chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: A little high from the vaccine; Redness of the injection site; Swelling of the injection site; Delayed hypersensitivity reaction; Infection; Lymph nodes tenderness; Lymph nodes swelling; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), INFECTION (Infection), EUPHORIC MOOD (A little high from the vaccine), VACCINATION SITE ERYTHEMA (Redness of the injection site) and VACCINATION SITE SWELLING (Swelling of the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM LEVOMEFOLATE, DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (BEYAZ), MINOXIDIL (ROGAINE), EPHEDRINE HYDROCHLORIDE (EPHEDRIN) and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Headache.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes tenderness) and LYMPHADENOPATHY (Lymph nodes swelling). On 13-Jan-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), INFECTION (Infection), VACCINATION SITE ERYTHEMA (Redness of the injection site) and VACCINATION SITE SWELLING (Swelling of the injection site). On 15-Jan-2021, the patient experienced EUPHORIC MOOD (A little high from the vaccine). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), INFECTION (Infection), EUPHORIC MOOD (A little high from the vaccine), VACCINATION SITE ERYTHEMA (Redness of the injection site), VACCINATION SITE SWELLING (Swelling of the injection site), LYMPH NODE PAIN (Lymph nodes tenderness) and LYMPHADENOPATHY (Lymph nodes swelling) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment were included Keflex, Zyrtec and Ice.; 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: redness at injection site; swelling to the size of a 50 cent piece to injection site; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling to the size of a 50 cent piece to injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling to the size of a 50 cent piece to injection site). At the time of the report, VACCINATION SITE PAIN (Injection site pain) had not resolved and VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swelling to the size of a 50 cent piece to injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    This case was linked to MOD-2021-008838 (E2B Linked Report).; 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. MOD-2021-008838:Same reporter
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Retching, Vomiting
Clinical narrative: Fever; Almost threw up; Retching; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), VOMITING (Almost threw up) and RETCHING (Retching) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history) since an unknown date. Concomitant products included METOPROLOL, AMLODIPINE, ATORVASTATIN, SILDENAFIL, HYDROCHLOROTHIAZIDE, B-COMPLEX 2000, UBIQUINOL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), COLFORSIN, CURCUMA LONGA (TURMERIC + FORSKOLIN), ZINC and MAGNESIUM.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Jan-2021, the patient experienced PYREXIA (Fever), VOMITING (Almost threw up) and RETCHING (Retching). On 16-Jan-2021, PYREXIA (Fever), VOMITING (Almost threw up) and RETCHING (Retching) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Tylenol
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pruritus, Myalgia
Clinical narrative: itchiness; muscle hardness; discomfort at the site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchiness), MYALGIA (muscle hardness) and INJECTION SITE DISCOMFORT (discomfort at the site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Multiple myeloma (Was in treatment for three years.). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchiness), MYALGIA (muscle hardness) and INJECTION SITE DISCOMFORT (discomfort at the site). At the time of the report, INJECTION SITE PRURITUS (itchiness), MYALGIA (muscle hardness) and INJECTION SITE DISCOMFORT (discomfort at the site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: shot site soreness; red; itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (shot site soreness), INJECTION SITE ERYTHEMA (red) and INJECTION SITE PRURITUS (itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INJECTION SITE PAIN (shot site soreness), INJECTION SITE ERYTHEMA (red) and INJECTION SITE PRURITUS (itching). At the time of the report, INJECTION SITE PAIN (shot site soreness) outcome was unknown and INJECTION SITE ERYTHEMA (red) and INJECTION SITE PRURITUS (itching) had not 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 treatment details was reported.; 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired more than normal/tired couple of days after each vaccination; sore arm-vaccination site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm-vaccination site) and FATIGUE (tired more than normal/tired couple of days after each vaccination) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013220A) for COVID-19 vaccination.     No medical history was reported by the reporter.  The patient's past medical history included No adverse event. Concomitant products included DICLOFENAC and FAMOTIDINE (PEPCID AC) 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 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm-vaccination site). On 17-Jan-2021, the patient experienced FATIGUE (tired more than normal/tired couple of days after each vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm-vaccination site) and FATIGUE (tired more than normal/tired couple of days after each vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090559 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Mass excision, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: 2-inch diameter red mark at the injection site, the outer part is darker; Has lumps under the skin; When you press, it hurts; Itches; A spontaneous report was received from a Reporter concerning a 30 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  The patient's medical history was not provided. No relevant concomitant medications were reported.  