chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Ultrasound foetal
Clinical narrative: Vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) in a 38-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Ectopic pregnancy in January 2018, Live birth (Live, full term, birth) on 07-May-2019 and Alcohol use (1-2 drinks/week) from 2004 to May 2020. Concurrent medical conditions included Hypothyroidism since August 2018. Concomitant products included LEVOTHYROXINE for Hypothyroidism, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pregnancy.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-May-2020 and the estimated date of delivery was 15-Feb-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccinated while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 30-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Glucose tolerance test: negative (Negative) Negative. On an unknown date, Ultrasound foetal: normal (normal) every monday.     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.   Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Exposure during pregnancy, Glucose tolerance test, Pain, Swelling
Clinical narrative: redness; sore; swelling; Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), ERYTHEMA (redness), PAIN (sore) and SWELLING (swelling) in a 36-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism in August 2018, Ectopic pregnancy in January 2018, Pregnancy (Live, full-term birth) on 2019 and Alcohol use (1-2 drinks/week) from 2004 to May 2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pregnancy, LEVOTHYROXINE for Thyroid activity decreased.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-May-2020 and the estimated date of delivery was 15-Feb-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On an unknown date, the patient experienced ERYTHEMA (redness), PAIN (sore) and SWELLING (swelling). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 30-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. At the time of the report, ERYTHEMA (redness), PAIN (sore) and SWELLING (swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Glucose tolerance test: negative. On an unknown date, Ultrasound scan: normal every Monday: normal.     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 medications were reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy (or "patient declined further contact). Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: redness; sore; swelling; Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), ERYTHEMA (redness), PAIN (sore) and SWELLING (swelling) in a 36-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism in August 2018, Ectopic pregnancy in January 2018, Pregnancy (Live, full-term birth) on 2019 and Alcohol use (1-2 drinks/week) from 2004 to May 2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pregnancy, LEVOTHYROXINE for Thyroid activity decreased.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-May-2020 and the estimated date of delivery was 15-Feb-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On an unknown date, the patient experienced ERYTHEMA (redness), PAIN (sore) and SWELLING (swelling). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 30-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. At the time of the report, ERYTHEMA (redness), PAIN (sore) and SWELLING (swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Glucose tolerance test: negative. On an unknown date, Ultrasound scan: normal every Monday: normal.     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 medications were reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy (or "patient declined further contact). Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant/vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy). On 07-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy). On 07-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Due date was not reported.   The patient received vaccine while pregnancy/ vaccine exposure during pregnancy.  No treatment information was provided.  Company comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: received the 1st Moderna vaccine and is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amoxicillin). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Sep-2020 and the estimated date of delivery was 05-Jun-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient's previous pregnancies included one live birth with the pregnancy end date 2019.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Soreness on the arm; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PAIN IN EXTREMITY (Soreness on the arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Mar-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness on the arm). On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness on the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with the associated AE , Pain in extremity, for this 40-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the event, Pain in extremity,  a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Nasal congestion, Tongue discomfort
