chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Vicadan).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Patient demographics updated and other relevant history 'Allergy to Vicadan' added
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm) in a male 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (sore arm). At the time of the report, PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Rash, Vaccination site pain
Clinical narrative: rash in left breast, left back; diarrhea; chills; sore left arm; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (diarrhea), CHILLS (chills), VACCINATION SITE PAIN (sore left arm) and RASH (rash in left breast, left back) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520-28) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX. Concomitant products included ENTECAVIR for Hepatitis B, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and METFORMIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills) and VACCINATION SITE PAIN (sore left arm). On 27-Jan-2021, the patient experienced RASH (rash in left breast, left back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of unknown. At the time of the report, DIARRHOEA (diarrhea), CHILLS (chills), VACCINATION SITE PAIN (sore left arm) and RASH (rash in left breast, left back) 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.   patient also had corpress 0.5mg 2 in the evening and some unknown medicine for liver transplant as concomitant medications.; Reporter's Comments: \; 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. Further information has been requested for the event "rash that looks like shingles"
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Rash
Clinical narrative: pale shadow; Quite substantial and developed into a raging; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PALLOR (pale shadow) and RASH (Quite substantial and developed into a raging) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PALLOR (pale shadow) and RASH (Quite substantial and developed into a raging). At the time of the report, PALLOR (pale shadow) outcome was unknown and RASH (Quite substantial and developed into a raging) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site pain  (arm is really sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 004M20A) for COVID-19 immunization. No medical history reported. On Jan 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 26, 2021, patient experienced injection site pain (arm is really sore). At the time of the report, injection site pain (arm is really sore) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No relevant concomitant medications or treatment information reported.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of adverse event following immunisation (side effects after vaccine) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On an unknown date, patient experienced adverse event following immunisation (side effects after vaccine). At the time of the report, adverse event following immunisation (side effects after vaccine) outcome: unknown.
Age: 109.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue and vaccination site rash in a 109-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On Jan 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 14, 2021, patient experienced fatigue. On Jan 24, 2021, patient experienced vaccination site rash. On Jan 17, 2021, fatigue resolved. At the time of the report, vaccination site rash outcome: unknown.The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pain, Headache, Hyperhidrosis
Clinical narrative: Swelling; Extreme rigors for 1/1.30 hours; Severe muscle ache; Severe joint ache; Headache; Sharp pain in ears for 4 hours; Extreme thirst; Drenching, heavy perspiration; A spontaneous report was received from a nurse concerning a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced swelling, extreme rigors for 1/1.30 hours, severe muscle ache, severe joint ache, headache, sharp pain in ears for 4 hours, chills, extreme thirst, drenching, and heavy perspiration.  The patient's medical history, was not provided by the reporter. Concomitant medications were reported included amlodipine 2.5 mg daily, rosuvastatin 10 mg/day, protasemone 225 mg every 12 hours, xarelto and a multivitamin.     On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 057620A) in intramuscular in the right arm for prophylaxis of COVID-19 infection.    On 25 Jan 2021 experienced swelling, extreme rigors for 1/1.30 hours, severe muscle ache, severe joint ache, sharp pain in ears for 4 hours, chills, extreme thirst. On 26 Jan 2021 patient experienced drenching, heavy perspiration.   Treatment included 650 mg Tylenol and 7.5 mg Meloxicam.  No relevant lab data was provided by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, swelling, severe muscle ache, severe joint ache, headache were unknown. On 25 Jan 2021 extreme rigors for 1/1.30 hours was recovered. On 26 Jan 2021 sharp pain in ears for 4 hours, chills, extreme thirst, drenching, heavy perspiration were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Swelling, Thirst
