chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth, Vaccination site pain
Clinical narrative: A spontaneous report (United States) was received from a patient concerning a 80-year-old, male patient,who received Moderna's COVID-19 vaccifene (mRNA-1273) and experienced  sore in her arm, injection site reaction like injection site rash, injection site erythema, injection site warmth, red and hot and kind of itchy. The patient's medical history was not  provided by the reporter. Concomitant medications reported included eicuted (blood thinner), pilutacion, pills for depression, liver low zero, function, baby aspirineAcetyl salicyclic acid), night ambiom for sleep, vitamins. On 03-FEB_2021, approximately six days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 03_FEB-2021, prior to receiving mRNA-1273, the patient felt sore in her arm, injection site reaction like injection site rash, injection site erythema, injection site warmth, red and hot and kind of itchy. lab report results were not provided. Treatment for the events were not included. Action taken with mRNA-1273 in response to the events was Unknown. The outcome of the events were not recovered or not resolved. Based on MSA comment, sore in her arm change to vaccination site pain and listed in all RSIs
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, the patient received dose of mRNA-1273 (lot/batch: unknown) unknown route for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event was unknown.  Based on comment Pyrexia is Listed in CCDS also
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: red rash on arm after receiving vaccine; A Spontaneous report was received from consumer concerning a 64 Year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red rash on arm. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 21 Jan 2021  , prior to the onset of the events, the patient received their first  planned dose of mRNA-1273 (Lot number: Unknown)  via unknown route and  unknown anatomical location for prophylaxis of COVID-19 infection.  On 21 Jan 2021 patient had a red rash on arm after receiving the vaccine. She wanted to know efficacy of first dose because might not be able to get the second dose due to bad weather. Caller had given consent for follow up.  Action taken with mRNA-1273 in response to the events was reported unknown. The outcome for the red rash on arm was considered unknown.  Based on MSA comment, vaccination site rash is Listed in CCDS also
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced joint pain. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. And wants to know the effectiveness after the second dose. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, joint pain was considered to be not resolved at the time of this report.  Based on MSA comment, joint pain is Listed in all RSIs
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin reaction, Wound
Clinical narrative: There are new lesions; rash being a delayed reaction and lasting for 4 weeks; Rash initially on her anterior chest and rash is still spreading to other parts; This spontaneous case was reported by a health care professional and describes the occurrence of WOUND (There are new lesions), SKIN REACTION (rash being a delayed reaction and lasting for 4 weeks) and RASH (Rash initially on her anterior chest and rash is still spreading to other parts) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 RASH (Rash initially on her anterior chest and rash is still spreading to other parts). On an unknown date, the patient experienced WOUND (There are new lesions) and SKIN REACTION (rash being a delayed reaction and lasting for 4 weeks). At the time of the report, WOUND (There are new lesions) and RASH (Rash initially on her anterior chest and rash is still spreading to other parts) had not resolved and SKIN REACTION (rash being a delayed reaction and lasting for 4 weeks) 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 product use was not provided by the reporter. Treatment information included topical steroid. She responded to topical steroid, but the rash is still spreading to other parts and there are new legions over the 4 weeks. They are not itchy.   Company comment 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.; 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site warmth, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: arm hurt; on the injection site which was hot; dramatic red circle, pretty big about 10 inches by 8 inches, erythema 10 x 8 cm in size; on the injection site which was painful; A spontaneous report was received from a health care professional regarding a 60 year old male patient who experienced red circle around injection site and erythrema after the 12th day of administion of vaccine. The patients medical history is not provided. Concomittant product usage was not provided.  The patient received 1st dose of mRNA-1273 on 23 Jan 2021  in the right arm , Batch Number 012L20A for prophylaxis of covid 19 infection. Treatment information was not provided. She gave her consent for follow up. Lab parameters and no other reactions are reported. Action taken with mRNA-1273 in response to the event was not provided. She wants to know whether she can take the second dose.