chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red knot at the site of injection; A spontaneous report was received from a pharmacist who is a 55-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a red knot at injection site.  The patient's medical history was not provided. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A, Exp. date: 11 May 2021) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced a red knot at injection site. No treatment was administered for the event.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the event of a red knot at injection site was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; A spontaneous report was received from a consumer concerning a 76-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea.  The patient's medical history was not provided. Concomitant medications were not reported.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 11L20A) for the prophylaxis of COVID-19 infection.  On 04 Jan 2021, after receiving the vaccine, the patient experienced diarrhea. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event diarrhea was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of diarrhea, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 19 weeks Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (19 weeks Pregnant) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) 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 19-Aug-2020 and the estimated date of delivery was 01-Jun-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (19 weeks Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth 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 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (19 weeks Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity
Clinical narrative: Diarrhea; Slight headache; Sorenessin the arm; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness in arm / pain in extremity, slight headache / headache and diarrhea.  No prior medical history and concomitant medications were reported.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) in left arm for prophylaxis of COVID-19 infection. The dose quantity was reported as 0.5 ml. The expiry date of drug was reported as 31 Jul 2021.  On 04 Jan 2021, the patient experienced soreness in arm and headache. On 06 Jan 2021, the patient experienced diarrhea. Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, soreness in arm, headache and diarrhea, were not provided.; Reporter's Comments: This case concerns a 72-year-old female who experienced NS events of unexpected pain in extremity and diarrhea and expected headache. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Eye swelling, Injection site erythema, Injection site swelling
Clinical narrative: Site reaction at injection site was red; Site reaction at injection site was swollen; Site reaction at injection site was hot; Bumpy rash on her neck; Skin on her face had a sandpaper feeling, chapped; Lower eye puffy; Lower eye reddish; Red face; Swollen face and cheeks; Hive on face; A spontaneous report was received from a nurse concerning a 48-year-old female patient, who was the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced eye swelling, eye redness, neck rash, dry skin face, injection site warmth, hive on face, face and cheek swelling, injection site redness, and injection site swelling.  The patient's medical history, as provided by the reported, included hives.  No relevant concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch/Lot Number: 025J202A/039K20A) in her right deltoid for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient had a dime-sized raised hive on her face. Treatment included cetirizine.  On 30 Dec 2020, the patient's lower eye was puffy and red; it looked like she was punched in the face.  She took cetirizine and famotidine.  Her face got redder and more swollen, so she took more famotidine. The patient's eyes, nose, and cheeks were swollen.  On 31 Dec 2020, the patient went to urgent care and was prescribed prednisone.  She also took diphenhydramine.  She developed a bumpy rash on her neck which cleared up. The patient's skin was dry and chapped.  On 06 Jan 2020, the patient's symptoms were back to normal after tapering off the steroids.  The patient was still experiencing a hot, red, and swollen injection site reaction.  She didn't have facial fillers.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, eye swelling, eye redness, neck rash, dry skin face, hive on face, face and cheek swelling, was considered recovered/resolved on 06 Jan 2021.  The outcome of the events, injection site redness, injection site warmth, and injection site swelling, was considered not recovered/resolved.; Reporter's Comments: This case concerns a 48-year-old female patient with medical history of hives, who received their first of two planned doses of mRNA-1273 (Lot 025J202A/039K20A), and who experienced the non-serious listed events of injection site redness and injection site swelling, and experienced the non-serious unlisted events of eye swelling, eye redness, neck rash, dry skin, injection site warmth, hive on face, face and cheek swelling, and erythema (face).  Based on the current available information and temporal association between the use of the product and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  The patient's medical history of hives remains a confounder for the events.
