chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Peripheral swelling, Skin discolouration
Clinical narrative: Severe pain in left arm/Soreness in left arm; Swelling in left arm; Left arm turned black, then blue and now purple; hot; Doctor thinks tendon was torn; chills; fatigue; Vaccination provider did not let patient sit down, pulled the jacket little bit down and quickly ran the; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain in left arm/Soreness in left arm), PERIPHERAL SWELLING (Swelling in left arm), SKIN DISCOLOURATION (Left arm turned black, then blue and now purple), FEELING HOT (hot) and TENDON RUPTURE (Doctor thinks tendon was torn) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE REACTION (Vaccination provider did not let patient sit down, pulled the jacket little bit down and quickly ran the). On an unknown date, the patient experienced VACCINATION SITE PAIN (Severe pain in left arm/Soreness in left arm), PERIPHERAL SWELLING (Swelling in left arm), SKIN DISCOLOURATION (Left arm turned black, then blue and now purple), FEELING HOT (hot), TENDON RUPTURE (Doctor thinks tendon was torn), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (Severe pain in left arm/Soreness in left arm), PERIPHERAL SWELLING (Swelling in left arm), SKIN DISCOLOURATION (Left arm turned black, then blue and now purple), FEELING HOT (hot), TENDON RUPTURE (Doctor thinks tendon was torn), VACCINATION SITE REACTION (Vaccination provider did not let patient sit down, pulled the jacket little bit down and quickly ran the), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up report received on 05 Aug 2021, Updated outcome for the events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon rupture, Vaccination site pain, Vaccination site reaction
Clinical narrative: Severe pain in left arm/Soreness in left arm; Swelling in left arm; Left arm turned black, then blue and now purple; hot; Doctor thinks tendon was torn; chills; fatigue; Vaccination provider did not let patient sit down, pulled the jacket little bit down and quickly ran the; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain in left arm/Soreness in left arm), PERIPHERAL SWELLING (Swelling in left arm), SKIN DISCOLOURATION (Left arm turned black, then blue and now purple), FEELING HOT (hot) and TENDON RUPTURE (Doctor thinks tendon was torn) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE REACTION (Vaccination provider did not let patient sit down, pulled the jacket little bit down and quickly ran the). On an unknown date, the patient experienced VACCINATION SITE PAIN (Severe pain in left arm/Soreness in left arm), PERIPHERAL SWELLING (Swelling in left arm), SKIN DISCOLOURATION (Left arm turned black, then blue and now purple), FEELING HOT (hot), TENDON RUPTURE (Doctor thinks tendon was torn), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (Severe pain in left arm/Soreness in left arm), PERIPHERAL SWELLING (Swelling in left arm), SKIN DISCOLOURATION (Left arm turned black, then blue and now purple), FEELING HOT (hot), TENDON RUPTURE (Doctor thinks tendon was torn), VACCINATION SITE REACTION (Vaccination provider did not let patient sit down, pulled the jacket little bit down and quickly ran the), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up report received on 05 Aug 2021, Updated outcome for the events.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Hyperhidrosis, Injection site erythema
Clinical narrative: Sweating; Fast Heart Beat; Not able to lift the Injected Arm; Lightheaded; Red Injection Site; Tender Injection Site; sore and Pain with movement (Injected Arm); injection site swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweating), HEART RATE INCREASED (Fast Heart Beat), MOBILITY DECREASED (Not able to lift the Injected Arm), DIZZINESS (Lightheaded) and INJECTION SITE ERYTHEMA (Red Injection Site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 HYPERHIDROSIS (Sweating), HEART RATE INCREASED (Fast Heart Beat), MOBILITY DECREASED (Not able to lift the Injected Arm), DIZZINESS (Lightheaded), INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), MYALGIA (sore and Pain with movement (Injected Arm)) and INJECTION SITE SWELLING (injection site swelling). On 09-Apr-2021, HYPERHIDROSIS (Sweating), HEART RATE INCREASED (Fast Heart Beat) and DIZZINESS (Lightheaded) had resolved. At the time of the report, MOBILITY DECREASED (Not able to lift the Injected Arm) outcome was unknown and INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), MYALGIA (sore and Pain with movement (Injected Arm)) and INJECTION SITE SWELLING (injection site swelling) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Fallow up received on 12-APR-2021 contains no new information. On 19-Apr-2021: Fallow up is received at 19-APR-2021 included new events and out come of the event was updated
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Myalgia
