chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: 1 hour after administration, patient's lips tingling and she experienced swelling as well. Patient received 25mg diphenhydramine and was observed for 30 mins. Symptoms resolved over 30 minutes.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Broke out in Itchy bumps around arms, legs and stomach
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Extraocular muscle paresis, Facial paralysis, Headache, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: I had right sided headache for the first two days, then resolved.  The right sided headaches recurred along with right tongue numbness initially on 12/29/2020.  The symptoms worsen on 12/31/2020 and severe on 1/1/2021.  I was initially started on Valtrex thinking it maybe due to shingles but soon with the right sided facial paralysis, it was obvious it was Bell's Palsy and was started on steriods on 1/1/21 and also received acupuncture treatment on 1/2/21 which significant help improve the symptoms.  I still have some residual weakness of the right eye with some tearing and mouth weakness.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Lightheadedness and heart palpatations
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: Chills, Vomitting
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic, Skin warm
Clinical narrative: RASH ROUGHLY THE SIZE OF A BASEBALL, RAISED RING AROUND THE EDGE, VERY ITCHING SLIGHTLY WARM TO TOUCH.  STILL PRESENT AT 10 DAYS POST VACCINE
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lymphadenopathy
Clinical narrative: Itchy, swollen reddened arm at sit of injection, starting on 6th day after injection.  Left armpit axillary swollen lymph node
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given 12/28/2020 and it had expired 12/13/2020. No know adverse reactions to the patient.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting diarrhea
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in the Neck  area. Benadryl and cortisone cream.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Moderna COVID 19 Vaccine: Developed left arm achiness, site swelling and pain radiation into back of neck. 1/3/2021 during the night developed chills, achiness, back pain, general malaise. As of time of this report 1/4 symptoms continue... Was feeling 100% healthy at time of vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site swelling
Clinical narrative: Moderna COVID 19 Vaccine: Developed left arm achiness, site swelling and pain radiation into back of neck. 1/3/2021 during the night developed chills, achiness, back pain, general malaise. As of time of this report 1/4 symptoms continue... Was feeling 100% healthy at time of vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Palpitations, Pyrexia, Tremor
Clinical narrative: Heart Palpitations, still on going.  High fever Sweats Chills Shakes
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: On day 1 (12/23/2020) after receiving her vaccine she states  her arm was sore.  On 12/31/2020 she developed Pruritus.  On 1/1/2021 a baseball size welt developed. She used ice and started taking Zyrtec.  She does not have any other symptoms.  On 1/2/2020 the baseball size welt decreased, but 2 more welts developed that were thumb print size..  Today she does feel like the redness and swelling are getting better.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Insomnia, Malaise
Clinical narrative: Temp, diarrhea  for 4 hrs, malaise, bad headache , insomnia
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia
Clinical narrative: Headache x 3 days (very uncommon for patient) with only minimal relief from naproxen and acetaminophen dosed multiple times Fatigue (slept more than normal)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Employee received the vaccine at 0805, reported at 0812 that he was dizzy, lightheaded, nauseated and diaphoretic. Employee assisted to cot to lie down. Skin pale, continued to be diaphoretic, respirations in the 20's, BP 115/82, HR 110, O2 98% on RA, denied any difficulty breathing, no coughing or evidence of throat tightening, no sign of any swelling at vaccination site, no rash. Code called overhead, Code team arrived. No medications given at time in clinic. Near syncopal episode, No anaphylaxis. Employee taken to ED for further evaluation and observation.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Employee received the vaccine at 0805, reported at 0812 that he was dizzy, lightheaded, nauseated and diaphoretic. Employee assisted to cot to lie down. Skin pale, continued to be diaphoretic, respirations in the 20's, BP 115/82, HR 110, O2 98% on RA, denied any difficulty breathing, no coughing or evidence of throat tightening, no sign of any swelling at vaccination site, no rash. Code called overhead, Code team arrived. No medications given at time in clinic. Near syncopal episode, No anaphylaxis. Employee taken to ED for further evaluation and observation.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine that may not be fully effective due to room temperature storage for more than 12 hours
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Oropharyngeal discomfort, Peripheral coldness
Clinical narrative: ? After her shot in the afternoon, she sat outside for 15 minutes.  She came back in and said her throat is warm and scratchy, and her left hand felt cold.  ? I escorted her over to the ER and she was checked in.  I then went right back to EOHD since we were so busy.  ? Around 4pm in the afternoon after we closed EOHD, I went back to the ER.  She was recovering and doing fine.  Her ER nurse did have a question about receiving the 2nd dose, and I provided the same answer that Dr. provided to other Dr. about taking an Allegra 30 minutes before the second dose.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Feeling hot, Hypersensitivity, Peripheral coldness, Pharyngeal paraesthesia
