chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Delivered live full term baby) on 16-Feb-2015, Pregnancy (Delivered live full term baby) on 23-Feb-2018 and Pregnancy (Delivered live full term baby) on 21-Aug-2019. Concurrent medical conditions included Epilepsy (9th grade) since 1998. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Nutritional supplement, ZINC for Zinc supplementation, VITAMIN D3, VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-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 22-Mar-2021. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.  Estimated date of conception is 29 Jun 2020. Company comment: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Headache, Pain
Clinical narrative: Stomache ache; Body aches; fever; chills; Headache; A spontaneous report was received from a consumer concerning a 61-year-old female patient who experienced fever: pyrexia, body aches: pain, chills: chills, headache: headache, stomach ache that come and go: abdominal pain upper.  The patient's medical history included COVID-19 in November 2020.  Concomitant product use were not provided by the reporter.  On 28-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number 036K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 29-Dec-2020 the patient developed a fever of 99.4° to 101.7°, body aches, chills, headache, and stomach aches that come and go.  The events were treated with Tylenol on 29-Dec-2020.     Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events pyrexia, body aches, chills, headache, and stomach ache that come and go were unknown.   Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Stomache ache; Body aches; fever; chills; Headache; A spontaneous report was received from a consumer concerning a 61-year-old female patient who experienced fever: pyrexia, body aches: pain, chills: chills, headache: headache, stomach ache that come and go: abdominal pain upper.  The patient's medical history included COVID-19 in November 2020.  Concomitant product use were not provided by the reporter.  On 28-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number 036K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 29-Dec-2020 the patient developed a fever of 99.4° to 101.7°, body aches, chills, headache, and stomach aches that come and go.  The events were treated with Tylenol on 29-Dec-2020.     Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events pyrexia, body aches, chills, headache, and stomach ache that come and go were unknown.   Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: Fever of 101.2; Fever of 100.6; Pain in right arm; Arm was hot; Arm was swelling; Feeling ill; Spinal pain; Pain in long bone; Pain in joints; Aching all over; A spontaneous report was received from a consumer 61 year old, female patient who developed pyrexia, pain in extremity, injection site warmth, injection site swelling, malaise, spinal pain, pain, and arthralgia.  The patient's medical history was not provided. No concomitant medication were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. While receiving she felt pain in her right arm and got hot and noticed swelling. Patient reported 12 hours later she woke up with severe pain in her arm, felt ill, had spinal pain, pain in long bones, joints and spine with aching all over and a fever of 100.6 degree fahrenheit . She contacted her HCP but he could not see her at that time. At the time she placed this call she checked her temperature and it was 101.2 degree fahrenheit. No treatment medications helped to relieve her symptoms. The treatment for the events included acetaminophen, ibuprofen, and naproxen.  Action taken with mRNA-1273 in response to the events were not reported.   The events, pyrexia, pain in extremity, injection site warmth, injection site swelling, malaise, spinal pain, pain, and arthralgia, were considered unknown.  The reporter did not provide an assessment for the events, pyrexia, pain in extremity, injection site warmth, injection site swelling, malaise, spinal pain, pain, and arthralgia.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of all events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Spinal pain
Clinical narrative: Fever of 101.2; Fever of 100.6; Pain in right arm; Arm was hot; Arm was swelling; Feeling ill; Spinal pain; Pain in long bone; Pain in joints; Aching all over; A spontaneous report was received from a consumer 61 year old, female patient who developed pyrexia, pain in extremity, injection site warmth, injection site swelling, malaise, spinal pain, pain, and arthralgia.  The patient's medical history was not provided. No concomitant medication were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. While receiving she felt pain in her right arm and got hot and noticed swelling. Patient reported 12 hours later she woke up with severe pain in her arm, felt ill, had spinal pain, pain in long bones, joints and spine with aching all over and a fever of 100.6 degree fahrenheit . She contacted her HCP but he could not see her at that time. At the time she placed this call she checked her temperature and it was 101.2 degree fahrenheit. No treatment medications helped to relieve her symptoms. The treatment for the events included acetaminophen, ibuprofen, and naproxen.  Action taken with mRNA-1273 in response to the events were not reported.   The events, pyrexia, pain in extremity, injection site warmth, injection site swelling, malaise, spinal pain, pain, and arthralgia, were considered unknown.  The reporter did not provide an assessment for the events, pyrexia, pain in extremity, injection site warmth, injection site swelling, malaise, spinal pain, pain, and arthralgia.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of all events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Myalgia, Pain, Vaccination site pain