Patient who is a pharmacy technician received the 1st Moderna vaccine 12Jan2021 2pm on left upper arm. The next day she noticed a red mark on the injection site. She states it has been getting bigger. On her arm she has a 2-inch diameter red mark at the injection site. The outer part is darker and has lumps under the skin and when you press it hurts and itches. No treatment taken. Wants to know if this is normal. Allergies include penicillin and seasonal. PMH includes Hashimoto's thyroiditis. No further information provided. Caller consents to follow up with her and HCP No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: tenderness at injection site; redness at injection site; swollen from shoulder to elbow; increased warmth at injection site; A spontaneous report was received from a consumer concerning a 82 year old female patient, whoreceived Moderna's COVID-19 vaccine (mRNA-1273) and experienced red and swollen arm.  The patient received their first of two planned doses of mRNA-1273 in(Lot number: 025LZ04 ) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 15/Jan/2021, the patient experienced arm felt warm and red and swollen, the outcome of the events are not reported.  Action taken with mRNA-1273 in response to the events was not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: "we both don't feel well"; This spontaneous case was reported by a  Female  age 67-year-old Patient who received the moderna vaccine in the Left arm on 18Jan2021.and  Patient  reported her spouse,71-year-old male patient, also received the moderna  vaccine in his Left arm on 18Jan2021.and describes the occurrence of Felling abnormal ("we both don't feel well") Caller wants to know if they can take aspirin. Caller also would like to know if she can take her antihistamines which she takes for allergies.No Medical History information was reported. Outcome of the event is 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.   This case was linked to MOD-2021-009911 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Periorbital swelling
Clinical narrative: both eyes are puffy underneath, both cheeks are red; both eyes are puffy underneath, both cheeks are red; A spontaneous report was received from a consumer concerning a -70 years old male patient who received Moderna's COVID-19 vaccine (Mrna-1273) and experienced events Periorbital swelling and erythema. The patients's medical history was provided and relevant concomitant medications were also reported. On 12Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 14Jan 2021, the patient experienced the events like both eyes puffy underneath and both cheeks appeared red.  The patient was on Brimonidine tartrate 1 drop both eyes TID, Dorzolamide HCl 1 drop both eyes TID, rhopressa one drop in both eyes at night before bed. The response provided was as follows: Redness of the cheeks and puffy eyes is not listed as a side effect however these may not be all the possible side effects of the Moderna COVID-19 Vaccine: Call the vaccination provider or your health care provider if you have any side effects that bother you or do not go away.  The reporter assessed the events as not related to the study drug.  Based on comment, repeated event line is delete
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: very, very bad rash; couldn't breathe through my nose; rash was all over my face; Per voicemail 20Jan2021 at 0929: Patient is reporting adverse effects from her first Moderna vaccination and also requesting advisability on second dose. Her physician, who did not administer the first dose, told her to call and report. She developed a very, very bad rash that traveled from the arm and kept her in the urgent care that vaccinated her. By the night, the rash was all over her face. She had difficulty breathing through her nose. She was advised to take 50mg of Benadryl, but she felt a little SOB for about 2 days following this. Upon calling back 20Jan2021 1404: Caller is a psychologist. Vaccine was given on left arm on 09Jan2021. She had a torn rotator cuff two years ago, so she felt it was safer to get the vaccine on her left arm. At the urgent care, her blood pressure, temperature, and respiration were normal. She took the Benadryl 25mg at home approximately 5:30 PM. On 09Jan2021, 7 hours post vaccination, she couldn't breathe through her nose; she was breathing through her mouth. Her nose was swollen. She never had anything like this before. Then she took another Benadryl 25 mg around 11:00 PM. She was uncomfortable that night and was up until 04:00 in the morning. Patient states she is very healthy and active. She had trouble breathing when she was taking a walk. Consent given for safety to contact patient. Patient states her HCP was not the one who administered the vaccine, but safety is ok to contact her HCP.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen/hard lymph node in armpit; A spontaneous report was received from consumer concerning female patient who was in late 20s who received Moderna's covid-19 vaccine (mRNA-1273) swollen/hard lymph node in armpit.  The patient's medical history and concomitant medication was not provided.  On 12 Jan 2021, the patient received first dose of mRNA-1273 for prophylaxis of covid-19 infection.  On an unknown date the patient developed swollen/hard lymph node in armpit (axillary lymph nodes enlarged).  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event axillary lymph nodes enlarged was unknown.; Sender's Comments: 26 Feb 2021: As per fact sheet lymphadenopathy, and axillary mass, kept as listed kindly reassess.
