chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Presyncope, Respiratory rate, Salivary hypersecretion
Clinical narrative: Felt like I was losing consciousness; Mouth watering; fought to breathe; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like I was losing consciousness), SALIVARY HYPERSECRETION (Mouth watering) and DYSPNOEA (fought to breathe) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in 2020, TETANUS VACCINE in 2020, PNEUMOCOCCAL VACCINE (pneumonia vaccine) in 2020 and INFLUENZA VACCINE in 2020. Concurrent medical conditions included Drug allergy ("allergic to caines"). Concomitant products included SIMVASTATIN, LISINOPRIL, METFORMIN and ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for an unknown indication.    On 29-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRESYNCOPE (Felt like I was losing consciousness), SALIVARY HYPERSECRETION (Mouth watering) and DYSPNOEA (fought to breathe). On 29-Jan-2021, PRESYNCOPE (Felt like I was losing consciousness), SALIVARY HYPERSECRETION (Mouth watering) and DYSPNOEA (fought to breathe) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Heart rate: increased (High) heart beating fast. On 29-Jan-2021, Respiratory rate: increased (High) rapid breathing.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not reported.  Per report, within 25 minutes following vaccination, the patient experienced two episodes of presyncope, dyspnea, and increased salivation. About one hour after vaccination the patient reported feeling normal again.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information received on 22APR2021 included updates on end date, outcome and events.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: (unknown route) unknown. 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) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This is a case of product exposure during pregnancy with no associated adverse events (AEs) for this female patient of unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events (AEs) for this female patient of unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: a larger red spot around the injection site; large red spot is itching; her arm became sore for a day; arm was itchy; arm was a little warm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jan-2021 and was forwarded to Moderna on 20-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm became sore for a day), PRURITUS (arm was itchy), FEELING HOT (arm was a little warm), VACCINATION SITE ERYTHEMA (a larger red spot around the injection site) and VACCINATION SITE PRURITUS (large red spot is itching) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (her arm became sore for a day), PRURITUS (arm was itchy) and FEELING HOT (arm was a little warm). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (a larger red spot around the injection site) and VACCINATION SITE PRURITUS (large red spot is itching). On 13-Jan-2021, PAIN IN EXTREMITY (her arm became sore for a day), PRURITUS (arm was itchy) and FEELING HOT (arm was a little warm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (a larger red spot around the injection site) and VACCINATION SITE PRURITUS (large red spot is itching) had not resolved.            Treatment information was not provided by reporter.   Action taken with the drug in response to the events was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non significant follow up
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling
Clinical narrative: swollen arm; hot arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and FEELING HOT (hot arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm) and FEELING HOT (hot arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and FEELING HOT (hot arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Per report, the patient reports that after the first dose of the vaccine she experienced a swollen, hot arm that initially recovered and then reoccurred 8 days later.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-037467 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 01J20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Outcome induced abortion) from 2006 to 13-Sep-2006. Concurrent medical conditions included Epilepsy (stable for years-no seizures) since 1998, SLE (Lupus-stable) since June 2006, Asthma (childhood asthma), Drug allergy (sulfa) and Fruit allergy (Blueberries). Concomitant products included LAMOTRIGINE (LAMICTAL), HYDROXYCHLOROQUINE, MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LEVOTHYROXINE, ALBUTEROL SULFATE, SALBUTAMOL (ALBUTEROL HFA), FOLIC ACID and 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].   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-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 20-Dec-2020 and the estimated date of delivery was 02-Oct-2021. In January 2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  In January 2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Pregnancy: positive (Positive) Positive.         No treatment information provided.  This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchiness at injection site; redness at injection site; raised spot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20-Jan-2021, the patient experienced itchiness, redness and a raised spot at injection site. Concomitant medications were not provided. The patient did not receive any treatment medications.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Musculoskeletal stiffness, Night sweats, Pain, Pyrexia
Clinical narrative: stiff neck; Pain; night sweats; Fever, temperature of 103 degrees; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN (Pain), NIGHT SWEATS (night sweats) and PYREXIA (Fever, temperature of 103 degrees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN (Pain), NIGHT SWEATS (night sweats) and PYREXIA (Fever, temperature of 103 degrees). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, Pain and Stiff neck, at an unspecified dose and frequency. On 16-Jan-2021, MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN (Pain) and PYREXIA (Fever, temperature of 103 degrees) had resolved. At the time of the report, NIGHT SWEATS (night sweats) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 103 (High) 103 degrees.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications was not provided.  Patient had reported that reactions after the first dose settled in about three days. He Had the second dose without any reactions  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  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   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received and event duration updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Fatigue, Feeling hot, Headache, Pain in extremity