Clinical narrative: Swelling; Extreme rigors for 1/1.30 hours; Severe muscle ache; Severe joint ache; Headache; Sharp pain in ears for 4 hours; Extreme thirst; Drenching, heavy perspiration; A spontaneous report was received from a nurse concerning a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced swelling, extreme rigors for 1/1.30 hours, severe muscle ache, severe joint ache, headache, sharp pain in ears for 4 hours, chills, extreme thirst, drenching, and heavy perspiration.  The patient's medical history, was not provided by the reporter. Concomitant medications were reported included amlodipine 2.5 mg daily, rosuvastatin 10 mg/day, protasemone 225 mg every 12 hours, xarelto and a multivitamin.     On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 057620A) in intramuscular in the right arm for prophylaxis of COVID-19 infection.    On 25 Jan 2021 experienced swelling, extreme rigors for 1/1.30 hours, severe muscle ache, severe joint ache, sharp pain in ears for 4 hours, chills, extreme thirst. On 26 Jan 2021 patient experienced drenching, heavy perspiration.   Treatment included 650 mg Tylenol and 7.5 mg Meloxicam.  No relevant lab data was provided by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, swelling, severe muscle ache, severe joint ache, headache were unknown. On 25 Jan 2021 extreme rigors for 1/1.30 hours was recovered. On 26 Jan 2021 sharp pain in ears for 4 hours, chills, extreme thirst, drenching, heavy perspiration were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Pain, Palpitations, Tremor
Clinical narrative: Dizziness; Heart palpitation; Hand tremo; Sore; Head felt hot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PALPITATIONS (Heart palpitation), TREMOR (Hand tremo), PAIN (Sore) and HEAD DISCOMFORT (Head felt hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PALPITATIONS (Heart palpitation), TREMOR (Hand tremo), PAIN (Sore) and HEAD DISCOMFORT (Head felt hot). At the time of the report, DIZZINESS (Dizziness), PALPITATIONS (Heart palpitation), TREMOR (Hand tremo), PAIN (Sore) and HEAD DISCOMFORT (Head felt hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Paraesthesia
Clinical narrative: This is a spontaneous report received from a consumer, concerning a 76-year-old female patient, who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced adverse events: body aches, red rump, warm-to-the-touch and mild tingling in the arm. The patient's medical history and concomitant medications not provided. On Jan 14, 2021, prior to the onset of the events, patient received the first of two planned doses of mRNA-1273 (batch/lot# 028L20A), intramuscularly, in the left arm, for prophylaxis of COVID-19 infection. On Jan 17, 2021, patient experienced body aches. On Jan 26, 2021, patient experienced red rump, warm-to-the-touch and mild tingling in the arm. Treatment details not provided. Action taken with mRNA-1273 in response to the events not reported. On an unknown date, the outcome of body aches, red rump, warm-to-the-touch and mild tingling in the arm: not resolved. Reporter's comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersensitivity, Influenza, Vaccination site pain
Clinical narrative: This spontaneous case reported by a physician (subsequently medically confirmed), describes the occurrence of influenza, diarrhea), hypersensitivity (mild reactions) and vaccination site pain (arm pain) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine, unknown route; unspecified dose. On an unknown date, patient experienced influenza, diarrhea, hypersensitivity (mild reactions) and vaccination site pain (arm pain). At the time of the report, influenza, diarrhea, hypersensitivity (mild reactions) and vaccination site pain (arm pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Oropharyngeal pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of oropharyngeal pain (sore throat) and burning sensation in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced oropharyngeal pain (sore throat) and burning sensation. At the time of the report, oropharyngeal pain (sore throat) and burning sensation outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of erythema (arm really red, almost purple) and erythema (redness extends to her elbow) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 24, 2021, patient experienced erythema (arm really red, almost purple) and erythema (redness extends to her elbow). At the time of the report, erythema (arm really red, almost purple) and erythema (redness extends to her elbow) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site oedema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: at the injection site It's red; rash; Swollen; Itchy; A spontaneous case report From from a Physician on 25-JAN-2021, concerning a Female aged 52 Years  who experienced received the vaccine about 9 days ago and is having some reaction, it's at the injection site, it's red, it's swollen. She believes she's having a rash, but it's already been 9 days since she got the vaccine. This is happening to more people who got the vaccine at the same location The patients past medical history included: No adverse event   . .  On 16JAN2021  the patient received first of two planned doses of t Moderna COVID-19 Vaccine for COVID-19 vaccination. injection site redness, the patient also developed rash,,Swollen and was Itchy. Treatment information was not provided.  Relevant laboratory results were not provided.    Action taken with m-RNA -1273 was not reported.  Outcome of all the reported events were unknown/not provided.  .
