chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain in extremity, Peripheral swelling
Clinical narrative: I got the vaccine felt fine arm felt sore that night. I exp redness on left arm appeared to become larger. I contacted my PCP set up a Telehealth was told to come in the office. She wanted to give it few more days for observation and was prescribed a Prednisone dose pack 6 days,EpiPen. The symptoms started to slowly go away.My PCP took blood work (2)was concerned that vaccine might have triggered Hepatitis over 40 years ago.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received a Modena COVID vaccine instead of Prevnar 13. Patient has already received two PFIZER COVID vaccines.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; A spontaneous report was received from a consumer concerning a male patient who experienced a stroke/cerebrovascular accident.  The patient's medical history was not provided. Concomitant medications were not provided.   On an unspecified date, the patient received one of two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient reported that he had a stroke.   Treatment information was not provided.   Action taken with mRNA-1273 was not reported.   The outcome of the event, stroke, was not reported/unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No further information is expected
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 6 days after second injection - full body rash with hives and itch. 2 ED visits. Dermatology consult - treated with Prednisone and Zyrtec. In day 4 patient appears to be improving - steroids and antihistamines prescribed for additional week.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Feeling abnormal
Clinical narrative: Loss of vision, feeling of "feeling weird" Patient refused transport
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Moderna COVID-19 Vaccine EUA Fever - approximately 12 hours post-injection and lasted approximately 5 hours (resolved) Swelling of right side of the face (under eye area) - approximately 20 hours post-injection and still occurring 48 hours post-injection.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Contusion, Full blood count, Haemorrhage, Immune thrombocytopenia
Clinical narrative: Extreme ITP,  platelets <1,000, spontaneous bleeding, bruising, petechiae
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Metabolic function test, Petechiae, Platelet count decreased
Clinical narrative: Extreme ITP,  platelets <1,000, spontaneous bleeding, bruising, petechiae
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient presented to clinic for 2nd dose of COVID vaccine after being unable to receive 1st dose.  Patient advised he had one COVID vaccine  for 1st dose.  After injection by the nurse and entry into -it was discovered that patient had Covid vaccine for 1st dose-not other.  After explanation to patient-he insisted that he still had COVID VACCINE.  Called call center  and they advised nothing else for patient to do-no further vaccination required.  Patient monitored for 30 minutes and no reaction.  Patient called 1 hour post injection and still no reaction.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nodule, Pruritus, Skin warm
Clinical narrative: Started out yesterday, 8 days after the vaccine on 2/25/21 the arm was itchy, then got a real hard knot underneath the skin, which has been warm and hard since that time.   He took an Aleve for that and muscle aches.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: After my first vaccine, I inexperienced myalgia and about ten days later I began to have low back pain.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the second dose of the vaccine 14 days after the first dose; A spontaneous report was received from a pharmacist regarding a male patient of unreported age that received Moderna's COVID-19 vaccine (mRNA-1273)  that received the second dose 14 days after the first/inappropriate schedule of vaccine administered.    The patient's medical history was not included.  Products known to have been used by the patient were not provided.  On 28 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 11 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   The second dose was scheduled and given 14 days after the first dose.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, the second dose being administered 14 days after the first dose, was considered resolved on 11 Feb 2021.   The outcome of the events, the second dose being administered 14 days after the first dose, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported. Patient received second dose 14 days after the first dose.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eustachian tube dysfunction, Hypoaesthesia, Injection site pain, Mobility decreased, Pain
