chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Eating disorder, Fatigue, Headache, Hyperhidrosis, Incorrect route of product administration
Clinical narrative: like she had a lupus flare; Headache; feeling Tired; Trouble eating; Sweating; felt pretty sick; Intramuscular formulation administered by other route; This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 23rd February 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 23rd February 2020, unknown after receiving Shingrix and an unknown time after starting Benlysta Autoinjector Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), headache, tiredness, eating disorder, sweating and feeling unwell. The patient was treated with belimumab autoinjector device (Benlysta Autoinjector Device). On an unknown date, the outcome of the systemic lupus erythematosus, headache and sweating were not recovered/not resolved and the outcome of the tiredness, eating disorder, feeling unwell and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the systemic lupus erythematosus, headache, tiredness, eating disorder, sweating and feeling unwell to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. She reported that she received a Shingrix shot on 23rd February 2020 as she had a history of getting Shingles. She said that after getting the Shingrix shot, she felt pretty sick like she had a lupus flare and experienced feeling tired, headache, trouble eating and sweating.  The patient was taking Benlysta and used the autoinjector for SLE. She stated she started Benlysta in December of 2020. She reported that after starting Benlysta she was experienced headaches and nausea. She said these symptoms were getting better that she pre-medicates for the headache, but they had not resolved. She did not have lot numbers to provide for either medication. The reporter consented to follow up. The case has been linked with the case US2021AMR055627 reported for same patient by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR055627:same patient
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Systemic lupus erythematosus
Clinical narrative: like she had a lupus flare; Headache; feeling Tired; Trouble eating; Sweating; felt pretty sick; Intramuscular formulation administered by other route; This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 23rd February 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 23rd February 2020, unknown after receiving Shingrix and an unknown time after starting Benlysta Autoinjector Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), headache, tiredness, eating disorder, sweating and feeling unwell. The patient was treated with belimumab autoinjector device (Benlysta Autoinjector Device). On an unknown date, the outcome of the systemic lupus erythematosus, headache and sweating were not recovered/not resolved and the outcome of the tiredness, eating disorder, feeling unwell and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the systemic lupus erythematosus, headache, tiredness, eating disorder, sweating and feeling unwell to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. She reported that she received a Shingrix shot on 23rd February 2020 as she had a history of getting Shingles. She said that after getting the Shingrix shot, she felt pretty sick like she had a lupus flare and experienced feeling tired, headache, trouble eating and sweating.  The patient was taking Benlysta and used the autoinjector for SLE. She stated she started Benlysta in December of 2020. She reported that after starting Benlysta she was experienced headaches and nausea. She said these symptoms were getting better that she pre-medicates for the headache, but they had not resolved. She did not have lot numbers to provide for either medication. The reporter consented to follow up. The case has been linked with the case US2021AMR055627 reported for same patient by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR055627:same patient
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypertension, Intracranial pressure increased
Clinical narrative: intracranial hypertension; elevated blood pressure; Headache; A Spontaneous report  received from a consumer concerning a male patient (demographics not provided) who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced intracranial hypertension, Headache, and elevated blood pressure.  The medical history of patient was not reported. Concomitant medications included unspecified blood pressure medications.  On 11 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot # not provided) intramuscularly (site of administration not provided) for prophylaxis of COVID-19 infection.  On an unknown date in Feb 2021, post vaccination, the patient developed a headache and elevated blood pressure which was relieved by blood pressure medicine. The patient reported that the headache was caused by  intracranial hypertension and would like the manufacturers to study the correlation between Covid vaccines and intracranial hypertension. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was not reported.