Clinical narrative: ? After her shot in the afternoon, she sat outside for 15 minutes.  She came back in and said her throat is warm and scratchy, and her left hand felt cold.  ? I escorted her over to the ER and she was checked in.  I then went right back to EOHD since we were so busy.  ? Around 4pm in the afternoon after we closed EOHD, I went back to the ER.  She was recovering and doing fine.  Her ER nurse did have a question about receiving the 2nd dose, and I provided the same answer that Dr. provided to other Dr. about taking an Allegra 30 minutes before the second dose.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: ? After her shot in the afternoon, she sat outside for 15 minutes.  She came back in and said her throat is warm and scratchy, and her left hand felt cold.  ? I escorted her over to the ER and she was checked in.  I then went right back to EOHD since we were so busy.  ? Around 4pm in the afternoon after we closed EOHD, I went back to the ER.  She was recovering and doing fine.  Her ER nurse did have a question about receiving the 2nd dose, and I provided the same answer that Dr. provided to other Dr. about taking an Allegra 30 minutes before the second dose.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Vomiting
Clinical narrative: Chills, Vomiting. Malaise
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Influenza virus test negative, Nausea
Clinical narrative: Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization (12.17.20). Patient had "extreme" fatigue and weakness for 2 weeks. Went to urgent care on 12.28.2020, no medications or treatment given. Resolved as of 1.4.21 with continued "slight" weakness. Patient also reports to have lost a considerable amount of weight.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tremor, Vomiting, Weight decreased
Clinical narrative: Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization (12.17.20). Patient had "extreme" fatigue and weakness for 2 weeks. Went to urgent care on 12.28.2020, no medications or treatment given. Resolved as of 1.4.21 with continued "slight" weakness. Patient also reports to have lost a considerable amount of weight.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Hot flush, Myalgia, Thirst
Clinical narrative: Muscle pain all over, fatigue and hot/cold flashes. Patient also reports feeling very thirsty.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Arthralgia, Asthenia, Dizziness, Injection site pain
Clinical narrative: Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea.  Symptoms are ongoing.  Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Night sweats
Clinical narrative: Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea.  Symptoms are ongoing.  Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain, Pain in extremity, Rash
Clinical narrative: Half dollar size knot with rash down my arm. Painful to raise my arm. Took 2 Benadryl  saturday afternoon and 2 at night before bed ,by morning the knot was pea size and rash was gone
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Vomiting
Clinical narrative: Patient had multiple episodes of vomiting but has a history of dysphagia, patient also reported generalized weakness in bilateral lower extremities. Was sent to the ER and discharged
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash erythematous, Rash pruritic
Clinical narrative: red hot rash appeared 1 week after received vaccine. it was slightly itchy. Rash grew slightly on 2nd day but decreased in redness, still hot. Third day size and redness decreased as well as temperature. 4th day gone.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: Patient had some dizziness and flushing post vaccine administration, but she declined calling the rapid response team. This resolved within 5 minutes without intervention. Closely monitored for 30 minutes.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fine motor skill dysfunction, Hypoaesthesia, Magnetic resonance imaging spinal normal, Sensory loss
Clinical narrative: On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of dexterity.  It improved somewhat over the next 45 minutes, but I continue to have loss of sensation in all 10 fingertips, worse in both thumb and 5th digits.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fine motor skill dysfunction, Hypoaesthesia
Clinical narrative: On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of dexterity.  It improved somewhat over the next 45 minutes, but I continue to have loss of sensation in all 10 fingertips, worse in both thumb and 5th digits.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, chills, arthralgia/myalgia, low-grade fever: all symptoms began 16 hours after vaccine and subsided within 24 hours of vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Nervousness
Clinical narrative: Anxiety attack lasting 2 hours,. Took some benadryl and wellbutrin. Within 40 minutes calmed down enough, until the next day started feeling shaky and anxious again..called Dr. at home. She says to take my wellbutrin in the morning as well as my evening dose and benedryl every 4 hours. Has been good since then.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Erythema, Induration, Myalgia
Clinical narrative: Fever greater than 100 degrees F, full body muscle aches, chills, sore throat, tender armpit (left)- 12/27/2020 (all day) Itchy, blanched, swollen, hard, warm patch on left arm 4.5" x 3" with surrounding redness and tender armpit- 01/02/2021- present