Clinical narrative: Moderna COVID-19 Vaccine EUA 1) Woke up at 2am with great pain in my left arm and my left hand feeling "asleep" and difficult to move.  This sometimes happens when my arm is in an awkward position over my head, but I was sleeping on my back and my arm was straight at my side in a position where I've never before had it lose sensation. 2) I was not able to move my arm without extreme discomfort (i.e. the worst I've ever felt after any shot) from about 5 hours after until about 20 hours after receiving the shot.   3) Diagnosed with Eustachian Tube Dysfunction as a side effect of vaccination (onset 37 hours after vaccination).  Diagnosis by Dr 2/19/2021.  Treated with Loratadine 10mg and Prednisone 40mg for 5 days.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red patch developed on 02/25/2021 at injection site (approx. 2? across) warm to touch and occasional slight itch.   Used cold compress twice to ease down.   On 02/26/2021 -  Red patch increased in size to 3? across and still warm to the touch.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: Within 30 minutes of vaccination, client experiences difficulty swallowing and breathing. Epinephrine was administered and EMS/911 activated. Respiratory symptoms slightly improved with epinephrine, and EMS arrive and transported to ER.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Dizziness, Fatigue, Influenza virus test negative
Clinical narrative: Patient had 1st COVID vaccine on 01-22-21. Had 48 hrs of typical reactogenicity symptoms including low fever, fatigue, dizziness. Felt well for post vaccination days 3-5. Then on post-vaccination day 6, he developed fevers, sore throat. Symptoms persisted x10 days and sore throat pain led to decreased appetite and 10lb weight loss. Due to fever, he was tested for COVID by PCR on 02-01-21 and was positive. He had no anosmia and Respiratory Pathogen Panel on 02-01-21 was negative for influenza and 17 other viral pathogens including negative testing to Coronavirus 229e, OC43, N163, and HKU1.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory viral panel, SARS-CoV-2 test positive, Weight decreased
Clinical narrative: Patient had 1st COVID vaccine on 01-22-21. Had 48 hrs of typical reactogenicity symptoms including low fever, fatigue, dizziness. Felt well for post vaccination days 3-5. Then on post-vaccination day 6, he developed fevers, sore throat. Symptoms persisted x10 days and sore throat pain led to decreased appetite and 10lb weight loss. Due to fever, he was tested for COVID by PCR on 02-01-21 and was positive. He had no anosmia and Respiratory Pathogen Panel on 02-01-21 was negative for influenza and 17 other viral pathogens including negative testing to Coronavirus 229e, OC43, N163, and HKU1.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Vital signs measurement
Clinical narrative: After waiting here 15 minutes she got up to walk back to her apartment. She began to feel a little light headed, dizzy, and and warm. She felt like she needed to sit down immediately. Her temperature and BP were check; both were normal. We gave her some water and cold towel to put on the back of her neck then had her sit down for a while longer till she was feeling better. She said she felt immediately better after the water and after a while a facility staff member came to take her home.  As I talked to her she did tell me that she has a history of passing out so this may have played a part in the event.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Covid Arm - swelling and redness
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Today is Friday, 02/26/2021. I Received 2nd Moderna vaccine on Sunday, 02/21/2021, at 12:15 PM; for the next 96 hours, sore arm, ran fever,  off and on, between 101 and 100, body aches, continued headache, taking Tylenol. 5th day, fever subsided, body aches improved, but headaches continue. I have a compromised lung issue due to recurrent pneumonias in the past, last episode 3 years ago.  However, whenever I get a cold, or sinus infection, my lungs are affected, and I need to check in with my doctor how to prevent the pneumonia. Treatment is usually antibiotics and /or inhaler.  After the flu like symptoms described above, I feel a burning in my lungs that indicate a possible problem. I have put in a call to Dr. office regarding this issue. The severe headaches continue today, the 5th day after Covid Vaccine Moderna #2. I continue taking Tylenol for the headaches.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on both sides of the face
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: SLIGHT RAISED RED AREA AROUND THE INJECTION SITE.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm soreness day 2 day 4 swelling at site, day 5/6 red round patch itchiness still slightly sore
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Angioedema, Bone swelling, Palatal disorder, Skin burning sensation
Clinical narrative: skin is on fire after second dose; swelling in her soft palate after second dose; angioedema after 2nd dose; Ribs were swollen after 2nd dose; tongue was swollen//2nd dose; Covered in hives after 2nd dose; small reaction// 1st dose; A spontaneous report was received from a healthcare facility staff member concerning a 36-year female patient who developed urticaria, angioedema, swollen ribs, swollen tongue, hives that were welts, skin burning and soft palate swelling.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) on 14-JAN-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After the patient's first injection on 14-Jan-2021 the patient developed a small reaction within 45 minutes.  The patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) on 11-FEB-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   After the receiving their second injection on 11-FEB-2021 the patient went to the ER on 12Feb2021. The patient developed angioedema and an epinephrine pen was used.  