Clinical narrative: Cramps; Body aches; arm soreness; MUSCLE PAIN; soreness in knee right joints; A spontaneous report was received from a nurse a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness/pain in extremity, muscle pain/myalgia, body aches/pain, cramps/muscle spasms, and soreness in knee joints/arthralgia.   The patient's medical history, as provided by the reporter, included a positive COVID-19 test. No relevant concomitant medications were reported.    On 29 Dec 2020 at 7:30 pm, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 29 Dec 2020 the patient received the Moderna Covid-19 vaccine. After a few hours, she started to feel symptoms. She experienced arm soreness, muscle pain, body aches, cramps, and soreness in her knee joints. Per the patient, the soreness moved all around her body through the day. Her condition improved with treatment. Treatment for the events included ibuprofen for the pain.   Action taken with mRNA-1273 in response to the events was not reported.     The events, arm soreness, muscle pain, body aches, cramps, and soreness in her knee joints, were considered resolving.; 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: Fatigue, Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: Headache; Arm started to burn; Arm swollen; Fatigue; A report was received from a physician concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced arm started to burn, arm swollen, fatigue, and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020 at 14:00, approximately 0 hours prior to the onset of the events, arm started to burn, arm swollen and fatigue, and approximately 1 day prior to the onset of the event, headache, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient's arm started to burn after receiving the vaccine. Later that evening her arm became swollen and she felt fatigued. The following morning, 24 Dec 2020, she woke up with a headache and fatigue. She reported taking Tylenol or Advil after a couple days and the pain on her arm decreased, but fatigue and headache were still ongoing.   Treatment for the event included ibuprofen or paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The events arm started to burn and arm swollen were considered resolved on 24 Dec 2020. The outcomes of the events fatigue, and headache, were 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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure/got shot & several years later had shingles, but not as severe.; had shingles, but not as severe.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and several years later had shingles, but not as severe. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Back pain, Blood glucose increased, Chest pain
Clinical narrative: Trouble sleeping; Blood sugar levels were elevated; Cannot hardly walk; Weak in both knees; Pain in/ knee; Pain in the top of both legs; Pain radiating from chest; Pain radiating from chest, underarm, to back; Pain radiating from chest, underarm, to back; This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included methylprednisolone for knee pain and leg pain.   The patient's past medical history included shingles (had shingles in 1st January 2021). Concomitant products included Herpes zoster (Shingrix).   On 12th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, the patient started methylprednisolone at an unknown dose and frequency. On 12th July 2021, less than a day after receiving Shingrix, the patient experienced difficulty sleeping, blood sugar increased, walking difficulty, lower extremities weakness of, knee pain, leg pain, chest pain, axillary pain and back pain. The patient was treated with lidocaine (Lidocaine Cream). The action taken with methylprednisolone was unknown. On an unknown date, the outcome of the difficulty sleeping, walking difficulty, lower extremities weakness of, knee pain, leg pain, chest pain, axillary pain and back pain were not recovered/not resolved and the outcome of the blood sugar increased was recovered/resolved.   It was unknown if the reporter considered the difficulty sleeping, blood sugar increased, walking difficulty, lower extremities weakness of, knee pain, leg pain, chest pain, axillary pain and back pain to be related to Shingrix.  Additional details were reported as follows: The consumer reported that he had shingles. The patient received his first dose of shimgrix with no adverse events. Then patient received second dose of shingrix and experienced pain in the top of both legs, pain in his left knee, and pain radiating across his chest to his underarm to his back along the same path as his shingles outbreak. The consumer states that he was weak in both knees and cannot hardly walk, and has trouble sleeping.  The consumer visited a HCP and was given a steroid shot, lidocaine cream for his knee, and oral Methylprednisolone 4mg. The consumer stated that as a result of the steroids his blood sugar levels were elevated but have now come back down to normal. Consented to follow up. ER Visit Required.