chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Tendon injury
Clinical narrative: Achilles tendon was affected; his balance was affected; he was put him in a wheel chair; Cant move his ankle to any degree; worsened conditions after taking the Moderna vaccine; his right ankle and foot has swollen up; leg is swollen from the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (his right ankle and foot has swollen up), PERIPHERAL SWELLING (leg is swollen from the vaccine), TENDON INJURY (Achilles tendon was affected), BALANCE DISORDER (his balance was affected) and GAIT DISTURBANCE (he was put him in a wheel chair) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced JOINT SWELLING (his right ankle and foot has swollen up) and PERIPHERAL SWELLING (leg is swollen from the vaccine). On an unknown date, the patient experienced TENDON INJURY (Achilles tendon was affected), BALANCE DISORDER (his balance was affected), GAIT DISTURBANCE (he was put him in a wheel chair), JOINT INJURY (Cant move his ankle to any degree) and CONDITION AGGRAVATED (worsened conditions after taking the Moderna vaccine). At the time of the report, JOINT SWELLING (his right ankle and foot has swollen up), TENDON INJURY (Achilles tendon was affected), BALANCE DISORDER (his balance was affected), JOINT INJURY (Cant move his ankle to any degree) and CONDITION AGGRAVATED (worsened conditions after taking the Moderna vaccine) had not resolved and PERIPHERAL SWELLING (leg is swollen from the vaccine) and GAIT DISTURBANCE (he was put him in a wheel chair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: No specific follow-up information recorded. On 20-Apr-2021: Follow up received, Updated -  Events tab; Events added: Achilles tendon was affected (Tendon injury); his balance was affected (Balance disorder); put him in a wheelchair (Gait disturbance). Patient mentioned that his Achilles tendon was affected and put him in a wheelchair, and it has affected his balance. He believes that if he falls, he will die or will die from the escalation of swelling or blood clot. On 23-Apr-2021: Follow up received on: 23-Apr-2021Outcome for event "worsened conditions after taking the Moderna vaccine" updated to "Not Recovered/Not Resolved"
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Tired; Arm hurting; Achy all over body; Fever 100F; Nausea; Vomiting; Felt like have QVID all over again; headache; Tingling in cheek; Sinuses opened Up; Felt like her lungs were opened up (Similar to having Albuterol nebulizer treatment); A spontaneous report was received from a healthcare professional concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up, headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 4 Jan 2021, the patient experienced the event(s) tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up. On 5 Jan 2021, the patient experienced the event(s) headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Jan 2021 the outcome of event(s), tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up, headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again was resolved.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pulmonary function test, Pyrexia, Sinus disorder, Suspected COVID-19
Clinical narrative: Tired; Arm hurting; Achy all over body; Fever 100F; Nausea; Vomiting; Felt like have QVID all over again; headache; Tingling in cheek; Sinuses opened Up; Felt like her lungs were opened up (Similar to having Albuterol nebulizer treatment); A spontaneous report was received from a healthcare professional concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up, headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 4 Jan 2021, the patient experienced the event(s) tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up. On 5 Jan 2021, the patient experienced the event(s) headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Jan 2021 the outcome of event(s), tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up, headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again was resolved.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Tired; Arm hurting; Achy all over body; Fever 100F; Nausea; Vomiting; Felt like have QVID all over again; headache; Tingling in cheek; Sinuses opened Up; Felt like her lungs were opened up (Similar to having Albuterol nebulizer treatment); A spontaneous report was received from a healthcare professional concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up, headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 4 Jan 2021, the patient experienced the event(s) tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up. On 5 Jan 2021, the patient experienced the event(s) headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Jan 2021 the outcome of event(s), tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up, headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pain in extremity
