chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fear, Ocular vascular disorder, Vaccination site pain, Vaccination site swelling
Clinical narrative: Deep Vein Thrombosis in both legs; eye was completely black/veins in the back of eye are completely black; eyes started to go very blurry; scared to sleep at night, scared to move/afraid to live life, petrified with this; arm is sore and puffed up; arm is sore and puffed up; A spontaneous report was received from a consumer, concerning a 72-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed deep vein thrombosis (DVT) in both legs/deep vein thrombosis, one clot from groin to mid chest and one behind knee to groin, quite large and very risky, extremely large thrombus, scared to sleep at night, scared to move, afraid to live life, petrified with this/ fear, eyes started to go very blurry/ vision blurred, left eye was completely black and veins in the back of eye are completely black/ eye contusion and arm was sore/ pain in extremity and puffed up/ peripheral swelling.  The patient's medical history included being a cancer survivor twice. No relevant concomitant medications were reported.  On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 014M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 09 Mar 2021, approximately ten days after receiving vaccine, the patient's eyes started to go very blurry, her left eye was completely black and veins in the back of eye were completely black. On 10 Mar 2021, she had one clot from groin to mid chest and one behind knee to groin, quite large and very risky, extremely large. She was afraid to live her life and  was petrified.  She developed a DVT in both legs and was taken to the emergency room.  She was hospitalized on 10 Mar 2021and had positron emission tomography (PET) scan, doppler, echocardiogram with pictures of face and neck. Her lung was dyed, she had 3 types of dye, had PET scan for brain, chest, blood draws from finger and shots of blood thinner in stomach. She was scared to sleep at night and scared to move. Her arm was sore and puffed up. On 13 Mar 2021, she was discharged from the hospital.  Treatment of the events included Eliquis.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, deep vein thrombosis, fear, vision blurred, eye contusion, pain in extremity and peripheral swelling were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Deep Vein Thrombosis in both legs; eye was completely black/veins in the back of eye are completely black; eyes started to go very blurry; scared to sleep at night, scared to move/afraid to live life, petrified with this; arm is sore and puffed up; arm is sore and puffed up; A spontaneous report was received from a consumer, concerning a 72-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed deep vein thrombosis (DVT) in both legs/deep vein thrombosis, one clot from groin to mid chest and one behind knee to groin, quite large and very risky, extremely large thrombus, scared to sleep at night, scared to move, afraid to live life, petrified with this/ fear, eyes started to go very blurry/ vision blurred, left eye was completely black and veins in the back of eye are completely black/ eye contusion and arm was sore/ pain in extremity and puffed up/ peripheral swelling.  The patient's medical history included being a cancer survivor twice. No relevant concomitant medications were reported.  On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 014M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 09 Mar 2021, approximately ten days after receiving vaccine, the patient's eyes started to go very blurry, her left eye was completely black and veins in the back of eye were completely black. On 10 Mar 2021, she had one clot from groin to mid chest and one behind knee to groin, quite large and very risky, extremely large. She was afraid to live her life and  was petrified.  She developed a DVT in both legs and was taken to the emergency room.  She was hospitalized on 10 Mar 2021and had positron emission tomography (PET) scan, doppler, echocardiogram with pictures of face and neck. Her lung was dyed, she had 3 types of dye, had PET scan for brain, chest, blood draws from finger and shots of blood thinner in stomach. She was scared to sleep at night and scared to move. Her arm was sore and puffed up. On 13 Mar 2021, she was discharged from the hospital.  Treatment of the events included Eliquis.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, deep vein thrombosis, fear, vision blurred, eye contusion, pain in extremity and peripheral swelling were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Urticaria
