chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 11-Jun-2020 and the estimated date of delivery was 22-Mar-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported; Reporter's Comments: This is a case of product exposure during pregnancy with associated sore arm for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: The entire right arm is hurting on movement and is sore; Mild Diarrhea; Pain on the injection site; Mild headache; A spontaneous report was received from a 62-year-old female patient who participated in the mRNA-1273 Emergency Use Program and experienced pain on the injection site, right arm pain and soreness, a mild headache, and diarrhea.  The patient's medical history was not reported.  No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection on 29 Dec 2020.  On 30 Dec 2020, the patient experienced pain on the injection site, right arm pain and soreness, a mild headache, and diarrhea. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was not reported.; Reporter's Comments: This case concerns a 62-year-old female who experienced NS unexpected events of pain in extremity and diarrhea and NS expected events of injection site pain and headache.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcome known. 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: Anxiety, Dyspnoea, Paraesthesia, Pruritus, Tachycardia
Clinical narrative: Mild shortness of breath; Tachycardia; Severe itching to her face; Tingling to her face; Overall generalized anxiety; A report was received from a healthcare professional concerning a 37-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety.   The patient's medical history was not provided. Concomitant medications included an intrauterine contraceptive device (IUD).   On 30 Dec 2020, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 30 Dec 2020, following vaccine administration, the patient experienced mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety that lasted for about an hour. They took Zyrtec and reported the symptoms resolved within 20 minutes. Treatment for the event included Zyrtec.   Action taken with mRNA-1273 in response to the events was unknown.  The events, mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety, were considered resolved on 30 Dec 2020.   The reporter did not provide an assessment for the events, mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety.; Reporter's Comments: This case concerns a 37-year-old, female patient who experienced non-serious adverse events of mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety. Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm, can't even lift my arm, feels worse than tetanus shot/arm is painful; A spontaneous report  was received from a 38 year old female patient (Nures) concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and developed pain in arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20A) intramuscularly in left arm for prophylaxis of COVID-19.  On 28 Dec 2020, a few hours after administration, the patient stated that her arm was "pretty painful", that she can't even lift her arm. She stated that there was no redness and it's not swollen. She mentioned that it "feels worse than tetanus, it is past soreness". She also mentions that the pain was not "excruciating". Treatment included ibuprofen, which she mentioned taking around the clock.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event was unknown.; Reporter's Comments: This case concerns a 38-Year-old female who experienced NS unexpected event of pain of extremity.  Event onset occurred a few hours after the first dose of mRNA-1273. Treatment included ibuprofen. Event outcome known. 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: A spontaneous report was received from a non-healthcare professional of a 55-year-old, male consumer who received Moderna's COVID-19 vaccine and experienced heartburn.  The patient's past medical history, as provided by the reporter, included heartburn.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 30 Dec 2020, the patient experienced heartburn after he ate something spicy. It is unknown if the prior history of heartburn was exacerbated regarding the vaccine. Treatment included omeprazole. Action taken with the second dose of mRNA-1273 in response to the event was unknown.  The outcome of the event was unknown.  The reporter's assessment of 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 event, a causal relationship cannot be excluded.  The patient's medical history of heart burn remains a confounder.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Cough, Decreased appetite, Dizziness
