chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral, Swollen tongue
Clinical narrative: Swollen Tongue; Tingling lips; A metallic taste in the mouth; This spontaneous case was reported by a patient and describes the occurrence of SWOLLEN TONGUE (Swollen Tongue), PARAESTHESIA ORAL (Tingling lips) and DYSGEUSIA (A metallic taste in the mouth) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010821A) 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 02-Mar-2021, the patient experienced SWOLLEN TONGUE (Swollen Tongue), PARAESTHESIA ORAL (Tingling lips) and DYSGEUSIA (A metallic taste in the mouth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swollen tongue, Tingling lips and Taste metallic, at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Swollen Tongue), PARAESTHESIA ORAL (Tingling lips) and DYSGEUSIA (A metallic taste in the mouth) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Hypersensitivity, Pain, Pain in extremity
Clinical narrative: swollen arm; sore arm; warm sensation in arm; covid arm; red; itchy; sore; mettalic taste in her mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (mettalic taste in her mouth), HYPERSENSITIVITY (covid arm), ERYTHEMA (red), PRURITUS (itchy) and PAIN (sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 038AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (asthma) on 17-Jul-1968. Concomitant products included SALBUTAMOL SULFATE (PROVENTIL HFA [SALBUTAMOL SULFATE]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DYSGEUSIA (mettalic taste in her mouth). On 28-Feb-2021, the patient experienced HYPERSENSITIVITY (covid arm), ERYTHEMA (red), PRURITUS (itchy) and PAIN (sore). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm sensation in arm). On 19-Feb-2021, DYSGEUSIA (mettalic taste in her mouth) had resolved. At the time of the report, HYPERSENSITIVITY (covid arm), ERYTHEMA (red), PRURITUS (itchy) and PAIN (sore) outcome was unknown and PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm sensation in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: FU received VAERS addition of second dose information, addition of three new events swell arm, pain in arm and vaccination site warmth
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site warmth
Clinical narrative: swollen arm; sore arm; warm sensation in arm; covid arm; red; itchy; sore; mettalic taste in her mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (mettalic taste in her mouth), HYPERSENSITIVITY (covid arm), ERYTHEMA (red), PRURITUS (itchy) and PAIN (sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 038AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (asthma) on 17-Jul-1968. Concomitant products included SALBUTAMOL SULFATE (PROVENTIL HFA [SALBUTAMOL SULFATE]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DYSGEUSIA (mettalic taste in her mouth). On 28-Feb-2021, the patient experienced HYPERSENSITIVITY (covid arm), ERYTHEMA (red), PRURITUS (itchy) and PAIN (sore). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm sensation in arm). On 19-Feb-2021, DYSGEUSIA (mettalic taste in her mouth) had resolved. At the time of the report, HYPERSENSITIVITY (covid arm), ERYTHEMA (red), PRURITUS (itchy) and PAIN (sore) outcome was unknown and PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm sensation in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: FU received VAERS addition of second dose information, addition of three new events swell arm, pain in arm and vaccination site warmth
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: experience the cramping in his arms; experience the cramping in his calves; cramps woke him up at least five times; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (experience the cramping in his arms), MUSCLE SPASMS (experience the cramping in his calves) and MUSCLE SPASMS (cramps woke him up at least five times) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE SPASMS (experience the cramping in his arms), MUSCLE SPASMS (experience the cramping in his calves) and MUSCLE SPASMS (cramps woke him up at least five times). At the time of the report, MUSCLE SPASMS (experience the cramping in his arms), MUSCLE SPASMS (experience the cramping in his calves) and MUSCLE SPASMS (cramps woke him up at least five times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red Rash on left side of torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on left side of torso) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on left side of torso). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red Rash on left side of torso) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on left side of torso) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on left side of torso). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red Rash on left side of torso) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: vaccine injected it into the hanging flesh of her arm; A spontaneous report was received from a consumer concerning an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and expererienced the vaccine administered at the hanging flesh of her arm/inappropriate route of vaccination.