Clinical narrative: metallic taste; burning on the tongue; Feeling stuffed up; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (metallic taste), TONGUE DISCOMFORT (burning on the tongue) and NASAL CONGESTION (Feeling stuffed up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DYSGEUSIA (metallic taste), TONGUE DISCOMFORT (burning on the tongue) and NASAL CONGESTION (Feeling stuffed up). At the time of the report, DYSGEUSIA (metallic taste) and TONGUE DISCOMFORT (burning on the tongue) had not resolved and NASAL CONGESTION (Feeling stuffed up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: Vaccine exposure during Pregnancy; Arm soreness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PAIN IN EXTREMITY (Arm soreness) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Pregnancy.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Jul-2020 and the estimated date of delivery was 06-May-2021. On 12-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PAIN IN EXTREMITY (Arm soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 12-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) 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 medication details was reported.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain
Clinical narrative: Couldn't sleep all night; Terrible pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep all night) and PAIN (Terrible pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INSOMNIA (Couldn't sleep all night) and PAIN (Terrible pain). At the time of the report, INSOMNIA (Couldn't sleep all night) and PAIN (Terrible pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Very limited information regarding these events of pain and insomnia has been provided at this time.  Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: A spontaneous report was received from a 47-year-old, female patient concerning herself , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen lymph node under the same arm which got vaccinated (Vaccination site lymphadenopathy).  The patient's medical history was not provided by the reporter. No Concomitant medications present.   On 31 Jan 2020, prior to the onset of the events, the patient received their shot (Lot number: 300042460) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient experienced swollen lymph node under the same arm which she got vaccinated (Vaccination site lymphadenopathy). Its not confirmed whether it is of Moderna COVID-19 vaccine. The patient took rest.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome events, swollen lymph node 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on right arm; Red, itchy rash on right arm; Red, itchy rash on injection site; Red, itchy rash on injection site; Body ache; Pain in injection site; soreness in the injection site; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red, itchy rash on right arm), RASH ERYTHEMATOUS (Red, itchy rash on right arm), MYALGIA (Body ache), VACCINATION SITE PAIN (Pain in injection site; soreness in the injection site) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced MYALGIA (Body ache), VACCINATION SITE PAIN (Pain in injection site; soreness in the injection site), CHILLS (Chills) and PYREXIA (Fever). On 05-Jan-2021, the patient experienced VACCINATION SITE RASH (Red, itchy rash on injection site) and VACCINATION SITE PRURITUS (Red, itchy rash on injection site). On 06-Jan-2021, the patient experienced RASH PRURITIC (Red, itchy rash on right arm) and RASH ERYTHEMATOUS (Red, itchy rash on right arm). On 01-Jan-2021, MYALGIA (Body ache), VACCINATION SITE PAIN (Pain in injection site; soreness in the injection site), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, RASH PRURITIC (Red, itchy rash on right arm), RASH ERYTHEMATOUS (Red, itchy rash on right arm), VACCINATION SITE RASH (Red, itchy rash on injection site) and VACCINATION SITE PRURITUS (Red, itchy rash on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment medication included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red, itchy rash on right arm; Red, itchy rash on right arm; Red, itchy rash on injection site; Red, itchy rash on injection site; Body ache; Pain in injection site; soreness in the injection site; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red, itchy rash on right arm), RASH ERYTHEMATOUS (Red, itchy rash on right arm), MYALGIA (Body ache), VACCINATION SITE PAIN (Pain in injection site; soreness in the injection site) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced MYALGIA (Body ache), VACCINATION SITE PAIN (Pain in injection site; soreness in the injection site), CHILLS (Chills) and PYREXIA (Fever). On 05-Jan-2021, the patient experienced VACCINATION SITE RASH (Red, itchy rash on injection site) and VACCINATION SITE PRURITUS (Red, itchy rash on injection site). On 06-Jan-2021, the patient experienced RASH PRURITIC (Red, itchy rash on right arm) and RASH ERYTHEMATOUS (Red, itchy rash on right arm). On 01-Jan-2021, MYALGIA (Body ache), VACCINATION SITE PAIN (Pain in injection site; soreness in the injection site), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, RASH PRURITIC (Red, itchy rash on right arm), RASH ERYTHEMATOUS (Red, itchy rash on right arm), VACCINATION SITE RASH (Red, itchy rash on injection site) and VACCINATION SITE PRURITUS (Red, itchy rash on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment medication included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling drunk
