chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Mobility decreased, Pain, Pyrexia
Clinical narrative: I got my vaccine at 4:00 p.m. About 10 hours (2:00 a.m.) after the vaccine I started getting aching back pain and bilateral shoulder pain.  About 12 hours after the vaccine I spiked a fever and felt like I was hallucinating.  I was unable to check my temperature until 10:30 a.m. the next morning and it was 102.4.  I had a fever, body aches, and headache the entire following day. My fever broke to 99.0 around 6:00 p.m.  I also had severe pain at the injection site that started several hours after my injection and continued to get worse.  The pain was so bad it was too painful to move my arm.  Today is day two post-vaccine, I have no fever but feel very weak and lethargic.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Fatigue, Headache, Impaired work ability
Clinical narrative: Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and pain, and generalized fatigue resulting in inability to work the day after dose given. Fatigue started around 20:00 on 1/5/2021 (same date as 2nd dose administration), with increasing discomfort throughout the night. Symptoms continued until about 1:00 on 1/7/2021. Peak symptoms 1:00am-12:00pm on 1/6/2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and pain, and generalized fatigue resulting in inability to work the day after dose given. Fatigue started around 20:00 on 1/5/2021 (same date as 2nd dose administration), with increasing discomfort throughout the night. Symptoms continued until about 1:00 on 1/7/2021. Peak symptoms 1:00am-12:00pm on 1/6/2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA. Vaccine recipient received vaccine on 1/19/2021. On 1/10/2021 reported fever, headache, chills, aches/pain, and fatigue. She self-managed at home. She reported that she developed a tinnitus (high pitch, intermittent buzzing) for 10 days. She does not have a history of tinnitus. She reports that her she self-managed at home and her symptoms resolved.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Moderna COVID-19 Vaccine EUA. Vaccine recipient received vaccine on 1/19/2021. On 1/10/2021 reported fever, headache, chills, aches/pain, and fatigue. She self-managed at home. She reported that she developed a tinnitus (high pitch, intermittent buzzing) for 10 days. She does not have a history of tinnitus. She reports that her she self-managed at home and her symptoms resolved.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: No symptoms appeared immediately after vaccination, although patient passed away around 6:00 pm unexpectedly. Staff talked with her last time at 5:30 pm and then found her at 6:00 pm passed away.  Unknown at this time if death is directly related to receiving the vaccine.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Death
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Skin rash on right side, back of head, between hairline and right ear.  Extremely itchy, red bumps, spread down neck.   Resolved by 1/25/2021 after 5 days of prescription steroid cream.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: severe Headache, low grade fever, some dizziness
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anal incontinence, Anxiety, Arthralgia, Asthenia, Blood alkaline phosphatase normal
Clinical narrative: 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours,  took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine normal, Blood pH increased, Brain natriuretic peptide increased, Chest discomfort, Chest pain
Clinical narrative: 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours,  took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Complement factor C3, Complement factor C4 decreased, Cough, Diarrhoea, Dizziness
Clinical narrative: 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours,  took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eosinophil percentage, Erythema, Fatigue, Feeling hot
Clinical narrative: 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours,  took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Hypotonia, International normalised ratio increased, Lymphocyte percentage increased
Clinical narrative: 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours,  took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea, Neutrophil count decreased, Neutrophil percentage decreased, PCO2 decreased
Clinical narrative: 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours,  took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary pain, Pyrexia, Red cell distribution width normal, Retching, Sensation of foreign body
Clinical narrative: 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours,  took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary incontinence, Urticaria
Clinical narrative: 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours,  took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Swelling and pain at injection site that evening  Fever, chills and body aches the next morning
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area of erythema and mild induration  1 1/2 in from the injection site 3 in long
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Injection site induration, Injection site rash, Pain in extremity
Clinical narrative: Extreme sore arm after vaccine that went down.  Then 7 days later, same area covered with bumpy rash like welts.  Still hard. The area is below the injection site.  Otherwise, feel kind of low flu-ish. Felt fine first week.  Then on day 7 rash and feeling off.  Maybe an immune response.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Extreme sore arm after vaccine that went down.  Then 7 days later, same area covered with bumpy rash like welts.  Still hard. The area is below the injection site.  Otherwise, feel kind of low flu-ish. Felt fine first week.  Then on day 7 rash and feeling off.  Maybe an immune response.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Injection site pruritus, Injection site urticaria, Skin lesion, Throat irritation