The patient also had swollen ribs, a swollen tongue and hives and was given a steroid shot. The patient then returned to the ER on 14Feb2021 for angioedema. The patient was given intravenous Diphenhydramine, intravenous dexamethasone and intravenous Famotidine. The patient developed hives that became welts, that were bright red in color and burned. The patient described that their skin felt like it was on fire, and there was swelling in their soft palate.    The outcome of the events were unknown/not reported.; Reporter's Comments: This case concerns a 36 year old, female patient, who experienced a serious unexpected event of Angioedema, and a few non-serious events, after receiving second dose mRNA-1273 (Lot# 006M20A).  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. Further information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: skin is on fire after second dose; swelling in her soft palate after second dose; angioedema after 2nd dose; Ribs were swollen after 2nd dose; tongue was swollen//2nd dose; Covered in hives after 2nd dose; small reaction// 1st dose; A spontaneous report was received from a healthcare facility staff member concerning a 36-year female patient who developed urticaria, angioedema, swollen ribs, swollen tongue, hives that were welts, skin burning and soft palate swelling.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) on 14-JAN-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After the patient's first injection on 14-Jan-2021 the patient developed a small reaction within 45 minutes.  The patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) on 11-FEB-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   After the receiving their second injection on 11-FEB-2021 the patient went to the ER on 12Feb2021. The patient developed angioedema and an epinephrine pen was used.  The patient also had swollen ribs, a swollen tongue and hives and was given a steroid shot. The patient then returned to the ER on 14Feb2021 for angioedema. The patient was given intravenous Diphenhydramine, intravenous dexamethasone and intravenous Famotidine. The patient developed hives that became welts, that were bright red in color and burned. The patient described that their skin felt like it was on fire, and there was swelling in their soft palate.    The outcome of the events were unknown/not reported.; Reporter's Comments: This case concerns a 36 year old, female patient, who experienced a serious unexpected event of Angioedema, and a few non-serious events, after receiving second dose mRNA-1273 (Lot# 006M20A).  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. Further information has been requested.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: I got my first and seconds doses at this site and both times there were massive issues w/ lack of organization such as;  At the registration table, you're handed paperwork but no way to clean your hands after there are multiple people milling around and no organized staff I was taken inside to a small office to be registered for 25 min., the staff hand on 1 layer mask, and 2 other people came into the office while I was there.  you have to pass everyone in the waiting line outside the outside line funnels inside into a narrow hallway (less than 5' across)  this inside hallway is open to 2way foot traffic the whole time.  inside the vaccine room I saw 2 providers not sanitize their hands between people.  cloth chairs were used and not wiped down a man (staff, unable to see the last name on the badge) took off their mask 2x in the vaccine area.  the observation area was understaffed.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: REDNESS AND ITCHING  NO TRETMENT
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Multiple sclerosis relapse
Clinical narrative: Pt reported feeling weak and tired, like he was about to have a MS relapse during refill consult for MS medication.  His second dose of CoVID Moderna was received on 2/25/2021.  Advised common reaction to feel fatigued and weak esp after second dose.  If it were to continue past 5 days consider follow up with neurologist to r/o relapse.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash noted in right armpit day following vaccine, spread down the same side of torso, then appeared in other armpit a few days later. Continued to spread down that second side of torso. Saw partner of my PCP who put me on Doxycycline 100mg BID for 7 days with no change. Saw dermatologist who dx with pityriasis rosea and suggested reporting to VAERS.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Still experiencing Swollen Lymph nodes under arms
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Rash
Clinical narrative: delayed arm rash about 6 inches by 3.    Not itchy 'delayed cutaneous hypersensitivity
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild soreness at the site of the injection beginning about two hours after the injection. Took Tylenol about four hours after the injection.  Soreness went away fairly quickly after taking the Tylenol.  Had only a fairly slight soreness during day two.  No soreness from day three onward.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pelvic pain, Vaginal haemorrhage
Clinical narrative: After my second vaccine, I experienced worsening low back pain and bilateral pelvic pain. I tested positive for pregnancy.  I followed up with my gynecologist due to my vaginal bleeding and worsening low back pain.
