chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Skin was still discolored; Injection site warm to touch; entire arm was itching; Injection site was pink; Injection site swelling; Pain and soreness at site of injection; A spontaneous report was received from a consumer, who was also a 50-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain and soreness at the site of the injection, noticed site of injection was pink, swollen, warm to touch and entire arm was itching.   The patient's medical history was not provided by the reporter.  No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received their first two planned doses of mRNA-1273 (batch number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 and 25 Dec 2020, the patient experienced pain and soreness at the site of the injection. On 30 DEC 2020, she also noticed that site of injection was pink, swollen, warm to touch and entire arm was itching.  Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, pain and soreness at the site of the injection, swollen, warm to touch, arm itching, were not reported; injection site was pink, was reduced over the weekend (unspecified date).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Skin was still discolored; Injection site warm to touch; entire arm was itching; Injection site was pink; Injection site swelling; Pain and soreness at site of injection; A spontaneous report was received from a consumer, who was also a 50-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain and soreness at the site of the injection, noticed site of injection was pink, swollen, warm to touch and entire arm was itching.   The patient's medical history was not provided by the reporter.  No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received their first two planned doses of mRNA-1273 (batch number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 and 25 Dec 2020, the patient experienced pain and soreness at the site of the injection. On 30 DEC 2020, she also noticed that site of injection was pink, swollen, warm to touch and entire arm was itching.  Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, pain and soreness at the site of the injection, swollen, warm to touch, arm itching, were not reported; injection site was pink, was reduced over the weekend (unspecified date).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site pain, Peripheral swelling
Clinical narrative: Arm redness; Arm swollen; Arm was warm and hot; pain at the injection side (left arm); A spontaneous report () was received from a consumer who was also a 36-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at injection side. arm was warm and hot, arm redness and arm swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A or 011J708) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, in the 24 hours after the administration, the patient experienced pain at the injection side (left arm).  On 05 Jan 2021, the patient woke up with pain in her arm and it was warm, hot, had redness and was swollen. Treatment included antihistamine (not specified). Symptoms were still ongoing at the time of this report.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, pain at injection side (left arm), arm was warm and hot, arm redness and arm swollen, were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Non itchy rash on the left cheek; A spontaneous report was received from other health care professional concerning a 56-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced non itchy rash on the left cheek.  The patient's medical history was not provided. Concomitant medications included Plaquenil for Sjogren Syndrome.  On 02 Jan 2021, the patient received their first of the two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 02 Jan 2021, the patient experienced non itchy rash on the left cheek.   Treatment medication included Benadryl.  No lab tests were mentioned.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event non itchy rash on the left cheek was considered recovered/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 events, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Neck stiffness that went away after moving around; Minor tenderness at injection site; Achy-ness in arm; A spontaneous report was received from a consumer concerning a 69-year-old, male patient who developed neck stiffness, minor tenderness at injection site and achy-ness in arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 025J20A) for prophylaxis of COVID-19 infection.    On 05 Jan 2021, approximately six hours after vaccination, the patient developed achiness in the arm. On 06 Jan 2021, 24 hours later the patient's arm was tender at the injection site. His neck was stiff but, went away after moving around.   No treatment information was provided for the event.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, neck stiffness, was considered resolved.  The outcome of the events, minor tenderness at injection site and achy-ness in arm,  injection site pain and pain in extremity was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Lip swelling, Pruritus, Swelling, Visual impairment
