chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Dry throat, Vomiting
Clinical narrative: DRY THROAT; DIARRHOEA; VOMITING; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: aspirin allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609, expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 on left arm for prophylactic vaccination. It was unknown if patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient later received non-company suspect vaccine tozinameran (Pfizer) (dose number in series 2) (form of admin, route of admin were not reported, batch number: FD7218 expiry: unknown) dose was not reported, administered on 18-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2022, the patient experienced symptoms like diarrhoea and vomiting (dose number in series 2). On an unspecified date, patient experienced dry throat (dose number in series 2). The patient did not undergo any Covid-19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from diarrhoea, dry throat and vomiting. This report was non-serious.
Age: 0.33
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a 4-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On 08-Jul-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jul-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). The delivery occurred on an unknown date, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Concomitant medication was not provided.  Treatment information was not provided. Upon internal review on 04-Aug-2021, the age was corrected to 4 months.  Upon internal review on 03-Nov-2021, birth type captured as normal pregnancy outcome and fetal outcome captured delivered NOS.   This case was linked to MOD-2021-252946 (Parent-Child Link).   See case MOD-2021-252946 for details regarding the Parent case.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of exposure via breast milk (breastfeeding mother received mRNA-1273, Moderna COVID-19 vaccine, during pregnancy) in a 43-year-old female's baby exposed to mRNA-1273 (Moderna COVID-19) for immunization. No medical history reported. On Jun 19, 2021, patient received the 1st dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Last menstrual period and estimated date of delivery: not provided. On an unknown date, her baby exposed via breast milk (breastfeeding mother received mRNA-1273, Moderna COVID-19 vaccine, during pregnancy). At the time of the report, exposure via breast milk (breastfeeding mother received mRNA-1273, Moderna COVID-19 vaccine, during pregnancy): outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-254173 (parent-child link). See case MOD-2021-254173 for details regarding the parent case.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Underweight
Clinical narrative: Breastfeeding; low weight for gestation period; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) and UNDERWEIGHT (low weight for gestation period) in a male infant of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 031L20A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Anxiety in 2009.    MEDICAL HISTORY (Patient): The patient's past medical history included Exposure during pregnancy from 26-Jan-2021 to 26-Feb-2021.   On 26-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The mother's last menstrual period was in August 2020 and the estimated date of delivery was 11-May-2021. On an unknown date, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding) and UNDERWEIGHT (low weight for gestation period). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The cesarean delivery occurred on 06-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 2325 grams (5lbs 2oz). The outcome was reported as Term Birth NOS. Low weight for gestation period. At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) and UNDERWEIGHT (low weight for gestation period) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-031905 (Parent-Child Link).   See case MOD-2021-031905 for details regarding the Parent case.; Sender's Comments: QC Process - please don't review this case This is a case of product exposure during pregnancy with associated AEs of Exposure via breast milk and underweight . 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. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a 40-week-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    No Medical History information was reported.    On 24-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The mother's last menstrual period was on 19-Aug-2020 and the estimated date of delivery. On an unknown date, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The vaginal delivery occurred  which was reported as Full-term. For neonate 1, the birth weight was 3500 grams (7lbs 11oz). The outcome was reported as Delivered NOS. Complication during pregnancy: Yes. At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments. Date of positive pregnancy test: 23-SEP-2020. Mother had test on 3-MAR and Glucose intolerance test on 17-MAR-2021 as normal.  Mother has history of prior alcohol consumption. Mother took prenatal vitamin and vitamin-D during pregnancy.  No treatment medication was reported by reporter.  Upon internal review on 03-Nov-2021, In the Patient tab child only case and  Patient route of administration to Transmammary is updated.   This case was linked to MOD-2021-058260 (Parent-Child Link).   See case MOD-2021-058260 for details regarding the Parent case.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: about to breastfeed following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (about to breastfeed following vaccination) in an 8-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026p21a) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding. Concurrent medical conditions included Diabetes mellitus.    No Medical History information was reported.    On 30-Jul-2021, the mother received first 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 infant was diagnosed with EXPOSURE VIA BREAST MILK (about to breastfeed following vaccination). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE VIA BREAST MILK (about to breastfeed following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       No concomitant and treatment information were reported by the reporter.  Upon internal review on 09-Nov-2021, Patient and parent route of administration updated to trans mammary and intramuscular respectively, causality of event exposure via breast milk updated to Not Applicable, pregnancy information and breast-feeding checkbox updated.   This case was linked to MOD-2021-271968 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of maternal exposure during breastfeeding (breastfeeding/stopped breastfeeding for 48 hours after getting the vaccine) in a patient, of an unknown age and gender, exposed to mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939893), while the mother received the product for COVID-19 immunization. No medical history reported. On Aug 23, 2021, patient's mother received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), transmammary route; 1 dosage form. Last menstrual period and estimated date of delivery: not provided. On Aug 25, 2021, patient had maternal exposure during breastfeeding (breastfeeding/stopped breastfeeding for 48 hours after getting the vaccine). On Aug 25, 2021, maternal exposure during breastfeeding (breastfeeding/stopped breastfeeding for 48 hours after getting the vaccine) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-299887 (parent-child link). See case MOD-2021-299887 for details regarding the parent case.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 34-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the mother received first 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 adult was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       The parent experienced symptoms such as coughing, chest condition, loss of smell, runny nose and diarrhea and received treatment with ibuprofen for the fever and some sinus medicine for the coughing and congestion.   This case was linked to MOD-2021-299764 (Parent-Child Link).   See case MOD-2021-299764 for details regarding the Parent case.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased, Neck pain, Teething, Vaccination site pain
Clinical narrative: pain in the neck; pain in the teeth; Arm where she received the vaccine is very painful, she can not move it; pain in the shoulder; Area in the arm where she received the vaccine is very painful; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in the neck), TEETHING (pain in the teeth), MOBILITY DECREASED (Arm where she received the vaccine is very painful, she can not move it), ARTHRALGIA (pain in the shoulder) and VACCINATION SITE PAIN (Area in the arm where she received the vaccine is very painful) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Vitamin D.).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain in the neck), TEETHING (pain in the teeth), MOBILITY DECREASED (Arm where she received the vaccine is very painful, she can not move it), ARTHRALGIA (pain in the shoulder) and VACCINATION SITE PAIN (Area in the arm where she received the vaccine is very painful). At the time of the report, NECK PAIN (pain in the neck), TEETHING (pain in the teeth), MOBILITY DECREASED (Arm where she received the vaccine is very painful, she can not move it), ARTHRALGIA (pain in the shoulder) and VACCINATION SITE PAIN (Area in the arm where she received the vaccine is very painful) had not resolved.            The patient was not on any concomitant medication. The patient have not received other vaccines within 1 month prior to Moderna. The patient tested positive for COVID on 24 Dec 2021 and some more times but not remember the dates. Patient received booster dose on 13 Dec 2021 or 14 Dec 2021 reporter was not sure. The patient did not experienced similar event in the past. Patient  went to the doctor because it was very painful.Patient had never taken painkillers and at the time of reporting patient was on painkillers.Patient received physical therapy and acupuncture .   This case was linked to MOD-2022-511800, MOD-2022-511845 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: pain in the neck; pain in the teeth; Arm where she received the vaccine is very painful, she can not move it; pain in the shoulder; Area in the arm where she received the vaccine is very painful; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in the neck), TEETHING (pain in the teeth), MOBILITY DECREASED (Arm where she received the vaccine is very painful, she can not move it), ARTHRALGIA (pain in the shoulder) and VACCINATION SITE PAIN (Area in the arm where she received the vaccine is very painful) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Vitamin D.).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain in the neck), TEETHING (pain in the teeth), MOBILITY DECREASED (Arm where she received the vaccine is very painful, she can not move it), ARTHRALGIA (pain in the shoulder) and VACCINATION SITE PAIN (Area in the arm where she received the vaccine is very painful). At the time of the report, NECK PAIN (pain in the neck), TEETHING (pain in the teeth), MOBILITY DECREASED (Arm where she received the vaccine is very painful, she can not move it), ARTHRALGIA (pain in the shoulder) and VACCINATION SITE PAIN (Area in the arm where she received the vaccine is very painful) had not resolved.            The patient was not on any concomitant medication. The patient have not received other vaccines within 1 month prior to Moderna. The patient tested positive for COVID on 24 Dec 2021 and some more times but not remember the dates. Patient received booster dose on 13 Dec 2021 or 14 Dec 2021 reporter was not sure. The patient did not experienced similar event in the past. Patient  went to the doctor because it was very painful.Patient had never taken painkillers and at the time of reporting patient was on painkillers.Patient received physical therapy and acupuncture .   This case was linked to MOD-2022-511800, MOD-2022-511845 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Speech disorder, Vomiting