Sex: M
Vaccine: COVID19
Symptoms: Gout, Infection, Pain in extremity
Clinical narrative: infection; suspected gout; huge pain at middle finger on right arm; A spontaneous report  received from a consumer who is 33-year-old male patient who received first dose of Moderna COVID-19 vaccine and experienced pain in middle finger of the opposite vaccine arm.   The patient's medical history was not provided. Concomitant product use was not provided.   On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch #: 032L20A) intramuscularly in the left arm or prophylaxis of COVID-19 infection.   Patient stated that he received his 1st dose of the Moderna COVID-19 vaccine on 27 Jan 2021 in his left arm and had no soreness. The next morning, on 28 Jan 2021, he woke up with a huge pain in his middle finger on the right arm.  The doctor gave him antibiotics and suspected it was gout. Patient stated he went to his PCP and he asked him to go to emergency room.  The patient stated that he was given IV and antibiotics. The patient stated that they did a lot of blood work and blood culture (results not provided).  He stated that a 90 min surgery was performed, and he stayed in the hospital for three to four days.  The hospital lost the specimen, so he doesn't know what kind of infection he had.  The patient stated that he doesn't know if he should receive the 2nd dose of the Moderna COVID-19 vaccine or not.  Patient was treated with antibiotics and surgery.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: 24 hrs after vaccine got low grade fever, chills anad myalgias, called off work
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Limb discomfort
Clinical narrative: Patient experienced dizziness after administration. She told me she felt numbness and heaviness in her arms and legs about 10 minutes after the vaccine. I checked her blood pressure two times and both times they were in the 140s/90s. I gave her a bottle of water and monitored her for 30 minutes. She did say the dizziness went away and felt better. She left after 30 minutes feeling well.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Syncope
Clinical narrative: client was administered vaccine by IM inj. LD in a semi fowlers in private room at 06:20pm. Client remained alert and moved to chair in sitting position. client then had an episode of syncope in chair and was held upright. client had reduced consciousness but was able to respond verbally to voice. client was assist of two to a wheel chair and moved back to private room and administered O2 via NRB @ 4lpm.  Client responded well and quickly, was more alert and oriented x3. client given orange juice at 06:30 and was fully alert and orientated, talkative and calm. O2 off at 06:35. Continued to monitor symptoms q 5 mins for 30 mins. Client is an athletic runner. His BP remained in the 92/48 range and his HR at 54. Client was released 06:55.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain
Clinical narrative: Per NP note, "...presented to vaccine cancer center to receive first dose of COVID 19 vaccination. First dose of Pfizer vaccine (Lot # EN6202) administered. Immediately after administration, Pt complained of acute mid-sternal chest pain described pressure. EKG completed, Pt observed for an additional 20 minutes, reported spontaneous resolution of symptoms. Prior to discharge pain completely resolved, lungs clear to auscultation , cardiac exam with normal S1 & S2,no rubs, gallops or murmurs. Pt admitted to being anxious, has a documented history of white coat syndrome."
