chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Swollen throat glands + sore throat, beginning January 1, 2021 through January  7, 2021. Stiff and sore right shoulder and neck (muscular and joint pain), mid-January through present. Multiple Canker Sores on lower lip, January 22 through present.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: runny nose, symptoms occurred 14 hours post vaccine, reaction site pain, nausea, fever 100.5, muscle aches, chills, abdominal pain, fatigue, joint pain and headche
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose, symptoms occurred 14 hours post vaccine, reaction site pain, nausea, fever 100.5, muscle aches, chills, abdominal pain, fatigue, joint pain and headche
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Erythema, Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: First 3 days after injection on 1/14/21, there was soreness and slight swelling with a bit of redness. It went away after 3 days and no other symptoms. 10 days later, small rash consisting of lots of red spots near site of injection. Day 11, the red bumps are no longer visible but a large singular pink rash that's elevated and localized to the injection site with some itchiness, arm fatigue and warmth.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pain, Swelling
Clinical narrative: First 3 days after injection on 1/14/21, there was soreness and slight swelling with a bit of redness. It went away after 3 days and no other symptoms. 10 days later, small rash consisting of lots of red spots near site of injection. Day 11, the red bumps are no longer visible but a large singular pink rash that's elevated and localized to the injection site with some itchiness, arm fatigue and warmth.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: pain at site, joint pain, headache, fever and nausea
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site rash, Rash
Clinical narrative: Rash at injection arm and trunk on that side of body, congestion and fatigue, chills and headaches
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Rash at injection arm and trunk on that side of body, congestion and fatigue, chills and headaches
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: Itching on injection site, itching on same side arm and neck. A couple days later noticed a sort of hive surrounding injection site.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash erythematous
Clinical narrative: Very red, swollen arm about 3x3 inches with a few red dots
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: sever rash, swelling, and pain at the injection site 2-3 days after vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Pain in extremity
Clinical narrative: Pain in arm, bright red spot and hard like a bump/lump at injection site.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Headache, Malaise
Clinical narrative: leg aches, chills, joint pain, malaise started on 3rd day after injection.  Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: leg aches, chills, joint pain, malaise started on 3rd day after injection.  Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: leg aches, chills, joint pain, malaise started on 3rd day after injection.  Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: headache, fatigue, muscle aches and nausea
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: Moderna COVID-19 Vaccine EUA After receiving the vaccine, I felt my throat swell up a bit, which caused me to slightly panic during the 15 minute observational period; however, it went away after approximately 5 minutes. I initially wasn't convinced it had anything to do with the vaccine. Later that day, I went into work for third shift. At approximately 1:30 am (approx 11 hrs. after the vaccine), I began to feel very ill. I developed flu like symptoms and a headache, which caused me to leave work. I continued having flu symptoms, chills, nausea, body aches, and a very severe migraine on and off until I woke up on  01-22-20 at approximately 6:00 am. At this time, the migraine had subsided and I just had some minor body aches,, which over the next 24 hrs. also went away. The migraine should be noted as debilitating to the point I was dizzy, my mind was foggy, but worst of all, the pain was so bad I was constantly nauseous and my eyes were regularly watering.   I never was tested for COVID-19; however, I believe my family had potentially had the virus in October. My wife and I exhibited many of the signs and symptoms of the virus, including my wife losing taste and smell for an extended period of time.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lacrimation increased, Malaise, Migraine, Nausea
Clinical narrative: Moderna COVID-19 Vaccine EUA After receiving the vaccine, I felt my throat swell up a bit, which caused me to slightly panic during the 15 minute observational period; however, it went away after approximately 5 minutes. I initially wasn't convinced it had anything to do with the vaccine. Later that day, I went into work for third shift. At approximately 1:30 am (approx 11 hrs. after the vaccine), I began to feel very ill. I developed flu like symptoms and a headache, which caused me to leave work. I continued having flu symptoms, chills, nausea, body aches, and a very severe migraine on and off until I woke up on  01-22-20 at approximately 6:00 am. At this time, the migraine had subsided and I just had some minor body aches,, which over the next 24 hrs. also went away. The migraine should be noted as debilitating to the point I was dizzy, my mind was foggy, but worst of all, the pain was so bad I was constantly nauseous and my eyes were regularly watering.   I never was tested for COVID-19; however, I believe my family had potentially had the virus in October. My wife and I exhibited many of the signs and symptoms of the virus, including my wife losing taste and smell for an extended period of time.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Panic reaction, Pharyngeal swelling
