chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Nausea, Pain in extremity
Clinical narrative: Popping or fluttering in my right ear; Arm pain; Little nausea; A spontaneous report was received from a consumer concerning a 46 year old, female patient who received Moderna's COVID-19 vaccine and developed arm pain, a little nausea and popping or fluttering in her right ear.  The patient's medical history includes bell's palsy, no additional medical history was provided. Concomitant product use was not provided by the reporter.   On 28-Dec-2020 The patient received their first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.   The reporter called stating the patient feels mostly fine after receiving the vaccine in her right arm on 28 Dec 2020. After receiving the vaccine the patient is having arm pain and maybe a little nausea and popping in her ear on the side she got the vaccine. The patient requested to have this call deleted for fear of not being able to get the second dose of the vaccine.   Treatment for the event included ibuprofen.   Action taken with mRNA-1273 in response to the events was not provided.   The event, arm pain, a little nausea and popping or fluttering in her right ear, was 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.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; A spontaneous report was received from a consumer concerning a 76-year old male patient who received Moderna's COVID-19 vaccine and experienced shortness of breath  The patient's medical history included cancer. No relevant concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient experienced shortness of breath.  He wondered if he should take his cancer therapy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event "shortness of breath " was unknown.; Reporter's Comments: This case concerns a 76- year-old male patient with a medical history of cancer, who experienced a non-serious unexpected event of Dyspnea. The event of Dyspnea occurred approximately one day (same day) 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. Of note, patient's underlying malignancy may have been contributory.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever like 102; Chills; A report was received from a physician concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and experienced chills and fever like 102°.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 29 Dec 2020, approximately 0 days prior to the onset of the events chills, and 1 day prior to the event, fever like 102°, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient developed chills following vaccine administration. On 30 Dec 2020, the chills resolved, but the patient reported fever of around 102. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, chills, was considered resolved on 30 Dec 2020. The outcome of the event, fever like 102°, was unknown.   The reporter did not provide an assessment for the events, chills and fever like 102°.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Began having diarrhea; A spontaneous report was received from a consumer who is an unidentified patient that received Moderna's covid-19 vaccine(mRNA-1273) and experienced diarrhea.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29-Dec-2020, at 1:50 PM, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 29-Dec-2020, around 6:00 PM, the patient experienced diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event diarrhea was not reported.  The outcome of the event diarrhea was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Discomfort, Headache, Nausea
Clinical narrative: Had chills; legs were achy; could not get comfortable; low grade temperature of 99.2 F; slight headache; little nausea; A spontaneous report was received from a female health care provider who received Moderna's COVID-19 vaccine and experienced chills, achy legs, could not get comfortable, low grade temperature of 99.2°F, slight headache and a little nausea.   The patient's medical history, as provided by the reporter, included negative COVID-19 test 2 weeks prior to vaccine administration No relevant concomitant medications were reported.  On 29-Dec-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient prophylactically took ibuprofen prior to vaccine administration on 29-Dec-2020. On 30-Dec-2020, the patient had chills, legs were achy, and she could not get comfortable. She again took ibuprofen. Later that day, she had a low grade temperature of 99.2°F, a slight headache, and a little nausea.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, chills, achy legs, could not get comfortable, low grade temperature of 99.2°F, slight headache and a little nausea, were 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Had chills; legs were achy; could not get comfortable; low grade temperature of 99.2 F; slight headache; little nausea; A spontaneous report was received from a female health care provider who received Moderna's COVID-19 vaccine and experienced chills, achy legs, could not get comfortable, low grade temperature of 99.2°F, slight headache and a little nausea.   The patient's medical history, as provided by the reporter, included negative COVID-19 test 2 weeks prior to vaccine administration No relevant concomitant medications were reported.  On 29-Dec-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient prophylactically took ibuprofen prior to vaccine administration on 29-Dec-2020. On 30-Dec-2020, the patient had chills, legs were achy, and she could not get comfortable. She again took ibuprofen. Later that day, she had a low grade temperature of 99.2°F, a slight headache, and a little nausea.