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pallor, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Fever greater than 100 degrees F, full body muscle aches, chills, sore throat, tender armpit (left)- 12/27/2020 (all day) Itchy, blanched, swollen, hard, warm patch on left arm 4.5" x 3" with surrounding redness and tender armpit- 01/02/2021- present
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Fever greater than 100 degrees F, full body muscle aches, chills, sore throat, tender armpit (left)- 12/27/2020 (all day) Itchy, blanched, swollen, hard, warm patch on left arm 4.5" x 3" with surrounding redness and tender armpit- 01/02/2021- present
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Minimum interval from last dose not met
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Gait inability, SARS-CoV-2 test negative, Self-medication
Clinical narrative: Patient received the covid vaccine on 12/30/2020.  Tolerated the vaccine without problem. c/o new onset of "stomach pain" at the RLQ.  Unable to walk starting on Jan 3rd. Pain persists today. Denies fever, HA, Dizziness, cough, nausea, vomiting, diarrhea, or constipation. She has reached out to her rheumatologist.  She noticed the pain occurred after she self administered the Taltz injection on 12/31/2020. She is concerned about the drug-to-drug interactions with the vaccine.    Covid test on 12/23/2020 was negative.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: My arm was so sore I could not hardly move it, starting approx. 6 hours after injection.  Now 5 days after injection still quite sore. Entire upper arm, approx. 7"x4" area erythema and hot to touch (even through clothing).  Redness started a couple hours after injection.   Now 5 days after vaccine red area is approx. 3"x3". At injection site, approx. 1"x1" hard bump that is still present 5 days after vaccine Area of upper arm where injection given, severe itching, which continues now 5 days after vaccine. Approx 9 hours after injection and continuing for approx. 36 hours, body aches and joint pain.  I took Tylenol and Benadryl for 48 hours after vaccine reaction first noted.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Skin warm
Clinical narrative: My arm was so sore I could not hardly move it, starting approx. 6 hours after injection.  Now 5 days after injection still quite sore. Entire upper arm, approx. 7"x4" area erythema and hot to touch (even through clothing).  Redness started a couple hours after injection.   Now 5 days after vaccine red area is approx. 3"x3". At injection site, approx. 1"x1" hard bump that is still present 5 days after vaccine Area of upper arm where injection given, severe itching, which continues now 5 days after vaccine. Approx 9 hours after injection and continuing for approx. 36 hours, body aches and joint pain.  I took Tylenol and Benadryl for 48 hours after vaccine reaction first noted.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a dose of vaccine that may be less than fully effective due to storage at room temperature for more than 12 hours
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site warmth, Oropharyngeal pain, Pain
Clinical narrative: Woke up during the night (12/24) with a sore throat, felt like it was closing and called 911. Did not go to ER. took Benadryl with relief. Injection site hot with an  extremely sore arm the first day which is better now. Fatigue, achy all over persists taking tylenol and ibuprofen for symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Woke up during the night (12/24) with a sore throat, felt like it was closing and called 911. Did not go to ER. took Benadryl with relief. Injection site hot with an  extremely sore arm the first day which is better now. Fatigue, achy all over persists taking tylenol and ibuprofen for symptoms.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Rash
Clinical narrative: Rash on chest, neck and arms  Nausea, loss of appetite Severe Headache Extreme Fatigue
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became very red, swollen, hot to the touch and soreness returned 10 days after vaccination.  Called my healthcare provider and he prescribed Cephalexin 500 MG  to be taken three times a day for seven days.  Three days after starting antibiotic treatment, redness and swelling were gone along with the fever in the arm.  Healthcare provider suggested I not take the second dose.  I would like an opinion from your facility.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysphonia, Electrocardiogram normal, Full blood count normal
Clinical narrative: pt began to feel tingling in her left arm and her throat. she felt tightness in the throat and voice was hoarse. she felt ligh headed like she might pass out but did not pass out. she felt chest discomfort with deep breath.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Paraesthesia, Pharyngeal paraesthesia, Throat tightness
Clinical narrative: pt began to feel tingling in her left arm and her throat. she felt tightness in the throat and voice was hoarse. she felt ligh headed like she might pass out but did not pass out. she felt chest discomfort with deep breath.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever, chills, head ache, body aches
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I am currently experiencing a swollen lymphnode in my left armpit which is the same arm that I received the vaccine in. This first presented around 11:00pm on Saturday 01/02/2021. I received my first dose of the moderna covid-19 vaccine on 12/28/2020. I did look on Moderna's website for further reaction information and it states that 4% of their test group reported this same symptom 5 to 7 days after first injection.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray, Cough, Dizziness
