chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: slight cough; headache; body aches; lethargy; chills; fever; could not get out of bed next two days; sore throat; congestion; arm was really sore; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (slight cough), HEADACHE (headache), MYALGIA (body aches), LETHARGY (lethargy) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Dental surgery NOS. Concurrent medical conditions included Allergy to antibiotic and Hypothyroidism since 2019. Concomitant products included LORATADINE for Allergy, AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN BAMBINI) for Dental treatment NOS, LEVOTHYROXINE for Hypothyroidism, ASA for Prevention, MULTIVITAMIN & MINERAL for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (slight cough), HEADACHE (headache), MYALGIA (body aches), LETHARGY (lethargy) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL A) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, COUGH (slight cough), HEADACHE (headache), MYALGIA (body aches), LETHARGY (lethargy) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-1 test: positive (Positive) Nasopharyngeal swab.     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.   This case was linked to MOD-2021-080866 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received and contains : Concomitant medications, second dose detail was updated .
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test
Clinical narrative: slight cough; headache; body aches; lethargy; chills; fever; could not get out of bed next two days; sore throat; congestion; arm was really sore; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (slight cough), HEADACHE (headache), MYALGIA (body aches), LETHARGY (lethargy) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Dental surgery NOS. Concurrent medical conditions included Allergy to antibiotic and Hypothyroidism since 2019. Concomitant products included LORATADINE for Allergy, AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN BAMBINI) for Dental treatment NOS, LEVOTHYROXINE for Hypothyroidism, ASA for Prevention, MULTIVITAMIN & MINERAL for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (slight cough), HEADACHE (headache), MYALGIA (body aches), LETHARGY (lethargy) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL A) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, COUGH (slight cough), HEADACHE (headache), MYALGIA (body aches), LETHARGY (lethargy) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-1 test: positive (Positive) Nasopharyngeal swab.     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.   This case was linked to MOD-2021-080866 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received and contains : Concomitant medications, second dose detail was updated .
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: short of breath; Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (short of breath) and DIZZINESS (Dizziness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperglycemia and Hypothyroidism. Concomitant products included CETIRIZINE HYDROCHLORIDE (BENADRYL ONE) for Hyperglycemia, LEVOTHYROXINE for Hypothyroidism, ROSUVASTATIN CALCIUM (CRESTOR).    On 18-Jan-2021 at 4:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (short of breath) and DIZZINESS (Dizziness). On 21-Jan-2021, DYSPNOEA (short of breath) and DIZZINESS (Dizziness) had 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 treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site swelling
Clinical narrative: pain to the touch; swelling - pea sized just above injection, maybe peach size; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   Treatment drugs were not reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant patient received the second dose of Moderna covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the second dose of Moderna covid-19 vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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] for Pregnancy.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Jul-2020 and the estimated date of delivery was 17-Apr-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the second dose of Moderna covid-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the second dose of Moderna covid-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) Positive.         No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Peripheral coldness
Clinical narrative: arm became cold; Blood pressure increased to 202/90; Heart rate increased to 105 bpm; A spontaneous report from was received from a non HCP concerning a 83 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm became cold, blood pressure increased to 202/90, and heart rate increased to 105 bpm.  The patient's medical history was not provided.   On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the Arm for prophylaxis of COVID-19 infection.   On 27 Jan 2021, the patient was transported to emergency room with arm became cold, blood pressure increased to 202/90, and heart rate of 105 bpm. She was released from hospital 4 hrs. later.  At home, her blood pressure was 178/92 and heart rate 105bpm.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events was resolved on 28 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site on her left arm was sore; Itchy injection site; Swollen injection site; Red (4"X6") Injection Site; Hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site on her left arm was sore), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE ERYTHEMA (Red (4"X6") Injection Site) and VACCINATION SITE WARMTH (Hot to touch) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site on her left arm was sore), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE ERYTHEMA (Red (4"X6") Injection Site) and VACCINATION SITE WARMTH (Hot to touch). At the time of the report, VACCINATION SITE PAIN (Injection site on her left arm was sore), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE ERYTHEMA (Red (4"X6") Injection Site) and VACCINATION SITE WARMTH (Hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Somnolence
