chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain of skin, Vaccination site pain
Clinical narrative: Crest in her scalp and around her earlobe, broken out with shingles; had some pain that went from the injection site up through her neck and to the area of her skin; had some pain that went from the injection site; A spontaneous report was received from a consumer concerning a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced crest in her scalp and around her earlobe, broken out with shingles (Herpes zoster), had some pain that went from the injection site (vaccination site pain), and had some pain that went from the injection site up through her neck and to the area of her skin (pain of skin).  The patient's past medical history was not provided. Concomitant product use included hydrocodone and gabapentin.  On 27 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch number: 022M20T) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Feb 2021 the patient experienced pain that went from the injection site, up through her neck and to the area of her skin that seems to have broken out with shingles. The patient thinks that the shot reduced her immunity to give her shingles or got it from the vaccine. The patient also experienced crest in her scalp and around her earlobe.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, crest in her scalp and around her earlobe, broken out with shingles, had some pain that went from the injection site, and had some pain that went from the injection site up through her neck and to the area of her skin, 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.
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced BRONCHITIS (Bronchitis). At the time of the report, BRONCHITIS (Bronchitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medication included antibiotic and steroids.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chills; soreness; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and PAIN (soreness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and PAIN (soreness). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Neck pain, Pain, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), TREMOR (shaking uncontrollably during the night), NECK PAIN (pain in the neck) and BURNING SENSATION (burning sensation in the legs.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. Patient had no medical history. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (pain) and TREMOR (shaking uncontrollably during the night). On an unknown date, the patient experienced NECK PAIN (pain in the neck) and BURNING SENSATION (burning sensation in the legs.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pain), TREMOR (shaking uncontrollably during the night), NECK PAIN (pain in the neck) and BURNING SENSATION (burning sensation in the legs.) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. The action taken with mRNA-1273 in response to the event was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Feeling hot, Pruritus, Rash erythematous, Vaccination site reaction
Clinical narrative: itching; scratched arm and felt a tiny blister like hair follicle blister; arm felt hot on right arm at injection site; red hot rash, hot red and itchy about 3 inches in diameter; covid arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching), BLISTER (scratched arm and felt a tiny blister like hair follicle blister), FEELING HOT (arm felt hot on right arm at injection site), RASH ERYTHEMATOUS (red hot rash, hot red and itchy about 3 inches in diameter) and VACCINATION SITE REACTION (covid arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (itching), BLISTER (scratched arm and felt a tiny blister like hair follicle blister), FEELING HOT (arm felt hot on right arm at injection site), RASH ERYTHEMATOUS (red hot rash, hot red and itchy about 3 inches in diameter) and VACCINATION SITE REACTION (covid arm). On 03-Mar-2021, PRURITUS (itching), BLISTER (scratched arm and felt a tiny blister like hair follicle blister), FEELING HOT (arm felt hot on right arm at injection site), RASH ERYTHEMATOUS (red hot rash, hot red and itchy about 3 inches in diameter) and VACCINATION SITE REACTION (covid arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient mentioned she was currently enrolled as a participant in the Astrazenica covid vaccine trial (AZD1222) in which both of her injections were placebo. The trial started 11Nov2020 and she will continue to be monitored for 2 years. Astrazenica is aware that she has received the Moderna vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Hot like you can cook on it; Her arm is red, black and blue; Feverish; Her arm is swollen; Red to her elbow, her arm is red, black and blue; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (Hot like you can cook on it), INJECTION SITE DISCOLOURATION (Her arm is red, black and blue), PYREXIA (Feverish), INJECTION SITE SWELLING (Her arm is swollen) and INJECTION SITE ERYTHEMA (Red to her elbow, her arm is red, black and blue) 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 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE WARMTH (Hot like you can cook on it), INJECTION SITE DISCOLOURATION (Her arm is red, black and blue), PYREXIA (Feverish), INJECTION SITE SWELLING (Her arm is swollen) and INJECTION SITE ERYTHEMA (Red to her elbow, her arm is red, black and blue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Hot like you can cook on it), INJECTION SITE DISCOLOURATION (Her arm is red, black and blue), PYREXIA (Feverish), INJECTION SITE SWELLING (Her arm is swollen) and INJECTION SITE ERYTHEMA (Red to her elbow, her arm is red, black and blue) outcome was unknown.            No relevant concomitant medications were reported.  Treatment details included Ice.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Headache; Chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) 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.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second vaccine 3 weeks and 2 days after the 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 3 weeks and 2 days after the 1st vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 3 weeks and 2 days after the 1st vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 3 weeks and 2 days after the 1st vaccine) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Unknown) with no associated AEs.