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: soreness in arm; lymph node on same arm has a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in arm) and VACCINATION SITE LYMPHADENOPATHY (lymph node on same arm has a burning sensation) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B(or D) 32L20A) for an unknown indication.     The patient's past medical history included Hypertension and High cholesterol.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in arm) and VACCINATION SITE LYMPHADENOPATHY (lymph node on same arm has a burning sensation). At the time of the report, VACCINATION SITE PAIN (soreness in arm) and VACCINATION SITE LYMPHADENOPATHY (lymph node on same arm has a burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified cholesterol pill, blood pressure pill and thyroid pill.  No treatment information was provided.  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.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema
Clinical narrative: left arm red (injection site); left arm itchy (injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left arm red (injection site)) and INJECTION SITE PRURITUS (left arm itchy (injection site)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION SITE ERYTHEMA (left arm red (injection site)) and INJECTION SITE PRURITUS (left arm itchy (injection site)). At the time of the report, VACCINATION SITE ERYTHEMA (left arm red (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. It is reported that patient is taking (glifotes 5ml) for diabetes type 2 and for treating high blood pressure.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: developed fever temperature of 101.4F; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) for and experienced fever temperature of 101.4F.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event a fever with a  temperature of 101.4F.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event fever temperature of 101.4F. was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, COVID-19, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: thinks her symptoms were mild because of the first dose of the vaccine; only a little congested; tested positive for COVID; mild symptoms, sneezing and runny nose; mild symptoms, sneezing and runny nose; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (mild symptoms, sneezing and runny nose), RHINORRHOEA (mild symptoms, sneezing and runny nose), COVID-19 (tested positive for COVID), NASAL CONGESTION (only a little congested) and ASYMPTOMATIC COVID-19 (thinks her symptoms were mild because of the first dose of the vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE), MULTIVITAMIN & MINERAL, FISH OIL and CALCIUM, COLECALCIFEROL (CALCIUM WITH D3) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SNEEZING (mild symptoms, sneezing and runny nose) and RHINORRHOEA (mild symptoms, sneezing and runny nose). On 17-Feb-2021, the patient experienced COVID-19 (tested positive for COVID). On 19-Feb-2021, the patient experienced NASAL CONGESTION (only a little congested). On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (thinks her symptoms were mild because of the first dose of the vaccine). The patient was treated with GUAIFENESIN (MUCINEX) at a dose of Unknown and PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, SNEEZING (mild symptoms, sneezing and runny nose), RHINORRHOEA (mild symptoms, sneezing and runny nose), COVID-19 (tested positive for COVID), NASAL CONGESTION (only a little congested) and ASYMPTOMATIC COVID-19 (thinks her symptoms were mild because of the first dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, COVID-19: positive and 11-feb-2021 negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received significant information. Event outcome updated to resolved and patient declined further follow-up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Dizziness, Fatigue, Headache
Clinical narrative: THROAT FELT SWOLLEN; TONGUE FELT SWOLLEN; clammy; EXHAUSTED; MUSCLE PAIN; nausea; JOINT PAIN; CHEEKS FELT PUFFY; DIZZY; HEADACHE; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, dizzy, headache, throat felt swollen, tongue felt swollen, cheeks felt puffy, clammy, exhausted, muscle pain, joint pain, nausea.  The patient's medical history was  provided asthma for current condition. No relevant concomitant medications were reported.  On 18 Feb 2021 , prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A)  for prophylaxis of COVID-19 infection.  .  Treatment information was provided Benadryl and albuterol inhaler.  Action taken with mRNA-1273 in response to the events was unknown  Outcomes of the events were unknown..
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: THROAT FELT SWOLLEN; TONGUE FELT SWOLLEN; clammy; EXHAUSTED; MUSCLE PAIN; nausea; JOINT PAIN; CHEEKS FELT PUFFY; DIZZY; HEADACHE; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, dizzy, headache, throat felt swollen, tongue felt swollen, cheeks felt puffy, clammy, exhausted, muscle pain, joint pain, nausea.  The patient's medical history was  provided asthma for current condition. No relevant concomitant medications were reported.  On 18 Feb 2021 , prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A)  for prophylaxis of COVID-19 infection.  .  Treatment information was provided Benadryl and albuterol inhaler.  Action taken with mRNA-1273 in response to the events was unknown  Outcomes of the events were unknown..
