chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Protein total, Red blood cell count normal, Red blood cell sedimentation rate, Red cell distribution width normal, Throat irritation
Clinical narrative: Pleasant 40-year-old male comes in the emergency room with concern related to allergic reaction. Patient had received his COVID-19 vaccination approximate 60 minutes ago, at approximate 45 minutes after vaccination he developed flank pain left greater than right rated a 3 out of 10 extending down to his thighs he also noted a scratchy type sensation in the back of his throat feeling as if he needed to frequently clear his throat. The symptoms have been ongoing now for the past 15 to 30 minutes with no increasing or change in symptoms. Has never had allergic reaction in the past, unsure of previous Covid 19 infection though he describes in February of last year having upper respiratory illness which time he lost his sense of taste and smell. Currently denies any fevers, chills, nausea or vomiting. Denies any diarrhea. Denies cough or shortness of breath. Denies any swelling of the lips, face, eyes or nose. Denies any rash.  Upon presentation emergency room patient was seen, evaluated, treated following standards of care given. Given patient's presenting symptoms and the recent COVID-19 vaccination will treat patient as adverse allergic reaction.   Patient was given 50 mg of Benadryl IV, 20 mg of Pepcid IV, 10 mg of Zyrtec p.o. and 125 Solu-Medrol IV. Patient was observed in the emergency room for minimum of 2 hours, with complete resolution of symptoms. Patient was discharged home on Zyrtec to take 10 mg by mouth daily as well as Pepcid 20 mg by mouth twice daily for minimum of next 14 days, prednisone 20 mg 1 by mouth daily x5 days. Patient was given a prescription for EpiPen should his symptoms return or progress, recommend he call 911 and return immediately. Risks and warnings were discussed in detail, all questions were answered, patient verbalized understanding agreement plan of care.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count normal
Clinical narrative: Pleasant 40-year-old male comes in the emergency room with concern related to allergic reaction. Patient had received his COVID-19 vaccination approximate 60 minutes ago, at approximate 45 minutes after vaccination he developed flank pain left greater than right rated a 3 out of 10 extending down to his thighs he also noted a scratchy type sensation in the back of his throat feeling as if he needed to frequently clear his throat. The symptoms have been ongoing now for the past 15 to 30 minutes with no increasing or change in symptoms. Has never had allergic reaction in the past, unsure of previous Covid 19 infection though he describes in February of last year having upper respiratory illness which time he lost his sense of taste and smell. Currently denies any fevers, chills, nausea or vomiting. Denies any diarrhea. Denies cough or shortness of breath. Denies any swelling of the lips, face, eyes or nose. Denies any rash.  Upon presentation emergency room patient was seen, evaluated, treated following standards of care given. Given patient's presenting symptoms and the recent COVID-19 vaccination will treat patient as adverse allergic reaction.   Patient was given 50 mg of Benadryl IV, 20 mg of Pepcid IV, 10 mg of Zyrtec p.o. and 125 Solu-Medrol IV. Patient was observed in the emergency room for minimum of 2 hours, with complete resolution of symptoms. Patient was discharged home on Zyrtec to take 10 mg by mouth daily as well as Pepcid 20 mg by mouth twice daily for minimum of next 14 days, prednisone 20 mg 1 by mouth daily x5 days. Patient was given a prescription for EpiPen should his symptoms return or progress, recommend he call 911 and return immediately. Risks and warnings were discussed in detail, all questions were answered, patient verbalized understanding agreement plan of care.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Thirst
Clinical narrative: Severe headache from 12/30 0400 to 1/3/21, extreme fatigue, and excessive thirst
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site movement impairment, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Moderna EUA;  moderate swelling and itching and pain lifting arm at injection site occured 7 days after injection. This swelling and pain is more severe than the initial reaction I had in the three days following the injection.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Full blood count normal, Head discomfort, Headache
Clinical narrative: I worked the night of 18th and 19th (night shift nurse) -  night of 18th  - arm very sore (dominant arm where shot was taken) by end of night arm was sore; continued for several days. (Got my period either the night of 18th or morning of 19th). About 36 hours after vaccine; stood up to attend an alarm and felt very ill at patient's bedside and had to sit down: nauseous (felt similar to co-vid) - took Motrin an hour later; the day of 20th - slept all day; 21st - no appetite; mild headache - nauseous - period at same time of vaccine; 22nd - felt bleh; didn't eat much food - period going away but I  was feeling worse; feel like I have the return of internal vibrations (can sit in my hands when I'm trying to do something for a patient that needs done quickly)  back in July when I had Co-Vid (when I was out of work out of month - and had to see a cardiologist - two months until normal (neural and cardiac symptoms that went away with time) - so was returning of buzzing/etc. 23rd: could feel like I had internal vibrations sensations; nauseous - increased - got a refill from an old dental prescription - started Zofran; headache pressure (head pressure); a vertigo-ish feeling - felt like I just walked off a boat; at that point - called out of work - COVID hotline hospital call - did a rapid test that was negative (on 24th) and on 24th: had still all the same symptoms - nausea was worse and felt a bit more dizzy occasionally and called out of work again but could take care of myself (laid around) - " it felt like baby covid" 25th - work wanted me to get tested again; 26th - Panther Co-vid test - which was also negative. 