Clinical narrative: trouble talking; Headache; Vomiting; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (trouble talking), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills) and NAUSEA (Nausea) in a 66-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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SPEECH DISORDER (trouble talking), VOMITING (Vomiting) and NAUSEA (Nausea). 01-Feb-2021, the patient experienced HEADACHE (Headache). In February 2021, the patient experienced CHILLS (Chills). At the time of the report, SPEECH DISORDER (trouble talking), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills) and NAUSEA (Nausea) had resolved.            No relevant concomitant medications were reported. The patient experienced headaches that were so bad that felt like she was going to die. The patient had gone to urgent care and the patient was given a shot used for migraine headaches and given anti-nausea medication. The patient could not remember the name of the shot given for migraine headaches and anti nausea medication.   This case was linked to MOD-2022-512561 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Spasmodic dysphonia, Vomiting
Clinical narrative: diagnosed with spasmodic dysphonia; headache/The headaches were so bad that I felt like I was going to die; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SPASMODIC DYSPHONIA (diagnosed with spasmodic dysphonia), HEADACHE (headache/The headaches were so bad that I felt like I was going to die), VOMITING (vomiting) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (headache/The headaches were so bad that I felt like I was going to die), VOMITING (vomiting) and NAUSEA (nausea). In August 2021, the patient experienced SPASMODIC DYSPHONIA (diagnosed with spasmodic dysphonia). At the time of the report, SPASMODIC DYSPHONIA (diagnosed with spasmodic dysphonia), HEADACHE (headache/The headaches were so bad that I felt like I was going to die), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.            The patient took some pain and anti nausea medication that she had on hand from a previous surgery. No concomitant medication was reported.   This case was linked to MOD-2022-512516, MOD-2022-512562 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Follow up received on 16-MAR-2022: No new information received
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: The patient reports a headache, nausea and vomiting.; The patient reports a headache, nausea and vomiting.; The patient reports a headache, nausea and vomiting.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (The patient reports a headache, nausea and vomiting.), NAUSEA (The patient reports a headache, nausea and vomiting.) and VOMITING (The patient reports a headache, nausea and vomiting.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Spasmodic dysphonia in August 2021 and Surgery (The patient took some pain and anti nausea medication that she had on hand from a previous surgery.).    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced HEADACHE (The patient reports a headache, nausea and vomiting.), NAUSEA (The patient reports a headache, nausea and vomiting.) and VOMITING (The patient reports a headache, nausea and vomiting.). At the time of the report, HEADACHE (The patient reports a headache, nausea and vomiting.), NAUSEA (The patient reports a headache, nausea and vomiting.) and VOMITING (The patient reports a headache, nausea and vomiting.) outcome was unknown.            Concomitant medications reported were: shot used for migraine headaches, anti nausea medication and pain medication.  The patient received her first and second dose of Moderna Covid-19 injection on 01-Feb-2021 (lot number 042L20A) and 03-Mar-2021 (lot number 036A21A) respectively.   This case was linked to MOD-2022-512561 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Non Significant follow up was received: no new information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  No treatment medications were reported.  The patient did not have any allergies to medications, food, and other products.  The patient had not taken any other vaccines within 1 month prior to Moderna COVID-19 vaccination. The patient had a runny nose a week after getting the booster which led the patient to getting tested for COVID-19.  Company Comment: This spontaneous case concerns a 79-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. Lack of drug effect was considered as an additional event. The events occurred approximately 10 months after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2. Treatment information was not provided. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-512683, MOD-2022-512669 (Patient Link).; Sender's Comments: This spontaneous case concerns a 79-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. Lack of drug effect was considered as an additional event. The events occurred approximately 10 months after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2. Treatment information was not provided. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: caller states they have received four booster (doses); This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (caller states they have received four booster (doses)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Type 2 diabetes mellitus, Asthma and Heart disease, unspecified.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced EXTRA DOSE ADMINISTERED (caller states they have received four booster (doses)). At the time of the report, EXTRA DOSE ADMINISTERED (caller states they have received four booster (doses)) outcome was unknown.            No concomitant medications were reported.  