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Ocular hyperaemia, Rash, Swelling face, Urticaria
Clinical narrative: Site reaction at injection site was red; Site reaction at injection site was swollen; Site reaction at injection site was hot; Bumpy rash on her neck; Skin on her face had a sandpaper feeling, chapped; Lower eye puffy; Lower eye reddish; Red face; Swollen face and cheeks; Hive on face; A spontaneous report was received from a nurse concerning a 48-year-old female patient, who was the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced eye swelling, eye redness, neck rash, dry skin face, injection site warmth, hive on face, face and cheek swelling, injection site redness, and injection site swelling.  The patient's medical history, as provided by the reported, included hives.  No relevant concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch/Lot Number: 025J202A/039K20A) in her right deltoid for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient had a dime-sized raised hive on her face. Treatment included cetirizine.  On 30 Dec 2020, the patient's lower eye was puffy and red; it looked like she was punched in the face.  She took cetirizine and famotidine.  Her face got redder and more swollen, so she took more famotidine. The patient's eyes, nose, and cheeks were swollen.  On 31 Dec 2020, the patient went to urgent care and was prescribed prednisone.  She also took diphenhydramine.  She developed a bumpy rash on her neck which cleared up. The patient's skin was dry and chapped.  On 06 Jan 2020, the patient's symptoms were back to normal after tapering off the steroids.  The patient was still experiencing a hot, red, and swollen injection site reaction.  She didn't have facial fillers.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, eye swelling, eye redness, neck rash, dry skin face, hive on face, face and cheek swelling, was considered recovered/resolved on 06 Jan 2021.  The outcome of the events, injection site redness, injection site warmth, and injection site swelling, was considered not recovered/resolved.; Reporter's Comments: This case concerns a 48-year-old female patient with medical history of hives, who received their first of two planned doses of mRNA-1273 (Lot 025J202A/039K20A), and who experienced the non-serious listed events of injection site redness and injection site swelling, and experienced the non-serious unlisted events of eye swelling, eye redness, neck rash, dry skin, injection site warmth, hive on face, face and cheek swelling, and erythema (face).  Based on the current available information and temporal association between the use of the product and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  The patient's medical history of hives remains a confounder for the events.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; A spontaneous report was received from a consumer, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced adverse reaction.  The patient's medical history was not provided.  Concomitant medications were not reported.  On an unknown, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for the prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced an adverse reaction due to vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event adverse reaction was considered resolved on an unspecified date.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: sore throat; did become positive for COVID19; body aches; fever; severe arm pain; A spontaneous report was received from a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe arm pain, body aches, fever, sore throat and became positive for COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 for infection prophylaxis.  On 30 Dec 2020 in the evening, the patient reported that she had severe arm pain, body aches, fever and a sore throat. At the time of report, she stated that she still had the symptoms and that they had worsened.  On an unknown date, the patient tested positive for COVID-19. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, severe arm pain, body aches, fever and sore throat, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the event of Covid-19 positive, is Unlikely related to mRNA-1273 and a very limited information regarding this event has been provided.  Further information has been requested
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 14-Aug-2020 and the estimated date of delivery was 21-May-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided Estimated date of conception was reported in Aug-2020.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2021: Additional information received as pregnancy form received with pregnancy details.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) 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's last menstrual period was on an unknown date and the estimated date of delivery was 13-May-2021. On 24-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 24-Dec-2020, EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 24dec2021, post vaccination, the patient reported that she experienced symptoms of exposure during pregnancy   Concomitant medications were not provided No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: Feels really bad; Aches and pains at the injection site; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine and experienced aches and pain at the injection site and feels really bad.  The patient's medical history was not provided. No relevant concomitant were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot/batch number: unknown) in the arm for prophylaxis of COVID-19 infection.    On an unknown date, the experienced aches and pain at the injection site of arm and feels really bad. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events aches and pain at the injection site and feels really bad was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Nausea
