chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharitis, Erythema, Eye irritation, Eye pruritus, Eyelids pruritus
Clinical narrative: During the 15 minute observation time post vaccine on January 25, 2021, my eye lids were itchy (this is a typical allergic reaction for me). Reaction reported to Nurse.  On Sunday, January 31, 2021, 4:00 pm, my face became red and blotchy, eyelids slightly inflamed. On Monday, February 1, 2021, 6:00 p.m., eyelids were swollen, area around the eyes were red, irritated and itchy. Hydroxyzine Pamoate 25 mg taken Monday evening would normally alleviate any signs of allergic reaction.  On Tuesday, February 2, 2021, upon waking and throughout the day the area around the eyes were red, irritated, itchy and  eyelids swollen with red blotchy skin on forehead and cheeks. Possible consumption of small amounts of soy lecithin (a known allergen) present in baked goods consumed on February 1 at 12:30 pm.  Normally, I do not have an allergic reaction to small amounts of soy.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Rash macular, Swelling of eyelid
Clinical narrative: During the 15 minute observation time post vaccine on January 25, 2021, my eye lids were itchy (this is a typical allergic reaction for me). Reaction reported to Nurse.  On Sunday, January 31, 2021, 4:00 pm, my face became red and blotchy, eyelids slightly inflamed. On Monday, February 1, 2021, 6:00 p.m., eyelids were swollen, area around the eyes were red, irritated and itchy. Hydroxyzine Pamoate 25 mg taken Monday evening would normally alleviate any signs of allergic reaction.  On Tuesday, February 2, 2021, upon waking and throughout the day the area around the eyes were red, irritated, itchy and  eyelids swollen with red blotchy skin on forehead and cheeks. Possible consumption of small amounts of soy lecithin (a known allergen) present in baked goods consumed on February 1 at 12:30 pm.  Normally, I do not have an allergic reaction to small amounts of soy.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: I exp muscle aches, joint pains, headaches, nausea, and chills.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Blood pressure measurement
Clinical narrative: Bells Palsy after 2nd dose given on Jan 27th. Onset that Friday night with full effects of BP that Saturday
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Nervous system disorder
Clinical narrative: Bells Palsy after 2nd dose given on Jan 27th. Onset that Friday night with full effects of BP that Saturday
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Discovered on second shot that patient receiving Moderna which is not approved for patients under 18 YO.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Oropharyngeal pain
Clinical narrative: Injection site became red and raised and swollen- patient describes as 2x2 oval area. Patient also noted body aches, headache, chills, rash across chest and upper back, sore throat and swollen glands in throat. Symptoms started within 6 hours of injection and came and went over the course of the next 5 days. Patient took acetaminophen and ibuprofen and noted relief. As of today- 02/02/2021, the only remaining symptoms are the injection site redness and swollen gland in her neck. Patient instructed to follow-up with her primary care physician for further evaluation.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal swelling, Rash
Clinical narrative: Injection site became red and raised and swollen- patient describes as 2x2 oval area. Patient also noted body aches, headache, chills, rash across chest and upper back, sore throat and swollen glands in throat. Symptoms started within 6 hours of injection and came and went over the course of the next 5 days. Patient took acetaminophen and ibuprofen and noted relief. As of today- 02/02/2021, the only remaining symptoms are the injection site redness and swollen gland in her neck. Patient instructed to follow-up with her primary care physician for further evaluation.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: A few hours after receiving the vaccine my arm started to become sore. On 01/28/2021 my arm started to become pink and very itchy. The next couple of days it remained very itchy, started light pink and got pinker never got really red color. On Sunday 31st in the morning it looked normal but later in the day it got pink again. Yesterday and today it is fine besides it is itchy. I have not been scratching it.  One day I put some Benadryl cream on it one time.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Visual impairment
Clinical narrative: After lunch today resident had c/o of nausea and poor vision
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Ear pain, Fatigue, Feeling abnormal, Influenza virus test negative
Clinical narrative: Couple days later began to feel fatigued again, ear pain, brain fog, 101.4 temp so was sent from work to  and tested neg for COVID and Flu.  I was advised I had fluid on my ears and was advised I may have and Upper Respriatory infection and was given antibiotics and advised if the symptoms didnt get any better to return but I am still taking the antibiotics to date and still experiencing the no taste and smell, brain fog, fatigued and tired but feeling a whole lot better today.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Middle ear effusion, SARS-CoV-2 test negative
