chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; A spontaneous report was received from a Nurse concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shingles.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 24 Jan 2021, the patient experienced the event shingles.  Treatment details included Anti shingles medication.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, shingles was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: The patient's past medical history included Rash (Reaction occurred after administration of shingles vaccine). Previously administered products included for an unreported indication: SHINGRIX (Shingles vaccine) on 28-Jan-2013. Concurrent medical conditions included Drug allergy (Macrobid-dizzy).   On 15-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Huge rash (3-4inches)/rash:pimply & ring shaped), VACCINATION SITE PRURITUS (Itching/ pruritis) and VACCINATION SITE ERYTHEMA (Redness/ erythema). The patient was treated with CORTISONE (topical) for Itching, at a dose of 1 dosage form. On 05-Feb-2021, VACCINATION SITE RASH (Huge rash (3-4inches)/rash:pimply & ring shaped), VACCINATION SITE PRURITUS (Itching/ pruritis) and VACCINATION SITE ERYTHEMA (Redness/ erythema) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up report attached on 06-05-2021 which updated Event details, second dose details,medical history details and patient details.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Type IV hypersensitivity reaction
Clinical narrative: delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of a rash on the arm of the shot that itches; delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of a rash on the arm of the shot that itches; A spontaneous report was received from a healthcare professional concerning a 73 years old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events delayed subcutaneous hypersensitivity reaction, otherwise called covid arm, which consists of a rash on the arm of the shot that itches/ type IV hypersensitivity reaction and rash pruritic  The patient's medical history was not provided. Concomitant medications reported were vitamins, calcium, biotin, levothyroxine, escitalopram, atorvastatin, alendronate sodium, omega 3, antihistamine tablet, probiotic for drug use for unknown indication.  On 9 Feb 2021,approximately 9 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) delayed subcutaneous hypersensitivity reaction, otherwise called covid arm, which consists of.a rash on the arm of the shot that itches.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), delayed subcutaneous hypersensitivity reaction, otherwise called covid arm, which consists of was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Light headache; dizziness; Fever off and on; Sore arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events light headache, fever off and on, sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Light headache, Fever off and on, Sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), light headache, fever off and on, sore arm was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test
Clinical narrative: Tested positive for COVID-19; A spontaneous report was received from a consumer concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for COVID-19.  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: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event tested positive for COVID-19.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 9 Feb 2021, the outcome of event tested positive for COVID-19 was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: dizziness; Fever off and on; bad nausea; light headache; Sore arm; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events light headache, fever off and on, sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced fever 99.8F coming and going, bad nausea, a light headache, dizziness, and an annoying sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), light headache, fever off and on, sore arm was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site swelling, Pain in extremity, Vaccination site erythema, Vaccination site induration
Clinical narrative: Realy sore arms; injection site is hard, raised and red; injection site is hard, raised and red; injection site is hard, raised and red; allergic reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really sore arms /pain in extremity, injection site is hard /injection site induration, raised /injection site swelling and red /injection site erythema, looks like an allergic reaction /hypersensitivity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) Really sore arms, Injection site is hard, raised and red, Looks like an allergic reaction.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), really sore arms, injection site is hard, raised and red, looks like an allergic reaction was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Visual impairment
Clinical narrative: vision had like patch pink; little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision had like patch pink) and PAIN IN EXTREMITY (little sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and High cholesterol.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VISUAL IMPAIRMENT (vision had like patch pink) and PAIN IN EXTREMITY (little sore arm). On 25-Feb-2021, VISUAL IMPAIRMENT (vision had like patch pink) had resolved. At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  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.; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: her arm started bothering again; warm; bump; red; it itches; it hurt; her arm a little bit swollen; Tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (bump), VACCINATION SITE SWELLING (her arm a little bit swollen) and VACCINATION SITE PAIN (Tender) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (her arm a little bit swollen), VACCINATION SITE PAIN (Tender) and VACCINATION SITE PAIN (it hurt). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (it itches). 24-Feb-2021, the patient experienced VACCINATION SITE INDURATION (bump). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (bump), VACCINATION SITE SWELLING (her arm a little bit swollen), VACCINATION SITE PAIN (Tender), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: her arm started bothering again; warm; bump; red; it itches; it hurt; her arm a little bit swollen; Tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (bump), VACCINATION SITE SWELLING (her arm a little bit swollen) and VACCINATION SITE PAIN (Tender) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (her arm a little bit swollen), VACCINATION SITE PAIN (Tender) and VACCINATION SITE PAIN (it hurt). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (it itches). 24-Feb-2021, the patient experienced VACCINATION SITE INDURATION (bump). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (bump), VACCINATION SITE SWELLING (her arm a little bit swollen), VACCINATION SITE PAIN (Tender), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching at injection site; Wide swelling at injection site; Red swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE SWELLING (Wide swelling at injection site) and INJECTION SITE ERYTHEMA (Red swelling at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE SWELLING (Wide swelling at injection site) and INJECTION SITE ERYTHEMA (Red swelling at injection site). On 26-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching at injection site). At the time of the report, INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE SWELLING (Wide swelling at injection site) and INJECTION SITE ERYTHEMA (Red swelling at injection site) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information  received on 14 Jul 2021 contains non significant information
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), CALCIUM, BIOTIN, LEVOTHYROXINE, ESCITALOPRAM, ATORVASTATIN, ALENDRONATE SODIUM, CARBINOXAMINE MALEATE (OMEGA 3), DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) and PROBIOTIC 10 for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE REACTION (delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of). At the time of the report, VACCINATION SITE REACTION (delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of) outcome was unknown. 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.  There is no information about treatment medications.