Clinical narrative: 12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeding disorder, Full blood count, Headache, Hypoaesthesia
Clinical narrative: 12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Influenza virus test negative, Injection site pain, Injection site swelling, Metabolic function test
Clinical narrative: 12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Unresponsive to stimuli, Urine analysis
Clinical narrative: 12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Migraine, Nausea, Neck pain
Clinical narrative: On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Injection site pain
Clinical narrative: Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Patient received 2nd dose of Bexsero and after she left the building and was at home she began to vomit.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, COVID-19, Dizziness, Fatigue
Clinical narrative: Headache; fatigue; muscles aches; Fever/ 103.6/100.8/"102 something"; Dizziness; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: Mar2021, via an unspecified route of administration from 20Dec2020 at a single dose (dose unknown, by injection once) for covid-19 immunization. Medical history included multiple sclerosis (MS) from 2015 and ongoing. The patient's concomitant medications were not reported. The patient previously took ocrevus for multiple sclerosis. She had COVID in August, and got antibody testing, as the medication she was on (ocrevus) for MS knocked out antibodies, so she received the vaccine. The patient spiked a fever of 103.6. She couldn't get out of bed all day and she started having dizziness and headache yesterday, which got progressively worse, and last night she had fever of like 100.8, muscles aches and fatigue, and she woke up this morning and her temperature was "102 something", and she took ibuprofen. She stated that she then got out of bed, as she could hardly get out of bed before or she would pass out, and now her temperature is 103.6, and she has never had it that high before. The dizziness started soon after vaccine. It is all over the place, when she stands, she is incredibly dizzy, but is ok now that she is sitting. She added that she has MS, so dizziness was not abnormal for her. The headache started soon after vaccine; it comes and goes, it goes away and comes back. For the muscle aches and fatigue, they got a lot worse, but was ok now, the Ibuprofen is kicking in. She had stayed in bed all day, then her temperature was 103.6, she had finally got out of bed and took her temperature and ibuprofen. Outcome of events fever, fatigue, myalgia was not recovered whereas the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; fatigue; muscles aches; Fever/ 103.6/100.8/"102 something"; Dizziness; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: Mar2021, via an unspecified route of administration from 20Dec2020 at a single dose (dose unknown, by injection once) for covid-19 immunization. Medical history included multiple sclerosis (MS) from 2015 and ongoing. The patient's concomitant medications were not reported. The patient previously took ocrevus for multiple sclerosis. She had COVID in August, and got antibody testing, as the medication she was on (ocrevus) for MS knocked out antibodies, so she received the vaccine. The patient spiked a fever of 103.6. She couldn't get out of bed all day and she started having dizziness and headache yesterday, which got progressively worse, and last night she had fever of like 100.8, muscles aches and fatigue, and she woke up this morning and her temperature was "102 something", and she took ibuprofen. She stated that she then got out of bed, as she could hardly get out of bed before or she would pass out, and now her temperature is 103.6, and she has never had it that high before. The dizziness started soon after vaccine. It is all over the place, when she stands, she is incredibly dizzy, but is ok now that she is sitting. She added that she has MS, so dizziness was not abnormal for her. The headache started soon after vaccine; it comes and goes, it goes away and comes back. For the muscle aches and fatigue, they got a lot worse, but was ok now, the Ibuprofen is kicking in. She had stayed in bed all day, then her temperature was 103.6, she had finally got out of bed and took her temperature and ibuprofen. Outcome of events fever, fatigue, myalgia was not recovered whereas the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day; she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day (17Dec2020). She is scheduled to take her second dose on 20Jan2021. The patient wanted to know what Pfizer recommendations are. Outcome of the event was unknown.   That information on the lot/batch number has been requested.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination and the event onset.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: (L) increased arm soreness, sl. redness resolved after 2 days, Dec 31st swelling redness @ site 1/2 dollar size. progressed to saucer size over weekend of 1/1 - 1/3 Less swelling, increased redness and size
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Heart rate, Heart rate increased, Joint range of motion decreased
