chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site warm to touch; Injection site red; Injection site itchy; Soreness at the injection site; A spontaneous report was received from a consumer concerning a 55-year-old, male patient who received Moderna's COVID-19 vaccine and experienced pain at site of injection, redness, itchiness and warmth at the injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient felt soreness at the injection site.   On 31 Dec 2020, the patient noticed that the injection site was red, itchy, and warm to touch. No treatment information was reported.    Action taken with mRNA-1273 in response to the event was not reported.   The event, pain at the site of injection, was considered resolved on 23 Dec 2020. The outcome of the event(s), redness, itchiness and warmth at the injection site, 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Tremor
Clinical narrative: shaking that lasted 3 to 4 hours; severe headache; joint pain; muscle pain; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced shaking that lasted 3-4 hours, severe headache, joint pain and muscle pain.   The patient's medical history, as provided by the reporter, included hypertension. Concomitant medications reported included unspecified hypertension medication.  On 30 Dec 2020, approximately 8 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH # 011G20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020 about 8 hours after vaccine administration, the patient experienced shaking that lasted 3 to 4 hours, severe headache, joint pain, and muscle pain. Treatment for the event included naproxen.  Action taken with mRNA-1273 in response to the events was not reported.  The event, shaking that lasted 3-4 hours, was considered resolved on 31 Dec 2020. The outcome of the events, severe headache, joint pain and muscle pain were unknown.; Reporter's Comments: This case concerns a female of unknown age, with PMH of COVID-19,  who had NS events of unexpected tremor and expected headache, arthralgia, myalgia.  Event onset occurred Day 1 after the first dose of mRNA-1273. Treatment included naproxen. Tremor resolved, but other outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: A spontaneous report (United States) was received from a consumer concerning a 65-year-old, male patient who received Moderna's COVID-19 vaccine and experienced tightness in the stomach that was kind of painful, felt unwell, weakness, feverish and soreness at the location of injection.  The patient's medical history, as provided by the reporter, included diabetes, high blood pressure and triglycerides. Concomitant medications reported included drugs for diabetes, high blood pressure, triglycerides and vitamin D with fish oil supplement.  On 28 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, after receiving the mRNA-1273 vaccination, the patient felt tightness in my stomach kind of painful and feeling unwell. He went to the bathroom to relieve. The pain in stomach felt better. However, the weakness and feeling unwell stayed. He developed soreness at the location of injection. He felt feverish. The patient's fever was reported as 97.5 F.  On 30 Dec 2020, he felt better but still weak. Treatment for the event included acetaminophen and aspirin. Now he was feeling better.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events, tightness in the stomach that was kind of painful, felt unwell, weakness, feverish and soreness at the location of injection was considered resolving.  The reporter assessed the events as possibly due to food poisoning or the mRNA-1273 vaccine.; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Oropharyngeal pain, Pain in extremity
Clinical narrative: Not feeling good; Sore throat; running  nose; Sore arms; Hurting joint; Getting tired; A spontaneous report was received from a consumer who was also a 56-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)and experienced not feeling good (malaise), sore throat (oropharyngeal pain), running nose (rhinorrhea), tired (fatigue), hurting joint (arthralgia), and sore arms (pain in extremity).  The patient's medical history was not provided. The patient was taking no concomitant medications.  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: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.     On 30 Dec 2020, the day after receiving the vaccine, the patient experienced tiredness. She did not feel good, had a sore throat, running nose, joints that hurt, and sore arms. The patient stated she felt worse.   Treatment for the event included cold medicine on the 30 Dec 2020.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, not feeling good, sore throat, running nose, tired, hurting joint, and sore arms, was unknown.; Reporter's Comments: This case concerns a 56-year-old female who experienced NS events of unexpected malaise, oropharyngeal pain, rhinorrhea, pain in extremity and expected arthralgia and fatigue.  Event onset occurred Day 2 after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Not feeling good; Sore throat; running  nose; Sore arms; Hurting joint; Getting tired; A spontaneous report was received from a consumer who was also a 56-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)and experienced not feeling good (malaise), sore throat (oropharyngeal pain), running nose (rhinorrhea), tired (fatigue), hurting joint (arthralgia), and sore arms (pain in extremity).  The patient's medical history was not provided. The patient was taking no concomitant medications.  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: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.     On 30 Dec 2020, the day after receiving the vaccine, the patient experienced tiredness. She did not feel good, had a sore throat, running nose, joints that hurt, and sore arms. The patient stated she felt worse.   Treatment for the event included cold medicine on the 30 Dec 2020.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, not feeling good, sore throat, running nose, tired, hurting joint, and sore arms, was unknown.; Reporter's Comments: This case concerns a 56-year-old female who experienced NS events of unexpected malaise, oropharyngeal pain, rhinorrhea, pain in extremity and expected arthralgia and fatigue.  Event onset occurred Day 2 after the first dose of mRNA-1273. 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: Fatigue, Tachycardia