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in his right thigh; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in his right thigh) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 RASH (Rash in his right thigh). At the time of the report, RASH (Rash in his right thigh) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Arm was swollen; Hot; Rash around the injection site; Rash also pushed down to her elbow; Sore; Sore arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Hot), VACCINATION SITE RASH (Rash around the injection site) and RASH (Rash also pushed down to her elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Hot), VACCINATION SITE RASH (Rash around the injection site), RASH (Rash also pushed down to her elbow) and PAIN (Sore). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) on 11-Mar-2021 for Rash, at a dose of 10 mg and CORTISONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Hot), VACCINATION SITE RASH (Rash around the injection site), RASH (Rash also pushed down to her elbow) and PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Reportedly, patient sent a picture to her MD to see if she needed any aggressive treatment.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Arm was swollen; Hot; Rash around the injection site; Rash also pushed down to her elbow; Sore; Sore arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Hot), VACCINATION SITE RASH (Rash around the injection site) and RASH (Rash also pushed down to her elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Hot), VACCINATION SITE RASH (Rash around the injection site), RASH (Rash also pushed down to her elbow) and PAIN (Sore). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) on 11-Mar-2021 for Rash, at a dose of 10 mg and CORTISONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Hot), VACCINATION SITE RASH (Rash around the injection site), RASH (Rash also pushed down to her elbow) and PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Reportedly, patient sent a picture to her MD to see if she needed any aggressive treatment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Felt pressure, felt like a gun, not like a needle; A spontaneous report was received from a consumer concerning a 50-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and concerned that it felt pressure, felt like a gun, not like a needle/discomfort.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 10 Mar 2021, approximately same day prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10 Mar 2021, after to receiving mRNA-1273, the patient felt concerned that it didn't feel like a needle, felt pressure, felt like a gun, not like a needle. Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events felt pressure, felt like a gun, not like a needle/discomfort as resolved on 10 Mar 2021.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Retching, Vomiting
Clinical narrative: stomach felt off; dry heaves; extreme nausea; vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (stomach felt off), RETCHING (dry heaves), NAUSEA (extreme nausea) and VOMITING (vomiting) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach felt off), RETCHING (dry heaves), NAUSEA (extreme nausea) and VOMITING (vomiting). At the time of the report, ABDOMINAL DISCOMFORT (stomach felt off), RETCHING (dry heaves), NAUSEA (extreme nausea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received NNI
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on chest, left stomach, left back; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on chest, left stomach, left back) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunisation.     Concurrent medical conditions included Down's syndrome (She mentioned that he has down syndrome.). Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH PRURITIC (itchy rash on chest, left stomach, left back). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itchy rash, at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (itchy rash on chest, left stomach, left back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-041194 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up document attached contains NNI
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immune thrombocytopenia, Rash
Clinical narrative: red dots on the arm below the injection site - left arm; Rash on the arm below the injection site - left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red dots on the arm below the injection site - left arm) and RASH (Rash on the arm below the injection site - left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 ERYTHEMA (red dots on the arm below the injection site - left arm) and RASH (Rash on the arm below the injection site - left arm). At the time of the report, ERYTHEMA (red dots on the arm below the injection site - left arm) and RASH (Rash on the arm below the injection site - left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Immune thrombocytopenia: negative (Negative) Her doctor did ITP test which came back negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle twitching, Neck pain, Pain in extremity
Clinical narrative: arms hurts; right arm is twitching; neck hurt; head hurts; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021. The most recent information was received on 15-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arms hurts), MUSCLE TWITCHING (right arm is twitching), NECK PAIN (neck hurt) and HEADACHE (head hurts) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Tumor (benign tumor on left side.) and Lichen sclerosis atrophicus in 2019. Concurrent medical conditions included Food allergy (allergic to melon) and Food allergy (allergic to mango). Concomitant products included LEVOTHYROXINE for Thyroiditis.   On 28-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arms hurts), MUSCLE TWITCHING (right arm is twitching), NECK PAIN (neck hurt) and HEADACHE (head hurts). The patient was treated with NAPROXEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arms hurts), MUSCLE TWITCHING (right arm is twitching), NECK PAIN (neck hurt) and HEADACHE (head hurts) outcome was unknown. Not Provided          The patient was given Vitamin and Topical treatment for autoimmune disease as concomitant medication. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up is received on 04-may-2021 which contains  added no new information. On 15-May-2021: Follow up is received on 15-may-2021 which contains  patient demographic details, concomitant medications, historical diseases of the patient and second dose details updated. Updated information about facility where vaccine was given.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Muscle tightness, Rash