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, chills, achy legs, could not get comfortable, low grade temperature of 99.2°F, slight headache and a little nausea, were 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: heat, cluster of little bity bumps on the backside of my back, lower part of the back; A spontaneous report was received from a consumer, concerning a female patient (age unspecified) who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced heat, cluster of little bity bumps on the backside of my back, lower part of the back.  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 (Lot number: unknown) unknown route, in an unknown arm for prophylaxis of COVID-19 infection.   Reporter stated that she is calling concerning Moderna Covid-19 vaccine that she had received on 23-DEC-2020. Patient reported having  "heat, clusters of little bity bumps on the  lower part of the back" "looks a little rash, thought it was heat bumps at first, but not sure". Patient stated she did not have this before the vaccine.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   Outcome of the event, heat, cluster of little bity bumps on the backside of my back, lower part of the back, was 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive Covid rapid test; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine and tested positive for COVID-19 rapid test.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, prior to onset of the events, the patient received their dose of mRNA-1273 (Lot/batch number: unknown), for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient tested positive for COVID-19 rapid test. The patient does not have any symptoms. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event positive COVID-19 test was not reported.; Reporter's Comments: Based on the current available information, patient testing positive for COVID-19 is unlikely related to vaccine. Very limited information regarding this event has been provided at this time.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Fatigue; Nausea; Headache; A spontaneous report was received from consumer concerning a 61-year-old male patient who received Moderna's COVID-19 vaccine and developed headache, fatigue, and nausea.  The patient's medical history, as provided by the reporter, included human immunodeficiency virus (HIV). Concomitant medications reported included metoprolol, acyclovir, baby aspirin, clopidogrel, tramadol, atorvastatin, raltegravir potassium, diazepam, and edesse.  On 28 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 28 Dec 2020, the patient developed a slight headache after receiving the vaccine. On 30 Dec 2020, patient developed fatigue, nausea and still had an ongoing headache. Treatment for the events included acetaminophen.   Action taken with the second dose of mRNA-1273 in response to the events was not reported.    The outcome of the events headache, fatigue, and nausea was not reported.; Reporter's Comments: This spontaneous report concerns a 61-year-old male patient with medical history of HIV infection who experienced non-serious events of headache, fatigue and nausea. The event of headache occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 025J20A, expiration date-Unknown).  The events of fatigue and nausea occurred the following day after the administration of mRNA-1273 vaccine. Treatment administered included Tylenol and outcome is unknown. The events of headache, fatigue and nausea are consistent with the safety profile for mRNA-1273 vaccine.  Based on the information provided, including temporal association a causal association cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site pain, Insomnia, Pyrexia
Clinical narrative: Fever up to 102.1°F; Chills; Could not fall asleep; Shoulder pain localized around injection site; A spontaneous report was received from a consumer concerning a 30 year old male patient who received Moderna's COVID-19 vaccine and experienced insomnia, injection site pain, fever, and chills.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 29-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 29-Dec-2020, the patient experienced shoulder pain localized around the injection site.  At night, he woke up with a fever of up to 102.1°F, chills, and could not fall back asleep. Treatment medications included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  The events fever and chills were recovering/resolving. The outcome of events, insomnia and injection site pain, were considered as not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: A spontaneous report was received from a consumer concerning a 30-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced breastfeeding.  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 (Lot# 037K20A) intramuscularly for prophylaxis of COVID-19 infection on 29 Dec 2020.  On 30 Dec 2020, the patient was breastfeeding after taking the vaccine.  She reported no symptoms and consented to follow-up with her primary care physician.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.; Reporter's Comments: This is a case of product exposure for  mRNA-1273 (Lot# 037K20A)  during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: half dollar size, erythematous, tender lump on the injection site; sand papery type of skin rash on the neck; Half dollar size, erythematous, tender lump on the injection site; Half dollar size, erythematous, tender lump on the injection site; Erythematous swelling at the injection site; A spontaneous report was received from a nurse concerning a 44-year- old, female patient who who received Moderna's COVID-19 vaccine and experienced erythematous swelling at the injection site (R. deltoid) and later, a half dollar size, erythematous tender lump on the injection site. This was associated with sand papery type of skin rash on the neck.  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 # 039K20A) on 23-Dec-2020 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   A healthcare provider (HCP) reported that the patient received the Moderna vaccine at their facility on 23-Dec-2020.  