Clinical narrative: Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg).  On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.  Information regarding lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain assessment, Pain in extremity, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg).  On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.  Information regarding lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Chills; fever; fatigue; tiredness; nausea; Little bit of vomiting; This case was missing the following minimum criteria: there is unspecified event. Upon receipt of follow-up information on (22Dec2020), this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable other HCP reporting for herself.  A 51-year-old female patient received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on 21Dec2020 at  single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unknown date the patient experienced the following symptoms chills, fever, fatigue, tiredness, nausea, little bit of vomiting, the outcome of all the reported events was unknown. The patient stated that before receiving the vaccine, she was in contact with her husband who discovered to be positive to COVID 19. The patient is now concerned because she does not know if the symptoms she is experiencing are caused by the vaccine or by the illness.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: chills; fever; bodyaches; fatigue; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 24Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ej1685), via intramuscular in left arm on 22Dec2020 14:45 at first single dose, via intramuscular in left arm on 22Dec2020 15:00 at second single dose (pending to clarify), for COVID-19 immunisation. Medical history included COVID-19, high blood pressure (BP) and high cholesterol and myocarditis. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. 24 hours after receiving the first vaccine (23Dec2020 16:00), the patient experienced chills fever body aches and fatigue. The events were non-serious. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered in Dec2020.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Off label use, Product use issue
Clinical narrative: Headache; Fatigue; The patient received BNT162B2 and was lactating; The patient received BNT162B2 and was lactating; This is a spontaneous report from a contactable healthcare professional reporting for herself and her baby. This is the maternal report.  A 35-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EH9899) intramuscular, on 16Dec2020 at 10:00, in right arm, for COVID-19 immunisation. No other vaccine was given within 4 weeks before. The patient was breastfeeding. Allergies to medications, food, or other products: no. The patient had no COVID before vaccination. Concomitant medications included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), vitamin D and calcium. The patient was lactating and on 17Dec2020 her baby seemed to have had an upset stomach, she had trouble sleeping and spit up a few times which was abnormal for her. On 17Dec2020 the patient experienced headache and fatigue which both resolved with lasting effects on an unspecified date in Dec2020. Treatment included paracetamol (TYLENOL). Since the vaccine she had had a headache daily. The events required physician office visit. COVID was not tested after vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020511585 baby case
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea and vomited x 1 the morning after receiving the vaccine
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: being tested positive; being tested positive; felt very sick; congestion; This is a spontaneous report from a contactable other healthcare professional (patient herself). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt very sick and that's not her normal. The patient felt great after getting the vaccine she hadn't felt that in a while. Today (23Dec2020) the patient had this congestion and 4 -5 people came back positive post covid-19 vaccination on unknown date. All of them sent home after being tested positive. The patient just someone to keep track, she just wanted Pfizer to know. She didn't have any problems, she was working COVID patients. They had a lot new cases. She just didn't feel 100%. The patient wanted to know if it's safe for her to get the second dose after being tested COVID positive post vaccination. The outcome of events was unknown.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the reported events and vaccination with BNT162B2. Additional information regarding therapy vaccination date, lot number and investigation results will aid in comprehensive assessment of the case.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: she reported on 18Dec2020 got vaccine later that day tested positive; she reported on 18Dec2020 got vaccine later that day tested positive; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 18Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. She reported on 18Dec2020 got vaccine later that day tested positive with outcome of unknown. She asked can she still receive the 2nd dose of the vaccine or should she repeat the vaccination series.  The patient underwent lab tests and procedures which included Sars-Cov-2 test: positive on 18Dec2020.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive; received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Device Type: Vial), intramuscularly on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive on 23Dec2020. PharmD asked if it's possible to administer Bamlanivimab to a patient who received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive. Pharmacist mentioned that as Bamlanivimab was an EUA drug, they cannot go outside of the recommendations, and given that no information was available about its use after a dose of the COVID-19 vaccine, it is possible that Bamlanivimab may not be administered. Explained Pfizer MI is unable to provide a direct recommendation, was referred to the patient's Docton for guidance: Before receiving the next dose of the COVID-19 vaccine, and to clarify if Bamlanivimab should be administered. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The reported  tested positive 5 days after COVID-19 vaccine is considered related to the administration of BNT162B2.