Clinical narrative: lethargic; Very chill to the point that used 5 blankets; a bit nauseated; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LETHARGY (lethargic), CHILLS (Very chill to the point that used 5 blankets) and NAUSEA (a bit nauseated) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced LETHARGY (lethargic), CHILLS (Very chill to the point that used 5 blankets) and NAUSEA (a bit nauseated). On 01-Jan-2021, LETHARGY (lethargic), CHILLS (Very chill to the point that used 5 blankets) and NAUSEA (a bit nauseated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication were reported   Patient did not took any meds.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: update to case On 09-Apr-2021: Information added for the second dose, verbatim 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 event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site pruritus, Injection site swelling, Taste disorder
Clinical narrative: Feeling of warmth; A weird taste in her mouth; Swollen injection site; vaccination site pain; Redness in the injection site that spread and looked like when you fell and the upper layer of your skin scrapes off; Arm feels itchy; A spontaneous report was received from a nurse who was a 51-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced a weird taste in her mouth, feeling of warmth, pain, swollen injection site and redness in the injection site that spread and looked like when you fell and the upper layer of your skin scrapes off, arm started to feel itchy and the injection site turned into a bump.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter  On 30-Dec-2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT# 034K20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 30-Dec-2020.  Initially, she experienced a weird taste in her mouth and a feeling of warmth.  She also reported pain, swelling and redness at the injections.  She stated that the redness spread and looked like when you fall and the upper layer of skin gets scraped off.  On 02-Jan-2021, she reported that her arm started to feel itchy and the injection site turned into a bump.  She was concerned since her side effects still persisted a week after injection. Treatment for the events included paracetamol.   Action  taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, a weird taste in her mouth, feeling of warmth, pain, swollen injection site and redness in the injection site that spread and looked like when you fell and the upper layer of your skin scrapes off, arm started to feel itchy and the injection site turned into a bump, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Feeling of warmth; A weird taste in her mouth; Swollen injection site; vaccination site pain; Redness in the injection site that spread and looked like when you fell and the upper layer of your skin scrapes off; Arm feels itchy; A spontaneous report was received from a nurse who was a 51-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced a weird taste in her mouth, feeling of warmth, pain, swollen injection site and redness in the injection site that spread and looked like when you fell and the upper layer of your skin scrapes off, arm started to feel itchy and the injection site turned into a bump.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter  On 30-Dec-2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT# 034K20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 30-Dec-2020.  Initially, she experienced a weird taste in her mouth and a feeling of warmth.  She also reported pain, swelling and redness at the injections.  She stated that the redness spread and looked like when you fall and the upper layer of skin gets scraped off.  On 02-Jan-2021, she reported that her arm started to feel itchy and the injection site turned into a bump.  She was concerned since her side effects still persisted a week after injection. Treatment for the events included paracetamol.   Action  taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, a weird taste in her mouth, feeling of warmth, pain, swollen injection site and redness in the injection site that spread and looked like when you fell and the upper layer of your skin scrapes off, arm started to feel itchy and the injection site turned into a bump, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: Arm was sore; lymph nodes underneath his arm and around right collar bone were swollen; Muscle pain; Joint pain in right shoulder; A spontaneous report was received from consumer concerning himself, a male patient, of 40-year-old, who was administered Moderna COVID-19 Vaccine (mRNA-1273) and experienced arm was sore, lymph nodes underneath the arm and around his right collar bone were swollen, muscle pain and joint pain in right shoulder.  The patient's medical history was not reported. The patient's concomitant medication included were multivitamin and fish oil daily.  The patient received his first of two planned doses of mRNA-1273 (Batch number: unknown) in his right arm below the shoulder for prophylaxis of COVID-19 infection on 30 Dec 2020.   The patient experienced his arm was sore on 04 Jan 2021. The patient also noticed that his lymph nodes underneath his arms and around his right collar bone were swollen, muscle pain and joint pain in right shoulder on 02 Jan 2021 (2 days ago).   The patient was treated with ibuprofen.