27th and 28th - dizziness better; still taking Zofran one time /day (for nausea); was able to go to work on 29th - still had some nausea but didn't have to lie down all day anymore - still had internal vibrations - feels like I should be having a tremor but can't see it externally; 30th finally able to see primary care Dr and she ordered lab work: Dr wasn't certain it was an adverse effect vs. me feeling my own immune response to spike protein; Initial covid symptoms in July were similar to this; and she will see how things go; SED Rate was 1 so not concerning; CBC was fine and B12 was fine. Not much as changed since then: returned to work; can go about things in every day; stopped taking Zofran on 31st; I still had nausea but it was mild enough that I didn't need to take it and Dr said it would be best to stop due to it's on effects. Yesterday, was first day with no nausea (1/4/2021); still have internal vibrations sensation but it has gone down quite a bit - now more of a mild buzzing electric current sensation - like insides are buzzing super fast ; when I noticed when not occupied with other things which is how it faded out with original illness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Hypophagia, Impaired work ability, Malaise, Nausea
Clinical narrative: I worked the night of 18th and 19th (night shift nurse) -  night of 18th  - arm very sore (dominant arm where shot was taken) by end of night arm was sore; continued for several days. (Got my period either the night of 18th or morning of 19th). About 36 hours after vaccine; stood up to attend an alarm and felt very ill at patient's bedside and had to sit down: nauseous (felt similar to co-vid) - took Motrin an hour later; the day of 20th - slept all day; 21st - no appetite; mild headache - nauseous - period at same time of vaccine; 22nd - felt bleh; didn't eat much food - period going away but I  was feeling worse; feel like I have the return of internal vibrations (can sit in my hands when I'm trying to do something for a patient that needs done quickly)  back in July when I had Co-Vid (when I was out of work out of month - and had to see a cardiologist - two months until normal (neural and cardiac symptoms that went away with time) - so was returning of buzzing/etc. 23rd: could feel like I had internal vibrations sensations; nauseous - increased - got a refill from an old dental prescription - started Zofran; headache pressure (head pressure); a vertigo-ish feeling - felt like I just walked off a boat; at that point - called out of work - COVID hotline hospital call - did a rapid test that was negative (on 24th) and on 24th: had still all the same symptoms - nausea was worse and felt a bit more dizzy occasionally and called out of work again but could take care of myself (laid around) - " it felt like baby covid" 25th - work wanted me to get tested again; 26th - Panther Co-vid test - which was also negative. 27th and 28th - dizziness better; still taking Zofran one time /day (for nausea); was able to go to work on 29th - still had some nausea but didn't have to lie down all day anymore - still had internal vibrations - feels like I should be having a tremor but can't see it externally; 30th finally able to see primary care Dr and she ordered lab work: Dr wasn't certain it was an adverse effect vs. me feeling my own immune response to spike protein; Initial covid symptoms in July were similar to this; and she will see how things go; SED Rate was 1 so not concerning; CBC was fine and B12 was fine. Not much as changed since then: returned to work; can go about things in every day; stopped taking Zofran on 31st; I still had nausea but it was mild enough that I didn't need to take it and Dr said it would be best to stop due to it's on effects. Yesterday, was first day with no nausea (1/4/2021); still have internal vibrations sensation but it has gone down quite a bit - now more of a mild buzzing electric current sensation - like insides are buzzing super fast ; when I noticed when not occupied with other things which is how it faded out with original illness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, SARS-CoV-2 antibody test, SARS-CoV-2 test negative, Sensory disturbance
