chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness has gotten bigger; it feeling a little bit warm; redness on the right arm; Hardness when she touches the injected area; A spontaneous report was received from a healthcare facility staff member concerning a 49-year-old  female patient who was participating in the mRNA-1273 Emergency Use Program and developed hardness, and redness, over the injected area.  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# unknown) on 29-Dec-2020 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 29-Dec-2020 in the right arm..  On 05-Jan-2021, she reported that she had hardness when she touched the injected area.  On 06-Jan-2021, she reported that she had some redness on her right arm and that it felt warm.  Additionally, she stated that the nurse had circled the red area earlier and that she noticed that it had gotten bigger over the course of the day.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event,   injected site hardness, redness, warm on the right arm, and the redness has gotten bigger over the course of the day,  was not provided.   The outcome of the events, Injected site  hardness, redness, warm, the redness has gotten bigger over the course of the day, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Some tenderness; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine and experienced some tenderness.   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 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported having no reaction, just some tenderness for a few days. No treatment information was reported.   Action taken with mRNA-1273 in response to the event is not appplicable.   The outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: area around the injection site became red; area around the Injection site became hot; area around the injection site became itchy; area around the Injection site became swollen; lumps on and under the clavical that are super super sensative; Little bumps when touched lightly around the lymph nodes; arm was sore; A spontaneous report was received from a consumer concerning a 59 year-old, female patient who received Moderna's COVID-19 vaccine and experienced sore arm, injection site "red, hot, swollen, and itchy", and lumps on and under the clavicle.   The patient's medical history was not provided. Concomitant medication includes a multivitamin.    On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient reported having a sore arm for 2-3 days. On 03 Jan 2021, the patient's injection site became red, hot, swollen, and itchy. The symptoms did not worsen, but are ongoing and have not gotten better. The patient also reported lumps on and under the clavicle on the left side, around the lymph nodes that are "super, super sensitive". Treatment included ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, sore arm, injection site "red, hot, swollen, and itchy", and lumps on and under the clavicle was considered not recovered/not resolved; Reporter's Comments: This case concerns a 59-year-old female who had nonserious events of unexpected injection site warmth and expected injection site erythema, injection site pain, injection site swelling, injection site pruritus, lymphadenopathy, and lymph node pain. Treated with ibuprofen. Event onset occurred the same day as the first dose of mRNA-1273. Based on 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: area around the injection site became red; area around the Injection site became hot; area around the injection site became itchy; area around the Injection site became swollen; lumps on and under the clavical that are super super sensative; Little bumps when touched lightly around the lymph nodes; arm was sore; A spontaneous report was received from a consumer concerning a 59 year-old, female patient who received Moderna's COVID-19 vaccine and experienced sore arm, injection site "red, hot, swollen, and itchy", and lumps on and under the clavicle.   The patient's medical history was not provided. Concomitant medication includes a multivitamin.    On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient reported having a sore arm for 2-3 days. On 03 Jan 2021, the patient's injection site became red, hot, swollen, and itchy. The symptoms did not worsen, but are ongoing and have not gotten better. The patient also reported lumps on and under the clavicle on the left side, around the lymph nodes that are "super, super sensitive". Treatment included ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, sore arm, injection site "red, hot, swollen, and itchy", and lumps on and under the clavicle was considered not recovered/not resolved; Reporter's Comments: This case concerns a 59-year-old female who had nonserious events of unexpected injection site warmth and expected injection site erythema, injection site pain, injection site swelling, injection site pruritus, lymphadenopathy, and lymph node pain. Treated with ibuprofen. Event onset occurred the same day as the first dose of mRNA-1273. Based on 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: Dysgeusia
Clinical narrative: Metal taste; A spontaneous report was received from a consumer concerning a female patient who experienced a metal taste (dysgeusia).  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  for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient reported having a metal taste in her mouth that is ongoing and doesn't stop. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, metal taste, was considered not recovered.; Reporter's Comments: This case concerns a female of unknown age who had a nonserious unexpected event of dysgeusia.  Event onset occurred 2 days after the first dose of mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the dysgeusia, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling abnormal, Illness, Lymphadenopathy