Sex: M
Vaccine: COVID19
Symptoms: Tooth loss
Clinical narrative: tooth fell out today; A spontaneous report was received from a consumer concerning  her husband, a 76 year male patient  who was administered Moderna's vaccine  has experienced tooth fall. The patient's medical history was not provided. No concomitant medications were reported. On 20- Jan-2021 prior to the onset of events, the patient received  1st dose of mRNA( batch no.-013L20A) for prophylaxis of COVID-19 infection. The patient's tooth fall out.Treatment drugs were not reported. Action taken was unknown. The event outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Injection site pain, Ocular hyperaemia, Vision blurred
Clinical narrative: Pain in both eyes; Swelling in both eyes; Redness in both eyes; Blurred vision in both eyes; Pain at injection site; A spontaneous case report was received from a consumer on 20-01-2021 04:01pm which refers to a 75yrs female gender  The patients had a past medical history of Asthma and osteopenia and allergies include shell fish, soy, latex and sulfa .Relevant concominant medications were reported.  On  13-01-2021,  the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination.   On 14-01-2021 the patient developed Vaccination site pain, also developed pain, swelling, Redness and blurred vision in both eyes. Relevant laboratory results were not included .  Ophthalmologist advised the caller to not take second vaccine.   The company believes the following facts are also relevant in this case: vaccination site pain The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship. At this time of Report , the outcome of the event was recovered
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait disturbance, Headache, Injection site erythema
Clinical narrative: Could not sleep; Joint pain; Unable to walk that well; Intense itching in left deltoid; Body aches; Fatigue; Headache; Congestion; Sore throat; Injection site warm to touch; Slightly erythematous; Induration; Low grade fever 99.9; A spontanious report was received from other healthcare professional concerning a 38 Years old, female patient who injection site warmth, injection site erythema, injection site induration, pyrexia, pain, fatigue, headache, nasal congestion, oropharyngeal pain, injection site pruritus, gait disturbance, insomnia, arthralgia.   The patient's medical history was reported included chronic fatigue, COVID, depression, anxiety lupus. Current illness included allergies to oxycodone, sulfa and doxycycline. Concomitant medication reported included vyvansa, sertraline, folic acid, methotrexate, topiramate, hydrochloroquine.   On 22-Dec-2020, prior to the onset events patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    On 24-Dec-2020 patient experienced Injection site warm to touch, Slightly erythematous, Induration, Low grade fever 99.9, Body aches, Fatigue, Congestion, Sore throat. On 29-Dec-2020 patient experienced Intense itching in left deltoid. On 8-Jan-2021 experienced unable to walk that well. On an unknown date patient reported she could not sleep, joint pain, Intense itching in left deltoid. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events injection site warmth, injection site erythema, injection site induration, pyrexia, pain, fatigue, headache, nasal congestion, oropharyngeal pain, injection site pruritus, gait disturbance, insomnia, arthralgia was unknown.  Based on comment, (Injection site pruritus) is deleted
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site warmth, Insomnia, Nasal congestion