Clinical narrative: I worked the night of 18th and 19th (night shift nurse) -  night of 18th  - arm very sore (dominant arm where shot was taken) by end of night arm was sore; continued for several days. (Got my period either the night of 18th or morning of 19th). About 36 hours after vaccine; stood up to attend an alarm and felt very ill at patient's bedside and had to sit down: nauseous (felt similar to co-vid) - took Motrin an hour later; the day of 20th - slept all day; 21st - no appetite; mild headache - nauseous - period at same time of vaccine; 22nd - felt bleh; didn't eat much food - period going away but I  was feeling worse; feel like I have the return of internal vibrations (can sit in my hands when I'm trying to do something for a patient that needs done quickly)  back in July when I had Co-Vid (when I was out of work out of month - and had to see a cardiologist - two months until normal (neural and cardiac symptoms that went away with time) - so was returning of buzzing/etc. 23rd: could feel like I had internal vibrations sensations; nauseous - increased - got a refill from an old dental prescription - started Zofran; headache pressure (head pressure); a vertigo-ish feeling - felt like I just walked off a boat; at that point - called out of work - COVID hotline hospital call - did a rapid test that was negative (on 24th) and on 24th: had still all the same symptoms - nausea was worse and felt a bit more dizzy occasionally and called out of work again but could take care of myself (laid around) - " it felt like baby covid" 25th - work wanted me to get tested again; 26th - Panther Co-vid test - which was also negative. 27th and 28th - dizziness better; still taking Zofran one time /day (for nausea); was able to go to work on 29th - still had some nausea but didn't have to lie down all day anymore - still had internal vibrations - feels like I should be having a tremor but can't see it externally; 30th finally able to see primary care Dr and she ordered lab work: Dr wasn't certain it was an adverse effect vs. me feeling my own immune response to spike protein; Initial covid symptoms in July were similar to this; and she will see how things go; SED Rate was 1 so not concerning; CBC was fine and B12 was fine. Not much as changed since then: returned to work; can go about things in every day; stopped taking Zofran on 31st; I still had nausea but it was mild enough that I didn't need to take it and Dr said it would be best to stop due to it's on effects. Yesterday, was first day with no nausea (1/4/2021); still have internal vibrations sensation but it has gone down quite a bit - now more of a mild buzzing electric current sensation - like insides are buzzing super fast ; when I noticed when not occupied with other things which is how it faded out with original illness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vibratory sense increased, Vitamin B12 normal
Clinical narrative: I worked the night of 18th and 19th (night shift nurse) -  night of 18th  - arm very sore (dominant arm where shot was taken) by end of night arm was sore; continued for several days. (Got my period either the night of 18th or morning of 19th). About 36 hours after vaccine; stood up to attend an alarm and felt very ill at patient's bedside and had to sit down: nauseous (felt similar to co-vid) - took Motrin an hour later; the day of 20th - slept all day; 21st - no appetite; mild headache - nauseous - period at same time of vaccine; 22nd - felt bleh; didn't eat much food - period going away but I  was feeling worse; feel like I have the return of internal vibrations (can sit in my hands when I'm trying to do something for a patient that needs done quickly)  back in July when I had Co-Vid (when I was out of work out of month - and had to see a cardiologist - two months until normal (neural and cardiac symptoms that went away with time) - so was returning of buzzing/etc. 23rd: could feel like I had internal vibrations sensations; nauseous - increased - got a refill from an old dental prescription - started Zofran; headache pressure (head pressure); a vertigo-ish feeling - felt like I just walked off a boat; at that point - called out of work - COVID hotline hospital call - did a rapid test that was negative (on 24th) and on 24th: had still all the same symptoms - nausea was worse and felt a bit more dizzy occasionally and called out of work again but could take care of myself (laid around) - " it felt like baby covid" 25th - work wanted me to get tested again; 26th - Panther Co-vid test - which was also negative. 27th and 28th - dizziness better; still taking Zofran one time /day (for nausea); was able to go to work on 29th - still had some nausea but didn't have to lie down all day anymore - still had internal vibrations - feels like I should be having a tremor but can't see it externally; 30th finally able to see primary care Dr and she ordered lab work: Dr wasn't certain it was an adverse effect vs. me feeling my own immune response to spike protein; Initial covid symptoms in July were similar to this; and she will see how things go; SED Rate was 1 so not concerning; CBC was fine and B12 was fine. Not much as changed since then: returned to work; can go about things in every day; stopped taking Zofran on 31st; I still had nausea but it was mild enough that I didn't need to take it and Dr said it would be best to stop due to it's on effects. Yesterday, was first day with no nausea (1/4/2021); still have internal vibrations sensation but it has gone down quite a bit - now more of a mild buzzing electric current sensation - like insides are buzzing super fast ; when I noticed when not occupied with other things which is how it faded out with original illness.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy, Skin lesion
Clinical narrative: 7 days post vaccine enlarging erythematous, warm, tender circular skin lesion(6cm x 5 cm); reactive lymphadenopathy L axilla
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Neck pain, Pain, Swelling
Clinical narrative: pulling sensation on left arm to neck. took ibuprofen for discomfort. 1/4/21 began to get painful. feels a lump in neck area that has movement. sharp pain in neck, hurts to turn head.   Rotating hot/cold presses to site. Using a topical cream Voltaren for pain on neck/arm.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: developed a red non-raised rash on one side of vaccination site, occurred 15 post vaccine, and resolved 1/2 hour later
