chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Nasal congestion, Pyrexia, Vomiting
Clinical narrative: Horrendous reaction; Left arm injection site tingling; Felt tired; Back pain; Ran a fever; Congested; Left arm injection site still feels hot to touch; had vomiting; lingering shortness of breath; A spontaneous report was received from a consumer 71-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced horrendous reaction, left arm injection site tingling, felt tired, back pain, ran a fever, vomiting, congested, left arm injection site still feels hot to touch and lingering shortness of breath.  The patient's medical history included Covid-19 approximately two weeks prior to receiving the injection.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 23-Dec-2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient reported that she had a horrendous reaction after receiving the Moderna vaccine (mRNA-1273) on 23-Dec-2020.  She stated that on that day, her left arm tingled and she felt tired.  During the night, she stated that she had back pain, ran a fever, vomited and was congested.  The patient said that although she experienced these symptoms for 3 days, she did notice some improvement over the course of the 3 days.  As of 28-Dec-2020, she reported that her left shoulder, the injection site, still felt hot to the touch and that she still had some lingering shortness of breath.    Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, horrendous reaction, left arm injection site tingling, felt tired, back pain, ran a fever, vomiting, congested, left arm injection site still feels hot to touch and lingering shortness of breath, was not provided.  The outcome of the events, horrendous reaction, left arm injection site tingling, felt tired, back pain, ran a fever, vomiting, congested was reported as recovering and for left arm injection site still feels hot to touch and lingering shortness of breath was reported as not recovered.; Reporter's Comments: This case concerns a 71-year-old female patient with medical history of recent COVID-19, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of fatigue, fever, and vomiting, and the non-serious unlisted events of horrendous reaction, left arm injection site tingling, back pain, nasal congestion, injection site warmth, and lingering shortness of breath.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing
Clinical narrative: Face red, hot; face flush; A report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced face hot an face flush.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient reported that her face was red, flushed and hot. She denied fever. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, face hot an face flush, were unknown.   The reporter did not provide an assessment for the events, face hot an face flush.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history was not provided. The patient experienced NS, unexpected event of face erythema and flushing. The events occurred the day the first dose of mRNA-1273 was administered. She denied fever. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain in injection site; A spontaneous report was received from a consumer, concerning a 22 year-old female patient, who received Moderna's COVID-19 vaccine and experienced pain in injection site.  There were no medical history and concomitant medications provided.  On 28-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28-Dec-2020 the patient developed pain in the injection site. It was confirmed that she was not pregnant and did not have any other side effects.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, experienced pain in injection site was unknown.; Reporter's Comments: This case concerns a 22-year old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown) and experienced an expected non-serious event of Injection site pain. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Abnormally heavy menstrual flow; A spontaneous report was received from a consumer, concerning a female Hispanic patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced abnormally heavy menstrual flow.   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 their first of two planned doses of mRNA-1273 (lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.   The consumer reported that her colleague had experienced an abnormally heavy menstrual flow after receiving the vaccine. Reporter also stated that she wonders if the vaccine affects certain demographics differently. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, abnormally heavy menstrual flow was considered unknown.; Reporter's Comments: This case concerns a Hispanic, female patient, who experienced a non-serious unexpected event of Menorrhagia. The event occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment details was no provided. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A spontaneous report (United States) was received from a 74-year old, female nurse, who was also a patient, who received Moderna's COVID-19 vaccine and experienced a little soreness in her left arm.   The patient's medical history was not provided by the reporter. Products known to have been used by the patient, within two weeks prior to the event, included pregabalin.   On 28 DEC 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 309K209) intramuscularly in the Left Arm for prophylaxis of COVID-19 infection.   On 28 DEC 2020, the patient stated that she had a little soreness in her left arm that began approximately five hours after receiving the vaccine. She had no other reported symptoms, and stated that her and her husband are both doing well and pleasantly surprised. The patient confirmed with her orthopedic surgeon that she would be receiving a cortisone injection in her knee on 29 DEC 2020.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event a little soreness in her left arm was not reported.   The reporter did not provide an assessment for the event a little soreness in her left arm.; Reporter's Comments: This case concerns a 74-year old, female nurse. The patient's medical history was not provided. The patient experienced the NS expected event of pain in arm. The event occurred the day the first dose of mRNA-1273 (Lot number: 309K209) was administered. 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: Pain in extremity