Clinical narrative: Hives on the neck and face and anxiety. BP 166/110 HR 78 Sp02 98%. Benadryl 50mg po given and monitored for 30 min
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Culture urine negative
Clinical narrative: I noticed when I urinated about 09:15 am on 17th, the toilet paper looked pink after I wiped myself. I went again an hour later and I was experiencing irritation and issue with not urinating. This time there was a trickle of blood down the toilet. This is very unusual for me -  have not experienced it before. The pink color on the toilet paper continued for about 4 hours. I was having to go to the bathroom frequently. I upped my fluid intake knowing that it may be a bladder infection. I made an appt with doctor - on the 17th -  by the time I got to see her in the afternoon I saw a physician in the same office as my normal doctor - I saw Dr. - the pink on the toilet paper wasn't happening anymore. Was prescribed Cephalexin -500 mg - twice a day for 5 days. It took until yesterday before I didn't have urgency and irritation and an issue with urinating - at this point - it feels like it may be almost back to normal. We are watching now to make sure if I have any more blood or pink staining, I will get an appt with an urologist.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swollen, red and itchy arm. It began two days after the shot. Then resolved. Then came back worse on the 20th, 11 days post shot.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Erythema, Flushing, Injection site swelling, Peripheral swelling
Clinical narrative: 12 hours after receiving the covid vaccine I had a sudden onset of the following symptoms:  extremely flushed in arms, chest and face,  clammy, both my arms swelled and were very red.  the arm with the injection site swelled more than the non-injection arm.  Itchy all over and what seemed to be hives formed on inside of both arms.  I was itchy and prickly behind both knees, inside of elbows, and under breasts, and top of stomach.   I was NOT wheezing and NO trouble breathing.  I did NOT have any fever.  I took 2 over the counter benadryl. The symptoms subsided substantially within an hour, but did not go away completely.  The next morning, swelling is down, redness is down, slight hives/rash on inside elbow of NON vaccinated arm.  Feel fine overall.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 12 hours after receiving the covid vaccine I had a sudden onset of the following symptoms:  extremely flushed in arms, chest and face,  clammy, both my arms swelled and were very red.  the arm with the injection site swelled more than the non-injection arm.  Itchy all over and what seemed to be hives formed on inside of both arms.  I was itchy and prickly behind both knees, inside of elbows, and under breasts, and top of stomach.   I was NOT wheezing and NO trouble breathing.  I did NOT have any fever.  I took 2 over the counter benadryl. The symptoms subsided substantially within an hour, but did not go away completely.  The next morning, swelling is down, redness is down, slight hives/rash on inside elbow of NON vaccinated arm.  Feel fine overall.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient first dose was Moderna vaccine on 2-23-21. When he came back for his second dose he accidently received the Pfizer and he was aware his series is complete.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Moderna COVID?19 Vaccine EUA On 3/23 I was fatigued and slept the entire day, woke at 9 am and slept 11 am to 603 pm. Today, 3/24, the injection site has developed a rash which is itchy and hot to the touch and some mild swelling. I plan to get my second dose on 4/8
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Moderna COVID?19 Vaccine EUA On 3/23 I was fatigued and slept the entire day, woke at 9 am and slept 11 am to 603 pm. Today, 3/24, the injection site has developed a rash which is itchy and hot to the touch and some mild swelling. I plan to get my second dose on 4/8
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Nausea, Pollakiuria
Clinical narrative: 8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?.  Symptoms lasted 4 days . Then intermittent fever & chills .  After 4 days red & swollen @ site of FIRST injection (NOT the 2nd injection !)  . Extreme fatigue for a week .
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Psychomotor hyperactivity, Pyrexia
Clinical narrative: 8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?.  Symptoms lasted 4 days . Then intermittent fever & chills .  After 4 days red & swollen @ site of FIRST injection (NOT the 2nd injection !)  . Extreme fatigue for a week .