Clinical narrative: Couple days later began to feel fatigued again, ear pain, brain fog, 101.4 temp so was sent from work to  and tested neg for COVID and Flu.  I was advised I had fluid on my ears and was advised I may have and Upper Respriatory infection and was given antibiotics and advised if the symptoms didnt get any better to return but I am still taking the antibiotics to date and still experiencing the no taste and smell, brain fog, fatigued and tired but feeling a whole lot better today.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Exactly one week after the vaccine, I awoke to feel the injection site very itchy and hot.  When I looked, it was swollen around the injection area...previously no irritation at all.  At the same time, I felt like I was catching a head cold:  lots of postnasal drip and some coughing and general tiredness.  Injection site symptoms lasted about 24 hours.  Cold like symptoms lasted 3 days.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: Exactly one week after the vaccine, I awoke to feel the injection site very itchy and hot.  When I looked, it was swollen around the injection area...previously no irritation at all.  At the same time, I felt like I was catching a head cold:  lots of postnasal drip and some coughing and general tiredness.  Injection site symptoms lasted about 24 hours.  Cold like symptoms lasted 3 days.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Other- Patient had ate lunch before vaccine administration and had emesis after 1 minute of receiving the vaccination
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: 1/29/2021 (day of injection): 2 PM, felt dizzy, developed headache which got worse over course of half hour. Took Tylenol, headache went away and didn't return.  1/30/2021 (day after injection): 4 PM, injection arm which had been only slightly tender to touch became so sore I could hardly bear to touch it, shoulder and upper arm became very stiff and painful, moving arm even slightly upward or across body was so painful that I could not continue with this motion. This  got worse as day went on. Tylenol helped some but not much.  1/31/2021 (2 days after injection): Still experiencing above-noted pain and stiffness in arm. Also running low grade fever. Took Tylenol which helped. Fever did not return and arm was much easier to move by end of day. All reaction symptoms gone by 2/1/2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: 1/29/2021 (day of injection): 2 PM, felt dizzy, developed headache which got worse over course of half hour. Took Tylenol, headache went away and didn't return.  1/30/2021 (day after injection): 4 PM, injection arm which had been only slightly tender to touch became so sore I could hardly bear to touch it, shoulder and upper arm became very stiff and painful, moving arm even slightly upward or across body was so painful that I could not continue with this motion. This  got worse as day went on. Tylenol helped some but not much.  1/31/2021 (2 days after injection): Still experiencing above-noted pain and stiffness in arm. Also running low grade fever. Took Tylenol which helped. Fever did not return and arm was much easier to move by end of day. All reaction symptoms gone by 2/1/2021.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: shortness of breath, chest pain
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Night sweats, Pain in extremity
Clinical narrative: I started running a fever of 101 on the day I received the vaccination. I had muscle aches, headache, nausea and arm pain. I have continuing night sweats soaking through my clothes multiple times a night it is now four days past the vaccine. The fever is broken at this time.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I started running a fever of 101 on the day I received the vaccination. I had muscle aches, headache, nausea and arm pain. I have continuing night sweats soaking through my clothes multiple times a night it is now four days past the vaccine. The fever is broken at this time.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site mass, Injection site rash, Injection site warmth, Pruritus
Clinical narrative: Developed a bumpy rash at injection site that spread down arm to back with other spots where skin was sensitive and extremely itchy and with various shades of red.  A lump also developed and lasted one for on day at that time at injection site.  Area warm.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Sensitive skin
Clinical narrative: Developed a bumpy rash at injection site that spread down arm to back with other spots where skin was sensitive and extremely itchy and with various shades of red.  A lump also developed and lasted one for on day at that time at injection site.  Area warm.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site rash, Pruritus
Clinical narrative: On January 18, 2021, I received my first moderna vaccine.   On Tuesday, I noticed a rash starting where I got my shot.  I was a bit black and blue on my after the shot.  The rash actually woke me up in the night because it was itching.  It isn't itching now, but it seems to be getting bigger.    I have contacted the doctor virtually.  Doctor said to keep an eye on the rash.  Took Benadryl to ease itching.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Fatigued and light headed
