chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Tremor, Vaccination site pain
Clinical narrative: Lightheaded; Shaking and very weak; Shaking and very weak; A lot of pain around the injection site and near elbow; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), TREMOR (Shaking and very weak), ASTHENIA (Shaking and very weak) and VACCINATION SITE PAIN (A lot of pain around the injection site and near elbow) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (A lot of pain around the injection site and near elbow). On 26-Feb-2021, the patient experienced DIZZINESS (Lightheaded), TREMOR (Shaking and very weak) and ASTHENIA (Shaking and very weak). On 26-Feb-2021, DIZZINESS (Lightheaded), TREMOR (Shaking and very weak) and ASTHENIA (Shaking and very weak) had resolved. At the time of the report, VACCINATION SITE PAIN (A lot of pain around the injection site and near elbow) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter Patient used ice packs and his arm has gotten better.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR form: NNI
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site pain, Vomiting
Clinical narrative: pain in the arm; pink rash at the site of injection; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm), INJECTION SITE RASH (pink rash at the site of injection) and VOMITING (vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm), INJECTION SITE RASH (pink rash at the site of injection) and VOMITING (vomiting). At the time of the report, VACCINATION SITE PAIN (pain in the arm), INJECTION SITE RASH (pink rash at the site of injection) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was denied   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site warmth
Clinical narrative: small red knot at the injection site that increased to the size of a silver dollar; injection site is still warm to touch; small red knot at the injection site that increased to the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (small red knot at the injection site that increased to the size of a silver dollar), VACCINATION SITE WARMTH (injection site is still warm to touch) and VACCINATION SITE ERYTHEMA (small red knot at the injection site that increased to the size of a silver dollar) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (small red knot at the injection site that increased to the size of a silver dollar), VACCINATION SITE WARMTH (injection site is still warm to touch) and VACCINATION SITE ERYTHEMA (small red knot at the injection site that increased to the size of a silver dollar). At the time of the report, VACCINATION SITE NODULE (small red knot at the injection site that increased to the size of a silver dollar), VACCINATION SITE WARMTH (injection site is still warm to touch) and VACCINATION SITE ERYTHEMA (small red knot at the injection site that increased to the size of a silver dollar) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed lumps (hives)in her face which have been on and off.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed lumps (hives)in her face which have been on and off.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Developed lumps (hives)in her face which have been on and off.). At the time of the report, URTICARIA (Developed lumps (hives)in her face which have been on and off.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were No daily medicine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Pruritus, Pyrexia, Rash
Clinical narrative: petechiae like rash on the breast; itching; fever of 100F; broke out into rash all over chest, stomach, back, waist at the back, and under breast; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (petechiae like rash on the breast), PRURITUS (itching), PYREXIA (fever of 100F) and RASH (broke out into rash all over chest, stomach, back, waist at the back, and under breast) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HCL, IRBESARTAN and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PETECHIAE (petechiae like rash on the breast), PRURITUS (itching), PYREXIA (fever of 100F) and RASH (broke out into rash all over chest, stomach, back, waist at the back, and under breast). On 08-Feb-2021, PETECHIAE (petechiae like rash on the breast), PYREXIA (fever of 100F) and RASH (broke out into rash all over chest, stomach, back, waist at the back, and under breast) had resolved. At the time of the report, PRURITUS (itching) 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.   No treatment information provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Terrible headache; A spontaneous report was received from a consumer concerning an 82-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed terrible headache.  The patient's medical history was not provided. Concomitant medications were not provided.  On 22 Jan 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient received their second of the two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection.  Patient reported after the first dose that they had a terrible headache for a short time. Treatment information not provided. Lab tests not included.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event terrible headache was resolved after a short time.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site urticaria, Pain in extremity, Rash