Clinical narrative: Painful Shoulder; Hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful Shoulder) and DRY SKIN (Hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Painful Shoulder) and DRY SKIN (Hot). At the time of the report, PAIN IN EXTREMITY (Painful Shoulder) and DRY SKIN (Hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Tiredness; Soreness; A spontaneous report was received from a healthcare professional concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tiredness / fatigue and soreness/ pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 7 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced the events, tiredness and soreness.   Treatment details included Tylenol and Advil.  Action taken with mRNA-1273 in response to the events was not reported.   On 12 Jan 2021 the outcome of events, tiredness and soreness was resolved.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Pain, Pyrexia
Clinical narrative: stuffy nose/nose congestion; body aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose/nose congestion), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided by reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced NASAL CONGESTION (stuffy nose/nose congestion), PAIN (body aches), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NASAL CONGESTION (stuffy nose/nose congestion), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were included blood pressure medicine, cholesterol medicine.   This case was linked to MOD-2021-033551 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Illness, Pyrexia
Clinical narrative: severely sick; no energy to get up; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (severely sick), ASTHENIA (no energy to get up), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D 3), ACETYLSALICYLIC ACID (ASPIRIN 81) and LEVOFLOXACIN (LEFOX [LEVOFLOXACIN]) for an unknown indication.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ILLNESS (severely sick), ASTHENIA (no energy to get up), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (severely sick), ASTHENIA (no energy to get up), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Patient was having cholesterol medicine at night and Cholesterol injection every other week on Tuesday as concomitant medication. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration, Vaccination site induration, Vaccination site pain
Clinical narrative: Small spots at the injection site; Hardness at the injection site; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Small spots at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE PAIN (Injection site pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE DISCOLOURATION (Small spots at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE DISCOLOURATION (Small spots at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE PAIN (Injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported   This case was linked to MOD21-027217 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: received on 22-APR-2021 and does not contain any new information; Sender's Comments:  MOD21-027217:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: Sore arm; Pain in my legs when I walk or sit down; Hurts a lot; Knot at the injection site, it was red; It was red; Low grade fever; muscle pain; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever/pyrexia, sore arm/pain in extremity, knot at the injection site/vaccination site induration, red/vaccination site erythema, pain in my legs when i walk or sit down/pain, muscle pain/myalgia, hurts a lot/pain.  The patient's medical history was not provided. Concomitant medications reported were gabapentin used for unknown indication.  On 7 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  No adverse events were reported related to the first dose of the vaccine.  On 3 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch:028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events low grade fever, sore arm, knot at the injection site, red, pain in legs when she walked or sat down, muscle pain, hurt alot.  Treatment details included aspirin with acetaminophen.  Since the patient received both the planned doses of the vaccine, action taken with mRNA-1273 in response to the events was not applicable. The outcome of events low grade fever, sore arm, knot at the injection site, red, pain in my legs when i walk or sit down, muscle pain, hurts alot was unknown on 8 Feb 2021.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Sore arm; Pain in my legs when I walk or sit down; Hurts a lot; Knot at the injection site, it was red; It was red; Low grade fever; muscle pain; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever/pyrexia, sore arm/pain in extremity, knot at the injection site/vaccination site induration, red/vaccination site erythema, pain in my legs when i walk or sit down/pain, muscle pain/myalgia, hurts a lot/pain.  The patient's medical history was not provided. Concomitant medications reported were gabapentin used for unknown indication.  On 7 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  No adverse events were reported related to the first dose of the vaccine.  On 3 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch:028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events low grade fever, sore arm, knot at the injection site, red, pain in legs when she walked or sat down, muscle pain, hurt alot.  Treatment details included aspirin with acetaminophen.  Since the patient received both the planned doses of the vaccine, action taken with mRNA-1273 in response to the events was not applicable. The outcome of events low grade fever, sore arm, knot at the injection site, red, pain in my legs when i walk or sit down, muscle pain, hurts alot was unknown on 8 Feb 2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced RASH (Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Fatigue, Feeling abnormal
