chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: heaviness in breathing/shortness of breath; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, heaviness in breathing/shortness of breath.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11/Jan/2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 12-JAN-2021, the patient experienced event, heaviness in breathing/shortness of breath.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event, heaviness in breathing/shortness of breath was not reported.   On 13-JAN-2021, the outcome of event, heaviness in breathing/shortness of breath was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; A spontaneous report was received from a consumer concerning 70 years old, female patient who experienced Sore arm.  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 012620A  on 17-Jan-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced Sore arm since 18-Jan-2021. Treatment information was unknown.   Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the reported event Sore arm was not reported.   Company Comment: The reported event, Sore arm was considered possible to mRNA-1273.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: the arm where I received the shot is sore; A spontaneous report \was received from a Consumer concerning a  51-Years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness on left arm where she received the shot.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 24th Dec 2020, prior to the onset of the event, the patient received their first of dose of mRNA-1273 (lot/Batch No: 039K20A) intramuscularly in the left arm  for prophylaxis of COVID-19 infection.  On 24th Dec 2020, the patient experienced the soreness on her left arm where she received vaccine.  Laboratory details not provided.  She used to treat with  Bengay on the area for soreness.  Action taken with mRNA-1273 in response to the events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 3hs after vaccination she felt lots of itching, diffused all over her body; 1 hive, very small on her neck; A spontaneous report was received from a nurse concerning a 31 years old, female patient who experienced itching all over and hive on her neck.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, Concomitant product use was not provided by the reporter.   On 31-Dec-2020, approximately 3 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A ) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced itching all over the body and hive on neck since 31-Dec-2020.Treatment for the event included [List all drug and non-drug therapies administered to treat the event] OR Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event(s), itching all over and hive on neck, were considered recovered/resolved on 02-Jan-2021.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Minimal swelling of her throat; A spontaneous report was received from a physician, concerning a female patient of unspecified age, who received Moderna's COVID-19 Vaccine and experienced minimal swelling of her throat.  The patient's medical history was not provided. Concomitant product use was not provided.  On 17-Jan-2021, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (batch number 41620A) intramuscularly for COVID-19 infection prophylaxis.   On 17-Jan-2021, the patient complained of minimal swelling of her throat. The swelling got resolved in about an hour and there was no effect on respiration. The patient did not seek medical attention or treatment. Reporter denied consent to follow-up.  Action taken with mRNA-1273 in response to the event was not provided.  The event, minimal swelling of her throat, was considered resolved on 17-Jan-2021.; Reporter's Comments: This spontaneous report concerns a female patient who experienced an event of minimal swelling of her throat. The event occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 41620A, expiration date-Unknown).  No treatment was administered and the event resolved 1 hour later.  Based on the information provided, which includes a strong temporal association between the reported event of minimal swelling of her throat and the administration of mRNA-1273 vaccine,  a causal association cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: headache; nausea; Fever 100 degrees; A spontaneous report  was received from a consumer concerning herself a male patient of age 78-years-old received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a headache, nausea and a fever 100 Degrees.  The patient's medical history was not provided. Concomitant medications were not reported by reporter.  On 24 Jan 2021, prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch:030L20A) intramuscularly for prophylaxis of COVID-19 infection.   After vaccination he experienced headache, nausea and a fever 100 Degrees and   want to know whether he can take Tylenol, but he said he is feeling better now.  Action taken with mRNA-1273 in response to the events was unknown.   On unknown date the outcome of event(s), headache, nausea and a fever 100 Degrees was resolve
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pain in extremity, Rash
Clinical narrative: inflammatory response; sore arm; redness; rash; A spontaneous report was received from a  health care professional  concerning about a 60 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, redness/erythema, pain in arm/pain in extremity and inflammatory reaction/inflammation.  The patient's medical history was reported as have hypothyroidism.  Concomitant medications were reported as having medication levothyroxine sodium.  On 05 Jan 2021, prior to the onset of the events, the patient received their first planned doses of mRNA-1273 (Batch number: 026L20A) via intramuscular in left deltoid for the prophylaxis of COVID-19 infection.  On 05 Jan 2021, same day of vaccination the patient experienced events sore arm, redness and rash.  On 15 Jan 2021, the rashes came back.  On 17 Jan 2021, patient seeks medical consult and advised that rash might be an inflammatory response and a beginning of cellulitis (not certain).  Laboratory details was not provided.  Treatment information was provided as patient prescribed to take hydrocortisone steroid cream, anti-bacterial cream and benadryl.  On 06 Jan 2021, the events sore arm, redness and rash resolved.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of the event which reappeared remain unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Flatulence, Headache, Injection site pain