Clinical narrative: Moderna COVID-19 Vaccine EUA After receiving the vaccine, I felt my throat swell up a bit, which caused me to slightly panic during the 15 minute observational period; however, it went away after approximately 5 minutes. I initially wasn't convinced it had anything to do with the vaccine. Later that day, I went into work for third shift. At approximately 1:30 am (approx 11 hrs. after the vaccine), I began to feel very ill. I developed flu like symptoms and a headache, which caused me to leave work. I continued having flu symptoms, chills, nausea, body aches, and a very severe migraine on and off until I woke up on  01-22-20 at approximately 6:00 am. At this time, the migraine had subsided and I just had some minor body aches,, which over the next 24 hrs. also went away. The migraine should be noted as debilitating to the point I was dizzy, my mind was foggy, but worst of all, the pain was so bad I was constantly nauseous and my eyes were regularly watering.   I never was tested for COVID-19; however, I believe my family had potentially had the virus in October. My wife and I exhibited many of the signs and symptoms of the virus, including my wife losing taste and smell for an extended period of time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Fatigue, Oedema peripheral, Pain
Clinical narrative: Persistent itching, redness, and swelling.  Left armpit pain and swelling.  Body aches and fatigue.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Persistent itching, redness, and swelling.  Left armpit pain and swelling.  Body aches and fatigue.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: swollen lymph nodes, fever of 103, malaise
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy of left axillary on the side of injection
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oral herpes, Pain in extremity, Stomatitis
Clinical narrative: I don't know if this was from the vaccine but it has been abnormal for me. Three days after the vaccine I got a cold sore. I took acyclovir and it subsided. Two days later I got another cold sore in the same location. That was very different. Usually when I take acyclovir it clears up very well. I took acyclovir again.  Then today (1/24) I have another cold sore, this time in a different location.  I have not had excessive stress or bad sleep which can sometimes trigger cold sores for me.  I have never had multiple in a week. I will get one cold sore every 6 months or so on average. I wondered if it is due to an immune response from the vaccine.  Also, I have some large cancer sores inside my mouth.   (I had arm pain for three days after the vaccine  and some fatigue the day after)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Sudden severe swelling, heat, redness at injection site 1 week after injection. Joint and muscular pain in left arm (side of injection).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, headache, muscle aches and chills
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Injection site soreness, headache, fever to 101 F, myalgia, fatigue Duration of symptoms 18 hours Back to normal 48 hours after injection
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Cough, shortness of breath wheezing
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report \ was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiresome and some chips
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: hard lump and red spot the size of a half dollar coin at injection site
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Within 10 minutes of receiving the vaccine on 01/22/21, slight tickle in back of throat, wave came over me, heart rate increased to 118, nauseous, chest slightly tight, light headed; heart rate regulated (about 70-72 bpm) and chest felt okay then body went tingly from arms to legs with some light headedness. Oxygen fine the whole time; heart rate regulated after the beginning and no fever - feeling a bit better within 1 hour. Headache started that night and lasted until midnight the next day. Very tired the whole next day until about 5:30pm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation, Paraesthesia, Throat irritation
Clinical narrative: Within 10 minutes of receiving the vaccine on 01/22/21, slight tickle in back of throat, wave came over me, heart rate increased to 118, nauseous, chest slightly tight, light headed; heart rate regulated (about 70-72 bpm) and chest felt okay then body went tingly from arms to legs with some light headedness. Oxygen fine the whole time; heart rate regulated after the beginning and no fever - feeling a bit better within 1 hour. Headache started that night and lasted until midnight the next day. Very tired the whole next day until about 5:30pm.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: fever of 99.6 fahrenheit, moderate headache, fatigue, malaise
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia
Clinical narrative: Received the vaccine on January 22, 2021 at approximately 14:30 hours. Started feeling muscle soreness in the left arm later that night. I woke up on January 23rd, 2021 at approximately 0800 hours and felt general soreness in my muscles and joints. By 0900 hours, joint pain was much worse as it hurt just to stand. At approximately 1130 hours, I started feeling chills. I wore two layers of sweatshirts and sweatpants plus blankets. I could not get warm. By approximately 1300 hours, I had a low grade fever of 100.3 - 100.6. I went to bed at approximately 2200 hours, woke up at approximately 1030 hours  on Sunday the 24th, 2021 and had no longer felt the pain, chills or fever.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: I had a delayed reaction with a red and itchy rash at site of injection about 7 days later. It was also warm to the touch. It  resolved 2 days later. I also had a very low grade fever that was also delayed (I believe it was 4 days later which was momentary and resolved after an hour). No other side effects.