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the events, which were arm was sore, lymph nodes underneath the arm and around his right collar bone were swollen, muscle pain and joint pain in right shoulder were unknown.; Reporter's Comments: This case concerns a 40-year-old male who experienced nonserious events of unexpected pain in extremity and expected lymphadenopathy, arthralgia, myalgia. Event onset 4 days after the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: localized initial reaction with itch; localized initial reaction sith swelling; localized initial reaction with erythema; localized initial reaction with pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (localized initial reaction with itch), VACCINATION SITE SWELLING (localized initial reaction sith swelling), VACCINATION SITE ERYTHEMA (localized initial reaction with erythema) and VACCINATION SITE PAIN (localized initial reaction with pain) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (localized initial reaction with itch), VACCINATION SITE SWELLING (localized initial reaction sith swelling), VACCINATION SITE ERYTHEMA (localized initial reaction with erythema) and VACCINATION SITE PAIN (localized initial reaction with pain). At the time of the report, VACCINATION SITE PRURITUS (localized initial reaction with itch), VACCINATION SITE SWELLING (localized initial reaction sith swelling), VACCINATION SITE ERYTHEMA (localized initial reaction with erythema) and VACCINATION SITE PAIN (localized initial reaction with pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  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.   This case was linked to MOD-2021-052670 (Patient Link).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: 7 or 8 red spots around the injection site, they are just like red blotches; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 Vaccine and developed 7 or 8 red spots around the injection site, they are just like red blotches/Vaccination site erythema.  The patient's medical history was not provided. Concomitant medications included levothyroxine and simvastatin.  The patient received her first of two planned doses of mRNA-1273 (Lot number 011L20A) on 04 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, two days post first dose of the COVID  19 vaccine the patient developed 7 or 8 red spots around the injection site. The red spots did not itch and were not found anywhere else on her body.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event 7 or 8 red spots around the injection site, they are just like red blotches was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vertigo
Clinical narrative: vertigo when getting up in the morning; numbness and tingling in toes; numbness and tingling in toes; A spontaneous report was received from a 61 year-old male patient who received Moderna's COVID-19 Vaccine and experienced vertigo when getting up in the morning, numbness and tingling in toes.  The patient's medical history was not provided. Relevant concomitant medications included lansoprazole, cyanocobalamin, and nicotinamide.   On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm for COVID-19 for infection prophylaxis.  On 04 Jan 2021, the patient started having vertigo when getting up in the morning. He also stated he had numbness and tingling in his toes.   On 05 Jan 2021, the patient's vertigo continued more severely. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events numbness and tingling in toes was unknown and for vertigo when getting up in the morning not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of vertigo, hypoesthesia and paresthesia, a causal relationship cannot be excluded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Hot flashes; Fatigued and drained energy; Nauseous; Chills; Fatigued and drained energy; Continuous headache; Dizziness; Feeling out of place and not feeling 100%; Diarrhea and was continuously going to the bathroom; A spontaneous report was received from a 20-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, drained energy, nauseous, dizziness, feeling out of place, not feeling 100 percent, diarrhea, headache, hot flashes and chills.   The patient's medical history was not provided. Concomitant medications included unknown birth control.    On 04 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient started to experience side effects. She felt a little fatigued, and drained energy and physically wise. During lunch, she felt nauseous and was trying force herself to eat because she had not eaten all day. After lunch she stated she "felt more nausea, fatigue and dizziness, describing it as feeling out of place and not feeling 100 percent. Later that evening she experienced diarrhea. She also experienced hot flashes and chills. She stated that she has a continuous headache and was unsure if it was from not eating, but she drank water and still had it.    On 06 Jan 2021, the patient stated that she still feels the chills, diarrhea and headache. No treatment was provided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of events, fatigue, drained energy, nauseous and hot flashes, were resolved.   The outcome of events, chills, diarrhea and headache, were ongoing.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hot flush, Nausea
Clinical narrative: Hot flashes; Fatigued and drained energy; Nauseous; Chills; Fatigued and drained energy; Continuous headache; Dizziness; Feeling out of place and not feeling 100%; Diarrhea and was continuously going to the bathroom; A spontaneous report was received from a 20-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, drained energy, nauseous, dizziness, feeling out of place, not feeling 100 percent, diarrhea, headache, hot flashes and chills.   The patient's medical history was not provided. Concomitant medications included unknown birth control.    On 04 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient started to experience side effects. She felt a little fatigued, and drained energy and physically wise. During lunch, she felt nauseous and was trying force herself to eat because she had not eaten all day. After lunch she stated she "felt more nausea, fatigue and dizziness, describing it as feeling out of place and not feeling 100 percent. Later that evening she experienced diarrhea. She also experienced hot flashes and chills. She stated that she has a continuous headache and was unsure if it was from not eating, but she drank water and still had it.    On 06 Jan 2021, the patient stated that she still feels the chills, diarrhea and headache. No treatment was provided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of events, fatigue, drained energy, nauseous and hot flashes, were resolved.   The outcome of events, chills, diarrhea and headache, were ongoing.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Hypersomnia