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: 2 HOURS AFTER INJECTION I EXPERIENCED SORENESS AT THE INJECTION SITE. 13.5 HOURS AFTER INJECTION I WOKE UP WITH A FEVER AND CHILLS. I TOOK ONE TYLENOL WHEN THE FEVER AND CHILLS WOKE ME. THE FEVER AND CHILLS LASTED APPROXIMATELY 3 HOURS. THE SORENESS HAD SPREAD TO MY UPPER BODY BY 4AM, 17.5 HOURS AFTER INJECTION. THE  SORENESS/BODYACHE PERSISTED FOR THE DAY FOLLOWING INJECTION. I DID NOT SEE A DOCTOR AS THE SYMPTOMS RESOLVED THEMSELVES.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood thyroid stimulating hormone, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: Experienced atrial fibrillation- after leaving site. Went to Hospital and without treatment, restored heart rhythm after several hours and was released to follow up with primary doctor
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Experienced atrial fibrillation- after leaving site. Went to Hospital and without treatment, restored heart rhythm after several hours and was released to follow up with primary doctor
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Asthenia, Headache
Clinical narrative: Received vaccine at 4 pm and got instant Headache,  and got funny taste in mouth. Sore arm started at 5 pm. Lost taste and smell and couldn't sense hot or cold. Weak, shaky with severe joint and muscle pain. Middle of night, full nasel congestion began. In the morning  was able to taste cold and mouth does not feel funny any more.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Sensory loss, Tremor
Clinical narrative: Received vaccine at 4 pm and got instant Headache,  and got funny taste in mouth. Sore arm started at 5 pm. Lost taste and smell and couldn't sense hot or cold. Weak, shaky with severe joint and muscle pain. Middle of night, full nasel congestion began. In the morning  was able to taste cold and mouth does not feel funny any more.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Flushing, Hot flush
Clinical narrative: 0825  flushed, nausea , slightly SOB,  O2 sat 96%, RR24 HR 77 BP 137/97.  Pepcid 40mg, Benadryl 50mg 0830 Dizzy, flushed, SOB 0835 Dizzy, not flushed feeling, slightly SOB. O2 sat 95% 0840 Throat  scratchy - slight difficulty to swallow O2 sat 93-94% HR 90 RR 28 0850 Epi pen injection, Throat tight and scratchy, hard to catch breath after coughing 911 called 0900 Ambulance transported to ER 0909 Ambulance arrived to ER still somewhat SOB and scratchy throat and nauseated, Dizziness improved. No stridor or wheezing, no hives or itching, no swelling of tongue or lips or facial swelling Received IV Benadryl, IV Decadron, IV Pepcid and albuterol nebulizer treatment and observed for an extended amount of time.  SOB cleared, throat issue resolved and was discharged with just a slight residual tiny scratchy throat.  He was discharged on Benadryl every 6hours until symptoms are completely resolved and Prednisone for 3 days starting on 1/26 if any residual symptoms are felt.  Also given Albuterol inhaler if develop any recurrent SOB. Released home at 1413 on 1/25. Follow up on 1/27 and he stated he had fully recovered
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Throat irritation, Throat tightness
Clinical narrative: 0825  flushed, nausea , slightly SOB,  O2 sat 96%, RR24 HR 77 BP 137/97.  Pepcid 40mg, Benadryl 50mg 0830 Dizzy, flushed, SOB 0835 Dizzy, not flushed feeling, slightly SOB. O2 sat 95% 0840 Throat  scratchy - slight difficulty to swallow O2 sat 93-94% HR 90 RR 28 0850 Epi pen injection, Throat tight and scratchy, hard to catch breath after coughing 911 called 0900 Ambulance transported to ER 0909 Ambulance arrived to ER still somewhat SOB and scratchy throat and nauseated, Dizziness improved. No stridor or wheezing, no hives or itching, no swelling of tongue or lips or facial swelling Received IV Benadryl, IV Decadron, IV Pepcid and albuterol nebulizer treatment and observed for an extended amount of time.  SOB cleared, throat issue resolved and was discharged with just a slight residual tiny scratchy throat.  He was discharged on Benadryl every 6hours until symptoms are completely resolved and Prednisone for 3 days starting on 1/26 if any residual symptoms are felt.  Also given Albuterol inhaler if develop any recurrent SOB. Released home at 1413 on 1/25. Follow up on 1/27 and he stated he had fully recovered
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash hives primary on feet (toes and heels)
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: I was feeling fine for most of the day. The next day I woke up in sweats and chills but I didn?t think much of it. As I was standing up I notice all of the following-  headaches, body pain, fever, low energy (although this one went away fast). I also felt like puking most of the day. I woke up at 7am and After work I took a nap. I woke up at 7pm feeling a lot better.  I still had some minor headache but it went away with Advil.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I was feeling fine for most of the day. The next day I woke up in sweats and chills but I didn?t think much of it. As I was standing up I notice all of the following-  headaches, body pain, fever, low energy (although this one went away fast). I also felt like puking most of the day. I woke up at 7am and After work I took a nap. I woke up at 7pm feeling a lot better.  I still had some minor headache but it went away with Advil.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site abscess, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 8 days after injection I had a quarter-size welt. 9 days after injection the welt grew to the size of my shoulder muscle. It was red, itchy, and very hot to the touch. It was sore if touched, but did not affect my movement. I managed it with ice and tylenol.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Rash (other than injection site)-Mild; symptoms lasted 1 day