Clinical narrative: watery eyes; tightness in jaw; rash on her neck and chest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a nurse and describes the occurrence of LACRIMATION INCREASED (watery eyes), MUSCLE TIGHTNESS (tightness in jaw) and RASH (rash on her neck and chest) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20a) for COVID-19 vaccination.     No Medical History information was reported.    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 LACRIMATION INCREASED (watery eyes), MUSCLE TIGHTNESS (tightness in jaw) and RASH (rash on her neck and chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. At the time of the report, LACRIMATION INCREASED (watery eyes), MUSCLE TIGHTNESS (tightness in jaw) and RASH (rash on her neck and chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient called nurse to report she began having adverse events within 1 hour after receiving first dose of vaccination. Patient was due for her second dose tomorrow and nurse was questioning whether to give the patient her second dose. No concomitant medication were reported  No concomitant medication use was provided by the reporter.  Treatment of events was with diphenhydramine (Benadryl ). Nurse reporter was unsure of how long the symptoms lasted.   This case was linked to MOD-2021-040823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up document received on 04-MAY-2021 contains no newinformation
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Communication disorder, Dizziness, Heart rate increased
Clinical narrative: Dizziness; Weakness; Difficulty Communicating; Fast Heartbeat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), COMMUNICATION DISORDER (Difficulty Communicating) and HEART RATE INCREASED (Fast Heartbeat) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), COMMUNICATION DISORDER (Difficulty Communicating) and HEART RATE INCREASED (Fast Heartbeat). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), COMMUNICATION DISORDER (Difficulty Communicating) and HEART RATE INCREASED (Fast Heartbeat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 127/70 normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter. No treatment medication were reported.  Reporter does not consent for further contact   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR is attached as follow-up document on 04-MAY-2021 where is mentioned that patient is fine now and not interest in FU.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Palpitations, Platelet count, Tachycardia
Clinical narrative: Elevated heart rate; palpitations/ heart palpitations, things progressing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Elevated heart rate) and PALPITATIONS (palpitations/ heart palpitations, things progressing) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PALPITATIONS (palpitations/ heart palpitations, things progressing). On an unknown date, the patient experienced TACHYCARDIA (Elevated heart rate). At the time of the report, TACHYCARDIA (Elevated heart rate) and PALPITATIONS (palpitations/ heart palpitations, things progressing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Full blood count: abnormal (abnormal) Elevated. On 04-May-2021, Platelet count: 697 (High) Laboratory normal was 150-450.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment information was provided.  Echocardiogram and halter monitor were scheduled on friday7MAY2021 for Patient. Patient did not received scheduled 2nd vaccine(5 APR 2021) as symptoms were still on.   Company comment: 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.   This case was linked to MOD21-051002 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Lab test information, Product route of administration, New events, iNarrative information added.; 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  no concomitant drugs included no treatment drugs included; 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: F
Vaccine: COVID19
Symptoms: Lethargy, Swelling face
Clinical narrative: Lethargy; Swollen face; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and SWELLING FACE (Swollen face) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargy) and SWELLING FACE (Swollen face). The patient was treated with PREDNISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, LETHARGY (Lethargy) and SWELLING FACE (Swollen face) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  Additional treatment of events was reported with antibiotics.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site...it doubled the size and swollen and hot; swelling...at injection site; rash at injection site; itchiness...at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site...it doubled the size and swollen and hot), VACCINATION SITE SWELLING (swelling...at injection site), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PRURITUS (itchiness...at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling...at injection site), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PRURITUS (itchiness...at injection site). On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site...it doubled the size and swollen and hot). The patient was treated with HYDROCORTISONE ACETATE (CORTISONE [HYDROCORTISONE ACETATE]) (topical) for Allergy, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (injection site..it doubled the size and swollen and hot), VACCINATION SITE SWELLING (swelling..at injection site), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PRURITUS (itchiness..at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was reported as hormone pills since an unknown start date. Treatment medications include allergy pill .