Clinical narrative: warmness under the sternum; felt like throat was closing up; blood pressure went lowat time of the vaccine administration; heart racing, heart rate was (93-103); arm soreness; fatigue; mild headache; 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 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with LORAZEPAM (ATIVAN) on 24-Dec-2020 for Adverse event, at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24-Dec-2020, the patient experienced symptoms like warmness under the sternum, felt like his throat was closing up and blood pressure went low at time of the vaccine administration. He was laid down by the vaccine provider and for about 15-20 mins felt better and he was released to go after. He stated he refused to get blood sugar checked while at the vaccine site and did not eat breakfast or drink anything before getting the vaccine. He experienced fatigue, mild headache, arm soreness, heart racing, heart rate of 93-103 and took half of lorazepam and laid down until about 8pm on same day as first dose vaccination. Concomitant medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Throat tightness
Clinical narrative: warmness under the sternum; felt like throat was closing up; blood pressure went lowat time of the vaccine administration; heart racing, heart rate was (93-103); arm soreness; fatigue; mild headache; 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 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with LORAZEPAM (ATIVAN) on 24-Dec-2020 for Adverse event, at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24-Dec-2020, the patient experienced symptoms like warmness under the sternum, felt like his throat was closing up and blood pressure went low at time of the vaccine administration. He was laid down by the vaccine provider and for about 15-20 mins felt better and he was released to go after. He stated he refused to get blood sugar checked while at the vaccine site and did not eat breakfast or drink anything before getting the vaccine. He experienced fatigue, mild headache, arm soreness, heart racing, heart rate of 93-103 and took half of lorazepam and laid down until about 8pm on same day as first dose vaccination. Concomitant medications were not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: She is in such pain that she cannot use her arm; Knot in arm; A spontaneous report was received from a consumer concerning his wife, a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a knot in her arm, and such pain that she couldn't use her arm.  The patient's medical history was not provided. Concomitant product use was not provided.  On 27 Jan 2021, the patient received her dose of mRNA-1273 (Lot number unknown) in the right arm for prophylaxis of COVID-19 infection.   On 31 Jan 2021 she had a knot in her arm.  She was in such pain that she couldn't use her arm.  Treatments of these events included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were unknown.; Reporter's Comments: This case concerns a 77 year old female patient who received her dose of mRNA-1273 (Lot number unknown) in the right arm for prophylaxis of COVID-19 infection  and experienced a non-serious listed event of "knot in her arm" and non-serious unlisted event of  "such pain that she couldn't use her arm". Treatment included Tylenol. 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 and the events are possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: she woke up in the middle of the night because she felt like something was biting her. It was hot; she woke up in the middle of the night because she felt like something was biting her. It was itching; she woke up in the middle of the night because she felt like something was biting her. It was red; little swollen and little painful; little swollen and little painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (she woke up in the middle of the night because she felt like something was biting her. It was hot), VACCINATION SITE PRURITUS (she woke up in the middle of the night because she felt like something was biting her. It was itching), VACCINATION SITE ERYTHEMA (she woke up in the middle of the night because she felt like something was biting her. It was red), VACCINATION SITE PAIN (little swollen and little painful) and VACCINATION SITE SWELLING (little swollen and little painful) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (little swollen and little painful) and VACCINATION SITE SWELLING (little swollen and little painful). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (she woke up in the middle of the night because she felt like something was biting her. It was hot), VACCINATION SITE PRURITUS (she woke up in the middle of the night because she felt like something was biting her. It was itching) and VACCINATION SITE ERYTHEMA (she woke up in the middle of the night because she felt like something was biting her. It was red). The patient was treated with CEPHALEXIN [CEFALEXIN] on 14-Jan-2021 for Adverse event, at a dose of 500 mg four times per day. At the time of the report, VACCINATION SITE WARMTH (she woke up in the middle of the night because she felt like something was biting her. It was hot), VACCINATION SITE PRURITUS (she woke up in the middle of the night because she felt like something was biting her. It was itching), VACCINATION SITE ERYTHEMA (she woke up in the middle of the night because she felt like something was biting her. It was red) and VACCINATION SITE SWELLING (little swollen and little painful) had not resolved and VACCINATION SITE PAIN (little swollen and little painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Hyperhidrosis, Nausea
Clinical narrative: having sweats; having hot spells; Dizzy; feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (having sweats), HOT FLUSH (having hot spells), DIZZINESS (Dizzy) and NAUSEA (feeling nauseous) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Spinal fusion (Five spinal fusion) in 1995, Cancer (He lost a kidney from the drugs for his cancer) and Dialysis (he was getting dialysis for four years.). Concomitant products included TACROLIMUS for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (having sweats), HOT FLUSH (having hot spells), DIZZINESS (Dizzy) and NAUSEA (feeling nauseous). At the time of the report, HYPERHIDROSIS (having sweats), HOT FLUSH (having hot spells) and NAUSEA (feeling nauseous) outcome was unknown and DIZZINESS (Dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Email was provided On 24-May-2021: Patient details was updated. Concomitant medication was added. Past historical conditions were added