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Skin warm, Tenderness
Clinical narrative: on 2/1/21 patient started have redness and swelling; says the swelling is about 3 inches down the arm. Arm is painful, warm and tender to the touch. Patient continues to take Ibuprofin for pain.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Nausea, Muscle aches, chills slight headache.  Treated with soda and crackers, ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Rash
Clinical narrative: Low grade fever; chills; muscle aches; fatigue; rash
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: My left arm - around the injection site - suddenly became warm, itchy, red, and swollen on the evening of 1/23. I took some ibuprofen but was still unable to sleep that night due to the discomfort. The next morning the swelling and pain was worse - I called and spoke to a nurse. Gave her my symptoms and medical history. She shared my concern about a possible DVT (I previously had a DVT in my right arm in 2008). I then went to the ER to have an ultrasound - Dr did rule out a DVT and stated that it was likely just an adverse reaction to the vaccine. Over the next several days the swelling went down, but a red itchy rash continued for the next 7 days.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: My left arm - around the injection site - suddenly became warm, itchy, red, and swollen on the evening of 1/23. I took some ibuprofen but was still unable to sleep that night due to the discomfort. The next morning the swelling and pain was worse - I called and spoke to a nurse. Gave her my symptoms and medical history. She shared my concern about a possible DVT (I previously had a DVT in my right arm in 2008). I then went to the ER to have an ultrasound - Dr did rule out a DVT and stated that it was likely just an adverse reaction to the vaccine. Over the next several days the swelling went down, but a red itchy rash continued for the next 7 days.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: SEVERE ITCHING, HIVES, SWELLING, REDNESS, SHE WENT TO THE DOCTOR WHO DREW A CIRCLE AROUND THE REACTION AREA TO MONITOR SPREAD, PRESCRIPTION MEDICATION WAS GIVEN FOR REACTION
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash erythematous, Rash macular
Clinical narrative: APPROXIMATELY 35 MINUTES AFTER INJECTION I BEGAN EXPERIENCING PRURITIS ON MY CHEST AND FOREARMS.  WITHIN 3 HRS I HAD RED, SUNBURN-LIKE SPLOTCHY AREAS ON MY CHEST, JOWLS, EARS, NOSE, INNER & OUTER FOREARMS.  THE REDNESS AND ITCHINESS LASTED FOR APPROX 36 HOURS. SELF TREATED WITH BENADRYL WITH ADEQUATE RESULTS.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: patient presented for booster vaccine and visit noted for Pfizer booster. After administration it was noted in vaccine history and vaccine card that the initial dose was Moderna.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever, 102.7 fatigue, nausea, blood (probably myoglobin) in urine Treated with D5 and zofran in primary care office (treatment for any illness where oral intake cannot be maintained or if febrile and unable to maintain calories at home)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Headache, Myalgia
Clinical narrative: I exp muscle aches, joint pain, headaches, fever (101.4) and really bad chills.The headache was bordered on a migraine level.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram abnormal, Condition aggravated, Dyspnoea, Lymphadenopathy
Clinical narrative: Pulmonary embolism; Chest pain; Shortness of breath; Arm swelling; Soreness in her arm; Local reaction in the lymph nodes of the axilla; A spontaneous report was received from a physician concerning a female patient who  received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pulmonary embolism, arm swelling and soreness, shortness of breath, chest pain and a reaction in the lymph nodes of the axilla   The patient's medical history includes pulmonary embolisms. Relevant concomitant medications were not reported.   On an unknown date, approximately five 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.   The patient experienced a pulmonary embolism, arm swelling, arm soreness, a local reaction in the lymph nodes of the axilla, shortness of breath, and chest pain.  CT scan showed small acute embolism.    Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events pulmonary embolism, arm swelling and soreness, shortness of breath, chest pain and a reaction in the lymph nodes of the axilla were not reported.; Reporter's Comments: Company Comment: This spontaneous report concerning a female patient who experienced unexpected serious event of pulmonary embolism and nonserious events of arm swelling and soreness, a reaction in the lymph nodes of the axilla, shortness of breath, and chest pain. The patient developed the events on an approximately 5 days after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Pulmonary embolism was confirmed via CT. There is not enough information to adequately evaluate and assess the event of pulmonary embolism.  Swelling and soreness, a reaction in the lymph nodes of the axilla are temporally associated with the vaccine administration and in the absence of any other etiology, a causal association between these events and the administration of mRNA-1273 vaccine cannot be excluded. main field defaults to possibly related' for all events.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary embolism