Following vaccine administration, the patient initially developed erythematous swelling at the injection site which she did not treat and per HCP report, resolved without treatment the same day.  However, on 30-Dec-2020, the patient was seen by the HCP and had developed a half dollar-sized, erythematous, tender lump at the injection site.  Additionally, the patient had developed a sand-papery type of skin rash on her neck.  The patient was prescribed prednisone for 10 days.    Treatment for the event included Prednisone for 10 days.    Action taken with mRNA-1273 in response to the events, erythematous swelling at the injection site (R. deltoid) and a half dollar size, erythematous tender lump on the injection site associated with a sand papery type of skin rash on the neck was not provided.   The events, erythematous swelling at the injection site (R. deltoid), were considered resolved. The events, a half dollar size, erythematous tender lump on the injection site associated with a sand papery type of skin rash on the neck was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Anosmia, Chills, Headache
Clinical narrative: whole body hurts; Not sure if can smell; Not sure if can taste; Stomach is killing her, Has stomach pains; arm feels like a sledgehammer hit it where she was injected; Feels nausea; Headache; Body chills; Can't keep anything down she throws up everything; A spontaneous report was received from a healthcare professional concerning a 56 year  old, female patient who experienced her whole body "hurts," arm feels like a sledgehammer where injected, can't keep anything down, she just throws up everything, feels nauseous, not sure if she can taste or smell, head is pounding, body chills, and stomach pains.   The patient's medical history was in Mar-2020 the patient was positive for COVID-19. The patient's concomitant medications included omeprazole magnesium.  On 28 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch: unknown) in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient experienced events, her whole body hurt, arm felt like a sledgehammer hit it where she was injected, couldn't keep anything down and she threw up everything, felt nauseous, and wasn't sure she could smell or taste, her head was pounding, body chills, and stomach pains.  Treatment for the event included ibuprofen.    Action taken with mRNA-1273 in response to the events was not provided.  .  The outcome of the events, whole body "hurts," arm feels like a sledgehammer where injected, can't keep anything down, she just throws up everything, feels nauseous, not sure if she can taste or smell, head is pounding, body chills, and stomach pains was unknown.; Reporter's Comments: This case concerns a 56-year-old female, with PMH of COVID-19, who had NS unexpected events of pain, anosmia, ageusia, abdominal pain upper and NS expected events of injection site pain, chills, nausea, vomiting, and headache. Event onset the same day as the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between 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, Nausea, Pain, Vomiting
Clinical narrative: whole body hurts; Not sure if can smell; Not sure if can taste; Stomach is killing her, Has stomach pains; arm feels like a sledgehammer hit it where she was injected; Feels nausea; Headache; Body chills; Can't keep anything down she throws up everything; A spontaneous report was received from a healthcare professional concerning a 56 year  old, female patient who experienced her whole body "hurts," arm feels like a sledgehammer where injected, can't keep anything down, she just throws up everything, feels nauseous, not sure if she can taste or smell, head is pounding, body chills, and stomach pains.   The patient's medical history was in Mar-2020 the patient was positive for COVID-19. The patient's concomitant medications included omeprazole magnesium.  On 28 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch: unknown) in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient experienced events, her whole body hurt, arm felt like a sledgehammer hit it where she was injected, couldn't keep anything down and she threw up everything, felt nauseous, and wasn't sure she could smell or taste, her head was pounding, body chills, and stomach pains.  Treatment for the event included ibuprofen.    Action taken with mRNA-1273 in response to the events was not provided.  .  The outcome of the events, whole body "hurts," arm feels like a sledgehammer where injected, can't keep anything down, she just throws up everything, feels nauseous, not sure if she can taste or smell, head is pounding, body chills, and stomach pains was unknown.; Reporter's Comments: This case concerns a 56-year-old female, with PMH of COVID-19, who had NS unexpected events of pain, anosmia, ageusia, abdominal pain upper and NS expected events of injection site pain, chills, nausea, vomiting, and headache. Event onset the same day as the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: feeling achey; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling achey.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown, Exp unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced feeling achey. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  Outcome for the event, feeling achey 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: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Hyperhidrosis, Lymphadenopathy