Clinical narrative: Sweating; Fast Heart Beat; Not able to lift the Injected Arm; Lightheaded; Red Injection Site; Tender Injection Site; sore and Pain with movement (Injected Arm); injection site swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweating), HEART RATE INCREASED (Fast Heart Beat), MOBILITY DECREASED (Not able to lift the Injected Arm), DIZZINESS (Lightheaded) and INJECTION SITE ERYTHEMA (Red Injection Site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 HYPERHIDROSIS (Sweating), HEART RATE INCREASED (Fast Heart Beat), MOBILITY DECREASED (Not able to lift the Injected Arm), DIZZINESS (Lightheaded), INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), MYALGIA (sore and Pain with movement (Injected Arm)) and INJECTION SITE SWELLING (injection site swelling). On 09-Apr-2021, HYPERHIDROSIS (Sweating), HEART RATE INCREASED (Fast Heart Beat) and DIZZINESS (Lightheaded) had resolved. At the time of the report, MOBILITY DECREASED (Not able to lift the Injected Arm) outcome was unknown and INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), MYALGIA (sore and Pain with movement (Injected Arm)) and INJECTION SITE SWELLING (injection site swelling) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Fallow up received on 12-APR-2021 contains no new information. On 19-Apr-2021: Fallow up is received at 19-APR-2021 included new events and out come of the event was updated
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Phantom limb syndrome
Clinical narrative: phantom pains or tingle sensations that randomly occur; phantom pains or tingle sensations that randomly occur; This spontaneous case was reported by a consumer and describes the occurrence of PHANTOM LIMB SYNDROME (phantom pains or tingle sensations that randomly occur) and PARAESTHESIA (phantom pains or tingle sensations that randomly occur) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030l20a and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AMIFAMPRIDINE PHOSPHATE (3 4 DIAMINOPYRIDINE), LEVOCETIRIZINE DIHYDROCHLORIDE (1 AL), CHLORAL HYDRATE, PROMETHAZINE HYDROCHLORIDE (PHENERGAN AND CHLORAL HYDRATE), SALBUTAMOL (ALBUTEROL HFA), LOSARTAN, TRAZODONE, ALENDRONATE SODIUM (FOSAMAX) and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PHANTOM LIMB SYNDROME (phantom pains or tingle sensations that randomly occur) and PARAESTHESIA (phantom pains or tingle sensations that randomly occur). At the time of the report, PHANTOM LIMB SYNDROME (phantom pains or tingle sensations that randomly occur) and PARAESTHESIA (phantom pains or tingle sensations that randomly occur) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD21-074084 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information contains non-significant information; Sender's Comments:  MOD21-074084:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness in arm), back pain and arthralgia (knee pain/hip pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included pain (has pain from pre-diagnosed medical conditions). On Mar 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 24, 2021, patient experienced pain in extremity (soreness in arm). On an unknown date, patient experienced back pain and arthralgia (knee pain/hip pain). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. On Mar 27, 2021, pain in extremity (soreness in arm) resolved. At the time of the report, back pain and arthralgia (knee pain/hip pain) outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; dosing remained unchanged. After his completion on the Moderna vaccination, he will schedule surgery. No concomitant medications reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: fever; Both feet started feeling tingly; 2 big toes on both feet felt numb; numbing on left cheek; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), PARAESTHESIA (Both feet started feeling tingly), HYPOAESTHESIA (numbing on left cheek) and HYPOAESTHESIA (2 big toes on both feet felt numb) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     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) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HYPOAESTHESIA (numbing on left cheek). On 20-Mar-2021, the patient experienced PYREXIA (fever), PARAESTHESIA (Both feet started feeling tingly) and HYPOAESTHESIA (2 big toes on both feet felt numb). At the time of the report, PYREXIA (fever), PARAESTHESIA (Both feet started feeling tingly), HYPOAESTHESIA (numbing on left cheek) and HYPOAESTHESIA (2 big toes on both feet felt numb) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Slight dizziness after 2nd dose; Little Soreness in arm after 2nd dose; Headache after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Slight dizziness after 2nd dose), PAIN IN EXTREMITY (Little Soreness in arm after 2nd dose) and HEADACHE (Headache after 2nd dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DIZZINESS (Slight dizziness after 2nd dose), PAIN IN EXTREMITY (Little Soreness in arm after 2nd dose) and HEADACHE (Headache after 2nd dose). At the time of the report, DIZZINESS (Slight dizziness after 2nd dose), PAIN IN EXTREMITY (Little Soreness in arm after 2nd dose) and HEADACHE (Headache after 2nd dose) had not resolved.            Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea
Clinical narrative: diarrhea; has hardly eaten anything; stomach constantly growling; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (has hardly eaten anything) and ABDOMINAL PAIN UPPER (stomach constantly growling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-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 07-Apr-2021, the patient experienced DIARRHOEA (diarrhea), DECREASED APPETITE (has hardly eaten anything) and ABDOMINAL PAIN UPPER (stomach constantly growling). At the time of the report, DIARRHOEA (diarrhea), DECREASED APPETITE (has hardly eaten anything) and ABDOMINAL PAIN UPPER (stomach constantly growling) outcome was unknown.            Treatment and concomitant medicines were not reported  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling abnormal, Lacrimation increased, Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: Sore Throat; Stuffed Ears; Watery Eyes; Tickling In Throat; Felt Like Death Warmed Over; 99 F Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), EAR DISCOMFORT (Stuffed Ears), LACRIMATION INCREASED (Watery Eyes), OROPHARYNGEAL DISCOMFORT (Tickling In Throat) and FEELING ABNORMAL (Felt Like Death Warmed Over) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus infection.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), EAR DISCOMFORT (Stuffed Ears), LACRIMATION INCREASED (Watery Eyes), OROPHARYNGEAL DISCOMFORT (Tickling In Throat), FEELING ABNORMAL (Felt Like Death Warmed Over) and PYREXIA (99 F Fever). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), EAR DISCOMFORT (Stuffed Ears), LACRIMATION INCREASED (Watery Eyes), OROPHARYNGEAL DISCOMFORT (Tickling In Throat) and PYREXIA (99 F Fever) was resolving and FEELING ABNORMAL (Felt Like Death Warmed Over) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-073681 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073681:wife case
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore Throat; Stuffed Ears; Watery Eyes; Tickling In Throat; Felt Like Death Warmed Over; 99 F Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), EAR DISCOMFORT (Stuffed Ears), LACRIMATION INCREASED (Watery Eyes), OROPHARYNGEAL DISCOMFORT (Tickling In Throat) and FEELING ABNORMAL (Felt Like Death Warmed Over) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus infection.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), EAR DISCOMFORT (Stuffed Ears), LACRIMATION INCREASED (Watery Eyes), OROPHARYNGEAL DISCOMFORT (Tickling In Throat), FEELING ABNORMAL (Felt Like Death Warmed Over) and PYREXIA (99 F Fever). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), EAR DISCOMFORT (Stuffed Ears), LACRIMATION INCREASED (Watery Eyes), OROPHARYNGEAL DISCOMFORT (Tickling In Throat) and PYREXIA (99 F Fever) was resolving and FEELING ABNORMAL (Felt Like Death Warmed Over) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-073681 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073681:wife case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gastrointestinal pain, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (I had severe sharp pain in stomach and intestinal tract for 24 hours, kept me up all night, next day was intermittent), CHILLS (Started next morning chills, fatigue, nausea), FATIGUE (Started next morning chills, fatigue, nausea) and NAUSEA (Started next morning chills, fatigue, nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The patient's past medical history included Blood pressure high since an unknown date. Concurrent medical conditions included Hypercholesteremia (High cholesterol). Concomitant products included POTASSIUM and VITAMIN D NOS for an unknown indication. On 03-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 GASTROINTESTINAL PAIN (I had severe sharp pain in stomach and intestinal tract for 24 hours, kept me up all night, next day was intermittent), CHILLS (Started next morning chills, fatigue, nausea), FATIGUE (Started next morning chills, fatigue, nausea) and NAUSEA (Started next morning chills, fatigue, nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GASTROINTESTINAL PAIN (I had severe sharp pain in stomach and intestinal tract for 24 hours, kept me up all night, next day was intermittent), CHILLS (Started next morning chills, fatigue, nausea), FATIGUE (Started next morning chills, fatigue, nausea) and NAUSEA (Started next morning chills, fatigue, nausea) 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. Patient took Tylenol and drank lots of water to relieve symptoms.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site rash, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: rash is hot,rash is getting bigger,rash is red,rash does not itch; rash is red; fever; chills; Rash on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (rash is hot,rash is getting bigger,rash is red,rash does not itch), RASH ERYTHEMATOUS (rash is red), INJECTION SITE RASH (Rash on arm of injection), PYREXIA (fever) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INJECTION SITE RASH (Rash on arm of injection). On 10-Apr-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 12-Apr-2021, the patient experienced INJECTION SITE WARMTH (rash is hot,rash is getting bigger,rash is red,rash does not itch) and RASH ERYTHEMATOUS (rash is red). At the time of the report, INJECTION SITE WARMTH (rash is hot,rash is getting bigger,rash is red,rash does not itch), RASH ERYTHEMATOUS (rash is red), INJECTION SITE RASH (Rash on arm of injection), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue, Muscle spasms, Myalgia