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Headache, Injection site pain, Pruritus
Clinical narrative: ?Moderna COVID- 19 Vaccine EUA? - Patient received Moderna vaccine 12/23/20, developed rigor and low grade temperature 99.8 degrees F, pain at injection site same day as injection. 12/27/2020 developed worst headache of life for 5-6 hours, vomiting, welts and hives on face, bruising of upper thighs, itching of legs. Patient considered going to emergency department due to severe headache and vomiting but improved after 5-6 hours. As of 1/5/2021, patient still has welts and hives on face and healing bruises on thighs, has been taking diphenhydramine with little improvement.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: ?Moderna COVID- 19 Vaccine EUA? - Patient received Moderna vaccine 12/23/20, developed rigor and low grade temperature 99.8 degrees F, pain at injection site same day as injection. 12/27/2020 developed worst headache of life for 5-6 hours, vomiting, welts and hives on face, bruising of upper thighs, itching of legs. Patient considered going to emergency department due to severe headache and vomiting but improved after 5-6 hours. As of 1/5/2021, patient still has welts and hives on face and healing bruises on thighs, has been taking diphenhydramine with little improvement.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever of 100.8, body aches, and headache...this was after the first dose
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dysgeusia, Erythema, Face oedema, Musculoskeletal stiffness
Clinical narrative: Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Pain
Clinical narrative: Chills, Body Aches, Temp 99.3, fatigue resolved within 48 hours from onset
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: about 3 minutes after receiving vaccine, heart rate jumped to extremely high.  Patient did not report until today so we were not able to get actual heart rate.  This lasted for about 30 seconds, then went back to normal.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: headache,nausea and vomiting ,chills
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: mild numbness left side of face, starting day of vaccination; no f/u info available at this time. discussed with local health office.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Mass, Pruritus
Clinical narrative: Hard painful lump post injection (day 1), itching and redness 7 days post injection.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Clusters of cold sores around mouth and in nose after 3 years of not having any. I take a daily dosage of Valtrex (1gm).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Chills and fever for one night and pain at injection site for three days
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Developed numbness in left hand then subsequently, sharp burning pain in left upper chest, upper arm radiating to back.  Also felt vertigo type symptoms
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Developed numbness in left hand then subsequently, sharp burning pain in left upper chest, upper arm radiating to back.  Also felt vertigo type symptoms
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Client experienced nausea and slight dizziness while walking  to be seen by EMT 4 minutes after vaccine was administered.  Client's symptoms stopped while with EMT.  EMT checked cleared client with no issues.  Client confirmed she was okay to go home.  No medications were administered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Flushing, Headache, Pyrexia
Clinical narrative: headache, low grade fever,runny nose, loss taste and smell, feels flushed
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: headache, low grade fever,runny nose, loss taste and smell, feels flushed
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hyperhidrosis, Injection site erythema, Malaise
Clinical narrative: Arm has a huge redness around injection site.  "Not feeling well."  "hot/cold sweats"
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA Headache, chills, body aches, fever, nausea
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On Jan 1 came down with fever, chills, aches and pain.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Malaise, Pyrexia
Clinical narrative: Got second shot in the morning: Last night 11:00pm started having fever 101, chill, bad headache.  Took Tylenol. Today has a little headache, no fever, chills are better. Don't feel well enough to go to work.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever, body aches, chills, headaches all for 48 hours starting on 12/31/2020
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Tenderness around injection site, slight fatigue, slight chills, slight fever. No treatment other than sleep and rest.  Symptoms disappear by Wednesday, 1/5/2021, a.m.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Flushing, Nausea
Clinical narrative: mild flushing, elevated temp 99.2, nausea
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Paraesthesia oral, Rash
Clinical narrative: At 2:08pm patient received dose #1 of Moderna COVID-19 vaccine. She began having lip tingling, lightheadedness and chest pounding at 2:10pm. On exam her BP was 126/82, HR 113, 95% O2 sat on RA. Patient was administered 50 mg of oral Benadryl at 2:17pm. She developed a rash on her chest and neck ? not hives. Lip tingling and chest pounding improved. Rescue arrived and upon discharge from the clinic to EMS her HR was 100, 99% O2 sat on RA.  PMH significant for chronic urticaria and angioedema with 4 lifetime episodes of severe allergic reactions, but never to a vaccine. Had had epi administered x 2, last in 2016.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paranasal sinus discomfort, Sinus pain