Clinical narrative: sore arm; rash is still there, spread across body; became hard to breathe went to urgent care; arm flared up, got hives at injection site; A spontaneous report was received from a Consumer concerning a 26-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, arm flared up, got hives at injection site, went to urgent care, became hard to breathe, rash is still there, spread across body.  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 their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   on unknown date the patient experienced events sore arm, arm flared up, got hives at injection site, went to urgent care, became hard to breathe, rash is still there, spread across body.  Treatment details included Benadryl  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, sore arm, On an unknown date the outcome of events, arm flared up, On an unknown date the outcome of events, got hives at injection site, On an unknown date the outcome of events, went to urgent care, On an unknown date the outcome of events, became hard to breathe, On an unknown date the outcome of events, rash is still there, On an unknown date the outcome of events, spread across body was not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: arm pain (felt sore); felt groggy; felt super tired; A spontaneous report was received from a Consumer concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain (felt sore), felt groggy, felt super tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events arm pain (felt sore). felt groggy, felt super tired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the outcome of events, arm pain (felt sore), On an unknown date the outcome of events, felt groggy, On an unknown date the outcome of events, felt super tired was not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Head discomfort
Clinical narrative: Didn't feel right in the head; Lower back hurt; Arm was still swollen; Sore at injection site (3-inch diameter); red; Joint pain in knees; Arm was itchy; Red rash on injection site; Felt a bit tired; Arm was sore; Slight headache; Chills; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  slight headache, chills, arm was sore, did not feel right in the head, felt a bit tired, arm was itchy, feeling fatigue again, red rash on injection site, did not feel right in the head again, arm was still swollen, sore at injection site (3 inch diameter), joint pain in knees, and lower back hurt.  The patient's medical history was not provided. Patient was allergic to tetracycline and ampicillin. Concomitant medications reported were methotrexate, hydroxychloroquine,and levothyroxine sodium .  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 307K20A) intramuscularly in left upper arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the events,  slight headache, chills, sore arm, she also did not feel right in the head and this lasted for 12 hours. On 15 Jan 2021, the she  felt a bit tired . On 25 Jan 2021, she noticed her  arm was itchy and sore. She started feeling fatigue again. Then she noticed a red rash on injection site. On 26 Jan 2021, she did not feel right in the head again . Her arm was still swollen and sore at injection site (3 inch diameter), red and itchy. She also had  joint pain in knees and her lower back hurt . Treatment details included naproxen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were considered unknown for all events except sore arm (not recovered).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: Didn't feel right in the head; Lower back hurt; Arm was still swollen; Sore at injection site (3-inch diameter); red; Joint pain in knees; Arm was itchy; Red rash on injection site; Felt a bit tired; Arm was sore; Slight headache; Chills; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  slight headache, chills, arm was sore, did not feel right in the head, felt a bit tired, arm was itchy, feeling fatigue again, red rash on injection site, did not feel right in the head again, arm was still swollen, sore at injection site (3 inch diameter), joint pain in knees, and lower back hurt.  The patient's medical history was not provided. Patient was allergic to tetracycline and ampicillin. Concomitant medications reported were methotrexate, hydroxychloroquine,and levothyroxine sodium .  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 307K20A) intramuscularly in left upper arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the events,  slight headache, chills, sore arm, she also did not feel right in the head and this lasted for 12 hours. On 15 Jan 2021, the she  felt a bit tired . On 25 Jan 2021, she noticed her  arm was itchy and sore. She started feeling fatigue again. Then she noticed a red rash on injection site. On 26 Jan 2021, she did not feel right in the head again . Her arm was still swollen and sore at injection site (3 inch diameter), red and itchy. She also had  joint pain in knees and her lower back hurt . Treatment details included naproxen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were considered unknown for all events except sore arm (not recovered).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Didn't feel right in the head; Lower back hurt; Arm was still swollen; Sore at injection site (3-inch diameter); red; Joint pain in knees; Arm was itchy; Red rash on injection site; Felt a bit tired; Arm was sore; Slight headache; Chills; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  slight headache, chills, arm was sore, did not feel right in the head, felt a bit tired, arm was itchy, feeling fatigue again, red rash on injection site, did not feel right in the head again, arm was still swollen, sore at injection site (3 inch diameter), joint pain in knees, and lower back hurt.  