chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Incontinence, Pain
Clinical narrative: Incontinence; Aches all over the body; Shortness of breath; Fever > 102°F; Headache; Pain in the arm of the injection; Tiredness; A Spondaneous report was received from a Healthcare professional concerning a 70 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pain in the arm of the injection, Tiredness, Incontinence, Fever > 102°F, Aches all over the body, Headache, Shortness of breath, sore arm  The patient's medical history was not given. No information about the concomitant medication was given. On 22-01-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 batch no: 011J20A  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22-01-2021, The patient experienced Pain in the arm of the injection, Tiredness. On 23-01-2021, the patient experienced incontinence, Fever > 102°F, Aches all over the body, headache, Shortness of Breath, Sore arm.  The laboratory information is not given. The patient was given Tylenol as treatment medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events pain in the arm of the injection, Tiredness, Incontinence was resolved on 24-01-2021. The outcome of the events , Fever > 102°F, Aches all over the body, headache, Shortness of Breath, Sore arm are unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Incontinence; Aches all over the body; Shortness of breath; Fever > 102°F; Headache; Pain in the arm of the injection; Tiredness; A Spondaneous report was received from a Healthcare professional concerning a 70 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pain in the arm of the injection, Tiredness, Incontinence, Fever > 102°F, Aches all over the body, Headache, Shortness of breath, sore arm  The patient's medical history was not given. No information about the concomitant medication was given. On 22-01-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 batch no: 011J20A  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22-01-2021, The patient experienced Pain in the arm of the injection, Tiredness. On 23-01-2021, the patient experienced incontinence, Fever > 102°F, Aches all over the body, headache, Shortness of Breath, Sore arm.  The laboratory information is not given. The patient was given Tylenol as treatment medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events pain in the arm of the injection, Tiredness, Incontinence was resolved on 24-01-2021. The outcome of the events , Fever > 102°F, Aches all over the body, headache, Shortness of Breath, Sore arm are unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives/ Hives appear in different areas of body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/ Hives appear in different areas of body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced URTICARIA (Hives/ Hives appear in different areas of body). At the time of the report, URTICARIA (Hives/ Hives appear in different areas of body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Updated reported term of event Hives. Patient continued to have issues with hives. NNI.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: hives; soreness at the injection; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives) and VACCINATION SITE PAIN (soreness at the injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, LEVOTHYROXINE, OXYBUTYNIN and BUPROPION HYDROCHLORIDE (WELLBUTRIN).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection). On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) and VACCINATION SITE PAIN (soreness at the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       unspecified topical antihistamines were used by patient as treatment.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Erythema, Flatulence, Limb mass, Nausea
Clinical narrative: 6-inch mass of swollen red; 6-inch mass of swollen red; 6-inch mass of swollen red; nauseous; extremely gassy; heart burn; A spontaneous report was received from a other healthcare professional concerning a 55 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID arm (6-inch mass of swollen red)/limb mass peripheral swelling erythema, heart burn/dyspepsia, extremely gassy/flatulence and nausea.  The patient's medical history was not provided by the reporter.The relevant concomitant medications use were not reported.  On 12 Jan 2021, about 2-3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) through unknown route for prophylaxis of COVID-19 infection.   On 14  Dec 2020,about 2-3 days after vaccination the patient experienced  COVID arm (6-inch mass of swollen red), extremely gassy,  heart burn and nauseous. No treatment information was provided. Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, COVID arm (6-inch mass of swollen red), extremely gassy,  heart burn and nauseous were considered unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: 6-inch mass of swollen red; 6-inch mass of swollen red; 6-inch mass of swollen red; nauseous; extremely gassy; heart burn; A spontaneous report was received from a other healthcare professional concerning a 55 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID arm (6-inch mass of swollen red)/limb mass peripheral swelling erythema, heart burn/dyspepsia, extremely gassy/flatulence and nausea.  The patient's medical history was not provided by the reporter.The relevant concomitant medications use were not reported.  On 12 Jan 2021, about 2-3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) through unknown route for prophylaxis of COVID-19 infection.   