Clinical narrative: Arm really really hurt; A spontaneous report was received from a consumer which refers to a 56-year-old female patient who received the Moderna COVID-19 vaccine and experienced arm pain at the injection site which resulted in worsening arm pain during the day.   The patient's medical history was not provided. Concomitant medications were not reported.   On 28 Dec 2020, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: not provided). Sometime later, on the same day, in the morning 7.30 a.m. the patient experienced pain at the injection site, and pain in the injection arm which progressed during the day. The patient reported that her arm really, really hurt for which the patient took 4 advil and iced at the injection site, but the pain still remained and got worse during the day.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, arm really, really hurt, was not recovered.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the events cannot be excluded
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: felt some soreness after 15 minutes/pain is really unbearable, that her arm is very sore; bump at injection site; A spontaneous report was received from a 50-year old, female patient, who received Moderna's COVID-19 vaccine and experienced bump at injection site and felt some soreness after 15 minutes/pain is really unbearable, that her arm is very sore.   The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 27 DEC 2020 at 11:30, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 27 DEC 2020, the patient received a COVID-19 injection in her right shoulder. She felt some soreness after 15 minutes, but was not uncomfortable. On 28 DEC 2020, the patient reported that the pain was really unbearable and that her arm was really sore. There was no redness or swelling at the time, but she said there was a bump at the injection site. Treatment for the events included paracetamol wiping the injection site with alcohol, and rinsing it with hot water.   Action taken with mRNA-1273 in response to the events was not reported.   The events bump at injection site and felt some soreness after 15 minutes/pain is really unbearable, that her harm is very sore were considered not resolved.   The reporter did not provide an assessment for the events bump at injection site and felt some soreness after 15 minutes/pain is really unbearable, that her arm is very sore.; Reporter's Comments: This case concerns 50-year old, female patient, who experienced non-serious , expected event of pain and arm and non-serious unexpected event of injection site mass 15 minutes after the first dose of mRNA-1273 vaccine.. The event was assessed as possibly related due to temporal association.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: Soreness at the injection site; Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (wine twice a night) in August 2020 and Pregnancy (Live, full-term birth No complications) in August 2019. Concurrent medical conditions included Food allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) from 24-Nov-2020 to an unknown date for an unknown indication.    On 29-Dec-2020 at 9:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Aug-2020 and the estimated date of delivery was 18-May-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 29-Dec-2020, EXPOSURE DURING PREGNANCY (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.   Treatment medication use was not provided by the reporter. Patient have already done all the screening, first trimester and second trimester screening for my baby, so far everything is looking good.  Company Comment: This is a case of product exposure during pregnancy and Injection site pain. 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. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2020: No specific follow-up information recorded. On 29-Dec-2020: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy and Injection site pain. 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. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Pain at injection site; Numbness in right hand and left feet and right deltoid; Tingling in right and left hand; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at injection site, numbness and tingling in her right and left hand, numbness in the right deltoid and numbness in her right and left feet.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown, Exp. unknown). On the same day, the patient experienced pain at injection site, numbness and tingling in her right and left hand, numbness in the right deltoid and numbness in her right and left feet. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, pain at injection site, numbness and tingling in her right and left hand, numbness in the right deltoid and numbness in her right and left feet was considered as Not recovered/ Not resolved.  