chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving the first dose of Pfizer vaccine, patient experienced lightheadedness. Vital signs include BP 121/54, P 78, O2 99%. Cetirizine 10mg PO administered at 08:28. Before leaving clinic, patient felt comfortable with no additional or worsening symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This started exactly 14 days after i received the Janssen vaccine. I received it from pharmacy. I have a rash that started on my left shoulder within a few hours it spread to my entire back and stomach.  It is now on the back of my neck and has lightened a bit on my stomach. I have been taking benedryl and using cortisone cream. it does not itch at all.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Dizziness, Gait disturbance, Glomerular filtration rate decreased
Clinical narrative: 1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days.   June 17: Chest pain of # 9and jaw pain.  No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Gout, Headache, Laboratory test, Nausea, Neck pain
Clinical narrative: 1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days.   June 17: Chest pain of # 9and jaw pain.  No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pain in jaw, Vomiting
Clinical narrative: 1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days.   June 17: Chest pain of # 9and jaw pain.  No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Fatigue, Gout
Clinical narrative: 1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days.   June 17: Chest pain of # 9and jaw pain.  No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Muscle spasms, Muscular weakness, Nausea, Pain
Clinical narrative: 1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days.   June 17: Chest pain of # 9and jaw pain.  No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days.   June 17: Chest pain of # 9and jaw pain.  No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chillblains, Cryoglobulins absent, SARS-CoV-2 antibody test negative
Clinical narrative: Chillblains/Pernio of the toes following administration of vaccine and possibly rituximab
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt like I had a bad case of COVID-19.  I was sick with COVID-19 in February, and, this was worse.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient experienced syncope about 2 minutes after administration of vaccine.  Consciousness regained within 15 seconds.  Patient has reported previous syncopal episodes with vaccines in the past.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test, Pain in extremity, Pelvic pain, Rash
Clinical narrative: I had a rash that broke out on my face, severe fatigue, sore arms, major pelvic pain
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, Hypersomnia
Clinical narrative: day after: all CDC side effects + sore chest + neck pain + sleeping for 16 or more hours 2 days after: all CDC side effects + chest pain + trouble breathing 3 days after: lessening of all CDC side effects to no CDC side effect + trouble breathing through ER prescribed medication (2 inhalers) 4 days - 4 weeks after: intermittent shortness of breath fixed through further prescribed medication (2 inhalers) and steroid given 5+ weeks after: no noticeable side effects
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neck pain
Clinical narrative: day after: all CDC side effects + sore chest + neck pain + sleeping for 16 or more hours 2 days after: all CDC side effects + chest pain + trouble breathing 3 days after: lessening of all CDC side effects to no CDC side effect + trouble breathing through ER prescribed medication (2 inhalers) 4 days - 4 weeks after: intermittent shortness of breath fixed through further prescribed medication (2 inhalers) and steroid given 5+ weeks after: no noticeable side effects
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Severe Left Ear Tinnitus, high pitch.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: pt was itching away fromt the site but on the same arm and also rash on the chest...pt was otherwise fine no other symptoms
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza A virus test, SARS-CoV-2 test positive, Streptococcus test
Clinical narrative: After being fully vaccinated I contracted the COVID virus (05/14/2021). I had an bamlanizimab IV infusion.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Electrocardiogram abnormal, Intensive care, Laboratory test abnormal, Lung disorder
Clinical narrative: Having what felt like a heart attack and ended up in the hospital for 4 days went home everything thing was fine but got admitted to the ICU  again for 5 days on 05/23/2021. ECG kept changing and issues in lungs. Followed up on June 9th had to get IV fluid in the office went and saw PCP on the 10th and all of her numbers shot back up so she got 2 different shots in the office. CRP was 700. Has a follow up on July 2th.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Decreased appetite, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: SO the following day I was extremely tired and nauseous. I was shaky didn't have much of an appetite either. Those symptoms lasted for about two days, I was also a little bit out of breath and I thought at the time that it was just my asthma flaring up. On Sunday I contacted the employee health and talked to them about it and they told me it was "normal". I saw them in the beginning of February, I couldn't walk 50 steps in my living room without my chest getting really tight, they said not to worry about it and that it was "normal". My Oxygen levels were also going low like 91/92 for my blood oxygen levels. My pulse would go up to 102 at the lowest and jump up to 160/170 just to walk from my couch to my kitchen. That and the oxygen dropping lasted for 2 to 2.5 weeks. I also got a Covid test and that was negative.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness, Oxygen saturation decreased, SARS-CoV-2 test negative
