chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Tenderness
Clinical narrative: Eczema reaction than a rash on her face, primarily on her cheeks; Severe digestive issues, kind of like gastritis; Severe tenderness; She couldn't eat much of anything; Her stomach hurt when she was standing up or walking; Flu-like symptoms; Intestinal pain; Fever around 99 to just under 101F; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema reaction than a rash on her face, primarily on her cheeks), GASTRITIS (Severe digestive issues, kind of like gastritis), TENDERNESS (Severe tenderness), EATING DISORDER (She couldn't eat much of anything) and ABDOMINAL PAIN UPPER (Her stomach hurt when she was standing up or walking) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema reaction than a rash on her face, primarily on her cheeks), GASTRITIS (Severe digestive issues, kind of like gastritis), TENDERNESS (Severe tenderness), EATING DISORDER (She couldn't eat much of anything), ABDOMINAL PAIN UPPER (Her stomach hurt when she was standing up or walking), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Intestinal pain) and PYREXIA (Fever around 99 to just under 101F). The patient was treated with PANTOPRAZOLE at an unspecified dose and frequency and IBUPROFEN (MOTRIN IB) at an unspecified dose and frequency. On 28-Jan-2021, ECZEMA (Eczema reaction than a rash on her face, primarily on her cheeks), GASTRITIS (Severe digestive issues, kind of like gastritis), TENDERNESS (Severe tenderness), EATING DISORDER (She couldn't eat much of anything), ABDOMINAL PAIN UPPER (Her stomach hurt when she was standing up or walking), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Intestinal pain) and PYREXIA (Fever around 99 to just under 101F) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up received on 06-Apr-2021 reported minimal side effects from the second shot as well, not otherwise specified. On 08-Jun-2021: FU NNI : Reporter said: No need for additional follow up she is fine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Neck pain, Oral pain, Pain in extremity, Swelling
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Mouth started hurting/pain started again after trying to eat lunch), NECK PAIN (entire left part under left ear to the neck started hurting), SWELLING (the entire left part under my left ear to the neck on the same side I got the vaccine was swollen) and HYPERAESTHESIA (Sensitive/sore to touch) in a 49-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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Jan-2021, the patient experienced ORAL PAIN (Mouth started hurting/pain started again after trying to eat lunch), NECK PAIN (entire left part under left ear to the neck started hurting), SWELLING (the entire left part under my left ear to the neck on the same side I got the vaccine was swollen) and HYPERAESTHESIA (Sensitive/sore to touch). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Mouth started hurting/pain started again after trying to eat lunch), NECK PAIN (entire left part under left ear to the neck started hurting), SWELLING (the entire left part under my left ear to the neck on the same side I got the vaccine was swollen) and HYPERAESTHESIA (Sensitive/sore to touch) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment included icepack. The patient went to see the doctor who said it could be a delayed reaction.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is pregnant and received the first Moderna shot on Friday; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first Moderna shot on Friday) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Sep-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first Moderna shot on Friday). On 22-Jan-2021, EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first Moderna shot on Friday) had resolved.            Concomitant medication was not reported. Treatment medication was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Myalgia, Pyrexia
Clinical narrative: Body ache; Pain at injection site; Chills; Fever; Headache; SOB; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (SOB), MYALGIA (Body ache), VACCINATION SITE PAIN (Pain at injection site), CHILLS (Chills) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive in August 2020.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced DYSPNOEA (SOB), VACCINATION SITE PAIN (Pain at injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 26-Jan-2021, the patient experienced MYALGIA (Body ache). On 28-Jan-2021, VACCINATION SITE PAIN (Pain at injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 02-Feb-2021, MYALGIA (Body ache) had resolved. At the time of the report, DYSPNOEA (SOB) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Body ache; Pain at injection site; Chills; Fever; Headache; SOB; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (SOB), MYALGIA (Body ache), VACCINATION SITE PAIN (Pain at injection site), CHILLS (Chills) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive in August 2020.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced DYSPNOEA (SOB), VACCINATION SITE PAIN (Pain at injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 26-Jan-2021, the patient experienced MYALGIA (Body ache). On 28-Jan-2021, VACCINATION SITE PAIN (Pain at injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 02-Feb-2021, MYALGIA (Body ache) had resolved. At the time of the report, DYSPNOEA (SOB) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chest pain, Dyspnoea, Headache