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Herpes zoster, Insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Trouble sleeping; Blood sugar levels were elevated; Cannot hardly walk; Weak in both knees; Pain in/ knee; Pain in the top of both legs; Pain radiating from chest; Pain radiating from chest, underarm, to back; Pain radiating from chest, underarm, to back; This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included methylprednisolone for knee pain and leg pain.   The patient's past medical history included shingles (had shingles in 1st January 2021). Concomitant products included Herpes zoster (Shingrix).   On 12th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, the patient started methylprednisolone at an unknown dose and frequency. On 12th July 2021, less than a day after receiving Shingrix, the patient experienced difficulty sleeping, blood sugar increased, walking difficulty, lower extremities weakness of, knee pain, leg pain, chest pain, axillary pain and back pain. The patient was treated with lidocaine (Lidocaine Cream). The action taken with methylprednisolone was unknown. On an unknown date, the outcome of the difficulty sleeping, walking difficulty, lower extremities weakness of, knee pain, leg pain, chest pain, axillary pain and back pain were not recovered/not resolved and the outcome of the blood sugar increased was recovered/resolved.   It was unknown if the reporter considered the difficulty sleeping, blood sugar increased, walking difficulty, lower extremities weakness of, knee pain, leg pain, chest pain, axillary pain and back pain to be related to Shingrix.  Additional details were reported as follows: The consumer reported that he had shingles. The patient received his first dose of shimgrix with no adverse events. Then patient received second dose of shingrix and experienced pain in the top of both legs, pain in his left knee, and pain radiating across his chest to his underarm to his back along the same path as his shingles outbreak. The consumer states that he was weak in both knees and cannot hardly walk, and has trouble sleeping.  The consumer visited a HCP and was given a steroid shot, lidocaine cream for his knee, and oral Methylprednisolone 4mg. The consumer stated that as a result of the steroids his blood sugar levels were elevated but have now come back down to normal. Consented to follow up. ER Visit Required.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Swelling; Redness; A spontaneous report was received from a healthcare professional concerning a 61-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling and redness.    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 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient reported having a slight reaction from the vaccine she was administered a week ago. On 23 Dec 2020, she experienced swelling and redness. It was stated that "the median length for the site reaction for 2-3 days". Treatment was not provided.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events swelling and redness was unknown.; Reporter's Comments: This case concerns a 61 year-old, female patient, who experienced events of swelling and redness. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-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. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 29-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Vaccination site induration
Clinical narrative: severe pain radiating to breast; severe pain radiating to fingers; hardness of the injection site; entire upper arm swelling; low grade fever (100.3 F to 100.8 F); Headache; A report was received from a nurse concerning a 59-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced low grade fever (100.3 F to 100.8 F), headache, severe pain radiating to breast, severe pain radiating to fingers, hardness of the injection site, and entire upper arm swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, approximately 3 to 4 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient developed a low grade fever of 100.3 F to 100.8 F and a headache. She took Tylenol that night, and the following night. On 29 Dec 2020, she began to experience severe pain radiating to breast and fingers, hardness of the injection site and entire upper arm swelling, but denies fever. Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not reported.  The event, low grade fever (100.3 F to 100.8 F), was considered resolved on 29 Dec 2020. The outcomes of the events, headache, severe pain radiating to breast, severe pain radiating to fingers, hardness of the injection site, and entire upper arm swelling were unknown.   The reporter did not provide an assessment for the events, low grade fever (100.3 F to 100.8 F), headache, severe pain radiating to breast, severe pain radiating to fingers, hardness of the injection site, and entire upper arm swelling.; 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: severe pain radiating to breast; severe pain radiating to fingers; hardness of the injection site; entire upper arm swelling; low grade fever (100.3 F to 100.8 F); Headache; A report was received from a nurse concerning a 59-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced low grade fever (100.3 F to 100.8 F), headache, severe pain radiating to breast, severe pain radiating to fingers, hardness of the injection site, and entire upper arm swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, approximately 3 to 4 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient developed a low grade fever of 100.3 F to 100.8 F and a headache. She took Tylenol that night, and the following night. On 29 Dec 2020, she began to experience severe pain radiating to breast and fingers, hardness of the injection site and entire upper arm swelling, but denies fever. Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not reported.  The event, low grade fever (100.3 F to 100.8 F), was considered resolved on 29 Dec 2020. The outcomes of the events, headache, severe pain radiating to breast, severe pain radiating to fingers, hardness of the injection site, and entire upper arm swelling were unknown.   The reporter did not provide an assessment for the events, low grade fever (100.3 F to 100.8 F), headache, severe pain radiating to breast, severe pain radiating to fingers, hardness of the injection site, and entire upper arm swelling.; 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: Asthenia, Dizziness, Heart rate increased, Hypersensitivity, Tenderness
Clinical narrative: Immediately Fast Heart Beat; Weakness; Dizziness; Throat is closing; Severe allergic reaction; Arm  is tender; A spontaneous report was received from a 43-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273, and experienced severe allergic reaction, arm is tender, immediately fast heartbeat, weakness, dizziness and throat is closing.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number: 011-J20A) intramuscularly in the left arm for COVID-19 infection prophylaxis.  On 29 Dec 2020, The patient reported that she had a severe allergic reaction. She stated that at the time of vaccine administration, she immediately felt she had a fast heartbeat. Approximately 4 hours after vaccine administration, the patient reported that her arm was tender, that she was experiencing weakness, throat closing and dizziness. Treatment for the event included diphenhydramine and ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The event immediately fast heartbeat was considered resolved on 29 Dec 2020. The outcome of the events, severe allergic reaction, arm is tender, weakness, dizziness, and throat is closing, 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: Throat tightness
Clinical narrative: Immediately Fast Heart Beat; Weakness; Dizziness; Throat is closing; Severe allergic reaction; Arm  is tender; A spontaneous report was received from a 43-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273, and experienced severe allergic reaction, arm is tender, immediately fast heartbeat, weakness, dizziness and throat is closing.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number: 011-J20A) intramuscularly in the left arm for COVID-19 infection prophylaxis.  On 29 Dec 2020, The patient reported that she had a severe allergic reaction. She stated that at the time of vaccine administration, she immediately felt she had a fast heartbeat. Approximately 4 hours after vaccine administration, the patient reported that her arm was tender, that she was experiencing weakness, throat closing and dizziness. Treatment for the event included diphenhydramine and ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The event immediately fast heartbeat was considered resolved on 29 Dec 2020. The outcome of the events, severe allergic reaction, arm is tender, weakness, dizziness, and throat is closing, 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: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: So sick; A spontaneous report was received from a patient on unknown age and gender who received Moderna's COVID-19 Vaccine and experienced the event "so sick".  There were no medical history and concomitant medications provided.  On 27 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec2020, the patient reported that they took the shot 27 Dec 2020 and were so sick. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, so sick was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender who received the first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection and experienced a non-serious unlisted event "so sick" two days later. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) in a female patient of an unknown age (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20/2A) for COVID-19 vaccination.     Family history included Congestive heart failure (Family history- Mother (patient believes it to be genetic)). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and PARACETAMOL (TYLENOL) for an unknown indication.    On 28-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 03-Mar-2021. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant). On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Ultrasound and Glucose screening were done on 12 Jul 2020 (results not reported). No Treatment medications were reported.  Live, full-term birth on 2021 and 2018.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2020: Contact information added
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Headache