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: major drop in blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (major drop in blood pressure) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HYPOTENSION (major drop in blood pressure). On 18-Feb-2021, HYPOTENSION (major drop in blood pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; A spontaneous report was received from a consumer concerning a 84-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, chills.  The patient's medical history was not provided. Concomitant medications reported were Inderal for drug use for unknown indication.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 12M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient developed fever between 99-99.9 Degrees Fahrenheit, as well as chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, fever and chills was not reported.; Reporter's Comments: This case concerns an 84-year-old female with NS expected events of fever and chills. Event onset occurred on Day 2 after the second dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Facial pain, Fatigue, Headache
Clinical narrative: Her "face hurt"; Sweating; Blurred vision; rash; Muscle aches; Achy joints; Vomiting; Chills; Headaches; High fever of 103.8 F; General tiredness; hives; A spontaneous report was received from a consumer concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever.  The patient's medical history was not provided. Concomitant medications reported were Hailey 24 FE (birth control), Singulair, Zyrtec, Red Yeast Rice for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever.  Treatment details included Tylenol and Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.  On 8 Feb 2021 the outcome of events, rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt was resolved. On7 Feb 2021 the outcome of events, low-grade fever was resolved.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia, Rash, Urticaria
Clinical narrative: Her "face hurt"; Sweating; Blurred vision; rash; Muscle aches; Achy joints; Vomiting; Chills; Headaches; High fever of 103.8 F; General tiredness; hives; A spontaneous report was received from a consumer concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever.  The patient's medical history was not provided. Concomitant medications reported were Hailey 24 FE (birth control), Singulair, Zyrtec, Red Yeast Rice for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever.  Treatment details included Tylenol and Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.  On 8 Feb 2021 the outcome of events, rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt was resolved. On7 Feb 2021 the outcome of events, low-grade fever was resolved.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: Her "face hurt"; Sweating; Blurred vision; rash; Muscle aches; Achy joints; Vomiting; Chills; Headaches; High fever of 103.8 F; General tiredness; hives; A spontaneous report was received from a consumer concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever.  The patient's medical history was not provided. Concomitant medications reported were Hailey 24 FE (birth control), Singulair, Zyrtec, Red Yeast Rice for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever.  Treatment details included Tylenol and Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.  On 8 Feb 2021 the outcome of events, rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt was resolved. On7 Feb 2021 the outcome of events, low-grade fever was resolved.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash
Clinical narrative: rash; injection site itching; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site itching, rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) injection site itching. On an unknown date, the patient experienced the event(s) Rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), injection site itching, rash was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Vaccination site induration, Vaccination site pain
Clinical narrative: 3 of 10 pain/hardness at the injection site; low grade fever; nausea; vomiting; exhausted; 3 of 10 pain/hardness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea) and VOMITING (vomiting) in a female patient of an unknown age 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 information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (exhausted). On an unknown date, the patient experienced VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site). At the time of the report, VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 3 of 10 pain/hardness at the injection site; low grade fever; nausea; vomiting; exhausted; 3 of 10 pain/hardness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea) and VOMITING (vomiting) in a female patient of an unknown age 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 information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (exhausted). On an unknown date, the patient experienced VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site). At the time of the report, VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Redness; Pain at injection site; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Itching) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Itching). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: blinking uncontrollably; A spontaneous report was received from a consumer concerning a 42-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blinking uncontrollably.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event blinking uncontrollably.  Treatment details included antihistamines..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, blinking uncontrollably was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: itching the place on their arm where they had the shot; real red on arm; arm where they had the shot was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching the place on their arm where they had the shot), VACCINATION SITE ERYTHEMA (real red on arm) and VACCINATION SITE PAIN (arm where they had the shot was sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ04) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching the place on their arm where they had the shot), VACCINATION SITE ERYTHEMA (real red on arm) and VACCINATION SITE PAIN (arm where they had the shot was sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching the place on their arm where they had the shot), VACCINATION SITE ERYTHEMA (real red on arm) and VACCINATION SITE PAIN (arm where they had the shot was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever - Temperature of 99.7F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever - Temperature of 99.7F) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 24-Feb-2021, the patient experienced PYREXIA (Fever - Temperature of 99.7F). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever - Temperature of 99.7F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 99.7 f (High) 99.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site swelling