Clinical narrative: patient stated that she did not see anything; Itching; Swelling of lips; Swelling in left neck; Metallic taste in mouth; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching), LIP SWELLING (Swelling of lips), SWELLING (Swelling in left neck), DYSGEUSIA (Metallic taste in mouth) and VISUAL IMPAIRMENT (patient stated that she did not see anything) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025-520A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] and B-COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PRURITUS (Itching), LIP SWELLING (Swelling of lips), SWELLING (Swelling in left neck) and DYSGEUSIA (Metallic taste in mouth). On an unknown date, the patient experienced VISUAL IMPAIRMENT (patient stated that she did not see anything). At the time of the report, PRURITUS (Itching), DYSGEUSIA (Metallic taste in mouth) and VISUAL IMPAIRMENT (patient stated that she did not see anything) outcome was unknown and LIP SWELLING (Swelling of lips) and SWELLING (Swelling in left neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Decreased appetite, Dysgeusia, Headache, Malaise
Clinical narrative: Pressure in Lungs; m I've been very ill; bad taste in mouth; loss of appetite; Phlegm; fell asleep for 5-6 hours; Sore Arm; Fever of 100.6; Severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Pressure in Lungs), MALAISE (m I've been very ill), DYSGEUSIA (bad taste in mouth), DECREASED APPETITE (loss of appetite) and PRODUCTIVE COUGH (Phlegm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nerve damage. Concomitant products included GABAPENTIN and MORPHINE for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Pressure in Lungs), MALAISE (m I've been very ill), DYSGEUSIA (bad taste in mouth), DECREASED APPETITE (loss of appetite), PRODUCTIVE COUGH (Phlegm), SOMNOLENCE (fell asleep for 5-6 hours), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 100.6) and HEADACHE (Severe headache). At the time of the report, CHEST DISCOMFORT (Pressure in Lungs), MALAISE (m I've been very ill), DYSGEUSIA (bad taste in mouth), DECREASED APPETITE (loss of appetite), PRODUCTIVE COUGH (Phlegm), SOMNOLENCE (fell asleep for 5-6 hours), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 100.6) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Productive cough, Pyrexia, Somnolence
Clinical narrative: Pressure in Lungs; m I've been very ill; bad taste in mouth; loss of appetite; Phlegm; fell asleep for 5-6 hours; Sore Arm; Fever of 100.6; Severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Pressure in Lungs), MALAISE (m I've been very ill), DYSGEUSIA (bad taste in mouth), DECREASED APPETITE (loss of appetite) and PRODUCTIVE COUGH (Phlegm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nerve damage. Concomitant products included GABAPENTIN and MORPHINE for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Pressure in Lungs), MALAISE (m I've been very ill), DYSGEUSIA (bad taste in mouth), DECREASED APPETITE (loss of appetite), PRODUCTIVE COUGH (Phlegm), SOMNOLENCE (fell asleep for 5-6 hours), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 100.6) and HEADACHE (Severe headache). At the time of the report, CHEST DISCOMFORT (Pressure in Lungs), MALAISE (m I've been very ill), DYSGEUSIA (bad taste in mouth), DECREASED APPETITE (loss of appetite), PRODUCTIVE COUGH (Phlegm), SOMNOLENCE (fell asleep for 5-6 hours), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 100.6) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hyperhidrosis, Injection site erythema, Nausea, Pain in extremity
Clinical narrative: sweating; large circular rash; joint ache from shoulder to hands; redness; nausea; sore arm; itchy at the injection site; A spontaneous  report was received from a consumer concerning a 51 year old, female patient who experienced itching at the injection site, redness, sore arm, large circular rash, joint ache from shoulders to hands, nausea and sweating following their first dose of Moderna's COVID-19 vaccine.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included aspirin.  On 22 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (lot number 011J20A, Expiry date: 11-MAY-2021) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 22 DEC 2020 the patient experienced itching at the injection site right after the administration, and then off and on.  On 04 JAN 2021 she began experiencing redness, itching, sore arm, large circular rash, joint ache from shoulders to hands, nausea and sweating. No treatments have been given during this event.   No treatment medications were reported.   The events, itching at injection site, redness, itching, sore arm, large circular rash, joint ache from shoulders to hands, nausea and sweating were recovering.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Itching at the injection site, redness, large circular rash, joint ache from shoulders to hands and nausea are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus
Clinical narrative: sweating; large circular rash; joint ache from shoulder to hands; redness; nausea; sore arm; itchy at the injection site; A spontaneous  report was received from a consumer concerning a 51 year old, female patient who experienced itching at the injection site, redness, sore arm, large circular rash, joint ache from shoulders to hands, nausea and sweating following their first dose of Moderna's COVID-19 vaccine.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included aspirin.  On 22 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (lot number 011J20A, Expiry date: 11-MAY-2021) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 22 DEC 2020 the patient experienced itching at the injection site right after the administration, and then off and on.  On 04 JAN 2021 she began experiencing redness, itching, sore arm, large circular rash, joint ache from shoulders to hands, nausea and sweating. No treatments have been given during this event.   No treatment medications were reported.   The events, itching at injection site, redness, itching, sore arm, large circular rash, joint ache from shoulders to hands, nausea and sweating were recovering.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Itching at the injection site, redness, large circular rash, joint ache from shoulders to hands and nausea are consistent with the known safety profile of the vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives; A spontaneous report was received from a health care professional who received the Moderna COVID-19 Vaccine mRNA-1273) and experienced severe hives (urticaria).  The patient's medical history was unknown. Concomitant pantoprazole, levothyroxine, Vitamin D, and hydroxychloroquine use was reported.  On 31Dec2020, nine days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08Jan2021, 9 days after getting the vaccine, the patient experienced severe hives and reported they were terrible on the 9th, 10th, and 11th. They would not go away. The medication administered to treat the reaction was intravenous diphenhydramine, famotidine, and prednisone. The patient stopped taking prednisone after a couple of days because the reaction got worse and she thought she might be allergic. She stated she was going to see her doctor and they may give her something else.  Treatment information was intravenous diphenhydramine, famotidine, and prednisone.   Action taken with mRNA-1273 in response to the events was unknown.  At the time of the report, the outcome of the event, severe hives, was not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Hypoaesthesia, Nasal congestion
Clinical narrative: Sore arm like I was punched; Going Numb down the left side  of my body; Diarrhea every hour on the hour; I feel so weak all over; Small stuffy nose; Chills; A spontaneous report was received from a consumer who was an 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm like I was punched, going numb, chills, diarrhea every hour, feel so weak all over and small stuffy nose.   The patient's medical history was not provided. No 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 (Lot number: 026L20A, Exp. date: 28 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, the patient experienced, sore arm like I was punched, going numb, chills, diarrhea every hour, feel so weak all over and small stuffy nose. Treatment for the events included heating pad for the arm and paracetamol.  On 06 Jan 2021, the patient reported that she felt better. However, the event, sore arm like I was punched was ongoing.   Action taken with mRNA-1273 in response to the events was not applicable.  The event going numb, chills, diarrhea every hour, feel so weak all over and small stuffy nose, was considered resolved on 06 Jan 2021.   The outcome for the event, sore arm like I was punched was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm like I was punched; Going Numb down the left side  of my body; Diarrhea every hour on the hour; I feel so weak all over; Small stuffy nose; Chills; A spontaneous report was received from a consumer who was an 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm like I was punched, going numb, chills, diarrhea every hour, feel so weak all over and small stuffy nose.   The patient's medical history was not provided. No 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 (Lot number: 026L20A, Exp. date: 28 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, the patient experienced, sore arm like I was punched, going numb, chills, diarrhea every hour, feel so weak all over and small stuffy nose. Treatment for the events included heating pad for the arm and paracetamol.  On 06 Jan 2021, the patient reported that she felt better. However, the event, sore arm like I was punched was ongoing.   Action taken with mRNA-1273 in response to the events was not applicable.  The event going numb, chills, diarrhea every hour, feel so weak all over and small stuffy nose, was considered resolved on 06 Jan 2021.   The outcome for the event, sore arm like I was punched was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia eye, Hypoaesthesia oral