Clinical narrative: Felt overall sickness; Pain down her back and arm; Pain down her back and arm; Woke up feeling like ball in armpit, got an ultra sound and discovered there were four oversized lymph nodes.; Muscle area where received the shot with sore with some tightness; Brain fog; Fever; Fatigue; Malaise; A spontaneous report was received from an adult female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle area where received the shot with sore with some tightness (vaccination site pain), woke up feeling like ball in armpit, got an ultrasound and discovered there were four oversized lymph nodes (lymphadenopathy), felt an overall sickness (illness), fatigue, malaise, brain fog (feeling abnormal), fever (pyrexia), and felt pain down her back and arm (back pain/pain in extremity).  There was no medical history provided. There were no concomitant medications provided.  On 21 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient experienced muscle area where received the shot was sore with some tightness. On 26 Dec 2020, she woke up feeling like there was a ball in armpit, got an ultrasound and discovered there were four oversized lymph nodes. It was noted the largest lymph node was 5cm and was very painful. On unknown dates in Dec 2020, the patient felt an overall sickness, fatigue, malaise, brain fog, and fever, and the symptoms have been slowly dissipating. On 28 Dec 2020, described as the worst day, she felt pain down her back and arm. There was no further treatment information provided.  Relevant laboratory on unknown date in December 2020, included an ultrasound which showed four oversized lymph nodes.   Action taken with mRNA-1273 in response to the reported events was not reported.   The events of felt an overall sickness, fatigue, malaise, brain fog, fever were reported as recovering at the time of this report. The outcome for the remaining events, woke up feeling like ball in armpit, got an ultrasound and discovered there were four oversized lymph nodes, and felt pain down her back and 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia, Ultrasound Doppler, Vaccination site pain
Clinical narrative: Felt overall sickness; Pain down her back and arm; Pain down her back and arm; Woke up feeling like ball in armpit, got an ultra sound and discovered there were four oversized lymph nodes.; Muscle area where received the shot with sore with some tightness; Brain fog; Fever; Fatigue; Malaise; A spontaneous report was received from an adult female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle area where received the shot with sore with some tightness (vaccination site pain), woke up feeling like ball in armpit, got an ultrasound and discovered there were four oversized lymph nodes (lymphadenopathy), felt an overall sickness (illness), fatigue, malaise, brain fog (feeling abnormal), fever (pyrexia), and felt pain down her back and arm (back pain/pain in extremity).  There was no medical history provided. There were no concomitant medications provided.  On 21 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient experienced muscle area where received the shot was sore with some tightness. On 26 Dec 2020, she woke up feeling like there was a ball in armpit, got an ultrasound and discovered there were four oversized lymph nodes. It was noted the largest lymph node was 5cm and was very painful. On unknown dates in Dec 2020, the patient felt an overall sickness, fatigue, malaise, brain fog, and fever, and the symptoms have been slowly dissipating. On 28 Dec 2020, described as the worst day, she felt pain down her back and arm. There was no further treatment information provided.  Relevant laboratory on unknown date in December 2020, included an ultrasound which showed four oversized lymph nodes.   Action taken with mRNA-1273 in response to the reported events was not reported.   The events of felt an overall sickness, fatigue, malaise, brain fog, fever were reported as recovering at the time of this report. The outcome for the remaining events, woke up feeling like ball in armpit, got an ultrasound and discovered there were four oversized lymph nodes, and felt pain down her back and 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site mass, Vaccination site rash, Vaccination site swelling
Clinical narrative: like a lump; Rashes 1-2 inch below the injection site; swollen; injection site irreregular; A spontaneous report was received from a consumer a female patient who experienced rashes 1-2 inches below the injection site, an irregular in shape and swollen lump-like injection site.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided by administration site, per patient) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events rashes 1-2 inches below the injection site, an irregular in shape and swollen lump-like injection site were unknown/not reported.; Reporter's Comments: This case concerns a female of unknown age who had NS events of unexpected vaccination site mass and expected vaccination site swelling, vaccination site induration, vaccination site rash.  Event onset 2 days after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the Vaccination site mass, vaccination site swelling, vaccination site induration and vaccination site rash, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: A spontaneous report  was received from a consumer concerning a 63-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced feeling extremely dizzy, headache, soreness of the arm and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of events, the patient received their dose of mRNA-1273 (Batch Number: 026126A) for prophylaxis of COVID-19 infection.   On 01-Jan-2021, the patient experienced feeling extremely dizzy, headache, soreness of the arm and fatigue.  No treatment information was provided  Action taken with mRNA-1273 in response to the events feeling extremely dizzy, headache, soreness of the arm and fatigue was not reported.  The outcome of the events feeling extremely dizzy, headache, soreness of the arm and fatigue was not reported.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded. Headache and fatigue. are consistent with the known safety profile of mRNA-1273.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dizziness, Headache, Hypoaesthesia, Nausea