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 011A21A) for prophylaxis of COVID-19 infection.  The patient stated that the vaccine was incorrectly administered, because they injected it into the hanging flesh of her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, inappropriate route of vaccination was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Inappropriate route of vaccination.  for mRNA-1273, lot #011A21Awith no associated AEs.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: back of tongue swelled up; throat swelled up; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (back of tongue swelled up) and PHARYNGEAL SWELLING (throat swelled up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfa).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced SWOLLEN TONGUE (back of tongue swelled up) and PHARYNGEAL SWELLING (throat swelled up). On 11-Feb-2021, SWOLLEN TONGUE (back of tongue swelled up) and PHARYNGEAL SWELLING (throat swelled up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment related information was reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Vaccine was administered 1ml instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and 1ml of dose instead of 0.5ml.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 014M20A) in right arm for prophylaxis of COVID-19 infection.   On 01 Mar 2021, pharmacist administered 1ml instead of 0.5ml of the vaccine to the patient (Accidental overdose).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event administered 1ml instead of 0.5ml of the vaccine to the patient is not applicable.  The outcome of the event administered 1ml instead of 0.5ml of the vaccine to the patient, was considered recovered.; Reporter's Comments: This report refers to a case of Accidental overdose for mRNA-1273, lot # 014M20A with no associated AEs.; Sender's Comments: MOD-2021-034019:Crosslink case. MOD-2021-034220:Crosslinked case.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: arm where she got the injection hurt so bad; chills; ran a temperature; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm where she got the injection hurt so bad), CHILLS (chills) and PYREXIA (ran a temperature) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-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 INJECTION SITE PAIN (arm where she got the injection hurt so bad), CHILLS (chills) and PYREXIA (ran a temperature). On 13-Feb-2021, INJECTION SITE PAIN (arm where she got the injection hurt so bad), CHILLS (chills) and PYREXIA (ran a temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient called to say she received the 2nd dose with no issues to report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Woke up with random hives/very mild hives) and PRURITUS (Itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced URTICARIA (Woke up with random hives/very mild hives) and PRURITUS (Itching). On 04-Mar-2021, URTICARIA (Woke up with random hives/very mild hives) and PRURITUS (Itching) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. On 04-Mar-2021, the patient woke up with random hives and itching but it was mild and unexpected. On 25-May-2021, the patient reported that the patient had very mild hives and itching that only lasted a couple of hours. Reportedly, the patient had received their second dose. No Concomitant product use was reported. The patient took antihistamine and felt relief. This case was linked to MOD-2021-169947. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up was received on received on 25-May-2021.Updated outcome of the events. Added treatment medication and updated the action taken.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Nasal congestion, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: COVID arm; Stuffy nose; drainage in throat; Plugged ears; right arm itching; right arm red; right arm hot; right arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm hurt a little), PRURITUS (right arm itching), ERYTHEMA (right arm red), SKIN WARM (right arm hot) and NASAL CONGESTION (Stuffy nose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (right arm hurt a little). On 12-Feb-2021, the patient experienced PRURITUS (right arm itching), ERYTHEMA (right arm red) and SKIN WARM (right arm hot). On 02-Mar-2021, the patient experienced NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL DISCOMFORT (drainage in throat) and EAR DISCOMFORT (Plugged ears). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). On 19-Feb-2021, PRURITUS (right arm itching), ERYTHEMA (right arm red) and SKIN WARM (right arm hot) had resolved. At the time of the report, PAIN IN EXTREMITY (right arm hurt a little), NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL DISCOMFORT (drainage in throat), EAR DISCOMFORT (Plugged ears) and VACCINATION SITE REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Cortisone Cream..