Clinical narrative: Pulmonary embolism; Chest pain; Shortness of breath; Arm swelling; Soreness in her arm; Local reaction in the lymph nodes of the axilla; A spontaneous report was received from a physician concerning a female patient who  received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pulmonary embolism, arm swelling and soreness, shortness of breath, chest pain and a reaction in the lymph nodes of the axilla   The patient's medical history includes pulmonary embolisms. Relevant concomitant medications were not reported.   On an unknown date, approximately five 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.   The patient experienced a pulmonary embolism, arm swelling, arm soreness, a local reaction in the lymph nodes of the axilla, shortness of breath, and chest pain.  CT scan showed small acute embolism.    Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events pulmonary embolism, arm swelling and soreness, shortness of breath, chest pain and a reaction in the lymph nodes of the axilla were not reported.; Reporter's Comments: Company Comment: This spontaneous report concerning a female patient who experienced unexpected serious event of pulmonary embolism and nonserious events of arm swelling and soreness, a reaction in the lymph nodes of the axilla, shortness of breath, and chest pain. The patient developed the events on an approximately 5 days after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Pulmonary embolism was confirmed via CT. There is not enough information to adequately evaluate and assess the event of pulmonary embolism.  Swelling and soreness, a reaction in the lymph nodes of the axilla are temporally associated with the vaccine administration and in the absence of any other etiology, a causal association between these events and the administration of mRNA-1273 vaccine cannot be excluded. main field defaults to possibly related' for all events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Musculoskeletal chest pain, Neck pain, Pain, Pneumonia
Clinical narrative: Pneumonia in left lung; Pain in neck; Acute serious pain under her ribs, all the way around her body; A spontaneous report was received from a consumer concerning a 78 year old female who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed acute serious pain under her ribs, all the way around her upper body, pneumonia in her left lung and neck pain.    The patient's medical history was not provided. Concomitant medications included non specified medication for blood pressure, calming down, dementia and thyroid.   On 04 Jan 2021, approximately 2.5 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient developed acute serious pain under her ribs, all the way around her upper body that lasted ten days. The patient also experienced neck pain. On an unknown date, she was treated in the emergency room for pneumonia in her left lung and given antibiotics. She later followed up with her primary care doctor and additional x-rays were taken and she was treated with prednisone.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, acute pain under her ribs, all the way around her upper body, was considered resolved on 14 Jan 2021. The outcome of the event, pain neck was resolved on 19 Jan 2021. The outcome of the event, pneumonia in left lung, was unknown.; Reporter's Comments: Company Comment: This case concerns a 78-year-old female patient who experienced unexpected serious event of pneumonia and non-serious event of acute serious pain under her ribs, all the way around her upper body and neck pain.  The event developed on the same day after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # unknown, expiration date-unknown).  Although a temporal association exist between the event of pneumonia and the administration of the vaccine, in the absence of clinical details including diagnostic test, a definite diagnosis was not established. The events of acute serious pain under her ribs, all the way around her upper body and neck pain are also temporarily associated with vaccine administration and a causal association cannot be excluded. Main field defaults to possibly related' for all events.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Contusion, Dehydration, Dizziness