Clinical narrative: some dizziness; sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (some dizziness) and SOMNOLENCE (sleepiness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIZZINESS (some dizziness) and SOMNOLENCE (sleepiness). At the time of the report, DIZZINESS (some dizziness) had not resolved and SOMNOLENCE (sleepiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: FU-1 is added. The patient is fine. The symptoms settled in 48 hours. Had the second dose also withoutany issues.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Maternal  exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Cancer and Heart disease, unspecified. Concurrent medical conditions included Hypertension and Polycystic ovarian syndrome. Concomitant products included AMLODIPINE, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and LEVOFLOXACIN (LEVOFROXIN) for an unknown indication.    On 09-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-Dec-2020 and the estimated date of delivery was 23-Sep-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The date of positive pregnancy test 18-Jan-2021 and ultrasound scan was done on 02-Feb-2021. The patient has an established prenatal care. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: Internal review on 21-Jul-2021 resulted in update of pregnancy details.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-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 02-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.            Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up  received on 22-APR-2021. included no new significant information.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Fatigue, Muscle spasms, Myalgia, Nervousness
Clinical narrative: spasm, like epileptic jerking of legs and arm.; muscle drop; almost had a nervous breakdown; muscle aches; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (spasm, like epileptic jerking of legs and arm.), DYSKINESIA (muscle drop), FATIGUE (exhausted), NERVOUSNESS (almost had a nervous breakdown) and MYALGIA (muscle aches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (exhausted). On 08-Feb-2021, the patient experienced MUSCLE SPASMS (spasm, like epileptic jerking of legs and arm.), DYSKINESIA (muscle drop), NERVOUSNESS (almost had a nervous breakdown) and MYALGIA (muscle aches). On 09-Feb-2021, MUSCLE SPASMS (spasm, like epileptic jerking of legs and arm.), DYSKINESIA (muscle drop), FATIGUE (exhausted), NERVOUSNESS (almost had a nervous breakdown) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: chemical taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (chemical taste in mouth) in a 71-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 Hypertension (Taking medications) since an unknown date.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (chemical taste in mouth). At the time of the report, DYSGEUSIA (chemical taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI On 20-Apr-2021: NNI
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Headache, Myalgia
Clinical narrative: Pain on throat; Throat was closing; Tightness on the lungs; Felt like a breathing problem; Fever; Chills; Muscle soreness; Headache; A spontaneous report was received from a consumer who was also a 23-years-old male patient who received Moderna's COVID-19 vaccine and experienced throat was closing (throat tightness), tightness on the lungs (chest discomfort), felt like a breathing problem (dyspoea), pain on throat (oropharyngeal pain), chills, muscle soreness (myalgia), and headache.  Patient medical history was not provided, and concomitant medicines taken by the patient, within two weeks prior to the event, included vitamins.  On 31 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient experienced fever, chills, body ache, muscle soreness, and headache. His lungs felt tight, and he had trouble breathing.  On 20 Jan 2021, the patient felt pain on his throat and like his throat was closing.  All symptoms were still ongoing, but the symptoms went on and off.  Treatment included nighttime cough medicine.  Action taken with mRNA-1273 was not reported.  The outcome of the events, throat was closing, tightness on the lungs, felt like a breathing problem, pain on throat, chills, muscle soreness, and headache, was considered not recovered/resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Throat tightness
Clinical narrative: Pain on throat; Throat was closing; Tightness on the lungs; Felt like a breathing problem; Fever; Chills; Muscle soreness; Headache; A spontaneous report was received from a consumer who was also a 23-years-old male patient who received Moderna's COVID-19 vaccine and experienced throat was closing (throat tightness), tightness on the lungs (chest discomfort), felt like a breathing problem (dyspoea), pain on throat (oropharyngeal pain), chills, muscle soreness (myalgia), and headache.  Patient medical history was not provided, and concomitant medicines taken by the patient, within two weeks prior to the event, included vitamins.  On 31 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient experienced fever, chills, body ache, muscle soreness, and headache. His lungs felt tight, and he had trouble breathing.  On 20 Jan 2021, the patient felt pain on his throat and like his throat was closing.  All symptoms were still ongoing, but the symptoms went on and off.  Treatment included nighttime cough medicine.  Action taken with mRNA-1273 was not reported.  The outcome of the events, throat was closing, tightness on the lungs, felt like a breathing problem, pain on throat, chills, muscle soreness, and headache, was considered not recovered/resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No reported medical history.).  On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.     No concomitant information provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash on arm; Redness on the arm; Swelling on the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE RASH (Rash on arm), INJECTION SITE ERYTHEMA (Redness on the arm) and INJECTION SITE SWELLING (Swelling on the arm) in a patient of an unknown age and gender 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 INJECTION SITE RASH (Rash on arm), INJECTION SITE ERYTHEMA (Redness on the arm) and INJECTION SITE SWELLING (Swelling on the arm). At the time of the report, INJECTION SITE RASH (Rash on arm), INJECTION SITE ERYTHEMA (Redness on the arm) and INJECTION SITE SWELLING (Swelling on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: I have stiff joints; arm is swollen; injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of   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 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-Mar-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information received included no new significant information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Injection site mass, Injection site pruritus, Pyrexia