The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 24-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Jul-2020 and the estimated date of delivery was 30-May-2021. On 24-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 24-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) 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.   No Concomitant medications were provided. No treatment information provided.  This is a case of product exposure during pregnancy with no associated AEs for this 35-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 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red, warm to touch, and itchy only on the injection site; Red, warm to touch, and itchy only on the injection site; Golf ball size swelling; Red, warm to touch, and itchy only on the injection site; Pain and bruising on the injection site; Pain and bruising on the injection site; A spontaneous report was received from a nurse who was also a 32-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain and bruising on the injection site, golf ball sized swelling, red, warm to touch, and itchy only on the injection site.  The patient's medical history was not provided. Concomitant product use was not provided.  On 22 Dec 2020, the day of the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011I20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the patient experienced pain and bruising on the injection site.  On 29 Dec 2020, the patient experienced newreactions at the injection site that included golf ball sized swelling, redness, warmth, and itchiness. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, pain and bruising on the injection site, were considered resolved on 23 Dec 2020.  The events, golf ball sized swelling, red, warm to touch, and itchy only on the injection site, were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Red, warm to touch, and itchy only on the injection site; Red, warm to touch, and itchy only on the injection site; Golf ball size swelling; Red, warm to touch, and itchy only on the injection site; Pain and bruising on the injection site; Pain and bruising on the injection site; A spontaneous report was received from a nurse who was also a 32-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain and bruising on the injection site, golf ball sized swelling, red, warm to touch, and itchy only on the injection site.  The patient's medical history was not provided. Concomitant product use was not provided.  On 22 Dec 2020, the day of the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011I20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the patient experienced pain and bruising on the injection site.  On 29 Dec 2020, the patient experienced newreactions at the injection site that included golf ball sized swelling, redness, warmth, and itchiness. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, pain and bruising on the injection site, were considered resolved on 23 Dec 2020.  The events, golf ball sized swelling, red, warm to touch, and itchy only on the injection site, were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Feel like I have the flu; Dry heaving; Fever of 101.3; Lots of joint pain; Headache; Fatigue; Nausea; Chills; A spontaneous report was received from a 53-year-old, female consumer who received Moderna's COVID-19 vaccine and developed headache, fatigue, joint pain, flu-like feeling, nausea, dry heaving, chills, and fever of 101.3.  The patient's medical history, as provided by the reporter, included COVID-19 infection. No relevant concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.     On 28 Dec 2020, the patient developed headache, fatigue, joint pain, flu-like feeling, nausea, dry heaving, chills, and fever of 101.3. Treatment for the events included Tylenol on 28 Dec 2020.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events developed headache, fatigue, joint pain, flu-like feeling, nausea, dry heaving, chills, and fever of 101.3 were considered not recovered.; Reporter's Comments: This case concerns a 53-year-old, female consumer with medical history of COVID-19 infection, who experienced NS, expected event of headache, fatigue, chills, pyrexia, arthralgia, nausea and unexpected events of influenza-like symptoms and retching. The events occurred the day the first dose of mRNA-1273 (Lot number: 011J20A) was administered. Treatment for the events included Tylenol.  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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pyrexia, Retching
Clinical narrative: Feel like I have the flu; Dry heaving; Fever of 101.3; Lots of joint pain; Headache; Fatigue; Nausea; Chills; A spontaneous report was received from a 53-year-old, female consumer who received Moderna's COVID-19 vaccine and developed headache, fatigue, joint pain, flu-like feeling, nausea, dry heaving, chills, and fever of 101.3.  The patient's medical history, as provided by the reporter, included COVID-19 infection. No relevant concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.     On 28 Dec 2020, the patient developed headache, fatigue, joint pain, flu-like feeling, nausea, dry heaving, chills, and fever of 101.3. Treatment for the events included Tylenol on 28 Dec 2020.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events developed headache, fatigue, joint pain, flu-like feeling, nausea, dry heaving, chills, and fever of 101.3 were considered not recovered.; Reporter's Comments: This case concerns a 53-year-old, female consumer with medical history of COVID-19 infection, who experienced NS, expected event of headache, fatigue, chills, pyrexia, arthralgia, nausea and unexpected events of influenza-like symptoms and retching. The events occurred the day the first dose of mRNA-1273 (Lot number: 011J20A) was administered. Treatment for the events included Tylenol.