Clinical narrative: swollen lymph nodes the size of a lemon; Fever; Chills; Ackyness; Soreness; Nausea; Dizziness; Sweating; Felt clammy; A spontaneous report was received from a consumer concerning a 55-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple event(s) of swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy.  The patient's medical history included hypertension. The concomitant medications reported included chlorthalidone.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient experienced multiple events of swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy. Treatment for the event(s) included Acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event(s), swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy were considered unknown.; Reporter's Comments: This case concerns a 55-year-old male with PMH of COVID-19 who had NS unexpected pain, lymphadenopathy, dizziness, hyperhidrosis, cold sweat, and NS expected fever, chills, nausea, myalgia.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included acetaminophen. 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: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: swollen lymph nodes the size of a lemon; Fever; Chills; Ackyness; Soreness; Nausea; Dizziness; Sweating; Felt clammy; A spontaneous report was received from a consumer concerning a 55-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple event(s) of swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy.  The patient's medical history included hypertension. The concomitant medications reported included chlorthalidone.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient experienced multiple events of swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy. Treatment for the event(s) included Acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event(s), swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy were considered unknown.; Reporter's Comments: This case concerns a 55-year-old male with PMH of COVID-19 who had NS unexpected pain, lymphadenopathy, dizziness, hyperhidrosis, cold sweat, and NS expected fever, chills, nausea, myalgia.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included acetaminophen. 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: Arthralgia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: didn't feel well; dizziness; fast heartbeat; fever, temperature was 101.6; headache; body aches; joint pain; chills; her left arm was really sore at the injection site; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not feeling well/malaise, dizziness, fever temperature was 101.6/pyrexia, headache, body aches/pain, joint pains/arthralgia, chills, fast heartbeat/heart rate increased and left arm sore at injection site/injection site pain.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot#) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient didn't feel well, had dizziness, had a fever of 101.6 degrees Fahrenheit, headache, body aches, joint pains, chills, fast heartbeat and her left arm was sore at injection site.  Treatment information included Tylenol, Benadryl and Nyquil.   The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, didn't feel well, dizziness, headache, body aches, joint pains, chills, fast heartbeat and left arm sore at injection site was considered unknown.  The outcome for the event, fever temperature was 101.6 considered recovered/resolved on 30 Dec 2020.; 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: Heart rate increased, Malaise, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: didn't feel well; dizziness; fast heartbeat; fever, temperature was 101.6; headache; body aches; joint pain; chills; her left arm was really sore at the injection site; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not feeling well/malaise, dizziness, fever temperature was 101.6/pyrexia, headache, body aches/pain, joint pains/arthralgia, chills, fast heartbeat/heart rate increased and left arm sore at injection site/injection site pain.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot#) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient didn't feel well, had dizziness, had a fever of 101.6 degrees Fahrenheit, headache, body aches, joint pains, chills, fast heartbeat and her left arm was sore at injection site.  Treatment information included Tylenol, Benadryl and Nyquil.   The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, didn't feel well, dizziness, headache, body aches, joint pains, chills, fast heartbeat and left arm sore at injection site was considered unknown.  The outcome for the event, fever temperature was 101.6 considered recovered/resolved on 30 Dec 2020.; 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: Fatigue, Headache, Pain
Clinical narrative: Body ache; Headache; Fatigue; This spontaneous case was reported by a paramedic (subsequently medically confirmed) and describes the occurrence of   in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (and was hospitalized for over 2 weeks.) in October 2020.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. 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. Follow up #1 received with no new information which does not change company causality assessment.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Agency; 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. Follow up #1 received with no new information which does not change company causality assessment.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Foot soreness; A spontaneous report was received from a consumer on 29 Dec 2020. This case concerns a 68 year old female patient. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced foot soreness with the use of mRNA-1273.    Relevant medical history included foot soreness. There were no concomitant medications provided.  On 29 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the non-serious event foot soreness. It was noted the patient experienced the event of foot soreness prior to vaccination and she went to the urgent care seeking treatment on 30 Dec 2020. She was prescribed cephalexin for treatment. It was also noted the reporter did not believe the urgent care visit had anything to do with his wife getting the vaccine.