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: small rash at injection site on 7th day, with severe itchiness radiating all the way down the arm to hand, the rash quadrupled in size by next day, with continued severe itchiness radiating all the way down to hand, and rash  still large and severe itchiness on 9th day. There is still pain at injection site and a sensation of warm with mild swelling. Treated with hydrocortisone crème and Neosporim but no real benefit from those treatments.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: small rash at injection site on 7th day, with severe itchiness radiating all the way down the arm to hand, the rash quadrupled in size by next day, with continued severe itchiness radiating all the way down to hand, and rash  still large and severe itchiness on 9th day. There is still pain at injection site and a sensation of warm with mild swelling. Treated with hydrocortisone crème and Neosporim but no real benefit from those treatments.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 4 days after getting the first Moderna shot, I developed an intense headache that has lasted for 10 hours.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Headache, Musculoskeletal discomfort, Pain
Clinical narrative: Facial tingling 30 minutes post injection, facial swelling and flushing at 12 hours post injection, fever (99.0 F-101.0 F), chills, body aches, and shivering starting at 16 hours post injection and continuing for 48 hours post injection, headache and neck ache from 48-72 hours post injection.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Swelling face
Clinical narrative: Facial tingling 30 minutes post injection, facial swelling and flushing at 12 hours post injection, fever (99.0 F-101.0 F), chills, body aches, and shivering starting at 16 hours post injection and continuing for 48 hours post injection, headache and neck ache from 48-72 hours post injection.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspepsia, Dysphagia, Dyspnoea, Hyperventilation
Clinical narrative: within minutes after my shot, I started to have difficulty swallowing. i was monitored for 30 minutes at the vaccine site before being escorted to the medical observation area. While in the medical observation area I tried to take a sip of water but could not swallow it. At that moment I began having a tight feeling in my chest. I began to hyperventilate followed by difficulty breathing or talking. This was accompanied by feelings of impending doom, and uncontrollable trembling and inability to concentrate on what the medical observation area Doctor was saying. The time from the drink of water until I was able to breathe, speak, and concentrate normally was about 20 minutes. Tightness in my chest has improved but not fully recovered. General malaise and headache have developed.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Muscle strain, Pain, Pain of skin, Sensitive skin
Clinical narrative: The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Thinking it was hives, I applied cortisone cream and took Zyrtec. This continued through following week. I went to my personal physician and was diagnosed with shingles though I never had any outward rash or blisters.  Just skin sensitivity . I was prescribed  triamcinolone acetonide cream 0.5% which I have been applying twice daily. I have not had an outbreak but have had minimal internal pain that feels like strained or pulled muscle in the same area.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Itchy, redness, hot
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Delayed symptom about a week later where I woke up with an itchy red bump at the injection site. Today is day 3 and it's been red, itchy, and a hard lump.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Chills, Discomfort
Clinical narrative: Covid Vaxx #2  1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5  1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet  1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps  1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Hunger, Hyperhidrosis
Clinical narrative: Covid Vaxx #2  1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5  1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet  1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps  1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Covid Vaxx #2  1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5  1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet  1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps  1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Covid Vaxx #2  1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5  1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet  1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps  1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy on right side.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA; moderate fatigue, very mild fever, moderate sore arm centered on injection site, beginning about 18 hours post vaccination. Resolved spontaneously within a day and a half after onset of symptoms.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema
Clinical narrative: Redness around injection site upon waking up, redness spread across chest.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash erythematous, Skin warm
Clinical narrative: On day10, 01/22/2021 about 3pm I went to touch my arm and it felt sore. When I got home from work, I noticed what looked like 3 round/oval shaped redness and swelling spots that were warm to touch on my arm, I applied Benadryl cream and that helped decrease. The next day the three spots had became one and was the size of a tennis ball; it was red, a little swollen and warm to touch. The following day (today 01/24/2021) the the redness and swelling had grown about 6 inches wide and 5 inches in height; I took Benadryl 25 mg po and within 30 minutes then swelling and redness had began to decrease, warm to touch was still there and it began to get a little itchy but very manageable, I applied benadryl cream and that seemed to help a little, but when cream wore off it began to get a little itchy, but still very manageable; I did not reapply the cream.  No pain or discomfort at the area of concern on any days above.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Headache