Clinical narrative: Tachycardia higher than normal; Some Tiredness; A spontaneous report was received from a health care facility staff member concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced feeling tachycardia higher than normal and having some tiredness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received her first of two planned doses of mRNA-1273 on 30-Dec-2020  intramuscularly for prophylaxis of COVID-19 infection.   After receiving the Moderna vaccine on 30-Dec-2020, the patient began to experience tachycardia as well as some tiredness (Fatigue).  She stated that she was unsure if she was having a reaction.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported.  There was no causality assessment provided by the reporter for the events, feeling tachycardia higher than normal and having some tiredness (Fatigue).; 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: Bursitis
Clinical narrative: Bursitis; A spontaneous report  was received from a pharmacist, concerning a male patient who received Moderna's COVID-19 vaccine and experienced bursitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On, an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot# 025J20A) for prophylaxis of COVID-19 infection.     On, 31 Dec 2020, the reporter stated that one of their vaccine participants was known to have bursitis. Treatment for the event was not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, bursitis, was considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2018 to an unknown date for Pregnancy.    On 05-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 04-Aug-2021. On 05-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccinated while pregnant). On 05-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) to be not applicable.    No concomitant information provided. Treatment included pre-natal vitamins/ once daily; 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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Site of vaccine is warm; Site of vaccine is red; Site of vaccine is hard; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced site of vaccine is red, hard and warm.  The patient's medical history was not provided. Concomitant product used was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date not provided) for prophylaxis of COVID-19 infection.   A consumer who is the patient called to report he had received the Moderna COVID-19 vaccine. He reported the injection site was red, hard and warm.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, site of vaccine is red, hard and warm, was considered as unknown.   The reporter did not provide an assessment of the events, site of vaccine is red, hard and warm.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Injection site swelling; A spontaneous report was from a physician, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced local swelling 12 days after vaccination.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the physician called with question regarding vaccine reaction. Stated local swelling 12 days after vaccination. Treatment information not reported.  Action taken with mRNA-1273 vaccine was unknown.  The outcome of event, local swelling 12 days after vaccination, was unknown.  Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported event and the product use cannot be excluded. Injection site swelling is consistent with the known safety profile of the vaccine
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Rash
Clinical narrative: Trouble breahting; Lightheaded; Rash; A spontaneous report  was received from a 49-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced rash, trouble breathing and felt quite lightheaded.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving the vaccine, the patient experienced rash and treated the rash with Benadryl 50mg every 6 hours.  On 03 Jan 2021, she had trouble breathing and felt quite lightheaded. Treatment for the events was Benadryl.  On 04 Jan 2021, she started having trouble breathing again.   Action taken with the second dose of mRNA-1273 in response to the events was not reported.   The outcome for the event, rash is recovered/resolved. The outcome for trouble breathing and lightheadedness is 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 reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pain in extremity