Clinical narrative: Blood sugar levels exceed 200; Body cramps; Left arm soreness at the site of the inejction; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar levels exceed 200), MUSCLE SPASMS (Body cramps), MYALGIA (Left arm soreness at the site of the inejction) and FATIGUE (Extremely tired) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN and GABAPENTIN for an unknown indication.   On 16-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced MYALGIA (Left arm soreness at the site of the inejction) and FATIGUE (Extremely tired). On 22-Mar-2021, the patient experienced MUSCLE SPASMS (Body cramps). On 22-Mar-2021 at 1:00 PM, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar levels exceed 200). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar levels exceed 200), MUSCLE SPASMS (Body cramps), MYALGIA (Left arm soreness at the site of the inejction) and FATIGUE (Extremely tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was provided as adjustment of Insulin. Patient's carb to insulin ratio is 6 1/2 to 1, correction factor is 30 and insulin duration is 5 hours. Ate 58 carbs took 8.68 units of insulin -2 hrs. Later had to eat an additional 115 carbs to keep sugar above 100. On 09-Apr-2021, diabetic lab work was done and result was awaiting.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal discomfort, Rash, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arms), SWELLING (swelling of neck), DYSPNEA (breathing got bad), RASH (rash on hands) and RASH (rash on body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product VITAMIN D NOS for an unknown indication. Concurrent medical conditions included Drug allergy (Geodon), Drug allergy (Levaquin), Drug allergy (Tessalon pearls) and Drug allergy (A blood pressure medication that patient cannot recall.). Concomitant products included SALBUTAMOL SULFATE (PROAIR DIGIHALER), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), MAGNESIUM, HYDROCODONE, OMEPRAZOLE, PREGABALIN, HYDROXYZINE PAMOATE, CETIRIZINE, FOLIC ACID, MELOXICAM, CYCLOBENZAPRINE, LEFLUNOMIDE, BENAZEPRIL HYDROCHLORIDE, HYDROCHLOROTHIAZIDE (BENAZEPRIL/HCTZ) and SODIUM FLUORIDE (PREVIDENT) for an unknown indication. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VITAMIN D NOS (unknown route) at an unspecified dose. On 07-Apr-2021, the patient experienced RASH (rash on arms), SWELLING (swelling of neck), RASH (rash on hands), RASH (rash on body) and MUSCULOSKELETAL DISCOMFORT (neck appeared to be filled out). On 08-Apr-2021, the patient experienced DYSPNOEA (breathing got bad) and DYSPNOEA (labored breathing). At the time of the report, RASH (rash on arms), SWELLING (swelling of neck), DYSPNOEA (breathing got bad), RASH (rash on hands), RASH (rash on body), MUSCULOSKELETAL DISCOMFORT (neck appeared to be filled out) and DYSPNOEA (labored breathing) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Headache, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE, CHILLS, FATIGUE, BURNING SENSATION, and PRURITUS in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event, No reported medical history. Concomitant products included ROSUVASTATIN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE. On 13-Feb-2021, the patient experienced CHILLS and FATIGUE. On 19-Feb-2021, the patient experienced BURNING SENSATION. On 21-Feb-2021, the patient experienced PRURITUS. On 26-Feb-2021, the patient experienced BURNING SENSATION and PRURITUS. On 12-Feb-2021, HEADACHE had resolved. On 14-Feb-2021, CHILLS and FATIGUE had resolved. On 12-Mar-2021, BURNING SENSATION, PRURITUS, BURNING SENSATION, and PRURITUS had resolved. 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.   Patient was treated with hydrocortisone cream.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye disorder, Injection site bruising
Clinical narrative: Dizzy; White floaters in right eye, when eye is closed/Black floaters in right eye; Small bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), INJECTION SITE BRUISING (Small bump at injection site) and EYE DISORDER (White floaters in right eye, when eye is closed/Black floaters in right eye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced INJECTION SITE BRUISING (Small bump at injection site). On 01-Apr-2021, the patient experienced DIZZINESS (Dizzy) and EYE DISORDER (White floaters in right eye, when eye is closed/Black floaters in right eye). At the time of the report, DIZZINESS (Dizzy), INJECTION SITE BRUISING (Small bump at injection site) and EYE DISORDER (White floaters in right eye, when eye is closed/Black floaters in right eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included vitamins and IGG infusion. No treatment medications were provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Nasal congestion, Rash, Vaccination site pruritus