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: Injection site cellulitis noted on 2.26.21
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Rash, Rash pruritic
Clinical narrative: rash - two pink itchy spots on neck and lower jaw - no other rash - present for several days without spread at time of evaluation
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hunger, Thirst, Vital signs measurement
Clinical narrative: Pt c/o dizziness and feeling tired after injection.  Denies SOA or other sx.  VSS. Pt given oral hydration and snacks.  Pt observed for 45 minutes without change in dizziness.  Pt recommended to go to ER.  Pt declined.  Left ambulatory.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Heart rate increased
Clinical narrative: Pounding chest turned red, tapid heart beat & breathing, muscle pain, mild headache, fatigue, diarrhea, low grade fever
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Respiratory rate increased
Clinical narrative: Pounding chest turned red, tapid heart beat & breathing, muscle pain, mild headache, fatigue, diarrhea, low grade fever
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Dysstasia, Fall, Headache
Clinical narrative: Within 24 hrs, experienced severe dizziness, resulting in 2 falls while attempting to stand up.   Also had headache, loss of appetite, and nausea, but the alarming  side effect was the dizziness.  Dizziness also subsided after less than 12 hrs.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Within 24 hrs, experienced severe dizziness, resulting in 2 falls while attempting to stand up.   Also had headache, loss of appetite, and nausea, but the alarming  side effect was the dizziness.  Dizziness also subsided after less than 12 hrs.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain of skin, Pruritus, Urticaria
Clinical narrative: 2 inch welt, red, hot, itchy, pain when touched
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19 pneumonia, Chest pain, Decreased appetite, Diarrhoea
Clinical narrative: Started feeling unwell; Headaches; Body aches; Chest pain; Didn't had wishes to eat; Diarrhea; COVID-19 pneumonia; A spontaneous report was received from a consumer concerning a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19 pneumonia, feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea  The patient's medical history high blood pressure which was controlled with medication. Concomitant product use included nifedipine and fenofibrate.  On 20-JAN-2021, approximately a week and a half or two prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  A week and a half or two later the patient stated feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea for which patient was hospitalized on 06-FEB-2021. Since everything seemed to be fine the patient was discharged on an unknown date in FEB-2021 however, patient's family was not notified that it was a late reaction to the vaccine's first dose. Later, due to shortness of breath he was hospitalized again on 08-FEB-2021 and was diagnosed for pneumonia and was intubated on the same day. Due to COVID-19 situation patient's family could not be in the facilities and that there wasn't any follow up of the patient given to the family, so family did not have much information.  During the first hospitalization(06-FEB-2021) the patient had a blood test which showed a normal result and was tested for COVID-19 and Influenza, both were negative. During second hospitalization (08-FEB-2021) the hospital said that the patient was stable. The patient's family did not know the results of the tests conducted at the time.   The action taken with the vaccine in response to the events is not applicable.  The outcome of COVID-19 pneumonia was fatal. The patient died on 14 Feb 2021  The cause of death was reported as COVID-19 related pneumonia. The autopsy was not done.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  The cause of death was reported as COVID-19 related pneumonia. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events are assessed as unlikely related. Further information has been requested.; Reported Cause(s) of Death: COVID-19 pneumonia
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza virus test negative, Malaise, Myalgia, Viral test negative
Clinical narrative: Started feeling unwell; Headaches; Body aches; Chest pain; Didn't had wishes to eat; Diarrhea; COVID-19 pneumonia; A spontaneous report was received from a consumer concerning a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19 pneumonia, feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea  The patient's medical history high blood pressure which was controlled with medication. Concomitant product use included nifedipine and fenofibrate.  On 20-JAN-2021, approximately a week and a half or two prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  A week and a half or two later the patient stated feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea for which patient was hospitalized on 06-FEB-2021. Since everything seemed to be fine the patient was discharged on an unknown date in FEB-2021 however, patient's family was not notified that it was a late reaction to the vaccine's first dose. Later, due to shortness of breath he was hospitalized again on 08-FEB-2021 and was diagnosed for pneumonia and was intubated on the same day. Due to COVID-19 situation patient's family could not be in the facilities and that there wasn't any follow up of the patient given to the family, so family did not have much information.  