chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: The patient received Janssen COVID vaccine on 3/6 to RIGHT deltoid. She has a past medical history significant for LEFT sided breast cancer, treated with lumpectomy and radiation ~5 yrs prior. Remains on Letrozole. 1 day post-vaccine, she developed fevers (tmax 104), chills, malaise. 2 days post-vaccine, the fevers, chills, malaise dissipated but she developed a "rash" to her LEFT breast (same site as prior malignancy). This rash became a widespread erythematous area encompassing her entire breast. Axilla excluded.  No palpable lymphadenopathy. She reports area to be tender and itching. Rash is blanchable. It is somewhat response to OTC antihistamines (Claritin/Benadryl) and OTC hydrocortisone. She has no respiratory distress, lingering fever, or other allergic reactions. She was given a prescription topical steroid (triamcinolone) and will follow up with her in a few days, if she remains stable. If not back to baseline within the week, will obtain breast MRI for further evaluation.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood potassium decreased, Chills, Dyskinesia, Hypokalaemia
Clinical narrative: Pt developed fever, intense body aches/pains all over, and significant weakness at 11:30pm 2/15/21. She had nausea, one episode of vomiting and chills that made her body jerk.  She was treated for hypokalemia in ED 3/5/21. She continues to have more persistent pain in legs and weakness.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Pt developed fever, intense body aches/pains all over, and significant weakness at 11:30pm 2/15/21. She had nausea, one episode of vomiting and chills that made her body jerk.  She was treated for hypokalemia in ED 3/5/21. She continues to have more persistent pain in legs and weakness.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pt developed fever, intense body aches/pains all over, and significant weakness at 11:30pm 2/15/21. She had nausea, one episode of vomiting and chills that made her body jerk.  She was treated for hypokalemia in ED 3/5/21. She continues to have more persistent pain in legs and weakness.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Pyrexia, Rhinorrhoea
Clinical narrative: soreness at injection sight; sniffles; felt like a fever; aches and pains at joints; fatigue for 12 hours.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain, Sensitive skin, Sensory disturbance
Clinical narrative: Body pain more reminiscent of radiating nerve pain than flu body aches.  Its the worst around my sacrum and radiating down the backs of my legs to the soles of my feet.  I also have pain radiating up my spine over the top of my head and down the backs of my arms to my palms.  My skin is hypersensitive and everything that touches it feels like sand paper.  I started getting chills so bad my hands and feet went numb.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Impaired work ability, Joint range of motion decreased, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: I could not move my right side from neck to finger tips by 5:30 p.m. I have never been in more pain in my whole life.   It was difficult to do anything and laying down hurt the most.  This has been 8 nights now that I cannot sleep through the night because I wake up with shooting pains in my shoulder blade/shoulder/arm area.   Even with ipruprophen and/or Tylenol - the pain still comes back.  As of yesterday, I can use my arm better as the day goes by but lifting my arm over should height is extremly difficult and painful without the assistance from my other hand.  I believe this is called a Shoulder Injury Related to Vaccine Administration.   I writhed with pain the first night and got no sleep.  I took 2 days off of work and even working today is difficult to write on the board, lift things or reach higher than my shoulder.  Even last night I woke up 4 times because of the pain.  I couldn't get back to sleep for about 1 hour each night since this happened 8 nights ago. When I visited my Doctor 2 days ago, she said maybe it was Shoulder Injury Related to Vaccine Administration.  She said to come back for another visit if the pain lasts for a few more days.  Physical Therapy, Steroids or ?   I just want to be able to sleep, be able to dress myself and to wash my hair without pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain, Pain in extremity, Sleep disorder