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Intracranial pressure increased among others, after receiving first dose mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; A spontaneous report was received from a consumer concerning a 76-year-old, female patient who received Moderna's COVID-19 Vaccine and developed polymyalgia rheumatica.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 04FEB2021, approximately 15days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received the 1st dose of the vaccine in her left/non-dominant arm on 04Feb2021. Patient was later diagnosed with polymyalgia rheumatica and treatment for the event included prednisone 10 mg. Patient wanted to know if prednisone would interfere with the Moderna covid vaccine she received.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event was unknown.; Reporter's Comments: This case concerns a 76 year old female patient, who experienced a serious unexpected event of polymyalgia rheumatica, after receiving first dose mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Peripheral coldness
Clinical narrative: High blood pressure (200 systolic); Cold palms; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cold palms and high blood pressure (200) systolic.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced cold palms and high blood pressure (200 systolic) for which she was taken to the emergency room (ER). No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.    The outcome of the events, cold palms and high blood pressure (200) systolic was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hemiparaesthesia, Hypoaesthesia, Paraesthesia, Swollen tongue
Clinical narrative: Tingling on left side of the body; Elevated blood pressure; Tongue began to swell; Facial tingling; Facial numbness; A spontaneous report was received from a physician concerning a 54-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling and numbness on the left side of the body, elevated blood pressure, swelling of tongue, facial tingling, and facial numbness.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Feb 2021, immediately prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (batch# unknown) for prophylaxis of COVID-19 infection.   The patient had an immediate reaction that resulted in tingling/numbness on the left side of her body as well as an elevated blood pressure. The numbness continued to her face/mouth and her tongue began to swell. After a short period of time, the tingling in the body subsided, but the numbness/tingling in the face persists. The health department where the patient received the vaccine attempted to call an ambulance, but the patient refused medical treatment.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of tingling on the left side of the body was recovered. The outcome of the events, elevated blood pressure, and swelling of the tongue were unknown. The events, facial tingling, and facial numbness were not recovered.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose given early before 28 days had passed.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: IT WAS UNKNOWN AT TIME OF ADMINSTRATION PATIENT HAD RECEIVED 2 DOSES OF MODERNA ALREADY, SO PATIENT WAS ADMINISTERED A 3RD DOSE ON 3/2/21.  UPON BILLING IT WAS DETERMINED PATIENT HAD ALREADY RECEIVED 2 PRIOR DOSES ON 1/14/21  AND 2/10/21
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Delayed localized rash. Onset occurred about 8 days after vaccination. Symptoms included redness and mild itching. Rash was about 2 inches in diameter.  Resolved within 4 days.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Phantom limb syndrome
Clinical narrative: Phantom pain in heel of left amputated leg - has been amputated for 15 years with no phantom pain .  The phantom paid resolved by morning.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Extreme chills and shaking - 5 hours,  nausea,  aches,  headache, fatigue, cough, shortness of breath ,  no appetite after shaking stopped.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Tremor
Clinical narrative: Extreme chills and shaking - 5 hours,  nausea,  aches,  headache, fatigue, cough, shortness of breath ,  no appetite after shaking stopped.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: 6 hours (3 pm) after getting the second dose, my left arm was very sore, even though I had been applying ice, so I took 200 mg of Advil.  At 9:15 pm, I had chills and fever for 3 hours  and during that time, my right forearm, wrist and hand became very, very sore.  I  couldn't even flex my fingers the pain was so bad.  Pain throughout my body continued during the night, including stomach cramps, back and leg pain and then I took another 200 mg of Advil at 9:15 am on 3/4.  I feel I am 20% improved 25 hours after my second shot.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 6 hours (3 pm) after getting the second dose, my left arm was very sore, even though I had been applying ice, so I took 200 mg of Advil.  At 9:15 pm, I had chills and fever for 3 hours  and during that time, my right forearm, wrist and hand became very, very sore.  I  couldn't even flex my fingers the pain was so bad.  Pain throughout my body continued during the night, including stomach cramps, back and leg pain and then I took another 200 mg of Advil at 9:15 am on 3/4.  I feel I am 20% improved 25 hours after my second shot.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disturbance in attention, Fall, Hypoaesthesia, Impaired driving ability