Clinical narrative: rash; round circle which was swollen, around the injection site; arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm soreness), RASH (rash) and VACCINATION SITE SWELLING (round circle which was swollen, around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 24-Feb-2021, the patient experienced RASH (rash) and VACCINATION SITE SWELLING (round circle which was swollen, around the injection site). On 13-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, RASH (rash) and VACCINATION SITE SWELLING (round circle which was swollen, around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed antibiotics by her HCP but she did not take it.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Malaise, Off label use
Clinical narrative: lots of itching; who instructed her not to receive a second dose of the vaccine. And she has not received the second dose; Headache; Felt tired; Feeling like she was coming down with the flu or something; Hives; some diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (some diarrhea), PRURITUS (lots of itching), URTICARIA (Hives), VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something) and OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Unspecified allergies).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (some diarrhea). On 28-Jan-2021, the patient experienced URTICARIA (Hives). On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something), HEADACHE (Headache) and FATIGUE (Felt tired). On an unknown date, the patient experienced PRURITUS (lots of itching) and OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose). On 28-Jan-2021, URTICARIA (Hives) had resolved. At the time of the report, DIARRHOEA (some diarrhea), PRURITUS (lots of itching), VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something), OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose), HEADACHE (Headache) and FATIGUE (Felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information included Allergy medicine and Aspirin.  Allergist advised not to take Second dose of Vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Batch number added, New events added, Onset dates updated, Outcome of the event Hives updated to recovered, Treatment information updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: lots of itching; who instructed her not to receive a second dose of the vaccine. And she has not received the second dose; Headache; Felt tired; Feeling like she was coming down with the flu or something; Hives; some diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (some diarrhea), PRURITUS (lots of itching), URTICARIA (Hives), VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something) and OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Unspecified allergies).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (some diarrhea). On 28-Jan-2021, the patient experienced URTICARIA (Hives). On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something), HEADACHE (Headache) and FATIGUE (Felt tired). On an unknown date, the patient experienced PRURITUS (lots of itching) and OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose). On 28-Jan-2021, URTICARIA (Hives) had resolved. At the time of the report, DIARRHOEA (some diarrhea), PRURITUS (lots of itching), VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something), OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose), HEADACHE (Headache) and FATIGUE (Felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information included Allergy medicine and Aspirin.  Allergist advised not to take Second dose of Vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Batch number added, New events added, Onset dates updated, Outcome of the event Hives updated to recovered, Treatment information updated.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Paraesthesia oral, Sinus pain
Clinical narrative: Tingling of the Lips; dizziness; Pain in Sinuses; Nausea; Headache; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, headache, pain in sinuses, tingling of the lips/paresthesia oral, dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, immediately after receiving the vaccine the patient experienced the events nausea, headache, pain in sinuses, tingling of the lips, dizziness.  Treatment details included diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported.   On 8 Feb 2021 the outcome of events, nausea, headache, pain in sinuses, tingling of the lips, dizziness was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Lethargy, Tremor
Clinical narrative: Lethargy; Soreness at the injection site; Shaking; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of LETHARGY (Lethargy), TREMOR (Shaking), CHILLS (Chills) and INJECTION SITE PAIN (Soreness at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced TREMOR (Shaking) and CHILLS (Chills). On 04-Feb-2021, the patient experienced LETHARGY (Lethargy) and INJECTION SITE PAIN (Soreness at the injection site). At the time of the report, LETHARGY (Lethargy), TREMOR (Shaking), CHILLS (Chills) and INJECTION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No new Information
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphonia
Clinical narrative: cough; throat hoarse; voice box hoarse; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), DYSPHONIA (throat hoarse) and DYSPHONIA (voice box hoarse) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 31-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 COUGH (cough), DYSPHONIA (throat hoarse) and DYSPHONIA (voice box hoarse). At the time of the report, COUGH (cough), DYSPHONIA (throat hoarse) and DYSPHONIA (voice box hoarse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included On antibiotic for throat.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), throat hoarse, voice box hoarse, cough was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on her arm /rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, approximately 9 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) rash on her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash on her arm was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash (around the injection site); Swelling (around the injection site); Redness (around the injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash (around the injection site)), VACCINATION SITE SWELLING (Swelling (around the injection site)) and VACCINATION SITE ERYTHEMA (Redness (around the injection site)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash (around the injection site)), VACCINATION SITE SWELLING (Swelling (around the injection site)) and VACCINATION SITE ERYTHEMA (Redness (around the injection site)). At the time of the report, VACCINATION SITE RASH (Rash (around the injection site)), VACCINATION SITE SWELLING (Swelling (around the injection site)) and VACCINATION SITE ERYTHEMA (Redness (around the injection site)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pain, Pruritus
Clinical narrative: A spontaneous report was received from a consumer concerning a 80 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore /pain, itched really bad /pruritus, bothered her more at night /anxiety. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L2OA) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M2OA) via unknown route in the left arm for prophylaxis of COVID-19 infection. On Feb 2021, the patient experienced the event(s) sore, itched really bad, bothered her more at night. Treatment details included used vinegar in the bath water, acetaminophen and aspirin. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of event(s), sore, itched really bad, bothered her more at night was unknown.