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypoaesthesia
Clinical narrative: Had same numbing feeling when he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Had same numbing feeling when he got the shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Had same numbing feeling when he got the shot). At the time of the report, HYPOAESTHESIA (Had same numbing feeling when he got the shot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Blood pressure measurement: 190/110 mmHg High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: Running temperature; Diarrhea; sore arm, arm really hurts; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Running temperature), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (sore arm, arm really hurts) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 PYREXIA (Running temperature), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (sore arm, arm really hurts). At the time of the report, PYREXIA (Running temperature), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (sore arm, arm really hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter. No treatment was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: currently 5 weeks pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (currently 5 weeks 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Dec-2020 and the estimated date of delivery was 06-Oct-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (currently 5 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (currently 5 weeks 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 considered MATERNAL EXPOSURE DURING PREGNANCY (currently 5 weeks pregnant) to be not related.    It was reported that the patient is getting their second dose of the vaccine on 2Feb2021. Patient is calling to sign up for the registry. No concomitant information was reported. No treatment information was reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tachycardia, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: first dose of the Moderna COVID-19 Vaccine on January; Tachycardia; erythema around the injection site described as a red; Raised area; Itchy area; local site reaction below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (local site reaction below the injection site), VACCINATION SITE ERYTHEMA (erythema around the injection site described as a red), VACCINATION SITE SWELLING (Raised area), VACCINATION SITE PRURITUS (Itchy area) and PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna COVID-19 Vaccine on January) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Graves' disease, Asthma (Mild Ashtma) and Thyroidectomy. Concurrent medical conditions included Allergy (Allergic to sulfa.), Iodine contrast media allergy and Drug allergy (Sulpha allergy). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), LEVOTHYROXINE SODIUM (SYNTHROID), NADOLOL and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE REACTION (local site reaction below the injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (erythema around the injection site described as a red), VACCINATION SITE SWELLING (Raised area) and VACCINATION SITE PRURITUS (Itchy area). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna COVID-19 Vaccine on January) and TACHYCARDIA (Tachycardia). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 19-Jan-2021 for Itchy, Redness and Induration, at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE REACTION (local site reaction below the injection site) had resolved. On 20-Jan-2021, VACCINATION SITE ERYTHEMA (erythema around the injection site described as a red), VACCINATION SITE SWELLING (Raised area) and VACCINATION SITE PRURITUS (Itchy area) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna COVID-19 Vaccine on January) and TACHYCARDIA (Tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant Follow-up contained New Events Tachycardia and Moderna Arm.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: first dose of the Moderna COVID-19 Vaccine on January; Tachycardia; erythema around the injection site described as a red; Raised area; Itchy area; local site reaction below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (local site reaction below the injection site), VACCINATION SITE ERYTHEMA (erythema around the injection site described as a red), VACCINATION SITE SWELLING (Raised area), VACCINATION SITE PRURITUS (Itchy area) and PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna COVID-19 Vaccine on January) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Graves' disease, Asthma (Mild Ashtma) and Thyroidectomy. Concurrent medical conditions included Allergy (Allergic to sulfa.), Iodine contrast media allergy and Drug allergy (Sulpha allergy). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), LEVOTHYROXINE SODIUM (SYNTHROID), NADOLOL and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE REACTION (local site reaction below the injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (erythema around the injection site described as a red), VACCINATION SITE SWELLING (Raised area) and VACCINATION SITE PRURITUS (Itchy area). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna COVID-19 Vaccine on January) and TACHYCARDIA (Tachycardia). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 19-Jan-2021 for Itchy, Redness and Induration, at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE REACTION (local site reaction below the injection site) had resolved. On 20-Jan-2021, VACCINATION SITE ERYTHEMA (erythema around the injection site described as a red), VACCINATION SITE SWELLING (Raised area) and VACCINATION SITE PRURITUS (Itchy area) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna COVID-19 Vaccine on January) and TACHYCARDIA (Tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant Follow-up contained New Events Tachycardia and Moderna Arm.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound abdomen, Vaccination site pain