Clinical narrative: Dizzy; cough; Rib pain; Urine output down; Pulse OX 94 (normal pO2 is 95); Bowels felt crampy; He was unable to get out of bed; Appetite down; Persistent fever up to 102 F.; Nausea; Headache; Extreme chills.; feeling sick.; Body aches and pains; He began feeling fatigued; A spontaneous report was received from a dietician concerning a 57 year-old, male patient experienced fatigue, extreme chills, body aches and pains, persistent fever, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, decreased pulse ox, and bowel cramps.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient began to feel fatigued. On 25 Dec 2020, he was feeling sick and by that night had extreme chills, and body aches and pains. On 26 Dec 2020, he had a persistent fever up to 102F, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, and bowel cramping. His pulse oxygen saturation was reported to be 94 percent. Patient was unable to confirm COVID-19 exposure. Treatment for the event included paracetamol, prochlorperazine, and dextromethorphan hydrobromide.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal pain, Headache, Illness, Musculoskeletal chest pain
Clinical narrative: Dizzy; cough; Rib pain; Urine output down; Pulse OX 94 (normal pO2 is 95); Bowels felt crampy; He was unable to get out of bed; Appetite down; Persistent fever up to 102 F.; Nausea; Headache; Extreme chills.; feeling sick.; Body aches and pains; He began feeling fatigued; A spontaneous report was received from a dietician concerning a 57 year-old, male patient experienced fatigue, extreme chills, body aches and pains, persistent fever, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, decreased pulse ox, and bowel cramps.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient began to feel fatigued. On 25 Dec 2020, he was feeling sick and by that night had extreme chills, and body aches and pains. On 26 Dec 2020, he had a persistent fever up to 102F, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, and bowel cramping. His pulse oxygen saturation was reported to be 94 percent. Patient was unable to confirm COVID-19 exposure. Treatment for the event included paracetamol, prochlorperazine, and dextromethorphan hydrobromide.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation decreased, Pain, Pyrexia, Urine output decreased
Clinical narrative: Dizzy; cough; Rib pain; Urine output down; Pulse OX 94 (normal pO2 is 95); Bowels felt crampy; He was unable to get out of bed; Appetite down; Persistent fever up to 102 F.; Nausea; Headache; Extreme chills.; feeling sick.; Body aches and pains; He began feeling fatigued; A spontaneous report was received from a dietician concerning a 57 year-old, male patient experienced fatigue, extreme chills, body aches and pains, persistent fever, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, decreased pulse ox, and bowel cramps.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient began to feel fatigued. On 25 Dec 2020, he was feeling sick and by that night had extreme chills, and body aches and pains. On 26 Dec 2020, he had a persistent fever up to 102F, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, and bowel cramping. His pulse oxygen saturation was reported to be 94 percent. Patient was unable to confirm COVID-19 exposure. Treatment for the event included paracetamol, prochlorperazine, and dextromethorphan hydrobromide.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Tired; Nausea; Headache; Body ache; A spontaneous report was received from a consumer who is 38-year-old female patient that received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, feeling tired, body ache, and nausea. Patient was breastfeeding but this was reported as a separate case.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28-Dec-2020, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K-202A) in the left deltoid for COVID-19 for infection prophylaxis.  On 28-Dec-2020, the patient reported she had a bad headache, was tired, had body ache, and nausea. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, headache, tired, body ache, and nausea 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: Exposure during pregnancy
Clinical narrative: Pregnant; This female patient was participating in mRNA-1273 Emergency Use Program and became pregnant.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date ,the patient received the first of the two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient called to state that she would like to register for the pregnancy patient information for Moderna COVID-19 vaccine.    The estimated date of conception was not provided.   Action taken with mRNA-1273 was not provided.; Reporter's Comments: This report concerns a female subject of unknown age, who became pregnant (Vaccine exposure during pregnancy) on an unknown date after administration of the of mRNA-1273 vaccine. The patient's last menstrual period, expected date of conception and delivery are all unknown
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna (mRNA-1273) and experienced a sore arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date in 2020, the patient reported having a sore arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event having a sore arm 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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Arm was sore in the area of injection; A spontaneous report was received from a consumer concerning a female patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced arm soreness in the area of injection.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced a sore arm in the area of injection. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.; Reporter's Comments: This case concerns a female patient of unspecified age, who experienced a non-serious expected event of Injection site pain. The event occurred on unknown date after first dose of mRNA-1273, (lot unknown).  Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101 fever; A spontaneous report was received from a certified nurse assistant concerning a 53 year- old, female patient who received Moderna's COVID-19 vaccine and experienced 101 fever.   There were no medical history and concomitant medications reported.  On 30 Dec 2020, approximately twenty-four hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient woke up with a 101 fever. Treatment for this event included ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 101 fever was unknown.; Reporter's Comments: This case concerns a 53 year-old female patient, who experienced a non-serious expected event of Pyrexia. The event of Pyrexia occurred approximately one day after first dose of mRNA-1273, lot # 025J20A.  Treatment included ibuprofen. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: Ear pain; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed ear pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on (date of vaccine not provided) intramuscularly for prophylaxis of COVID-19 infection.   The pharmacist called to report that she has received an email from HR at her work facility asking if ear pain is a common side effect of the Moderna vaccine due to a "couple people experiencing it".  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, ear pain, was considered unresolved.   The reporter did not provide an assessment of the event, ear pain.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Fever really bad; Chills; arm site is sore; Tired; A spontaneous report was received from a 61 year old female healthcare facility staff member who received Moderna (mRNA-1273) and developed fever, sore arm site, feeling tired, shivery.and  chills  The patient's medical history, included history of COVID-19 infection in May 2020. No relevant concomitant medications were reported.   On 29 Dec 2020,  the patient received her first of two planned doses of mRNA-1273 (Lot # 026L20A) in the left arm for prophylaxis of COVID-19 infection.   Patient developed fever 101.8-102°F, , sore arm site, feeling tired, chills and shivery after receiving vaccine.    Treatment for the event included alternating paracetamol and ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, fever, chills, sore arm site, feeling tired and shivery, were unknown.  The reporter did not provide an assessment 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Pyrexia
Clinical narrative: Numbness in fingers; Fever; Chills; Severe headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, severe headache and numbness of her fingers.  The patient's medical history was not provided. Concomitant medications reported included blood thinner.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: Unknown).   On an unknown date, the patient experienced fever, chills, severe headache and numbness of her fingers. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome of fever, chills, severe headache and numbness of her fingers were considered as unknown.  The reporter did not provide an assessment 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Oropharyngeal pain
Clinical narrative: Ear pain; Sore Throat; This spontaneous case was reported by a pharmacist and describes the occurrence of EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat) in a 40-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 No adverse event.    On 28-Dec-2020 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat). At the time of the report, EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat) to be possibly related.    No concomitant information provided. No treatment information provided.   This case was linked to MOD-2020-001825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2021: The reporter information, patient identifiers, event details and vaccine information were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Oropharyngeal pain
Clinical narrative: Sore throat; Ear pain; Discomfort in shoulder, neck and jaw; A spontaneous report was received from a healthcare professional who was a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore throat [Oropharyngeal pain], ear pain [Ear pain] and some discomfort in her shoulder, neck and jaw [arthralgia].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   The patient reported that after receiving the vaccine, she experienced a sore throat, ear pain and some discomfort in her shoulder, neck and jaw. Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were considered 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.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and recieved vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and recieved vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and recieved vaccine). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and recieved vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No treatment information provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female of unknown age. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy .
Sex: U
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: bursitis; A spontaneous report was received from a pharmacist, concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bursitis.     The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced bursitis.    Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, bursitis, was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: having a lot of chills; muscle aching; Joint aching; injection site is swollen; injection site hurts very badly; A spontaneous report was received from a 30-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced having a lot of chills, muscle aching, joint aching, injection site is swollen and injection site hurts very badly.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date in Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Batch number: 025L20A) in her right arm for prophylaxis of COVID-19 infection.  On 30-Dec-2020, the patient reported that she was experiencing some side effects after taking the vaccine. She stated she was having a lot of chills, muscle and join aching, and that the injection site was swollen and hurts very badly.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, having a lot of chills, muscle aching, join aching, injection site is swollen, and injection site hurts very badly, were considered 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.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Nausea
Clinical narrative: A spontaneous report was received from a consumer concerning a male patient of unknown age, who experienced dizziness, nausea, diarrhea and weakness.   The patient's medical history was not provided. Concomitant product use was not provided.   The patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) for prophylaxis of COVID-19 infection.   The patient left a voicemail inquiring what to take for the side effects he was experiencing. Per patient, he was experiencing dizziness, nausea/diarrhea, and reported being "real, real weak." Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events is not applicable.   The outcome of the events, dizziness, nausea, diarrhea, and weakness were not reported.   The reporter did not provide causality for the events, dizziness, nausea, diarrhea, and weakness were unknown/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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Felt pretty crummy; Fever; Chills; Body ache; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced fever, chills, body ache and felt pretty crummy.  The patient's medical history included COVID-19 since 11-Dec-2020.  Concomitant product use was not provided by the reporter.  On 29-Dec-2020, approximately one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 30-Dec-2020 at 11:00AM, the patient developed fever, chills, body ache and felt pretty crummy until waking up the next day on 31-Dec-2020 and at this time patient was feeling much better.   Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events, fever, chills, body ache and felt pretty crummy were considered resolved on 31-Dec-2020.; Reporter's Comments: This case concerns a female patient, with a historical medication condition of Covid-19 infection (fully recovered), who experienced a non-serious unexpected event of malaise and pain, non-serious expected events of pyrexia and chills. The event occurred 1 day after first dose of mRNA-1273, lot # unknown. Treatment details was no provided. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Muscular weakness, Neck pain
Clinical narrative: A spontaneous report was received from a consumer concerning  a female patient who received Modena's COVID-19 vaccine (mRNA-1273) and  experienced generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain and headache.  The patient's medical history was not reported.  No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 30-Dec-2020.  On an unknown date, the patient experienced generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain, and headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcomes of the events, generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain and headache, were considered 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A spontaneous report was received from a consumer concerning  a female patient who received Modena's COVID-19 vaccine (mRNA-1273) and  experienced generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain and headache.  The patient's medical history was not reported.  No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 30-Dec-2020.  On an unknown date, the patient experienced generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain, and headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcomes of the events, generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain and headache, were considered 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.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: A spontaneous report  was received from a consumer who was a pregnant, female patient of unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced vaccine exposure during pregnancy.   There was no medical history and no relevant concomitant medications reported  On an unknown date in 2020, the patient received her first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection while.   The patient's estimated date of conception was not reported. The patient's due date was not reported. She wished to participate in the pregnancy registry.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome event, vaccine exposure during pregnancy, was considered recovered/resolved.; 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: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (No reported medical history.).    In December 2020, the mother 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 was diagnosed with EXPOSURE VIA BREAST MILK (breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The patient's medical history and relevant concomitant medications weren't reported Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Added reporter contact information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on PCR test; A spontaneous report was received from a pharmacist concerning a female patient in her mid 40s who received Moderna's COVID-19 Vaccine and then tested positive for COVID-19 on PCR test.   The patient's medical history included lupus. No relevant concomitant medications were reported.   On 24-Dec-2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On the 26th or 27th of December 2020, the patient was swabbed via PCR test for COVID-19 which was positive.   Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, tested positive for COVID on PCR test, was considered unknown.; Reporter's Comments: This case concerns a female of unknown age, with medical history of Lupus, who had a nonserious unexpected event of COVID-19 (SARS-CoV-2 test positive).  Event onset 3-4 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia, Tremor