Clinical narrative: Could not sleep; Joint pain; Unable to walk that well; Intense itching in left deltoid; Body aches; Fatigue; Headache; Congestion; Sore throat; Injection site warm to touch; Slightly erythematous; Induration; Low grade fever 99.9; A spontanious report was received from other healthcare professional concerning a 38 Years old, female patient who injection site warmth, injection site erythema, injection site induration, pyrexia, pain, fatigue, headache, nasal congestion, oropharyngeal pain, injection site pruritus, gait disturbance, insomnia, arthralgia.   The patient's medical history was reported included chronic fatigue, COVID, depression, anxiety lupus. Current illness included allergies to oxycodone, sulfa and doxycycline. Concomitant medication reported included vyvansa, sertraline, folic acid, methotrexate, topiramate, hydrochloroquine.   On 22-Dec-2020, prior to the onset events patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    On 24-Dec-2020 patient experienced Injection site warm to touch, Slightly erythematous, Induration, Low grade fever 99.9, Body aches, Fatigue, Congestion, Sore throat. On 29-Dec-2020 patient experienced Intense itching in left deltoid. On 8-Jan-2021 experienced unable to walk that well. On an unknown date patient reported she could not sleep, joint pain, Intense itching in left deltoid. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events injection site warmth, injection site erythema, injection site induration, pyrexia, pain, fatigue, headache, nasal congestion, oropharyngeal pain, injection site pruritus, gait disturbance, insomnia, arthralgia was unknown.  Based on comment, (Injection site pruritus) is deleted
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Could not sleep; Joint pain; Unable to walk that well; Intense itching in left deltoid; Body aches; Fatigue; Headache; Congestion; Sore throat; Injection site warm to touch; Slightly erythematous; Induration; Low grade fever 99.9; A spontanious report was received from other healthcare professional concerning a 38 Years old, female patient who injection site warmth, injection site erythema, injection site induration, pyrexia, pain, fatigue, headache, nasal congestion, oropharyngeal pain, injection site pruritus, gait disturbance, insomnia, arthralgia.   The patient's medical history was reported included chronic fatigue, COVID, depression, anxiety lupus. Current illness included allergies to oxycodone, sulfa and doxycycline. Concomitant medication reported included vyvansa, sertraline, folic acid, methotrexate, topiramate, hydrochloroquine.   On 22-Dec-2020, prior to the onset events patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    On 24-Dec-2020 patient experienced Injection site warm to touch, Slightly erythematous, Induration, Low grade fever 99.9, Body aches, Fatigue, Congestion, Sore throat. On 29-Dec-2020 patient experienced Intense itching in left deltoid. On 8-Jan-2021 experienced unable to walk that well. On an unknown date patient reported she could not sleep, joint pain, Intense itching in left deltoid. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events injection site warmth, injection site erythema, injection site induration, pyrexia, pain, fatigue, headache, nasal congestion, oropharyngeal pain, injection site pruritus, gait disturbance, insomnia, arthralgia was unknown.  Based on comment, (Injection site pruritus) is deleted
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia
Clinical narrative: High blood pressure 140/72; fever; A spontaneous report was received from a (Reporter like consumer) concerning a  68 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.        The patient's medical history was not provided. No relevant concomitant medications were reported.        On 12-JAN-2021 prior to the onset of the events, like increase in the blood pressure and fever the patient received their first planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the Anatomical location of left arm for prophylaxis of COVID-19 infection.      On 12-JAN-2021, The patient experienced the events list (verbatims) with non serious   Patient took metoprolol, and lisinopril. Symptoms have subsided.     Action taken with mRNA-1273 in response to the events was not reported.     Patient took metoprolol, and lisinopril. Symptoms have subsided.  The patient was recovered after took the medication for events and it was as non serious case  The reporter assessed the event(s), [EVENT VERBATIM TERM(S)], as not related to study drug.