Clinical narrative: she fell down and blacked out; dehydration; Dizzy; weak; woke up 3 different times to use the bathroom; Broke out in terrible sweat twice; was bruised up; Fever; Really sore arm; flu like symptoms; A spontaneous report was received from a consumer concerning an 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, blacked out, bruised up, broke out in a terrible sweat twice, and dehydration.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 13 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient experienced flu-like symptoms and a really sore arm. The following two days she "was okay".   On 17 Jan 2021, the patient had a fever of 99 degrees F; it was reported that she was already taking acetaminophen. She woke up three times in the middle of the night to use the bathroom, which was unusual for her. The third time she woke up, she could not get off the toilet; she felt dizzy and weak, and thought she was going to pass out. While she was trying to return to the bedroom, she blacked out and fell down. She was bruised up and "broke out in terrible sweat twice". It was reported that she drank water and orange juice to help with dehydration.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, blacked out, bruised up, broke out in a terrible sweat twice, and dehydration were not reported.; Reporter's Comments: Company Comment: This spontaneous report concerns a 82-Year-old, female patient who experienced unexpected serious event of blacked out and non-serious events of flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, bruised up, broke out in a terrible sweat twice and dehydration. The patient developed flu-like symptoms and a really sore arm 1 day after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). The other events developed 4 days after vaccine initiation. No treatment was provided, and the outcome of the events was not reported. There is limited information to assess all events in the absence of the patient's medical history and advanced age.  Based on the information provided which includes a temporal association and in the absence of any other etiology, a causal association between the other reported events and the administration of mRNA-1273 vaccine cannot be excluded. The event of fever is consistent with the safety profile of mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Loss of consciousness, Pain in extremity, Pyrexia
Clinical narrative: she fell down and blacked out; dehydration; Dizzy; weak; woke up 3 different times to use the bathroom; Broke out in terrible sweat twice; was bruised up; Fever; Really sore arm; flu like symptoms; A spontaneous report was received from a consumer concerning an 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, blacked out, bruised up, broke out in a terrible sweat twice, and dehydration.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 13 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient experienced flu-like symptoms and a really sore arm. The following two days she "was okay".   On 17 Jan 2021, the patient had a fever of 99 degrees F; it was reported that she was already taking acetaminophen. She woke up three times in the middle of the night to use the bathroom, which was unusual for her. The third time she woke up, she could not get off the toilet; she felt dizzy and weak, and thought she was going to pass out. While she was trying to return to the bedroom, she blacked out and fell down. She was bruised up and "broke out in terrible sweat twice". It was reported that she drank water and orange juice to help with dehydration.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, blacked out, bruised up, broke out in a terrible sweat twice, and dehydration were not reported.; Reporter's Comments: Company Comment: This spontaneous report concerns a 82-Year-old, female patient who experienced unexpected serious event of blacked out and non-serious events of flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, bruised up, broke out in a terrible sweat twice and dehydration. The patient developed flu-like symptoms and a really sore arm 1 day after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). The other events developed 4 days after vaccine initiation. No treatment was provided, and the outcome of the events was not reported. There is limited information to assess all events in the absence of the patient's medical history and advanced age.  Based on the information provided which includes a temporal association and in the absence of any other etiology, a causal association between the other reported events and the administration of mRNA-1273 vaccine cannot be excluded. The event of fever is consistent with the safety profile of mRNA-1273 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Intensive care, Life support
Clinical narrative: cardiac arrest; This is a spontaneous report from a contactable consumer.  An elderly ( older that 65-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), via an unspecified route of administration on 20Jan2021 as the second single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. He was reported as with unspecified  health issues, and no known allergies.   The patient previously received BNT162B2 for immunization, on an unspecified date. The patient experienced cardiac arrest on 23Jan2021, at 20:30, which was serious as it was life-threatening and involved hospitalization (in the intensive care unit (ICU)).  Details were as follows: after the patient received the  2nd dose of the vaccine on 20Jan2021. The reporter indicated that he was released to go on 23Jan2021. The patient went into cardiac arrest. Therapeutic measures were taken as a result of cardiac arrest. The patient was reported as in the ICU, and critical on life support. There was no note of COVID prior to vaccination.  It was unknown if the patient has had a  COVID tested post vaccination. The outcome of cardiac arrest was not recovered.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Terrible headache for about 16 hours that started about 14 hours post vaccine. Day 3 developed rash and pain at and below injection site with itchiness, has not subsided yet, day 5 post