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event of foot soreness was not reported.   The event of a little soreness was not recovered/not resolved at the time of this report.; Reporter's Comments: Based on the current available information the event is unrelated to vaccination (started prior to the first dose of the vaccine).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Muscle cramps; Achy all over; A spontaneous report was received from a nurse concerning a 47 year old female patient, who received Moderna's COVID-19 vaccine and experienced muscle spasms and aches.  The patient's medical history, as provided by the reporter, included cancer in 2017 and Rocky Mountain Spotted Fever in 2019. Concomitant medications included Vitamin D3, Vitamin C, and occasionally Benadryl for sleep.  On an unknown date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the right arm for prophylaxis of Covid-19 infection.  On an unknown date, the patient experienced muscle cramps, muscle spasms and aches. She was feeling better at the time of the report. Treatment medications included Advil and Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, muscle cramps, muscle spasms and aches, was considered as 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.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Strong wave of intense nausea; Minor sore arm; A spontaneous report was received from a healthcare professional (reporting on self) concerning a 66-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced minor sore arm and strong wave of intense nausea.  The patient's medical history was not provided. No concomitant medications were reported.  On 28-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 039K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection  On 28-DEC-2020, the patient experienced minor sore arm.  On 29-DEC-2020, the patient experienced strong wave of intense nausea. She did not vomit, but she had to take Zofran to help with nausea. It wiped her out for the evening. She felt fine this morning (30-DEC-2020) and went to work and again was hit by an intense nausea.   Action taken with mRNA-1273 in response to events was not reported.  The outcome for the event, minor sore arm was unknown and for strong wave of intense nausea was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included GERD (worsened with pregnancy, no change with vaccine, improved after delivery) and Food poisoning (food poisioning with dehydration, electrolyte changes) from 01-Dec-2020 to 02-Dec-2020. Previously administered products included for Product used for unknown indication: Tdap on 10-Dec-2020. Past adverse reactions to the above products included Product used for unknown indication with Tdap. Concurrent medical conditions included Penicillin allergy, Drug allergy and Sulfonamide allergy (sulfa allergy). Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Acid reflux (esophageal), ONDANSETRON (ZOFRAN [ONDANSETRON]) and PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 28-Dec-2020 at 6:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-May-2020 and the estimated date of delivery was 25-Feb-2021. On 28-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The cesarean delivery occurred on 13-Feb-2021, which was reported as Full-term. For neonate 1, the birth weight was 3160 grams (6lbs 15oz) with an APGAR score of 8 and 8 at (1, 5 minutes). The outcome was reported as Term Birth w Complications. Non-reassuring fetal tracing due to nuchal cord. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Ultrasound scan: normal (normal) normal. On 26-Jun-2020, Pregnancy test: positive (Positive) positive. In December 2020, Glucose tolerance test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception was 06 Jun 2021. Number of fetus is one.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Pregnancy outcome form added; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Limb discomfort, Myalgia
Clinical narrative: A spontaneous report  was received from a healthcare professional concerning a 27-year old, female patient who received Moderna's COVID-19 vaccine and experienced chills, sore arm, tingling in fingers, fatigue, fever, body aches, difficulty walking and legs feeling loose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch No: 039K20-24) in the left arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient started experiencing chills, sore arm, tingling in fingers, fatigue, fever, body aches. On 28 Dec 2020, 4 days after vaccination, the patient experienced difficulty walking and it was ongoing with legs feeling loose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, chills, sore arm, tingling in fingers, fatigue, fever, body aches, difficulty walking, and legs feeling loose, 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.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vaccination site pain