Clinical narrative: SO the following day I was extremely tired and nauseous. I was shaky didn't have much of an appetite either. Those symptoms lasted for about two days, I was also a little bit out of breath and I thought at the time that it was just my asthma flaring up. On Sunday I contacted the employee health and talked to them about it and they told me it was "normal". I saw them in the beginning of February, I couldn't walk 50 steps in my living room without my chest getting really tight, they said not to worry about it and that it was "normal". My Oxygen levels were also going low like 91/92 for my blood oxygen levels. My pulse would go up to 102 at the lowest and jump up to 160/170 just to walk from my couch to my kitchen. That and the oxygen dropping lasted for 2 to 2.5 weeks. I also got a Covid test and that was negative.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular period starting the following week on 5/24. 24 day cycle when usual cycle is 28 to 29 days.  Then started next menstrual cycle on 6/22 (at normal 29 day time frame) BUT cycle only lasted 1 day.  Have been menstruating 33 years and have never had just 1 day of bleeding.  Normal bleeding for me lasts 5 days.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, SARS-CoV-2 test negative, Streptococcus test negative, Upper respiratory tract infection
Clinical narrative: Upper Respiratory Infection and GERD attack.  Recovered from upper respiratory infection but still recovering from GERD attack
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Muscle tightness, Pain
Clinical narrative: Immediately following vaccine & last three days was a deep soreness in the arm of the injection site. This side effect was anticipated. However, since then, what feels like a tightness or pinched nerve sensation has continued in that arm. It has been over one month since the vaccination. It is mildly painful to raise that arm. No degree of stretching or exercise has relieved this pain. My concern is that it may be permanent.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient had faint feeling, chills, temperature normal, blood pressure 164/90 pulse 60. Chief complaint was unusual taste and numbness of lips. Symptoms improved over 30-45 min period
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Tremor
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient had faint feeling, chills, temperature normal, blood pressure 164/90 pulse 60. Chief complaint was unusual taste and numbness of lips. Symptoms improved over 30-45 min period
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Dizziness, Dyspnoea, Electrocardiogram, Palpitations
Clinical narrative: Sinus Tachycardia/SVT/Palpitations. Ongoing since January - Racing Heart -Heart beating hard -Shortness of breath -Dizziness
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia, Supraventricular tachycardia
Clinical narrative: Sinus Tachycardia/SVT/Palpitations. Ongoing since January - Racing Heart -Heart beating hard -Shortness of breath -Dizziness
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Endoscopy, Gastrooesophageal reflux disease, Pain
Clinical narrative: Horrible heart burn and GERD started the evening of my second Moderna shot- it has NOT stopped. Ive had to go on medicine - tried three different ones.   I?m taking twice a day Omeprazole 20mg.   Its very painful- Ive changed my diet, and still not helping.. Its Bad???..
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient came in w/ s/other to get 2nd covid shot. Gave shot to patients significant other first with patient watching. Patient got scared when they saw the needle, & we quickly moved forward with their dose. Patient walked to the observation area of the store and sat in the chair, before they felt light headed. Patient laid down on the floor on their side in fetal position, and went completely unconscious. Pharmacist shook pts arm and said name 4 times before pt regained consciousness. EMS calle
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given late. First dose given on 5/4/2021 Lot # 025B21A. Second dose given on 6/24/2021, Moderna, Lot # 025B21A.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site joint pain, Joint range of motion decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: States that within one month of dose 2 she has had shoulder pain Left arm that does not allow her to fully rotate the arm in a posterior position., Pain level 8. Unrelieved by tylenor or NSAIDS. Radiates to neck and down L arm. No numbness or tingling.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dysmenorrhoea, Menstrual discomfort, Menstrual disorder
Clinical narrative: Worse menstrual cycle of my life. One week late. Cramps so bad for three days that my back and hips hurt and couldn?t get off the couch. Normally I am twenty eight days and have no cramps.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Worse menstrual cycle of my life. One week late. Cramps so bad for three days that my back and hips hurt and couldn?t get off the couch. Normally I am twenty eight days and have no cramps.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Carbohydrate antigen 19-9 increased, Computerised tomogram abnormal
Clinical narrative: Shoulder and back pain that has persisted. After second vaccination, 02-27-2021, administered at 1:50 pm, nausea and vomiting for two days that started that night. Abdominal pain that has persisted, radiating to back, exacerbated by eating fats and sugars. Pancreatitis diagnosed by labs and imaging. Treatment: Creon and diet.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lipase increased, Magnetic resonance cholangiopancreatography, Nausea, Pain, Pancreatitis