Clinical narrative: Sinus pressure that could be felt in my teeth and headache began about 2 hours after vaccine. It has been almost a week and these sensations remain.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fever, chills, joint pain, headache, nausea, fatigue, bodyaches
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, joint pain, headache, nausea, fatigue, bodyaches
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural
Clinical narrative: Pt developed dizzyness - increased upon standing-postural changes . Drank water and observed for 40 minutes w/o improvementVS
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: 12/18 VACCINATION 12/19 WOKE UP, HA, FATIGUE, MUSCLE ACHES.  12/20; HA WORSE, SYMPTOMS WORSE 12/21 FELT BETTER 12/22 VERTIGO, FACE IS RED. URGENT CARE. PRESCRIBED NAUSEA MEDS.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 12/18 VACCINATION 12/19 WOKE UP, HA, FATIGUE, MUSCLE ACHES.  12/20; HA WORSE, SYMPTOMS WORSE 12/21 FELT BETTER 12/22 VERTIGO, FACE IS RED. URGENT CARE. PRESCRIBED NAUSEA MEDS.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: Significant soreness in the arm where I received the injection, as well as a swollen lymph node in the underarm of the same arm. In addition, muscle aches, fatigue and chills. No fever recorded so far.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Palpitations
Clinical narrative: Dizziness, nausea, light headedness, palpitations
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Electrocardiogram, Epinephrine, Heart rate decreased
Clinical narrative: Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure and pulse. Taken to ER. Also developed vomiting. Treated with epinephrine.  Initially improved, then after 40 minutes heart rate dropped to low 40's and developed chest pain. Treated with 4 mg solumedrol, benadryl and more  IV fluids.  Slow recovery and observed over 5 hours. Went home.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Laboratory test, Nausea, Vomiting
Clinical narrative: Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure and pulse. Taken to ER. Also developed vomiting. Treated with epinephrine.  Initially improved, then after 40 minutes heart rate dropped to low 40's and developed chest pain. Treated with 4 mg solumedrol, benadryl and more  IV fluids.  Slow recovery and observed over 5 hours. Went home.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: Sore arm  Pregnant at time of administration
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Appendicolith, Computerised tomogram abdomen abnormal
Clinical narrative: Abdominal pain that proceeded to get worse into the next day. Connected with PCP, had labs drawn and ultrasound ordered. Ended up going to ER. Determined to have Appendicitis, needed and had appendectomy on 12/29/2020.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Ultrasound abdomen abnormal
Clinical narrative: Abdominal pain that proceeded to get worse into the next day. Connected with PCP, had labs drawn and ultrasound ordered. Ended up going to ER. Determined to have Appendicitis, needed and had appendectomy on 12/29/2020.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient vaccinated outside of age range for vaccine
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Dizziness, Headache, Hyposmia
Clinical narrative: Around 10 am (2hrs post vaccination) I noticed some hives on my hands and dizziness. I also developed a mouth sore that later went away around 5pm. I drank 1.5 L of water and put some topical Benadryl cream on the hives, these symptoms resolved. At 8pm I began to get a temperature (temp max 101.2 around 11:17pm), a very sore swollen arm, massive headache, and myalgia/arthralgia in knees bilaterally. On 1/5 temperature has subsided to low grade (99.2F) but I still don?t feel well and have no sense of smell with a runny nose.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Oral pain, Pain in extremity, Peripheral swelling
Clinical narrative: Around 10 am (2hrs post vaccination) I noticed some hives on my hands and dizziness. I also developed a mouth sore that later went away around 5pm. I drank 1.5 L of water and put some topical Benadryl cream on the hives, these symptoms resolved. At 8pm I began to get a temperature (temp max 101.2 around 11:17pm), a very sore swollen arm, massive headache, and myalgia/arthralgia in knees bilaterally. On 1/5 temperature has subsided to low grade (99.2F) but I still don?t feel well and have no sense of smell with a runny nose.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: Around 10 am (2hrs post vaccination) I noticed some hives on my hands and dizziness. I also developed a mouth sore that later went away around 5pm. I drank 1.5 L of water and put some topical Benadryl cream on the hives, these symptoms resolved. At 8pm I began to get a temperature (temp max 101.2 around 11:17pm), a very sore swollen arm, massive headache, and myalgia/arthralgia in knees bilaterally. On 1/5 temperature has subsided to low grade (99.2F) but I still don?t feel well and have no sense of smell with a runny nose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site induration, Injection site swelling, Throat irritation