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin warm, Vaccination site reaction
Clinical narrative: COVID arm; Stuffy nose; drainage in throat; Plugged ears; right arm itching; right arm red; right arm hot; right arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm hurt a little), PRURITUS (right arm itching), ERYTHEMA (right arm red), SKIN WARM (right arm hot) and NASAL CONGESTION (Stuffy nose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (right arm hurt a little). On 12-Feb-2021, the patient experienced PRURITUS (right arm itching), ERYTHEMA (right arm red) and SKIN WARM (right arm hot). On 02-Mar-2021, the patient experienced NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL DISCOMFORT (drainage in throat) and EAR DISCOMFORT (Plugged ears). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). On 19-Feb-2021, PRURITUS (right arm itching), ERYTHEMA (right arm red) and SKIN WARM (right arm hot) had resolved. At the time of the report, PAIN IN EXTREMITY (right arm hurt a little), NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL DISCOMFORT (drainage in throat), EAR DISCOMFORT (Plugged ears) and VACCINATION SITE REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Cortisone Cream..
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Nausea; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) in a 65-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 03-Mar-2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his arm) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in his arm). At the time of the report, PAIN IN EXTREMITY (pain in his arm)  had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information was reported.    This case was linked to MOD-2021-030731 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: fever; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (fever) and DIARRHOEA (diarrhea). At the time of the report, PYREXIA (fever) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment RX not given Drinking Pedialyte.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vaccination site mass
Clinical narrative: Swelling on left side of neck / Bump in neck went away; Bump on his injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling on left side of neck / Bump in neck went away) and VACCINATION SITE MASS (Bump on his injection site arm) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING (Swelling on left side of neck / Bump in neck went away) and VACCINATION SITE MASS (Bump on his injection site arm). At the time of the report, SWELLING (Swelling on left side of neck / Bump in neck went away) and VACCINATION SITE MASS (Bump on his injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up appended. Outcome of event Neck swelling updated to Resolved
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy.    On 02-Mar-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 04-Nov-2020 and the estimated date of delivery was 16-Aug-2021. On 02-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 02-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not have any complications or acute illnesses during this pregnancy till date.  Treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Decreased appetite, Illness, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (pressure in stomach), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (did not feel like eating or drinking), ILLNESS (sick since couple of hours after the shot) and VOMITING (three up half hour ago/throw up was dark greenish) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (pressure in stomach), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (did not feel like eating or drinking), ILLNESS (sick since couple of hours after the shot), VOMITING (three up half hour ago/throw up was dark greenish) and NAUSEA (nausea). At the time of the report, ABDOMINAL DISCOMFORT (pressure in stomach), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (did not feel like eating or drinking), ILLNESS (sick since couple of hours after the shot), VOMITING (three up half hour ago/throw up was dark greenish) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (pressure in stomach), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (did not feel like eating or drinking), ILLNESS (sick since couple of hours after the shot) and VOMITING (three up half hour ago/throw up was dark greenish) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (pressure in stomach), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (did not feel like eating or drinking), ILLNESS (sick since couple of hours after the shot), VOMITING (three up half hour ago/throw up was dark greenish) and NAUSEA (nausea). At the time of the report, ABDOMINAL DISCOMFORT (pressure in stomach), ABDOMINAL PAIN UPPER (stomach pain), DECREASED APPETITE (did not feel like eating or drinking), ILLNESS (sick since couple of hours after the shot), VOMITING (three up half hour ago/throw up was dark greenish) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Myalgia, Pyrexia, Rash