Clinical narrative: blood vessel bleeding in my nose; Slight headache; A spontaneous report was received from a 70 year-old, male patient, who received Moderna's COVID-19 vaccine and experienced slight headache and blood vessel bleeding in my nose.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 26 Dec 2020, 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 26 Dec 2020, the patient experienced a slight headache on his way home and continued to have symptoms of the headache since, occasionally. On 29 Dec 2020, the patient woke up and had a blood vessel bleeding in his nose. The patient's nose bleed had stopped at the time of reporting. Treatment for the events included two acetylsalicyclic acid, and one paracetamol.  Action taken with mRNA-1273 in response to the event was unknown.   The event headache was considered not resolved.  The event blood vessel bleeding in my nose was considered resolved on 29 Dec 2020.; 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: Abdominal discomfort, Arthralgia, Asthenia, Autoscopy, Bone pain
Clinical narrative: Feel weird; Face feels tingly; Face feels numb; Feeling hot; Out of body experience, like she got into an accident; Out of body experience, like she got into an accident; Fatigue; Vomiting; Headache; Delusions; Hair hurting; Dizziness; Shaking; Weakness; Heart racing; Scratchy throat; Sweating; Bone hurting; Elbow hurts; Ankle hurts; Jittery stomach; Chin hurts; A spontaneous report was received from a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident, feeling weird, the left side of her face was tingly and numb.   The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 27 Dec 2020 at 9pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On the morning of 28 Dec 2020, the patient experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, and chin hurts. Treatment included paracetamol, which she stated did not work, but ibuprofen reduced some of the pain.  On 29 Dec 2020, she still experienced dizziness, shaking, feeling hot and weakness. She said the experience is an out of body experience, like she got into an accident, she felt worse than she felt when she had COVID 19. On 01 Jan 2021, the patient reported dizziness, feeling weird and stated that the left side of her face was tingly and numb. No additional treatment information was reported.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, delusions, hair hurting, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident and feeling weird, were unknown.  The outcome of the event, dizziness, was ongoing.  The outcome of events, the left side of her face was tingly and numb, were resolved on 01 Jan 2021.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Fatigue, vomiting and headache are consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Discomfort, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Feel weird; Face feels tingly; Face feels numb; Feeling hot; Out of body experience, like she got into an accident; Out of body experience, like she got into an accident; Fatigue; Vomiting; Headache; Delusions; Hair hurting; Dizziness; Shaking; Weakness; Heart racing; Scratchy throat; Sweating; Bone hurting; Elbow hurts; Ankle hurts; Jittery stomach; Chin hurts; A spontaneous report was received from a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident, feeling weird, the left side of her face was tingly and numb.   The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 27 Dec 2020 at 9pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On the morning of 28 Dec 2020, the patient experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, and chin hurts. Treatment included paracetamol, which she stated did not work, but ibuprofen reduced some of the pain.  On 29 Dec 2020, she still experienced dizziness, shaking, feeling hot and weakness. She said the experience is an out of body experience, like she got into an accident, she felt worse than she felt when she had COVID 19. On 01 Jan 2021, the patient reported dizziness, feeling weird and stated that the left side of her face was tingly and numb. No additional treatment information was reported.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, delusions, hair hurting, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident and feeling weird, were unknown.  The outcome of the event, dizziness, was ongoing.  The outcome of events, the left side of her face was tingly and numb, were resolved on 01 Jan 2021.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Fatigue, vomiting and headache are consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis, Hypoaesthesia, Pain
Clinical narrative: Feel weird; Face feels tingly; Face feels numb; Feeling hot; Out of body experience, like she got into an accident; Out of body experience, like she got into an accident; Fatigue; Vomiting; Headache; Delusions; Hair hurting; Dizziness; Shaking; Weakness; Heart racing; Scratchy throat; Sweating; Bone hurting; Elbow hurts; Ankle hurts; Jittery stomach; Chin hurts; A spontaneous report was received from a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident, feeling weird, the left side of her face was tingly and numb.   The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 27 Dec 2020 at 9pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On the morning of 28 Dec 2020, the patient experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, and chin hurts. Treatment included paracetamol, which she stated did not work, but ibuprofen reduced some of the pain.  