Clinical narrative: Headache; Diarrhea; Gas; Stomach Rumbling; Nausea; Severe Injection Site Pain; This spontaneous case was reported by an occupational therapist and describes the occurrence of DIARRHOEA (Diarrhea), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach Rumbling), NAUSEA (Nausea) and INJECTION SITE PAIN (Severe Injection Site Pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-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 DIARRHOEA (Diarrhea), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach Rumbling), NAUSEA (Nausea) and INJECTION SITE PAIN (Severe Injection Site Pain). On 16-Jan-2021, the patient experienced HEADACHE (Headache). On 15-Jan-2021, INJECTION SITE PAIN (Severe Injection Site Pain) had resolved. On 16-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, DIARRHOEA (Diarrhea), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach Rumbling) and NAUSEA (Nausea) had not 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.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Headache; Diarrhea; Gas; Stomach Rumbling; Nausea; Severe Injection Site Pain; This spontaneous case was reported by an occupational therapist and describes the occurrence of DIARRHOEA (Diarrhea), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach Rumbling), NAUSEA (Nausea) and INJECTION SITE PAIN (Severe Injection Site Pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-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 DIARRHOEA (Diarrhea), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach Rumbling), NAUSEA (Nausea) and INJECTION SITE PAIN (Severe Injection Site Pain). On 16-Jan-2021, the patient experienced HEADACHE (Headache). On 15-Jan-2021, INJECTION SITE PAIN (Severe Injection Site Pain) had resolved. On 16-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, DIARRHOEA (Diarrhea), FLATULENCE (Gas), ABDOMINAL DISCOMFORT (Stomach Rumbling) and NAUSEA (Nausea) had not 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.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rash
Clinical narrative: rash on left side of the face; chills in her hands; Case reference number MOD-2021-008781 is a spontaneous case report sent by a Non-Health Professional on 18-JAN-2021, which refers to a Female aged 78 Years .  On 15Jan2021  the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. 2 days later, the patient developed chills in her hands, the patient also developed rash on left side of the face.    The Non-Health Professional did not declare any relatedness between chills in her hands and Moderna COVID-19 Vaccine In their opinion,   PMH includes Covid infection in May2020. No further information provided. Caller consents to follow up.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age- 78 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: Bruise at injection site; Sore arm; Puffy at injection site; Slight headache; A spontaneous report was received from a HCP and Consumer concerning a 48 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events:  headache, injection site pain, vaccination site swelling, vaccination site bruising.  The patient's medical history was not provided. Relevant concomitant medications include Thyroid pill.    On 10JAN2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient stated that, on 10 JAN 2021, she had a slight headache through night. On 11 JAN 2021, she also experienced sore arm, puffy at the injection site. lastly, around the 14 JAN 2021, she started noticing there was a bruise. She wanted to know whether she should take the vaccine in the same arm are or not  Laboratory details were not provided.  The patient took Ibuprofen for the treatment of symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   On date, the outcome of the events: headache, injection site pain, vaccination site swelling, vaccination site bruising was unknown.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; congestion; runny nose; Muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), MYALGIA (Muscle pain) and CHILLS (chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), MYALGIA (Muscle pain) and CHILLS (chills). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), MYALGIA (Muscle pain) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Gastrooesophageal reflux disease
Clinical narrative: GERD acting up; Ice cold feeling her chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (GERD acting up) and FEELING COLD (Ice cold feeling her chest) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included GERD on 15-Jan-2021 and Acute bronchitis on 15-Jan-2021.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD acting up) and FEELING COLD (Ice cold feeling her chest). On 15-Jan-2021, GASTROOESOPHAGEAL REFLUX DISEASE (GERD acting up) and FEELING COLD (Ice cold feeling her chest) had resolved.        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. Treatment included a heating pad.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: After I went to bed, I had to get up to urinate every 15 minutes and it is still occuring today; A spontaneous report was received from a consumer concerning a 86 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after I went to bed, I had to get up to urinate every 15 minutes and it is still occuring today.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18/Jan/2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: or unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18-JAN-2021, the patient experienced event, after I went to bed, I had to get up to urinate every 15 minutes and it is still occuring today.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event, after I went to bed, I had to get up to urinate every 15 minutes and it is still occuring today was not reported.   On an unknown date the outcome of event, after I went to bed, I had to get up to urinate every 15 minutes and it is still occuring today was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Small red spot increased in size; Low grade fever; A spontaneous report was received from a consumer who was also a female patient who received Moderna's COVID-19 vaccine on 15 Jan 2021 and experienced small red spot increased in size and low-grade fever. Patient's medical history and concomitant medicines were not reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced small red spots increased in size and low grade fever and took some aspirin after. Treatment included Aspirin Action taken with mRNA-1273 was not reported. The outcome of the events, small red spots increased in size and low grade fever  was considered unknown.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dizziness, Hot flush, Injected limb mobility decreased