On 14  Dec 2020,about 2-3 days after vaccination the patient experienced  COVID arm (6-inch mass of swollen red), extremely gassy,  heart burn and nauseous. No treatment information was provided. Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, COVID arm (6-inch mass of swollen red), extremely gassy,  heart burn and nauseous were considered unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Area is tender , but not painful; at the site of the injection, there is an approximate 3" circular red rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (at the site of the injection, there is an approximate 3" circular red rash) and VACCINATION SITE PAIN (Area is tender , but not painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (at the site of the injection, there is an approximate 3" circular red rash). On an unknown date, the patient experienced VACCINATION SITE PAIN (Area is tender , but not painful). At the time of the report, VACCINATION SITE RASH (at the site of the injection, there is an approximate 3" circular red rash) and VACCINATION SITE PAIN (Area is tender , but not painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema
Clinical narrative: Redness that is spreading below the injection site; Warmness of arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warmness of arm) and VACCINATION SITE ERYTHEMA (Redness that is spreading below the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warmness of arm). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness that is spreading below the injection site). At the time of the report, INJECTION SITE WARMTH (Warmness of arm) and VACCINATION SITE ERYTHEMA (Redness that is spreading below the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received updated reporter contact details and is considered non-significant.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Mass, Pain, Pain in extremity
Clinical narrative: Coughing; Soreness; Felt tightness in chest that lasted for 45min-1hr; Lump on center of chest, that lasted for 45min-1hr; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), PAIN IN EXTREMITY (Soreness in arm), CHEST DISCOMFORT (Felt tightness in chest that lasted for 45min-1hr), MASS (Lump on center of chest, that lasted for 45min-1hr) and PAIN (Soreness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm). On 03-Feb-2021, the patient experienced CHEST DISCOMFORT (Felt tightness in chest that lasted for 45min-1hr) and MASS (Lump on center of chest, that lasted for 45min-1hr). On 04-Feb-2021, the patient experienced PAIN (Soreness). On 04-Feb-2021 at 6:00 AM, the patient experienced COUGH (Coughing). On 03-Feb-2021, PAIN IN EXTREMITY (Soreness in arm), CHEST DISCOMFORT (Felt tightness in chest that lasted for 45min-1hr) and MASS (Lump on center of chest, that lasted for 45min-1hr) had resolved. At the time of the report, COUGH (Coughing) had resolved and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient took ibuprofen to treat symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up TCR report received included no new information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain, Spinal pain, Vaccination site pain
Clinical narrative: I felt like I had the flu/I was really sick.; I started to feel achy; My arm hurt/Felt like someone sucker-punched me in the arm; ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen), ILLNESS (I felt like I had the flu/I was really sick.), PAIN (I started to feel achy) and VACCINATION SITE PAIN (My arm hurt/Felt like someone sucker-punched me in the arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (In left breast.). Concomitant products included LISINOPRIL, ATENOLOL, CLONIDINE, OMEPRAZOLE, ROSUVASTATIN and AMLODIPINE BESYLATE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SPINAL PAIN (ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen) and VACCINATION SITE PAIN (My arm hurt/Felt like someone sucker-punched me in the arm). On 02-Feb-2021, the patient experienced ILLNESS (I felt like I had the flu/I was really sick.) and PAIN (I started to feel achy). The patient was treated with IBUPROFEN on 20-Jan-2021 for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 02-Feb-2021 for Flu like symptoms, at a dose of 2 dosage form. On 21-Jan-2021, VACCINATION SITE PAIN (My arm hurt/Felt like someone sucker-punched me in the arm) had resolved. On 05-Feb-2021, SPINAL PAIN (ince I got the shot, I got more pain in my spine area. I had to increase the frequency of Ibuprofen), ILLNESS (I felt like I had the flu/I was really sick.) and PAIN (I started to feel achy) had resolved. Split for coding purposes      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Vitamin D, E  and Ibuprofen as needed.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Non-significant follow-up information was received.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on both shoulders/ a little on stomach/ on his back/ on the thighs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both shoulders/ a little on stomach/ on his back/ on the thighs) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH (Rash on both shoulders/ a little on stomach/ on his back/ on the thighs). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on both shoulders/ a little on stomach/ on his back/ on the thighs) outcome was unknown. Not Provided          No concomitant medications were reported.  On 31-Jan-2021, the patient had a rash on both shoulders and a little on stomach. It was spreading more and more. It was also on his back and thighs. It was looking like mosquito bites.     Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: only e-mail address provided