The patient's medical history was not provided. Patient was allergic to tetracycline and ampicillin. Concomitant medications reported were methotrexate, hydroxychloroquine,and levothyroxine sodium .  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 307K20A) intramuscularly in left upper arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the events,  slight headache, chills, sore arm, she also did not feel right in the head and this lasted for 12 hours. On 15 Jan 2021, the she  felt a bit tired . On 25 Jan 2021, she noticed her  arm was itchy and sore. She started feeling fatigue again. Then she noticed a red rash on injection site. On 26 Jan 2021, she did not feel right in the head again . Her arm was still swollen and sore at injection site (3 inch diameter), red and itchy. She also had  joint pain in knees and her lower back hurt . Treatment details included naproxen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were considered unknown for all events except sore arm (not recovered).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia, Swelling
Clinical narrative: Tingling at the right side of her face; Swelling at the right side of her face; Redness in the right side of her face; A spontaneous report was received from a Healthcare Professional concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, swelling and tingling .  The patient's medical history was not provided. The patient was allergic to a bird. Concomitant medications reported were Aspirin.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On unknown date the patient reported experienced redness, swelling and tingling in the right side of the face for 5 days  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome redness, swelling, tingling was not reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound foetal
Clinical narrative: 38 weeks pregnancy patient who received the first dose of the Moderna COVID-19; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (38 weeks pregnancy patient who received the first dose of the Moderna COVID-19) in a 27-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion in January 2019, Spontaneous abortion in April 2019 and Ex-alcohol user (Twice a year). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Jun-2020 and the estimated date of delivery was 09-Mar-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (38 weeks pregnancy patient who received the first dose of the Moderna COVID-19). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 26-Feb-2021, EXPOSURE DURING PREGNANCY (38 weeks pregnancy patient who received the first dose of the Moderna COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Prenatal screening test: inconclusive (Inconclusive) healthy. On an unknown date, Ultrasound foetal: inconclusive (Inconclusive) No red flags.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea
Clinical narrative: Gassiness in abdomen; Diarrhea; A spontaneous report was received from a consumer concerning an 86-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced gassiness in abdomen and diarrhea.  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 number: unknown) for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced events gassiness in abdomen and diarrhea. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events gassiness in abdomen and diarrhea was not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 05-Feb-2021, DIARRHOEA (Diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Horrible itching; Redness; A spontaneous report was received from a Healthcare Professional concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events horrible itching, redness.  The patient's medical history was not provided. Concomitant medications reported were Alendronate, Simvastatin, Gabapentin, Keflex, Tramadol, Estrace, Aspirin, Lactate (before meals), Ellura, Probiotics, Vitamin D3 for drug use for unknown indication.  On 16 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced the events horrible itching. redness.  Treatment details included A cream (unknown)  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, horrible itching, redness was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness
Clinical narrative: dizziness; Weakness; diarrhea; A spontaneous report was received from a Consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, weakness, diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the events dizziness. weakness, diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, dizziness, weakness, diarrhea was not reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081324:1st dose case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: headache for several days; felt that heat is coming out of my shoulder; itchy around injection site; swelling at the injection site/ swollen arm - around injection site; redness at the injection site/ red arm - around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN WARM (felt that heat is coming out of my shoulder), INJECTION SITE PRURITUS (itchy around injection site), INJECTION SITE SWELLING (swelling at the injection site/ swollen arm - around injection site), INJECTION SITE ERYTHEMA (redness at the injection site/ red arm - around injection site) and HEADACHE (headache for several days) in a 54-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 No adverse event. Concomitant products included TAMOXIFEN, Venlafaxine HCL ER and COLECALCIFEROL (VITBABY D) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced SKIN WARM (felt that heat is coming out of my shoulder), INJECTION SITE PRURITUS (itchy around injection site), INJECTION SITE SWELLING (swelling at the injection site/ swollen arm - around injection site) and INJECTION SITE ERYTHEMA (redness at the injection site/ red arm - around injection site). On an unknown date, the patient experienced HEADACHE (headache for several days). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Feb-2021, INJECTION SITE PRURITUS (itchy around injection site) and INJECTION SITE ERYTHEMA (redness at the injection site/ red arm - around injection site) had resolved. On 21-Feb-2021, INJECTION SITE SWELLING (swelling at the injection site/ swollen arm - around injection site) had resolved. At the time of the report, SKIN WARM (felt that heat is coming out of my shoulder) and HEADACHE (headache for several days) 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.   On 01-Feb-2021, the injection site swelling, redness, and itching resolved.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: reddsh circular raised area on arm where vaccination recieved; It is painful where I received the vaccine; redness and localized pain; localized pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness and localized pain), PAIN (localized pain), VACCINATION SITE ERYTHEMA (reddsh circular raised area on arm where vaccination recieved) and VACCINATION SITE PAIN (It is painful where I received the vaccine) 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 04-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 VACCINATION SITE ERYTHEMA (reddsh circular raised area on arm where vaccination recieved) and VACCINATION SITE PAIN (It is painful where I received the vaccine). In January 2021, the patient experienced ERYTHEMA (redness and localized pain) and PAIN (localized pain). In January 2021, ERYTHEMA (redness and localized pain) and PAIN (localized pain) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (reddsh circular raised area on arm where vaccination recieved) and VACCINATION SITE PAIN (It is painful where I received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: Hardness at injection site; Very painful arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Very painful arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Very painful arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing from 27-Jan-2021 for Adverse event, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Very painful arm) had resolved.            No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant FU-: Second dose added, Outcome of the event updated to Recovered/Resolved; 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Pregnant patient received the 1st dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a physical therapist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna vaccine) in a 35-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (spontaneous abortion) on 27-Aug-2019. Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Jun-2020 and the estimated date of delivery was 12-Apr-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2020, Pregnancy test: positive (Positive) Positive. On 17-Feb-2021, Ultrasound foetal: normal (normal) everything okay.     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.   Estimated date of conception:18-Jul-2020 No treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FEELING HOT (felt a little warm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING HOT (felt a little warm). At the time of the report, PAIN IN EXTREMITY (sore arm) and FEELING HOT (felt a little warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    This case was linked to MOD-2021-018268 (Patient Link).   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature increased, Headache, Pyrexia
Clinical narrative: Upset stomach; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), PYREXIA (Fever) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032620A and 011J204) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-Jan-2000.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature increased: 100.1 (High) OTHER. On 26-Jan-2021, Body temperature increased: 100.7 (High) OTHER.         Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Second dose details, contact details and events were added
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: would like to speak to someone regarding side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (would like to speak to someone regarding side effects) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (would like to speak to someone regarding side effects). At the time of the report, ADVERSE DRUG REACTION (would like to speak to someone regarding side effects) outcome was unknown. Not Provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash
Clinical narrative: large rash at the injection site; Slight fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Slight fatigue) and VACCINATION SITE RASH (large rash at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and CALCIUM for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (Slight fatigue). On 31-Jan-2021, the patient experienced VACCINATION SITE RASH (large rash at the injection site). On 24-Jan-2021, FATIGUE (Slight fatigue) had resolved. At the time of the report, VACCINATION SITE RASH (large rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Nausea, Pyrexia