Clinical narrative: Hot flashes; Loss of mobility lasting 36 hours; bone aches; fever; full chills; light headed and dizzy towards evening of that day; A spontaneous report was received from a consumer who was an 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, hot flashes, Loss of mobility lasting 36 hours, light headed and dizzy, bone aches and fever  The patient's medical history was not provided. The concomitant medications reported included tramadol, trazodone, zolpidem, hydroxyzine, gabapentin, tamsulosin, primidone, atorvastatin, montelukast, pantoprazole, fluoxetine, losartan, glipizide, clopidogrel, armodafinil, metformin and furosemide for unspecified indications.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same evening, the patient experienced, lightheaded and dizzy. The treatment for the events included paracetamol.  On 12 Jan 2021, the patient developed, chills, bone aches and fever. The treatment for the events included paracetamol.  On 17 Jan 2021, the patient reported experiencing hot flashes, chills and loss of mobility lasting 36 hours on an unknown date. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, chills and hot flashes was unknown.  The events, bone aches and fever were considered resolved on 18 Jan 2021.  The events, loss of mobility lasting 36 hours, lightheaded and dizzy was considered resolved on an unknown date.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Hot flashes; Loss of mobility lasting 36 hours; bone aches; fever; full chills; light headed and dizzy towards evening of that day; A spontaneous report was received from a consumer who was an 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, hot flashes, Loss of mobility lasting 36 hours, light headed and dizzy, bone aches and fever  The patient's medical history was not provided. The concomitant medications reported included tramadol, trazodone, zolpidem, hydroxyzine, gabapentin, tamsulosin, primidone, atorvastatin, montelukast, pantoprazole, fluoxetine, losartan, glipizide, clopidogrel, armodafinil, metformin and furosemide for unspecified indications.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same evening, the patient experienced, lightheaded and dizzy. The treatment for the events included paracetamol.  On 12 Jan 2021, the patient developed, chills, bone aches and fever. The treatment for the events included paracetamol.  On 17 Jan 2021, the patient reported experiencing hot flashes, chills and loss of mobility lasting 36 hours on an unknown date. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, chills and hot flashes was unknown.  The events, bone aches and fever were considered resolved on 18 Jan 2021.  The events, loss of mobility lasting 36 hours, lightheaded and dizzy was considered resolved on an unknown date.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site itchiness; Injection site redness; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchiness), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchiness), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE PRURITUS (Injection site itchiness), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: Chills; Fatigue; Muscle pain and joint pain; Joint pain; Case reference number MOD-2021-008820 is a spontaneous case report sent by a Physician on 18-JAN-2021  which refers to a Male aged 53 years.  On 07jan2021 the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination.10 days later,  the patient experienced Chills. Patient also developed Fatigue, Muscle  pain and joint pain, Joint pain.   The health care professional did not provided any relatedness between Chills and Moderna COVID-19 Vaccine  .  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.   Brief 3 line summary of above listing: Report Source- Physician,  Age-  ,  Sex- Male,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Chills - Not Recovered/Not Resolved, Joint pain - Not Recovered/Not Resolved, Muscle pain and joint pain - Not Recovered/Not Resolved, Fatigue - Not Recovered/Not Resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A spontaneous report was received from a consumer concerning a 73-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left arm sore/pain in extremity. The patient's medical history, as provided by the reporter included sinus infection and COVID-19. No 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 number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the night of 15 Jan 2021, the patient's left arm was sore and it was annoying. She had no other side effects. On a scale of 1-10 it was about a 6-7.  Treatment for the event were not reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, sore arm is unknown.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: only gave him 1/2 of the normal dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (only gave him 1/2 of the normal dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included HIV positive, Stroke, Arthritis and Open heart surgery. Concomitant products included SACCHARATED IRON OXIDE (joluka) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 16-Jan-2021, the patient experienced INCORRECT DOSE ADMINISTERED (only gave him 1/2 of the normal dose). On 16-Jan-2021, INCORRECT DOSE ADMINISTERED (only gave him 1/2 of the normal dose) had resolved.            concomitant medications included psychotic medication, blood thinners. No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site rash