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: had a bruise; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (had a bruise) and VACCINATION SITE PAIN (arm was a little sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE BRUISING (had a bruise) and VACCINATION SITE PAIN (arm was a little sore). At the time of the report, VACCINATION SITE BRUISING (had a bruise) and VACCINATION SITE PAIN (arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19th Apr 2021 is non significant.Consumer denied further follow up.NNI
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: A really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (A really bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (A really bad headache). At the time of the report, HEADACHE (A really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took no treatment for events.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (muscle pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (muscle pain at the injection site). At the time of the report, VACCINATION SITE PAIN (muscle pain at the injection site) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: rash; itching; swollen; sore; tired; warmth; red rash at site of injection; redness; swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (red rash at site of injection), INJECTION SITE WARMTH (warmth), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE RASH (rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A029L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (water blisters on hands) since 1960, Allergy to antibiotic (cipro, sore muscles, tingling) since 2004, Allergy to antibiotic (tetracycline) since 1997 and Allergy to antibiotic (sulfa, red itching rash, head to toe) since 1963. Concomitant products included SIMVASTATIN (ZOCOR) for Hypercholesteremia, ZOLPIDEM TARTRATE (AMBIEN) for Sleep problem, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MULTIVITAMINS & MINERALS PLUS LUTEIN, ZINC, VITAMIN D3, CYANOCOBALAMIN (VITAMINE B12), VITAMIN C [ASCORBIC ACID] and PANTOPRAZOLE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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 VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 01-Feb-2021, the patient experienced HYPERSENSITIVITY (red rash at site of injection). On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (warmth), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS (itching), INJECTION SITE SWELLING (swollen), MYALGIA (sore) and FATIGUE (tired). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. On 27-Jan-2021, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) had resolved. On 08-Feb-2021, HYPERSENSITIVITY (red rash at site of injection) had resolved. At the time of the report, INJECTION SITE WARMTH (warmth), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS (itching), INJECTION SITE SWELLING (swollen), MYALGIA (sore) and FATIGUE (tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were Not Applicable. No treatment drugs are not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Patient medical history was updated, New adverse event - hypersensitivity reaction was updated,Second dose information was updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash; itching; swollen; sore; tired; warmth; red rash at site of injection; redness; swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (red rash at site of injection), INJECTION SITE WARMTH (warmth), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE RASH (rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A029L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (water blisters on hands) since 1960, Allergy to antibiotic (cipro, sore muscles, tingling) since 2004, Allergy to antibiotic (tetracycline) since 1997 and Allergy to antibiotic (sulfa, red itching rash, head to toe) since 1963. Concomitant products included SIMVASTATIN (ZOCOR) for Hypercholesteremia, ZOLPIDEM TARTRATE (AMBIEN) for Sleep problem, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MULTIVITAMINS & MINERALS PLUS LUTEIN, ZINC, VITAMIN D3, CYANOCOBALAMIN (VITAMINE B12), VITAMIN C [ASCORBIC ACID] and PANTOPRAZOLE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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 VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 01-Feb-2021, the patient experienced HYPERSENSITIVITY (red rash at site of injection). On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (warmth), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS (itching), INJECTION SITE SWELLING (swollen), MYALGIA (sore) and FATIGUE (tired). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. On 27-Jan-2021, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) had resolved. On 08-Feb-2021, HYPERSENSITIVITY (red rash at site of injection) had resolved. At the time of the report, INJECTION SITE WARMTH (warmth), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS (itching), INJECTION SITE SWELLING (swollen), MYALGIA (sore) and FATIGUE (tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were Not Applicable. No treatment drugs are not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Patient medical history was updated, New adverse event - hypersensitivity reaction was updated,Second dose information was updated.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: severe allergic reaction; Hives and itching throughout body; Hives and itching throughout body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), URTICARIA (Hives and itching throughout body) and PRURITUS (Hives and itching throughout body) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-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 08-Feb-2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction), URTICARIA (Hives and itching throughout body) and PRURITUS (Hives and itching throughout body). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (severe allergic reaction), URTICARIA (Hives and itching throughout body) and PRURITUS (Hives and itching throughout body) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Nausea, Somnolence
