chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Sunburn
Clinical narrative: Muscles in buttocks, top part felt like light sunburn on skin; Shingles; Muscles hurt where incision was from surgery; Blisters on waist; Really bad pain on right hip; Redness on waist; Arm was really sore; Chills real bad; Skin felt like it had mild acid on it like sunburn; Felt warmth in body; Back pain - quite intense; Metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt warmth in body), BACK PAIN (Back pain - quite intense), DYSGEUSIA (Metallic taste in mouth), SUNBURN (Muscles in buttocks, top part felt like light sunburn on skin) and SUNBURN (Skin felt like it had mild acid on it like sunburn) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L120A or 032LD0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthrodesis and Back surgery (History of 3 back surgeries).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced FEELING HOT (Felt warmth in body), BACK PAIN (Back pain - quite intense), DYSGEUSIA (Metallic taste in mouth), SUNBURN (Skin felt like it had mild acid on it like sunburn) and CHILLS (Chills real bad). On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was really sore). On 14-Feb-2021, the patient experienced ERYTHEMA (Redness on waist) and ARTHRALGIA (Really bad pain on right hip). On 15-Feb-2021, the patient experienced BLISTER (Blisters on waist). On an unknown date, the patient experienced SUNBURN (Muscles in buttocks, top part felt like light sunburn on skin), HERPES ZOSTER (Shingles) and MYALGIA (Muscles hurt where incision was from surgery). The patient was treated with GABAPENTIN at a dose of 100 milligram one a day at night and HYDROCODONE at a dose of 7.5 milligram 1/2 tablet. At the time of the report, FEELING HOT (Felt warmth in body), BACK PAIN (Back pain - quite intense), DYSGEUSIA (Metallic taste in mouth), SUNBURN (Muscles in buttocks, top part felt like light sunburn on skin), SUNBURN (Skin felt like it had mild acid on it like sunburn), PAIN IN EXTREMITY (Arm was really sore), ERYTHEMA (Redness on waist), BLISTER (Blisters on waist), HERPES ZOSTER (Shingles), CHILLS (Chills real bad), ARTHRALGIA (Really bad pain on right hip) and MYALGIA (Muscles hurt where incision was from surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Patient received treatment of Heating Pad and Physical Therapy. Patient scheduled second dose on 08Mar2021.   This case was linked to MOD21-045740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 and contains non significant information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever 102 F; Chills; Pain Injection Site; Headache; Body Aches.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 102 F), CHILLS (Chills), INJECTION SITE PAIN (Pain Injection Site), HEADACHE (Headache) and MYALGIA (Body Aches.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (Fever 102 F), CHILLS (Chills), INJECTION SITE PAIN (Pain Injection Site), HEADACHE (Headache) and MYALGIA (Body Aches.). At the time of the report, PYREXIA (Fever 102 F), CHILLS (Chills), INJECTION SITE PAIN (Pain Injection Site), HEADACHE (Headache) and MYALGIA (Body Aches.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Little itching; Rash around injection site around an inch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Little itching) and INJECTION SITE RASH (Rash around injection site around an inch) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L204) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Little itching) and INJECTION SITE RASH (Rash around injection site around an inch). At the time of the report, INJECTION SITE PRURITUS (Little itching) and INJECTION SITE RASH (Rash around injection site around an inch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: feeling very achy; the injection site is tender and sore; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feeling very achy), INJECTION SITE PAIN (the injection site is tender and sore) and NAUSEA (nausea) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OXCARBAZEPINE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (feeling very achy), INJECTION SITE PAIN (the injection site is tender and sore) and NAUSEA (nausea). At the time of the report, PAIN (feeling very achy), INJECTION SITE PAIN (the injection site is tender and sore) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Constipation, Nausea
Clinical narrative: Anything that was hot made him nauseas; Very hard bowel movements; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Anything that was hot made him nauseas) and CONSTIPATION (Very hard bowel movements) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.    Co-suspect product included non-company product CODEINE PHOSPHATE, METHOCARBAMOL, PARACETAMOL (MUSCLE & BACK PAIN RELIEF [CODEINE PHOSPHATE;METHOCARBAMOL;PARACETAMOL]) for an unknown indication.    No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started CODEINE PHOSPHATE, METHOCARBAMOL, PARACETAMOL (MUSCLE & BACK PAIN RELIEF [CODEINE PHOSPHATE;METHOCARBAMOL;PARACETAMOL]) (unknown route) at an unspecified dose. On 14-Feb-2021, the patient experienced NAUSEA (Anything that was hot made him nauseas) and CONSTIPATION (Very hard bowel movements). At the time of the report, NAUSEA (Anything that was hot made him nauseas) and CONSTIPATION (Very hard bowel movements) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rashes on skin, rash is coming and going; hurts with lots of itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes on skin, rash is coming and going) and PRURITUS (hurts with lots of itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M20A) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included FAMOTIDINE for an unknown indication, LOSARTAN and METFORMIN.