Clinical narrative: red rash around injection site; red rash around injection injection site of the size of half a dollar, not raised, big red circle; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (red rash around injection site) 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 06-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 VACCINATION SITE RASH (red rash around injection site). At the time of the report, VACCINATION SITE RASH (red rash around injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Soreness arm; General ache; Tenderness at the injection site; Chills; Headache; Case reference number MOD-2021-008833 is a spontaneous case report sent by a Non-Health Professional on 18-JAN-2021 00:00:00 , which refers to a Female aged   .  On  17-JAN-2021  the patient started taking Moderna COVID-19 Vaccine .  later,  the patient developed Pain in arm. Over a period of the next days, the patient also developed Injection site tenderness,Chills,Headache,Ache NOS. The patient experienced the following serious criteria:. The eventual diagnosis made on was Pain in extremity . .  An autopsy was performed on . The Non-Health Professional did not declare any relatedness between Soreness arm and Moderna COVID-19 Vaccine.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .    Narrative (for narratives and signal review) Brief 3 line summary of above for ADR listing: Report Source- Non-Health Professional,  Age-  ,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; rash chest, both arms and face; A spontaneous report was received from a consumer who was 69 years old male patient who received Moderna's COVID-19 vaccine and experienced itching, rash chest, both arms and face. Patients medical history  showed that he had allergy to raw peanuts, fresh berries and seasonal allergies. His concomitant medications were  not provided.   On 6th January 2021, the patient received1 dose of   mRNA-1273 vaccine intramuscularly.   On 07-JAN-2021, the patient felt itching ,rash chest, both arms and face.  On 12-JAN-2021 ,the patient spoke to the physician and he was treated with Claritin, Hydrocortisone 2.5%, Soap and Aloe Vera lotion.  Action taken with  mRNA-1273 was not reported.  The outcome of the events, itching, rash chest, both arms and face was considered as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left arm and leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on left arm and leg) 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-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 RASH (Rash on left arm and leg). At the time of the report, RASH (Rash on left arm and leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid; A spontaneous report was received from a Consumer concerning a 55-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history includes obesity and diabetes.  Concomitant medications were not reported.  On 31st Dec 2020, prior to the onset of events the patient received their first dose of mRNA-1273 (batch/ lot # 011L20A) for prophylaxis of COVID-19 infection.  On 7th JAN 2021 the patient was exposed to someone with COVID -19 and tested positive for Covid on 13th JAN 2021.  Laboratory details was not provided.  Treatment was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was considered as Unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive after 1st dose; A spontaneous report was received from a consumer concerning a 77-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive after first dose/COVID-19.  The patient's medical history, was not provided by the reporter. No concomitant medications were reported.   On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient tested positive for COVID-19.  Treatment for the event were not reported. Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event tested positive was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: rash down one side of her neck and the upper part of her chest; warm to touch; itchy; A spontaneous report was received from a consumer via voicemail  concerning a 59 years old female  patient who received Moderna's Covid-19 vaccine (mRNA-1273) and  experienced slight rash down one side of her neck and the upper part of her chest . It has gotten slightly worse. It was warm to touch and slightly itchy. Upon callback, patient confirmed information provided.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.      The patient received their first dose of mRNA-1273 (Batch number not provided) on 12-JAN-2021 and developed a slight rash down one side of her neck and the upper part of her chest. It has gotten slightly worse. It is warm to the touch and slightly itchy. She stated that the rash has deepened and she assumed it was related to the shot.   Treatment for the event included Prednisolone ( one week course) ,to which the rash has been responding. She also took Benadryl before for the rash. She plans to get the second dose unless told otherwise. Her HCP encouraged her to get the second shot and did not think it was a severe reaction   The outcome of the events were Recovering/Resolving.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea;Case reference number MOD-2021-008851 is a spontaneous case report sent by a Other Health Professional on 17-JAN-2021, which refers to a Female aged 51 Years .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  6 days later,  the patient developed Diarrhea.  No treatment was undertaken for the event.  The action taken for Moderna COVID-19 Vaccine was  Unknown. The Other Health Professional did not declare any relatedness between Diarrhea and Moderna COVID-19 Vaccine.    Narrative (for narratives and signal review) Brief 3 line summary of above for ADR listing: Report Source- Other Health Professional,  Age- 51 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Diarrhea - Recovered/Resolved.