Clinical narrative: Lightheaded/Dizzy; Off balance; feel like you had too much to drink; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded/Dizzy), BALANCE DISORDER (Off balance) and FEELING DRUNK (feel like you had too much to drink) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (Lightheaded/Dizzy), BALANCE DISORDER (Off balance) and FEELING DRUNK (feel like you had too much to drink). At the time of the report, DIZZINESS (Lightheaded/Dizzy), BALANCE DISORDER (Off balance) and FEELING DRUNK (feel like you had too much to drink) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.; 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around the injection site 8 days later), VACCINATION SITE SWELLING (Swelling around the injection site 8 days later) and VACCINATION SITE PAIN (It was painful) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Reported as "high blood pressure"). Concomitant products included AMLODIPINE for Hypertension.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site 8 days later), VACCINATION SITE SWELLING (Swelling around the injection site 8 days later) and VACCINATION SITE PAIN (It was painful). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around the injection site 8 days later), VACCINATION SITE SWELLING (Swelling around the injection site 8 days later) and VACCINATION SITE PAIN (It was painful) 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.   Treatment information provided as Unknown steroids and unknown antibiotics; Sender's Comments: This case concerns a 43-year-old female who experienced NS expected events of vaccination site pain, vaccination site erythema, and vaccination site swelling.  Event onset occurred 9 days after the first dose of mRNA-1273. Treatment with steroids and an antibiotic. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swelling/small lump in the right lymph nodein the armpit; Soreness in my right lymph node in her armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling/small lump in the right lymph nodein the armpit) and AXILLARY PAIN (Soreness in my right lymph node in her armpit) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE (NATURE'S BOUNTY CALCIUM) from 01-Jan-2020 to an unknown date for Bone disorder (NOS).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling/small lump in the right lymph nodein the armpit) and AXILLARY PAIN (Soreness in my right lymph node in her armpit). On 06-Jan-2021, LYMPHADENOPATHY (Swelling/small lump in the right lymph nodein the armpit) and AXILLARY PAIN (Soreness in my right lymph node in her armpit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow up received on- 01-APR-2021, Reporter details updated, Patient demographic updated, Outcome of the events updated from unknown to recovered.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Nausea, Somnolence
Clinical narrative: Sleepy; Dizziness; Bones hurting; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), DIZZINESS (Dizziness), BONE PAIN (Bones hurting) and NAUSEA (Nauseous) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SOMNOLENCE (Sleepy), DIZZINESS (Dizziness), BONE PAIN (Bones hurting) and NAUSEA (Nauseous). At the time of the report, SOMNOLENCE (Sleepy), DIZZINESS (Dizziness), BONE PAIN (Bones hurting) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (dizziness, bone pain and nausea), a causal relationship cannot be excluded. Very limited information regarding this event (somnolence) has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Lymphadenopathy, Muscle swelling, Tenderness, Vaccination site erythema
Clinical narrative: Muscle appears to be a little swollen at injection site; Eczema-like reaction - patchy like; Slightly tender; Red; Lymphadenopathy, slightly tender and red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ECZEMA (Eczema-like reaction - patchy like), TENDERNESS (Slightly tender), VACCINATION SITE ERYTHEMA (Red), MUSCLE SWELLING (Muscle appears to be a little swollen at injection site) and LYMPHADENOPATHY (Lymphadenopathy, slightly tender and red) 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 31-Dec-2020 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced TENDERNESS (Slightly tender), VACCINATION SITE ERYTHEMA (Red) and LYMPHADENOPATHY (Lymphadenopathy, slightly tender and red). On 07-Jan-2021, the patient experienced ECZEMA (Eczema-like reaction - patchy like). On 08-Jan-2021, the patient experienced MUSCLE SWELLING (Muscle appears to be a little swollen at injection site). On 08-Jan-2021, ECZEMA (Eczema-like reaction - patchy like) had resolved. At the time of the report, TENDERNESS (Slightly tender), MUSCLE SWELLING (Muscle appears to be a little swollen at injection site) and LYMPHADENOPATHY (Lymphadenopathy, slightly tender and red) outcome was unknown and VACCINATION SITE ERYTHEMA (Red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment details was reported.; Sender's Comments: This case concerns a female who experienced events of unexpected eczema, tenderness and expected vaccination site erythema, muscle swelling, lymphadenopathy.  