Clinical narrative: Shoulder and back pain that has persisted. After second vaccination, 02-27-2021, administered at 1:50 pm, nausea and vomiting for two days that started that night. Abdominal pain that has persisted, radiating to back, exacerbated by eating fats and sugars. Pancreatitis diagnosed by labs and imaging. Treatment: Creon and diet.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast abnormal, Ultrasound scan abnormal, Vomiting
Clinical narrative: Shoulder and back pain that has persisted. After second vaccination, 02-27-2021, administered at 1:50 pm, nausea and vomiting for two days that started that night. Abdominal pain that has persisted, radiating to back, exacerbated by eating fats and sugars. Pancreatitis diagnosed by labs and imaging. Treatment: Creon and diet.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I got shingles. I got the shingles shot that should have prevented me from getting the shingles. I went to the doctor and was diagnosed with it.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Pain
Clinical narrative: In order in which they occurred: Fatigue, chills, fever, body aches, headache, and vomiting. Treatment included cooling packs and ibuprofen, and when I was finally able to sleep I woke up with just exhaustion the next day.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: In order in which they occurred: Fatigue, chills, fever, body aches, headache, and vomiting. Treatment included cooling packs and ibuprofen, and when I was finally able to sleep I woke up with just exhaustion the next day.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bell's palsy, Dysstasia, Gastroenteritis viral, General physical health deterioration
Clinical narrative: Three weeks after receiving the first Moderna Co-Vid vaccine, pt developed a stomach virus (?) vomiting and not being able to hold down anything but water.  This lasted four days.  She then started getting pain in his hips and legs.  Over the next two weeks her condition worsened to where she couldn't even use a walker to stand.  We went to the ER where they diagnosed her with Bell's Palsy (which went away in a few days) and did an MRI and took X-rays to ascertain the source of the pain and weakness in her legs.  Another week at home and her condition deteriorated to where we went to the ER.  A neurologist was called in who diagnosed her with Guillain-Barre Syndrome.  She was admitted to the hospital and was given two  IVIG treatments.  She was released after three days to the rehab facility where she spent two weeks before being discharged to our home.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging, Muscular weakness, Pain in extremity
Clinical narrative: Three weeks after receiving the first Moderna Co-Vid vaccine, pt developed a stomach virus (?) vomiting and not being able to hold down anything but water.  This lasted four days.  She then started getting pain in his hips and legs.  Over the next two weeks her condition worsened to where she couldn't even use a walker to stand.  We went to the ER where they diagnosed her with Bell's Palsy (which went away in a few days) and did an MRI and took X-rays to ascertain the source of the pain and weakness in her legs.  Another week at home and her condition deteriorated to where we went to the ER.  A neurologist was called in who diagnosed her with Guillain-Barre Syndrome.  She was admitted to the hospital and was given two  IVIG treatments.  She was released after three days to the rehab facility where she spent two weeks before being discharged to our home.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, X-ray
Clinical narrative: Three weeks after receiving the first Moderna Co-Vid vaccine, pt developed a stomach virus (?) vomiting and not being able to hold down anything but water.  This lasted four days.  She then started getting pain in his hips and legs.  Over the next two weeks her condition worsened to where she couldn't even use a walker to stand.  We went to the ER where they diagnosed her with Bell's Palsy (which went away in a few days) and did an MRI and took X-rays to ascertain the source of the pain and weakness in her legs.  Another week at home and her condition deteriorated to where we went to the ER.  A neurologist was called in who diagnosed her with Guillain-Barre Syndrome.  She was admitted to the hospital and was given two  IVIG treatments.  She was released after three days to the rehab facility where she spent two weeks before being discharged to our home.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Aspiration, Death, Sepsis
Clinical narrative: The patient received his first dose of Pfizer COVID vaccine 6/9/21 at pharmacy. He was then admitted 6/20/21 at hospital with abdominal pain, sepsis and a suspected aspiration event and expired on 6/23/21. This was felt by the treating physicians to be most likely not related to or associated with the vaccine, but given the close proximity it was asked that this be reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed Shingles
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient mother stated that patient was 12 by filling out date of birth on consent with wrong year and signed consent after reviewing information.  When vaccine was processed a rejection was received "wrong date of birth".  Pharmacy called insurance and confirmed year of birth.  Mother then called and confirmed birth year.  Patient will be 12 in 10 days, doctor told her ok to get vaccine
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Loss of consciousness
Clinical narrative: loss of consciousness, shortness of breath was prescribed antibiotics they did not work.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches, fever, headaches, and fatigue
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoconcentration
Clinical narrative: hemocontration days later
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Supraventricular extrasystoles