During the first hospitalization(06-FEB-2021) the patient had a blood test which showed a normal result and was tested for COVID-19 and Influenza, both were negative. During second hospitalization (08-FEB-2021) the hospital said that the patient was stable. The patient's family did not know the results of the tests conducted at the time.   The action taken with the vaccine in response to the events is not applicable.  The outcome of COVID-19 pneumonia was fatal. The patient died on 14 Feb 2021  The cause of death was reported as COVID-19 related pneumonia. The autopsy was not done.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  The cause of death was reported as COVID-19 related pneumonia. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events are assessed as unlikely related. Further information has been requested.; Reported Cause(s) of Death: COVID-19 pneumonia
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Lymphadenopathy, Myalgia, Necrotic lymphadenopathy, Red blood cell sedimentation rate increased
Clinical narrative: 7cm neck posterior lymphadenopathy on the left side, patient received the vaccine in left deltoid.  Her CT scan showed diffuse matted necrotic lymphadenopathy with the largest one measuring 1.8cm.  Patient is still symptomatic with diffuse myalgias, elevated CRP, SED rate with concern for severe inflammatory reaction.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: 7cm neck posterior lymphadenopathy on the left side, patient received the vaccine in left deltoid.  Her CT scan showed diffuse matted necrotic lymphadenopathy with the largest one measuring 1.8cm.  Patient is still symptomatic with diffuse myalgias, elevated CRP, SED rate with concern for severe inflammatory reaction.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Head injury, Headache, Hypoacusis, Hypotension
Clinical narrative: Patient states she returned to worksite after vaccine received and felt fine. States around 12:00 pm she was having a conversation with a coworker about her history of fainting spells when she speaks about medical procedures. While she was talking to coworker she fainted and hit the back of her head on the floor. States she recovered within 5 minutes. School nurse was notified and reported a faint pulse and blood pressure was low (around80/40). Was transported home by parents. States she felt groggy after fainting and a slight headache, tunnel vision, and muffled hearing that resolved the next day, 2/25/2021 around 7:00 pm. States she has a bump on the back right side of her head but denies other injuries. States she did return to work the next day.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Syncope, Tunnel vision
Clinical narrative: Patient states she returned to worksite after vaccine received and felt fine. States around 12:00 pm she was having a conversation with a coworker about her history of fainting spells when she speaks about medical procedures. While she was talking to coworker she fainted and hit the back of her head on the floor. States she recovered within 5 minutes. School nurse was notified and reported a faint pulse and blood pressure was low (around80/40). Was transported home by parents. States she felt groggy after fainting and a slight headache, tunnel vision, and muffled hearing that resolved the next day, 2/25/2021 around 7:00 pm. States she has a bump on the back right side of her head but denies other injuries. States she did return to work the next day.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Hyperhidrosis, Nausea, Nervousness
Clinical narrative: (nauseated, pale, diaphoretic, confused, Shaky, Dizzy) 1st dose. Sent to Urgent Care for evaluation. Unsure of outcome
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: (nauseated, pale, diaphoretic, confused, Shaky, Dizzy) 1st dose. Sent to Urgent Care for evaluation. Unsure of outcome
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Swelling in right arm below vaccination site began evening 02/25/2021 and worsened to entire upper right arm
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Pain in extremity, Sleep disorder, Swelling face, Urticaria
Clinical narrative: First, I got an extremely sore arm.  The arm was so sore I could not sleep because every time I moved it hurt enough to wake me up. The next day (~midday) I broke out in severe hives. At around 12.20 I became very, very sleepy and I lost my voice. At around 12.30 my partner noticed my face was swelling (around my jaw and cheeks).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: Platelet count: 01/28/2021 169 02/04/2021 130 02/11/2021 170 02/18/2021 134 02/25/2021 121 No bleeding or bruising issues noted
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling of eyelid
Clinical narrative: Swollen eyelids and lips starting about 1 hour after the vaccine, lasted about another hour
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Patient presents with redness around the injection site, approximately 3' x 3', not raised or warm.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Confusional state, Fatigue
Clinical narrative: Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021).  Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes.  Debilitating and confusing.    Glad to have received the vaccine in any case (small price to pay).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Injection site pain, Insomnia, Lymph node pain