Clinical narrative: A spontaneous report was received from a 30-year-old, female healthcare facility staff member who received Moderna's COVID-19 vaccine (mRNA-1273) and developed nausea, lightheadedness, headaches, numbness of injection arm and loss of sense of taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31-Dec-2020, after receiving vaccine, patient reported nausea, lightheadedness, headaches, numbness of injection arm that lasted for a few hours. On 01-Jan-2021, patient lost her sense of taste and was tested for COVID-19. Patient's rapid COVID-19 test was negative and she is waiting results from a PCR test she took 04-Jan-2021.   No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, nausea, lightheadedness, headaches, numbness of injection arm and loss of sense of taste, were considered recovered/resolved.; Reporter's Comments: This case concerns a 29-year-old female who had nonserious events of unexpected ageusia, hypoaesthesia, dizziness and expected headache, nausea.  Event onset occurred the same day as the first dose of mRNA-1273. Based on 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: A spontaneous report was received from a 30-year-old, female healthcare facility staff member who received Moderna's COVID-19 vaccine (mRNA-1273) and developed nausea, lightheadedness, headaches, numbness of injection arm and loss of sense of taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31-Dec-2020, after receiving vaccine, patient reported nausea, lightheadedness, headaches, numbness of injection arm that lasted for a few hours. On 01-Jan-2021, patient lost her sense of taste and was tested for COVID-19. Patient's rapid COVID-19 test was negative and she is waiting results from a PCR test she took 04-Jan-2021.   No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, nausea, lightheadedness, headaches, numbness of injection arm and loss of sense of taste, were considered recovered/resolved.; Reporter's Comments: This case concerns a 29-year-old female who had nonserious events of unexpected ageusia, hypoaesthesia, dizziness and expected headache, nausea.  Event onset occurred the same day as the first dose of mRNA-1273. Based on 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: Adverse reaction, Pyrexia
Clinical narrative: fever; adverse reaction; A spontaneous report was received from a male patient who received Moderna's COVID-19 Vaccine and experienced adverse reaction and fever.   The patient's medical history was not provided. No concomitant medications were reported.   On 31 Dec 2020, the patient received the first of two planned doses of mRNA-1273 for COVID-19 for infection prophylaxis.  On an unknown date, the patient began having an adverse reaction. He reported that he had a fever and some other symptoms. Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, adverse reaction and fever, 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 pyrexia, a causal relationship cannot be excluded.  Further information has been requested regarding the unnamed 'adverse reaction' event.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccination (mRNA-1273) and who experienced loss of taste.  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 intramuscularly for prophylaxis of COVID-19 infection.   On 28-Dec-2020, the patient experienced loss of taste.  No treatment information was provided.  Action taken with mRNA-1273 vaccine was not provided.  The outcome of the event, loss of taste, was considered unknown.; Reporter's Comments: This case concerns a female of unknown age who had a NS event of unexpected ageusia.  Event onset occurred the same day as the first dose of mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the ageusia, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Dizziness; Naseua; Vomiting; She experienced a really bad headache; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a really bad headache, nausea, vomiting and dizziness.  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 on 30-Dec-2020 intramuscularly in the left shoulder for prophylaxis of COVID-19 infection.    Patient received their Moderna vaccine on 30-Dec-2020 at the Health Department in the left shoulder.  One day later, on 31-Dec-2020, she reported a bad headache which was resolved by the next day, 01-Jan-2021.  She continued to feel normal on 01-Jan-2021, however, on 02-Jan-2021, she again reported experiencing a bad headache as well as nausea and vomiting, all of which were resolved by 03-Jan-2021.  She stated that she was fine for the remainder of that day.  Finally, on 04-Jan-2021, she reported that experienced nausea and dizziness.    Treatment for the event included paracetamol for symptom management.   Action taken with mRNA-1273 in response to the events  was not provided.  The outcomes of the events, a really bad headache and vomiting, were considered recovered/resolved.  The outcomes of the events, nausea and dizziness, 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. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (18 weeks pregnant) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Psoriasis, Anxiety, Depression and Drug allergy (Patient reported drug allergy to quinolones.). Concomitant products included LORATADINE (CLARITINE) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 04-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (18 weeks pregnant). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (18 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no treatment medication reported.  The patient's had one previous pregnancy which was a live full term birth 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Vaccination site pain