Clinical narrative: chest pain; left breast and going down arm pit is painful; out of breath; left breast and going down arm pit is painful; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), BREAST PAIN (left breast and going down arm pit is painful), DYSPNOEA (out of breath), AXILLARY PAIN (left breast and going down arm pit is painful) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Emphysema. Concomitant products included PARACETAMOL (TYLENOL), TRAZODONE, LEVOTHYROXINE SODIUM (SYNTHROID), PANTOPRAZOLE, ATORVASTATIN, TRAMADOL and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHEST PAIN (chest pain), BREAST PAIN (left breast and going down arm pit is painful), DYSPNOEA (out of breath), AXILLARY PAIN (left breast and going down arm pit is painful) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 28-Jan-2021 at a dose of UNK dosage form. At the time of the report, CHEST PAIN (chest pain), BREAST PAIN (left breast and going down arm pit is painful) and AXILLARY PAIN (left breast and going down arm pit is painful) was resolving and DYSPNOEA (out of breath) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Pain assessment: 2-6 (High) 6 in the morning and 2 at the time of report..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Aspirin. The patient had to go to the ER due to the chest pain where they did tests on her heart and everything came back normal. The pain was still ongoing but has become less compared to the morning. The patient said on a scale of 1-10, her pain has gone from a 6 in the morning to a 2 at the time of report. The patient also stated she had been out of breath also, but that was due to her emphysema.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment
Clinical narrative: chest pain; left breast and going down arm pit is painful; out of breath; left breast and going down arm pit is painful; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), BREAST PAIN (left breast and going down arm pit is painful), DYSPNOEA (out of breath), AXILLARY PAIN (left breast and going down arm pit is painful) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Emphysema. Concomitant products included PARACETAMOL (TYLENOL), TRAZODONE, LEVOTHYROXINE SODIUM (SYNTHROID), PANTOPRAZOLE, ATORVASTATIN, TRAMADOL and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHEST PAIN (chest pain), BREAST PAIN (left breast and going down arm pit is painful), DYSPNOEA (out of breath), AXILLARY PAIN (left breast and going down arm pit is painful) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 28-Jan-2021 at a dose of UNK dosage form. At the time of the report, CHEST PAIN (chest pain), BREAST PAIN (left breast and going down arm pit is painful) and AXILLARY PAIN (left breast and going down arm pit is painful) was resolving and DYSPNOEA (out of breath) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Pain assessment: 2-6 (High) 6 in the morning and 2 at the time of report..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Aspirin. The patient had to go to the ER due to the chest pain where they did tests on her heart and everything came back normal. The pain was still ongoing but has become less compared to the morning. The patient said on a scale of 1-10, her pain has gone from a 6 in the morning to a 2 at the time of report. The patient also stated she had been out of breath also, but that was due to her emphysema.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Large rash at the site of injection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE RASH (Large rash at the site of injection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Large rash at the site of injection). At the time of the report, VACCINATION SITE RASH (Large rash at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizzy; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and HEADACHE (Bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizzy) and HEADACHE (Bad headache). At the time of the report, DIZZINESS (dizzy) and HEADACHE (Bad headache) 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 details were not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and HEADACHE (Bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizzy) and HEADACHE (Bad headache). At the time of the report, DIZZINESS (dizzy) and HEADACHE (Bad headache) 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 details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash was very red and in splotches; The rash worsened and itch; Rash around the waist, under her arms, down her legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (The rash worsened and itch), RASH (Rash around the waist, under her arms, down her legs) and RASH ERYTHEMATOUS (rash was very red and in splotches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 012A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ANTIBIOTICS (2 weeks prior vaccine). Concurrent medical conditions included Drug allergy (macrodantin) and Hypothyroidism. Concomitant products included TIMOLOL from 2012 to an unknown date and LATANOPROST from 2010 to an unknown date for Glaucoma, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 1992 to an unknown date for Hypothyroidism, CLOTRIMAZOLE and MICONAZOLE NITRATE (ANTIFUNGAL [MICONAZOLE NITRATE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced RASH (Rash around the waist, under her arms, down her legs). On 06-Feb-2021, the patient experienced RASH PRURITIC (The rash worsened and itch). On an unknown date, the patient experienced RASH ERYTHEMATOUS (rash was very red and in splotches). The patient was treated with NYSTATIN at a dose of unknown; HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) in February 2021 for Itchy rash and Rash, at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in February 2021 for Itchy rash and Rash, at a dose of UNK dosage form and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) at a dose of unknown. At the time of the report, RASH PRURITIC (The rash worsened and itch) and RASH (Rash around the waist, under her arms, down her legs) was resolving and RASH ERYTHEMATOUS (rash was very red and in splotches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications included antifungal drugs.   This case was linked to MOD-2021-185621.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: significant follow up received on 27-MAY-2021 Contains dosage information was updated, concomitant medications was updated, events was updated, treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Felt like tongue was swelling; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Felt like tongue was swelling) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Felt like tongue was swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling of tongue, at a dose of UNK dosage form. At the time of the report, SWOLLEN TONGUE (Felt like tongue was swelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used was not provided by the reporter. Treatment included diphenhydramine.  