Clinical narrative: Patient states she was weak, and couldn't feel her arms or legs about an hour after getting her COVID 19 vaccine. States on the way home she ended up on the wrong side of the road and felt like she wasn't focused and this progressed to numbness. States that when she went to get out of her car she had a fall and is unsure if she passed out or just fell. States these symptoms lasted 3-4 hours but it gradually improved. States almost all symptoms had improved by the next day.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site ulcer, Injection site warmth
Clinical narrative: red lesion at the injection site, approx 2 in across, firm, tender, and warm to the touch. very painful and slightly itchy
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Lethargy, Malaise, Pain
Clinical narrative: By 6 pm 3/2/21 my arm was getting very sore, hurt to move it, was warm and had a lump. By 9pm was starting to get achy and generally not feeling well. by 10 pm I had a temp of 101. Took Ibuprofen and went to bed. Woke up at 4am temp was 101.5, had chills and could not get warm Took Tylenol. continued to have chills and achy till 3pm. Started feeling better after that was just very lethargic and arm still sore.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: By 6 pm 3/2/21 my arm was getting very sore, hurt to move it, was warm and had a lump. By 9pm was starting to get achy and generally not feeling well. by 10 pm I had a temp of 101. Took Ibuprofen and went to bed. Woke up at 4am temp was 101.5, had chills and could not get warm Took Tylenol. continued to have chills and achy till 3pm. Started feeling better after that was just very lethargic and arm still sore.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Vertigo, Vision blurred
Clinical narrative: Woke up and the room was spinning, carefully walked to the bathroom for drink of water, had to sit and wait for the room to stop spinning. When I tried to lay down it started spinning again and I found I could not focus on single spot. At 9am The spinning stopped but I feel very weak.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Headache, Insomnia, Myasthenia gravis
Clinical narrative: Severe weakness worsened Myasthenia Gravis. Respiratory muscle weakness, chronic weakness, headaches painful scar tissue. Restlessness unable to sleep. Started 4 day course of IVIG, high dose of prednisone
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory muscle weakness, Restlessness
Clinical narrative: Severe weakness worsened Myasthenia Gravis. Respiratory muscle weakness, chronic weakness, headaches painful scar tissue. Restlessness unable to sleep. Started 4 day course of IVIG, high dose of prednisone
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: On day 7 after shot at around 10am my upper left arm began itching . In the early afternoon a rash appeared. It  turned into a solid red patch of about 6 inches long by 5 inches wide which continued to itch. The upper arm also was also  sore.  It began to fade after two days and is almost gone at day 4.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: March 1 the day of vaccine my arm had pain and itchy at injection site. March 2 my arm red and itchy site of injection. March 3 my arm a little more red and itchy at site of injection. March 4 the red area a little bigger and itchy.  This is my second shot. the first shot this did not happen till a week after shot. I had the same symptoms after first shot but they were delayed a week and this time it stated within hours.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Musculoskeletal chest pain, Pain, Pain in extremity
Clinical narrative: About a day after the vaccine, (Thursday) I developed a mild headache and mild general aches . These resolved quickly. But  about Friday, my  right hand began to ache a bit. It became excruciating by Sunday.  My right elbow and my right ribs also hurt, but the joints in my right hand were on fire. I could not open, close, or flex it without severe joint pain. It was sore even to the touch especially at the joints.  The hand appeared to be a bit swollen as well. I took ibuprofen and it helped a bit. By Monday morning it was much better, but my hand still aches some.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: About a day after the vaccine, (Thursday) I developed a mild headache and mild general aches . These resolved quickly. But  about Friday, my  right hand began to ache a bit. It became excruciating by Sunday.  My right elbow and my right ribs also hurt, but the joints in my right hand were on fire. I could not open, close, or flex it without severe joint pain. It was sore even to the touch especially at the joints.  The hand appeared to be a bit swollen as well. I took ibuprofen and it helped a bit. By Monday morning it was much better, but my hand still aches some.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash, uticaria