Clinical narrative: I could not move my right side from neck to finger tips by 5:30 p.m. I have never been in more pain in my whole life.   It was difficult to do anything and laying down hurt the most.  This has been 8 nights now that I cannot sleep through the night because I wake up with shooting pains in my shoulder blade/shoulder/arm area.   Even with ipruprophen and/or Tylenol - the pain still comes back.  As of yesterday, I can use my arm better as the day goes by but lifting my arm over should height is extremly difficult and painful without the assistance from my other hand.  I believe this is called a Shoulder Injury Related to Vaccine Administration.   I writhed with pain the first night and got no sleep.  I took 2 days off of work and even working today is difficult to write on the board, lift things or reach higher than my shoulder.  Even last night I woke up 4 times because of the pain.  I couldn't get back to sleep for about 1 hour each night since this happened 8 nights ago. When I visited my Doctor 2 days ago, she said maybe it was Shoulder Injury Related to Vaccine Administration.  She said to come back for another visit if the pain lasts for a few more days.  Physical Therapy, Steroids or ?   I just want to be able to sleep, be able to dress myself and to wash my hair without pain.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Sciatica, X-ray
Clinical narrative: Felt mild sciatica pain Thu morning following 1st vaccine shot that Monday. Through the day (I was just working at home like every other day) Sciatica began to get worse deteriorating to probably the worst pain I've ever experienced. As I mentioned, my Sciatica has been well controlled for 10+ years. I would have occasional mild sciatica pain following hard falls wakeboarding or snowboarding, but haven't done either in weeks nor had any hard falls.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Approximately 3+ days after the second shot I began experiencing  intense joint pain of the wrists, shoulders, hips and knees that has intensified over the next 3 weeks.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat irritation, Tongue erythema
Clinical narrative: Scratchy throat, redness on tongue ~25 minutes post-vaccination. Assessed by medical director, given Zyrtec. ~90 minutes after vaccination, developed rash on chest.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Influenza like illness
Clinical narrative: Within 30 minutes started a dry cough which lasted for 3 weeks.  (Had a dry cough off and on before but had gotten better, possible long haul from flu last Feb/March that lasted 3 weeks.  Not tested, so could have been Covid 19.) Severe chills and joint pain and fever like symptoms through out the night. - Better in the morning but still slight flu like symptoms, but only lasted 48 hours.  However, the dry cough lasted 3 weeks.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Enlarged uvula, Oral pruritus, Pharyngeal swelling
Clinical narrative: Pt started complaining of itching at the roof of her mouth. It was noted she had oralpharynx swelling, uvula swelling at the 17 minute mark post vaccine. Report was called to the ED Charge Nurse. Pt walked over to ED check in.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: Received COVID Vaccine Dose #1 Friday morning around 8am. Pain at injection site was manageable. Friday evening I began to feel achy. Went to bed and woke up around 1am Saturday with a fever (101.5), muscle aches and chills. I also had a headache but headaches are more common for me so may or may not have been related to the vaccine.   Fever subsided with ibuprofen. Continued to take ibuprofen every 6 hrs throughout the day on Saturday. By Sunday, I felt fine.    FYI I did have COVID back in December.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Received COVID Vaccine Dose #1 Friday morning around 8am. Pain at injection site was manageable. Friday evening I began to feel achy. Went to bed and woke up around 1am Saturday with a fever (101.5), muscle aches and chills. I also had a headache but headaches are more common for me so may or may not have been related to the vaccine.   Fever subsided with ibuprofen. Continued to take ibuprofen every 6 hrs throughout the day on Saturday. By Sunday, I felt fine.    FYI I did have COVID back in December.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Formication, Headache, Limb discomfort, Nausea
Clinical narrative: pt states that she began feeling sleepy and had a very heavy feeling.  She woke up w/ severe pain that started on under her left arm and went down to her foot that lasted for about 10 minutes.  She had headache, nausea, chills, and fatigue that lasted all day.    She had a funny sensation in the back of her head and her arm felt very heavy.  Today on 3/11/2021 she is feeling better but she like she had something moving under her skin on her left shoulder.   Pt has taken Tylenol for her pain and already has an appt scheduled tomorrow at 1 PM w/ her PCP.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: pt states that she began feeling sleepy and had a very heavy feeling.  She woke up w/ severe pain that started on under her left arm and went down to her foot that lasted for about 10 minutes.  She had headache, nausea, chills, and fatigue that lasted all day.    She had a funny sensation in the back of her head and her arm felt very heavy.  Today on 3/11/2021 she is feeling better but she like she had something moving under her skin on her left shoulder.   Pt has taken Tylenol for her pain and already has an appt scheduled tomorrow at 1 PM w/ her PCP.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Rash, Rash pruritic