Clinical narrative: could not raise her arm shoulder high; looked like a cherry; I looked like a cherry - had rash on my body - also spread to my arms and neck; Muscle was so sore, could not raise arm shoulder high; That night, she started getting a pressure headache; running a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (could not raise her arm shoulder high), SWELLING FACE (looked like a cherry), RASH (I looked like a cherry - had rash on my body - also spread to my arms and neck), PYREXIA (running a low grade fever) and MYALGIA (Muscle was so sore, could not raise arm shoulder high) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D10A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Cholesterol and Ear infection NOS (Dexamethasone for ear). Concomitant products included DEXAMETHASONE for Ear infection NOS, POTASSIUM and MAGNESIUM for an unknown indication.   On 01-Mar-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PYREXIA (running a low grade fever) and HEADACHE (That night, she started getting a pressure headache). On 01-Mar-2021 at 2:00 PM, the patient experienced MYALGIA (Muscle was so sore, could not raise arm shoulder high). On 02-Mar-2021, the patient experienced HYPOKINESIA (could not raise her arm shoulder high), SWELLING FACE (looked like a cherry) and RASH (I looked like a cherry - had rash on my body - also spread to my arms and neck). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 01-Mar-2021 for Headache, at a dose of 2 dosage form and MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) (topical) on 02-Mar-2021 for Myalgia, at a dose of 1 dosage form. On 03-Mar-2021, MYALGIA (Muscle was so sore, could not raise arm shoulder high) outcome was unknown. At the time of the report, HYPOKINESIA (could not raise her arm shoulder high), SWELLING FACE (looked like a cherry), PYREXIA (running a low grade fever) and HEADACHE (That night, she started getting a pressure headache) outcome was unknown and RASH (I looked like a cherry - had rash on my body - also spread to my arms and neck) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: could not raise her arm shoulder high; looked like a cherry; I looked like a cherry - had rash on my body - also spread to my arms and neck; Muscle was so sore, could not raise arm shoulder high; That night, she started getting a pressure headache; running a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (could not raise her arm shoulder high), SWELLING FACE (looked like a cherry), RASH (I looked like a cherry - had rash on my body - also spread to my arms and neck), PYREXIA (running a low grade fever) and MYALGIA (Muscle was so sore, could not raise arm shoulder high) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D10A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Cholesterol and Ear infection NOS (Dexamethasone for ear). Concomitant products included DEXAMETHASONE for Ear infection NOS, POTASSIUM and MAGNESIUM for an unknown indication.   On 01-Mar-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PYREXIA (running a low grade fever) and HEADACHE (That night, she started getting a pressure headache). On 01-Mar-2021 at 2:00 PM, the patient experienced MYALGIA (Muscle was so sore, could not raise arm shoulder high). On 02-Mar-2021, the patient experienced HYPOKINESIA (could not raise her arm shoulder high), SWELLING FACE (looked like a cherry) and RASH (I looked like a cherry - had rash on my body - also spread to my arms and neck). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 01-Mar-2021 for Headache, at a dose of 2 dosage form and MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) (topical) on 02-Mar-2021 for Myalgia, at a dose of 1 dosage form. On 03-Mar-2021, MYALGIA (Muscle was so sore, could not raise arm shoulder high) outcome was unknown. At the time of the report, HYPOKINESIA (could not raise her arm shoulder high), SWELLING FACE (looked like a cherry), PYREXIA (running a low grade fever) and HEADACHE (That night, she started getting a pressure headache) outcome was unknown and RASH (I looked like a cherry - had rash on my body - also spread to my arms and neck) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling hot, Oropharyngeal pain, Pain
Clinical narrative: Some chills; Fuzzy, woozy head; Mild sore throat; Achy; Started feeling warm/had hot sensations; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Started feeling warm/had hot sensations), FEELING ABNORMAL (Fuzzy, woozy head), OROPHARYNGEAL PAIN (Mild sore throat), PAIN (Achy) and CHILLS (Some chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease, Hypothyroidism, Digestion impaired and Sulfonamide allergy (sulfa+ sulfites). Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, THYROID (ARMOUR THYROID) and LEVOTHYROXINE, LIOTHYRONINE (LEVOTHYROXINE AND LIOTHYRONINE [LEVOTHYROXINE;LIOTHYRONINE]) for Hypothyroidism, FAMOTIDINE (PEPCID AC) and PROGESTERONE for an unknown indication, VITAMIN D3.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING HOT (Started feeling warm/had hot sensations). On 28-Feb-2021, the patient experienced FEELING ABNORMAL (Fuzzy, woozy head), OROPHARYNGEAL PAIN (Mild sore throat) and PAIN (Achy). On an unknown date, the patient experienced CHILLS (Some chills). At the time of the report, FEELING HOT (Started feeling warm/had hot sensations), FEELING ABNORMAL (Fuzzy, woozy head), OROPHARYNGEAL PAIN (Mild sore throat) and PAIN (Achy) outcome was unknown and CHILLS (Some chills) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took multivitamin for unknown indication.  Patient stopped taking Pepcid AC from 05-???-2021.  Patient stopped taking progesterone from 03-???-2021  Patient started taking Levothyroxine from 12-???-2020   This case was linked to MOD-2021-060912.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up information received on 04-MAY-2021 contains no new information. On 29-Jun-2021: Updated patient's height, weight, race information, added medical history, concomitant drug information and event as chills and out come of the event of chills.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Fatigue, Vaccination site pain