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 1 day of itching on face and scalp
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Dizziness, Headache, Illness
Clinical narrative: Dizzy; Sick to the stomach; Could not eat; Sore throat; Pain in arm; Horrendous headaches; Pass out the day after; Very sick; A spontaneous report was received from consumer concerning female patient of unknown age, who experienced pass out the day after (syncope), very sick (illness), horrendous headaches (headache), dizzy (dizziness), sick to the stomach (abdominal discomfort), could not eat (decreased appetite), pain in arm (vaccination site pain), and sore throat (oropharyngeal pain).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received first dose of two planned doses of mRNA-1273  on 11 Mar 2021 intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021 the patient was very sick.  On 12 Mar 2021 the patient passed out. Patient stated she had horrendous headaches, was dizzy, sick to stomach and could not eat. Patient stated she had pain in arm and sore throat.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The event, pass out the day after (syncope), was considered as recovered on 12 Mar 2021. The outcome for the events of very sick (illness), horrendous headaches (headache), dizzy (dizziness), sick to the stomach (abdominal discomfort), could not eat (decreased appetite), pain in arm (pain in extremity), and sore throat (oropharyngeal pain) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Syncope, Vaccination site pain
Clinical narrative: Dizzy; Sick to the stomach; Could not eat; Sore throat; Pain in arm; Horrendous headaches; Pass out the day after; Very sick; A spontaneous report was received from consumer concerning female patient of unknown age, who experienced pass out the day after (syncope), very sick (illness), horrendous headaches (headache), dizzy (dizziness), sick to the stomach (abdominal discomfort), could not eat (decreased appetite), pain in arm (vaccination site pain), and sore throat (oropharyngeal pain).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received first dose of two planned doses of mRNA-1273  on 11 Mar 2021 intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021 the patient was very sick.  On 12 Mar 2021 the patient passed out. Patient stated she had horrendous headaches, was dizzy, sick to stomach and could not eat. Patient stated she had pain in arm and sore throat.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The event, pass out the day after (syncope), was considered as recovered on 12 Mar 2021. The outcome for the events of very sick (illness), horrendous headaches (headache), dizzy (dizziness), sick to the stomach (abdominal discomfort), could not eat (decreased appetite), pain in arm (pain in extremity), and sore throat (oropharyngeal pain) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received 1st dose Pfizer then 2nd dose Moderna.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Syncope
Clinical narrative: Patient stated that he started to feel itchy, dizzy, and fainted when he bent over. Fell asleep and said he was dreaming when we woke him up a few seconds later. It started happening around 5 minutes after he received the vaccine. He stated that he felt fine and back to normal after he was woken up. Had him stay until paramedics came to check him out. Was cleared to go home.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient states about an hour after Pfizer dose #1, she developed itching on back with one hive - lasted approximately 4 days. Patient estimates the size of hive was around 3cm-5cm. EE states still feels itchy on/off to this day.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pruritus, Urticaria
Clinical narrative: Face became numb, had mild hives, continue itchiness for 2 days
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Facial paralysis, Muscle twitching, Paraesthesia oral
Clinical narrative: Patient had facial twitch and his tongue felt like it had a film on it around 3/17/2021. Patient had right sided facial paralysis starting 3/21/2021. Patient went to the ER that day and was diagnosed with Bells Palsy. Was Given IV steroids that day in the ER and was put on oral Valtrex and Prednisone. Patient was told that symptoms were caught early. 3/24/2021 patient reports that symptoms are starting to resolve and he is starting to get more feeling around his mouth.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient presented to SJMC in Brainerd by private car, 3/23/21 DOA.  Family with patient wanted no resuscitation.  Patient pronounced deceased 2:49 pm.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Fever 99.8, nausea, tiredness, feeling unwell. Slept and rested. Symptoms gone by 3-24-2021 at 11:00 AM
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Nausea
Clinical narrative: Chills, nausea, headache, fatigue, fever, arm soreness with pain in armpit,
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills, nausea, headache, fatigue, fever, arm soreness with pain in armpit,
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dyskinesia, Fatigue, Vaccination site pain