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), fatigue (tiredness) and injection site erythema (redness at injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# O41L20A) for COVID-19 immunization. The patient's past medical history included cardiac; pacemaker insertion. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pyrexia (fever), fatigue (tiredness) and injection site erythema (redness at injection site). At the time of the report, pyrexia (fever), fatigue (tiredness) and injection site erythema (redness at injection site) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Reporter'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. Further information requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ALOPURINOL and MAGNESIUM for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) had not resolved.            Concomitant medications also included statins (not specified). Treatment included Ibuprofen.     Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender 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.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, 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.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: Itch; Red rash (bigger than the parm of my hand); Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch), RASH ERYTHEMATOUS (Red rash (bigger than the parm of my hand)) and ERYTHEMA (Redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PRURITUS (Itch), RASH ERYTHEMATOUS (Red rash (bigger than the parm of my hand)) and ERYTHEMA (Redness). At the time of the report, PRURITUS (Itch), RASH ERYTHEMATOUS (Red rash (bigger than the parm of my hand)) and ERYTHEMA (Redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment taken for symptoms.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in whole body; Pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm) and PAIN (Pain in whole body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia (Patient has pre existing medical condition of fibromyalgia.). Concomitant products included DULOXETINE for General body pain, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Pain.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm). On 29-Jan-2021, the patient experienced PAIN (Pain in whole body). On 28-Jan-2021, PAIN IN EXTREMITY (Pain in left arm) had resolved. On 29-Jan-2021, PAIN (Pain in whole body) had resolved.            Treatment details included -Ice pack for pain in arm, Cymbalta,Duloxetine for whole body pain.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of cough and oropharyngeal pain (sore throat) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included: No adverse event. On Jan 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 26, 2021, patient experienced cough and oropharyngeal pain (sore throat). At the time of the report, cough and oropharyngeal pain (sore throat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Feeling cold, Headache, Insomnia
Clinical narrative: Bone-killing cold; Sore throat; Troubles sleeping; Itchy rash on the back; Difficulty breathing; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Bone-killing cold), OROPHARYNGEAL PAIN (Sore throat), INSOMNIA (Troubles sleeping), RASH PRURITIC (Itchy rash on the back) and DYSPNOEA (Difficulty breathing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (No reported medical history.).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FEELING COLD (Bone-killing cold), OROPHARYNGEAL PAIN (Sore throat), INSOMNIA (Troubles sleeping), RASH PRURITIC (Itchy rash on the back), DYSPNOEA (Difficulty breathing), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of UNK dosage form and PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING COLD (Bone-killing cold), OROPHARYNGEAL PAIN (Sore throat), INSOMNIA (Troubles sleeping), RASH PRURITIC (Itchy rash on the back), DYSPNOEA (Difficulty breathing), HEADACHE (Headache) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 103 (Inconclusive) 103°F.     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 product use was not provided by the reporter.    Treatment for the event included Ibuprofen, inhaler, Prednisone and Z pack unspecified.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Rash pruritic
Clinical narrative: Bone-killing cold; Sore throat; Troubles sleeping; Itchy rash on the back; Difficulty breathing; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Bone-killing cold), OROPHARYNGEAL PAIN (Sore throat), INSOMNIA (Troubles sleeping), RASH PRURITIC (Itchy rash on the back) and DYSPNOEA (Difficulty breathing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (No reported medical history.).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FEELING COLD (Bone-killing cold), OROPHARYNGEAL PAIN (Sore throat), INSOMNIA (Troubles sleeping), RASH PRURITIC (Itchy rash on the back), DYSPNOEA (Difficulty breathing), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of UNK dosage form and PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING COLD (Bone-killing cold), OROPHARYNGEAL PAIN (Sore throat), INSOMNIA (Troubles sleeping), RASH PRURITIC (Itchy rash on the back), DYSPNOEA (Difficulty breathing), HEADACHE (Headache) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 103 (Inconclusive) 103°F.     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 product use was not provided by the reporter.    Treatment for the event included Ibuprofen, inhaler, Prednisone and Z pack unspecified.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Balance disorder, Headache, Vaccination site erythema, Vaccination site pain