He received fourth booster was a couple days ago. Caller stated that he received two full doses plus 1 booster very 6 months. Caller initially stated they received a booster every 6 months after dose 2 and then they stated some of the intervals "may" have been about 4 months.   No treatment medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dose 1 and dose 2 though I had a mild fever.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (dose 1 and dose 2 though I had a mild fever.) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (dose 1 and dose 2 though I had a mild fever.). At the time of the report, PYREXIA (dose 1 and dose 2 though I had a mild fever.) 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 was reported. No concomitant medication was reported.   This case was linked to MOD-2022-512781, MOD-2022-512787 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had a mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a mild fever) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had a mild fever). At the time of the report, PYREXIA (Had a mild fever) outcome was unknown.            No concomitant medications was provided.  No treatment medications was provided.   This case was linked to MOD-2022-512787 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: Pre-existing ulcerative colitis flare up/pre-existing ulcerative colitis flare up and Remicade use; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Pre-existing ulcerative colitis flare up/pre-existing ulcerative colitis flare up and Remicade use) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (She is immunocompromised) and Ulcerative colitis (Pre-existing ulcerative colitis). Concomitant products included INFLIXIMAB (REMICADE) for Colitis ulcerative aggravated, PREDNISONE for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (Pre-existing ulcerative colitis flare up/pre-existing ulcerative colitis flare up and Remicade use). At the time of the report, COLITIS ULCERATIVE (Pre-existing ulcerative colitis flare up/pre-existing ulcerative colitis flare up and Remicade use) outcome was unknown.            On 16-Mar-2022, the patient called and stated that she was immunocompromised due to pre-existing ulcerative colitis and was taking Remicade for a recent flare up. She also states she takes the steroid prednisone and asked if there was any interaction with the Moderna vaccine.  She states that she had two primary series Moderna doses and a third dose but she was not sure if it was 0.5mL or 0.25 mL.  No treatment medications were reported.  The caller asked if she could get an additional booster due to being immunocompromised.   Caller declined she was reporting side effects after Moderna vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The Patient was instructed to receive a third full dose of the Moderna COVID-19 vaccine. Treatment information was not provided. COMPANY COMMENT: This is an Spontaneous case concerning an unknown-years-old male patient with clinical history of COVID-19 immunisation with two doses and booster Moderna mRNA-1273 vaccine who experienced the unexpected event of NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) unknown days after a booster dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: COMPANY COMMENT: This is a Spontaneous case concerning an unknown-years-old male patient with clinical history of COVID-19 immunisation with two doses and booster Moderna mRNA-1273 vaccine who experienced the unexpected event of NEOPLASM MALIGNANT (Diagnosed with Cancer after receiving primary series and booster dose) unknown days after a booster dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm after the booster dose/minor soreness in her injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after the booster dose/minor soreness in her injection site arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm after the booster dose/minor soreness in her injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore arm after the booster dose/minor soreness in her injection site arm) outcome was unknown.            No concomitant medications were provided. Patient did not report any other adverse reactions. No treatment medications were provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 3 days/ 10 days later fever 2 more days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 3 days/ 10 days later fever 2 more days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Hives (The patient had a allergy history of Hives/urticaria.), Coronary artery bypass (triple by-pass), Coronary arterial stent insertion (12 stents), Cardiac catheterization (18 heart catherizations) and Arterial graft (a bovine artery grafted into the right femoral artery). Concurrent medical conditions included Drug allergy (hives from vitamin C in fruits, or a new fruit , or large quantity of tablet) since 03-May-1951, Heart attack (10 heart attacks) since May 2000 and Depression since May 2000. Concomitant products included ESCITALOPRAM OXALATE for Depression, FUROSEMIDE, LISINOPRIL and ATORVASTATIN for Heart disorder, LEVOTHYROXINE for Thyroid disorder, TRAZODONE, EZETIMIBE, CARVEDILOL, ALBUTEROL [SALBUTAMOL], BUPROPION, CLOBETASOL and CLOPIDOGREL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PYREXIA (Fever 3 days/ 10 days later fever 2 more days). In March 2021, PYREXIA (Fever 3 days/ 10 days later fever 2 more days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       On 05-Mar-2021, the patient received the first shot and had fever for 3 days and 10 days later fever for 2 more days.  No treatment information was provided.   This case was linked to MOD-2022-507135 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Lip swelling, Swelling face, Trismus