Clinical narrative: Mouth stroke; Speech affected; Tired; Little soreness at the injection site; A spontaneous report was received from a consumer concerning a 68-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mouth stroke/dyskinesia, speech affected/dysarthria, little soreness at injection site/vaccination site pain and tired/fatigue.  The patient's medical history mentions history of diabetes. Concomitant medications were not provided.  On 25 Feb 2021, approximately 16 days prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (Batch number: 012A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 12 Mar 2021, reporter mentions that apart from having a little soreness at the injection site, the patient had to stay in bed all day, was tired and her speech was affected. Reports she is much better, but the doctors confirmed that she had symptoms of a mild stroke and mouth stroke.  Treatment information was not provided. Lab tests were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, mouth stroke, speech affected, little soreness at injection site and tired, were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: One hour after the injection the itching started in the scalp are and progressed to the face and jaw line.  By the second hour the itching progressed to the chest and bra line area.  I also started to experience a dull headache which did not go away.  Took 2 Benadryl but this did not help.  Took another round of Benadryl 6 hours later and went to bed.  The next day (3-24-21) I woke with no itching, but the dull headache remains.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Full blood count normal, Metabolic function test normal, Urticaria
Clinical narrative: Patient developed urticaria days 5-7 post vaccination.  Day 7-10 developed angioedema tongue- not involving lips.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: The patient contacted the pharmacy the morning of 03/24/21. She stated that this past monday (03/22/21) she began to have an adverse reaction to her vaccine. She stated that she began to develop tenderness, erythema, pain, and swelling at the injection site. She stated she had looked into her symptoms online and believed it was "COVID arm". After talking with the patient about her symptoms, I agreed. She was applying a topical corticosteroid as needed for the discomfort. I instructed her to contact her physician if her symptoms did not subside within the next few days.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was at a shot exercise for his second dose of Pfizer COVID Vaccine, he got his second vaccine and went to the next table where he then got another dose of vaccine. Thus got 2 second doses.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Fatigue and myalgias set in about 6 hours after vaccine was administered  Shortly after, tachycardia set in with pulse at 140-150 bpm resting. Fever set in at 8 pm at 103F.  One OTC Benadryl brought pulse down to 130s resting.  Performed Valsalva Maneuver with pulse improvement  to 110s.  By morning, fever was still at 103F, with headache, muscle pain, chills, fatigue, pain at injection site,  and swollen lymph nodes present. Tachycardia had resolved.  Within 48 hours after vaccine was administered, all side effects had resolved except fatigue and swollen lymph nodes and headache.  All side effects had completely resolved 9 days after vaccine was administered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tachycardia
Clinical narrative: Fatigue and myalgias set in about 6 hours after vaccine was administered  Shortly after, tachycardia set in with pulse at 140-150 bpm resting. Fever set in at 8 pm at 103F.  One OTC Benadryl brought pulse down to 130s resting.  Performed Valsalva Maneuver with pulse improvement  to 110s.  By morning, fever was still at 103F, with headache, muscle pain, chills, fatigue, pain at injection site,  and swollen lymph nodes present. Tachycardia had resolved.  Within 48 hours after vaccine was administered, all side effects had resolved except fatigue and swollen lymph nodes and headache.  All side effects had completely resolved 9 days after vaccine was administered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Laboratory test, Myalgia, Night sweats
Clinical narrative: Generalized myalgias, fatigue, chills, nocturnal sweats and vomiting.  Tx: 1000ml Sodium Chloride IV  Discharged to home
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Generalized myalgias, fatigue, chills, nocturnal sweats and vomiting.  Tx: 1000ml Sodium Chloride IV  Discharged to home
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain in extremity
Clinical narrative: Extreme stabbing, at times crushing  bone pain that has lasted for over 2 1/2 weeks. Most prevalent in hands, feet, and elbows.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling cold, Gait disturbance
Clinical narrative: I had only pain at the injection site after the first dose on February 12. I got my second dose on Friday, March 12 at 1pm and woke up at 2am Saturday  with debilitating headache and severe nausea . I took tylenol and fell back asleep. I woke up again around 6am with the same severe headache and excruciating  pain in my left arm at the injection site and tried to get up to get some ibuprofen. I felt extremely dizzy and could barely walk which ended up in me fainting in the kitchen. I somehow got back to bed, took ibuprofen and went back to sleep. I started feeling better after that, severe headache went away but I had low grade fever, chills, slight nausea and painful arm the whole Saturday up until Sunday morning. I had dizziness on Sunday, was very tired on Monday and still felt weak on Tuesday but after that I recovered and experienced no more symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Pyrexia, Syncope