Clinical narrative: Fever - Temperature of 100.0F; Headache; Redness - Near Injection Site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SUMATRIPTAN for Migraine headache.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and NAUSEA (Nausea) 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Pruritus
Clinical narrative: Itching; 4/5 bumps; Sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), MASS (4/5 bumps) and PAIN (Sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRURITUS (Itching), MASS (4/5 bumps) and PAIN (Sore). The patient was treated with IVABRADINE HYDROCHLORIDE (IVAREST [IVABRADINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching), MASS (4/5 bumps) and PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 28 Jan 2021, the patient stated her achiness went away but the night before her arm was itching and around 4-5 bumps appeared. It woke her up in the middles of the night so she put some Ivarest on the area. She is a little sore from her shoulder to her elbow.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm; Sinus Pain; Chills; Headache; Fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), SINUS PAIN (Sinus Pain), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 100F) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), SINUS PAIN (Sinus Pain), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 100F). On 04-Feb-2021, PAIN IN EXTREMITY (Sore Arm), SINUS PAIN (Sinus Pain), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 100F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100 f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatments were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: Sore Arm; Sinus Pain; Chills; Headache; Fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), SINUS PAIN (Sinus Pain), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 100F) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), SINUS PAIN (Sinus Pain), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 100F). On 04-Feb-2021, PAIN IN EXTREMITY (Sore Arm), SINUS PAIN (Sinus Pain), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 100F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100 f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatments were reported.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Gait inability, Vaccination site induration, Vaccination site swelling
Clinical narrative: not able to walk at all; cannot stand up easily; lightheaded; injection site was hard and swollen; injection site was hard and swollen; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (not able to walk at all), DYSSTASIA (cannot stand up easily), DIZZINESS (lightheaded), VACCINATION SITE INDURATION (injection site was hard and swollen) and VACCINATION SITE SWELLING (injection site was hard and swollen) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced GAIT INABILITY (not able to walk at all), DYSSTASIA (cannot stand up easily), DIZZINESS (lightheaded), VACCINATION SITE INDURATION (injection site was hard and swollen) and VACCINATION SITE SWELLING (injection site was hard and swollen). At the time of the report, GAIT INABILITY (not able to walk at all), DYSSTASIA (cannot stand up easily), DIZZINESS (lightheaded), VACCINATION SITE INDURATION (injection site was hard and swollen) and VACCINATION SITE SWELLING (injection site was hard and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Body temperature increased, Chills
Clinical narrative: I felt fatigue, I had go lie down.; I could not sleep well because of the pain; pain got worse;  I could not sleep well because of the pain; Joints started to hurt a little bit/Hips, back, legs and shoulders hurt; my temperature was 100.4 F; chills; My hips, back, legs and shoulders hurt; Face swollen; Cheeks and lips swollen; arm was a little bit sore; A spontaneous report was received from a 72-years-old female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events face swollen, cheeks and lips swollen, my joints started to hurt a little bit, my hips, back, legs and shoulders hurt, my arm was a little bit sore, pain got worse, my temperature was 100.4 f, chills, felt fatigue, had go lie down..  The patient's medical history was not provided. Concomitant medications reported were Nexium, Statin, Calcium, probiotics, iron supplements, fish oil for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route and unknown anatomical location for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced the event arm was a little bit sore .   On 23 Jan 2021, the patient developed face swollen, cheeks and lips swollen.   On 27 Jan 2021, the patient experienced the events joints started to hurt a little bit,hips, back ,legs and shoulders hurt and temperature was 100.4 F.   On 29 Jan 2021, the patient experienced the events pain got worse and chills. On 31 Jan 2021, the patient experienced the event felt fatigue .   Treatment details included Benadryl, Hydroxyzine HCL 25 mg, Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event fatigue was considered resolved on 2 Feb 2021. The outcome of events face swollen, cheeks and lips swollen, joints started to hurt a little bit , hips, back ,legs and shoulders hurt, arm was a little bit sore ,pain got worse, temperature was 100.4 F and chills was unknown..; Reporter's Comments: This case concerns a 72-year-old female with NS unexpected events of swelling face, lip swelling, back pain, and 'could not sleep because of pain' and NS expected events of arthralgia, vaccination site swelling, fatigue, body temperature increased and chills. Event onset the same day as the first dose of mRNA-1273. 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.