONTUSION (Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long), RASH (Rash), LYMPHADENOPATHY (swelling in lymph nodes on side where the injection was) and FATIGUE (tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006-T21A and 038-A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LIOTHYRONINE for Thyroid disorder.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced DYSPNOEA (mild shortness of breathe which elevating her head with pillows helped), LYMPHADENOPATHY (swelling in lymph nodes on side where the injection was), FATIGUE (tired) and PYREXIA (102.5 fever). On 07-May-2021, the patient experienced RASH (Rash). On 08-May-2021, the patient experienced CONTUSION (Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (mild shortness of breathe which elevating her head with pillows helped), CONTUSION (Bruise on the underarm (vaccination side) that is "sizeable" and oval shaped, about 3 inches long), RASH (Rash), LYMPHADENOPATHY (swelling in lymph nodes on side where the injection was), FATIGUE (tired) and PYREXIA (102.5 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Body temperature: 102.5 (abnormal) 102.5 fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114421 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Productive cough, Rhinorrhoea, Vaccination site pain
Clinical narrative: sore throat; runny nose; phlegm; sore arm for 3 hours post first dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), PRODUCTIVE COUGH (phlegm) and VACCINATION SITE PAIN (sore arm for 3 hours post 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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm for 3 hours post first dose). On 08-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose) and PRODUCTIVE COUGH (phlegm). At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), PRODUCTIVE COUGH (phlegm) and VACCINATION SITE PAIN (sore arm for 3 hours post first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided. No treatment information was reported.