Clinical narrative: I had only pain at the injection site after the first dose on February 12. I got my second dose on Friday, March 12 at 1pm and woke up at 2am Saturday  with debilitating headache and severe nausea . I took tylenol and fell back asleep. I woke up again around 6am with the same severe headache and excruciating  pain in my left arm at the injection site and tried to get up to get some ibuprofen. I felt extremely dizzy and could barely walk which ended up in me fainting in the kitchen. I somehow got back to bed, took ibuprofen and went back to sleep. I started feeling better after that, severe headache went away but I had low grade fever, chills, slight nausea and painful arm the whole Saturday up until Sunday morning. I had dizziness on Sunday, was very tired on Monday and still felt weak on Tuesday but after that I recovered and experienced no more symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Feeling abnormal, Myocardial necrosis marker, Somnolence, Speech disorder
Clinical narrative: wasn't making sense in conversation, starred off/Could not talk; Very groggy; could not  respond, couldn't follow instructions or directions; not his normal self; shaking; Patient not his normal self; Starred off when spoke to; A spontaneous report  was received from a consumer for a 79 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tremor (shaking), speech disorder (wasn't making sense in conversation, starred off/could not talk), somnolence (very groggy), vaccination related malaise (not his normal self), and cognitive disorder (could not respond, couldn't follow instructions or directions).  The patient's medical history was not provided. No concomitant product use was reported.  On an 07 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.    On 08 Mar 2021, The patient experienced tremor (shaking), speech disorder (wasn't making sense in conversation, starred off/could not talk, feeling abnormal (not his normal self), vaccination related malaise(not his normal self), and cognitive disorder (could not respond, couldn't follow instructions or directions).  On 08-Mar-2021, the patient was admitted to the hospital. On the day of hospital admission, the patient experienced somnolence (very groggy) and was known to have elevated cardiac enzymes.  Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the events, tremor (shaking), speech disorder (wasn't making sense in conversation, starred off/could not talk), somnolence (very groggy), vaccination related malaise (not his normal self), and cognitive disorder (could not respond, couldn't follow instructions or directions), were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Staring, Tremor, Vaccination complication
Clinical narrative: wasn't making sense in conversation, starred off/Could not talk; Very groggy; could not  respond, couldn't follow instructions or directions; not his normal self; shaking; Patient not his normal self; Starred off when spoke to; A spontaneous report  was received from a consumer for a 79 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tremor (shaking), speech disorder (wasn't making sense in conversation, starred off/could not talk), somnolence (very groggy), vaccination related malaise (not his normal self), and cognitive disorder (could not respond, couldn't follow instructions or directions).  The patient's medical history was not provided. No concomitant product use was reported.  On an 07 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.    On 08 Mar 2021, The patient experienced tremor (shaking), speech disorder (wasn't making sense in conversation, starred off/could not talk, feeling abnormal (not his normal self), vaccination related malaise(not his normal self), and cognitive disorder (could not respond, couldn't follow instructions or directions).  On 08-Mar-2021, the patient was admitted to the hospital. On the day of hospital admission, the patient experienced somnolence (very groggy) and was known to have elevated cardiac enzymes.  Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the events, tremor (shaking), speech disorder (wasn't making sense in conversation, starred off/could not talk), somnolence (very groggy), vaccination related malaise (not his normal self), and cognitive disorder (could not respond, couldn't follow instructions or directions), were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Covid arm (swelling, redness, itchiness, 10 days after first shot)
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia, low fever
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Ophthalmological examination, Sensation of foreign body
Clinical narrative: My right eye felt like there was something in it and it still seems to be twitching