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced RASH (rashes on skin, rash is coming and going) and PRURITUS (hurts with lots of itching). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, RASH (rashes on skin, rash is coming and going) and PRURITUS (hurts with lots of itching) 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: sore arm; headaches; neck pain that started on the same side as the injection site and then spread to the other side of; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headaches) and NECK PAIN (neck pain that started on the same side as the injection site and then spread to the other side of) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included MERCAPTOPURINE and PARACETAMOL for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headaches) and NECK PAIN (neck pain that started on the same side as the injection site and then spread to the other side of). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headaches) and NECK PAIN (neck pain that started on the same side as the injection site and then spread to the other side of) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Pain
Clinical narrative: Tired; Low energy level; Not feeling well; Ache all over; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tired, low energy level, not feeling well, ache all over.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events- Tired, Low energy level, Not feeling well, Ache all over.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tired, low energy level,not feeling well,ache all over was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever (temp 101.4)), NAUSEA (nauseous) and HEADACHE (very bad headache and it "knocked me down") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she had Covid "pretty bad" at the end of October for 6 weeks) in October 2020. Concomitant products included CITALOPRAM, ALENDRONIC ACID and NAPROXEN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever (temp 101.4)), NAUSEA (nauseous) and HEADACHE (very bad headache and it "knocked me down"). On 03-Mar-2021, CHILLS (chills), PYREXIA (fever (temp 101.4)), NAUSEA (nauseous) and HEADACHE (very bad headache and it "knocked me down") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: temp101.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear swelling, Erythema, Feeling hot, Pain
Clinical narrative: Arm Pain; Joint Aches; Redness of the Face; Ear Swelling; Hot Sensation of the Face; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), ARTHRALGIA (Joint Aches), ERYTHEMA (Redness of the Face), EAR SWELLING (Ear Swelling) and FEELING HOT (Hot Sensation of the Face) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), ARTHRALGIA (Joint Aches), ERYTHEMA (Redness of the Face), EAR SWELLING (Ear Swelling), FEELING HOT (Hot Sensation of the Face) and PAIN (Soreness). On 16-Feb-2021, PAIN IN EXTREMITY (Arm Pain), ARTHRALGIA (Joint Aches), ERYTHEMA (Redness of the Face), EAR SWELLING (Ear Swelling), FEELING HOT (Hot Sensation of the Face) and PAIN (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Pain; Joint Aches; Redness of the Face; Ear Swelling; Hot Sensation of the Face; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), ARTHRALGIA (Joint Aches), ERYTHEMA (Redness of the Face), EAR SWELLING (Ear Swelling) and FEELING HOT (Hot Sensation of the Face) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), ARTHRALGIA (Joint Aches), ERYTHEMA (Redness of the Face), EAR SWELLING (Ear Swelling), FEELING HOT (Hot Sensation of the Face) and PAIN (Soreness). On 16-Feb-2021, PAIN IN EXTREMITY (Arm Pain), ARTHRALGIA (Joint Aches), ERYTHEMA (Redness of the Face), EAR SWELLING (Ear Swelling), FEELING HOT (Hot Sensation of the Face) and PAIN (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A12A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE, GLIMEPIRIDE, LAMOTRIGINE, LISINOPRIL, RASAGILINE, CYCLOBENZAPRINE, ATORVASTATIN and ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hand deformity, Instillation site paraesthesia, Pain
Clinical narrative: Throbbing pain; unusual sensation at injection site; cannot move the hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Throbbing pain), INSTILLATION SITE PARAESTHESIA (unusual sensation at injection site) and HAND DEFORMITY (cannot move the hand) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-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 PAIN (Throbbing pain), INSTILLATION SITE PARAESTHESIA (unusual sensation at injection site) and HAND DEFORMITY (cannot move the hand). At the time of the report, PAIN (Throbbing pain), INSTILLATION SITE PARAESTHESIA (unusual sensation at injection site) and HAND DEFORMITY (cannot move the hand) outcome was unknown.            Concomitant medications were not provided. Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Felt the Side Effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt the Side Effects) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION COMPLICATION (Felt the Side Effects). At the time of the report, VACCINATION COMPLICATION (Felt the Side Effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Tenderness