Clinical narrative: Chest feels like what if feels before getting a chest cold; Cough; Significant pain at the injection site; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest feels like what if feels before getting a chest cold), COUGH (Cough), VACCINATION SITE PAIN (Significant pain at the injection site) and FATIGUE (Felt tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (Felt tired). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest feels like what if feels before getting a chest cold), COUGH (Cough) and VACCINATION SITE PAIN (Significant pain at the injection site). At the time of the report, CHEST DISCOMFORT (Chest feels like what if feels before getting a chest cold), COUGH (Cough), VACCINATION SITE PAIN (Significant pain at the injection site) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Electrocardiogram, Fatigue, Headache
Clinical narrative: A spontaneous report was received from a consumer who was a 79-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced intermittent headache, crushing feeling in her chest between her breast, red, swollen arm and had pain shooting down to the elbow and felt very fatigued.  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 # 037N20A) on 23-Dec-2020 in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   The consumer called to report she had received the Moderna Covid-19 vaccine on 23-Dec-2020 in her left deltoid. She stated she did not have any reaction until 30-Dec-2020. She began to experience intermittent headache, a crushing feeling in her chest between her breast. She stated the crushing feeling was not pain, only lasted 10-15 seconds and was intermittent. She stated her arm began to get red, swollen and had pain shooting down to the elbow. She stated she felt very fatigued. Her son took her to Urgent care where she had a chest x-ray, blood work, an electrocardiogram and her vitals were taken. There were no specific results of these tests reported, but the patient reported that everything "checked out good."  She reported that on 02-Jan-2021, all of the symptoms went away except for the red, sore arm. She stated that that continued. The consumer reported her symptoms online through VAERS system.  Treatment included a topical steroid cream on the injection site which was not prescribed.  Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events, intermittent headache, crushing feeling in her chest between her breast, swollen arm, pain shooting down to the elbow, and felt very fatigued, were considered resolved as of 02-Jan-2021. The outcome of the event, red, sore arm, 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. Further information has been requested
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: A spontaneous report was received from a consumer who was a 79-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced intermittent headache, crushing feeling in her chest between her breast, red, swollen arm and had pain shooting down to the elbow and felt very fatigued.  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 # 037N20A) on 23-Dec-2020 in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   The consumer called to report she had received the Moderna Covid-19 vaccine on 23-Dec-2020 in her left deltoid. She stated she did not have any reaction until 30-Dec-2020. She began to experience intermittent headache, a crushing feeling in her chest between her breast. She stated the crushing feeling was not pain, only lasted 10-15 seconds and was intermittent. She stated her arm began to get red, swollen and had pain shooting down to the elbow. She stated she felt very fatigued. Her son took her to Urgent care where she had a chest x-ray, blood work, an electrocardiogram and her vitals were taken. There were no specific results of these tests reported, but the patient reported that everything "checked out good."  She reported that on 02-Jan-2021, all of the symptoms went away except for the red, sore arm. She stated that that continued. The consumer reported her symptoms online through VAERS system.  Treatment included a topical steroid cream on the injection site which was not prescribed.  Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events, intermittent headache, crushing feeling in her chest between her breast, swollen arm, pain shooting down to the elbow, and felt very fatigued, were considered resolved as of 02-Jan-2021. The outcome of the event, red, sore arm, 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. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at the vaccination site; A spontaneous report was received from a female consumer of unknown age, who was also the patient, who received Moderna's COVID-19 vaccine and experienced swelling at the site.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On the night of 31 Dec 2020, the patient developed swelling of the site of the VCG vaccination they received in the remote past. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event swelling at the site was unknown.; Reporter's Comments: This case concerns a female of unknown age who had a NS event of expected Vaccination site swelling.  Event onset occurred Day 9 after the first dose of mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the Vaccination site swelling, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Somnolence, Vaccination site reaction