Clinical narrative: Diarrhea; nauseated; Bad headache; Body aches and pain; Sleep all day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleep all day), DIARRHOEA (Diarrhea), NAUSEA (nauseated), HEADACHE (Bad headache) and MYALGIA (Body aches and pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (nauseated), HEADACHE (Bad headache) and MYALGIA (Body aches and pain). On an unknown date, the patient experienced SOMNOLENCE (Sleep all day). The patient was treated with CITRIC ACID, GLUCOSE, POTASSIUM CHLORIDE, SODIUM CHLORIDE (PEDIALYTE [CITRIC ACID;GLUCOSE;POTASSIUM CHLORIDE;SODIUM CHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form; PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of UNK dosage form. On 22-Jan-2021, DIARRHOEA (Diarrhea), NAUSEA (nauseated), HEADACHE (Bad headache) and MYALGIA (Body aches and pain) had resolved. At the time of the report, SOMNOLENCE (Sleep all day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug was  used. The BRAT diet was taken by patient on advice of pharmacist.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received contains non-significant information.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Fever,  temperature of 101.4; Chills; Tired; Second dose given on day 24(14th Jan 2021-1st dose & 7th feb-2nd dose); Sore Left Arm (within 24 hours of first dose); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24 (14th Jan 2021-1st dose & 7th Feb-2nd dose)), PYREXIA (Fever,  temperature of 101.4), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)). On 07-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24(14th Jan 2021-1st dose & 7th feb-2nd dose)). On an unknown date, the patient experienced PYREXIA (Fever,  temperature of 101.4), CHILLS (Chills) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24 (14th Jan 2021-1st dose & 7th feb-2nd dose)), PYREXIA (Fever, temperature of 101.4), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 101.4 (High) 101.4 F.         Patient reported unspecified blood pressure and statin medication as concomitant medication.   This case was linked to MOD-2021-021749 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Significant Follow up added. Dose details and action taken was updated.  Concomitant and treatment medication information added. New Event Vaccination site pain was added.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever,  temperature of 101.4; Chills; Tired; Second dose given on day 24(14th Jan 2021-1st dose & 7th feb-2nd dose); Sore Left Arm (within 24 hours of first dose); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24 (14th Jan 2021-1st dose & 7th Feb-2nd dose)), PYREXIA (Fever,  temperature of 101.4), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)). On 07-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24(14th Jan 2021-1st dose & 7th feb-2nd dose)). On an unknown date, the patient experienced PYREXIA (Fever,  temperature of 101.4), CHILLS (Chills) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24 (14th Jan 2021-1st dose & 7th feb-2nd dose)), PYREXIA (Fever, temperature of 101.4), CHILLS (Chills), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore Left Arm (within 24 hours of first dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 101.4 (High) 101.4 F.         Patient reported unspecified blood pressure and statin medication as concomitant medication.   This case was linked to MOD-2021-021749 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Significant Follow up added. Dose details and action taken was updated.  Concomitant and treatment medication information added. New Event Vaccination site pain was added.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Exposure during pregnancy, Pregnancy test, Ultrasound abdomen normal
Clinical narrative: Pregnant patient received second dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received second dose) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 04L320A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy normal (Live full term birth.) on 11-Aug-2018, Miscarriage (miscarriage approximately in 9 weeks, Spontaneous abortion.) on 14-Aug-2020 and Irritable bowel syndrome in 1990. Concurrent medical conditions included Low blood pressure in 2007. Concomitant products included IRON from 20-Jul-2021 to an unknown date for Anemia, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], VITAMIN B6, DOXYLAMINE SUCCINATE (UNISOM 2) and FISH OIL for Pregnancy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 05-Jan-2021 and the estimated date of delivery was 12-Oct-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received second dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 26-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood glucose normal: 15jul2021 (normal) normal. On 12-Feb-2021, Pregnancy test: positive (Positive) Positive. On 12-Feb-2021, Ultrasound abdomen normal: 23feb2021 (normal) normal and 04oct2021 (normal) normal.         No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: significant followup received including medical history, concomitant medication and action taken updated.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Counterfeit product administered