Clinical narrative: Little numbness on the left side of eye; Little numbness on left corner of mouth; Mild fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPOAESTHESIA EYE (Little numbness on the left side of eye), HYPOAESTHESIA ORAL (Little numbness on left corner of mouth) and FATIGUE (Mild fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (No reported medical history.).    On 05-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 HYPOAESTHESIA EYE (Little numbness on the left side of eye), HYPOAESTHESIA ORAL (Little numbness on left corner of mouth) and FATIGUE (Mild fatigue). At the time of the report, HYPOAESTHESIA EYE (Little numbness on the left side of eye), HYPOAESTHESIA ORAL (Little numbness on left corner of mouth) and FATIGUE (Mild fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Lingering headache; A spontaneous report was received from a other healthcare professional, concerning a 50-year-old female patient, who received Moderna's COVID-19 vaccine and experienced lingering headache.  The patient's medical history reported included coronavirus on Jun 2020. Concomitant medications were not provided.  On 30 Dec 2020, prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 30 Dec 2020, after the vaccination, the patient experienced headache for about six days. The severity of the headache was unknown. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, lingering headache was resolved on 04 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; A spontaneous report was received from a pharmacist concerning a 31-year-old female patient, who was also the patient, who was participating in the mRNA-1273 Emergency Use Program and experienced a positive test for COVID-19.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 037K20A) in her left arm for the prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient tested positive for COVID-19 and experienced sore throat, body aches, congestion of the nose and throat, fatigue, and dizziness.    On 04 Jan 2021, the symptoms had improved.    Treatment information included Paracetamol, Acetaminophen, Vitamin C, Vitamin D, and Zinc.  Action taken for the event was not reported.  The event, positive test for COVID-19, was considered recovering/resolving.; Reporter's Comments: This case concerns a 31-year old pharmacist who experienced a positive test for COVID-19 5 days after receiving the first dose of mRNA-1273 vaccine. The causality for the event COVID-19 is assessed as unlikely, based on its known causative agent. It is likely that the patient was already infected with the virus but was asymptomatic before being administered with the mRNA-1273 vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Itching; Swelling, 3 inch area of swelling; Redness; Tenderness; Sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling, 3 inch area of swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Tenderness) and MYALGIA (Sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) for Asthma, DORZOLAMIDE, BETAXOLOL, LATANOPROSTENE BUNOD (VYZULTA) and LEVOTHYROXINE for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Swelling, 3 inch area of swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Tenderness) and MYALGIA (Sore). On 04-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itching). At the time of the report, INJECTION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling, 3 inch area of swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Tenderness) and MYALGIA (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Soreness at the site of the injection; Red welt at site of the injection; A spontaneous report was received from an other reporter (unspecified) concerning a patient of an unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain and erythema.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to onset of the events, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced soreness and red welt at site of the injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events soreness and red welt at site of the injection was 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 event, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-003087:cross linked case Patient CB
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity, Tinnitus
Clinical narrative: Headache; Ringing in the ears; Sore arm; Difficulty sleeping; A spontaneous report was received from a consumer, who was also a 31-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced ringing ears, sore arm, had difficulty sleeping and woke up with headache.  The patient's medical history was not provided by the reporter.  No concomitant medications were reported.  On 04 JAN 2021, the patient received their first two planned doses of mRNA-1273 (batch number: 037K20A) intramuscularly on her right arm for prophylaxis of COVID-19 infection.  On 04 JAN 2021, the patient received her first dose of vaccine and at 22:00 patient experienced ringing ears, sore arm, had difficulty sleeping and on 05 JAN 2021, woke up with headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, ringing ears, sore arm, had difficulty sleeping and woke up with headache were not reported.  The reporter did not provide causality for the events; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Discomfort, Heart rate increased, Hypertension
Clinical narrative: Heart rate was high - never got higher than 100; Blood pressure was high; My stomach started to hurt; Felt heavy pressure; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart rate was high, never got higher that 100, high blood pressure, stomach started to hurt and felt heavy pressure.   The patient's medical history included seasonal allergies. The concomitant medications reported included fexofenadine hydrochloride and montelukast sodium.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly for prophylaxis of COVID-19 infection.   Within 15 minutes of receiving the vaccine, the patient experienced heart rate was high, never got higher that 100, high blood pressure, stomach started to hurt and felt heavy pressure. She stated that it got intense for couple minutes and was cyclic.   The patient was taken to the emergency room (ER) for further observation. The whole episode had lasted a total of 3 hours. Upon contacting her allergist.  Action taken with mRNA-1273 in response to the events was considered unknown.   The outcome of heart rate was high, never got higher that 100, high blood pressure, stomach started to hurt and felt heavy pressure was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Pain, Pyrexia
Clinical narrative: Covid-19 results came back positive; Lost taste; Lost smell; Fever; Chills; Severe body aches; A spontaneous report was received from a consumer concerning a 27-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a positive for COVID-19 test, fever, generalized aching, loss of taste, loss of smell and chills.  The patient's medical history was not provided. Concomitant product use was not provided.  On 02 Jan 2021, the patient received their first dose of mRNA-1273 (Lot number:  026L20A) in her right deltoid for prophylaxis of COVID-19 infection.   The patient stated that the night of her first dose she went to work and started to feel feverish, chills and body aches.  The next morning, 03 JAN 2021, she woke up with severe body aches, loss of taste and smell and fever that was still ongoing.  She was told to get tested for COVID-19 and the results came back positive.    Treatment medications reported were Tylenol and Advil.    The events, positive COVID-19 test, fever, generalized aching, loss of taste, loss of smell and chills were unknown as of this report.; Reporter's Comments: Based on the information provided, the natural history of COVID-19, a causal association between the event of positive COVID test and mRNA-1273 use is assessed as unlikely as well as the events of generalized aches, loss of taste and loss of smell as the patient was most likely exposed to the disease prior to vaccination. The other events of fever and chills are consistent with the product safety profile, although confounded by the COVID-19 infection.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid-19 results came back positive; Lost taste; Lost smell; Fever; Chills; Severe body aches; A spontaneous report was received from a consumer concerning a 27-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a positive for COVID-19 test, fever, generalized aching, loss of taste, loss of smell and chills.  The patient's medical history was not provided. Concomitant product use was not provided.  On 02 Jan 2021, the patient received their first dose of mRNA-1273 (Lot number:  026L20A) in her right deltoid for prophylaxis of COVID-19 infection.   The patient stated that the night of her first dose she went to work and started to feel feverish, chills and body aches.  The next morning, 03 JAN 2021, she woke up with severe body aches, loss of taste and smell and fever that was still ongoing.  She was told to get tested for COVID-19 and the results came back positive.    Treatment medications reported were Tylenol and Advil.    The events, positive COVID-19 test, fever, generalized aching, loss of taste, loss of smell and chills were unknown as of this report.; Reporter's Comments: Based on the information provided, the natural history of COVID-19, a causal association between the event of positive COVID test and mRNA-1273 use is assessed as unlikely as well as the events of generalized aches, loss of taste and loss of smell as the patient was most likely exposed to the disease prior to vaccination. The other events of fever and chills are consistent with the product safety profile, although confounded by the COVID-19 infection.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeling hot, Headache, Influenza like illness
Clinical narrative: Stomach ache; Felt like I had the flu; Sore throat; Feeling hot without having a fever; Nausea; Tiredness; Headache; Hives all over chest; V-shaped rash on both sides of her neck near her lymph nodes; Tight throat; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over chest), RASH (V-shaped rash on both sides of her neck near her lymph nodes), THROAT TIGHTNESS (Tight throat), ABDOMINAL PAIN UPPER (Stomach ache) and INFLUENZA LIKE ILLNESS (Felt like I had the flu) in a 45-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.     The patient's past medical history included No adverse event (no reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced URTICARIA (Hives all over chest), RASH (V-shaped rash on both sides of her neck near her lymph nodes) and THROAT TIGHTNESS (Tight throat). On 01-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), INFLUENZA LIKE ILLNESS (Felt like I had the flu), OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Feeling hot without having a fever), NAUSEA (Nausea), FATIGUE (Tiredness) and HEADACHE (Headache). On 01-Jan-2021, URTICARIA (Hives all over chest), RASH (V-shaped rash on both sides of her neck near her lymph nodes) and THROAT TIGHTNESS (Tight throat) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), INFLUENZA LIKE ILLNESS (Felt like I had the flu), OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Feeling hot without having a fever), NAUSEA (Nausea), FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tylenol (paracetamol),Sudafed (pseudoephedrine) and ibuprofen. No relevant concomitant medications were reported. Company comment: 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.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Rash, Throat tightness, Urticaria