Clinical narrative: Covid-19; Fever 102 F; Very Fatigue; Under weather; Cough; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cough, very fatigue, under weather, fever 102 f, covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event cough. On 6 Feb 2021, the patient experienced the events  very fatigue, under weather. On 7 Feb 2021, the patient experienced the events fever 102 f. On 9 Feb 2021, the patient experienced the event covid-19.Consumer visited HCP. HCP recommended over the counter medications to treat symptoms.  Treatment details included acetaminophen, azithromycin, mucinex, Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  On 5 Feb 2021 the outcome of event, cough was resolved. The outcome of events, very fatigue, under weather, fever 102 f, covid-19 was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Covid-19; Fever 102 F; Very Fatigue; Under weather; Cough; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cough, very fatigue, under weather, fever 102 f, covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event cough. On 6 Feb 2021, the patient experienced the events  very fatigue, under weather. On 7 Feb 2021, the patient experienced the events fever 102 f. On 9 Feb 2021, the patient experienced the event covid-19.Consumer visited HCP. HCP recommended over the counter medications to treat symptoms.  Treatment details included acetaminophen, azithromycin, mucinex, Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  On 5 Feb 2021 the outcome of event, cough was resolved. The outcome of events, very fatigue, under weather, fever 102 f, covid-19 was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hypersensitivity, Paraesthesia, Pruritus
Clinical narrative: Hypersensitivity cutaneous reaction; Red rash on the inside of her forearm; Itchy rash on the inside of her forearm; Look like mosquito bumps or hives; "Finger tingling"; "Rashes" started popping up in different areas (including the left arm, face, jawline, body) and "alongside her rear"; Chills; Redness; Intense itching; A spontaneous report was received from a nurse concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypersensitivity reaction, red rash, itchy rash, hives, tingling, rash all over, chills, redness and itching.  The patient's medical history, as provided by the reporter, includes hypertension, and shingles. Concomitant medications reported includes HCTZ.   On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Feb 2021 she experienced red and itchy rash on the inside of her forearm, that lasted one-half hour and resolved.  For the past 3 days she reported to have rash on left arm, face, jawline and body. She reported intense itching and redness (that last for 15-20 minutes) associated with the rash looks like hives (that last for about 45 minutes and resolved). She started feeling chills and thingling. She called her HCP. She was diagnosed with known delayed hypersensitivity cutaneous reaction after receiving Moderna's COVID-19 vaccine. Treatment for the events include Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The events red rash, itchy rash, hives, redness, itching, rash were resolved.  The events chills, tingling, hypersensitivity reaction were unknown at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Hypersensitivity cutaneous reaction; Red rash on the inside of her forearm; Itchy rash on the inside of her forearm; Look like mosquito bumps or hives; "Finger tingling"; "Rashes" started popping up in different areas (including the left arm, face, jawline, body) and "alongside her rear"; Chills; Redness; Intense itching; A spontaneous report was received from a nurse concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypersensitivity reaction, red rash, itchy rash, hives, tingling, rash all over, chills, redness and itching.  The patient's medical history, as provided by the reporter, includes hypertension, and shingles. Concomitant medications reported includes HCTZ.   On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Feb 2021 she experienced red and itchy rash on the inside of her forearm, that lasted one-half hour and resolved.  For the past 3 days she reported to have rash on left arm, face, jawline and body. She reported intense itching and redness (that last for 15-20 minutes) associated with the rash looks like hives (that last for about 45 minutes and resolved). She started feeling chills and thingling. She called her HCP. She was diagnosed with known delayed hypersensitivity cutaneous reaction after receiving Moderna's COVID-19 vaccine. Treatment for the events include Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The events red rash, itchy rash, hives, redness, itching, rash were resolved.  The events chills, tingling, hypersensitivity reaction were unknown at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: Rash; Burning; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and BURNING SENSATION (Burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced RASH (Rash) and BURNING SENSATION (Burning). At the time of the report, RASH (Rash) and BURNING SENSATION (Burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was  not reported.   Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Hyperhidrosis, Neck pain