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Injection site pain
Clinical narrative: Sore arm at site of injection; balance problems (from a couple hours after injection continuing and worsening somewhat morning after.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Syringe issue, Underdose
Clinical narrative: First dose leaked out of needle and injection site, second dose was administered right after.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: About 8 days after the injection administration, I started getting a rash on the injection site. It was about 3 inches in diameter, itchy, and warm to the touch. I still have it today, but it is fading and not as itchy or as warm. Prior to this, the only other symptoms were slight tenderness/pain at the injection site.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Body temperature increased, Headache, Heart rate increased
Clinical narrative: Elevated heart rate, elevated blood pressure, headache, nausea, increased joint pain in right shoulder rotator cuff and joint pain in both Achilles tendon?s, Temperature of 101.5
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Elevated heart rate, elevated blood pressure, headache, nausea, increased joint pain in right shoulder rotator cuff and joint pain in both Achilles tendon?s, Temperature of 101.5
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Facial pain, Hypoaesthesia, Pain in jaw
Clinical narrative: Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Severe.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Paraesthesia, Paraesthesia oral
Clinical narrative: Client was sitting for 30 min after receiving COVID-19 vaccine #1--due to her history of anaphylaxis with Bactrim. After about 20 minutes client states that her face and tongue was becoming tingly. EMS was on-site and began monitoring her. For about 5 minutes, client states that she did not feel worse just "numb/tingly feeling face", client then began to cough and state that she was having difficulty breathing. EMS administered 1 EpiPen injection into her thigh and then transported her to a local hospital.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Erythema, Fatigue, Peripheral swelling, Pruritus
Clinical narrative: Arm is inflamed, red, itchy. Moderate fatigue. Lightheadedness resulting in nearly fainting. Fever of 100-100.4.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Arm is inflamed, red, itchy. Moderate fatigue. Lightheadedness resulting in nearly fainting. Fever of 100-100.4.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Fatigue, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Arm is inflamed, red, itchy. Moderate fatigue. Lightheadedness resulting in nearly fainting. Fever of 100-100.4.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Myalgia, Pain in extremity, Pruritus, Tenderness
Clinical narrative: Arm is inflamed, red, itchy. Moderate fatigue. Lightheadedness resulting in nearly fainting. Fever of 100-100.4.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site oedema
Clinical narrative: Arm is inflamed, red, itchy. Moderate fatigue. Lightheadedness resulting in nearly fainting. Fever of 100-100.4.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Arm is inflamed, red, itchy. Moderate fatigue. Lightheadedness resulting in nearly fainting. Fever of 100-100.4.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tunnel vision
Clinical narrative: Arm is inflamed, red, itchy. Moderate fatigue. Lightheadedness resulting in nearly fainting. Fever of 100-100.4.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Erythema, Fatigue, Peripheral swelling, Pruritus
Clinical narrative: same day arm soreness. Next day diaphoretic, fever to 101F, myalgias. Day 2fever to 100.4, fatigue, erythema increasing from injection site. Day 3 erythema, warmth to 13x14cm left arm, indurated, less myalgia and fever to 100F. Day 4 (2/2/21)seen in clinic and 13x14cm erythema, warmth, induration, mild itch, tender to palp. Treated with clindamycin 450mg TID x 5 days
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: same day arm soreness. Next day diaphoretic, fever to 101F, myalgias. Day 2fever to 100.4, fatigue, erythema increasing from injection site. Day 3 erythema, warmth to 13x14cm left arm, indurated, less myalgia and fever to 100F. Day 4 (2/2/21)seen in clinic and 13x14cm erythema, warmth, induration, mild itch, tender to palp. Treated with clindamycin 450mg TID x 5 days
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Fatigue, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: same day arm soreness. Next day diaphoretic, fever to 101F, myalgias. Day 2fever to 100.4, fatigue, erythema increasing from injection site. Day 3 erythema, warmth to 13x14cm left arm, indurated, less myalgia and fever to 100F. Day 4 (2/2/21)seen in clinic and 13x14cm erythema, warmth, induration, mild itch, tender to palp. Treated with clindamycin 450mg TID x 5 days
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Myalgia, Pain in extremity, Pruritus, Tenderness
Clinical narrative: same day arm soreness. Next day diaphoretic, fever to 101F, myalgias. Day 2fever to 100.4, fatigue, erythema increasing from injection site. Day 3 erythema, warmth to 13x14cm left arm, indurated, less myalgia and fever to 100F. Day 4 (2/2/21)seen in clinic and 13x14cm erythema, warmth, induration, mild itch, tender to palp. Treated with clindamycin 450mg TID x 5 days