Clinical narrative: Stomach ache; Felt like I had the flu; Sore throat; Feeling hot without having a fever; Nausea; Tiredness; Headache; Hives all over chest; V-shaped rash on both sides of her neck near her lymph nodes; Tight throat; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over chest), RASH (V-shaped rash on both sides of her neck near her lymph nodes), THROAT TIGHTNESS (Tight throat), ABDOMINAL PAIN UPPER (Stomach ache) and INFLUENZA LIKE ILLNESS (Felt like I had the flu) in a 45-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.     The patient's past medical history included No adverse event (no reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced URTICARIA (Hives all over chest), RASH (V-shaped rash on both sides of her neck near her lymph nodes) and THROAT TIGHTNESS (Tight throat). On 01-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), INFLUENZA LIKE ILLNESS (Felt like I had the flu), OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Feeling hot without having a fever), NAUSEA (Nausea), FATIGUE (Tiredness) and HEADACHE (Headache). On 01-Jan-2021, URTICARIA (Hives all over chest), RASH (V-shaped rash on both sides of her neck near her lymph nodes) and THROAT TIGHTNESS (Tight throat) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), INFLUENZA LIKE ILLNESS (Felt like I had the flu), OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Feeling hot without having a fever), NAUSEA (Nausea), FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tylenol (paracetamol),Sudafed (pseudoephedrine) and ibuprofen. No relevant concomitant medications were reported. Company comment: 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.; 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted covid-19; A spontaneous report was received from a health professional concerning a 26-year-old, female patient who received Moderna's COVID-19 vaccine and experienced COVID-19 infection.  The patient's medical history was not provided. Products known to have been used by the patient were not provided.  On 21 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 06 Jan 2021 , after she received the mRNA-1273 vaccination, the patient experienced COVID-19 infection. Patient is still having symptoms. Treatment information included only that the patient took tylenol.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, Covid-19 infection, was considered unknown.; Reporter's Comments: Based on reporter's causality , the event COVID-19 is assessed as unlikely related to mRNA-1273.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Vaccination site mass
Clinical narrative: firm to touch 4 in by 3 in lump at the injection site; redness at injection site; pain and soreness at injection site; A spontaneous report was received from a consumer concerning a 53 -years -old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain and soreness at injection site/ injection site pain ,firm to touch 4 in by 3 in lump at injection site/ vaccination site mass, redness at injection site/injection site erythema.  The patient's medical history as reported by the reporter as she had history of anaphylaxis with NSAIDs. Concomitant medication included diltiazem.  On 26 DEC 2020, prior to the onset of the events, patient received their first two doses of mRNA-1273 (Lot number: unknown) through intramuscular route at unspecified site  for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the first day she felt pain, soreness at injection site which went away on its own. On 04 Jan 2021,10 days later she noticed a 4 in by 3 in lump at the injection site along with redness. The lump was firm to touch.  Treatment activities for event was reported as none.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, pain and soreness at injection site was recovered/resolved on an unknown date, a 4 in by 3 in lump at the injection site along with redness, lump was firm to touch was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash, red, irregular borders; A spontaneous report was received from a consumer concerning a 23-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a rash that was red with irregular borders.  The patient's medical history was not provided. The patient had no known allergies.  Concomitant product use was not provided.  On 27 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number:  unknown) through an unknown route, in his left arm  for prophylaxis of COVID-19 infection.   The patient stated that on 02 JAN 2021 he began to experience a rash, red and irregular borders.  His health care provider looked at it and said it was a drug reaction. The patient was treated with Benadryl (diphenhydramine).  Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the event of rash with red, irregular borders was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of rash, a causal relationship cannot be excluded.