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash, Vaccination site pruritus
Clinical narrative: Rash all over arm; injection site is itchy; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over arm), VACCINATION SITE PRURITUS (injection site is itchy) and MYALGIA (muscle soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MYALGIA (muscle soreness). On 02-Feb-2021, the patient experienced RASH (Rash all over arm) and VACCINATION SITE PRURITUS (injection site is itchy). On 02-Feb-2021, MYALGIA (muscle soreness) had resolved. At the time of the report, RASH (Rash all over arm) and VACCINATION SITE PRURITUS (injection site is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site irritation, Injection site pain, Injection site warmth
Clinical narrative: Soft ball sized bump at injection site; Injection site soreness; Injection site warm and red; Injection site warm and red; sneezing; Itchy and sore throat; Itchy and sore throat; Sinus issues; Arm soreness in joints on right side; nausea; mild headache; A spontaneous report (United States) was received from a consumer concerning a 67-years- female patient, received Moderna's COVID-19 vaccine (mRNA-1273 and experienced a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches.   The patient's medical history included the patient has  had sickle cell traits since 17 years of age. No relevant concomitant medication were reported  On 11 feb 2021, the patient received their first planned dose of mRNA-1273 (Lot number: 024M20A) intramuscularly in right upper arm  for prophylaxis of COVID-19 infection.   On 11 feb 2021,prior to receiving  mRNA-1273  the patient experienced a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches.the patient felt like she's coming down with a cold.The patient did not receive any treatment  Action taken with mRNA-1273 in response to the event was unknown    Outcome of the events,a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches were unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Sinus disorder, Sneezing
Clinical narrative: Soft ball sized bump at injection site; Injection site soreness; Injection site warm and red; Injection site warm and red; sneezing; Itchy and sore throat; Itchy and sore throat; Sinus issues; Arm soreness in joints on right side; nausea; mild headache; A spontaneous report (United States) was received from a consumer concerning a 67-years- female patient, received Moderna's COVID-19 vaccine (mRNA-1273 and experienced a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches.   The patient's medical history included the patient has  had sickle cell traits since 17 years of age. No relevant concomitant medication were reported  On 11 feb 2021, the patient received their first planned dose of mRNA-1273 (Lot number: 024M20A) intramuscularly in right upper arm  for prophylaxis of COVID-19 infection.   On 11 feb 2021,prior to receiving  mRNA-1273  the patient experienced a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches.the patient felt like she's coming down with a cold.The patient did not receive any treatment  Action taken with mRNA-1273 in response to the event was unknown    Outcome of the events,a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches were unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Soft ball sized bump at injection site; Injection site soreness; Injection site warm and red; Injection site warm and red; sneezing; Itchy and sore throat; Itchy and sore throat; Sinus issues; Arm soreness in joints on right side; nausea; mild headache; A spontaneous report (United States) was received from a consumer concerning a 67-years- female patient, received Moderna's COVID-19 vaccine (mRNA-1273 and experienced a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches.   The patient's medical history included the patient has  had sickle cell traits since 17 years of age. No relevant concomitant medication were reported  On 11 feb 2021, the patient received their first planned dose of mRNA-1273 (Lot number: 024M20A) intramuscularly in right upper arm  for prophylaxis of COVID-19 infection.   On 11 feb 2021,prior to receiving  mRNA-1273  the patient experienced a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches.the patient felt like she's coming down with a cold.The patient did not receive any treatment  Action taken with mRNA-1273 in response to the event was unknown    Outcome of the events,a soft ball size bump/ injection site irritation, injection site that is sore, red and warm, sneezing, itchy and sore throat, sinus issues, arm was sore in joints on the right side/ myalgia, nausea, mild headaches were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Extrasystoles, Headache