Clinical narrative: Onset of chronic Sinus Rhythm with Supraventricular Ectopy with chest tightness and respiratory difficulty immediatey 5 minutes after the first Covid vaccine dose; Onset of chronic Sinus Rhythm with Supraventricular Ectopy with chest tightness and respiratory difficulty immediatey 5 minutes after the first Covid vaccine dose; Onset of chronic Sinus Rhythm with Supraventricular Ectopy with chest tightness and respiratory difficulty immediatey 5 minutes after the first Covid vaccine dose; This is a spontaneous report from a contactable other healthcare professional. A 52-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 12Mar2021 13:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included neuropathy peripheral from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, DCIS stage 0 (breast cancer) from an unknown date and unknown if ongoing. Concomitant medications included (TETANUS DIPTHERIA) taken for an unspecified indication from 20Mar2021 to 20Mar2021; duloxetine hydrochloride (CYMBALTA) and baclofen (BACLOFEN) taken for an unspecified indication, start and stop date were not reported. Patient received any other vaccinations prior to vaccination within 4 weeks. Patient received Cymbalta and Baclofen with in 2weeks prior to vaccination. Patient had no allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. On 12Mar2021 13:15 the patient experienced onset of chronic sinus rhythm with supraventricular ectopy with chest tightness and respiratory difficulty immediately 5 minutes after the first covid vaccine dose. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included heart monitor and diagnosis and DBT treatment. Respiratory difficulty and chest tightness persisted for two weeks. Chronic Sinus Rhythm with Supraventricular Ectopy continues to persist to date. The outcome of the events Supraventricular extra systoles, Chest discomfort, Dyspnoea was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort
Clinical narrative: Heaviness in my chest; Upset stomach; This is a spontaneous report received from a contactable consumer, the patient. A non-pregnant, female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route and in the left arm on 11Apr2021 at 00:15, as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route on an unknown date, as a single dose for COVID-19 immunisation The patients medical history included kidney disorder from an unknown date. No concomitant medications were taken by the patient. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested positive for COVID-19. On 13Apr2021, the patient experienced heaviness in chest and upset stomach. The clinical outcome of heaviness in chest and upset stomach was not resolved at the time of this report.   No follow-up attempts are possible. Information about lot number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph nodes Right side of body neck, underarm and groin areas; Fever; Headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 07Apr2021 at 1545, as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, melanoma and squamous cell skin cancers and small intestines bacterial overgrowth and also had drug allergy to erythromycin antibiotic. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 at 1730, as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and also did not receive any other vaccine within four weeks of vaccination. Since the vaccination, patient not tested positive for COVID-19. On 04Apr2021 at 0300, the patient experienced Swollen lymph nodes on the right side of body at neck, underarm and groin areas and also had fever, headache and diarrhea. Therapeutic measures were not taken. The clinical outcome of all events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tinnitus
Clinical narrative: Itching all over continuing for a week; Greatly increased tinnitis; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), estrogen;progesterone;testosterone (MANUFACTURER UNKNOWN) and LIZEN all for an unknown indication from unknown dates. The patient was allergic to medications, food, or other products (unspecified). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 09:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 06Apr2021 at 12:00, the patient experienced itching all over continuing for a week and increased tinnitus greatly. It was reported that the patient did not receive any treatment for the reported events. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of itching and tinnitus was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: chills; numbness inside mouth and face; numbness inside mouth and face; This is a spontaneous report from a contactable consumer (Patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734, Expiration date: Unknown), via an unspecified route of administration on 12Apr2021 at 10:00 (at the age of 45-year-old), as 1st dose, single in deltoid Left, for COVID-19 immunisation. The patient's medical history included sensitive to medication. Concomitant medications were not reported. The patient's historical vaccine included flu shot administrated on an unspecified date in 2021, and experienced pain in joints for like a couple of weeks. On an unspecified date, after the administration of the first dose of vaccine, the patient experienced chills for like a week, numbness inside mouth and face. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Visual impairment