Clinical narrative: Itchy red rash around neck ,cough, short of breath
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and itchy welt at the injection site. First presented 8 days after injection and persisted for 3 days.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 8 days after injection, rash, swelling, intense itching at site.  Rash measures 2.5" x 2.5"  After 2 days itching less intense but continues.  Rash persists.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: PT C/O OF DIZZINESS, NAUSEA, AND STATES THAT "ALL SHE READ ON THE INTERNET IS WHAT SHE IS FEELING." VS@ 10:10 AM BP 123/70 HR 67 SpO2 99% VS STABLE. PT WAS OBSERVED FOR 15 MINUTES UNTIL SHE "FELT FINE" AND SENT HOME.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swelling, aching arm. Lethargic (slept all day).  Slight fever, but that passed.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Hyperhidrosis, Pyrexia
Clinical narrative: High fever, chills, sweats, achy joints and continuing breathing issue
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen arm pit lymph nodes swollen and painful
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient may have inadvertently been given 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State of MD was notified.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Rash that is red, itchy, and  swollen around the injection site
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Eyelid function disorder
Clinical narrative: BELLS PALSY RE-EMERGENCE; IMPAIRED CLOSURE OF EYELID, IMPAIRED  ABILITY TO RAISE EYBROW, INABILITY TO SMILE, ALL FACIAL MANIFESTATIONS OF BELLS PALSY
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: Patient state she felt light headed and dizziness and "weird". Patient was sitting at the time and I had the patient lay on the ground to prevent any injury in the event she were to pass out. Due to her stating she felt so hot and "bad" 911 was called and dispatched. Upon arrival the patient was seated. and stated she felt weird to the EMS. She stated she did not want to go to the hospital but was unsure if she could stand without passing out. Vaccine was given around 11:40 am and around 11:50 to 11:54am patient started complaining of not feeling well.  EMS arrived within 10 minutes of calling 911. Patient stated she did not want to go to the hospital but would go to the ambulance to be evaluated. EMS stated they could exam her in the ambulance and decide from there if she wanted to go to the hospital.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Ear pain
Clinical narrative: pain in her ear; hearing loss; Information has been received from a lawyer regarding a case in litigation referring to a 66-year-old female patient (pt). Information about concurrent condition, medical history and concomitant medication was not reported. On 06-DEC-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) in a pharmacy for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in December 2013, the pt was caused to suffer pain in her ear and hearing loss, including any and all of its sequelae.  As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer serious and dangerous side effects including pain in her ear and hearing loss, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications (also reported as a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages). In addition, the pt required and would continue to require healthcare and services. The pt had incurred and would continue to incur medical and related expenses. The pt also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The pt's direct medical losses and costs include physician care, monitoring, and treatment. The pt had incurred and would continue to incur mental and physical pain and suffering. The outcome of the events was not recovered.  Upon internal review, hearing loss was determined to be medically significant. The lawyer considered both events to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 08-AUG-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the vaccine, the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  The events herpes zoster and postherpetic neuralgia were considered to be disabling by the lawyer.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incoherent, Oral herpes, Pyrexia