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Hip arthroplasty, Hip fracture
Clinical narrative: Patient presented to the ED after a mechanical fall resulting in left hip pain. She was found to have a fracture and underwent a left hip hemiarthroplasty. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Taste disorder
Clinical narrative: Mouth, tongue numbness and odd taste in mouth within 20 minutes of vaccine. Also occurred with 1st vaccine and a headache the next day.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: Received the vaccine intramuscularly in right arm at 1:00 PM on 3/3/21. Pain and muscle soreness began approx. 10 minutes after receiving vaccine. Fatigue and headache present by 3:00 PM on 3/3/21. Began hydrating with water and Gatorade at this time. Muscle pain and join soreness present from right shoulder to right hand by 4:00 PM on 3/3/21. Pain and stiffness in fingers of right hand by 5:00 PM on 3/3/21. Mild congestion, brain fog by 6:00 PM on 3/3/21. Any contact between right arm and other objects or surfaces caused significant pain by 8:00 PM on 3/3/21. Took 800 mg ibuprofin to alleviate pain (pre-existing tolerance to NSAIDs necessitates higher than normal dosages). Swelling of the right arm and hand identified by 9:00 PM on 3/3/21. Swelling was most significant in the hand, and accompanied worsening joint pain and stiffness in the fingers. Applied a cold pack to address swelling (20 minutes on, 20 minutes off). Could not identify these specific side effects in the information available online, took a Benadryl in case it was an allergic reaction. Swelling decreased overnight and was gone by 5:00 AM on 3/4/21. Diarrhea began at 6:00 AM on 3/4/21 and is still present at the time of this report. Will continue to hydrate with water and Gatorade. At the time of this report, pain in right arm still present from shoulder to wrist and entire arm is tender to the touch, but pain level has lessened. Pain and stiffness in right side of neck present by 5:00 AM on 3/4/21 and is still present at the time of this report. Lymph nodes in right underarm swollen by 5:00 AM on 3/4/21 and swelling is still present at the time of this report. Will continue with regimen of ibuprofin as needed.  * I am recovering fine at home, but I wanted to log these side effects for data collection purposes. I couldn't find any information about these side effects online and that really freaked me out, so I hope that writing this report will help people in a similar situation.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Received the vaccine intramuscularly in right arm at 1:00 PM on 3/3/21. Pain and muscle soreness began approx. 10 minutes after receiving vaccine. Fatigue and headache present by 3:00 PM on 3/3/21. Began hydrating with water and Gatorade at this time. Muscle pain and join soreness present from right shoulder to right hand by 4:00 PM on 3/3/21. Pain and stiffness in fingers of right hand by 5:00 PM on 3/3/21. Mild congestion, brain fog by 6:00 PM on 3/3/21. Any contact between right arm and other objects or surfaces caused significant pain by 8:00 PM on 3/3/21. Took 800 mg ibuprofin to alleviate pain (pre-existing tolerance to NSAIDs necessitates higher than normal dosages). Swelling of the right arm and hand identified by 9:00 PM on 3/3/21. Swelling was most significant in the hand, and accompanied worsening joint pain and stiffness in the fingers. Applied a cold pack to address swelling (20 minutes on, 20 minutes off). Could not identify these specific side effects in the information available online, took a Benadryl in case it was an allergic reaction. Swelling decreased overnight and was gone by 5:00 AM on 3/4/21. Diarrhea began at 6:00 AM on 3/4/21 and is still present at the time of this report. Will continue to hydrate with water and Gatorade. At the time of this report, pain in right arm still present from shoulder to wrist and entire arm is tender to the touch, but pain level has lessened. Pain and stiffness in right side of neck present by 5:00 AM on 3/4/21 and is still present at the time of this report. Lymph nodes in right underarm swollen by 5:00 AM on 3/4/21 and swelling is still present at the time of this report. Will continue with regimen of ibuprofin as needed.  * I am recovering fine at home, but I wanted to log these side effects for data collection purposes. I couldn't find any information about these side effects online and that really freaked me out, so I hope that writing this report will help people in a similar situation.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pulmonary congestion