Clinical narrative: severe headache; neck ache; excessive sweating; fatigue; weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), NECK PAIN (neck ache), HYPERHIDROSIS (excessive sweating), FATIGUE (fatigue) and ASTHENIA (weakness) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (severe headache), NECK PAIN (neck ache), HYPERHIDROSIS (excessive sweating), FATIGUE (fatigue) and ASTHENIA (weakness). At the time of the report, HEADACHE (severe headache), NECK PAIN (neck ache), HYPERHIDROSIS (excessive sweating), FATIGUE (fatigue) and ASTHENIA (weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Adverse rash on his foot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Adverse rash on his foot) 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 RASH (Adverse rash on his foot). At the time of the report, RASH (Adverse rash on his foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Adverse rash on his foot) 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 RASH (Adverse rash on his foot). At the time of the report, RASH (Adverse rash on his foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Feeling abnormal, Influenza, Nasopharyngitis
Clinical narrative: vaccinated and 5 days later got COVID; Flu positive; Feeling bad; seemed like cold; felt sleepy; Regular Dry Cough; whizzing that turns up during bedtime; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough) and WHEEZING (whizzing that turns up during bedtime) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough) and WHEEZING (whizzing that turns up during bedtime). On 08-Feb-2021, the patient experienced COVID-19 (vaccinated and 5 days later got COVID) and INFLUENZA (Flu positive). The patient was treated with OSELTAMIVIR PHOSPHATE (TAMIFLU) at an unspecified dose and frequency; DOXYCYCLINE at an unspecified dose and frequency and IPRATROPIUM BROMIDE (ATROVENT) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough), WHEEZING (whizzing that turns up during bedtime), COVID-19 (vaccinated and 5 days later got COVID) and INFLUENZA (Flu positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-APR-2021 and does not contain any new information
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Wheezing
Clinical narrative: vaccinated and 5 days later got COVID; Flu positive; Feeling bad; seemed like cold; felt sleepy; Regular Dry Cough; whizzing that turns up during bedtime; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough) and WHEEZING (whizzing that turns up during bedtime) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough) and WHEEZING (whizzing that turns up during bedtime). On 08-Feb-2021, the patient experienced COVID-19 (vaccinated and 5 days later got COVID) and INFLUENZA (Flu positive). The patient was treated with OSELTAMIVIR PHOSPHATE (TAMIFLU) at an unspecified dose and frequency; DOXYCYCLINE at an unspecified dose and frequency and IPRATROPIUM BROMIDE (ATROVENT) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough), WHEEZING (whizzing that turns up during bedtime), COVID-19 (vaccinated and 5 days later got COVID) and INFLUENZA (Flu positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-APR-2021 and does not contain any new information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Bad headache; Body Aches; Really Tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache), MYALGIA (Body Aches) and FATIGUE (Really Tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Bad headache), MYALGIA (Body Aches) and FATIGUE (Really Tired). At the time of the report, HEADACHE (Bad headache), MYALGIA (Body Aches) and FATIGUE (Really Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Her left arm and her shoulders muscles was sore for a few days; Her left arm and her shoulders muscles was sore for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her left arm and her shoulders muscles was sore for a few days) and ARTHRALGIA (Her left arm and her shoulders muscles was sore for a few days) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her left arm and her shoulders muscles was sore for a few days) and ARTHRALGIA (Her left arm and her shoulders muscles was sore for a few days). At the time of the report, PAIN IN EXTREMITY (Her left arm and her shoulders muscles was sore for a few days) and ARTHRALGIA (Her left arm and her shoulders muscles was sore for a few days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 and contains non-significant information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Pain in extremity
Clinical narrative: Uncomfortable from elbow to top of the shoulder; Arm is sore; (Arm) warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), FEELING HOT ((Arm) warm) and FEELING ABNORMAL (Uncomfortable from elbow to top of the shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and FEELING HOT ((Arm) warm). On 11-Feb-2021, the patient experienced FEELING ABNORMAL (Uncomfortable from elbow to top of the shoulder). At the time of the report, PAIN IN EXTREMITY (Arm is sore), FEELING HOT ((Arm) warm) and FEELING ABNORMAL (Uncomfortable from elbow to top of the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: site of injection is itching; site of injection developed red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (site of injection developed red mark) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (site of injection developed red mark). At the time of the report, VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (site of injection developed red mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Benadryl Benadryl, Cortisone cream Cortisone cream for drug use for unknown indication. Treatment details included Benadryl, Cortisone Cream.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Somnolence