Clinical narrative: A few days after receiving the first Pfizer Covid 19 vaccine I have an insidious mark running down my right forearm.  I initially thought it was a bruise but don't recall hitting my arm in such a violent way to create this big purple mark on my arm.  After weeks-the mark is still there and is not fading.  I've also been getting short flashes of headaches that I don't recall experiencing in the past.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: Patient developed wheal - like reaction at injection site the evening of receiving the vaccine.  Not tender to touch.  Not warm to touch.  Approximate size of 4.5cm in length and 5.5cm in height.  No other systemic symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Trigeminal neuralgia
Clinical narrative: The day after the first shot, I got a severe headache and felt very tired.  I don't normally get headaches or feel tired, but I was aware that they can be side effects of the vaccine.  I have trigeminal neuralgia type II, which causes facial pain headaches, but this was not that type of headache.  Since getting the first shot, I have had at least 5 trigeminal neuralgia headaches when I normally only have 1 per month if that.  I take Amitriptyline 150 mg nightly to regulate my trigeminal neuralgia and have not had any changes to my dosage or medication in several years.  I am concerned because I read (unfortunately after having the shot) that PEG's are in the vaccine and also in Amitriptyline and am wondering if the vaccine has caused my trigeminal neuralgia flare ups.  It has taken me several years to finally find the right medication to regulate my trigeminal neuralgia, and I am hoping the vaccine hasn't set me back.  I had been hesitant to have the vaccine, but I work in an emergency department and felt obligated to do so.  I wish I had consulted my neurologist or another health care provider of mine before having the shot.  I am due for my second shot on 1/28/21, and I will still have it.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Bullous haemorrhagic dermatosis, Epstein-Barr virus test negative, Hepatitis viral test negative, Immunoglobulin therapy, Petechiae
Clinical narrative: Onset of hemmoragic oral bullae after eating  very hot cheese toast 1-20-2021  Widely scattered petechiae lower and upper extremeties 1-21-2021 Extensive petechaie lower extremities and a few on trunk face 1-22-2021 CBC in ER showed severe thrombocytomenia with platelets less than 2000 1-22-2021 Admitteed and treated with Decadron 40 mg IV, and IVIG infusions once daily Jan. 23rd and 24th 2021 Hepatiitis pannel negative EBV negative, COVID Nasopharengeal negative, splenic U/S upper limit of normal but unchanged on comparison with old imaging. With treatment platlets increased to 65,000, Discharged from hospital.  IVIG discontinued Oral decadron 40mg will continue for 2 days with CBC hematology f/u in 36 hours
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, SARS-CoV-2 test negative, Thrombocytopenia, Ultrasound scan normal, Ultrasound spleen
Clinical narrative: Onset of hemmoragic oral bullae after eating  very hot cheese toast 1-20-2021  Widely scattered petechiae lower and upper extremeties 1-21-2021 Extensive petechaie lower extremities and a few on trunk face 1-22-2021 CBC in ER showed severe thrombocytomenia with platelets less than 2000 1-22-2021 Admitteed and treated with Decadron 40 mg IV, and IVIG infusions once daily Jan. 23rd and 24th 2021 Hepatiitis pannel negative EBV negative, COVID Nasopharengeal negative, splenic U/S upper limit of normal but unchanged on comparison with old imaging. With treatment platlets increased to 65,000, Discharged from hospital.  IVIG discontinued Oral decadron 40mg will continue for 2 days with CBC hematology f/u in 36 hours
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Despite not having any abnormal reactions immediately following the vaccine (except for pain at site of injection, muscle aches, chills - which went away after 3 days), a week after the vaccine, I noticed that my left arm was hard around the injection, and a bit itchy. I massaged it a bit, and it started hurting - that night, I woke up from the pain, and had to take ibuprofen to sleep (probably 4/10). The area of also warm, red, and swollen, so I iced it, which made the pain better. This went on all of Friday as well - I took some Benadryl, and that seemed to make it better (or it might have just made me sleepy enough that I didn't notice, I'm not sure). I measured the area of redness at 8.5cm at longest diameter. Saturday, the pain was mostly gone, but the skin remained red and itchy, although the redness was a bit faded. Some small bumps appeared, however. There was also a second area of redness and pruritus measuring 4.5cm that was located a bit more upwards on the arm than the original area of redness. Sunday, the redness in both areas continued to fade, but the bumps were noticeable and more itchy than before. The hardness seems to have resolved almost completely, although the area is still a bit sore when massaged.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Despite not having any abnormal reactions immediately following the vaccine (except for pain at site of injection, muscle aches, chills - which went away after 3 days), a week after the vaccine, I noticed that my left arm was hard around the injection, and a bit itchy. I massaged it a bit, and it started hurting - that night, I woke up from the pain, and had to take ibuprofen to sleep (probably 4/10). The area of also warm, red, and swollen, so I iced it, which made the pain better. This went on all of Friday as well - I took some Benadryl, and that seemed to make it better (or it might have just made me sleepy enough that I didn't notice, I'm not sure). I measured the area of redness at 8.5cm at longest diameter. Saturday, the pain was mostly gone, but the skin remained red and itchy, although the redness was a bit faded. Some small bumps appeared, however. There was also a second area of redness and pruritus measuring 4.5cm that was located a bit more upwards on the arm than the original area of redness. Sunday, the redness in both areas continued to fade, but the bumps were noticeable and more itchy than before. The hardness seems to have resolved almost completely, although the area is still a bit sore when massaged.