Clinical narrative: cold sore on her lip; fever of 105; states she was incoherent; This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th December 2020, several hours after receiving Shingrix, the patient experienced fever and incoherent. On 11th December 2020, the patient experienced cold sores lip. On 9th December 2020, the outcome of the fever and incoherent were recovered/resolved. On 13th December 2020, the outcome of the cold sores lip was recovered/resolved.   The reporter considered the fever and incoherent to be related to Shingrix. It was unknown if the reporter considered the cold sores lip to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient had no underlying disease and medication history The patient received her dose of Shingrix , on the same day, within few hours she developed fever and incoherent, after 1 day fever was resolved. Three days after, the patient developed a cold sores lip and it resolved in 2 days. No Lot or Expiration date was known.  No permission given to contact HCP. The reporter did not consent to follow-up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure increased, Cellulitis, Flushing
Clinical narrative: Pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection; Sugar was very high; Blood pressure was very high; Face look flushed; A spontaneous report was received from a consumer concerning a 61-years-old male patient who experienced pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection (cellulitis), sugar was very high (blood glucose increased), blood pressure was very high (blood pressure increased), and face looked flushed (flushing).  The patient's medical history included diabetes mellitus, heart disease (unspecified), kidney failure, and chronic obstructive pulmonary disease (COPD). Products known to have been used by the patient, within two weeks prior to the event, included insulin and oral medications for diabetes (unspecified), rosuvastatin calcium, acetylsalicylic acid, umeclidinium bromide and vilanterol trifenatate, diuretics unspecified (water pills), omeprazole magnesium, and cortisone.  On 15 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.    On 17 Feb 2021, the patient got cortisone injection.  On 18 Feb 2021, the patient experienced high sugar level, high blood pressure and face looked flushed.  On 20 Feb 2021, the patient started having pain in the ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection.   Treatment for the events included Keflex.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events of pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection, sugar was very high, blood pressure was very high, and face looked flushed, was considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Basophil count, Basophil count increased, Burning sensation, Dizziness
Clinical narrative: brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Full blood count, Neuralgia, Orthostatic hypotension, Pain assessment
Clinical narrative: brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Musculoskeletal stiffness, Myocardial infarction, Nausea
Clinical narrative: felt like she was having a "heart attack"; extremely nauseous and dizzy; extremely nauseous and dizzy; reported stiffness in both legs and could not walk; reported stiffness in both legs and could not walk; This is a spontaneous report from a contactable pharmacist. An elderly (65+ Years) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 23Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient was not Pregnant at Time of Vaccination. Facility type vaccine was Public Health Clinic/Administration facility. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 intramuscular on unknown date at SINGLE DOSE for covid-19 immunisation. After 2nd dose on 23Feb2021, the patient felt extremely nauseous and dizzy, felt like she was having a "heart attack" though no reported difficulty breathing or anaphylaxis. The patient also reported stiffness in both legs and could not walk and do could not reach phone to call anyone. No treatment received. The outcome was unknown. No covid prior vaccination.  Information about lot/batch number has been requested.; Sender's Comments: Based on temporal relationship, the causal association between BNT162B2 and the reported "felt like having a heart attack" cannot be completely excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: 11:28 am left sided redness on neck and arm.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: fever up to 101.2, chills, achy all over, tired - all day the following day on 7th, nauseas for about 3-4 hours that morning.  achy and tired continued for several days
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site discomfort, Pain
Clinical narrative: 3/9- 1pm vaccine, injection site discomfort 9pm-chills 10pm-fever (reaching 103.8), body/muscle aches, headache through night and into morning  3/10- 12pm-fever, body aches gone, slight headache remained and tired the next day but continued to improve  3/11- No symptom but  arm still sore
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 3/9- 1pm vaccine, injection site discomfort 9pm-chills 10pm-fever (reaching 103.8), body/muscle aches, headache through night and into morning  3/10- 12pm-fever, body aches gone, slight headache remained and tired the next day but continued to improve  3/11- No symptom but  arm still sore