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itching was so unbearable which spread from the injection site to the elbow and; Itching at injection site; Arm was painful; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), PRURITUS (Itching was so unbearable which spread from the injection site to the elbow and), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE PAIN (Arm was painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE PAIN (Arm was painful). On an unknown date, the patient experienced PRURITUS (Itching was so unbearable which spread from the injection site to the elbow and). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm was swollen), PRURITUS (Itching was so unbearable which spread from the injection site to the elbow and), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE PAIN (Arm was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided/unknown.   This case was linked to MOD-2021-231454 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Added reporter information.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: pain in the arm; typical soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE PAIN (typical soreness at the injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE PAIN (typical soreness at the injection site). On 09-Jan-2021, PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE PAIN (typical soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took ibuprofen 200mg on second night to help with the symptoms
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Tenderness
Clinical narrative: Fatigue; Arm soreness; Big tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), TENDERNESS (Big tenderness) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (Big tenderness). On 13-Jan-2021, the patient experienced FATIGUE (Fatigue). On 14-Jan-2021, FATIGUE (Fatigue) had resolved. On 15-Jan-2021, PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (Big tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination complication
Clinical narrative: very bad reaction; has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very bad reaction) and CONDITION AGGRAVATED (has gotten worse) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 VACCINATION COMPLICATION (very bad reaction) and CONDITION AGGRAVATED (has gotten worse). At the time of the report, VACCINATION COMPLICATION (very bad reaction) and CONDITION AGGRAVATED (has gotten worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia, Nausea
Clinical narrative: Diarrhea; Nausea; Body ache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and MYALGIA (Body ache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and MYALGIA (Body ache). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and MYALGIA (Body ache) outcome was unknown. 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.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: The bottom of her feet hurt; Kind of tired; Body aches; Joint cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The bottom of her feet hurt), FATIGUE (Kind of tired), MYALGIA (Body aches) and ARTHRALGIA (Joint cramps) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient stated she had COVID-19 approximately 60 days ago.) in October 2020.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced PAIN IN EXTREMITY (The bottom of her feet hurt), MYALGIA (Body aches) and ARTHRALGIA (Joint cramps). 27-Dec-2020, the patient experienced FATIGUE (Kind of tired). At the time of the report, PAIN IN EXTREMITY (The bottom of her feet hurt), FATIGUE (Kind of tired), MYALGIA (Body aches) and ARTHRALGIA (Joint cramps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: positive Date of test not provided. Approximately 60 days ago..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant products were reported. patient took acetaminophen and ibuprofen every 4 to 6 hours alternating for treatment.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: no new information, its not a follow up received.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus
Clinical narrative: arm started to itch like crazy; arm got a little red around the shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm started to itch like crazy) and INJECTION SITE ERYTHEMA (arm got a little red around the shot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease (has Grave's disease but doesn't know if she is immunosuppressed.), Iodine allergy, Penicillin allergy, Shellfish allergy and Seafood allergy.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PRURITUS (arm started to itch like crazy) and INJECTION SITE ERYTHEMA (arm got a little red around the shot). At the time of the report, PRURITUS (arm started to itch like crazy) and INJECTION SITE ERYTHEMA (arm got a little red around the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes Cholesterol medication and thyroid medication concomitantly regularly. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: Fax number provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Tongue discomfort, Vaccination site bruising
Clinical narrative: felt a little warmth in their body that passed quickly; tong begun to burn, like when one eats spicy food and still remains, but it is fading; arm also developed a little black and blue (bruise) on the site of the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (felt a little warmth in their body that passed quickly), TONGUE DISCOMFORT (tong begun to burn, like when one eats spicy food and still remains, but it is fading) and VACCINATION SITE BRUISING (arm also developed a little black and blue (bruise) on the site of the injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FEELING HOT (felt a little warmth in their body that passed quickly), TONGUE DISCOMFORT (tong begun to burn, like when one eats spicy food and still remains, but it is fading) and VACCINATION SITE BRUISING (arm also developed a little black and blue (bruise) on the site of the injection). On 16-Jan-2021, FEELING HOT (felt a little warmth in their body that passed quickly) had resolved. At the time of the report, TONGUE DISCOMFORT (tong begun to burn, like when one eats spicy food and still remains, but it is fading) and VACCINATION SITE BRUISING (arm also developed a little black and blue (bruise) on the site of the injection) 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.