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Extreme stomach pain she compared it to having kidney stones; Throwing up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Extreme stomach pain she compared it to having kidney stones) and VOMITING (Throwing up) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune deficiency syndrome and Gastrointestinal disorder.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Extreme stomach pain she compared it to having kidney stones) and VOMITING (Throwing up). At the time of the report, ABDOMINAL PAIN UPPER (Extreme stomach pain she compared it to having kidney stones) and VOMITING (Throwing up) outcome was unknown.            Concomitant medications were not reported. Treatment information in response to events was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Condition aggravated, Pruritus, Rash
Clinical narrative: Tenderness spread to involve back and abdomen has getting worsen on last days; Generalize itching; Itch started on injection site; Injection site tenderness; Chest on fire; Worse and worse; Rash all over back, side, legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest on fire), CONDITION AGGRAVATED (Worse and worse), RASH (Rash all over back, side, legs), BACK PAIN (Tenderness spread to involve back and abdomen has getting worsen on last days) and PRURITUS (Generalize itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced CHEST PAIN (Chest on fire), CONDITION AGGRAVATED (Worse and worse) and RASH (Rash all over back, side, legs). On 21-Feb-2021, the patient experienced BACK PAIN (Tenderness spread to involve back and abdomen has getting worsen on last days), PRURITUS (Generalize itching), VACCINATION SITE PRURITUS (Itch started on injection site) and VACCINATION SITE PAIN (Injection site tenderness). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest on fire), CONDITION AGGRAVATED (Worse and worse), RASH (Rash all over back, side, legs), BACK PAIN (Tenderness spread to involve back and abdomen has getting worsen on last days), PRURITUS (Generalize itching), VACCINATION SITE PRURITUS (Itch started on injection site) and VACCINATION SITE PAIN (Injection site tenderness) had not resolved.            No Concomitant products were reported.  Treatment medications include Antihistamines, Steroid creams.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021: Reporter details updated , Event Added and Outcome updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Tenderness spread to involve back and abdomen has getting worsen on last days; Generalize itching; Itch started on injection site; Injection site tenderness; Chest on fire; Worse and worse; Rash all over back, side, legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest on fire), CONDITION AGGRAVATED (Worse and worse), RASH (Rash all over back, side, legs), BACK PAIN (Tenderness spread to involve back and abdomen has getting worsen on last days) and PRURITUS (Generalize itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced CHEST PAIN (Chest on fire), CONDITION AGGRAVATED (Worse and worse) and RASH (Rash all over back, side, legs). On 21-Feb-2021, the patient experienced BACK PAIN (Tenderness spread to involve back and abdomen has getting worsen on last days), PRURITUS (Generalize itching), VACCINATION SITE PRURITUS (Itch started on injection site) and VACCINATION SITE PAIN (Injection site tenderness). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest on fire), CONDITION AGGRAVATED (Worse and worse), RASH (Rash all over back, side, legs), BACK PAIN (Tenderness spread to involve back and abdomen has getting worsen on last days), PRURITUS (Generalize itching), VACCINATION SITE PRURITUS (Itch started on injection site) and VACCINATION SITE PAIN (Injection site tenderness) had not resolved.            No Concomitant products were reported.  Treatment medications include Antihistamines, Steroid creams.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021: Reporter details updated , Event Added and Outcome updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the Injection Site), VACCINATION SITE INDURATION (Hardness on the Injection Site), VACCINATION SITE PAIN (Soreness on the Injection Site), AXILLARY PAIN (Sore Armpit) and VACCINATION SITE ERYTHEMA (Red Injection Site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness on the Injection Site). On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the Injection Site), VACCINATION SITE INDURATION (Hardness on the Injection Site), AXILLARY PAIN (Sore Armpit) and VACCINATION SITE ERYTHEMA (Red Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, VACCINATION SITE PAIN (Soreness on the Injection Site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching on the Injection Site), VACCINATION SITE INDURATION (Hardness on the Injection Site), AXILLARY PAIN (Sore Armpit) and VACCINATION SITE ERYTHEMA (Red Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Reporter did not allow further contact.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Pain in extremity, Swelling
Clinical narrative: sore arm; she got a really big bruise; shoulder and neck was swollen; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CONTUSION (she got a really big bruise), SWELLING (shoulder and neck was swollen) and FATIGUE (exhausted) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CONTUSION (she got a really big bruise), SWELLING (shoulder and neck was swollen) and FATIGUE (exhausted). At the time of the report, PAIN IN EXTREMITY (sore arm), CONTUSION (she got a really big bruise) and SWELLING (shoulder and neck was swollen) outcome was unknown and FATIGUE (exhausted) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided.   Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Headache
Clinical narrative: Double vision; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIPLOPIA (Double vision) and HEADACHE (Headache). At the time of the report, DIPLOPIA (Double vision) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain in extremity, Pruritus, Vaccination site mass
Clinical narrative: Felt a little knot; Painful to move arm, couldn't move it; Hot to touch at arm; Itches sporadically; Red next to the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Felt a little knot), PAIN IN EXTREMITY (Painful to move arm, couldn't move it), VACCINATION SITE WARMTH (Hot to touch at arm), PRURITUS (Itches sporadically) and ERYTHEMA (Red next to the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE MASS (Felt a little knot), PAIN IN EXTREMITY (Painful to move arm, couldn't move it), VACCINATION SITE WARMTH (Hot to touch at arm), PRURITUS (Itches sporadically), ERYTHEMA (Red next to the injection site) and MYALGIA (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Felt a little knot) was resolving, PAIN IN EXTREMITY (Painful to move arm, couldn't move it) outcome was unknown and VACCINATION SITE WARMTH (Hot to touch at arm), PRURITUS (Itches sporadically), ERYTHEMA (Red next to the injection site) and MYALGIA (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.