Clinical narrative: fatigue; pain at injection site; lower abdominal pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN LOWER (lower abdominal pain), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (lower abdominal pain) and VACCINATION SITE PAIN (pain at injection site). On 03-Feb-2021, the patient experienced FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. On 05-Feb-2021, ABDOMINAL PAIN LOWER (lower abdominal pain) had resolved. On 06-Feb-2021, FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysphagia, Lymphadenopathy, Neck pain, Pain
Clinical narrative: inflammation around lymph nodes in their neck; Neck pain; Pain spread from ear to clavicle; trouble swallowing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain), PAIN (Pain spread from ear to clavicle), DYSPHAGIA (trouble swallowing) and LYMPHADENOPATHY (inflammation around lymph nodes in their neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced NECK PAIN (Neck pain), PAIN (Pain spread from ear to clavicle) and DYSPHAGIA (trouble swallowing). On 14-Feb-2021, the patient experienced LYMPHADENOPATHY (inflammation around lymph nodes in their neck). At the time of the report, NECK PAIN (Neck pain), PAIN (Pain spread from ear to clavicle), DYSPHAGIA (trouble swallowing) and LYMPHADENOPATHY (inflammation around lymph nodes in their neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Computerised tomogram: inflammation around lymph nodes in neck inflammation around lymph nodes in neck.     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.   No relevant concomitant medications were reported. Treatment details were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: under eye swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EYE SWELLING (under eye swelling) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included HYDROCORTISONE for an unknown indication.    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 EYE SWELLING (under eye swelling). The patient was treated with HYALURONIC ACID, LIDOCAINE (RESTYLANE L) at a dose of 1 dosage form. At the time of the report, EYE SWELLING (under eye swelling) was resolving. 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.   Other concomitant medications include allergy medications   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: No new information
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19 after first 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19 after first dose). At the time of the report, COVID-19 (tested positive for COVID-19 after first dose) outcome was unknown. Not Provided    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) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Muscle tightness, Tachycardia
Clinical narrative: felt heart start to beat very fast/felt heart accelerating; chest pain; muscle tension; This spontaneous case was reported by a health care professional and describes the occurrence of TACHYCARDIA (felt heart start to beat very fast/felt heart accelerating), CHEST PAIN (chest pain) and MUSCLE TIGHTNESS (muscle tension) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TACHYCARDIA (felt heart start to beat very fast/felt heart accelerating), CHEST PAIN (chest pain) and MUSCLE TIGHTNESS (muscle tension). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (felt heart start to beat very fast/felt heart accelerating), CHEST PAIN (chest pain) and MUSCLE TIGHTNESS (muscle tension) 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.   Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruising; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising) 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 CONTUSION (bruising). At the time of the report, CONTUSION (bruising) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 25-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included Thyroid disorder NOS (found out  when pregnant for first time) and Drug allergy (Ibuprofen). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 17-Dec-2020 and the estimated date of delivery was 06-Oct-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Previous pregnancy end date included 12-26-2019 with live birth.  No treatment information provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: temperature of 99.8 F; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (temperature of 99.8 F) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temperature of 99.8 F). At the time of the report, PYREXIA (temperature of 99.8 F) 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.