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Heart rate increased
Clinical narrative: 10 hours after vaccination I got very tired. Went to bed at 9:30. Had chills. and slight head ache. Woke up around 12:30  with  rapid heart beat. My normal resting heart rate is 61(per activity tracker) It was 98 ish.  and somewhat eractic. (but not a lot). Also had nausea and diarrhea. Finally got some sleep. Woke up at 7:00am and took 2 aspirin. Today I'm feeling fine.  Maybe a little tired.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: 10 hours after vaccination I got very tired. Went to bed at 9:30. Had chills. and slight head ache. Woke up around 12:30  with  rapid heart beat. My normal resting heart rate is 61(per activity tracker) It was 98 ish.  and somewhat eractic. (but not a lot). Also had nausea and diarrhea. Finally got some sleep. Woke up at 7:00am and took 2 aspirin. Today I'm feeling fine.  Maybe a little tired.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hyperacusis, Lethargy, Nausea, Palpitations
Clinical narrative: Day 1: woke up to my heart racing, lethargy later in the day along with startling to sounds, seeing things not there in periphery, felt sunburned in armpits, bend of legs & front of shins, rash in armpit that came & went, hot spots on skin in various areas, felt I was burning up from the inside out, waves of nausea.  Day 12: random itching on throat, chest & arms(started slight on day 10 increased til day 12 then went away), felt sunburned all over, rash on chest that went away in approx 10 min, shoulder & wrist aches
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Throat irritation, Visual field defect
Clinical narrative: Day 1: woke up to my heart racing, lethargy later in the day along with startling to sounds, seeing things not there in periphery, felt sunburned in armpits, bend of legs & front of shins, rash in armpit that came & went, hot spots on skin in various areas, felt I was burning up from the inside out, waves of nausea.  Day 12: random itching on throat, chest & arms(started slight on day 10 increased til day 12 then went away), felt sunburned all over, rash on chest that went away in approx 10 min, shoulder & wrist aches
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Tenderness at injection site with appx four inch area around injection site that became red a week after injecton recieved slight itch to red area lasted appx 3-4 days
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Temperature, chills and body aches.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Fatigue, Hyperhidrosis
Clinical narrative: Chills, sweat, tiredness, LOSS OF TASTE (6/10)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site nodule, Pain in extremity
Clinical narrative: Sore arm, welt at injection site.  Tired next 2 days
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Aproximately 30 minutes after injection, I felt stimulated as if having drank too many energy drinks, mild diaphoresis, mild trembling, racing heart rate.  Suffered uncharateristic insomnia the same night.  On 2/23/21, I awoke after 6 hours sleep, with mild body aches and general torpor -malaise.  This progressed into the early afternoon to severe body aches 8/10 on pain scale of 10, a moderate headache of 3/10, excessive drowsiness, extreme diaphoresis, chills, and a temperature spike of 1 degree.  I had very mild motor trembling in upper extremeties (hands) that seemed unassociated with fever.  I took no medications and slept under these general conditions for 80% of the next 48 hours.  The headache did reduce after the 10 hours from onset.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Palpitations, Somnolence, Tremor
Clinical narrative: Aproximately 30 minutes after injection, I felt stimulated as if having drank too many energy drinks, mild diaphoresis, mild trembling, racing heart rate.  Suffered uncharateristic insomnia the same night.  On 2/23/21, I awoke after 6 hours sleep, with mild body aches and general torpor -malaise.  This progressed into the early afternoon to severe body aches 8/10 on pain scale of 10, a moderate headache of 3/10, excessive drowsiness, extreme diaphoresis, chills, and a temperature spike of 1 degree.  I had very mild motor trembling in upper extremeties (hands) that seemed unassociated with fever.  I took no medications and slept under these general conditions for 80% of the next 48 hours.  The headache did reduce after the 10 hours from onset.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram abnormal, Death, Dementia, Fall