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Herpes outbreak; A spontaneous report was received from a nurse concerning herself, a 50-year old, female patient who received Moderna's COVID-19 vaccine and experienced herpes outbreak.   The patient's medical history included herpes. Concomitant medications reported included gabapentin, ibuprofen, and celecoxib.   On 28 Dec 2020 at 2:00 pm, approximately several hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (LOT# 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Dec 2020, in the middle of the night, the patient reported starting to feel like she was going to have a herpes outbreak. On 29 Dec 2020, the next morning, she was sure she was starting to have an outbreak. The patient reported having an outbreak after receiving the flu vaccine and wanted to know if she could take Zorivax antiviral in response to the event. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event herpes outbreak was unknown.; Reporter's Comments: This case concerns a 50-year old female nurse who experienced a nonserious event of herpes outbreak. The event occurred one day after she received the first of two planned doses of mRNA01273 (Lot # 025L20A). The patient's past medical history includes herpes. The concomitant medications included gabapentin, ibuprofen, and celecoxib. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded. Additional information is required for further assessment.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: lost of taste; FATIGUE; MUSCLE ACHES; NAUSEA; A spontaneous report was received from a consumer on 29 Dec 2020. This case concerns a 51 year old female patient. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced lost of taste, fatigue, muscle aches, and nausea with the use of mRNA-1273.    Medical history included Celiac Sprue, reflux, asthma, extensive drug and environmental allergies. Concomitant medications included lansoprazole, fexofenadine hydrochloride, levomilnacipran hydrochloride, liothyronine sodium, and docusate sodium.  On 23 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient experienced the non-serious events of lost of taste, fatigue, muscle aches, and nausea. It was noted the patient works in a nursing home and had three negative tests performed. It was not confirmed what laboratory tests were performed. There was no treatment information provided.   There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the events of lost of taste, fatigue, muscle aches, and nausea was not reported.   The outcome for the reported events of lost of taste, fatigue, muscle aches, and nausea was unknown at the time of this report.  Causality was not provided for the event of lost of taste, fatigue, muscle aches, and nausea.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sore; A spontaneous report was received from a consumer concerning, a male patient who received Moderna's COVID-19 vaccine and experienced being sore.  The patient's medical history included Chronic lymphocytic leukemia (CLL). Concomitant medication used by the patient within two weeks prior to the event included intravenous immune globulin (IVIG).     On 28-Dec-2020, the patient received their first of two planned doses of mRNA-1273, intramuscularly in the left arm for prophylaxis of COVID-19 infection. Following his first vaccine dose, patient stated no symptoms, just sore. Treatment information was not provided. There was no change planned to the dosing schedule of mRNA-1273 in response to the event, sore.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, sore was not reported.   The reporter assessed the event sore as related to study drug.; Reporter's Comments: This case concerns a male patient of unknown age, who experienced a non-serious unexpected event of Pain after receiving the first dose of mRNA-1273, lot # unknown. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reactions; A spontaneous report was received from pharmacist concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced allergic reactions.   The patient's medical history included two reported allergic reactions. Concomitant product use was unknown by the reporter.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: A25L20A) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced allergic reactions. Treatment information was unknown.   Action taken with mRNA-1273 in response to the event was unknown.   The event outcome for the event allergic reactions was unknown.   The reporter did not provide an assessment for the event allergic reactions.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time, however a causal relationship cannot be excluded.  Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Blood clot left inner arm
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Pt entered the vaccination area to receive her single dose of the Janssen vaccine today 8/9/21. Post vaccination, pt disclosed that she had received two doses of the Moderna CV19 vaccine, dose #1 on 2/19/21, dose #2 on 4/1/21.  Pt was educated on the unknown effects of mixing both the Moderna EUA approved vaccine with the Janssen EUA approved vaccine. Pt reported that she was feeling fine. No immediate reaction occurred within the 15 minute observation period post vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Hypotension, Insomnia, Nausea