Clinical narrative: Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021).  Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes.  Debilitating and confusing.    Glad to have received the vaccine in any case (small price to pay).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Nausea, Tremor
Clinical narrative: Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021).  Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes.  Debilitating and confusing.    Glad to have received the vaccine in any case (small price to pay).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pruritus
Clinical narrative: Itching, SOB, cough, evaluated by EMS-cleared
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Rash macular, Rash pruritic
Clinical narrative: Patient reported blotchy itchy rash on  right cheek, neck and upper chest. No difficulty breathing, chest pain or shortness of air. Ambulatory and needed no assistance moving.  Vitals HR 85 BP 126/82 pulse ox room air 98%. Benadryl 50 mg administered IM right arm at 11:40 am. Patient observed until 12:35 pm when discharged to home (HR 60 BP 110/78 100% O2). Rash was much improved by this time.  Patient called 11:20 am. 2/26. Rash almost entirely gone - just one spot on check. Will take benadryl PO. Mentioned she had small spot of rash around injection site following first dose of vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Night sweats, Pain
Clinical narrative: Chills and nausea for 2 hours; night sweats for 2 nights; body aches for 48 hours; fatigue lasting 48 hours.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity, Skin induration
Clinical narrative: Normal redness and soreness at vaccination site for the first few days then a 3? circle appeared at the site on the 7th day and caused itch and soreness. It is now fading away with no after effects
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Loss of consciousness, Respiratory arrest, Tremor
Clinical narrative: Completely out/eyes were closed; looked like he wasn't breathing; Began to shake, patient's head and arm shocked; Weak; little confused; A spontaneous report  was received from a consumer concerning a 69 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced began to shake (MedDRA PT: tremor), head and arm shocked (MedDRA PT: tremor), completely out/eyes were closed (MedDRA PT: loss of consciousness), looked like he wasn't breathing (MedDRA PT: respiratory arrest), weak (MedDRA PT: asthenia), and little confused (MedDRA PT: confusional state).  The patient's medical history included stroke. Concomitant product use included unspecified blood pressure pills, cholesterol pills, vitamins, and a drug for the patient's brain due to the stroke.    On 17 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 17 Feb 2021, ten minutes after receiving the vaccination, the patient began to shake, patient's head and arm shocked and patient was completely out with eyes closed. The reporter stated it looked like the patient wasn't breathing. Seven minutes later, the patient was given an epi shot and oxygen. The patient was transported via ambulance to the emergency room (ER). At that time, a scan was performed - nothing was detected in patient's brain. Patient remained in ER from 0830 to 1500. Patient subsequently left ER very weak and a little confused. It was recommended for patient not to receive second vaccination dose.    Treatment information included epi shot and oxygen.  Action taken with mRNA-1273 in response to the events was not reported.    The events began to shake, head and arm shocked, completely out/eyes were closed, and looked like he wasn't breathing were considered resolved on 17 Feb 2021.  The events very weak and little confused were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Paraesthesia oral
Clinical narrative: tingling on tongue, neck pain, nausea.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site swelling, Lymphadenopathy
Clinical narrative: Chills, body aches - lasted approx. 1 day Headache, fatigue - lasted approx. 2 days Injection site swelling and Swollen lymph nodes in right armpit - lasted approx. 5 days  Alternated Tylenol and Motrin to relieve head and body aches. All swelling reduced gradually without direct treatment.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills, body aches - lasted approx. 1 day Headache, fatigue - lasted approx. 2 days Injection site swelling and Swollen lymph nodes in right armpit - lasted approx. 5 days  Alternated Tylenol and Motrin to relieve head and body aches. All swelling reduced gradually without direct treatment.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain in jaw, Swelling face
Clinical narrative: Bilateral pain and swelling at location of Preauricular Lymph Nodes (below right and left temple and jaw joint, pain location where lower ear attaches to side of face, with swelling from temple area down to rear of lower  jawline). Onset at about 4-5 days after injection.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness at injection site, slight swelling, itching
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram, Fall, Head injury, Hemiparesis
Clinical narrative: Patient looses control of it's left side, falls on it's left side and hits their head. Take to the Hospital and is now connected to a mechanical ventilator.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Mechanical ventilation
Clinical narrative: Patient looses control of it's left side, falls on it's left side and hits their head. Take to the Hospital and is now connected to a mechanical ventilator.