Clinical narrative: fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT scan, transferred to tertiary care center, f/u scan after 6 hours unchanged. Sent home. next morning unresponsive, transported back to tertiary care center. required ventilation en route.. massive cerebral hemorrhage noted on CT scan in different area. due to advanced dementia and unresponsiveness life support removed around 9pm that night. passed away at 9am on 3/1.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Loss of consciousness, Mechanical ventilation, Unresponsive to stimuli
Clinical narrative: fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT scan, transferred to tertiary care center, f/u scan after 6 hours unchanged. Sent home. next morning unresponsive, transported back to tertiary care center. required ventilation en route.. massive cerebral hemorrhage noted on CT scan in different area. due to advanced dementia and unresponsiveness life support removed around 9pm that night. passed away at 9am on 3/1.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site induration, Vaccination site rash
Clinical narrative: Raised, itchy rash at the vaccination site - erupting six days after administration of vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea
Clinical narrative: Janssen COVID-19 Vaccine EUA was administered on Monday March 8th at 4:30pm.  On Tuesday evening of March 9th, I experienced stomach cramping, abdominal paid, and explosive diarrhea. I took an Imodium following this episode. Then on the morning of Tuesday March 10th around 9:30am, I had another round of explosive diarrhea.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: 100's of small blisters on arm and hand that itch.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Mild headache and nausea after sitting in observation for about 25 minutes. Refused any intervention by observation staff including VS. Declined evaluation by EMS.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Injection site pain, Migraine
Clinical narrative: From 6pm-5am I experienced a terrible migraine,  horrible body aches (every joint and muscle was throbbing), upset stomach, uncontrollable shaking/chills, and light headedness. Could only sleep short spurts after taking 400 mg of Ibuprofen. 24 hours after the vaccination, my body is still achey, sore at injection site, and uneasy stomach.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sleep disorder, Tremor
Clinical narrative: From 6pm-5am I experienced a terrible migraine,  horrible body aches (every joint and muscle was throbbing), upset stomach, uncontrollable shaking/chills, and light headedness. Could only sleep short spurts after taking 400 mg of Ibuprofen. 24 hours after the vaccination, my body is still achey, sore at injection site, and uneasy stomach.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Ischaemic stroke, Sensory loss, Walking aid user
Clinical narrative: 74 y.o. female with a history of hypertension and hyperlipidemia who was admitted to this hospital on February 25, 2020 4 hours after the development of left-sided weakness.  She was found to have an acute ischemic stroke.  She has had slow progression with therapy but is now able to ambulate with a walker.  She is in need of further rehab, hence the transition to swing bed.  She denies any new complaints today, including headache, chest pain, shortness of breath, palpitations or feelings of tachyarrhythmias.  The sensory deficits on the left side have improved in particular in her left upper extremity.  She is noting some improvement as well and strength.  No new focal neurological deficits
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chief complaint of tightness in chest lasting for approximately 8 minutes. No SOB noted. BP 141/68, P 74, R 16. Patient remain under observation for 30 minutes. Released at 11:45AM, patient denies any chest tightness, pain or distress. She stated that after Dose #1 she experienced similar symptoms as well as lymph nodes swelling.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Nausea
Clinical narrative: patient started feeling adverse effects on 3/7/2021, day after vaccination. She reports being nauseous, appetite loss, fatigue, no fever and having diarrhea. She had the corona virus 19 in November and was hospitalized. We recommended to take loperamide for the diarrhea or Pepto-bismol  and emetrol or nauzene for nausea. She wanted to  go to urgent care which we said is a good idea.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia, Hypotension, Pruritus