Clinical narrative: Unrelenting headache from day 3 post second injection with eye focusing issues.; Unrelenting headache from day 3 post second injection with eye focusing issues.; This is a spontaneous report received from a contactable consumer (patient). A 57-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew0153 and Expiration date was not reported), via an unspecified route of administration, in left arm, on 09Apr2021 (at the age of 57 years), as a single dose for covid-19 immunization. The patient medical history included chronic neck back issue and concomitant medications received within 2 weeks of vaccination included diphenhydramine, trazondo (trazodone hydrochloride), gabapentin, and glimepiride for an unspecified indication. Known allergies included metformin (allergies to medications, food, or other products). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: RP8535 and Expiration date was not reported), via an unspecified route of administration, in left arm, on 19Mar2021 at 10:45 AM, as a single dose for covid-19 immunization.  Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Apr2021, the patient had experienced unrelenting headache from day 3 post second injection with eye focusing issues. The patient had not taken any treatment medications for reported events. The outcome of the events was not recovered. The seriousness of the events was reported as non-serious.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia, SARS-CoV-2 test
Clinical narrative: I developed shingles on my face included nerve pain.; I developed shingles on my face included nerve pain.; This is a spontaneous report from a contactable other HCP (patient). A 25-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6207), via unspecified route of administration, administered in left arm on 01Apr2021 at 15:15 AM at the age of 25 years as single dose for Covid-19 immunization. The patient's medical history included COVID-19. The patient had no other medical or allergic history. Concomitant medications included Aripiprazole (ABILIFY) and Venlafaxine hydrochloride (EFFEXOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19. The facility of vaccination was workplace clinic. On 13Apr2021 the patient developed shingles on face including nerve pain. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included Valacyclovir. The patient had been tested for COVID-19 since the vaccination. On 14Apr2021 the patient had COVID test via nasal swab and the result was negative. Outcome of the events was recovering.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events Neuralgia and Herpes Zoster and the suspect drug BNT162B2.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on left side of body, starting with the foot and going up; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6202 and expiry date was not provided), via an unspecified route of administration in the left arm on 25Feb2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Patient did not have any known allergies. Patient's medical history was not reported. Concomitant medication included pravastatin. Patient had previously received first dose of BNT162B2 (Lot Number: EN5318) in left arm, on 02Feb2021 at 16:00 (at age of 58-years-old) for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05Mar2021 at 08:00, patient experienced numbness on left side of body, starting with the foot and going up. This started 7 days after vaccine. Comes and goes every day still. Adverse events result in visit to Doctor or other healthcare professional office/ clinic. No treatment was received. The outcome of events was not recovered.  Information on Lot/ Batch number was available. Follow up letter has been generated for further information.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic neuroma, Arteriovenous malformation, Asthenia, Electric shock sensation, Electrocardiogram
Clinical narrative: Numbness on left side of body, starting with the foot and going up; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6202 and expiry date was not provided), via an unspecified route of administration in the left arm on 25Feb2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Patient did not have any known allergies. Patient's medical history was not reported. Concomitant medication included pravastatin. Patient had previously received first dose of BNT162B2 (Lot Number: EN5318) in left arm, on 02Feb2021 at 16:00 (at age of 58-years-old) for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05Mar2021 at 08:00, patient experienced numbness on left side of body, starting with the foot and going up. This started 7 days after vaccine. Comes and goes every day still. Adverse events result in visit to Doctor or other healthcare professional office/ clinic. No treatment was received. The outcome of events was not recovered.  Information on Lot/ Batch number was available. Follow up letter has been generated for further information.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Hypoaesthesia, Magnetic resonance imaging, Magnetic resonance imaging neck, Magnetic resonance imaging spinal
Clinical narrative: Numbness on left side of body, starting with the foot and going up; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6202 and expiry date was not provided), via an unspecified route of administration in the left arm on 25Feb2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Patient did not have any known allergies. Patient's medical history was not reported. Concomitant medication included pravastatin. Patient had previously received first dose of BNT162B2 (Lot Number: EN5318) in left arm, on 02Feb2021 at 16:00 (at age of 58-years-old) for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05Mar2021 at 08:00, patient experienced numbness on left side of body, starting with the foot and going up. This started 7 days after vaccine. Comes and goes every day still. Adverse events result in visit to Doctor or other healthcare professional office/ clinic. No treatment was received. The outcome of events was not recovered.  Information on Lot/ Batch number was available. Follow up letter has been generated for further information.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Numbness on left side of body, starting with the foot and going up; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6202 and expiry date was not provided), via an unspecified route of administration in the left arm on 25Feb2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Patient did not have any known allergies. Patient's medical history was not reported. Concomitant medication included pravastatin. Patient had previously received first dose of BNT162B2 (Lot Number: EN5318) in left arm, on 02Feb2021 at 16:00 (at age of 58-years-old) for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05Mar2021 at 08:00, patient experienced numbness on left side of body, starting with the foot and going up. This started 7 days after vaccine. Comes and goes every day still. Adverse events result in visit to Doctor or other healthcare professional office/ clinic. No treatment was received. The outcome of events was not recovered.  Information on Lot/ Batch number was available. Follow up letter has been generated for further information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Sinus disorder