Clinical narrative: Neck sore; Sleeping all day yesterday and today; Spot 2in below the site of injection; Left arm sore; Left shoulder sore; A spontaneous report was received from a consumer concerning himself, a 59-year-old, male patient who experienced a sore neck [Neck pain], sleepiness [Somnolence], a spot 2 inches below the injection site [vaccination site reaction], soreness in left arm [Pain in extremity] and soreness in shoulder [Arthralgia].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received one of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31-Dec-2020, the patient reported he noticed a spot 2 inches below the site of the injection. He also reported that his shoulder, arm and neck are sore, and he has been sleeping all day for two days. He was unable to provide the lot number received due to the number being unclear. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were not reported; Reporter's Comments: This case concerns a 59 Y/O M with a nonserious unexpected event of neck pain, somnolence, and expected vaccination site reaction, pain in extremity and arthralgia. Event onset 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Slight rash around the injection site; Slight itchiness on my left arm near the injection site; A spontaneous report was received from a 27-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight itchiness on her left arm near the injection site [vaccination site pruritus] and a very slight rash around the injection site [vaccination site rash].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 26-Dec-2021, approximately 8 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03-Jan-2021, the patient noticed a slight itchiness of her left arm near the injection site. On 04-Jan-2021, she also noticed a very slight rash around the injection site. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Vaccination site pain
Clinical narrative: Unable to get out of bed because of dizziness; High blood pressure; 145/84 now; Sore arm; A report was received from a consumer concerning a 59-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced unable to get out of bed because of dizziness (dizziness), sore arm (vaccination site pain), and high blood pressure (hypertension).  The patient's medical history and concomitant medications were not reported.   On 02 Jan 2021, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   The patient was unable to get out of bed because of dizziness, had a sore arm, and high blood pressure (145/84) beginning on 02 Jan 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, unable to get out of bed because of dizziness, sore arm, and high blood pressure, 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. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Upper temple site on the left side of the head, it is a lot of pain; Lot of joint pain in the knees and elbows; A spontaneous report was received from a consumer concerning an unknown age, male patient, who received Moderna's COVID-19 Vaccine and experienced woke up in the morning with a severe headache in the upper temple site on the left side of the head and a lot of joint pain in the knees and elbows.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, prior to the onset of events, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 1 Jan 2021, in morning the patient experienced severe headache in the upper temple site on the left side of the head and a lot of joint pain in the knees and elbows.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events, severe headache in the upper temple site on the left side of the head and a lot of joint pain in the knees and elbows was not reported.  The outcome of the events, severe headache in the upper temple site on the left side of the head and a lot of joint pain in the knees and elbows was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pain in extremity
Clinical narrative: Feeling really fatigued and tired; A lot of muscle aches; Nausea; Arm really, really sore; A spontaneous report was received from a healthcare facility staff member concerning a 42-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced fatigue and tiredness, sore arm, muscle aches, and nausea.   The patient's medical history was not provided. Concomitant medications reported included bupropion hydrochloride.   On 31 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number OZSLZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient's arm was sore and she experienced fatigue and nausea that lasted a few hours.  On 03 Jan 2021 the patient began to experience muscle aches.   On 04 Jan 2020, the patient reported the soreness to be gone but the fatigue had gotten worse and not improved with rest. Treatment for the event included ibuprofen, which per the patient, alleviated some of the soreness and aches and pains.   Action taken with mRNA-1273 in response to the events was not reported.  