Clinical narrative: 11pm that evening I woke up with nausea, fever and aches all over. I took Tylenol and fever did not go down. Didn't sleep well that night and next day very nauseas, with fever of over 101 and could not keep Tylenol down due to nausea. Slept all day on 2/4/21 and woke up around 6pm feeling a little better. Still with fever, took Tylenol and fluid. Fever finally broke late that evening. Felt exhausted next two days due to dehydration. Blood pressure low due to dehydration for next two days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: 11pm that evening I woke up with nausea, fever and aches all over. I took Tylenol and fever did not go down. Didn't sleep well that night and next day very nauseas, with fever of over 101 and could not keep Tylenol down due to nausea. Slept all day on 2/4/21 and woke up around 6pm feeling a little better. Still with fever, took Tylenol and fluid. Fever finally broke late that evening. Felt exhausted next two days due to dehydration. Blood pressure low due to dehydration for next two days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: While giving the injection it was noticed that the needle was not tightened onto the syringe enough which resulted in some of the vaccine leaking out and the patient not receiving the full dose.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: The client reported she developed itching and "red and white blotches" on her arms and legs bilaterally about 24 hours later. The client states the "blotches" were palpable on her skin. The client denied any symptoms on her torso. The client denied using any new skin products prior to noticing the symptoms. The client stated her symptoms lasted about 5 days. The client denied any dizziness or shortness of breath. The client did not seek treatment for the her symptoms at the time, did not follow up with a PCP. The client did not take any medications or use any topical cream for her symptoms. The client denies any chronic conditions. No current medications. No known allergies.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood test normal, Confusional state, Dizziness, Echocardiogram
Clinical narrative: 3 days after event patient had migraine, muscle ache, nausea, lethargy.   On July 9th, client had seizure, with no history of seizure.  Since July 9th patient suffers from migraines, headaches,  ringing in ears, nausea, light headed, confusion, short term memory loss which has persisted for over a month.  Patient is seeing neurologist and cardiologist, primary care, urgent care.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Electroencephalogram, Headache, Lethargy, Magnetic resonance imaging normal
Clinical narrative: 3 days after event patient had migraine, muscle ache, nausea, lethargy.   On July 9th, client had seizure, with no history of seizure.  Since July 9th patient suffers from migraines, headaches,  ringing in ears, nausea, light headed, confusion, short term memory loss which has persisted for over a month.  Patient is seeing neurologist and cardiologist, primary care, urgent care.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Nausea, Seizure, Tinnitus
Clinical narrative: 3 days after event patient had migraine, muscle ache, nausea, lethargy.   On July 9th, client had seizure, with no history of seizure.  Since July 9th patient suffers from migraines, headaches,  ringing in ears, nausea, light headed, confusion, short term memory loss which has persisted for over a month.  Patient is seeing neurologist and cardiologist, primary care, urgent care.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Currently Pregnant with estimated due date April 11th; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of PREGNANCY (Currently Pregnant) and MATERNAL EXPOSURE DURING PREGNANCY (Currently Pregnant with estimated due date April 11th) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]) for Gastroesophageal reflux.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Apr-2021. On 29-Dec-2020, the patient experienced PREGNANCY (Currently Pregnant) and MATERNAL EXPOSURE DURING PREGNANCY (Currently Pregnant with estimated due date April 11th). On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Currently Pregnant with estimated due date April 11th) had resolved. At the time of the report, PREGNANCY (Currently Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: patient fainted in chair. sweated profusely. then came back to consciousness.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: The pt. was seen for Pfizer vaccine second dose. Patient was screen for any adverse reaction from the first vaccine. Patient only stated soreness to vaccine site.  Patient was given the second dose to the right deltoid at 08:31 am.  At 8:43 am patient stated she felt mild dizziness and denied any other issues. Notified nurse and assess the patient.  At 8:48 am, the patient was moved to room for monitoring.  She was able to walk to the exam bed. She was placed in supine position and was awake, alert and verbalizing.  At 8:50 am, V/S were done noted as BP 116/77, P 57, O2SAT at 99% and patient verbalized decrease in dizziness. Patient verbalized not eating breakfast and only slept 4.5 hours last night.  At 8:58 am V/S retaken BP 116/77, P. 56, O2Sat 99%. Patient verbalized no more dizziness. Water was provided to pt. Continued to monitor pt. At 09:13 am, V/S taken BP 116/77, P 55, O2Sat 98%. Pt. was set back up slowly in chair. Denied having dizziness. Pt was in sitting position for a few minutes, then standing up without discomfort. At 09:15 am, Pt ambulated in steady gait & left the clinic in stable condition without distress noted, accompanied by his husband.