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: injection site rash; A spontaneous report was received from a Consumer who is the patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rashes at the injection site  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. Mild symptoms appeared and resolved within 15 days. On the 13th day i.e, 18-JAN-2021, the patient got 2 by 2-inch rash at the injection site.  The patient took Benadryl. As reported the rash has not resolved but has not gotten worse.  No Laboratory details provided. No other treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  As per the report the event has not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: arm got red; arm swelling; arm got bruising; arm got itchy; A spontaneous report was received from a consumer concerning a patient, who received Moderna COVID-19 vaccine (mRNA-1273) and experienced injection site redness, swelling bruising and itchy. The patient's medical history was not provided. No relevant concomitant medications was reported. On 6-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number :unknown) intramuscularly  for the prophylaxis of COVID-19 infection. On an unknown date , the patient experienced injection site redness, swelling bruising and itchy. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of report, the outcome of the events injection site redness, swelling bruising and itchy was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 101.4; Chills; A report was received from a consumer on 19-01-2021 concerning a PATIENT AGE 78 years old, Male   was participating in the mRNA-1273 Emergency Use Program and experienced Fever and Chills.  The patient stated that first dose had antibodies from previous COVID infection  The patient was treated with acetaminophen 1 Gm afebrile next day for the events.  The patient received their first of two planned doses of mRNA-1273 on  unknown date , Unknown route,  LOT/BATCH Lot number 039k202a  for prophylaxis of COVID-19 infection.  The Chronological order of the events were fever and chills.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events were unknown.  Report Source- Non-Health Professional,   Age- 78 Years,  Sex- Male,   Suspect Drug- Moderna COVID-19 Vaccine,   Treatment : acetaminophen 1 Gm Diagnosis  : Fever and chills Outcome - Unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: injection site is itching; red, blotchy; raised spot, silver dollar size; warm to the touch; some pain on the injection site for 3 days; A spontaneous report was  received from a consumer who was 41 years old female patient   who received Moderna's COVID-19 vaccine and experienced  pain on the injection site for 3 days and then  the injection site is itching, red, blotchy, raised spot Silver dollar size , and warm to the touch.  Patient's medical history  and concomitant medication list was not available.  On 11-JAN-2021 she received   first dose of Moderna's COVID-19 vaccine in the deltoid muscle of the right arm.She had some pain on the injection site for 3 days. On 20JAN2021 she noticed that the injection site is itching, red, blotchy, raised spot Silver dollar size , and warm to the touch.  Treatment actions was unknown .  Action taken with mRNA-1273 was not reported.  The outcome of the events, pain on the injection site for 3 days was recovered/resolved and   the injection site is itching, red, blotchy, raised spot Silver dollar size , and warm to the touch was unknown.  Based comment, all events (Reported causality missing, add Not reported. Determined causality missing, add possible.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Maternal exposure during pregnancy, Scan, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Polycystic ovary (PCOS in 20's, but no issues conceiving). Concurrent medical conditions included Drug allergy (sulfa), Angina pectoris, Coronary bypass in 1990 and Cardiac catheterisation on 28-Dec-2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], PROBIOTICS, VITAMIN D, CETIRIZINE HYDROCHLORIDE (ZYRTEC), CLARATIN, VITAMIN B6 and DOXYLAMINE SUCCINATE (UNISOM) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. The patient's last menstrual period was on 20-Aug-2020 and the estimated date of delivery was 30-May-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2020, Investigation:. On 26-Oct-2020, Ultrasound scan: normal normal. On an unknown date, Investigation: 09nov2020 invitae  - WNL. On an unknown date, Scan: 17nov2020 (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient previously had live full-term birth on 20-SEP-2018 The patient previously had Spontaneous abortion on 25-JUL-2020  No treatment medication was reported.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Vaccination site pain
Clinical narrative: Pain in the injection site; Lips and mouth numb and tingly; Lips and mouth numb and tingly; A spontaneous report was received from a Reporter concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  She received the 1st dose of moderna COVID19 vaccine on 14jan2021 (hospital) 20 min after her lips and mouth numb and tingly for 30 minutes. Also she experienced pain in the injection site during 3 days. Permission follow Up directly. Lot # 026L20A, Date The injection was administered in her Left arm by IM injection.  Is the patient pregnant: not currently. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dizziness, Influenza like illness