Clinical narrative: First dose: maybe a sore arm a little bit; a sinus issue and it led to mucus; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 4. A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 23Mar2021 20:10 (76-years-old at the time of vaccination), as a SINGLE DOSE for covid-19 immunization. Patient vaccination because high risk of getting Covid, cannot wear mask due to breathing and lung issues. The patient's medical history included Breathing issues, Inoperable lung cancer, Diagnosed Nov2010. She took 2 different chemos for 3.5 years and had 6 weeks of strong radiation so that's whys she is at a risk of getting Covid, Lung issues (respiratory illness), Allergies like in spring and summer, compromised immune status, genetic / chromosomal abnormality, endocrine abnormalities (including diabetes), and obesity. The patient's concomitant medication included Xyzal every night for the allergies which does not always work and Amoxicillin 500mg 3 times daily for sinus issue. The patient previously took flu shot. On an unspecified date, the patient experienced first dose: maybe a sore arm a little bit and a sinus issue and it led to mucus. On An unspecified date Mar2021, the patient underwent lab tests and procedures which included blood test: unknown. On 12Apr2021, the patient was taking Amoxicillin, as Therapeutic measures as a result of a sinus issue and it led to mucus. The outcome of the events first dose: maybe a sore arm a little bit was recovered on an unspecified date and a sinus issue and it led to mucus was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Influenza like illness, Nausea
Clinical narrative: Flu-like symptoms; Red raised welt with rash on arm at injection site of vaccine; Body aches; Fever (100F)/High fever of 102F; Chills; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via unspecified route of administration in left arm on 08Apr2021 at 11:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patients medical history included latex allergy. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced fever (100F), chills, body aches, nausea, headache within first 48 hours of vaccine then resolved, but then all came back again 10 days later along with red raised welt with rash on arm at injection site of vaccine and high fever of 102F, somewhat resolved, and came back again over two weeks later along. Flu-like symptoms were intermittent but continued over two weeks later. No therapeutic measures were taken for the events. On 18Apr2021, the patient underwent the nasal swab (helix) and result was negative. The clinical outcome of the events fever (100F)/ high fever of 102F, chills, body aches, nausea, headache, red raised welt with rash on arm at injection site of vaccine and flu-like symptoms was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vaccination site rash
Clinical narrative: Flu-like symptoms; Red raised welt with rash on arm at injection site of vaccine; Body aches; Fever (100F)/High fever of 102F; Chills; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via unspecified route of administration in left arm on 08Apr2021 at 11:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patients medical history included latex allergy. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced fever (100F), chills, body aches, nausea, headache within first 48 hours of vaccine then resolved, but then all came back again 10 days later along with red raised welt with rash on arm at injection site of vaccine and high fever of 102F, somewhat resolved, and came back again over two weeks later along. Flu-like symptoms were intermittent but continued over two weeks later. No therapeutic measures were taken for the events. On 18Apr2021, the patient underwent the nasal swab (helix) and result was negative. The clinical outcome of the events fever (100F)/ high fever of 102F, chills, body aches, nausea, headache, red raised welt with rash on arm at injection site of vaccine and flu-like symptoms was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersensitivity, Hypoaesthesia oral
Clinical narrative: tongue numbness/burn feeling similar to my food allergies; tongue numbness/burn feeling similar to my food allergies; tongue numbness/burn feeling similar to my food allergies; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EN6205, Pfizer NTEC), via an unspecified route of administration in left arm on 19Apr2021 at 15:00 (at the age of 63-years-old) as 2nd dose, single for covid-19 immunization. Medical history included Hypertension, arthritis, mostly great health and known allergies: Flagyl, pollen, melon, some shellfish, latex. Prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included losartan and amlodipine. The patient did not receive any other vaccines within 4 weeks. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EN62041, Pfizer NTEC), for COVID-19 immunization. On 20Apr2021 patient experienced tongue numbness/burn feeling similar to the food allergies, (melons/some shellfish). It lasted 3-4 days, lessened with Benadryl. The patient not hospitalized due to events. The patient received treatment for the events with Benadryl. The clinical outcome for the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.