Clinical narrative: A report was received from a physician concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and experienced fever, chills, bone crashing body aches (far worse than when he had COVID), shaking that would not let him hold a cup, and heavy sweating at night.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 29 Dec 2020, approximately 10 hours prior to the onset of the events,  fever, chills, bone crashing body aches (far worse than when he had COVID), shaking that would not let him hold a cup, and 1 day prior to the onset of the event heavy sweating at night, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient was reportedly feeling fine the first 10 hours following vaccine administration, then began to experience fever, chills, bone crashing body aches that were worse than when he had COVID, and shaking that would not let him hold a cup, for another 10 hours. On 30 Dec 2020, the patient reported experiencing heavy night sweating that caused him to change his clothes and sheets 3 times.   Action taken with mRNA-1273 in response to the events was not reported.  The events, fever, chills, bone crashing body aches (far worse than when he had COVID), shaking that would not let him hold a cup, were considered resolved on 30 Dec 2020. The outcome of the event, heavy sweating at night, 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 ten hours after vaccination, a causal relationship cannot be excluded. Further information has been requested
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Peripheral swelling, Pyrexia, Vaccination site bruising
Clinical narrative: Fever; Felt sweaty; Really nauseous; Arm was sore; Arm was bruised; Arm swollen; A spontaneous report was received from a consumer concerning herself, a 23-year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and who experienced feeling sweaty [Sweaty], a sore and bruised arm [Administration site bruise/Injection site pain], fever/ongoing fever [Pyrexia], feeling nauseous [Nausea] and her arm was swollen [Peripheral swelling].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-Dec-2020, one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection.   The morning after receiving the vaccine, at approximately 3 AM, the patient felt sweaty and really nauseous. Later that same day, she experienced a fever and her arm was sore, bruised and swollen. She is still able to lift her arm.  Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events, feeling sweaty [Sweaty], a sore and bruised arm [Administration site bruise/Injection site pain], fever/ongoing fever [Pyrexia], feeling nauseous [Nausea] and her arm was swollen [Peripheral swelling], were considered 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.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; Felt sweaty; Really nauseous; Arm was sore; Arm was bruised; Arm swollen; A spontaneous report was received from a consumer concerning herself, a 23-year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and who experienced feeling sweaty [Sweaty], a sore and bruised arm [Administration site bruise/Injection site pain], fever/ongoing fever [Pyrexia], feeling nauseous [Nausea] and her arm was swollen [Peripheral swelling].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-Dec-2020, one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection.   The morning after receiving the vaccine, at approximately 3 AM, the patient felt sweaty and really nauseous. Later that same day, she experienced a fever and her arm was sore, bruised and swollen. She is still able to lift her arm.  Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events, feeling sweaty [Sweaty], a sore and bruised arm [Administration site bruise/Injection site pain], fever/ongoing fever [Pyrexia], feeling nauseous [Nausea] and her arm was swollen [Peripheral swelling], were considered 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: lost sense of taste; A report was received from a consumer who is a 33-year old, female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost sense of taste.   The patient's medical history was not provided. Concomitant medications reported included ascorbic acid and colecalciferol.   On 23-Dec-2020, approximately 6 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (BATCH # 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29-Dec-2020, the patient noticed they lost their sense of taste. The patient took a SARS-CoV-2 test, which resulted negative. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, lost sense of taste, was unknown.   The reporter did not provide an assessment for the event lost sense of taste.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Paraesthesia, Vaccination site movement impairment
Clinical narrative: Can't move left arm because of the pain; Trouble moving her left arm yesterday; Tingling in the left arm from left shoulder to left hand; Sharp pain in the left shoulder that radiated to left elbow; A spontaneous report was received from a consumer concerning a 23-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of tingling in the left arm from left shoulder to left hand, sharp pain in the left shoulder that radiated to left elbow, trouble moving her left arm, can't move left arm because of pain.   The patient's medical history included connective tissue disorder. Concomitant medications included Montelukast, hydroxychloroquine, fexofenadine and vitamins.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 025J20-2A). On that same day, the patient experienced tingling in the left arm from left shoulder to left hand and sharp pain in the left shoulder that radiated to left elbow. The treatment information reported included aleve.   On 30 Dec 2020, the patient experienced trouble moving her left arm. The treatment information reported included aleve.  On 31 Dec 2020, the patient experienced can't move left arm because of pain. The treatment information reported included aleve.  The action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events, tingling in the left arm from left shoulder to left hand, sharp pain in the left shoulder that radiated to left elbow, trouble moving her left arm, can't move left arm because of pain, were considered unknown.; Reporter's Comments: This case concerns a 23-year-old female with nonserious events of unexpected injection site movement impairment, paraesthesia, pain in extremity, and expected arthralgia.  Event onset the same day as the first dose of mRNA-1273. Treatment with Aleve. Event outcomes 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.