Clinical narrative: Received the vaccine intramuscularly in right arm at 1:00 PM on 3/3/21. Pain and muscle soreness began approx. 10 minutes after receiving vaccine. Fatigue and headache present by 3:00 PM on 3/3/21. Began hydrating with water and Gatorade at this time. Muscle pain and join soreness present from right shoulder to right hand by 4:00 PM on 3/3/21. Pain and stiffness in fingers of right hand by 5:00 PM on 3/3/21. Mild congestion, brain fog by 6:00 PM on 3/3/21. Any contact between right arm and other objects or surfaces caused significant pain by 8:00 PM on 3/3/21. Took 800 mg ibuprofin to alleviate pain (pre-existing tolerance to NSAIDs necessitates higher than normal dosages). Swelling of the right arm and hand identified by 9:00 PM on 3/3/21. Swelling was most significant in the hand, and accompanied worsening joint pain and stiffness in the fingers. Applied a cold pack to address swelling (20 minutes on, 20 minutes off). Could not identify these specific side effects in the information available online, took a Benadryl in case it was an allergic reaction. Swelling decreased overnight and was gone by 5:00 AM on 3/4/21. Diarrhea began at 6:00 AM on 3/4/21 and is still present at the time of this report. Will continue to hydrate with water and Gatorade. At the time of this report, pain in right arm still present from shoulder to wrist and entire arm is tender to the touch, but pain level has lessened. Pain and stiffness in right side of neck present by 5:00 AM on 3/4/21 and is still present at the time of this report. Lymph nodes in right underarm swollen by 5:00 AM on 3/4/21 and swelling is still present at the time of this report. Will continue with regimen of ibuprofin as needed.  * I am recovering fine at home, but I wanted to log these side effects for data collection purposes. I couldn't find any information about these side effects online and that really freaked me out, so I hope that writing this report will help people in a similar situation.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red blotch appeared on left arm approximately 10 days after injection, fading after 3 or 4 days. Looked like a birth mark, was not itchy and no treatment needed.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Lethargy, Pain
Clinical narrative: General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat tightness
Clinical narrative: General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Swelling, Upper airway obstruction
Clinical narrative: Pt after discussion with treating allergist elected to complete dose 1 of Pfizer COVID-19 vaccination. Per pt report she had premedicated with Benadryl 100mg po prior to immunization and brought along her prescribed epi-pen. After reciept of vaccination, she proceed to recovery area where she was dictated to 30 minutes of observation, approximately 7 minutes after inoculation began having symptoms consistent with upper airway swelling and self-administered epi-pen and called for medical assistance. EMS was then called and upon arrival found her in stable condition and transported the patient to emergency room at Hospital.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event. 1st dose COVID 19 vaccine 1/11/21. Pt scheduled for 2nd vaccine on 2./5/21, 25 days after her 1st dose. CDC recommends 28 days with 4 day window before and after the 28 day mark. Pt 2nd dose rescheduled for 2/2/21 which was 22 days after 1st dose. Pt recieved 2nd dose outside the CDC recommendation time frame.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient developed a small erythematous spot at the site of injection of the vaccination; this area is slightly warm and itchy.  She reports that the symptoms are not severe and has read on-line that this should go away after about a week.  She has no SOB, wheezing, arm pain.  Plan for patient to take an OTC anti-histamine like Claritin and use topical hydrocortisone ointment for itching if needed.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Motion sickness, Nausea, Pain in extremity
Clinical narrative: Initially after the shot I had fatigue and arm pain and nausea that would come in waves. As the days went by the fatigue and arm pain went away, but I continue to have waves of nausea if I move around, almost like motion sickness. In the past 10 days I?ve completely lost my appetite. I gag at the thought of eating food, despite 24 hours going by with nothing being eaten. I?m forcing myself to eat at least once/day, but am full after half a portion.  I still experience the ?motion sickness? when I am physically active.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at the site of injection that started the night of the injection  No fever or systemic symptoms reported Applied topical calamine and the redness improved by day 3-4
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Tenderness
Clinical narrative: I had extreme soreness in my arm for about 2-3 days.  It went away, but oddly came back after about 6 days.  It was just as sore as the first time and took up to about 7 more days to go away. Not noticeably swollen or red.  After that I had residual pain, tenderness and itchiness for about 2-3 more weeks.  Finally gone.  I had tenderness and pain for a few days after the second vaccine, but it never came back like it did with the first vaccine.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pain in extremity