Age: 65.0
Sex: F
Vaccine: EBZR
Symptoms: Herpes zoster
Clinical narrative: Contracted shingles
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram normal, Confusional state, Electroencephalogram normal
Clinical narrative: I experienced my memory was foggy and I couldn't remember things that were discussed. It started to come to a head on 02/12/2021 while working from home and I was struggling to get my work done (became upset because it didn't happen to me prior to the vaccine and had to repeat things often...took me 50 minutes to remember). I simply could not retain anything memory wise. I went to work on Monday and needed to use my wife's car but could not process the information in my memory. My wife became concerned and told me that I have to make an appointment to go see the doctor but I couldn't remember to do so.  I ended up going to the ER on Monday, 02/15/2021 and the doctors prescribed antibiotics for a possible Urinary infection and I started to forget things such as my anniversary along with other normal activities that I could not remember. On Wednesday, 02/17/2020 and my doctor stated that I was still very confused and ordered some blood work and a series of tests. Then on 02/19/2020, I ended up having to go back to the ER because things became even worst. I was admitted and stayed there until Wednesday, 02/24/2020. They ran several series of tests and they all came back normal.  The doctor classified my symptoms as a stroke and then upon arriving home the memory fog continued even though it was not as bad as when I was in the hospital. I ended up going to the Neurologist and he stated the it was unknown why my symptoms were continuing. The Psychologists did not see any reason why I was continuing to have the same symptoms as well. I was prescribed a Statin and baby aspirin. I was on Cholesterol medication but they quickly took me off of it because I didn't need the medication.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Impaired work ability, Loss of personal independence in daily activities, Lumbar puncture normal, Magnetic resonance imaging normal
Clinical narrative: I experienced my memory was foggy and I couldn't remember things that were discussed. It started to come to a head on 02/12/2021 while working from home and I was struggling to get my work done (became upset because it didn't happen to me prior to the vaccine and had to repeat things often...took me 50 minutes to remember). I simply could not retain anything memory wise. I went to work on Monday and needed to use my wife's car but could not process the information in my memory. My wife became concerned and told me that I have to make an appointment to go see the doctor but I couldn't remember to do so.  I ended up going to the ER on Monday, 02/15/2021 and the doctors prescribed antibiotics for a possible Urinary infection and I started to forget things such as my anniversary along with other normal activities that I could not remember. On Wednesday, 02/17/2020 and my doctor stated that I was still very confused and ordered some blood work and a series of tests. Then on 02/19/2020, I ended up having to go back to the ER because things became even worst. I was admitted and stayed there until Wednesday, 02/24/2020. They ran several series of tests and they all came back normal.  The doctor classified my symptoms as a stroke and then upon arriving home the memory fog continued even though it was not as bad as when I was in the hospital. I ended up going to the Neurologist and he stated the it was unknown why my symptoms were continuing. The Psychologists did not see any reason why I was continuing to have the same symptoms as well. I was prescribed a Statin and baby aspirin. I was on Cholesterol medication but they quickly took me off of it because I didn't need the medication.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Urine analysis normal
Clinical narrative: I experienced my memory was foggy and I couldn't remember things that were discussed. It started to come to a head on 02/12/2021 while working from home and I was struggling to get my work done (became upset because it didn't happen to me prior to the vaccine and had to repeat things often...took me 50 minutes to remember). I simply could not retain anything memory wise. I went to work on Monday and needed to use my wife's car but could not process the information in my memory. My wife became concerned and told me that I have to make an appointment to go see the doctor but I couldn't remember to do so.  