Clinical narrative: pain at injection site; tenderness; arm very sore down to the elbow; arm feeling weak; stiffness in the arm, cannot lift without discomfort; discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), TENDERNESS (tenderness), PAIN IN EXTREMITY (arm very sore down to the elbow), MUSCULAR WEAKNESS (arm feeling weak) and MUSCULOSKELETAL STIFFNESS (stiffness in the arm, cannot lift without discomfort) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy (Patient has a history of epilepsy that has been stable) and Polycythemia vera (polycythemia vera which is in remission).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site), TENDERNESS (tenderness), PAIN IN EXTREMITY (arm very sore down to the elbow), MUSCULAR WEAKNESS (arm feeling weak), MUSCULOSKELETAL STIFFNESS (stiffness in the arm, cannot lift without discomfort) and DISCOMFORT (discomfort). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, VACCINATION SITE PAIN (pain at injection site), TENDERNESS (tenderness), PAIN IN EXTREMITY (arm very sore down to the elbow), MUSCULAR WEAKNESS (arm feeling weak), MUSCULOSKELETAL STIFFNESS (stiffness in the arm, cannot lift without discomfort) and DISCOMFORT (discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; tenderness; arm very sore down to the elbow; arm feeling weak; stiffness in the arm, cannot lift without discomfort; discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), TENDERNESS (tenderness), PAIN IN EXTREMITY (arm very sore down to the elbow), MUSCULAR WEAKNESS (arm feeling weak) and MUSCULOSKELETAL STIFFNESS (stiffness in the arm, cannot lift without discomfort) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy (Patient has a history of epilepsy that has been stable) and Polycythemia vera (polycythemia vera which is in remission).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site), TENDERNESS (tenderness), PAIN IN EXTREMITY (arm very sore down to the elbow), MUSCULAR WEAKNESS (arm feeling weak), MUSCULOSKELETAL STIFFNESS (stiffness in the arm, cannot lift without discomfort) and DISCOMFORT (discomfort). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, VACCINATION SITE PAIN (pain at injection site), TENDERNESS (tenderness), PAIN IN EXTREMITY (arm very sore down to the elbow), MUSCULAR WEAKNESS (arm feeling weak), MUSCULOSKELETAL STIFFNESS (stiffness in the arm, cannot lift without discomfort) and DISCOMFORT (discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Influenza, Pain, Vision blurred
Clinical narrative: dizzy; blurred vision; chills; aches; flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN (aches), INFLUENZA (flu symptoms), DIZZINESS (dizzy) and VISION BLURRED (blurred vision) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ROSUVASTATIN, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE), PANTOPRAZOLE, VITAMIN D [VITAMIN D NOS], MAGNESIUM and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (chills), PAIN (aches) and INFLUENZA (flu symptoms). On 05-Mar-2021, the patient experienced DIZZINESS (dizzy) and VISION BLURRED (blurred vision). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Mar-2021, CHILLS (chills), PAIN (aches) and INFLUENZA (flu symptoms) had resolved. At the time of the report, DIZZINESS (dizzy) and VISION BLURRED (blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications metformin, crestor, lotrel, protonix, vitamin D, magnesium, Vitamin B 12
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Redness - Near Injection Site; Swelling - Near Injection Site; Lump/Hardness Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Lump/Hardness Near Injection Site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included JUNIPERUS COMMUNIS (DIURETIC [JUNIPERUS COMMUNIS]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Lump/Hardness Near Injection Site). At the time of the report, VACCINATION SITE INDURATION (Lump/Hardness Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Diuretic, Cholesterol Medication, LowDose Aspirin Treatment information was not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Malaise
Clinical narrative: Dizzy; Don't feel well; Blood pressure will not go down 186/95; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), MALAISE (Don't feel well) and HYPERTENSION (Blood pressure will not go down 186/95) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No medical history was provided by the reporter.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Dizzy), MALAISE (Don't feel well) and HYPERTENSION (Blood pressure will not go down 186/95). At the time of the report, DIZZINESS (Dizzy), MALAISE (Don't feel well) and HYPERTENSION (Blood pressure will not go down 186/95) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood pressure measurement: 186/95 mmHg (High) 186/95.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medications were not provided. Treatment details were not provided.  