Clinical narrative: Dizzy, light headed, flu like symptoms,bad cough; Dizzy, light headed, flu like symptoms,bad cough; Dizzy, light headed, flu like symptoms,bad cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy, light headed, flu like symptoms,bad cough), INFLUENZA LIKE ILLNESS (Dizzy, light headed, flu like symptoms,bad cough) and COUGH (Dizzy, light headed, flu like symptoms,bad cough) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Dizzy, light headed, flu like symptoms,bad cough), INFLUENZA LIKE ILLNESS (Dizzy, light headed, flu like symptoms,bad cough) and COUGH (Dizzy, light headed, flu like symptoms,bad cough). At the time of the report, DIZZINESS (Dizzy, light headed, flu like symptoms,bad cough), INFLUENZA LIKE ILLNESS (Dizzy, light headed, flu like symptoms,bad cough) and COUGH (Dizzy, light headed, flu like symptoms,bad cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Pain
Clinical narrative: body pain; joint pain; tiredness; sore at injection site; A spontaneous report was received from a consumer concerning a 73- Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events general body pain, joint pain, tiredness, sore injection site.  The patient's medical history included lung infection and blood pressure. No relevant concomitant medications were reported.  On 08-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 012L20A) in the right arm for prophylaxis of COVID-19 infection.  On the same day, the patient experienced the events achy all over, joint pain, tiredness, sore injection site.  No Laboratory details provided.  Treatment details included Tylenol/Advil probably.  Action taken with mRNA-1273 in response to the events was not reported.   On 10/JAN/2021 the outcome of the events general body pain, joint pain, tiredness, sore injection site was 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: Exposure via breast milk
Clinical narrative: Nursing; This spontaneous case was reported by a physician and describes the occurrence of EXPOSURE VIA BREAST MILK (Nursing) in a  infant of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Nursing). At the time of the report, EXPOSURE VIA BREAST MILK (Nursing) 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.   This case was linked to MOD-2021-013188 (Parent-Child Link).   See case MOD-2021-013188 for details regarding the Parent case.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were provided.   Treatment information was unknown.   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; Headache; Muscle pain; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown. Not Provided          Concomitant information was not provided. Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound uterus
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 39-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Nov-2020 and the estimated date of delivery was 17-Aug-2021. On 08-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Ultrasound uterus: normal.     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.   Date of positive pregnancy test was on 15 Dec 2021. Estimated date of conception was on 20 Nov 2021. No relevant concomitant medications were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Peripheral swelling, Skin induration
Clinical narrative: knot as big as her baby fingernail in the back of her head on the bone; Arm is swollen; Slight temperature; This spontaneous case was reported by a patient and describes the occurrence of SKIN INDURATION (knot as big as her baby fingernail in the back of her head on the bone), PERIPHERAL SWELLING (Arm is swollen) and BODY TEMPERATURE INCREASED (Slight temperature) in a 68-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN INDURATION (knot as big as her baby fingernail in the back of her head on the bone), PERIPHERAL SWELLING (Arm is swollen) and BODY TEMPERATURE INCREASED (Slight temperature).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: area was hot; Red spot that is getting larger; area was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (area was hot), VACCINATION SITE SWELLING (Red spot that is getting larger) and VACCINATION SITE PRURITUS (area was itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (area was hot), VACCINATION SITE SWELLING (Red spot that is getting larger) and VACCINATION SITE PRURITUS (area was itchy). In January 2021, VACCINATION SITE PRURITUS (area was itchy) had resolved. At the time of the report, VACCINATION SITE WARMTH (area was hot) and VACCINATION SITE SWELLING (Red spot that is getting larger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Fatigue, Headache
Clinical narrative: Positive covid test after getting 1st dose; Arm was so sore couldn't lift; Muscle ache; Low grade fever; Nausea; Chills; Fatigue; Joint pain; Headache; A spontaneous report was received from a consumer concerning a 48 year old, female patient who had positive COVID test after getting 1st dose and experienced muscle ache, low grade fever, nausea, chills, fatigue, joint pain, headache and arm was so sore couldn't lift.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 025J202A in the left arm for prophylaxis of COVID-19 infection.    The patient received her first dose of Moderna vaccine 29-DEC-2020 in the left arm at vaccination center. She confirmed on 30-DEC-2020 that she was exposed to COVID. The patient tested at work on 31-DEC-2020 and results came back positive. Patient stated after receiving the vaccine the following day she experienced arm was so sore couldn't lift, muscle ache, low-grade fever, nausea, chills, fatigue, body aches, joint pain, headache. After that day she felt she was fine, but continues to feel lethargic and nauseous. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events  was/were unknown/not reported.; 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 of myalgia, arthralgia, pyrexia, chills, nausea, headache, fatigue,pain in extremity,  a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Covid-19 is assessed as unlikely related.