Clinical narrative: Immediately after injection into patient's left deltoid, site swelling and felt firm.  Some bruising noted.   Ice applied and patient monitored for over 30 minutes.  Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time.   Patient will notify her physician of this reaction to the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Laboratory test, Physical examination
Clinical narrative: Fatigue four days after vaccine. Shingles diagnosed one week after vaccine.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Insomnia, Nausea
Clinical narrative: Elevated heart rate, shortness of breath, fever (101.3), body aches, nausea, fatigue, impaired sleep - lasted 2 days
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Elevated heart rate, shortness of breath, fever (101.3), body aches, nausea, fatigue, impaired sleep - lasted 2 days
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Malaise, Pain, Pain in extremity
Clinical narrative: Rigorous chills x 3 hours, temperature up to 104.0 by mouth, increased arm tenderness (unable to lay on that side), malaise, body aches.  All symptoms lasted approximately 14 hours and then resolved except for the arm soreness which resolved in 3 days.  Treated fever with acetaminophen and Ibuprophen.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: temperature excursion; Dose/Frequency: 0.5 ml of ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug allergies and reactions were not reported.      On 14-DEC-2020, the patient was vaccinated with the temperate excursion vaccines of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not provided; lot# was S040483 and expiration date was 19-JUN-2021) 0.5 ml orally and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength and route were not provided; lot# was T001206 and expiration date was 03-JUN-2022) 0.5 ml for prophylaxis.      This is one of three cases from the same reporter.; Sender's Comments:  US-009507513-2012USA007474: US-009507513-2012USA007679:
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: migraine headache; Information has been received from a consumer referring to her daughter, a currently 21 years old female patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On an unknown date in 2010 (reported as when the patient was 11 years old), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced migraine headaches. The reported wanted to know why so much aluminum was put in the vaccine. The reporter stated her father was a judge and they were going to sue the balls off. The outcome of the event of migraine headaches was unknown. The causality between migraine headaches and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was unknown.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PROQUAD was administered to a 14 year old patient.; This spontaneous report was received from an educator referring to a 14-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 31-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # S035111, expiration date 03-MAY-2021, at a dose of 2.5 milliliter for prophylaxis. The reporter stated they are aware of the prescribing information that measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) should be administered between 12 months and 12 years. The reporter stated the patient had their initial dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) on 10-OCT-2019 and that the dose on 31-AUG-2020 was the second in the series. The reporter was requesting information on how to proceed, if the patient's dose was valid.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: administered IM instead of SC; This spontaneous report was received from a physician referring to a 64 year old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 21-DEC-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) lot # S039311, expiration date  04-DEC-2021 for prophylaxis (strength, dose and frequency were not reported). The vaccine was administered via intramuscular rather than subcutaneous.  No further information provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Nurse gave Varivax that expired 08/22/2020; This spontaneous report was received from a customer via email and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) that expired on 22-AUG-2020, (dose, anatomical location, route of administration and lot# were not reported) for prophylaxis.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/PQCs reported; administration of improperly stored PROQUAD; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 08-SEP-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) lot # T015598, expiration date: 02-NOV-2021 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported.   Administered dose of vaccine experienced the temperature excursion of 20.5 degrees Fahrenheit (F) for 1 hour 54 minutes and the previous excursion of 6F to 14F (12.3F) for 23 hours. Digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 28-AUG-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 dosage form, lot number T015598, expiration date 02-NOV-2021 (route of administration was not provided) for prophylaxis. No additional adverse events were reported.  The vaccine had a temperature excursion of 20.5 degrees Farhrenheit (°F) for 1 hour and 54 minutes. The previous temperature excursion was between 6°F and 14°F, with an average of 12.3°F for 23 hours. The call was due to digital data logger.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tired; This case was reported by a consumer and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 20th October 2017, the patient received the 2nd dose of Shingrix. On 20th November 2020, 1127 days after receiving Shingrix, the patient experienced tiredness. On 20th November 2020, the outcome of the tiredness was recovered/resolved.   The reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and experienced tiredness. This case has been linked with US2020AMR233686, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR233686:same reporter