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient c/o itching all over, vitals stable. Patient given 50mg Benadryl. She felt fine after 30 minutes and discharged.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: When patient's mother attempted to complete the screening questions, she was stopped when she entered the birth date of the patient informing her that he is not eligible for the Moderna vaccine due to age.  She then entered "unknown" for his birth date and was permitted by the system to continue.  When she arrived at the clinic with the patient, she informed the vaccinating nurse that "His doctor gave permission for him to get the vaccine.."  The vaccine was administered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: plates went from normal to 3000; A spontaneous report was received from a consumer concerning a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced having platelets went from normal to 3000 (Thrombocytopenia-unspecified).    The patient's medical history, as provided by the reporter, included leukemia. No relevant concomitant medications were reported.   On 27 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030O20A) intramuscularly for prophylaxis of COVID-19 infection.    On 07 Feb 2021, the patient had an infusion of obinutuzumab for leukemia because her platelets went from normal to 3000. She was at the hospital for three days.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, platelets went from normal to 3000 was unknown.; Reporter's Comments: This case concerns a 76-year-old female who was hospitalized for infusion of obinutuzumab for leukemia because of a medically significant and serious unexpected event of thrombocytopenia.  Event onset occurred 22 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Skin tightness, Vision blurred
Clinical narrative: Feeling tightness on the face for around 45 min. Blurred vision, very dizzy and unable to have good balance for 6 days.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hypertension, Syncope
Clinical narrative: Pt. experienced Syncope, has dizziness, light headed, cold-sweat, and almost fainted.  Pt. did not faint had remain in chair while being observed by pharmacist, administered a cold-compress to pt. with pt. reported immediate relief and continued to observe for 30 min.  Pt reported feeling better and no signs or symptoms and left with parents.  Told to check back with us if any new or further problems.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo symptoms developed about 2 weeks after 1st dose. Has symptoms intermittently for last 2 weeks.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: On 2/19/21 veteran had Moderna Covid-19 vaccine #1, then 2 days later developed  a rash on the trunk, which spread to extremities. He also had seafood recently and so cause of rash unclear at the time. He subsequently had vaccine dose #2 in 3/2021 and developed pruritic maculopapular rash again  (no recent seafood or other changes) that manifested over the same time course,  symptoms appearance and pattern of spread - trunk -> extremities .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Nausea, Pain, Pyrexia
Clinical narrative: At 5:00am the following morning I awoke you high fever of 101 and in severe pain throughout my body. I was heavily fatigued and had a difficult time walking. I made it to the toilet and vomited. I remained nauseous and heaved for about half an hour. My fever fluctuated for the next 24 hours before it broke and I am much better today, 2 days after getting my second vaccination.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: At 5:00am the following morning I awoke you high fever of 101 and in severe pain throughout my body. I was heavily fatigued and had a difficult time walking. I made it to the toilet and vomited. I remained nauseous and heaved for about half an hour. My fever fluctuated for the next 24 hours before it broke and I am much better today, 2 days after getting my second vaccination.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and PA DOH, decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Pain in extremity
Clinical narrative: Migraine, sore arm, swollen lymph node in armpit on left side.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Computerised tomogram abnormal, Dehydration, Diarrhoea, Dyspnoea
Clinical narrative: Symptoms includes: Chills Vomit Nausea Diarrhea Tiredness Headache Muscle pain Dry heaving Dehydration  Shortness of breath 20 pound weight loss in 15 days   Has been in the hospital two times since the vaccination. Both times on a slow drip IV to keep him hydrated urine was the same color as apple juice (Real apple juice not from concentrate or watered down whiskey if you will).  Did CAT scan of lungs found  4MM nodules that weren?t there before.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Myalgia, Nausea
Clinical narrative: Symptoms includes: Chills Vomit Nausea Diarrhea Tiredness Headache Muscle pain Dry heaving Dehydration  Shortness of breath 20 pound weight loss in 15 days   Has been in the hospital two times since the vaccination. Both times on a slow drip IV to keep him hydrated urine was the same color as apple juice (Real apple juice not from concentrate or watered down whiskey if you will).  Did CAT scan of lungs found  4MM nodules that weren?t there before.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Retching, Vomiting, Weight decreased