Clinical narrative: Patient is a 57 y.o. female who was seen at COVID Vaccine Clinic today for her second  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience itching.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes.   PMH: prediabetes, copd.      ALLERGY REVIEW OF SYSTEMS:  Patient complains of itching of skin   Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash and dizziness       Previous Reactions: none. Did well with 1st dose of Pfizer but did have a headache that lasted for 5 days.     Objective    Vitals Vitals:   03/08/21 0906 03/08/21 0916 BP: 136/88 120/76 BP Location: Right arm   Patient Position: Sitting   Pulse: 97 90 SpO2: 96% 96%            Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not diaphoretic.  HENT:     Mouth/Throat:     Pharynx: Oropharynx is clear.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Skin:    General: Skin is warm and dry.     Findings: No rash.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Gait: Gait normal.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: antihistamines pepcid and zyrtec Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Generalized itching.    She was observed in the medical bay for approx 15 minutes. She responded really well to the antihistamines. No further itching reported. No rash or other symptoms noted. She feels well to go home. Given handwritten instructions on medications received and when she can repeat if needed along with benadryl use.  Pt voiced appreciation of her care today. PT walked out by pharmacist.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Elevated heart rate beginning day after 2nd Pfizer dose administered; noted during exercise wearing heart rate monitor; about 15-20 bpm higher than normal; two weeks after 2nd Pfizer dose heart rate is still elevated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Pyrexia, Urticaria
Clinical narrative: Hives, fever, chills, body aches, swollen neck glands Hives lasted for 4 days would lesson after Benadryl, then came back on March 10th.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Wheezing
Clinical narrative: Wheezing couldn?t sollow
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Day of shot at 5:00 pm my palms on both hands had itching and I had to keep scratching them. It was driving me nuts. Later that evening my feet were also itching. All night long and into Tuesday but the itching also included my underarms, chest, and upper thighs. Finally on Tuesday I started taking 2 Benedryl tablets every 6 hours, however at 4 hours the itching came back but seemed to be only on the upper body. It is now a little over 72 hours since my shot and I'm still suffering the itching, but not quite as bad with Benedryl. Since I didn't see this on the list of possible side effects, I thought you should know.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Chills, fatigue, achy muscles
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Nausea, Pain, Pyrexia
Clinical narrative: Achiness, nausea, fever, cold sweats
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye pain, Headache, Nausea
Clinical narrative: I woke up on Sunday feeling like my eyeballs were being ripped out of my face. Took Tylenol Sinus which helped. As the day went by, I began to have body aches, chills, joint pain, nausea. I took my temp at bedtime, it was 101.9. On Monday, things were much worse. My temp was 102.4 upon awakening & the pain level for my head was excruciating. Again, Taking Tylenol Sinus helped w/the headache & fever, not so much for the rest. On Tuesday, I woke & took my temp, it was normal. It is now Thursday, 3/11 & although I have no fever, it still feels as though I have one. Regular Tylenol helps but the head ache,  body aches & fatigue remain.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: I woke up on Sunday feeling like my eyeballs were being ripped out of my face. Took Tylenol Sinus which helped. As the day went by, I began to have body aches, chills, joint pain, nausea. I took my temp at bedtime, it was 101.9. On Monday, things were much worse. My temp was 102.4 upon awakening & the pain level for my head was excruciating. Again, Taking Tylenol Sinus helped w/the headache & fever, not so much for the rest. On Tuesday, I woke & took my temp, it was normal. It is now Thursday, 3/11 & although I have no fever, it still feels as though I have one. Regular Tylenol helps but the head ache,  body aches & fatigue remain.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Feeling hot, Headache, Illness, Pruritus
Clinical narrative: Became very ill once vaccine was completed, became hot, pounding headache, skin itchy and red splotches , blood pressure was elevated and throat started  getting tight
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Throat tightness
Clinical narrative: Became very ill once vaccine was completed, became hot, pounding headache, skin itchy and red splotches , blood pressure was elevated and throat started  getting tight
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pyrexia
Clinical narrative: Slight headache for several days.  Feeling of ice water in random veins. First day was up left side of head, then in chest and last place several days later was in backbone.  Each time feeling was only for a few minutes.  Slight fever for 3 days.  No other symptoms.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Severe chills, headache, fever, cold sweats, swelling in armpit near injection site