Clinical narrative: Nasal congestion; Rashes; Covid rash; Itchy arm; Back pain; Within an hour shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Within an hour shortness of breath), BACK PAIN (Back pain), NASAL CONGESTION (Nasal congestion), RASH (Rashes) and VACCINATION SITE RASH (Covid rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Within an hour shortness of breath). On 20-Mar-2021, the patient experienced BACK PAIN (Back pain). On 25-Mar-2021, the patient experienced RASH (Rashes), VACCINATION SITE RASH (Covid rash) and VACCINATION SITE PRURITUS (Itchy arm). On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. On 18-Mar-2021, DYSPNOEA (Within an hour shortness of breath) had resolved. On 27-Mar-2021, RASH (Rashes), VACCINATION SITE RASH (Covid rash) and VACCINATION SITE PRURITUS (Itchy arm) had resolved. On 03-Apr-2021, BACK PAIN (Back pain) had resolved. At the time of the report, NASAL CONGESTION (Nasal congestion) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Nasal congestion; Rashes; Covid rash; Itchy arm; Back pain; Within an hour shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Within an hour shortness of breath), BACK PAIN (Back pain), NASAL CONGESTION (Nasal congestion), RASH (Rashes) and VACCINATION SITE RASH (Covid rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Within an hour shortness of breath). On 20-Mar-2021, the patient experienced BACK PAIN (Back pain). On 25-Mar-2021, the patient experienced RASH (Rashes), VACCINATION SITE RASH (Covid rash) and VACCINATION SITE PRURITUS (Itchy arm). On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. On 18-Mar-2021, DYSPNOEA (Within an hour shortness of breath) had resolved. On 27-Mar-2021, RASH (Rashes), VACCINATION SITE RASH (Covid rash) and VACCINATION SITE PRURITUS (Itchy arm) had resolved. On 03-Apr-2021, BACK PAIN (Back pain) had resolved. At the time of the report, NASAL CONGESTION (Nasal congestion) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Vaccination site pain
Clinical narrative: Soreness in the arm at the injection site after first dose; Cold feet after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Cold feet after first dose) and VACCINATION SITE PAIN (Soreness in the arm at the injection site after first dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Seafood allergy (shrimp), Dust allergy and Allergy to molds.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL COLDNESS (Cold feet after first dose). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in the arm at the injection site after first dose). At the time of the report, PERIPHERAL COLDNESS (Cold feet after first dose) had not resolved and VACCINATION SITE PAIN (Soreness in the arm at the injection site after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073780 (E2B Linked Report). This case was linked to MOD-2021-073780 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up was received and contains significant information: Patient's relevant history updated, contact details updated, patient information updated, event outcome added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073780:Dose 2
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 11-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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Erythema on day 8 after vaccination), VACCINATION SITE URTICARIA (Hives on day 8 after vaccination), VACCINATION SITE PRURITUS (Pruritus on Day 8 after vaccination) and INJECTION SITE PAIN (Tenderness at injection site on day 10 after vaccination) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.  No historical conditions were reported. Concomitant products included HYDROCHLOROTHIAZIDE, Claritin B, ESTROGENS CONJUGATED (PREMARIN), CEFALEXIN MONOHYDRATE (LEXIPRON) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 01-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 VACCINATION SITE ERYTHEMA (Erythema on day 8 after vaccination), VACCINATION SITE URTICARIA (Hives on day 8 after vaccination) and VACCINATION SITE PRURITUS (Pruritus on Day 8 after vaccination). On 10-Apr-2021, the patient experienced INJECTION SITE PAIN (Tenderness at injection site on day 10 after vaccination). On 10-Apr-2021, VACCINATION SITE URTICARIA (Hives on day 8 after vaccination) and VACCINATION SITE PRURITUS (Pruritus on Day 8 after vaccination) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Erythema on day 8 after vaccination) and INJECTION SITE PAIN (Tenderness at injection site on day 10 after vaccination) 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. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral coldness, Ultrasound scan, Vaccination site pain