Clinical narrative: He seems confused than normal; slept all day after getting home; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (He seems confused than normal) and SOMNOLENCE (slept all day after getting home) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CONFUSIONAL STATE (He seems confused than normal) and SOMNOLENCE (slept all day after getting home). At the time of the report, CONFUSIONAL STATE (He seems confused than normal) and SOMNOLENCE (slept all day after getting home) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported Treatment details included paracetamol 650 mg.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Erythema, Pruritus, Rash erythematous
Clinical narrative: Redness of neck; Had COVID arm; Itching neck; Chills; Confusion; Redness of face; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness of neck), RASH ERYTHEMATOUS (Had COVID arm), PRURITUS (Itching neck), CHILLS (Chills) and CONFUSIONAL STATE (Confusion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-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 ERYTHEMA (Redness of neck), RASH ERYTHEMATOUS (Had COVID arm), PRURITUS (Itching neck), CHILLS (Chills), CONFUSIONAL STATE (Confusion) and ERYTHEMA (Redness of face). At the time of the report, ERYTHEMA (Redness of neck), RASH ERYTHEMATOUS (Had COVID arm), PRURITUS (Itching neck), CHILLS (Chills), CONFUSIONAL STATE (Confusion) and ERYTHEMA (Redness of face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: shaking; bad headache; chills; fever; nausea; aching muscles; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) in a 73-year-old male patient who received mRNA-1273 (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aching muscles). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aching muscles) outcome was unknown.             No concomitant medication provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shaking; bad headache; chills; fever; nausea; aching muscles; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) in a 73-year-old male patient who received mRNA-1273 (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aching muscles). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aching muscles) outcome was unknown.             No concomitant medication provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Discomfort, Gastric disorder, Nausea
Clinical narrative: severe chills; stomach issues; Nausea; tightness; sharp pains in/near shoulder blades; runny nose; she had a little bit of a fever of 101.5F at 4AM. It has dropped to 99.7F and at the time of the call it is 99.6F; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (severe chills), GASTRIC DISORDER (stomach issues), NAUSEA (Nausea), DISCOMFORT (tightness) and ARTHRALGIA (sharp pains in/near shoulder blades) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (severe chills), GASTRIC DISORDER (stomach issues), NAUSEA (Nausea), DISCOMFORT (tightness), ARTHRALGIA (sharp pains in/near shoulder blades), RHINORRHOEA (runny nose) and PYREXIA (she had a little bit of a fever of 101.5F at 4AM. It has dropped to 99.7F and at the time of the call it is 99.6F). At the time of the report, CHILLS (severe chills), GASTRIC DISORDER (stomach issues), NAUSEA (Nausea), DISCOMFORT (tightness), ARTHRALGIA (sharp pains in/near shoulder blades), RHINORRHOEA (runny nose) and PYREXIA (she had a little bit of a fever of 101.5F at 4AM. It has dropped to 99.7F and at the time of the call it is 99.6F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant  Concomitant product medication was provided by reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: severe chills; stomach issues; Nausea; tightness; sharp pains in/near shoulder blades; runny nose; she had a little bit of a fever of 101.5F at 4AM. It has dropped to 99.7F and at the time of the call it is 99.6F; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (severe chills), GASTRIC DISORDER (stomach issues), NAUSEA (Nausea), DISCOMFORT (tightness) and ARTHRALGIA (sharp pains in/near shoulder blades) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (severe chills), GASTRIC DISORDER (stomach issues), NAUSEA (Nausea), DISCOMFORT (tightness), ARTHRALGIA (sharp pains in/near shoulder blades), RHINORRHOEA (runny nose) and PYREXIA (she had a little bit of a fever of 101.5F at 4AM. It has dropped to 99.7F and at the time of the call it is 99.6F). At the time of the report, CHILLS (severe chills), GASTRIC DISORDER (stomach issues), NAUSEA (Nausea), DISCOMFORT (tightness), ARTHRALGIA (sharp pains in/near shoulder blades), RHINORRHOEA (runny nose) and PYREXIA (she had a little bit of a fever of 101.5F at 4AM. It has dropped to 99.7F and at the time of the call it is 99.6F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant  Concomitant product medication was provided by reporter.