Clinical narrative: Headache; Joint pain; Nausea; Pain in arm; A spontaneous report was received from a 21-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain, headache, Nausea and joint pain.  The patient's medical history was not provided. Concomitant medications were included unknown birth control.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 03K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, immediately after, the patient experienced side effects like arm pain, headache, nausea and joint pain. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, arm pain, headache, Nausea and joint pain, were unknown.  Reporter's Comments: This case concerns a 21-year-old female who experienced NS unexpected event of pain in extremity and NS expected events of headache, nausea, arthralgia. 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: Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: Lump under the skin; Feels hot to the touch at the site; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump under the skin), VACCINATION SITE WARMTH (Feels hot to the touch at the site) and VACCINATION SITE ERYTHEMA (Redness) 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 medical history was reported.).    On 28-Dec-2020, 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 MASS (Lump under the skin), VACCINATION SITE WARMTH (Feels hot to the touch at the site) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE MASS (Lump under the skin), VACCINATION SITE WARMTH (Feels hot to the touch at the site) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: itchy; warm to touch; redness; A spontaneous report was received from a consumer concerning female patient (age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy, warm to the touch and red.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient stated that it was still warm, itchy and red, but there is minimal discomfort.  No treatment information was provided. She inquired if she should get the next shot and wanted to know the delayed reaction had been seen before.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, itchy, warm to the touch and red, were 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age (gravida 1) 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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment medication information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 and contains no new information.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unidentified female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Couldn't lift or put my left arm down), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Can't lay down, can't lay flat from the pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (Couldn't lift or put my left arm down), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Can't lay down, can't lay flat from the pain). At the time of the report, LIMB DISCOMFORT (Couldn't lift or put my left arm down), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Can't lay down, can't lay flat from the pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included hydrocodone, ibuprofen, and acetaminophen.  She went to urgent care for the pain and received pain medications. She has taken 4 tablets of Vicodin 5-325mg taken 4 tablets so far and alternates between Motrin and Tylenol so she is taking medications around the clock as the Vicodin is not enough.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up information was received on 06 Apr 2021 included no new information; 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: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extremely tired) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025-J202A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extremely tired). At the time of the report, FATIGUE (Extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Infection, Vaccination complication
Clinical narrative: Possibly have an "infection"; Experienced some symptoms after; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced some symptoms after) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, 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 COMPLICATION (Experienced some symptoms after). At the time of the report, VACCINATION COMPLICATION (Experienced some symptoms after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling abnormal, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Both eardrums were bulging; Half of the face was numb; Ear hurting; Weirdness on half of her face; Headache; Sore arm; A spontaneous report  was received from a consumer concerning a 58-years old female patient, who received 1 dose of Moderna's covid-19 vaccine (mRNA -1273) and experienced the events-headache(headache), sore arm(pain in extremity), both eardrums were bulging(tympanic membrane disorder), ear started hurting(ear pain) and half of the face was numb(hypoaesthesia).  The patient's medical history was not provided. Concomitant medications were not reported.  On 24 DEC 2020, prior to the onset of the symptoms, the patient received their first dose of mRNA-1273 (Batch number: M09K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 24 DEC 2020, the patient experienced headache and sore arm with severity of 7/8 out of 10. On 26 DEC 2020, she had some "weirdness" on half of her face and her ear started hurting. On 30 DEC 2020, she went to a clinic and the nurse detected that both eardrums were bulging, and half of the face was numb. Treatment for the events included Prednisone 10mg twice a day for 3 days and Valacyclovir 1g 3 times a day for 3 days.  Action taken with mRNA-1273 in response to the event(s) was unknown.  The events, headache and sore arm were resolved on 24 DEC 2020, eardrums were bulging recovered on 31 DEC 2020 ear started hurting recovered on 30 DEC 2020 and half of the face was numb were considered to be 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.  Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tympanic membrane disorder