Clinical narrative: Miid arm pain, general achiness, feeling unwell, chills. Mild symptoms overnight pretty much resolved by 10:00 am the day following vaccination. No treatment received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy-treated with Prednisone
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: splotchy Red arm, itchy 9 days after shot given
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Heart rate increased
Clinical narrative: about 1 min and 30 sec to 2 mins after getting the vaccine, I felt as if I was about to faint (felt a draining in my body and my arms got very weak) my HR had gone from resting 85bpm to 108bpm (recorded on my watch) this lasted for about 30 seconds and went away
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Patient had two witnessed seizure like episodes with nystagmus and unresponsive each episode lasted less than 20 seconds. Patient had prodrome prior to both events but no memory or either event. Both event happened within 15 minutes of vaccine administration. Patient was transported to the emegency department for further testing and care.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Pruritus, Skin reaction
Clinical narrative: skin reaction limited to upper arm-redness slight itching.  using Allegra and monitoring.    first dose caused slight redness at injection site and second dose the redness worsened
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: About 12 hours after 2nd dose of Modern Covid 10 vaccination, severe chills and fever of 101.5* lasting over 24 hours. Injection site is very red, very swollen, hard, and itches even 2 days later. Notable muscle aches throughout body and extreme fatigue. Headaches even 2 days later.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: About 12 hours after 2nd dose of Modern Covid 10 vaccination, severe chills and fever of 101.5* lasting over 24 hours. Injection site is very red, very swollen, hard, and itches even 2 days later. Notable muscle aches throughout body and extreme fatigue. Headaches even 2 days later.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Immediate post-injection reaction, Urticaria
Clinical narrative: Pt became flush and developed hives immediately upon injection. Medics on site administered antihistamine. Within 10 minutes the flushing and hives returned and the patient was transported to a local hospital for further assessment/treatment.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Retching, Syncope
Clinical narrative: Patient administered Moderna Covid-19 vaccine at 1:21 p.m. on 3/3/21.  Patient at 1:36 p.m. experienced syncope while being monitored; EMS staff and RN responded to patient. EMS staff and RN spoke to patient and assisted patient to EMS cart.  EMS staff took patient's vitals:  pulse 70, respirations 22, blood pressure 159/85.  ABC's clear at this time of response.  Patient speaking after recovery from syncope.  Patient, while strapped on EMS cart, began gagging and provided emesis bag.  Patient transported to EMS ambulance (which was parked immediately outside the facilities doors). two to three minutes after syncope event where reportedly patient given Benadryl and IV fluids in ambulance and transported to ER.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dyspnoea, Hypothyroidism, Hypoxia, Pulmonary oedema
Clinical narrative: Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Catheterisation cardiac abnormal, Chest discomfort, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coronary artery disease, Diastolic dysfunction, Dyspnoea, Echocardiogram abnormal, Ejection fraction normal
Clinical narrative: Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary congestion, Pulmonary hypertension, Pulmonary mass, Pulmonary oedema, Ventricular tachycardia
Clinical narrative: Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cough, Increased upper airway secretion, Swollen tongue, Throat tightness
Clinical narrative: At 1630 pt c/o tightness and tongue swelling. Administered benadryl 50mg PO and cetirizine 10mg PO  Pt taken to private observation room, reclined and VS taken WNL Extension of sx to include repetitive cough, throat secretions, anxiety, expiratory wheezes epinephrine 0.3mg IM  x1 administered at 1645, 2L O2 by NC applied for comfort; and EMS activated VS taken again and WNL Stable on discharge at 1705 and sent to nearest ER by ambulance
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: At 1630 pt c/o tightness and tongue swelling. Administered benadryl 50mg PO and cetirizine 10mg PO  Pt taken to private observation room, reclined and VS taken WNL Extension of sx to include repetitive cough, throat secretions, anxiety, expiratory wheezes epinephrine 0.3mg IM  x1 administered at 1645, 2L O2 by NC applied for comfort; and EMS activated VS taken again and WNL Stable on discharge at 1705 and sent to nearest ER by ambulance