Clinical narrative: Pregnant; Sore arm at the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 06-Jul-2020 to an unknown date for Pregnancy.    On 27-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 07-Jun-2020 and the estimated date of delivery was 14-Mar-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Sore arm at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2020, Pregnancy test: positive (Positive) Positive. On 08-Jul-2020, Blood glucose: normal normal. On 30-Oct-2020, Ultrasound abdomen: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Estimated date of conception reported as 16JUN2020. No Treatment medications was provided by the reporter.; Sender's Comments: This is the case of product exposure during pregnancy with an associated adverse event for this 32-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Pregnant at second dose; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant at second dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0030L20A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LABETALOL and PRENATAL VITAMINS for an unknown indication.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 26-Dec-2020 and the estimated date of delivery was 02-Oct-2021. On 29-Jan-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant at second dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 29-Jan-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant at second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: I am having some side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (I am having some side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (I am having some side effects). At the time of the report, ADVERSE REACTION (I am having some side effects) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Patient informed that the events resolved
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my left arm hurt; This spontaneous case was reported by a physician (subsequently medically confirmed) 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.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment  information was unknown  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chromosome analysis normal, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
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 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (occasional) from 2009 to 28-Sep-2020, Laparoscopic surgery (for endometriosis) in October 2016 and Artificial insemination (3-4 cycles unsuccessful). Family history included Autism (Brother - low functioning on autism spectrum) since an unknown date. Concurrent medical conditions included Drug allergy (sulfa medications) and Endometriosis. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Nasal congestion, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, VITAMIN D3, IRON and CALCIUM for Supplementation therapy, SIMETICONE (GAS-X) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Aug-2020 and the estimated date of delivery was 06-Jun-2021. On 25-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 25-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Chromosome analysis normal: normal (normal) At 12 weeks: normal. On an unknown date, Ultrasound scan: normal (normal) at 6-, 8-, 10-, and 20-weeks: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin, Pregnancy test urine
Clinical narrative: Three weeks pregnant; This spontaneous prospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Three weeks pregnant) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Dec-2020 and the estimated date of delivery was 15-Sep-2021. On 23-Dec-2020 at 11:00 AM, the patient experienced EXPOSURE DURING PREGNANCY (Three weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.   On 23-Jan-2021 at 11:00 AM, EXPOSURE DURING PREGNANCY (Three weeks pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Human chorionic gonadotropin: 144 Abnormal. In January 2021, Pregnancy test urine: positive 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: No specific follow-up information recorded. On 02-Feb-2021: No specific follow-up information recorded.  No treatment information was reported; Sender's Comments: This case concerns a 23-year-old female patient who received first dose of mRNA-1273 while pregnant (Vaccine exposure during pregnancy). Last menstrual period was 09-Dec-2020  which was 2 weeks before product administration. Urine pregnancy tests positive test was Jan 2020. Date of conception was not provided but estimated date of delivery is 15-Sep-2021. 19 days post vaccination Human chorionic gonadotropin was abnormal
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy
Clinical narrative: Pregnant; This spontaneous pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Oct-2021. On 29-Jan-2021, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash) in a 59-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 medical history provided).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Rash started 1 week after the vaccine and spread on the arm. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: woke up with a headache; patient is pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant), PAIN IN EXTREMITY (Sore arm) and HEADACHE (woke up with a headache) in a 34-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (wine -3 drinks) on 02-Oct-2020. Concurrent medical conditions included Allergy to antibiotic (Erythromycin).    On 26-Jan-2021 at 10:30 AM, the patient received first 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 13-Jun-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant). 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 27-Jan-2021, the patient experienced HEADACHE (woke up with a headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (woke up with a headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. 08 Oct 2020,Pregnancy test was Positive. 15 May 2017, the patient delivered live, full-term birth baby. 28 Jan 2020, the patient delivered live, full-term birth baby.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental implantation on 20-Jan-2021.   On 19-Jan-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 19-Jan-2021, the patient experienced SWELLING (swelling). At the time of the report, SWELLING (swelling) had not resolved.            The patient's concomitants had not provided. Treatment was not provided.  Patient want's to confirm if she can take prednisolone for dental implantation.  Action taken with mRNA-123 is not applicable.; Reporter's Comments: patient wants to know if she can take prednisone prescribed to her after receiving two dental implants at the dentist on 20jan2021 to help treat the swelling. She reports having the second Moderna COVID-19 vaccine on 19Jan2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Live birth on 31-May-2015, Pregnancy induced hypertension and Hemorrhage postpartum. Concurrent medical conditions included Drug allergy (Morphine), Bee sting hypersensitivity and Drug allergy (toradol). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) for an unknown indication.    On 20-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Jul-2020 and the estimated date of delivery was 10-May-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 20-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2020, Pregnancy test: positive (Positive) 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 drugs are not provided by reporter.