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site oedema
Clinical narrative: same day arm soreness. Next day diaphoretic, fever to 101F, myalgias. Day 2fever to 100.4, fatigue, erythema increasing from injection site. Day 3 erythema, warmth to 13x14cm left arm, indurated, less myalgia and fever to 100F. Day 4 (2/2/21)seen in clinic and 13x14cm erythema, warmth, induration, mild itch, tender to palp. Treated with clindamycin 450mg TID x 5 days
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: same day arm soreness. Next day diaphoretic, fever to 101F, myalgias. Day 2fever to 100.4, fatigue, erythema increasing from injection site. Day 3 erythema, warmth to 13x14cm left arm, indurated, less myalgia and fever to 100F. Day 4 (2/2/21)seen in clinic and 13x14cm erythema, warmth, induration, mild itch, tender to palp. Treated with clindamycin 450mg TID x 5 days
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tunnel vision
Clinical narrative: same day arm soreness. Next day diaphoretic, fever to 101F, myalgias. Day 2fever to 100.4, fatigue, erythema increasing from injection site. Day 3 erythema, warmth to 13x14cm left arm, indurated, less myalgia and fever to 100F. Day 4 (2/2/21)seen in clinic and 13x14cm erythema, warmth, induration, mild itch, tender to palp. Treated with clindamycin 450mg TID x 5 days
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Erythema, Fatigue, Peripheral swelling, Pruritus
Clinical narrative: Saturday Jan 30, 2021.  In the morning I became diaphoretic, tunnel vision (but didn't pass out), temp 101 F. body aches,  arm pain and redness, warmth  and edema at the injection site.  Alternate between chills and sweating most of the day.  Body aches and very tired. Sunday Jan 31 , cont chills and sweating, body aches, tired, and Temp 100 F - 100.4 F.  Arm continue with the same as above. Monday Feb 1, Fever resolved in the evening.  Body aches cont tiredness.  Arm had worsening redness, edema, warmth, some pain and itching.    Tuesday Feb, 2 .  Arm cont to worsen.  I went to my physician's office and saw a PA who examined my arm.  Started on antibiotics.  Continue with some body aches and tired.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Saturday Jan 30, 2021.  In the morning I became diaphoretic, tunnel vision (but didn't pass out), temp 101 F. body aches,  arm pain and redness, warmth  and edema at the injection site.  Alternate between chills and sweating most of the day.  Body aches and very tired. Sunday Jan 31 , cont chills and sweating, body aches, tired, and Temp 100 F - 100.4 F.  Arm continue with the same as above. Monday Feb 1, Fever resolved in the evening.  Body aches cont tiredness.  Arm had worsening redness, edema, warmth, some pain and itching.    Tuesday Feb, 2 .  Arm cont to worsen.  I went to my physician's office and saw a PA who examined my arm.  Started on antibiotics.  Continue with some body aches and tired.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Fatigue, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Saturday Jan 30, 2021.  In the morning I became diaphoretic, tunnel vision (but didn't pass out), temp 101 F. body aches,  arm pain and redness, warmth  and edema at the injection site.  Alternate between chills and sweating most of the day.  Body aches and very tired. Sunday Jan 31 , cont chills and sweating, body aches, tired, and Temp 100 F - 100.4 F.  Arm continue with the same as above. Monday Feb 1, Fever resolved in the evening.  Body aches cont tiredness.  Arm had worsening redness, edema, warmth, some pain and itching.    Tuesday Feb, 2 .  Arm cont to worsen.  I went to my physician's office and saw a PA who examined my arm.  Started on antibiotics.  Continue with some body aches and tired.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Myalgia, Pain in extremity, Pruritus, Tenderness
Clinical narrative: Saturday Jan 30, 2021.  In the morning I became diaphoretic, tunnel vision (but didn't pass out), temp 101 F. body aches,  arm pain and redness, warmth  and edema at the injection site.  Alternate between chills and sweating most of the day.  Body aches and very tired. Sunday Jan 31 , cont chills and sweating, body aches, tired, and Temp 100 F - 100.4 F.  Arm continue with the same as above. Monday Feb 1, Fever resolved in the evening.  Body aches cont tiredness.  Arm had worsening redness, edema, warmth, some pain and itching.    Tuesday Feb, 2 .  Arm cont to worsen.  I went to my physician's office and saw a PA who examined my arm.  Started on antibiotics.  Continue with some body aches and tired.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site oedema
Clinical narrative: Saturday Jan 30, 2021.  In the morning I became diaphoretic, tunnel vision (but didn't pass out), temp 101 F. body aches,  arm pain and redness, warmth  and edema at the injection site.  Alternate between chills and sweating most of the day.  Body aches and very tired. Sunday Jan 31 , cont chills and sweating, body aches, tired, and Temp 100 F - 100.4 F.  Arm continue with the same as above. Monday Feb 1, Fever resolved in the evening.  Body aches cont tiredness.  Arm had worsening redness, edema, warmth, some pain and itching.    Tuesday Feb, 2 .  Arm cont to worsen.  I went to my physician's office and saw a PA who examined my arm.  Started on antibiotics.  Continue with some body aches and tired.