Clinical narrative: I had facial fillers. I had a reaction 4 hrs later; My lips swelled up; My cheeks swelled up, Everything on my face just blew up; hard to open my mouth; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE REACTION (I had facial fillers. I had a reaction 4 hrs later), LIP SWELLING (My lips swelled up), SWELLING FACE (My cheeks swelled up, Everything on my face just blew up) and TRISMUS (hard to open my mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 booster (Booster) on 17-Jan-2022. Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 booster.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INJECTION SITE REACTION (I had facial fillers. I had a reaction 4 hrs later), LIP SWELLING (My lips swelled up), SWELLING FACE (My cheeks swelled up, Everything on my face just blew up) and TRISMUS (hard to open my mouth). In 2021, INJECTION SITE REACTION (I had facial fillers. I had a reaction 4 hrs later), LIP SWELLING (My lips swelled up), SWELLING FACE (My cheeks swelled up, Everything on my face just blew up) and TRISMUS (hard to open my mouth) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. Patient call her cosmetic surgeon on 14-Mar-2022 and did not get a call back.
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder
Clinical narrative: Patient experienced a problem in her ears after getting 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISORDER (Patient experienced a problem in her ears after getting 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR DISORDER (Patient experienced a problem in her ears after getting 2nd dose). At the time of the report, EAR DISORDER (Patient experienced a problem in her ears after getting 2nd dose) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Suffering long term side effects from the Moderna COVID-19 infection/Side effects are getting more severe and are not going away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Suffering long term side effects from the Moderna COVID-19 infection/Side effects are getting more severe and are not going away) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Suffering long term side effects from the Moderna COVID-19 infection/Side effects are getting more severe and are not going away). At the time of the report, VACCINATION COMPLICATION (Suffering long term side effects from the Moderna COVID-19 infection/Side effects are getting more severe and are not going away) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  The reporter had a friend who was suffering long term side effects from the Moderna COVID-19 infection. It was reported that her friend is a male who was suffering several of the listed side effects to the Moderna COVID-19 vaccine that one can find in the patient information. The reporter stated that the side effects were getting more severe and it was not going away.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID-19 after vaccination; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID-19 after vaccination) and DRUG INEFFECTIVE (Lack of drug effect) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced COVID-19 (diagnosed with COVID-19 after vaccination) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (diagnosed with COVID-19 after vaccination) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            No concomitant medications were reported. It was reported that patient received infusion and got a package of stuff on 14-Dec-2021  Company comment: This spontaneous case concerns a 69-year-old male patient, with no medical history reported, who experienced the unexpected non serious AESI of COVID 19. Drug ineffective was also captured as an additional event. The event occurred approximately 8 months after the 2nd dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-512996 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2022: Follow-up contains No New Information; Sender's Comments: This spontaneous case concerns a 69-year-old male patient, with no medical history reported, who experienced the unexpected non serious AESI of COVID 19. Drug ineffective was also captured as an additional event. The event occurred approximately 8 months after the 2nd dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Runny nose; Foot pain; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Foot pain) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Foot pain). At the time of the report, RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Foot pain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant product reported by reporter. No treatment medication reported by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L201A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus (since 10 years old). Concomitant products included INSULIN for Type 1 diabetes mellitus.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment drug information was provided after dose 1 . Patient reported lot number 025L201A - Said it was either an A or 4. Patient stated that her nose has ran since the day of the 1st dose but said it could be allergies.That runny nose has been going on and on.   This case was linked to MOD-2022-513603, MOD-2021-214960 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to 2 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 2 patients) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 2 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 2 patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Patient had no adverse event Patient received a dose from lot 058F21A five days after it was expired Treatment information was not provided
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (dose received 5 days after it expired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 058F21A) for COVID-19 immunization. No medical history reported. On Feb 11, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 11, 2022, patient experienced administered expired product (dose received 5 days after it expired). At the time of the report, administered expired product (dose received 5 days after it expired) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.