This patient was administered the vaccine at a Pharmacy. When he felt like his tongue was swelling, the pharmacist gave him a diphenhydramine and the issue quickly dissipated.    Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow-up received on 22-Mar-2021 included no new information. On 20-Apr-2021: Follow-up received on 20-Apr-2021 included no new information.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; A spontaneous report was received from a Consumer concerning a 31-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, sore arm was Unknown.; Reporter's Comments: This case concerns a 31-year-old female with a NS unexpected event of Pain in extremity.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Headache, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Woke up with redness at the injection site; It was itchy at the injection site; a little warm on the injection site; a little swollen at the injection site; fell down because she tripped; arm hurt; a little headache but it was mild; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell down because she tripped), PAIN IN EXTREMITY (arm hurt), HEADACHE (a little headache but it was mild), VACCINATION SITE ERYTHEMA (Woke up with redness at the injection site) and VACCINATION SITE PRURITUS (It was itchy at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Lung disorder NOS. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FALL (fell down because she tripped), PAIN IN EXTREMITY (arm hurt) and HEADACHE (a little headache but it was mild). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Woke up with redness at the injection site), VACCINATION SITE PRURITUS (It was itchy at the injection site), VACCINATION SITE WARMTH (a little warm on the injection site) and VACCINATION SITE SWELLING (a little swollen at the injection site). In January 2021, HEADACHE (a little headache but it was mild) had resolved. On 19-Jan-2021, FALL (fell down because she tripped) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt) had resolved, VACCINATION SITE ERYTHEMA (Woke up with redness at the injection site), VACCINATION SITE PRURITUS (It was itchy at the injection site) and VACCINATION SITE SWELLING (a little swollen at the injection site) had not resolved and VACCINATION SITE WARMTH (a little warm on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Woke up with redness at the injection site; It was itchy at the injection site; a little warm on the injection site; a little swollen at the injection site; fell down because she tripped; arm hurt; a little headache but it was mild; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell down because she tripped), PAIN IN EXTREMITY (arm hurt), HEADACHE (a little headache but it was mild), VACCINATION SITE ERYTHEMA (Woke up with redness at the injection site) and VACCINATION SITE PRURITUS (It was itchy at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Lung disorder NOS. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FALL (fell down because she tripped), PAIN IN EXTREMITY (arm hurt) and HEADACHE (a little headache but it was mild). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Woke up with redness at the injection site), VACCINATION SITE PRURITUS (It was itchy at the injection site), VACCINATION SITE WARMTH (a little warm on the injection site) and VACCINATION SITE SWELLING (a little swollen at the injection site). In January 2021, HEADACHE (a little headache but it was mild) had resolved. On 19-Jan-2021, FALL (fell down because she tripped) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt) had resolved, VACCINATION SITE ERYTHEMA (Woke up with redness at the injection site), VACCINATION SITE PRURITUS (It was itchy at the injection site) and VACCINATION SITE SWELLING (a little swollen at the injection site) had not resolved and VACCINATION SITE WARMTH (a little warm on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Myalgia, Pyrexia
Clinical narrative: Lost sense of smell; Lost sense of taste; chills; Fever; Body ache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), CHILLS (chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (Fever) and MYALGIA (Body ache). On 18-Jan-2021, the patient experienced ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste). On 18-Jan-2021, CHILLS (chills), PYREXIA (Fever) and MYALGIA (Body ache) had resolved. At the time of the report, ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications and treatment details were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received on 15-Apr-2021 contains information regarding outcome of the events.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Lost sense of smell; Lost sense of taste; chills; Fever; Body ache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ANOSMIA (Lost sense of smell), AGEUSIA (Lost sense of taste), CHILLS (chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (Fever) and MYALGIA (Body ache). On 18-Jan-2021, the patient experienced ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste). On 18-Jan-2021, CHILLS (chills), PYREXIA (Fever) and MYALGIA (Body ache) had resolved. At the time of the report, ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications and treatment details were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received on 15-Apr-2021 contains information regarding outcome of the events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypersensitivity, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site hot; Cutaneous hypersensitivity at the injection site; Injection site itchy; Injection site raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE HYPERSENSITIVITY (Cutaneous hypersensitivity at the injection site) and VACCINATION SITE SWELLING (Injection site raised) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     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 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE HYPERSENSITIVITY (Cutaneous hypersensitivity at the injection site) and VACCINATION SITE SWELLING (Injection site raised). At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE HYPERSENSITIVITY (Cutaneous hypersensitivity at the injection site) and VACCINATION SITE SWELLING (Injection site raised) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included pain reliever and antibiotics for the symptoms