Sex: M
Vaccine: MMR
Symptoms: Neuralgic amyotrophy
Clinical narrative: brachial plexus neuritis/Parsonage Turner syndrome; This spontaneous report was received from a consumer, who was reporting on himself as a 52-year-old male patient. His concurrent condition included seasonal allergy. No information regarding the patient's pertinent medical history, drug reactions and concomitant therapies was provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, he experienced vaccine reaction-brachial plexus neuritis (Parsonage Turner syndrome). The outcome of the event was unknown. The reporter considered neuralgic amyotrophy to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Gaze palsy, Nausea, Seizure like phenomena, Vomiting
Clinical narrative: Pt had seizure like activity-- head back, eyes rolled back, face red Lasted about 1 minute PT was lowered to the ground by staff out of chair No other injuries Pt then had nausea and vomiting -- was observed for about 1 hour-- more nausea and vomiting as he was taken to the car Pt agreed to be seen in the ED-- was given zofran and released   Later wife stated he has similar reactions to other immunizations
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: At around 11PM on 2/24/21, I had a severe headache, fatigue, chills, nausea, muscle and joint pain, and felt feverish. At around 2AM, I had vasovagal syncope (I lost consciousness and then woke up covered in sweat). Directly after I regained consciousness, I vomited several times over the next couple of minutes. I drank water and took Tylenol to try and alleviate symptoms. After that, I no longer vomited or lost consciousness but I continued to feel feverish, had a severe headache, fatigue, chills off and on, nausea, and muscle and joint pain until around 4PM on 2/24/21.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Myalgia, Nausea, Pyrexia
Clinical narrative: At around 11PM on 2/24/21, I had a severe headache, fatigue, chills, nausea, muscle and joint pain, and felt feverish. At around 2AM, I had vasovagal syncope (I lost consciousness and then woke up covered in sweat). Directly after I regained consciousness, I vomited several times over the next couple of minutes. I drank water and took Tylenol to try and alleviate symptoms. After that, I no longer vomited or lost consciousness but I continued to feel feverish, had a severe headache, fatigue, chills off and on, nausea, and muscle and joint pain until around 4PM on 2/24/21.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: At around 11PM on 2/24/21, I had a severe headache, fatigue, chills, nausea, muscle and joint pain, and felt feverish. At around 2AM, I had vasovagal syncope (I lost consciousness and then woke up covered in sweat). Directly after I regained consciousness, I vomited several times over the next couple of minutes. I drank water and took Tylenol to try and alleviate symptoms. After that, I no longer vomited or lost consciousness but I continued to feel feverish, had a severe headache, fatigue, chills off and on, nausea, and muscle and joint pain until around 4PM on 2/24/21.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Pollakiuria
Clinical narrative: Report symptoms of dry mouth 2 days post vaccination.  Treatment: drinking water. Outcome: Report increase urination due to drinking water.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Lymph node pain, Lymphadenopathy, Pain in extremity, Pruritus
Clinical narrative: Left lymph node in armpit swollen and painful. Left deltoid swollen, hard, seriously bad itchiness.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Discomfort, Dizziness, Feeling cold, Paraesthesia
Clinical narrative: After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly.  They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope).  They transferred me to the ER for further monitoring.  After a while, it stabilized more, but still continued to happen throughout the day.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly.  They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope).  They transferred me to the ER for further monitoring.  After a while, it stabilized more, but still continued to happen throughout the day.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Photosensitivity reaction
Clinical narrative: Rash/pink itchy covering upper arm where shot was given
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Acute myocarditis
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Asthenia, Brain natriuretic peptide, Computerised tomogram head, Computerised tomogram thorax
Clinical narrative: syncope followed by ER visit w/ many negative tests.  persistent weakness, apathy and loss of appetite
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Electrocardiogram, Full blood count, Metabolic function test, Syncope
Clinical narrative: syncope followed by ER visit w/ many negative tests.  persistent weakness, apathy and loss of appetite
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin I
Clinical narrative: syncope followed by ER visit w/ many negative tests.  persistent weakness, apathy and loss of appetite
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypertension
Clinical narrative: Dizzy short of breath hypertensive
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Dizziness, Feeling abnormal, Pain in extremity
Clinical narrative: sore arm, light headed, ringing in head, brain fog, disoriented, low energy
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: sore arm, light headed, ringing in head, brain fog, disoriented, low energy