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: low grade fever; hard lump at injection site; redness / at injection site; sore at injection site; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced low grade fever, injection site lump, injection site erythema and injection site pain. On an unknown date, the outcome of the low grade fever, injection site lump and injection site erythema were recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the low grade fever, injection site lump, injection site erythema and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received 2st dose of Shingrix and experienced low grade fever, hard lump at injection site, redness and sore at injection site. The all the symptoms were resolved after 1 week of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: UNK
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: did not feel good for a couple of hours; This is a spontaneous report from a Pfizer-sponsored program received from a non-contactable consumer. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein), via an unspecified route of administration on 13Dec2020 at single dose for immunization. The patient's medical history included COVID-19; relevant concomitant medications were not reported. The patient reported that he/she did not feel good for a couple of hours after vaccine, but it went away. He/she has had COVID but does not know if he/she still has antibodies or not. He/she doesn't want that again. He/she hopes pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) does not hurt him/her because he/she has had COVID. The reported event had resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Musculoskeletal disorder, Neurological symptom, Pain in extremity, Pruritus
Clinical narrative: felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself).  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization.  Medical history was none.  There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine.  On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability.  On 21Dec2020, the patient had itchiness in her head.  The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability.  The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020.  The outcome of the events was not recovered.  The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship.  However, stroke was not diagnosed. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself).  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization.  Medical history was none.  There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine.  On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability.  On 21Dec2020, the patient had itchiness in her head.  The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability.  The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020.  The outcome of the events was not recovered.  The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship.  However, stroke was not diagnosed. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Had a rapid test for COVID, and it was positive; Had a rapid test for COVID, and it was positive; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age started to receive BNT162B2 (lot number unknown), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist stated that they have vaccinated all their caregivers, and a physician (patient) who got the vaccine, called and reported to her that he had a rapid test for COVID, and it was positive. She is wondering if there was any data from the clinical trials where people tested positive after having the vaccine. The patient is now freaking out because he does not know if he needs to go to the hospital and get treatment for COVID. He works night shift and may have been exposed to COVID, but now she does not know how to guide him. The outcome of the events was unknown.  The following information on the batch number has been requested.; Sender's Comments: The reported positive rapid test for COVID after COVID-19 immunization is considered related to the administration of BNT162B2.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test positive, Viral test positive
Clinical narrative: Systemic pruritis (itching) all over body; COVID test type: Nasal Swab and Rapid Antigen and were both positive; COVID test type: Nasal Swab and Rapid Antigen and were both positive; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscular on 17Dec2020 16:30 at single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and spironolactone. The patient previously took cefprozil (CEFZIL) and tapazole and both experienced allergies. The patient experienced systemic pruritis (itching) all over body on 22Dec2020 10:00. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has been tested for COVID-19. On 22Dec2020, the patient took COVID test type: Nasal Swab and Rapid Antigen and were both positive. No treatment received for the event "Systemic pruritis (itching) all over body". The outcome of the event "Systemic pruritis (itching) all over body" was not recovered. The outcome of the other events was unknown.; Sender's Comments: BNT162b2 provides protection against COVID-19 after 7 days from the second dose. This case does not match this codition