Clinical narrative: Two-fold: 1. Patient reports that upon receiving the shot, her throat felt itchy and scratchy.  Mild and subsided quickly same day. 2. Patient reports that 7 days after the shot, a large solitary hive developed over the injection site. It's itchy and cell picture does indeed show a large urticarial lesion over the left lateral deltoid area.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Herpes ophthalmic, Lacrimation increased, Photophobia, Sleep disorder
Clinical narrative: Awakened with eye pain, severe light sensitivity, tearing.  On 1/21/2021 I went to visit the optometrist and was immediatley referred to the  opthamologist for a same day appointment. I was told it looked like a herpetic keratis (HSV 1 virus) by both physicians. I have a left corneal transplant. I have never had an HSV virus affect my eye in the past. The last fever blister I had was > 5 years ago.  Treated with maxitrol qid, Acyclovir five times a day, Cyclogel bid. Severe light sensitivity resolved after about 24 hours.  On f/u appointment on 1/26/2021 he said that the herpatic lesion was looking better. Eye pain resolved. I am continuing medication.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report () was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Throbbing Headache and full on body aches & chills for two days
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Injection site bruising, Migraine, Myalgia
Clinical narrative: Muscle soreness, cold chills, fever, migraine, bruised arm at site of injection
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Muscle soreness, cold chills, fever, migraine, bruised arm at site of injection
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: With the second dose I ended up with severe pain on my upper back through my neck/shoulder area and also had pain in my rib cages (both). I experienced joint pain in my ankles and knees (no known case of arthritis) they were off and on and extreme fatigue. I still have pain in my upper back/neck shoulder area and the fatigue. The rib cage pain and the joint pain are gone
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pain
Clinical narrative: Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 24 hours
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 24 hours
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Low grade fever  Joint aches Headaches Fatigue
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: A week after injection, armed turned red around injection site , itched, & a rash formed.  Still there a week later.  No pain or soreness now although I did have a little for several day after injection.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Allergic reaction approximately one week post vaccination. Severe Redness, swelling and soreness at site of application.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 9 days after the injection, her arm at the injection site is swollen and warm over around a 4"x4" area, encompassing much of her upper arm.  It has been this way for 1.5 days.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: I originally contacted the doctor's office because I had a runny nose, sore throat and a cough. 19 Also, I had been in contact with a friend who tested positive for COVID-19.   I did test positive for COVID-19 at that visit to my medical group's convenient care office.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I originally contacted the doctor's office because I had a runny nose, sore throat and a cough. 19 Also, I had been in contact with a friend who tested positive for COVID-19.   I did test positive for COVID-19 at that visit to my medical group's convenient care office.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Hallucination, Incoherent
Clinical narrative: Patient has Parkinson?s with dementia.  There has been some history of hallucination.  Upon awakening the day after receiving the vaccination, he was incoherent and having hallucinations much more pronounced than previously observed.  This lasted for about 3 hours and he slowly returned to his baseline status.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Lightheaded and palpitation
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Headache, Hypoaesthesia
Clinical narrative: ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way through the fingers lasting for 2 hours.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient reported a very sore arm and injection site swelling. The next day she had a fever of 101. She had overall body aches for several days. She reported adverse events 4 days after injection and said all symptoms have resolved accept injection site and still swollen and itchy
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Lymphadenopathy
Clinical narrative: lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on the injection side and it's painful; This is a spontaneous report from a contactable nurse and other hcp (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: EL1283, expiry date: unknown), via an unspecified route of administration on 11Jan2021 09:00 at single dose (left deltoid) for COVID-19 immunization. There were no medical history and concomitant medications. On 12Jan2021, patient had lymph node swelling on the same arm as the injection site. It got worse on the 13th. She described her experience as uncomfortable. She was asking how long it is expected to last. It was further reported that the patient received first Covid-19 vaccine on 11Jan2021 and is doing well, but had lymph node swelling in axillary area on the injection side and it's painful on 12Jan2021. She wanted to know how long it will be like that and if it doesn't go away when should she seek medical attention. Received the vaccine on the 11th and a couple days later had the lymph node swelling. She then clarified lymph node swelling started the 12th. Mentioned it got worse yesterday and it's staying about the same today with the swelling and is very uncomfortable (Jan2021) and is persisting. Causality not provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in the past. Vaccination Facility Type was Clinic. The outcome of the events was not recovered. Events reported as medically significant.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events swollen lymph nodes and lymph node pain.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Influenza A virus test negative, Influenza virus test negative