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Despite not having any abnormal reactions immediately following the vaccine (except for pain at site of injection, muscle aches, chills - which went away after 3 days), a week after the vaccine, I noticed that my left arm was hard around the injection, and a bit itchy. I massaged it a bit, and it started hurting - that night, I woke up from the pain, and had to take ibuprofen to sleep (probably 4/10). The area of also warm, red, and swollen, so I iced it, which made the pain better. This went on all of Friday as well - I took some Benadryl, and that seemed to make it better (or it might have just made me sleepy enough that I didn't notice, I'm not sure). I measured the area of redness at 8.5cm at longest diameter. Saturday, the pain was mostly gone, but the skin remained red and itchy, although the redness was a bit faded. Some small bumps appeared, however. There was also a second area of redness and pruritus measuring 4.5cm that was located a bit more upwards on the arm than the original area of redness. Sunday, the redness in both areas continued to fade, but the bumps were noticeable and more itchy than before. The hardness seems to have resolved almost completely, although the area is still a bit sore when massaged.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: received Covid19 vaccine on 14JAN2021 Left arm. States that the injection site was painful for 2 days after the injection. Denies SOB, fever, face and mouth swelling. She complains of itchiness and redness around the injection site. She tried to avoid scratching the area by taking OTC Zrytec and applied topical cream, Cortizone 10 to alleviate the itchiness but didn't work. She was told by her dermatologist in the past that she has a skin sensitivity and tends to react easily to new things. She denies changes on her diet, clothing, lotion, and medication. Left arm injection site redness, warm to touch,size14cmX10cm, zero drainage, skin intact. BP 119/82,HR100, RR14, TEMP 98.6. O2Sat 99%
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Flatulence
Clinical narrative: 12/18/20 abdominal pain, resembling gas pain, severe, lasted about two minutes
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Flatulence
Clinical narrative: Severe abdominal pain, resembling gas pain, intermittent over two minutes
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Very tired, aches, fever of 101 degrees F for 24 hours.  In 48 hours all symptoms were gone.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Mobility decreased, Pain
Clinical narrative: A lot of pain at site, can?t lift arm, had to ice, take pain medicine. fever 2 degrees higher than my normal, aches, pains, chills, didn?t sleep all night, headache.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: A lot of pain at site, can?t lift arm, had to ice, take pain medicine. fever 2 degrees higher than my normal, aches, pains, chills, didn?t sleep all night, headache.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: received dose 1 of the Moderna vaccine past the 6 hr used-by time; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received dose 1 of the Moderna vaccine past the 6 hour used-by time.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the nurse reported that the patient received 1 dose of the vaccine past the 6 hour used-by time. The nurse stated that the dose of the vaccine was administered 24 hours after the bottle was opened on 29 Dec 2020.  No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, received dose 1 of the Moderna vaccine past the 6 hour used-by time, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # 025L20A.  There were no reported AEs associated with this case of out of specification product use.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: received dose 1 of the Moderna vaccine past the 6 hr used-by time; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received dose 1 of the Moderna vaccine past the 6 hour used-by time.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the nurse reported that the patient received 1 dose of the vaccine past the 6 hour used-by time. The nurse stated that the dose of the vaccine was administered 72 hours after the bottle was opened on 29 Dec 2020.  No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, received dose 1 of the Moderna vaccine past the 6 hour used-by time, was considered resolved on 01 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # 025L20A.  There were no reported AEs associated with this case of out of specification product use.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Presyncope
Clinical narrative: short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the left arm, on 03Jan2021 at 10:00, at a single dose, for covid-19 immunization. Medical history included known allergies (unspecified). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a doctor's office/urgent care. The patient experienced 3 "waves" or what her many coworkers were describing as "whooshes". The first two occurred minutes apart approximately 4-5 minutes post vaccine-last less than one minute each. The 3rd wave occurred after lunch approximately 3 hours later-lasted approximately 2 hours but not as intense as the first times. The patient further described the symptoms as "felt like a rush" (unspecified) experienced when receiving epinephrine. She was short of breath, lightheaded, dizzy, like pre-syncope as she felt like she could pass out but did not do so. The events occurred on 03Jan2021. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date. The patient has not been tested for COVID-19 since vaccination.