Clinical narrative: Got achy,; Had a pink lump at injection site; slept a lot; it was itchy right away at injection site; low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Got achy,), INJECTION SITE MASS (Had a pink lump at injection site), HYPERSOMNIA (slept a lot), INJECTION SITE PRURITUS (it was itchy right away at injection site) and PYREXIA (low grade fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Thyroid disorder and Cholesterol.   On 27-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) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Got achy,), INJECTION SITE MASS (Had a pink lump at injection site), HYPERSOMNIA (slept a lot), INJECTION SITE PRURITUS (it was itchy right away at injection site), PYREXIA (low grade fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Got achy,), INJECTION SITE MASS (Had a pink lump at injection site), HYPERSOMNIA (slept a lot), INJECTION SITE PRURITUS (it was itchy right away at injection site), PYREXIA (low grade fever) and FATIGUE (Fatigue) outcome was unknown.            Action taken with vaccine was not applicable. Concomitant medications include blood pressure, thyroid and cholesterol medications.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Got achy,; Had a pink lump at injection site; slept a lot; it was itchy right away at injection site; low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Got achy,), INJECTION SITE MASS (Had a pink lump at injection site), HYPERSOMNIA (slept a lot), INJECTION SITE PRURITUS (it was itchy right away at injection site) and PYREXIA (low grade fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Thyroid disorder and Cholesterol.   On 27-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) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Got achy,), INJECTION SITE MASS (Had a pink lump at injection site), HYPERSOMNIA (slept a lot), INJECTION SITE PRURITUS (it was itchy right away at injection site), PYREXIA (low grade fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Got achy,), INJECTION SITE MASS (Had a pink lump at injection site), HYPERSOMNIA (slept a lot), INJECTION SITE PRURITUS (it was itchy right away at injection site), PYREXIA (low grade fever) and FATIGUE (Fatigue) outcome was unknown.            Action taken with vaccine was not applicable. Concomitant medications include blood pressure, thyroid and cholesterol medications.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeling abnormal, Lip swelling, Mouth swelling, Oral pain
Clinical narrative: Could not eat or drink; Mouth swelled up; Lips swelled up; Tongue swelled up; Fuzziness in her eye right after.; Severe pain in her mouth; A spontaneous report was received from a consumer, concerning a 72 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mouth swelled up/mouth swelling, lip swelled up/lip swelling, tongue swelled up/swollen tongue, experienced some fuzziness in her eyes/vision blurred, severe pain in her mouth/oral pain, could not eat or drink/dysphagia, swollen mouth got worse.  The patient's past medical history included rashes due to medication allergy. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 07 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly on left armfor prophylaxis of COVID-19 infection.  On 07 Feb 2021 after vaccination, the patient experienced fuzziness in right eye. Later that evening, the developed swollen mouth, lips ad tongue. The patient had severe pain in her mouth and subsequently consulted healthcare provider who recommended diphenhydramine, but it didn't work. On 09 Feb 2021, the patient swollen mouth got worse and was taken to emergency room. The patient was prescribed with solu-medrol shot and prescribed prednisone for next 5 days. This is medically significant. The patient could not eat or drink/dysphagia.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, mouth swelled up/mouth swelling, lip swelled up/lip swelling, tongue swelled up/swollen tongue, experienced some fuzziness in her eyes/vision blurred, severe pain in her mouth/oral pain, could not eat or drink/dysphagia, swollen mouth got worse were unknown.; Reporter's Comments: This case concerns a 72 Y/O F with a serious unexpected event of oral pain, and nonserious unexpected dysphagia, mouth swelling, lip swelling, swollen tongue, and feeling abnormal.  Event onset the same day as first dose mRNA-1273. Treated with diphenhydramine, solu-medrol, and prednisone. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Could not eat or drink; Mouth swelled up; Lips swelled up; Tongue swelled up; Fuzziness in her eye right after.; Severe pain in her mouth; A spontaneous report was received from a consumer, concerning a 72 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mouth swelled up/mouth swelling, lip swelled up/lip swelling, tongue swelled up/swollen tongue, experienced some fuzziness in her eyes/vision blurred, severe pain in her mouth/oral pain, could not eat or drink/dysphagia, swollen mouth got worse.  The patient's past medical history included rashes due to medication allergy. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 07 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly on left armfor prophylaxis of COVID-19 infection.  On 07 Feb 2021 after vaccination, the patient experienced fuzziness in right eye. Later that evening, the developed swollen mouth, lips ad tongue. The patient had severe pain in her mouth and subsequently consulted healthcare provider who recommended diphenhydramine, but it didn't work. On 09 Feb 2021, the patient swollen mouth got worse and was taken to emergency room. The patient was prescribed with solu-medrol shot and prescribed prednisone for next 5 days. This is medically significant. The patient could not eat or drink/dysphagia.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, mouth swelled up/mouth swelling, lip swelled up/lip swelling, tongue swelled up/swollen tongue, experienced some fuzziness in her eyes/vision blurred, severe pain in her mouth/oral pain, could not eat or drink/dysphagia, swollen mouth got worse were unknown.; Reporter's Comments: This case concerns a 72 Y/O F with a serious unexpected event of oral pain, and nonserious unexpected dysphagia, mouth swelling, lip swelling, swollen tongue, and feeling abnormal.  Event onset the same day as first dose mRNA-1273. Treated with diphenhydramine, solu-medrol, and prednisone. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Tenderness