Clinical narrative: Symptoms includes: Chills Vomit Nausea Diarrhea Tiredness Headache Muscle pain Dry heaving Dehydration  Shortness of breath 20 pound weight loss in 15 days   Has been in the hospital two times since the vaccination. Both times on a slow drip IV to keep him hydrated urine was the same color as apple juice (Real apple juice not from concentrate or watered down whiskey if you will).  Did CAT scan of lungs found  4MM nodules that weren?t there before.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: About 9.5 hours after the injection, I started feeling a bit shaky. Seemed to be on left side of chest. Shakiness got stronger and stronger, spread across chest and into head.  By 10 hours after injections, hands were shaking, voice, was shaking, teeth chattering.  The worst lasted about 20 minutes, and then started to subside in reverse order ending on left side of chest. By 90  minutes after initiation, all shaking was gone.  During the worst of it, I could sometimes control the shaking briefly with slow breathing. But then shaking would return.  Fitful sleep through the night. Aches and low fever next day.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bradycardia, Cardiac monitoring, Chest X-ray, Chest pain
Clinical narrative: Within 10 minutes of receiving vaccine, got very lightheaded in waves. Got very shaky, felt weak. Felt heart palpitations, increased respirations, shallow breathing Recovered within 30 minutes and returned home. Symptoms have continued since receiving vaccine to include chest pain, feeling jittery/shaky and weak in the limbs
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Feeling jittery, Full blood count, Hypopnoea
Clinical narrative: Within 10 minutes of receiving vaccine, got very lightheaded in waves. Got very shaky, felt weak. Felt heart palpitations, increased respirations, shallow breathing Recovered within 30 minutes and returned home. Symptoms have continued since receiving vaccine to include chest pain, feeling jittery/shaky and weak in the limbs
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Palpitations, Pregnancy test, Respiratory rate increased, Tremor
Clinical narrative: Within 10 minutes of receiving vaccine, got very lightheaded in waves. Got very shaky, felt weak. Felt heart palpitations, increased respirations, shallow breathing Recovered within 30 minutes and returned home. Symptoms have continued since receiving vaccine to include chest pain, feeling jittery/shaky and weak in the limbs
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin, Urine analysis
Clinical narrative: Within 10 minutes of receiving vaccine, got very lightheaded in waves. Got very shaky, felt weak. Felt heart palpitations, increased respirations, shallow breathing Recovered within 30 minutes and returned home. Symptoms have continued since receiving vaccine to include chest pain, feeling jittery/shaky and weak in the limbs
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: I have ?covid arm? near my injection site.  It appeared a week after my vaccine. It is red and swollen.  It itches at times and it painful at times.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: I have ?covid arm? near my injection site.  It appeared a week after my vaccine. It is red and swollen.  It itches at times and it painful at times.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling hot, Tremor
Clinical narrative: Client received 1st Pfizer Covid Vaccine (Lot # ER8732, Exp 3/24/21) approximately 1545. Client was sitting in post vaccine waiting area when she alerted EMT she was feeling lightheaded and dizzy. RN  joined and began to assess client. Vitals at 1600: blood pressure 126/80 pulse 84, respirations 18. Alert and oriented. No swelling noted. Client denied shortness of breath. Per client no history of allergies or reaction to vaccines in the past. Client asked for water. PHN  joined team, client instructed to take small sips of water. Client mentioned she had not ate yet and thought maybe it was related to that. Client informed she would be observed another 15 mins due to current symptoms. 1608 client stated feeling warm, anxious, and still lightheaded. PHN offered client benadryl and client accepted. Per client husband came with her and was going to drive her home. Benadryl 50mg was given orally at 1609. Vitals: blood pressure 144/90, pulse 76, respirations 18. Client informed staff she felt hands were shaky and body was warm. Client alert and oriented, no swelling noted. Vitals at 1616: 140/90, pulse 60, respirations 16. At 1622 client stated feeling better, did not want to wait rest of remaining time. Client was advised to consult primary provider prior to receiving second dose Pfizer. Client also given ER precautions. Husband was waiting in parking lot and was going to drive client home. Client left facility with a steady gait at 1630.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Pt developed dizziness and nausea approx 30 minutes after vaccination. Denies HA, SOB, chest pain.  BP 131/84 HR 88 RR 18, unlabored  SpO2 98% RA
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Impaired work ability, Induration, Pain
Clinical narrative: Pt states significant arm swelling, arm was hard to the touch, red and painful. Pt also had body aches, fatigue and fever for 3+days that required the patient to be out of work for 2 days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pt states significant arm swelling, arm was hard to the touch, red and painful. Pt also had body aches, fatigue and fever for 3+days that required the patient to be out of work for 2 days.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Sleep disorder
Clinical narrative: After the 2nd inj of Moderna, I?ve been experiencing a chronic pain on the injection site, now it?s forming a lump exactly where the needle was placed, the pain is increasing and sensitive to touch the area of the injection, I?m unable to sleep on the left side of my body..  What should I do?