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Numbness of tip of tongue and roof of mouth, lasting many hours.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and palms of hands), headaches, nausea.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and palms of hands), headaches, nausea.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Audiogram, Deafness, Otoscopy, Tinnitus
Clinical narrative: Ringing in the ear. Hearing loss. Prescribed prednisone Take 40 mg day 1-2, 30 mg on day 3-4, 20 mg on day 5-6, 10 mg on day 7-8, 5 mg on day 9-10. Prescribed on 1/20/2021. Then on 3/3/2021 prescribed prednisone 20 mg tablets TAKE 1 TABLET 3 TIMES A DAY FOR 7 DAYS, THEN 1 TABLET 2 TIMES A DAY FOR 4 DAYS, THEN 1 TABLET D FOR 4 DAYS, THEN 1/2 TABLET D FOR 4 DAYS. Currently still has hearing loss and ringing in the ear.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tympanometry
Clinical narrative: Ringing in the ear. Hearing loss. Prescribed prednisone Take 40 mg day 1-2, 30 mg on day 3-4, 20 mg on day 5-6, 10 mg on day 7-8, 5 mg on day 9-10. Prescribed on 1/20/2021. Then on 3/3/2021 prescribed prednisone 20 mg tablets TAKE 1 TABLET 3 TIMES A DAY FOR 7 DAYS, THEN 1 TABLET 2 TIMES A DAY FOR 4 DAYS, THEN 1 TABLET D FOR 4 DAYS, THEN 1/2 TABLET D FOR 4 DAYS. Currently still has hearing loss and ringing in the ear.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Erythema, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: About 12 hours after vaccine she felt like she had COVID all over again.  She had fever of 101, and then the body aches that were very painful.  She took Tylenol #3 for the pain and didn't notice the arm hurting yet.  The main thing was the body aches and fever.  She had chills off and on and a headache.  She felt like she just couldn't get up, wiped out.  She did not eat or drink much.  Through the day Saturday and by Sunday the body aches left, the chills went down during the day but returned Sunday night 2/28/21.  On 3/1/21 she went to the doctor and her temp was down, and is down now 3/4/21.  Through the night Sunday night started having terrible pain in her chest/esophagus, which she could not get the pain to go away.  She did the remedy that she read online, and has had some GERD over the years, but nothing like this.  She could hardly even swallow her own saliva without pain.  She got a prescription for Nexium from the doctor, and started taking that today.  She is trying to eat something, little bity bits to go down without pain in her esophagus.  The pain does get better at times during the day.  She read that it may take 2-3 weeks to heal and the Nexium should be working by then.  She is very fatigued and dealing with the acid reflux issues.   She did also notice redness on her arm was about 3" x 2" down her arm.  It was not at the site of the injection, was a little lower and it was hot to touch.  She kept putting a cold washcloth on it.  She took regular Tylenol.  The body aches went away but was left with such a heavy headache that she took up to 4 Tylenol #4 due to pain.  The redness had faded to about a square " by the time she went to the doctor on Monday, and is still really sore.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Odynophagia, Pain, Pyrexia, Skin warm
Clinical narrative: About 12 hours after vaccine she felt like she had COVID all over again.  She had fever of 101, and then the body aches that were very painful.  She took Tylenol #3 for the pain and didn't notice the arm hurting yet.  The main thing was the body aches and fever.  She had chills off and on and a headache.  She felt like she just couldn't get up, wiped out.  She did not eat or drink much.  Through the day Saturday and by Sunday the body aches left, the chills went down during the day but returned Sunday night 2/28/21.  On 3/1/21 she went to the doctor and her temp was down, and is down now 3/4/21.  Through the night Sunday night started having terrible pain in her chest/esophagus, which she could not get the pain to go away.  She did the remedy that she read online, and has had some GERD over the years, but nothing like this.  She could hardly even swallow her own saliva without pain.  She got a prescription for Nexium from the doctor, and started taking that today.  She is trying to eat something, little bity bits to go down without pain in her esophagus.  The pain does get better at times during the day.  She read that it may take 2-3 weeks to heal and the Nexium should be working by then.  She is very fatigued and dealing with the acid reflux issues.   She did also notice redness on her arm was about 3" x 2" down her arm.  It was not at the site of the injection, was a little lower and it was hot to touch.  She kept putting a cold washcloth on it.  She took regular Tylenol.  The body aches went away but was left with such a heavy headache that she took up to 4 Tylenol #4 due to pain.  The redness had faded to about a square " by the time she went to the doctor on Monday, and is still really sore.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, X-ray limb