I ended up going to the ER on Monday, 02/15/2021 and the doctors prescribed antibiotics for a possible Urinary infection and I started to forget things such as my anniversary along with other normal activities that I could not remember. On Wednesday, 02/17/2020 and my doctor stated that I was still very confused and ordered some blood work and a series of tests. Then on 02/19/2020, I ended up having to go back to the ER because things became even worst. I was admitted and stayed there until Wednesday, 02/24/2020. They ran several series of tests and they all came back normal.  The doctor classified my symptoms as a stroke and then upon arriving home the memory fog continued even though it was not as bad as when I was in the hospital. I ended up going to the Neurologist and he stated the it was unknown why my symptoms were continuing. The Psychologists did not see any reason why I was continuing to have the same symptoms as well. I was prescribed a Statin and baby aspirin. I was on Cholesterol medication but they quickly took me off of it because I didn't need the medication.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Injection site inflammation, Injection site pain, Nodule, Pain
Clinical narrative: Patient says that all of left deltoid and left tricep is inflammed and quite painful. Two floating nodules have appeared over the left collarbone. Both nodules are very sore. Range of motion OK. Temperature is 97.2 F. No Dizziness. Recommending ibuprofen and ice to patient. Recommending consulting MD.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient says that all of left deltoid and left tricep is inflammed and quite painful. Two floating nodules have appeared over the left collarbone. Both nodules are very sore. Range of motion OK. Temperature is 97.2 F. No Dizziness. Recommending ibuprofen and ice to patient. Recommending consulting MD.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Dyspnoea exertional, Fall, Headache
Clinical narrative: Patient said he had a terrible headache for 2 days. When he was slp he started waking up gasping for air. Now he is having respiration problems. He was an active person and now he has to stop and catch is breathe after walking down the steps. patient stated that on 8/8/21 he went to the bathroom and blacked out and fell in the tub. He is experiencing dizziness.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Respiratory disorder
Clinical narrative: Patient said he had a terrible headache for 2 days. When he was slp he started waking up gasping for air. Now he is having respiration problems. He was an active person and now he has to stop and catch is breathe after walking down the steps. patient stated that on 8/8/21 he went to the bathroom and blacked out and fell in the tub. He is experiencing dizziness.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Headache, Muscular weakness
Clinical narrative: @1410 Pt was brought in to the observation room via wheelchair. Per report, pt became dizzy and weak post vaccination. Fluids and crackers provided. Pt tol PO intake well even though she has complains of nausea. Elevated feet up with a chair.    @1415 Pt stated that she still feels nauseated but is a bit better. Attempted to stand pt, unable to. Pt automatically sat down halfway standing her up d/t "room is spinning." Transferred pt to a gurney. Placed on supine position. No sob noted. No s/sx of distress noted. Resp even and unlabored.    @1420 Pt is feeling better. Instructed to drink a can of juice and water. Tol well. Dizziness is mild. Nausea slightly. Tolerated PO fluids.    @1430 Orthostatics VS supine 125/72 (89) 84 99% RA 18. VS sitting 134/82 (96) 111 99%RA 18 with slight dizziness. Encourage pt to finish all her PO fluids as tolerated. Pt stated that she was in school earlier today and has been busy with everything. Pt stated that she didn't have a chance of drinking water.    @1440 Finished all her fluids. Pt is feeling better. Pt stated that her dizzy and headache are mild. C/O weakness to legs. Encourage to move around legs and feet to increase circulation. C/O wanting to urinate.    @1445 Transferred to from the gurney. Pt able to stand up straight without any problems. Gait stable and able to transfer by herself. Escorted bu nurse and mother to the bathroom. Pt able to transfer from the wheelchair to commode well. Pt able to go to the bathroom herself. Gait stable. Voided x1.    @1450 Pt is confident on going home. Mother is confident and willing to take her home. PT is feeling better with some mild weakness to legs, very mild dizziness.  Instructed to follow up with Primary Doctor and go to the ED for worsening symptoms. Pt and mother verbalized understanding.  Made Dr aware of the situation and agreed with plan.    @1500 Wheeled patient to outside and to mother's car. Pt tolerated activity well.