Event onset occurred 7 days after the first dose of mRNA-1273. Treated with diphenhydramine. Events resolved or resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness increased/swelling increased; Swelling increased and was about egg shaped size; Little bit of itchiness at the injection site; Redness at the vaccination site; Some swelling at the vaccination site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the vaccination site), VACCINATION SITE SWELLING (Some swelling at the vaccination site), VACCINATION SITE PRURITUS (Little bit of itchiness at the injection site), CONDITION AGGRAVATED (Redness increased/swelling increased) and VACCINATION SITE SWELLING (Swelling increased and was about egg shaped size) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymph node excision and Lumpectomy. Concurrent medical conditions included Penicillin allergy and Seasonal allergy.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the vaccination site) and VACCINATION SITE SWELLING (Some swelling at the vaccination site). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Little bit of itchiness at the injection site). On 09-Jan-2021, the patient experienced CONDITION AGGRAVATED (Redness increased/swelling increased) and VACCINATION SITE SWELLING (Swelling increased and was about egg shaped size). On 08-Jan-2021, VACCINATION SITE PRURITUS (Little bit of itchiness at the injection site) had resolved. On 14-Jan-2021, VACCINATION SITE ERYTHEMA (Redness at the vaccination site), VACCINATION SITE SWELLING (Some swelling at the vaccination site), CONDITION AGGRAVATED (Redness increased/swelling increased) and VACCINATION SITE SWELLING (Swelling increased and was about egg shaped size) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Arm  hurting; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm  hurting) and VOMITING (Threw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood sugar decreased (so she had to take two sugar pills).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VOMITING (Threw up). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm  hurting). At the time of the report, VACCINATION SITE PAIN (Arm  hurting) outcome was unknown and VOMITING (Threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; 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 of vaccination site pain, a causal relationship cannot be excluded.  Based on reporter's causality of the event of vomiting, the event is assessed as unlikely related to mRNA-1273.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm when I raise it certain ways and stretch; A spontaneous report was received from a consumer concerning herself, 74 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a sore arm when raised certain ways and stretched.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, after receiving the vaccine, the patient had a sore arm.  She stated it was really uncomfortable, only when raised certain ways and stretched.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event sore arm when raised certain ways and stretched, was not resolved at the time of this report.; Reporter's Comments: This case concerns a 74-year-old female who experienced nonserious unexpected event of pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness, Vaccination site pain
Clinical narrative: right arm was hurting; Tenderness; right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm was hurting), TENDERNESS (Tenderness) and VACCINATION SITE PAIN (right arm soreness) in a 59-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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (right arm was hurting), TENDERNESS (Tenderness) and VACCINATION SITE PAIN (right arm soreness). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 2. At the time of the report, PAIN IN EXTREMITY (right arm was hurting), TENDERNESS (Tenderness) and VACCINATION SITE PAIN (right arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 59-year-old female who experienced NS events of unexpected pain in extremity and expected vaccination site pain, tenderness.  Event onset occurred 3 days after the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: feverish warm area at the site; Streak about inches down feels itchy; the site is about 3 inches around, swollen and tender; the site is about 3 inches around, swollen and tender; red swollen tender; little bit of warmth on the arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (little bit of warmth on the arm), INJECTION SITE WARMTH (feverish warm area at the site), INJECTION SITE PRURITUS (Streak about inches down feels itchy), INJECTION SITE SWELLING (the site is about 3 inches around, swollen and tender) and INJECTION SITE PAIN (the site is about 3 inches around, swollen and tender) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis, Glaucoma, Atrial fibrillation, Blood pressure high and High cholesterol. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, CARVEDILOL and LOSARTAN for Blood pressure, ROSUVASTATIN for High cholesterol, MESALAZINE (ASACOL) for Ulcerative colitis, CALCIUM, XYLOMETAZOLINE HYDROCHLORIDE (FACOL) and LATANOPROST for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced SKIN WARM (little bit of warmth on the arm). On 07-Jan-2021, the patient experienced INJECTION SITE WARMTH (feverish warm area at the site), INJECTION SITE PRURITUS (Streak about inches down feels itchy), INJECTION SITE SWELLING (the site is about 3 inches around, swollen and tender), INJECTION SITE PAIN (the site is about 3 inches around, swollen and tender) and INJECTION SITE ERYTHEMA (red swollen tender). The patient was treated with PARACETAMOL (TYLENOL) for Injection site tenderness, Injection site swelling and Injection site warmth, at an unspecified dose and frequency. On 02-Jan-2021, SKIN WARM (little bit of warmth on the arm) had resolved. On 17-Jan-2021, INJECTION SITE WARMTH (feverish warm area at the site), INJECTION SITE PRURITUS (Streak about inches down feels itchy), INJECTION SITE SWELLING (the site is about 3 inches around, swollen and tender), INJECTION SITE PAIN (the site is about 3 inches around, swollen and tender) and INJECTION SITE ERYTHEMA (red swollen tender) had resolved.            Action taken with mRNA-1273 in response to the event/s was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received via ADR form. Patient address, email, medical history and outcome of events were updated. Dose 2 information was reported, no adverse events were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: feverish warm area at the site; Streak about inches down feels itchy; the site is about 3 inches around, swollen and tender; the site is about 3 inches around, swollen and tender; red swollen tender; little bit of warmth on the arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (little bit of warmth on the arm), INJECTION SITE WARMTH (feverish warm area at the site), INJECTION SITE PRURITUS (Streak about inches down feels itchy), INJECTION SITE SWELLING (the site is about 3 inches around, swollen and tender) and INJECTION SITE PAIN (the site is about 3 inches around, swollen and tender) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis, Glaucoma, Atrial fibrillation, Blood pressure high and High cholesterol. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, CARVEDILOL and LOSARTAN for Blood pressure, ROSUVASTATIN for High cholesterol, MESALAZINE (ASACOL) for Ulcerative colitis, CALCIUM, XYLOMETAZOLINE HYDROCHLORIDE (FACOL) and LATANOPROST for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced SKIN WARM (little bit of warmth on the arm). On 07-Jan-2021, the patient experienced INJECTION SITE WARMTH (feverish warm area at the site), INJECTION SITE PRURITUS (Streak about inches down feels itchy), INJECTION SITE SWELLING (the site is about 3 inches around, swollen and tender), INJECTION SITE PAIN (the site is about 3 inches around, swollen and tender) and INJECTION SITE ERYTHEMA (red swollen tender). The patient was treated with PARACETAMOL (TYLENOL) for Injection site tenderness, Injection site swelling and Injection site warmth, at an unspecified dose and frequency. On 02-Jan-2021, SKIN WARM (little bit of warmth on the arm) had resolved. On 17-Jan-2021, INJECTION SITE WARMTH (feverish warm area at the site), INJECTION SITE PRURITUS (Streak about inches down feels itchy), INJECTION SITE SWELLING (the site is about 3 inches around, swollen and tender), INJECTION SITE PAIN (the site is about 3 inches around, swollen and tender) and INJECTION SITE ERYTHEMA (red swollen tender) had resolved.            Action taken with mRNA-1273 in response to the event/s was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received via ADR form. Patient address, email, medical history and outcome of events were updated. Dose 2 information was reported, no adverse events were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: arm is stinging / feels like a strong bee sting in his arm; arm is hot; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced stinging and heat in his arm.   The patient's medical history, as provided by the reporter, included hearing loss.  Relevant concomitant medications were not reported.   On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   The patient reported feeling like he had a strong bee sting on his arm which was stinging and hot.  The patient treated the events with an ice pack.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events stinging and heat in his arm were not reported.; Sender's Comments: Although a temporal association cannot be defined, based on the information provided a causal association between the product administration and the reported events cannot be excluded.  Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: light headedness; back and neck stiffness; got lousy, feeling yucky; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness), MUSCULOSKELETAL STIFFNESS (back and neck stiffness), MALAISE (got lousy, feeling yucky) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DIZZINESS (light headedness), MUSCULOSKELETAL STIFFNESS (back and neck stiffness), MALAISE (got lousy, feeling yucky) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (light headedness), MUSCULOSKELETAL STIFFNESS (back and neck stiffness), MALAISE (got lousy, feeling yucky) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.