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Cough, Fatigue, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), COUGH (Cough), SINUS CONGESTION (Sinus congestion), ANOSMIA (Loss of smell) and FATIGUE (Tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), COUGH (Cough), SINUS CONGESTION (Sinus congestion), ANOSMIA (Loss of smell) and FATIGUE (Tired). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), COUGH (Cough), SINUS CONGESTION (Sinus congestion), ANOSMIA (Loss of smell) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case concerns a 55-year-old female who experienced NS unexpected events of SARS-CoV-2 test positive, cough, anosmia, sinus congestion and NS expected events of fatigue. Event onset occurred Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 55-year-old female who experienced NS unexpected events of SARS-CoV-2 test positive, cough, anosmia, sinus congestion and NS expected events of fatigue. Event onset occurred Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment Medication was available. No Concomitant Medication was available.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Breast pain, Chills, Fatigue, Headache
Clinical narrative: In bed since getting the vaccine; weakness in their legs; little pain under their right breas; feel worse than when having chemo; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (In bed since getting the vaccine), ASTHENIA (weakness in their legs), BREAST PAIN (little pain under their right breas), MALAISE (feel worse than when having chemo) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced FATIGUE (In bed since getting the vaccine), ASTHENIA (weakness in their legs), BREAST PAIN (little pain under their right breas), MALAISE (feel worse than when having chemo), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, FATIGUE (In bed since getting the vaccine), ASTHENIA (weakness in their legs), BREAST PAIN (little pain under their right breas), MALAISE (feel worse than when having chemo), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol and Advil.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: In bed since getting the vaccine; weakness in their legs; little pain under their right breas; feel worse than when having chemo; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (In bed since getting the vaccine), ASTHENIA (weakness in their legs), BREAST PAIN (little pain under their right breas), MALAISE (feel worse than when having chemo) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced FATIGUE (In bed since getting the vaccine), ASTHENIA (weakness in their legs), BREAST PAIN (little pain under their right breas), MALAISE (feel worse than when having chemo), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, FATIGUE (In bed since getting the vaccine), ASTHENIA (weakness in their legs), BREAST PAIN (little pain under their right breas), MALAISE (feel worse than when having chemo), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol and Advil.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: Increased heart rate 152 beat per min; Body aches; Fever of 102.7; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate 152 beat per min), MYALGIA (Body aches), PYREXIA (Fever of 102.7), NAUSEA (Nausea) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O25J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Increased heart rate 152 beat per min), MYALGIA (Body aches), PYREXIA (Fever of 102.7), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with ONDANSETRON for Myalgia, at a dose of 8 mg. At the time of the report, HEART RATE INCREASED (Increased heart rate 152 beat per min), MYALGIA (Body aches), PYREXIA (Fever of 102.7), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.7 (High) 102.7. On an unknown date, Heart rate: 152 (High) 152 beat per min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Increased heart rate 152 beat per min; Body aches; Fever of 102.7; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate 152 beat per min), MYALGIA (Body aches), PYREXIA (Fever of 102.7), NAUSEA (Nausea) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O25J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Increased heart rate 152 beat per min), MYALGIA (Body aches), PYREXIA (Fever of 102.7), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with ONDANSETRON for Myalgia, at a dose of 8 mg. At the time of the report, HEART RATE INCREASED (Increased heart rate 152 beat per min), MYALGIA (Body aches), PYREXIA (Fever of 102.7), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.7 (High) 102.7. On an unknown date, Heart rate: 152 (High) 152 beat per min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19 after the 1st dose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for Covid-19 after the 1st dose). At the time of the report, COVID-19 (tested positive for Covid-19 after the 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Red at the injection site; Minimally warm at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE WARMTH (Minimally warm at the injection site) 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 VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE WARMTH (Minimally warm at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE WARMTH (Minimally warm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information 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 the events, a causal relationship cannot be excluded.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Vaccination site erythema, Vaccination site warmth
Clinical narrative: warm to the touch; couldn't keep her eyes open; arm from shoulder to elbow started to get red; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), SOMNOLENCE (couldn't keep her eyes open), VACCINATION SITE ERYTHEMA (arm from shoulder to elbow started to get red) and FATIGUE (tired) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History reported).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), SOMNOLENCE (couldn't keep her eyes open), VACCINATION SITE ERYTHEMA (arm from shoulder to elbow started to get red) and FATIGUE (tired). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), SOMNOLENCE (couldn't keep her eyes open), VACCINATION SITE ERYTHEMA (arm from shoulder to elbow started to get red) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.