Clinical narrative: Counterfeit product administered; A spontaneous report was received from a Consumer concerning a 68 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) reported regarding a possible vaccine counterfeit.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273  (batch number - 012M20A) via unknown route for COVID-19 infection and reported regarding a possible vaccine counterfeit.  No Treatment information has been provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome, counterfeit product administered, was considered resolved.; Reporter's Comments: This report refers to a case of counterfeit product for mRNA-1273, batch number - 012M20A,  with no associated AEs. Causality is not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Red; Warm; Itchy; soreness at the injection site; A spontaneous report was received from a consumer concerning, a 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events warm, itchy, red, and sore at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, the patient experienced warmth, itchiness, redness at the injection site. The patient later developed soreness at the injection site. The redness at the injection site was still growing.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   On an unknown date, the outcome of events, warm, itchy, and sore at the injection site were considered unknown.  On an unknown date, the outcome of the event, red at the injection site was considered not resolved.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Hyperhidrosis
Clinical narrative: Blood pressure 184/82; ankles swollen up; Sweat; 101°F temp; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101°F temp) and CHILLS (severe chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101°F temp) and CHILLS (severe chills). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101°F temp) and CHILLS (severe chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Blood pressure measurement: 184/82 (High) increased. On 15-Feb-2021, Body temperature: 101 (High) degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow-up information received  on 29 Mar 2021 reporter contact details updated. On 31-Mar-2021: Follow up was received on 31 Mar 2021 included no new information.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pyrexia
Clinical narrative: Blood pressure 184/82; ankles swollen up; Sweat; 101°F temp; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101°F temp) and CHILLS (severe chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101°F temp) and CHILLS (severe chills). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101°F temp) and CHILLS (severe chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Blood pressure measurement: 184/82 (High) increased. On 15-Feb-2021, Body temperature: 101 (High) degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow-up information received  on 29 Mar 2021 reporter contact details updated. On 31-Mar-2021: Follow up was received on 31 Mar 2021 included no new information.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Vaccination site induration, Vaccination site pain
Clinical narrative: Localized allergic response on her arm; Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite; Injection site hard; Arm was sore right away; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Localized allergic response on her arm), ERYTHEMA (Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite), VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Arm was sore right away) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA), SERTRALINE HYDROCHLORIDE (ZOLOFT), ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Arm was sore right away). On an unknown date, the patient experienced HYPERSENSITIVITY (Localized allergic response on her arm) and ERYTHEMA (Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site induration and Redness, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Localized allergic response on her arm), ERYTHEMA (Red bump that is really big (around 3 inches) and spreading and looks like it is beginning to become cellulite), VACCINATION SITE INDURATION (Injection site hard) and VACCINATION SITE PAIN (Arm was sore right away) had resolved.            Concomitant products included unspecified statin.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received: contains updated event outcome.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Skin discolouration
Clinical narrative: Itching; Red for two days 2" by 2" at injection site; little pink a week later but not itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), INJECTION SITE ERYTHEMA (Red for two days 2" by 2" at injection site) and SKIN DISCOLOURATION (little pink a week later but not itchy) in a female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), INJECTION SITE ERYTHEMA (Red for two days 2" by 2" at injection site) and SKIN DISCOLOURATION (little pink a week later but not itchy). At the time of the report, PRURITUS (Itching), INJECTION SITE ERYTHEMA (Red for two days 2" by 2" at injection site) and SKIN DISCOLOURATION (little pink a week later but not itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact