chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Chills; Difficulty breathing; Fever; Leg pain; Nausea; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), HYPERHIDROSIS (lots of sweating), PAIN IN EXTREMITY (leg pain, a lot of pain), CHILLS (chills) and NAUSEA (minor nausea) in an 81-year-old male 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 Glaucoma (patient taking hydrox for glaucoma.). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing), HYPERHIDROSIS (lots of sweating), PAIN IN EXTREMITY (leg pain, a lot of pain), CHILLS (chills), NAUSEA (minor nausea) and PYREXIA (fever of 100 and 101°F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), HYPERHIDROSIS (lots of sweating), PAIN IN EXTREMITY (leg pain, a lot of pain), CHILLS (chills), NAUSEA (minor nausea) and PYREXIA (fever of 100 and 101°F) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 100 °F (High) 100-101°F and then came down to 99 after one day.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medication taken by the patient included cholesterol medicine, hydrox for glaucoma.  Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up information was received and the outcome of the events were updated to recovered.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills; Difficulty breathing; Fever; Leg pain; Nausea; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), HYPERHIDROSIS (lots of sweating), PAIN IN EXTREMITY (leg pain, a lot of pain), CHILLS (chills) and NAUSEA (minor nausea) in an 81-year-old male 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 Glaucoma (patient taking hydrox for glaucoma.). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing), HYPERHIDROSIS (lots of sweating), PAIN IN EXTREMITY (leg pain, a lot of pain), CHILLS (chills), NAUSEA (minor nausea) and PYREXIA (fever of 100 and 101°F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), HYPERHIDROSIS (lots of sweating), PAIN IN EXTREMITY (leg pain, a lot of pain), CHILLS (chills), NAUSEA (minor nausea) and PYREXIA (fever of 100 and 101°F) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 100 °F (High) 100-101°F and then came down to 99 after one day.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medication taken by the patient included cholesterol medicine, hydrox for glaucoma.  Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up information was received and the outcome of the events were updated to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (flared up), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site redness) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site redness). On 19-Feb-2021, the patient experienced CONDITION AGGRAVATED (flared up). The patient was treated with CORTISONE for Vaccination site erythema and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (flared up), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. The redness was spreading throughout the upper arm.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Hard spot) and RASH (Slight rash at that point) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20H) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced INDURATION (Hard spot) and RASH (Slight rash at that point). At the time of the report, INDURATION (Hard spot) outcome was unknown and RASH (Slight rash at that point) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Pain and heat at the injection site; Pain and heat at the injection site; Mild muscle / joint pain; Mild muscle / joint pain; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced pain and heat at the injection site and mild muscle / joint pain.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 23 Dec 2020, prior to the onset of the symptoms, the patient received their planned dose of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient experienced pain and heat the injection site. She also experienced mild muscle and joint pain.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events pain and heat at the injection site and mild muscle / joint pain were unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced a NS unexpected events of injection site warmth and NS expected events of injection site pain, myalgia, arthralgia.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy arm, leg and stomach; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy arm, leg and stomach) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itching.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy arm, leg and stomach). At the time of the report, PRURITUS (itchy arm, leg and stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Muscular weakness, Rash
Clinical narrative: Could not raise arm after injection; Rash on stomach across from belly button like a strip; Tiny Rash at injection site; Sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Could not raise arm after injection), RASH (Rash on stomach across from belly button like a strip), INJECTION SITE RASH (Tiny Rash at injection site) and INJECTION SITE PAIN (Sore at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Could not raise arm after injection), RASH (Rash on stomach across from belly button like a strip), INJECTION SITE RASH (Tiny Rash at injection site) and INJECTION SITE PAIN (Sore at injection site). At the time of the report, MUSCULAR WEAKNESS (Could not raise arm after injection), RASH (Rash on stomach across from belly button like a strip), INJECTION SITE RASH (Tiny Rash at injection site) and INJECTION SITE PAIN (Sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills
Clinical narrative: upset stomach; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills) 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 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 ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-036232 (E2B Linked Report). This case was linked to MOD21-045496, MOD21-045539 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036232:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: arm is still hot; Hard skin, leathery; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is still hot) and VACCINATION SITE INDURATION (Hard skin, leathery) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0C1A21A) for COVID-19 vaccination.     The patient's past medical history included Melanoma and Septicemia (Blood poisoning). Concurrent medical conditions included Sensitive skin, Psoriasis and Bone density abnormal. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for Bone density abnormal.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm is still hot) and VACCINATION SITE INDURATION (Hard skin, leathery). At the time of the report, VACCINATION SITE WARMTH (arm is still hot) and VACCINATION SITE INDURATION (Hard skin, leathery) 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.   The patient reported treatment of events was with antibiotic cream and allergen on an unknown start date.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE DISCOLOURATION (Three inch pink patch under the injection site that is warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE RASH (Three inch pink patch under the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SOTALOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Three inch pink patch under the injection site that is warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE RASH (Three inch pink patch under the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Three inch pink patch under the injection site that is warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE RASH (Three inch pink patch under the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Pain in extremity
Clinical narrative: Arm soreness; Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and EXPOSURE VIA BREAST MILK (Breast feeding) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Gestational hypertension. Concurrent medical conditions included Alcohol use (occasionally). Concomitant products included NATURE MADE MULTI PRENATAL from 09-Jan-2019 to an unknown date for Breast feeding, 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] and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm soreness) and EXPOSURE VIA BREAST MILK (Breast feeding). On 27-Dec-2020, PAIN IN EXTREMITY (Arm soreness) had resolved and EXPOSURE VIA BREAST MILK (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that she was exclusively breast feeding her 10 month old baby who was born on 09-09-2020 (4 weeks early, 34 weeks+ 2days f gestation). No associated adverse events reported.   This case was linked to MOD-2020-001985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: F/U-1 : VAERS, Dose 2 Vaccination date, Date of Birth; Reporter'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: U
Vaccine: COVID19
Symptoms: Body temperature increased, Heart rate increased
Clinical narrative: Increased body temperature; Heartbeat increased; A spontaneous report was received from a consumer of an unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced increased body temperature and heartbeat.  There were no medical history and concomitant medications reported.  On 31 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Patient reported that he began to experience increased body temperature and heartbeat. No treatment information was provided.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events increased body temperature and heartbeat was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender. The medical history is not provided. The patient experienced non-serious unexpected events of Body temperature increased and Heart rate increased at on unknown date after receiving their first of two planned doses of mRNA-1273 (Lot unknown).  Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Firmer; Itchy; Bruising; a lot of pain in her arm; red circle on arm; A report was received from a pharmacist concerning a 37-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced pain, red circle,  itchy, firmer and bruising on her arm.  The patient's medical history, as provided by the reporter, included Hashimoto's disease and rosacea. Concomitant medications reported included levothyroxine.   On 24 Dec 2020, hours prior to the onset of the events, pain in her arm and red circle on arm, approximately 7 days prior to the onset of the event, bruising, and 8 days prior to the onset of the events itchy and firmer, the patient received her first of two planned doses of mRNA-1273 (LOT number 011j20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Dec 2020 around midnight, the patient noticed she had a lot of pain in her arm and had a red circle, which grew over the next few days. On 31 Dec 2020, she noticed bruising. On 01 Jan 2020, the patient noticed a wider red oval on her arm that measured 3 inches long and 1.5 inches tall, and was itchy and firmer. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events were 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: Eye pruritus, Eye swelling, Hypoaesthesia, Lip swelling, Paraesthesia
Clinical narrative: Left side of her face was numb; Her feet were itchy; Puffiness underneath both her eyes, itchiness underneath bothe her eyes, left eye worse; Right side of her face was numb; Bottom lip was swollen; Underneath her eyes were swollen; Hives on her stomach; Left side of her face has been numb; Left side of her face has been tingling; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine and experienced numbness on the left side of her face/hypoaesthesia and tingling/paraesthesia, eyes were swollen/eye swelling, itchiness underneath both of her eyes/eye pruritus, lip was swollen/lip swelling, and her feet were itchy/pruritus, Hives on her stomach/hives.  The patient's medical history and concomitant product use were not provided by the reporter.  On 31 Dec 2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.  On 31 Dec 2020 the patient developed numbness on the left side of her face and experienced tingling.  On 09 Jan 2021 the patient experienced hives on her stomach as well as swelling and itchiness under hear eyes.  She treated the events with diphenhydramine and was better the next day.  On 19 Jan 2021 the patient experienced itchiness and puffiness underneath her eyes again.  She also reported the right side of her face became numb and her bottom lip was swollen for approximately 12 hours.  She treated the events with diphenhydramine again and the events subsided.  On 21 Jan 2021 the left side of her face was numb.  Her feet were itchy, and she treated the event with ice and elevation.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events face was numb, face was tingling was considered as unknown. The outcome of the events eyes were swollen, itchiness underneath both of her eyes, lip was swollen, and feet were itchy, hives on stomach was considered as resolved.   The reporter did not provide causality for the events.  Additional information received on 22 Jan 2021 included additional events and treatments.; Reporter's Comments: This case concerns a female of unknown age who had with NS events of unexpected urticaria, hypoesthesia, paresthesia, eye pruritus, eye swelling, lip swelling, and expected pruritus.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included diphenhydramine. Event s resolved. Based on 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: Pruritus, Urticaria
Clinical narrative: Left side of her face was numb; Her feet were itchy; Puffiness underneath both her eyes, itchiness underneath bothe her eyes, left eye worse; Right side of her face was numb; Bottom lip was swollen; Underneath her eyes were swollen; Hives on her stomach; Left side of her face has been numb; Left side of her face has been tingling; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine and experienced numbness on the left side of her face/hypoaesthesia and tingling/paraesthesia, eyes were swollen/eye swelling, itchiness underneath both of her eyes/eye pruritus, lip was swollen/lip swelling, and her feet were itchy/pruritus, Hives on her stomach/hives.  The patient's medical history and concomitant product use were not provided by the reporter.  On 31 Dec 2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.  On 31 Dec 2020 the patient developed numbness on the left side of her face and experienced tingling.  On 09 Jan 2021 the patient experienced hives on her stomach as well as swelling and itchiness under hear eyes.  She treated the events with diphenhydramine and was better the next day.  On 19 Jan 2021 the patient experienced itchiness and puffiness underneath her eyes again.  She also reported the right side of her face became numb and her bottom lip was swollen for approximately 12 hours.  She treated the events with diphenhydramine again and the events subsided.  On 21 Jan 2021 the left side of her face was numb.  Her feet were itchy, and she treated the event with ice and elevation.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events face was numb, face was tingling was considered as unknown. The outcome of the events eyes were swollen, itchiness underneath both of her eyes, lip was swollen, and feet were itchy, hives on stomach was considered as resolved.   The reporter did not provide causality for the events.  Additional information received on 22 Jan 2021 included additional events and treatments.; Reporter's Comments: This case concerns a female of unknown age who had with NS events of unexpected urticaria, hypoesthesia, paresthesia, eye pruritus, eye swelling, lip swelling, and expected pruritus.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included diphenhydramine. Event s resolved. Based on 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: Paraesthesia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: left arm is tingling; swelling, redness at old BCG site with tenderness; swelling, redness at old BCG site with tenderness; itching below injection site/itching in the injection area; pain in the injection site right away/myalgia local pain; A spontaneous report was received from a physician, who was also the patient, that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine injection site itching, tingling, vaccine injection site swelling, vaccine injection site redness and vaccine injection site pain.   The patient's medical history was not provided.  No concomitant medications were reported.  On 23-Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23-Dec-2020, the patient experienced injection site pain that resolved right away. On 31-Dec-2020, the patient experienced itching and redness where she previously received a vaccine many years ago.  She took Tylenol for those symptoms.  On 01-Jan-2021, the patient experienced swelling at the injection site that went away.  She also experienced random itching in the left arm area.  On 04-Jan-2021, the patient's left upper arm was tingling.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, injection site itching, tingling and injection site redness was not recovered/resolved.  The outcome of the events, injection site pain and injection site swelling, was 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate, Malaise, Oxygen saturation, Palpitations
Clinical narrative: Heart racing; Freaking out; Feeling like she was dying; Not functioning well; A spontaneous report was received from a healthcare facility staff member concerning a 28-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced her heart racing, was freaking out, and was feeling like she was dying.   The patient's medical history included a heart murmur, panic attacks, post-traumatic stress disorder, pneumonia and diarrhea.   Concomitant product use was denied by the reporter.   The patient received their first of two planned doses of mRNA-1273 (LOT# 025J20A) on 29-Dec-2020 intramuscularly in the for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 29-Dec-2020.  Approximately 2 hours after vaccine administration while driving to another job, she experienced her heart racing, said she was freaking out and feeling like she was dying.  She stated that her heart rate, at one point, reached 142 beats per minute and also stated that her pulse-oximetry remained between 97-98%.    Three days later on 01-Jan-2021, she reported still having these symptoms, however, they were more spaced out.  She stated that at one point, she had experienced panic while showering and said that she has not been functioning well.  Patient said that she has had a lot of anxiety about the pandemic.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, her heart racing, was freaking out, and was feeling like she was dying, was not provided.   The outcome of the events, her heart racing, was freaking out, and was feeling like she was dying, were considered as 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, a causal relationship cannot be excluded.  The patient's medical history of panic attacks, PTSD and heart murmur confounds causality. Patient said that she has had a lot of anxiety about the pandemic which is risk factor for panic attack.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction
Clinical narrative: Heart racing; Freaking out; Feeling like she was dying; Not functioning well; A spontaneous report was received from a healthcare facility staff member concerning a 28-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced her heart racing, was freaking out, and was feeling like she was dying.   The patient's medical history included a heart murmur, panic attacks, post-traumatic stress disorder, pneumonia and diarrhea.   Concomitant product use was denied by the reporter.   The patient received their first of two planned doses of mRNA-1273 (LOT# 025J20A) on 29-Dec-2020 intramuscularly in the for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 29-Dec-2020.  Approximately 2 hours after vaccine administration while driving to another job, she experienced her heart racing, said she was freaking out and feeling like she was dying.  She stated that her heart rate, at one point, reached 142 beats per minute and also stated that her pulse-oximetry remained between 97-98%.    Three days later on 01-Jan-2021, she reported still having these symptoms, however, they were more spaced out.  She stated that at one point, she had experienced panic while showering and said that she has not been functioning well.  Patient said that she has had a lot of anxiety about the pandemic.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, her heart racing, was freaking out, and was feeling like she was dying, was not provided.   The outcome of the events, her heart racing, was freaking out, and was feeling like she was dying, were considered as 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, a causal relationship cannot be excluded.  The patient's medical history of panic attacks, PTSD and heart murmur confounds causality. Patient said that she has had a lot of anxiety about the pandemic which is risk factor for panic attack.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Sore arm; Fever; A report was received from a consumer concerning a 26-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and developed sore arm and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT or BATCH  number 011320A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced sore arm that lasted about 1 day, and fever which lasted about 5 hours. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The events, sore arm and fever, were considered resolved on an unknown 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 events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: slightly itchy; little bit of a rash; knot at the site of injection; A report was received from a consumer concerning a 66-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced knot at the site of injection (vaccination site induration), rash (vaccination site rash), and slightly itchy (vaccination site pruritis).  The patient's medical history, as provided by the reporter, included left shoulder replacement. Concomitant medications reported included paracetamol.   On 31 Dec 2020, approximately 1 day prior to the onset of the event, knot at the site of injection, and 3 days prior to the onset of the events, rash and slightly itchy, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient felt a knot at the site of the injection in her right arm, which she described as big "like somebody punched you". On 03 Jan 2020, the patient had a rash, that was slightly itchy around it. On 04 Jan 2020, the knot and itching had resolved, though there was still some rash. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, knot at the site of injection and itching, were considered resolved on 04 Jan 2021. The outcome of the event, rash, was unknown.   Follow-up received on 05 Jan 2021 included the patient's initial report, updating the initial receipt date to 01 Jan 2020.; Reporter's Comments: This case concerns a 66-year-old female who experienced NS expected events of vaccination site rash, vaccination site pruritus, vaccination site induration.  Event onset occurred Day 2 after the first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the vaccination site rash, vaccination site pruritus, vaccination site induration, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: A spontaneous report, was received from a nurse practioner (patient), a 47 year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced numbness in both legs, hands and both arms (hypoaesthesia), tingling pins and needles in both legs, hands and both arms (paraesthesia), felt like cramps in legs (muscle spasms).  The patient's medical history was not provided. Concomitant medications reported included montelukast sodium, levothyroxine, and salbutamol sulfate.   On 28 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A), intramuscularly in the left arm for COVID-19 for infection prophylaxis.  The patient reported that she received the vaccine on 28 Dec 2020 around 2:00 pm. On the same day at around 5:00 pm, she started feeling numbness and tingling pins and needles in legs. She stated that it felt like cramps. The patient reported that she took acetaminophen and leg cramps OTC and was better and able to sleep at night.   On 29 Dec 2020, the patient went to occupational health at her work and reported the incident. She stated that she took acetaminophen and ibuprofen around the clock.   On 31 Dec 2020, the patient experienced numbness and tingling on her hands. She confirmed that it was both legs and both arms that were affected. The patient reported that her primary care doctor was aware.  On 02 Jan 2021, the patient stated that it was then almost a week and the numbness, pain, and tingling were still there. The patient stated that she took ibuprofen at 12:00 pm that day and the cramps were on and off. She reported that she was concerned and would like a follow up call. The patient also gave consent to follow up with her doctor.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, numbness in both legs, hands and both arms, tingling pins and needles in both legs, hands and both arms, and felt like cramps in legs, were considered as 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: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Swelling of the lymph node; Injection site discomfort; Injection site pain; A spontaneous report, was received from a pharmacist (patient), a 29 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced injection site discomfort, swelling of the lymph node (lymphadenopathy), and injection site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, for days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 025L20A), intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient began to experience swelling of the lymph node, injection site pain and discomfort. The symptoms were still ongoing. Currently, the patient has not received any treatment for her symptoms and wants to know if she can take any medication to treat her symptoms.