Clinical narrative: Injection site is now approximately the size of a baseball; Taste and smell just started to return; Taste and smell just started to return; Fever; Muscle spasms; Chills; Nausea; Headaches; Heart felt like it was skipping around, pounding; Heart felt like it was skipping around, pounding; Left arm has been expanding since the injection/Tightness in the left arm; Quarter size red area around the injection site; Case reference number MOD-2021-018713 is a spontaneous case report sent by a Non-Health Professional on 19-FEB-2021 00:00:00 , which refers to a Female aged 30 Years .  The patients past medical history included: Food allergy    , COVID-19 31-JAN-2021. The patient had a history of allergy to: Egg allergy .  The patient was administered the first dose of Moderna COVID-19 Vaccine for COVID-19 vaccination on 17FE2021 on her left arm.. Some  1 day later,  the patient developed Vaccination site erythema. Over a period of the next days, the patient also developed Smell loss,Fever,Muscle spasms,Chills,Nausea,Headache,Skipped beats,Heart pounding,Vaccination site swelling,Vaccination site induration,Taste loss.  The patient was treated for the event with  Ibuprofen.   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  Follow-up Required.  Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age- 30 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Quarter size red area around the injection site - Unknown,Taste and smell just started to return - Unknown,Injection site is now approximately the size of a baseball - Unknown,Left arm has been expanding since the injection/Tightness in the left arm - Unknown,Heart felt like it was skipping around, pounding - Unknown,Heart felt like it was skipping around, pounding - Unknown,Headaches - Unknown,Nausea - Unknown,Chills - Unknown,Muscle spasms - Unknown,Fever - Unknown,Taste and smell just started to return - Unknown.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Palpitations, Pyrexia, Vaccination site erythema
Clinical narrative: Injection site is now approximately the size of a baseball; Taste and smell just started to return; Taste and smell just started to return; Fever; Muscle spasms; Chills; Nausea; Headaches; Heart felt like it was skipping around, pounding; Heart felt like it was skipping around, pounding; Left arm has been expanding since the injection/Tightness in the left arm; Quarter size red area around the injection site; Case reference number MOD-2021-018713 is a spontaneous case report sent by a Non-Health Professional on 19-FEB-2021 00:00:00 , which refers to a Female aged 30 Years .  The patients past medical history included: Food allergy    , COVID-19 31-JAN-2021. The patient had a history of allergy to: Egg allergy .  The patient was administered the first dose of Moderna COVID-19 Vaccine for COVID-19 vaccination on 17FE2021 on her left arm.. Some  1 day later,  the patient developed Vaccination site erythema. Over a period of the next days, the patient also developed Smell loss,Fever,Muscle spasms,Chills,Nausea,Headache,Skipped beats,Heart pounding,Vaccination site swelling,Vaccination site induration,Taste loss.  The patient was treated for the event with  Ibuprofen.   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  Follow-up Required.  Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age- 30 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Quarter size red area around the injection site - Unknown,Taste and smell just started to return - Unknown,Injection site is now approximately the size of a baseball - Unknown,Left arm has been expanding since the injection/Tightness in the left arm - Unknown,Heart felt like it was skipping around, pounding - Unknown,Heart felt like it was skipping around, pounding - Unknown,Headaches - Unknown,Nausea - Unknown,Chills - Unknown,Muscle spasms - Unknown,Fever - Unknown,Taste and smell just started to return - Unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: Injection site is now approximately the size of a baseball; Taste and smell just started to return; Taste and smell just started to return; Fever; Muscle spasms; Chills; Nausea; Headaches; Heart felt like it was skipping around, pounding; Heart felt like it was skipping around, pounding; Left arm has been expanding since the injection/Tightness in the left arm; Quarter size red area around the injection site; Case reference number MOD-2021-018713 is a spontaneous case report sent by a Non-Health Professional on 19-FEB-2021 00:00:00 , which refers to a Female aged 30 Years .  The patients past medical history included: Food allergy    , COVID-19 31-JAN-2021. The patient had a history of allergy to: Egg allergy .  The patient was administered the first dose of Moderna COVID-19 Vaccine for COVID-19 vaccination on 17FE2021 on her left arm.. Some  1 day later,  the patient developed Vaccination site erythema. Over a period of the next days, the patient also developed Smell loss,Fever,Muscle spasms,Chills,Nausea,Headache,Skipped beats,Heart pounding,Vaccination site swelling,Vaccination site induration,Taste loss.  The patient was treated for the event with  Ibuprofen.   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  Follow-up Required.  Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age- 30 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Quarter size red area around the injection site - Unknown,Taste and smell just started to return - Unknown,Injection site is now approximately the size of a baseball - Unknown,Left arm has been expanding since the injection/Tightness in the left arm - Unknown,Heart felt like it was skipping around, pounding - Unknown,Heart felt like it was skipping around, pounding - Unknown,Headaches - Unknown,Nausea - Unknown,Chills - Unknown,Muscle spasms - Unknown,Fever - Unknown,Taste and smell just started to return - Unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever of 99-100 degrees; slight sore throat; bruised area of hip and pain in right hip; Muscle spasms; Arm pain; whole left arm hurt really bad; A spontaneous report was received from a consumer concerning a 62-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle spasms and arm pain, whole left arm hurt really bad, fever of 99-100 degrees, slight sore throat, bruised area of hip and pain in right hip.