Clinical narrative: strong lower back pain; slept the whole day; chills; headache; A spontaneous report was received from a consumer who was a 44-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, headache, slept the whole day and strong lower back pain.   The patient's medical history included COVID-19. No concomitant medications were reported.  On 04 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The same night, the patient experienced chills and headache.    On 05 Jan 2021, the patient reported having slept whole day.   On 06 Jan 2021, the patient experienced strong lower back pain. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The events, chills, headache, slept the whole day, was considered resolved on 05 Jan 2021. The outcome for the event, strong lower back pain was unknown.  The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction; A spontaneous report  was received from a consumer, regarding herself, a female patient of unspecified age who received Moderna's COVID-19 vaccine and experienced an unspecified reaction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Dec 2020, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 05 Jan 2021, after vaccination, the patient had unspecified reaction for which she had questions.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, reaction was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: dry cough; fever; chills; A spontaneous report was received from a consumer, a female patient, who received Moderna's COVID-19 Vaccine and experienced fever, chills, and dry cough.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 infection prophylaxis.   On an unknown date in Jan 2021, the patient developed a fever, chills, and a dry cough. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, fever, chills, and dry cough, was considered unknown.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia, Paraesthesia oral
Clinical narrative: Numbness and tingling in arm; Metallic taste; Tingling around mouth; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Numbness and tingling in arm), DYSGEUSIA (Metallic taste) and PARAESTHESIA ORAL (Tingling around mouth) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PARAESTHESIA (Numbness and tingling in arm), DYSGEUSIA (Metallic taste) and PARAESTHESIA ORAL (Tingling around mouth). On 07-Jan-2021, PARAESTHESIA (Numbness and tingling in arm), DYSGEUSIA (Metallic taste) and PARAESTHESIA ORAL (Tingling around mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Body aches; Chills; Fatigue; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced headache, body aches, chills, and fatigue.    The patient's medical history was not reported No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (batch: 011L20A) for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient reported body aches, chills, fatigue and headache. Treatment included ibuprofen.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache, body aches, chills and fatigue was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. All the events are listed in RA.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Heat to touch; Body aches; Plum size red spot on her arm; Itch; Tender to touch; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat to touch), PAIN (Body aches), VACCINATION SITE ERYTHEMA (Plum size red spot on her arm), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE PAIN (Tender to touch) in a female patient of an unknown age 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 No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Heat to touch), PAIN (Body aches), VACCINATION SITE ERYTHEMA (Plum size red spot on her arm), VACCINATION SITE PRURITUS (Itch), VACCINATION SITE PAIN (Tender to touch), PYREXIA (Fever) and HEADACHE (Headache). On 15-Jan-2021, VACCINATION SITE WARMTH (Heat to touch), PAIN (Body aches), VACCINATION SITE ERYTHEMA (Plum size red spot on her arm), VACCINATION SITE PRURITUS (Itch), VACCINATION SITE PAIN (Tender to touch), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Heat to touch; Body aches; Plum size red spot on her arm; Itch; Tender to touch; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat to touch), PAIN (Body aches), VACCINATION SITE ERYTHEMA (Plum size red spot on her arm), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE PAIN (Tender to touch) in a female patient of an unknown age 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 No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Heat to touch), PAIN (Body aches), VACCINATION SITE ERYTHEMA (Plum size red spot on her arm), VACCINATION SITE PRURITUS (Itch), VACCINATION SITE PAIN (Tender to touch), PYREXIA (Fever) and HEADACHE (Headache). On 15-Jan-2021, VACCINATION SITE WARMTH (Heat to touch), PAIN (Body aches), VACCINATION SITE ERYTHEMA (Plum size red spot on her arm), VACCINATION SITE PRURITUS (Itch), VACCINATION SITE PAIN (Tender to touch), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 28-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 12:00 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 an unknown date and the estimated date of delivery was 16-Aug-2021. On 12-Jan-2021 at 12:00 PM, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 12-Jan-2021 at 12:00 PM, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Trouble with diarrhea/bad episode; A spontaneous report was received from a consumer concerning a male patient of unknown age  who received their first of two planned doses of mRNA-1273 vaccine and experienced trouble with diarrhea/bad episode.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 24 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.   The patient reported that on 04 Jan 2021 he was having trouble with diarrhea. He stated he had a bad episode as of the morning of this report.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.