Clinical narrative: This patient received her 2nd COVID vaccine on 1/19 at her place of employment. She had no symptoms for 21 hours. At 4AM on January 20th, this patient awoke with chills and muscle/joint aches. This patient did not take a temperature at the time (knowing these were common symptoms), and instead managed them with Advil and Tylenol. On Friday the 22nd, this patient awoke with worsening chills and sudden nausea. She took her temperature, which was 100.5. This patient called employee health and asked if symptoms lasting  over 48 hours were ordinary or if she should be tested for COVID-19. Employee health informed patient to get tested in case of exposure. Patient was negative, however remained nauseous and had low grade fevers and aches. On the 23rd, patient awoke with severe nausea and vomiting. Patient called her primary care provider for zofran prescription, which was granted.  Zofran was taken around the clock until 1/26. Additionally, patient continued to have chills and aches until 1/25, again managed by alternating Advil and Tylenol.  Also on 1/25, patient noticed flat, erythemic rash covering her abdomen and back. Patient applied hydrocortisone cream and took Benadryl. As of today, 1/27, patient is afebrile, not nauseous, and rash has disappeared.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Rash, Rash erythematous, Respiratory syncytial virus test negative
Clinical narrative: This patient received her 2nd COVID vaccine on 1/19 at her place of employment. She had no symptoms for 21 hours. At 4AM on January 20th, this patient awoke with chills and muscle/joint aches. This patient did not take a temperature at the time (knowing these were common symptoms), and instead managed them with Advil and Tylenol. On Friday the 22nd, this patient awoke with worsening chills and sudden nausea. She took her temperature, which was 100.5. This patient called employee health and asked if symptoms lasting  over 48 hours were ordinary or if she should be tested for COVID-19. Employee health informed patient to get tested in case of exposure. Patient was negative, however remained nauseous and had low grade fevers and aches. On the 23rd, patient awoke with severe nausea and vomiting. Patient called her primary care provider for zofran prescription, which was granted.  Zofran was taken around the clock until 1/26. Additionally, patient continued to have chills and aches until 1/25, again managed by alternating Advil and Tylenol.  Also on 1/25, patient noticed flat, erythemic rash covering her abdomen and back. Patient applied hydrocortisone cream and took Benadryl. As of today, 1/27, patient is afebrile, not nauseous, and rash has disappeared.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: This patient received her 2nd COVID vaccine on 1/19 at her place of employment. She had no symptoms for 21 hours. At 4AM on January 20th, this patient awoke with chills and muscle/joint aches. This patient did not take a temperature at the time (knowing these were common symptoms), and instead managed them with Advil and Tylenol. On Friday the 22nd, this patient awoke with worsening chills and sudden nausea. She took her temperature, which was 100.5. This patient called employee health and asked if symptoms lasting  over 48 hours were ordinary or if she should be tested for COVID-19. Employee health informed patient to get tested in case of exposure. Patient was negative, however remained nauseous and had low grade fevers and aches. On the 23rd, patient awoke with severe nausea and vomiting. Patient called her primary care provider for zofran prescription, which was granted.  Zofran was taken around the clock until 1/26. Additionally, patient continued to have chills and aches until 1/25, again managed by alternating Advil and Tylenol.  Also on 1/25, patient noticed flat, erythemic rash covering her abdomen and back. Patient applied hydrocortisone cream and took Benadryl. As of today, 1/27, patient is afebrile, not nauseous, and rash has disappeared.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Headache, Lip swelling, Myalgia
Clinical narrative: Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient  received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On  to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great.  Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pallor, Paraesthesia oral, SARS-CoV-2 test negative, Tachypnoea
Clinical narrative: Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient  received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On  to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great.  Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis, Headache, Injection site erythema, Injection site pain
Clinical narrative: Patient reports experiencing right upper arm pain for 48 hours following injection and slight headache. 8 days later she woke up with a 5 x 4 cm area of redness at site of injection, warm to touch, painful and radiating into shoulder. Seen in clinic  the same day and placed on cephalexin for suspected cellulitis.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain, Pain in extremity
Clinical narrative: Patient reports experiencing right upper arm pain for 48 hours following injection and slight headache. 8 days later she woke up with a 5 x 4 cm area of redness at site of injection, warm to touch, painful and radiating into shoulder. Seen in clinic  the same day and placed on cephalexin for suspected cellulitis.