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) muscle spasms and arm pain, whole left arm hurt really bad, fever of 99-100 degrees, slight sore throat, bruised area of hip and pain in right hip.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), muscle spasms and arm pain, whole left arm hurt really bad, fever of 99-100 degrees, slight sore throat, bruised area of hip and pain in right hip was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: tested positive for COVID-19; Fever; Fatigue; Nausea; Diarrhea; A spontaneous report was reported by a physician and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 75-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. Concomitant product use was not provided by the reporter.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      On 16-Feb-2021 that  patient arrived at the ER department with fever, fatigue, nausea , diarrhea among others. These symptoms started 4 days ago, The physician wants to know if this patient is a good candidate for Monoclonal antibodies treatment. He has consulted with his colleagues and nobody is able to give him an answer. He would greatly appreciate if Moderna can give a call him as soon as possible.   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.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: pea-sized lymph node on left collar bone painful when pressed; This spontaneous case was reported by a consumer and describes the occurrence of Lymphadenopathy in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular route) at an unspecified dose.  On 20-Feb-2021, the patient experienced Lymphadenopathy. At the time of the report, Lymphadenopathy outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: very bad rash; injection site red; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (very bad rash), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PAIN (Injection site sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history).    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE RASH (very bad rash), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PAIN (Injection site sore). At the time of the report, INJECTION SITE RASH (very bad rash), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PAIN (Injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included went to urgent care, they give her a steroid cream  Recoded events (Vaccination site rash, Vaccination site erythema and Vaccination site pain)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Pain in extremity, Pruritus
Clinical narrative: bite marks developing little heads; bite marks started on the side of her neck; bite marks expanded to the other side of her neck, cheek, arms and one leg; bite marks itches; bite marks hurt; pretty sore arm; A spontaneous report was received from a Healthcare Professional concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pretty sore arm, bite marks started on the side of her neck, bite marks expanded to the other side of her neck, cheek, arms and one leg, bite marks itches, bite marks hurt, bite marks developing little heads.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events pretty sore arm . On 30 Jan 2021, the patient experienced the events bite marks started on the side of her neck. bite marks expanded to the other side of her neck, cheek, arms and one leg, bite marks itches, bite marks hurt. On 3 Feb 2021, the patient experienced the events bite marks developing little heads.  Treatment details included For the symptoms: antihistamines, cortisone cream, scrub for poison ivy, showers., Other: Ibuprofen one time a day., 03Feb2021  Action taken with mRNA-1273 in response to the events was not reported.  On 29 Jan 2021 the outcome of events pretty sore arm was resolved. On an unknown date the outcome of events, bite marks started on the side of her neck, On an unknown date the outcome of events, bite marks expanded to the other side of her neck, On an unknown date the outcome of events, cheek, On an unknown date the outcome of events, arms and one leg, On an unknown date the outcome of events, bite marks itches, On an unknown date the outcome of events, bite marks hurt, On an unknown date the outcome of events, bite marks developing little heads was not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pruritus, Rash