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, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of influenza-like illness (flu-like symptoms), pyrexia (low-grade fever), myalgia (muscle pain), headache and fatigue in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030M20A) for COVID-19 vaccination. The occurrence of additional events detailed below. No medical history reported. On Feb 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 6, 2021, patient experienced influenza-like illness (flu-like symptoms), pyrexia (low-grade fever), myalgia (muscle pain), headache, fatigue, pain in extremity (pain in her arm), vaccination site erythema (red mark in injection site) and arthralgia (joint pain). On Feb 7, 2021, influenza-like illness (flu-like symptoms), pyrexia (low-grade fever) and headache resolved. On Feb 9, 2021, myalgia (muscle pain), fatigue, pain in extremity (pain in her arm) and arthralgia (joint pain) resolved. On Feb 20, 2021, vaccination site erythema (red mark in injection site) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of influenza-like illness (flu-like symptoms), pyrexia (low-grade fever), myalgia (muscle pain), headache and fatigue in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030M20A) for COVID-19 vaccination. The occurrence of additional events detailed below. No medical history reported. On Feb 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 6, 2021, patient experienced influenza-like illness (flu-like symptoms), pyrexia (low-grade fever), myalgia (muscle pain), headache, fatigue, pain in extremity (pain in her arm), vaccination site erythema (red mark in injection site) and arthralgia (joint pain). On Feb 7, 2021, influenza-like illness (flu-like symptoms), pyrexia (low-grade fever) and headache resolved. On Feb 9, 2021, myalgia (muscle pain), fatigue, pain in extremity (pain in her arm) and arthralgia (joint pain) resolved. On Feb 20, 2021, vaccination site erythema (red mark in injection site) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-1 test negative, Tenderness
Clinical narrative: Loss of taste  could taste a little, muted taste; Arm tenderness; This spontaneous case was reported by a health care professional and describes the occurrence of TENDERNESS (Arm tenderness) and AGEUSIA (Loss of taste  could taste a little, muted taste) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-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) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced TENDERNESS (Arm tenderness). On 29-Jan-2021, the patient experienced AGEUSIA (Loss of taste  could taste a little, muted taste). At the time of the report, TENDERNESS (Arm tenderness) and AGEUSIA (Loss of taste  could taste a little, muted taste) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-1 test negative: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (had clear urine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHROMATURIA (had clear urine). At the time of the report, CHROMATURIA (had clear urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and RASH (Developed a rash on her legs) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), FAMOTIDINE and TRAZODONE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site). 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red injection site) and RASH (Developed a rash on her legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and RASH (Developed a rash on her legs) 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.   Concomitant medications Crestor, Protonix, Famotidine, Trazodone.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haematoma
Clinical narrative: looks like there is blood under the skin in the arm where patient received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMATOMA (looks like there is blood under the skin in the arm where patient received the injection) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMATOMA (looks like there is blood under the skin in the arm where patient received the injection). At the time of the report, VACCINATION SITE HAEMATOMA (looks like there is blood under the skin in the arm where patient received the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Vision blurred
Clinical narrative: Loss of balance; Dizziness; Blurry vision; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Loss of balance), DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and FATIGUE (Fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced BALANCE DISORDER (Loss of balance), DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and FATIGUE (Fatigue). At the time of the report, BALANCE DISORDER (Loss of balance), DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029m02a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria, Vaccination site warmth
Clinical narrative: itching; injection site seemed hot; 1 hive; red welt with hard top; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE WARMTH (injection site seemed hot), ERYTHEMA (red welt with hard top) and URTICARIA (1 hive) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z3MZOA) for COVID-19 vaccination.     The patient's past medical history included Angioedema. Previously administered products included for an unreported indication: MMR. Concurrent medical conditions included Hypothyroidism and Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, LEVOTHYROXINE for Hypothyroidism.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ERYTHEMA (red welt with hard top). On 04-Mar-2021, the patient experienced PRURITUS (itching), VACCINATION SITE WARMTH (injection site seemed hot) and URTICARIA (1 hive). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), VACCINATION SITE WARMTH (injection site seemed hot), ERYTHEMA (red welt with hard top) and URTICARIA (1 hive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Levothyroxine, Buspar  Patient stated she usually puts hydrocortisone.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Paraesthesia, Pruritus, Scratch, Vaccination site erythema