On 29 Dec 2020, she still experienced dizziness, shaking, feeling hot and weakness. She said the experience is an out of body experience, like she got into an accident, she felt worse than she felt when she had COVID 19. On 01 Jan 2021, the patient reported dizziness, feeling weird and stated that the left side of her face was tingly and numb. No additional treatment information was reported.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, delusions, hair hurting, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident and feeling weird, were unknown.  The outcome of the event, dizziness, was ongoing.  The outcome of events, the left side of her face was tingly and numb, were resolved on 01 Jan 2021.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Fatigue, vomiting and headache are consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Palpitations, Paraesthesia, Throat irritation, Tremor
Clinical narrative: Feel weird; Face feels tingly; Face feels numb; Feeling hot; Out of body experience, like she got into an accident; Out of body experience, like she got into an accident; Fatigue; Vomiting; Headache; Delusions; Hair hurting; Dizziness; Shaking; Weakness; Heart racing; Scratchy throat; Sweating; Bone hurting; Elbow hurts; Ankle hurts; Jittery stomach; Chin hurts; A spontaneous report was received from a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident, feeling weird, the left side of her face was tingly and numb.   The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 27 Dec 2020 at 9pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On the morning of 28 Dec 2020, the patient experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, and chin hurts. Treatment included paracetamol, which she stated did not work, but ibuprofen reduced some of the pain.  On 29 Dec 2020, she still experienced dizziness, shaking, feeling hot and weakness. She said the experience is an out of body experience, like she got into an accident, she felt worse than she felt when she had COVID 19. On 01 Jan 2021, the patient reported dizziness, feeling weird and stated that the left side of her face was tingly and numb. No additional treatment information was reported.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, delusions, hair hurting, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident and feeling weird, were unknown.  The outcome of the event, dizziness, was ongoing.  The outcome of events, the left side of her face was tingly and numb, were resolved on 01 Jan 2021.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Fatigue, vomiting and headache are consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feel weird; Face feels tingly; Face feels numb; Feeling hot; Out of body experience, like she got into an accident; Out of body experience, like she got into an accident; Fatigue; Vomiting; Headache; Delusions; Hair hurting; Dizziness; Shaking; Weakness; Heart racing; Scratchy throat; Sweating; Bone hurting; Elbow hurts; Ankle hurts; Jittery stomach; Chin hurts; A spontaneous report was received from a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident, feeling weird, the left side of her face was tingly and numb.   The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 27 Dec 2020 at 9pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On the morning of 28 Dec 2020, the patient experienced delusions, hair hurting, dizziness, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, and chin hurts. Treatment included paracetamol, which she stated did not work, but ibuprofen reduced some of the pain.  On 29 Dec 2020, she still experienced dizziness, shaking, feeling hot and weakness. She said the experience is an out of body experience, like she got into an accident, she felt worse than she felt when she had COVID 19. On 01 Jan 2021, the patient reported dizziness, feeling weird and stated that the left side of her face was tingly and numb. No additional treatment information was reported.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, delusions, hair hurting, headache, shaking, weakness, heart racing, scratchy throat, vomiting, sweating, bone hurting, fatigue, elbow hurts, ankle hurts, jittery stomach, chin hurts, out of body experience and like she got into an accident and feeling weird, were unknown.  The outcome of the event, dizziness, was ongoing.  The outcome of events, the left side of her face was tingly and numb, were resolved on 01 Jan 2021.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Fatigue, vomiting and headache are consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; A spontaneous report was received from a consumer, concerning a patient of unspecified age, who received Moderna's COVID-19 vaccine and tested positive for COVID-19.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 23-DEC-2020, prior to the onset of event, the patient received dose of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 28-Dec-2020, after getting dose of mRNA-1273 vaccine, the patient was tested positive for COVID-19 . No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, COVID-19 was not reported.  Follow-up received on 16 Mar 2021 included no new information.; Reporter's Comments: Based on the mechanism of action of mRNA-1273, the event of COVID-19 is assessed as unlikely related to mRNA-1273. Very limited information regarding the symptoms has been provided at this time. Further information has been requested.