Clinical narrative: Equilibrium problems since vaccine; Bad back; Alot of headaches; Arm red; Arm sore; Arm swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BALANCE DISORDER (Equilibrium problems since vaccine), BACK PAIN (Bad back), HEADACHE (Alot of headaches), VACCINATION SITE ERYTHEMA (Arm red) and VACCINATION SITE PAIN (Arm sore) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BALANCE DISORDER (Equilibrium problems since vaccine), BACK PAIN (Bad back), HEADACHE (Alot of headaches), VACCINATION SITE ERYTHEMA (Arm red), VACCINATION SITE PAIN (Arm sore) and VACCINATION SITE SWELLING (Arm swollen). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Vaccination site pain and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (Equilibrium problems since vaccine), BACK PAIN (Bad back), HEADACHE (Alot of headaches), VACCINATION SITE ERYTHEMA (Arm red), VACCINATION SITE PAIN (Arm sore) and VACCINATION SITE SWELLING (Arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had injections in her spine. Other concomitant medications included steroids for spine. Treatment also included ice for sore and swollen arm.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Equilibrium problems since vaccine; Bad back; Alot of headaches; Arm red; Arm sore; Arm swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BALANCE DISORDER (Equilibrium problems since vaccine), BACK PAIN (Bad back), HEADACHE (Alot of headaches), VACCINATION SITE ERYTHEMA (Arm red) and VACCINATION SITE PAIN (Arm sore) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BALANCE DISORDER (Equilibrium problems since vaccine), BACK PAIN (Bad back), HEADACHE (Alot of headaches), VACCINATION SITE ERYTHEMA (Arm red), VACCINATION SITE PAIN (Arm sore) and VACCINATION SITE SWELLING (Arm swollen). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Vaccination site pain and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (Equilibrium problems since vaccine), BACK PAIN (Bad back), HEADACHE (Alot of headaches), VACCINATION SITE ERYTHEMA (Arm red), VACCINATION SITE PAIN (Arm sore) and VACCINATION SITE SWELLING (Arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had injections in her spine. Other concomitant medications included steroids for spine. Treatment also included ice for sore and swollen arm.; 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: Itching on most of her body; Mild Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on most of her body) and VACCINATION SITE PAIN (Mild Soreness at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching on most of her body) and VACCINATION SITE PAIN (Mild Soreness at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching on most of her body) and VACCINATION SITE PAIN (Mild Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: 3 inch welt on injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE BRUISING (3 inch welt on injection site) in a 20-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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (3 inch welt on injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE BRUISING (3 inch welt on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine   Treatment include Benadryl and Claritin (did not resolve after a week),The PCP then prescribed prednisone (dose and duration unknown) which resulted in the resolution of the welts.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Hot to touch injection site; Really Red injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot to touch injection site) and INJECTION SITE ERYTHEMA (Really Red injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FEELING HOT (Hot to touch injection site) and INJECTION SITE ERYTHEMA (Really Red injection site). At the time of the report, FEELING HOT (Hot to touch injection site) and INJECTION SITE ERYTHEMA (Really Red injection site) outcome was unknown.            No relevant concomitant medications were reported.  Treatment details included Ice.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in top of shoulder around the bone; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in top of shoulder around the bone) in an 87-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Surgery (shoulder surgery in right arm.). Concomitant products included WARFARIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ARTHRALGIA (pain in top of shoulder around the bone). At the time of the report, ARTHRALGIA (pain in top of shoulder around the bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included none.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Ultrasound scan, Vaccination site pain