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event events, swelling of the lymph node, injection site pain and discomfort, were considered as 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 events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itches a little; Red dots on injection Site; Pain and tenderness at injection site; A spontaneous report was received from a dental hygienist, who was  a 53-year-old, female patient who experienced vaccination site pain, vaccination site erythema and vaccination site pruritus.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 26-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   The patient reported that she received her first shot of the Moderna Covid-19 Vaccine on 26-Dec-2020 and went through the normal side effects of pain and tenderness in the injection site. These events resolved. On 02-Jan-2021, she observed red dots on the injection site. The next day, 03-Jan-2021, she reported that the red dots were connected and that the red area looked a "little bigger than a golf ball" (about 2.5") on the injection site. The patient reported that it itched, but not much. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, vaccination site pain, was considered recovered/resolved. The outcome of the events, vaccination site erythema and vaccination site pruritus, were considered unknown.; Reporter's Comments: This case concerns a 53-year-old female who had nonserious expected event of vaccination site erythema, vaccination site pain, vaccination site pruritus.  Event onset the same day as the first dose of mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the vaccination site erythema, vaccination site pain, vaccination site pruritus, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension
Clinical narrative: Blood pressure high; High heart rate; A spontaneous report was received from a reporter, concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experience high blood pressure and heart rate.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the reporter stated that his step-mother who received the vaccine, experienced an adverse side effect of high blood pressure and heart rate which lasted about 2 hours. The reported mentioned that the patient was being monitored in the hospital where she received the vaccine. No treatment was information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of events, high blood pressure and heart rate, were unknown.  The Follow up information was received on 11 Mar 2021. No new information was provided.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced the non-serious unlisted events of Hypertension and Heart rate increased. The events occurred on unknown date after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based  on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Numbness above right eye; Headache; A spontaneous report was received from a consumer concerning a 23 years old male patient who received Moderna's COVID-19 vaccine and experienced numbness above his right eye and headache after receiving the Moderna COVID-19 vaccine.  There were no medical history and concomitant medications reported.  On 02 Jan 20201, the patient received his first of two planned doses of mRNA-1273 vaccine (batch# 025J20-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 03 JAN 2021, he reported that he had experienced numbness above the right eye and a headache after receiving the vaccine. The exact time interval between the vaccine administration and the event was not provided. The patient received no treatment and the symptoms resolved the same day.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events were considered resolved on 03 Jan 2021.; Reporter's Comments: This case concerns a 23 year-old, male patient, who experienced events of numbness above his right eye and headache. The events occurred the next day after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Hard time breathing; A spontaneous report was received from a consumer who is a 76 year old female patient who received Moderna's COVID-19 Vaccine and experienced a hard time breathing.   The patient's medical history was not provided. Concomitant medications, provided by the reporter, include Labetalol 200mg and Propafenone 150mg.  On 31 Dec 2020, approximately 3 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 037520A) intramuscularly for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient had a hard time breathing. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, hard time breathing, 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.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain
Clinical narrative: Excruciating pain in left hip, progressed to shoulders, wrist, left neck; Unable to hold/lift his phone; A spontaneous report was received from a consumer who was an 57-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced excruciating pain in left hip, shoulders, wrist, left neck and unable to hold/lift his phone.  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 039K20/2A) intramuscularly for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient experienced excruciating pain in left hip, shoulders, wrist, left neck and unable to hold/lift his phone. The patient reported he went to emergency room (ER) but was discharged. Treatment for the events included paracetamol and ibuprofen. The patient also stated that the pain medications have not been helpful.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, excruciating pain in left hip, shoulders, wrist, left neck and unable to hold/lift his phone was considered as 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to the touch; a lot of redness; very itchy; swelling; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced a lot of redness, swelling, hot to the touch and very itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, approximately 7 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient reported having a lot of redness, swelling, hot to the touch, and very itchy. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, a lot of redness, swelling, hot to the touch and very itchy were unknown.; Reporter's Comments: This case concerns a female of unknown age who had NS events of unexpected injection site warmth and expected injection site erythema, injection site pruritus, injection site swelling.  Event onset occurred 8 days after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the injection site swelling, injection site warmth, injection site erythema, injection site pruritus, a causal relationship cannot be excluded.