Clinical narrative: arm very red; arm tender to the touch; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 26620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No new information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Psoriatic arthritis, Hypertension and Diabetic neuropathy. Concomitant products included GLIMEPIRIDE, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN & HCTZ), DULAGLUTIDE, METFORMIN, SULFASALAZINE, HYDROCHLOROTHIAZIDE, GABAPENTIN, TAMSULOSIN, ROSUVASTATIN, PRAMIPEXOLE and TRAMADOL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and MYALGIA (Body aches). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-103698, US-MODERNATX, INC.-MOD-2021-103698 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04-MAY-2021 contains non-significant information follow up for Dose 1. New information applies to Dose 2 case. Right arm  for Dose 2 and many AEs after dose 2. On 05-Jun-2021: Action taken and Dechallenge Results updated to not applicable.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103698: US-MODERNATX, INC.-MOD-2021-103698:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (BABY ASPIRIN).    On 09-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 07-Sep-2020 and the estimated date of delivery was 14-Jun-2021. On 02-Oct-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2020, Pregnancy test: Positive.     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 was provided by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Received Moderna COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.     On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Jun-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant). The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) at an unspecified dose and frequency. On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant) had 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: severe pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (severe pain at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (severe pain at the injection site). At the time of the report, VACCINATION SITE PAIN (severe pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Lethargy, Libido decreased, Pain in extremity
Clinical narrative: 9 days later big red blotch on arm and pian; lethargy; lack luster; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE REACTION (9 days later big red blotch on arm and pian), LETHARGY (lethargy) and LIBIDO DECREASED (lack luster) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PRAVASTATIN.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-Jan-2021, the patient experienced INJECTION SITE REACTION (9 days later big red blotch on arm and pian), LETHARGY (lethargy) and LIBIDO DECREASED (lack luster). At the time of the report, PAIN IN EXTREMITY (sore arm), LETHARGY (lethargy) and LIBIDO DECREASED (lack luster) outcome was unknown and INJECTION SITE REACTION (9 days later big red blotch on arm and pian) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in injection site arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) and METFORMIN for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness in injection site arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain injection site, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Soreness in injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-JUN-2021:Outcome of event, and treatment medication added.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site erythema
Clinical narrative: Slightly pink, 4 inch long, 1.5 inch wide, oval of pink; Sore arm after the administration; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Sore arm after the administration) and VACCINATION SITE ERYTHEMA (Slightly pink, 4 inch long, 1.5 inch wide, oval of pink) 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.  Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced AXILLARY PAIN (Sore arm after the administration). On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Slightly pink, 4 inch long, 1.5 inch wide, oval of pink). On 08-Jan-2021, AXILLARY PAIN (Sore arm after the administration) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Slightly pink, 4 inch long, 1.5 inch wide, oval of pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Follow-up added including Concomitant medication added- Statin On 08-Jun-2021: Follow up added and Contact information updated.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Pruritus, Skin burning sensation
Clinical narrative: Tremors; Can hardly stand up; Blurred vision; Itching everywhere; Burning of the skin; Light headedness, dizziness; Weakness; Hives; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Tremors), DYSSTASIA (Can hardly stand up), VISION BLURRED (Blurred vision), PRURITUS (Itching everywhere) and SKIN BURNING SENSATION (Burning of the skin) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.) Concomitant products included PREDNISONE for an unknown indication.    On 28-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 TREMOR (Tremors), DYSSTASIA (Can hardly stand up), VISION BLURRED (Blurred vision), PRURITUS (Itching everywhere), SKIN BURNING SENSATION (Burning of the skin), DIZZINESS (Light headedness, dizziness), ASTHENIA (Weakness) and URTICARIA (Hives). At the time of the report, TREMOR (Tremors), DYSSTASIA (Can hardly stand up), VISION BLURRED (Blurred vision), PRURITUS (Itching everywhere), SKIN BURNING SENSATION (Burning of the skin), DIZZINESS (Light headedness, dizziness), ASTHENIA (Weakness) and URTICARIA (Hives) 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.   Concomitant product use was not provided by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.