Clinical narrative: experiencing pain under arm; pain under where she received injection; lymph nodes were swollen and still swollen; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (experiencing pain under arm), VACCINATION SITE PAIN (pain under where she received injection) and LYMPHADENOPATHY (lymph nodes were swollen and still swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (experiencing pain under arm), VACCINATION SITE PAIN (pain under where she received injection) and LYMPHADENOPATHY (lymph nodes were swollen and still swollen). At the time of the report, PAIN IN EXTREMITY (experiencing pain under arm), VACCINATION SITE PAIN (pain under where she received injection) and LYMPHADENOPATHY (lymph nodes were swollen and still swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Ultrasound scan: (Inconclusive) Confirmed swollen lymph nodes.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported.  Treatment details included none
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Muscular weakness
Clinical narrative: This spontaneous report received from a consumer, concerning a 73-year-old male patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced: legs felt a little weak/no strength in his legs, felt like he had no muscles in his legs and fell twice. The patient's medical history, current condition and concomitant medications not provided. On Jan 26, 2021, prior to the onset of events, patient received the first of two planned doses of mRNA-1273 (lot/batch# 031L20A), via unknown route, in the left arm, for prophylaxis of COVID-19 infection. On Jan 27, 2021, patient experienced: legs felt a little weak/no strength in his legs and felt like he had no muscles in his legs. On Jan 28, 2021, patient experienced a fall. No treatment information provided. Action taken with mRNA-1273 in response to the events not reported. On Jan 29, 2021 the outcome of legs felt a little weak/no strength in his legs, felt like he had no muscles in his legs and fell twice resolved.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 103 (High) fever of 103..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 onset date of the reported event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Rapid heart beat). At the time of the report, HEART RATE INCREASED (Rapid heart beat) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid heart beat (High) rapid heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Developed GI problems after the second dose of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL DISCOMFORT (Developed GI problems after the second dose of the Moderna COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Developed GI problems after the second dose of the Moderna COVID-19 vaccine). At the time of the report, ABDOMINAL DISCOMFORT (Developed GI problems after the second dose of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Neck Pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck Pain) and HEADACHE (Headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029C20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NECK PAIN (Neck Pain) and HEADACHE (Headache). At the time of the report, NECK PAIN (Neck Pain) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Injection site pain
Clinical narrative: Headache for 2 days after the shot; Injection site hurt/pain; Looked like purple bruise on left arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for 2 days after the shot), INJECTION SITE PAIN (Injection site hurt/pain) and CONTUSION (Looked like purple bruise on left arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEADACHE (Headache for 2 days after the shot), INJECTION SITE PAIN (Injection site hurt/pain) and CONTUSION (Looked like purple bruise on left arm). At the time of the report, HEADACHE (Headache for 2 days after the shot), INJECTION SITE PAIN (Injection site hurt/pain) and CONTUSION (Looked like purple bruise on left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Ibuprofen.; 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. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: dizziness; tingling legs; diarrhea; Headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PARAESTHESIA (tingling legs), DIARRHOEA (diarrhea), HEADACHE (Headache) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM for an unknown indication.    On 26-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 DIZZINESS (dizziness), PARAESTHESIA (tingling legs), DIARRHOEA (diarrhea), HEADACHE (Headache), NAUSEA (nausea) and CHILLS (chills). At the time of the report, DIZZINESS (dizziness), PARAESTHESIA (tingling legs), DIARRHOEA (diarrhea), HEADACHE (Headache), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: dizziness; tingling legs; diarrhea; Headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PARAESTHESIA (tingling legs), DIARRHOEA (diarrhea), HEADACHE (Headache) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM for an unknown indication.    On 26-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 DIZZINESS (dizziness), PARAESTHESIA (tingling legs), DIARRHOEA (diarrhea), HEADACHE (Headache), NAUSEA (nausea) and CHILLS (chills). At the time of the report, DIZZINESS (dizziness), PARAESTHESIA (tingling legs), DIARRHOEA (diarrhea), HEADACHE (Headache), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.