Clinical narrative: A spontaneous report  was received from a healthcare professional concerning a 27-year old, female patient who received Moderna's COVID-19 vaccine and experienced chills, sore arm, tingling in fingers, fatigue, fever, body aches, difficulty walking and legs feeling loose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch No: 039K20-24) in the left arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient started experiencing chills, sore arm, tingling in fingers, fatigue, fever, body aches. On 28 Dec 2020, 4 days after vaccination, the patient experienced difficulty walking and it was ongoing with legs feeling loose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, chills, sore arm, tingling in fingers, fatigue, fever, body aches, difficulty walking, and legs feeling loose, 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: Chest discomfort, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Feeling bad; Severe body aches; Dry cough; Oxygen went to 90; Chest felt heavy; Short of breath; Headache; Fever; Chills; Fatigue; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of feeling bad, severe body aches, fatigue, dry cough, fever, chills, headache, oxygen went to 90, short of breath and chest felt heavy.  The patient's medical history was not provided. Concomitant medications reported included blood thinner for unknown indication.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 025JA20) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced feeling bad, severe body aches, fatigue, dry cough, fever, chills, headache, oxygen went to 90 percent, short of breath and chest felt heavy. The treatment information reported included Tylenol number 3 for headache.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, feeling bad, severe body aches, fatigue, dry cough, fever and chills, was considered as resolving. The outcome for the event, headache was considered as not resolved. The outcome for the events, oxygen went to 90 percent, short of breath and chest felt heavy was considered as unknown.; Reporter's Comments: This case concerns a female of unknown age who had NS unexpected chest discomfort, dyspnea, cough, oxygen saturation decreased, feeling abnormal and NS expected fatigue, fever, chills, headaches. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treated with Tylenol #3. Most events resolving, but headache ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Oxygen saturation, Oxygen saturation decreased, Pain
Clinical narrative: Feeling bad; Severe body aches; Dry cough; Oxygen went to 90; Chest felt heavy; Short of breath; Headache; Fever; Chills; Fatigue; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of feeling bad, severe body aches, fatigue, dry cough, fever, chills, headache, oxygen went to 90, short of breath and chest felt heavy.  The patient's medical history was not provided. Concomitant medications reported included blood thinner for unknown indication.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 025JA20) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced feeling bad, severe body aches, fatigue, dry cough, fever, chills, headache, oxygen went to 90 percent, short of breath and chest felt heavy. The treatment information reported included Tylenol number 3 for headache.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, feeling bad, severe body aches, fatigue, dry cough, fever and chills, was considered as resolving. The outcome for the event, headache was considered as not resolved. The outcome for the events, oxygen went to 90 percent, short of breath and chest felt heavy was considered as unknown.; Reporter's Comments: This case concerns a female of unknown age who had NS unexpected chest discomfort, dyspnea, cough, oxygen saturation decreased, feeling abnormal and NS expected fatigue, fever, chills, headaches. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treated with Tylenol #3. Most events resolving, but headache ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling bad; Severe body aches; Dry cough; Oxygen went to 90; Chest felt heavy; Short of breath; Headache; Fever; Chills; Fatigue; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of feeling bad, severe body aches, fatigue, dry cough, fever, chills, headache, oxygen went to 90, short of breath and chest felt heavy.  The patient's medical history was not provided. Concomitant medications reported included blood thinner for unknown indication.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 025JA20) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced feeling bad, severe body aches, fatigue, dry cough, fever, chills, headache, oxygen went to 90 percent, short of breath and chest felt heavy. The treatment information reported included Tylenol number 3 for headache.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, feeling bad, severe body aches, fatigue, dry cough, fever and chills, was considered as resolving. The outcome for the event, headache was considered as not resolved. The outcome for the events, oxygen went to 90 percent, short of breath and chest felt heavy was considered as unknown.; Reporter's Comments: This case concerns a female of unknown age who had NS unexpected chest discomfort, dyspnea, cough, oxygen saturation decreased, feeling abnormal and NS expected fatigue, fever, chills, headaches. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treated with Tylenol #3. Most events resolving, but headache ongoing. Based on current available information and temporal association between 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 breast feeding, Vaccination site pain
Clinical narrative: Breast-feeding; Arm is Sore; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and developed a sore arm and breastfeeding.  The patient's medical history included pregnancy (date of LMP: 12 Jun 2020, live full-term birth. delivery type: vaginal) and alcohol use 1-2 per week. Products known to have been used by the patient, within two weeks prior to the event, included Wellbutrin 150 (unit unknown) daily via oral route, multivitamin daily and fish oil daily.   On 30 Dec 2020, prior to the onset of events, the patient's received their first of two planned doses of mRNA-1273 (Batch number: 027-K20A, Expiry date: 22 Jun 2021) intramuscularly in the right deltoid for prophylaxis of Covid-19 infection.  On an unknown date, the patient reported sore arm and breastfeeding. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, sore arm and breastfeeding, was considered unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with expected event of vaccination site pain. Patient will continue to be contacted for further monitoring of AEs.