Clinical narrative: Both eardrums were bulging; Half of the face was numb; Ear hurting; Weirdness on half of her face; Headache; Sore arm; A spontaneous report  was received from a consumer concerning a 58-years old female patient, who received 1 dose of Moderna's covid-19 vaccine (mRNA -1273) and experienced the events-headache(headache), sore arm(pain in extremity), both eardrums were bulging(tympanic membrane disorder), ear started hurting(ear pain) and half of the face was numb(hypoaesthesia).  The patient's medical history was not provided. Concomitant medications were not reported.  On 24 DEC 2020, prior to the onset of the symptoms, the patient received their first dose of mRNA-1273 (Batch number: M09K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 24 DEC 2020, the patient experienced headache and sore arm with severity of 7/8 out of 10. On 26 DEC 2020, she had some "weirdness" on half of her face and her ear started hurting. On 30 DEC 2020, she went to a clinic and the nurse detected that both eardrums were bulging, and half of the face was numb. Treatment for the events included Prednisone 10mg twice a day for 3 days and Valacyclovir 1g 3 times a day for 3 days.  Action taken with mRNA-1273 in response to the event(s) was unknown.  The events, headache and sore arm were resolved on 24 DEC 2020, eardrums were bulging recovered on 31 DEC 2020 ear started hurting recovered on 30 DEC 2020 and half of the face was numb were considered to be 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.  Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Ear disorder, Pruritus, Throat irritation
Clinical narrative: Burning in throat; Chest burning; Ear disorder; Itching; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in her feet and ears), THROAT IRRITATION (Burning in throat), CHEST PAIN (Burning in chest), DIZZINESS (Slight lightheadedness) and EAR DISORDER (Ears with sensation of fullness) in a 50-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 reported).   On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Jan-2021, the patient experienced PRURITUS (Itching in her feet and ears), THROAT IRRITATION (Burning in throat), CHEST PAIN (Burning in chest), DIZZINESS (Slight lightheadedness) and EAR DISORDER (Ears with sensation of fullness). At the time of the report, PRURITUS (Itching in her feet and ears), THROAT IRRITATION (Burning in throat), CHEST PAIN (Burning in chest), DIZZINESS (Slight lightheadedness) and EAR DISORDER (Ears with sensation of fullness) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Very limited information regarding these events has been provided at this time. Further information has been requested  Reporter did not allow further contact  Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Mobility decreased
Clinical narrative: Weak; Fatigue; On and off sharp spiking head pains; Arm started hurting; Extreme body aches everywhere; Fitful sleep; Immobilized; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), PAIN (Extreme body aches everywhere), POOR QUALITY SLEEP (Fitful sleep), ASTHENIA (Weak) and MOBILITY DECREASED (Immobilized) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020. Concurrent medical conditions included Meat allergy (Allergic to Chicken), Allergy to legumes (Allergic to Beans), Depression and Arthritis. Concomitant products included MELOXICAM from 01-Apr-2005 to an unknown date for Arthritis, CALCIUM for Bone disorder, BUPROPION HYDROCHLORIDE (BUPROPION HCL ER) from 01-Mar-2000 to an unknown date for Depression, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication.   On 26-Dec-2020 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Dec-2020, the patient experienced PAIN (Extreme body aches everywhere), POOR QUALITY SLEEP (Fitful sleep), MOBILITY DECREASED (Immobilized) and ARTHRALGIA (joint pain). On 26-Dec-2020 at 8:00 PM, the patient experienced PAIN IN EXTREMITY (Arm started hurting). On 27-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Weak), FATIGUE (Fatigue) and HEADACHE (On and off sharp spiking head pains). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), PAIN (Extreme body aches everywhere), POOR QUALITY SLEEP (Fitful sleep), ASTHENIA (Weak), MOBILITY DECREASED (Immobilized), ARTHRALGIA (joint pain), FATIGUE (Fatigue) and HEADACHE (On and off sharp spiking head pains) had resolved.            Patient took a hot bath which helped with pain. No other treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received on 07-APR-2021 included patient's few basic information, allergies, Second dose date, time and batch number, Concomitant medications, addition of new events experienced after first dose of vaccine and description of the event.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Weak; Fatigue; On and off sharp spiking head pains; Arm started hurting; Extreme body aches everywhere; Fitful sleep; Immobilized; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), PAIN (Extreme body aches everywhere), POOR QUALITY SLEEP (Fitful sleep), ASTHENIA (Weak) and MOBILITY DECREASED (Immobilized) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020. Concurrent medical conditions included Meat allergy (Allergic to Chicken), Allergy to legumes (Allergic to Beans), Depression and Arthritis. Concomitant products included MELOXICAM from 01-Apr-2005 to an unknown date for Arthritis, CALCIUM for Bone disorder, BUPROPION HYDROCHLORIDE (BUPROPION HCL ER) from 01-Mar-2000 to an unknown date for Depression, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication.   On 26-Dec-2020 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Dec-2020, the patient experienced PAIN (Extreme body aches everywhere), POOR QUALITY SLEEP (Fitful sleep), MOBILITY DECREASED (Immobilized) and ARTHRALGIA (joint pain). On 26-Dec-2020 at 8:00 PM, the patient experienced PAIN IN EXTREMITY (Arm started hurting). On 27-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Weak), FATIGUE (Fatigue) and HEADACHE (On and off sharp spiking head pains). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), PAIN (Extreme body aches everywhere), POOR QUALITY SLEEP (Fitful sleep), ASTHENIA (Weak), MOBILITY DECREASED (Immobilized), ARTHRALGIA (joint pain), FATIGUE (Fatigue) and HEADACHE (On and off sharp spiking head pains) had resolved.            Patient took a hot bath which helped with pain. No other treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received on 07-APR-2021 included patient's few basic information, allergies, Second dose date, time and batch number, Concomitant medications, addition of new events experienced after first dose of vaccine and description of the event.; 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Maternal exposure during breast feeding; A spontaneous report was received from a consumer concerning a 32-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced maternal exposure during breast feeding.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient received the Moderna vaccine while she was breastfeeding. She did not report any side effects at the time of the report. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, maternal exposure during breast feeding, was considered resolved on 04 Jan 2021.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Woke up in the night with a horrific headache; A spontaneous report was received from a nurse, concerning a 61-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced horrific headaches and currently in bed.  The patient's medical history was not provided. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A, expiry: 5-JAN-2021) intramuscularly in the left arm (deltoid) for prophylaxis of COVID-19 infection.   On the night of 05 Jan 2021, the patient experienced horrific headaches which she described as someone squeezing her head. The patient also reported that she's currently in bed. No treatment was administered.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, horrific headaches and currently in bed 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included PRENATAL MULTIVITAMIN + DHA for an unknown indication.    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 06-Jun-2020 and the estimated date of delivery was 23-Mar-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2020, Pregnancy test: positive (Positive) Pregnant.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided by Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: Internal review on 22 JUL 2021, resulted in the updates of pregnancy details.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; A spontaneous report was received from a consumer (patient's wife), concerning a 72-year old, male patient who received Moderna's COVID-19 vaccine and experienced fever.    The patient's medical history was not provided. Concomitant medications reported included rosuvastatin, fenofibrate, metoprolol, clopidogrel, ezetimibe, acetylsalicylic acid, colecalciferol, ubidecarenone, and ascorbic acid/vitamin B complex.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient began to run a fever after vaccination. The patient was treated with Advil (Ibuprofen). On 05 Jan 2021, the patient had experienced the fever again.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event of fever 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.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jan-2021 and was forwarded to Moderna on 11-Jan-2021.    This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 1) 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) (unknown route) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 01-May-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. 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.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided by the reporter.  Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow up information included reporter contact details; 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: M
Vaccine: COVID19
Symptoms: Cough, Pain, SARS-CoV-2 test
Clinical narrative: A little cough; Some aches; A spontaneous report was received from a consumer concerning himself a male patient of unknown age who received Moderna's COVID-19 vaccine and experienced a little cough and some aches.   The patient's medical history or concomitant medication was not provided.  On 04 Jan 2021, prior to the onset of the events, the patient received their dose of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 05 Jan 2021 , after he received the mRNA-1273 vaccination, the patient experienced a little cough and some aches. Treatment information was not provided. Patient reports a negative Covid-19 test from 04 Jan 2021.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, a little cough and some aches, 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 reported events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rash, Vaccination site pain
Clinical narrative: Body rash; Headache; Pain at the injection site; A spontaneous report was received from a consumer concerning a 57-year-old, male patient who experienced a headache, pain at the injection site and a body rash.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 26-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot 037K20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 27-Dec-2020, the patient experienced a headache and pain at the injection site. On 30-Dec-2020, he developed a body rash that has persisted to date (at the time of the report).The patient took  Benadryl (diphenhydramine), but there was no improvement.    Action taken with mRNA-1273 in response to the event was unknown.   The event, body rash was not resolved. The outcomes of the events headache and pain at injection site, were 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 events, a causal relationship cannot be excluded.