Clinical narrative: Still having cold feet which are not getting warm/ feet become very cold; Soreness in the arm at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Still having cold feet which are not getting warm/ feet become very cold), VACCINATION SITE PAIN (Soreness in the arm at the injection site) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Seafood allergy (Allergic to shrimp).   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) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL COLDNESS (Still having cold feet which are not getting warm/ feet become very cold). In April 2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm at the injection site) and HEADACHE (Headache). At the time of the report, PERIPHERAL COLDNESS (Still having cold feet which are not getting warm/ feet become very cold) had not resolved and VACCINATION SITE PAIN (Soreness in the arm at the injection site) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Ultrasound scan: normal (normal) ultrasound of blood pressure for ankle and toe were normal.         No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073774 (E2B Linked Report). This case was linked to MOD-2021-073774 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: follow-up document received on 15 Jul 2021; included reporter detail, laboratory data, date of the event (Cold feet) and outcome of event. On 15-Jul-2021: followup document received on 15 Jul 2021 contain NNI.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073774:Dose 1
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Feeling abnormal, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Sweating; Soaking in bed; can't stand; feeling fuzzy; intermittent numbness in face; Pain; pain, tenderness, and swelling in arm; pain, tenderness, and swelling in arm; shivering/chills; High fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), NIGHT SWEATS (Soaking in bed), DYSSTASIA (can't stand), FEELING ABNORMAL (feeling fuzzy) and HYPOAESTHESIA (intermittent numbness in face) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), NIGHT SWEATS (Soaking in bed), DYSSTASIA (can't stand), FEELING ABNORMAL (feeling fuzzy), HYPOAESTHESIA (intermittent numbness in face), PAIN (Pain), TENDERNESS (pain, tenderness, and swelling in arm), PERIPHERAL SWELLING (pain, tenderness, and swelling in arm), CHILLS (shivering/chills) and PYREXIA (High fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of 1 dosage form and ACETAMINOPHEN for Fever, at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweating), NIGHT SWEATS (Soaking in bed), DYSSTASIA (can't stand), FEELING ABNORMAL (feeling fuzzy), HYPOAESTHESIA (intermittent numbness in face), PAIN (Pain), TENDERNESS (pain, tenderness, and swelling in arm), PERIPHERAL SWELLING (pain, tenderness, and swelling in arm), CHILLS (shivering/chills) and PYREXIA (High fever) outcome was unknown.            Relevant concomitant medications included BP medications, thyroid medications,diabetic medications. Action taken with mRNA-1273 in response to the event was not applicable
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pain, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Sweating; Soaking in bed; can't stand; feeling fuzzy; intermittent numbness in face; Pain; pain, tenderness, and swelling in arm; pain, tenderness, and swelling in arm; shivering/chills; High fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), NIGHT SWEATS (Soaking in bed), DYSSTASIA (can't stand), FEELING ABNORMAL (feeling fuzzy) and HYPOAESTHESIA (intermittent numbness in face) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), NIGHT SWEATS (Soaking in bed), DYSSTASIA (can't stand), FEELING ABNORMAL (feeling fuzzy), HYPOAESTHESIA (intermittent numbness in face), PAIN (Pain), TENDERNESS (pain, tenderness, and swelling in arm), PERIPHERAL SWELLING (pain, tenderness, and swelling in arm), CHILLS (shivering/chills) and PYREXIA (High fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of 1 dosage form and ACETAMINOPHEN for Fever, at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweating), NIGHT SWEATS (Soaking in bed), DYSSTASIA (can't stand), FEELING ABNORMAL (feeling fuzzy), HYPOAESTHESIA (intermittent numbness in face), PAIN (Pain), TENDERNESS (pain, tenderness, and swelling in arm), PERIPHERAL SWELLING (pain, tenderness, and swelling in arm), CHILLS (shivering/chills) and PYREXIA (High fever) outcome was unknown.            Relevant concomitant medications included BP medications, thyroid medications,diabetic medications. Action taken with mRNA-1273 in response to the event was not applicable
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Seasonal allergy and Food allergy.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (Mild fever). On 28-Feb-2021, PYREXIA (Mild fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medication was listed for treatment of the event.