Clinical narrative: injection site feeling tingly inside; having a reaction to the vaccine; Left arm being itchy; scratch on left arm; Left arm warm to the touch; redness distal to the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (injection site feeling tingly inside), ADVERSE REACTION (having a reaction to the vaccine), PRURITUS (Left arm being itchy), SCRATCH (scratch on left arm) and VACCINATION SITE WARMTH (Left arm warm to the touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA (injection site feeling tingly inside), ADVERSE REACTION (having a reaction to the vaccine), PRURITUS (Left arm being itchy), SCRATCH (scratch on left arm), VACCINATION SITE WARMTH (Left arm warm to the touch) and VACCINATION SITE ERYTHEMA (redness distal to the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (injection site feeling tingly inside), ADVERSE REACTION (having a reaction to the vaccine), PRURITUS (Left arm being itchy), SCRATCH (scratch on left arm), VACCINATION SITE WARMTH (Left arm warm to the touch) and VACCINATION SITE ERYTHEMA (redness distal to the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Injectable Allergy medication Treatment medications ice, Benadryl
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site feeling tingly inside; having a reaction to the vaccine; Left arm being itchy; scratch on left arm; Left arm warm to the touch; redness distal to the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (injection site feeling tingly inside), ADVERSE REACTION (having a reaction to the vaccine), PRURITUS (Left arm being itchy), SCRATCH (scratch on left arm) and VACCINATION SITE WARMTH (Left arm warm to the touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA (injection site feeling tingly inside), ADVERSE REACTION (having a reaction to the vaccine), PRURITUS (Left arm being itchy), SCRATCH (scratch on left arm), VACCINATION SITE WARMTH (Left arm warm to the touch) and VACCINATION SITE ERYTHEMA (redness distal to the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (injection site feeling tingly inside), ADVERSE REACTION (having a reaction to the vaccine), PRURITUS (Left arm being itchy), SCRATCH (scratch on left arm), VACCINATION SITE WARMTH (Left arm warm to the touch) and VACCINATION SITE ERYTHEMA (redness distal to the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Injectable Allergy medication Treatment medications ice, Benadryl
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Limb discomfort, Vaccination site pain
Clinical narrative: Arm soreness; fatigue; arm tension when lift; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness), FATIGUE (fatigue), LIMB DISCOMFORT (arm tension when lift) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (FAMOTIDINE ACID REDUCER) for Acid reflux (esophageal), MONTELUKAST SODIUM (SINGULAIR) for Asthma and Allergy, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and NIFEDIPINE for Hypertension, CHLOROTHIAZIDE SODIUM and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness), FATIGUE (fatigue), LIMB DISCOMFORT (arm tension when lift) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg. On 06-Mar-2021, VACCINATION SITE PAIN (Arm soreness), FATIGUE (fatigue), LIMB DISCOMFORT (arm tension when lift) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Bystolic, Nifedipine, Chlorothiazide, Singulair, Breo, Famotidine.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Impaired work ability, Muscular weakness
Clinical narrative: Legs like rubber; Hardly able to make from one room to another; Was always independent, able to take care of her home and drive, and since she received the second dose this is not happening; Very, very fatigued; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Legs like rubber), GAIT DISTURBANCE (Hardly able to make from one room to another), IMPAIRED WORK ABILITY (Was always independent, able to take care of her home and drive, and since she received the second dose this is not happening), FATIGUE (Very, very fatigued) and CHILLS (Chills) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-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 02-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Legs like rubber), GAIT DISTURBANCE (Hardly able to make from one room to another), IMPAIRED WORK ABILITY (Was always independent, able to take care of her home and drive, and since she received the second dose this is not happening), FATIGUE (Very, very fatigued) and CHILLS (Chills). At the time of the report, MUSCULAR WEAKNESS (Legs like rubber), GAIT DISTURBANCE (Hardly able to make from one room to another), IMPAIRED WORK ABILITY (Was always independent, able to take care of her home and drive, and since she received the second dose this is not happening), FATIGUE (Very, very fatigued) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.