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Severe headache, chills, sweats, tired, weakness, every muscle I have hurt.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe headache, chills, sweats, tired, weakness, every muscle I have hurt.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: high pitch ringing
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began to turn white. Patient parked by EMS in observation parking and became unresponsive. EMS began vital signs and tried to get him to wake up. Patient stayed unresponsive and vital signs continued to decline. EMS transported patient to hospital. Upon arrival to hospital, staff conducted EKG, chest x-ray, and blood work. All tests came back normal. Patient began to become coherent, and staff began to try and feed him and get him up. After patient was able to get self up and eat food, he was sent home. Patient is now at home recovering. He states he only feels a sore arm and is fatigued.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Unresponsive to stimuli
Clinical narrative: Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began to turn white. Patient parked by EMS in observation parking and became unresponsive. EMS began vital signs and tried to get him to wake up. Patient stayed unresponsive and vital signs continued to decline. EMS transported patient to hospital. Upon arrival to hospital, staff conducted EKG, chest x-ray, and blood work. All tests came back normal. Patient began to become coherent, and staff began to try and feed him and get him up. After patient was able to get self up and eat food, he was sent home. Patient is now at home recovering. He states he only feels a sore arm and is fatigued.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Dizziness, Hypoaesthesia, Loss of consciousness
Clinical narrative: Right hand feels tingly with numbness; Moderate chest pains; Passed out in chair; Super dizzy; Suffocation in chest; Sick to their stomach; Heart racing immediately after vaccine administration; Fever; Had allergic reaction at the vaccine site; A spontaneous report was received from a consumer concerning a 61-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events suffocation in chest, super dizzy, moderate chest pains, sick to their stomach, heart racing immediately after vaccine administration, passed out in chair, fever, right hand feels tingly with numbness.  The patient's medical history included COPD (chronic obstructive pulmonary disease), staph infection, CAD (coronary artery disease), depression, anxiety, shortness of breath and suffocation on chest. Concomitant medications reported were amoxicillin, gliclazide, acetylsalicylic acid, amlodipin, atorvastatin, clonazepam, hydroxyzine, multi vitamin, inhaler, albuterol as needed and nebulizer, all were used for an unknown indication.  On 05 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 036A21A) Intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient had allergic reaction at the vaccine site, felt sick to their stomach, dizzy, heart racing immediately after inoculation with the vaccine. Pharmacist thought they were having a panic attack, but patient says no. That evening developed a fever. On 06 Mar 2021, the patient felt suffocation in chest that was tolerable. On 07 Mar 2021, the patient experienced bad suffocation in chest, super dizzy and passed out in chair. Stated that they were knocked out for 35 minutes. Suffocation decreased. On 14 Mar 2021, suffocation comes on with major chest pains. On 15 Mar 2021, the patient experienced the events moderate chest pains and right hand feels tingly with numbness.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, sick to their stomach and heart racing immediately after vaccine administration was resolved on 05 Mar 2021. The outcome of events, suffocation in chest and passed out in chair was resolved on 07 Mar 2021. The outcome of events, super dizzy, moderate chest pains, fever and right hand feels tingly with numbness was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (suffocation feeling, abdominal discomfort, pyrexia, tachycardia, and vaccination site reaction) a causal relationship cannot be excluded. Very limited information regarding the events (LOC, hypoaesthesia) has been provided at this time. Further information has been requested.