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: he reported a low blood pressure episode that requires hospitalization; This is a spontaneous report from a non-contactable consumer reported for her father.   A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date at SINGLE DOSE for COVID-19 immunization. Medical history and Concomitant medications were not reported. After 18 hours of the administration he reported a low blood pressure episode that required hospitalization. The outcome of the event was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, auditory
Clinical narrative: auditory hallucination; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 28Dec2020 in left arm at single dose for covid-19 immunization. The patient medical history was not reported. The patient had taken other medications in two weeks. No other vaccine in four weeks was taken. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Facility type vaccine was hospital. The patient experienced auditory hallucination on 29Dec2020 with outcome of recovered.  No treatment was received for the event.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event auditory hallucination 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dysgeusia, Flushing
Clinical narrative: metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily.  There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations.   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 RA, IEC, as appropriate.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Lightheaded was, headache, fatigue for 48 hours
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Nasal congestion, Pain, Pyrexia
Clinical narrative: intense chest pain; nasal congestion; Fever; body ache; This is a spontaneous report from a contactable physician. A 38-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at left arm on 06Jan2021 14:00 at single dose for COVID-19 immunization. Patient had Covid prior vaccination. There were no concomitant medications. No other medications in two weeks. No other vaccine in four weeks. On 07Jan2021, The patient experienced fever and body ache for the first 2 days. On the 3rd day (19Jan2021) experienced intense chest pain and nasal congestion. she needed to go to Emergency Room where she stayed for 4 hours, and performed Thorax CT. No treatment received. The outcome of events was recovering.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Electrocardiogram abnormal, Electrocardiogram ambulatory, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. This nurse reported similar events for three patients. This is 1st of 3 reports.  A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 as a single dose for COVID-19 immunization.  Medical history included ongoing arrhythmias, which started about 3 years ago (2018) and got worse over time.  Ongoing concomitant medications included metoprolol (MANUFACTURER UNKNOWN) taken arrythmia from Sep2020. On 13Jan2021, the patient received the vaccine. Afterwards her right wrist was itching. She took diphenhydramine hcl (BENADRYL) for the itching. Then, she felt different when she got home and was lightheaded. She also had a headache. She took acetaminophen/diphenhydramine (TYLENOL PM) before bed for the itching and headache.  In the morning of 14Jan2021, she felt really bad. She did not have itching, but it started back up again later. She also took acetaminophen for the headache as the headache was on and off. She called her cardiologist due to her cardiac history, and asked if she could come in. On 14Jan2021, she had an electrocardiogram done and was diagnosed with post COVID vaccine supraventricular tachycardia (SVT).  On 14Jan2021, she had head and chest congestion. She felt stuffed up. She was coughing but she had no mucus. She thought that when the arrhythmia occurred, she coughed because of the SVT. The cardiologist ordered her to wear a 24hour HOLTER monitor, the results of which were unknown. The clinical outcomes of the wrist itching and post-COVID vaccine SVT were not recovered; while the events of felt different, lightheaded, and headache were recovered on 13Jan2021. The outcome of felt really bad was recovering.  The outcomes of the cough and head and chest congestion were unknown. The events of felt different, lightheaded, felt really bad, and post-COVID vaccine SVT were reported as serious for being medically significant. The seriousness of the other events was not reported.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events supraventricular tachycardia, lightheadedness and feeling abnormal.  The patient's underlying arrhythmias may also predispose the patient to developing supraventricular tachycardia. 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.,Linked Report(s) : US-PFIZER INC-2021042313 same reporter, same drug and event, different patient.;US-PFIZER INC-2021042339 same reporter, same drug and event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pruritus, Respiratory tract congestion, Supraventricular tachycardia
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. This nurse reported similar events for three patients. This is 1st of 3 reports.  A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 as a single dose for COVID-19 immunization.  Medical history included ongoing arrhythmias, which started about 3 years ago (2018) and got worse over time.  Ongoing concomitant medications included metoprolol (MANUFACTURER UNKNOWN) taken arrythmia from Sep2020. On 13Jan2021, the patient received the vaccine. Afterwards her right wrist was itching. She took diphenhydramine hcl (BENADRYL) for the itching. Then, she felt different when she got home and was lightheaded. She also had a headache. She took acetaminophen/diphenhydramine (TYLENOL PM) before bed for the itching and headache.  In the morning of 14Jan2021, she felt really bad. She did not have itching, but it started back up again later. She also took acetaminophen for the headache as the headache was on and off. She called her cardiologist due to her cardiac history, and asked if she could come in. On 14Jan2021, she had an electrocardiogram done and was diagnosed with post COVID vaccine supraventricular tachycardia (SVT).  On 14Jan2021, she had head and chest congestion. She felt stuffed up. She was coughing but she had no mucus. She thought that when the arrhythmia occurred, she coughed because of the SVT. The cardiologist ordered her to wear a 24hour HOLTER monitor, the results of which were unknown. The clinical outcomes of the wrist itching and post-COVID vaccine SVT were not recovered; while the events of felt different, lightheaded, and headache were recovered on 13Jan2021. The outcome of felt really bad was recovering.  The outcomes of the cough and head and chest congestion were unknown. The events of felt different, lightheaded, felt really bad, and post-COVID vaccine SVT were reported as serious for being medically significant. The seriousness of the other events was not reported.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events supraventricular tachycardia, lightheadedness and feeling abnormal.  The patient's underlying arrhythmias may also predispose the patient to developing supraventricular tachycardia. 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.,Linked Report(s) : US-PFIZER INC-2021042313 same reporter, same drug and event, different patient.;US-PFIZER INC-2021042339 same reporter, same drug and event, different patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypoaesthesia, Pain in extremity
Clinical narrative: Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in arm.   Pt still having  Anxiety.