Clinical narrative: Extreme pain shooting down left arm that started after 3 days and has gotten worse every day. Now is unbearable
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Chills, Pain, Pyrexia
Clinical narrative: Day 1 I had fever chills body aches Day 2 I got a rash on my arm and chest pains  Day 3 still having chest pain
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Day 1 I had fever chills body aches Day 2 I got a rash on my arm and chest pains  Day 3 still having chest pain
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Chills, body aches, sore throat, sore arm
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Rash, Rash erythematous
Clinical narrative: circumferential rash of left upper arm, evidently appearing on day of vaccination (2/25/21) with increased warmth, redness, induration, and itching; reportedly progressing through 2/28/21 with a sunburn-like appearance; continuing to improve to the date of follow-up with me (3/3/21) to darkening of the arm from the shoulder down to the elbow and mild residual itching. Pt treated the rash with oral Benadryl and topical hydrocortisone.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin warm
Clinical narrative: circumferential rash of left upper arm, evidently appearing on day of vaccination (2/25/21) with increased warmth, redness, induration, and itching; reportedly progressing through 2/28/21 with a sunburn-like appearance; continuing to improve to the date of follow-up with me (3/3/21) to darkening of the arm from the shoulder down to the elbow and mild residual itching. Pt treated the rash with oral Benadryl and topical hydrocortisone.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Death, Fatigue, Flatulence
Clinical narrative: Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye pain
Clinical narrative: Within approximately 56  hours from 1st injection, I got an intense left eye pain.  Went to the ER where they flushed it, numbed it, and prescribed drops for conjunctivitis.  I had no symptoms prior.  Completed treatment and seemed fine.    Within 13 hours of second dose (3/3/21 @ 2:00 pm), I woke up with eye pain in the left eye and used part of the remaining drops; thankfully did not get as bad as the first one, so far.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Nausea
Clinical narrative: About 4 hours after injection had chills, and headache similar to caffeine withdrawal.   About 7 hours later more intense chills, body felt hot [ no increased temperature] and slight nausea.  This lasted until early morning hours
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: post vaccine patient complained of dizziness, had an extra 15 minutes of rest, felt no better and complained she felt out of it.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Every joint in my body hurts. No apparent rash. Headache but no fever
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea
Clinical narrative: Moderna COVID-19 Vaccine one day after getting his 2nd shot Chills, Muscle Pain, Nausea,
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Patient states that after waiting for the 15 minutes of observation, within 30 to 40 minutes she had a seizure. Said it resolved and she did not seek medical attention but wanted to know if she should receive the second shot.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: Headache, stomachache, nausea.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort
Clinical narrative: I just wanted to report extreme PHYSICAL  EXHAUSTION. The first day it felt like someone had drugged me with a full body sedative but my brain function was fine. Since then, I've only had a low grade temperature 98.4 (I normally have a much lower temp - 96.5/97) but my whole body feels so heavy - my legs and arms feel heavy to lift or to walk.  I just wanted to report this in case it can help anyone understand more about the vaccine. I'm 4 days in and it hasn't gone away so I figured it was worth mentioning. The strange part being that I have no real fever to go along with the extreme physical exhaustion, which is strange right? I started taking some Tylenol but otherwise just hydrating and trying to go for a walk every day.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Blood glucose normal, Blood test, C-reactive protein increased, Dermatitis allergic
Clinical narrative: I woke up with slightly itchy, severe skin rash on 2/23/2021 following second vaccine injection at 10:58 am on 2/21/2021. The rash completely covered both buttocks, the  top front inside of both thighs, both hips, the front groin area, inside/bottom of both feet. Given the extent and intensity of rash, it must have started on Monday 2/22/2021. The rash was red-purple with white spots (perhaps hives).   I contacted my primary care physician's office on 2/23/2021 and had a televisit with the nurse. Her diagnosis was Allergic Dermatitis/Itching. She prescribed Banophen (50 mg), Triamcinolone cream, and Cetirizine HCL (10 mg). I took the medicine.  Continued below.