The event, nausea, was considered resolved on 01 Jan 2021. The event sore arm was considered resolved on 04 Jan 2021. The outcomes of the events, feeling fatigued and tired and muscle aches, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: fatigue; Vomiting; nausea; teeth were chattering, had chills; Fever; Joint pains; Headache; starting to itch; arm hurts; arm is red; A spontaneous report was received from a healthcare professional who was also a female patient of unknown age who received Moderna's Covid-19 vaccine (mRNA-1273) and developed fatigue, nausea, chills, vomiting, fever (pyrexia), joint pains (arthralgia), arm hurts (pain in extremity), arm is red (erythema), itch (pruritus), and headache.  Historical condition included tested positive for Covid on 13 Dec 2021. Concomitant product use was not provided by the reporter.   On 31 Dec 2021, at 11 am, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   The patient felt fine until 11 pm on 31 Dec 2021, when she felt fatigue and nauseas. Later on, her teeth were chattering, had chills, vomiting, fever and joint pains. She stated she stopped vomiting on 01 Jan 2021 (reported as Friday) but still had fever and headache. She stated her arm was red and started to itch.   Treatment for the events were not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event of vomiting was resolved on 01 Jan 2021. The events of fever and headache were not resolved at the time of this report. The outcome of the events of fatigue, nausea, chills, joint pains, arm hurts, arm is red, and itch 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: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vomiting
Clinical narrative: fatigue; Vomiting; nausea; teeth were chattering, had chills; Fever; Joint pains; Headache; starting to itch; arm hurts; arm is red; A spontaneous report was received from a healthcare professional who was also a female patient of unknown age who received Moderna's Covid-19 vaccine (mRNA-1273) and developed fatigue, nausea, chills, vomiting, fever (pyrexia), joint pains (arthralgia), arm hurts (pain in extremity), arm is red (erythema), itch (pruritus), and headache.  Historical condition included tested positive for Covid on 13 Dec 2021. Concomitant product use was not provided by the reporter.   On 31 Dec 2021, at 11 am, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   The patient felt fine until 11 pm on 31 Dec 2021, when she felt fatigue and nauseas. Later on, her teeth were chattering, had chills, vomiting, fever and joint pains. She stated she stopped vomiting on 01 Jan 2021 (reported as Friday) but still had fever and headache. She stated her arm was red and started to itch.   Treatment for the events were not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event of vomiting was resolved on 01 Jan 2021. The events of fever and headache were not resolved at the time of this report. The outcome of the events of fatigue, nausea, chills, joint pains, arm hurts, arm is red, and itch 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.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Cough; Tested positive for COVID 19; Fever; A spontaneous report was received from a consumer (physician) concerning a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cough, fever and tested positive for COVID-19.  The patient's medical history included cough. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Batch Number Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient's cough continued since receiving mRNA-1273. On 02 Jan 2021, the patient developed fever and tested positive for COVID-19.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event cough was considered not recovered (still having a cough).  The outcome of the event fever was considered recovering .  The outcome of the event tested positive for COVID-19 was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the event of Covid-19 is Unlikely related to mRNA-1273 and a very limited information regarding this event has been provided.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at injection site; A spontaneous report was received from a nurse (patient), a female patient of unknown age, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced redness at injection site (injection site redness).   The patient's medical history was not provided. No concomitant medications were reported.  On 23 Dec 2020, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown), intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that still today on 01 Jan 2021, she has redness at the site that was very localised at the injection site was about an inch to inch and a half in size and almost square sort of shape. The patient does not have any other symptoms or discomforts. No treatment information was provided.  Action taken with second dose mRNA-1273 in response to the event was not reported.   The outcome of the event, redness at injection site, was not recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: 20 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, 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.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unidentified female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 99.6; Chills; Right arm pain at the injection site; Nausea; A spontaneous report, was received from a healthcare professional (patient), a 62 year old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced nausea, fever of 99.6 (pyrexia), chills, and right arm pain at the injection site (injection site pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A), intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, after administration of the vaccine, the patient developed nausea, fever of 99.6 with chills, and right arm pain at the injection site. No treatment information was provided.   Action taken with first dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, nausea, fever of 99.6, chills, and right arm pain at the injection site, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.