Clinical narrative: itchiness; rash returned on the ninth day much bigger and covered much larger area roughly 3 to 4 inches; intense nausea, never felt like that; small rash; slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slightly sore arm), PRURITUS (itchiness), RASH (rash returned on the ninth day much bigger and covered much larger area roughly 3 to 4 inches), RASH (small rash) and NAUSEA (intense nausea, never felt like that) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029C20A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer since 09-Apr-2010, Lipodermatosclerosis since 21-Feb-2019, Hypertension (High (Managed with medication (Toprol, hydrochlorothiazide)) since 1987 and Hearing loss (Hearing aids) since 2004. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) from 1992 to an unknown date, HYDROCHLOROTHIAZIDE from November 2020 to an unknown date, METFORMIN from 2014 to an unknown date, PANTOPRAZOLE SODIUM from 2014 to an unknown date and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) from 2002 to an unknown date for an unknown indication.    On 19-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (slightly sore arm). On 20-Jan-2021, the patient experienced RASH (small rash). On 28-Jan-2021, the patient experienced RASH (rash returned on the ninth day much bigger and covered much larger area roughly 3 to 4 inches). 28-Jan-2021, the patient experienced NAUSEA (intense nausea, never felt like that). On an unknown date, the patient experienced PRURITUS (itchiness). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. On 20-Jan-2021, RASH (small rash) had resolved. On 29-Jan-2021, PRURITUS (itchiness) and NAUSEA (intense nausea, never felt like that) had resolved. On 05-Feb-2021, RASH (rash returned on the ninth day much bigger and covered much larger area roughly 3 to 4 inches) had resolved. At the time of the report, PAIN IN EXTREMITY (slightly sore arm) had resolved. slightly          Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-227517 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up information received on 18-JUN-2021, contains non-significant information
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain in the ankles; Muscle soreness in his calf; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in the ankles) and MYALGIA (Muscle soreness in his calf) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and LANSOPRAZOLE (PREVACID).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Feb-2021, the patient experienced ARTHRALGIA (Joint pain in the ankles) and MYALGIA (Muscle soreness in his calf). At the time of the report, ARTHRALGIA (Joint pain in the ankles) and MYALGIA (Muscle soreness in his calf) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Joint pain; Muscle pain; Chills; Vomiting; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills), VOMITING (Vomiting) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Joint pain; Muscle pain; Chills; Vomiting; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills), VOMITING (Vomiting) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: chills; soreness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the vaccination site) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the vaccination site). On 22-Feb-2021, the patient experienced CHILLS (chills). On 27-Jan-2021, VACCINATION SITE PAIN (soreness at the vaccination site) had resolved. On 24-Feb-2021, CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.   This case was linked to MOD-2021-021553 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. The patient's last menstrual period was on 21-Sep-2020 and the estimated date of delivery was 28-Jun-2021. On 10-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 10-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2020, Pregnancy test: positive (Positive) pisitive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment and concomitant medications were not provided by reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: FEELING A LITTLE BIT WIERD; difficulty breathing; MEASURED HEART BEAT HAS BEEN VARIABLE; DISBALANCE; FATIGUE; MUSCLE PAIN; JOINT PAIN; A LITTLE BIT OF PAIN AT THE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (MEASURED HEART BEAT HAS BEEN VARIABLE), DYSPNOEA (difficulty breathing), FEELING ABNORMAL (FEELING A LITTLE BIT WIERD), BALANCE DISORDER (DISBALANCE) and VACCINATION SITE PAIN (A LITTLE BIT OF PAIN AT THE INJECTION SITE) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M207) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Sciatic hernia, Stress (stress disorder) and Prostate infection. Concomitant products included METOPROLOL for Hypertension, ACETYLSALICYLIC ACID (ASPRIN), FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6) and CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) for an unknown indication.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (A LITTLE BIT OF PAIN AT THE INJECTION SITE). On 18-Feb-2021, the patient experienced HEART RATE IRREGULAR (MEASURED HEART BEAT HAS BEEN VARIABLE), BALANCE DISORDER (DISBALANCE), FATIGUE (FATIGUE), MYALGIA (MUSCLE PAIN) and ARTHRALGIA (JOINT PAIN). On 19-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing). On 22-Feb-2021, the patient experienced FEELING ABNORMAL (FEELING A LITTLE BIT WIERD). At the time of the report, HEART RATE IRREGULAR (MEASURED HEART BEAT HAS BEEN VARIABLE), DYSPNOEA (difficulty breathing), FEELING ABNORMAL (FEELING A LITTLE BIT WIERD), BALANCE DISORDER (DISBALANCE), FATIGUE (FATIGUE), MYALGIA (MUSCLE PAIN) and ARTHRALGIA (JOINT PAIN) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tazulozil 0.4 mg for prostate.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Follow-up received on 22-02-2021: No new information