chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone; pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone; pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone; pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone; tenderness and soreness in bone, area around her shoulder blade and in muscle; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in the left arm, administration date 23Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medications included: METFORMIN, GLIPIZIDE all taken for diabetes mellitus. The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), NECK PAIN (non-serious), BONE PAIN (non-serious) all with onset 25Feb2021, outcome "unknown" and all described as "pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone"; MUSCULOSKELETAL PAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "tenderness and soreness in bone, area around her shoulder blade and in muscle".  Additional information: The patient reported that she was taking 3 medications, but only two drugs were reported. She also mentioned that the event start date might be about 25Feb2021. The patient wanted to know if the second shot is advised to get in the same (site) where she got in the first one.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; mild headaches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported PAIN IN EXTREMITY (non-serious), outcome unknown; HEADACHE (non-serious), outcome recovered; FATIGUE (non-serious), outcome recovered.  Additional information included Headache and fatigue resolved on an unspecified date within 24 hours.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood uric acid, Blood uric acid increased, Pain in extremity
Clinical narrative: sore arm; Her uric acid level was 7.8 on 01Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 11:30 (Lot number: EL9269, Expiration Date: May2021) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing), notes: She had her first episode of gout 3 or 4 years ago and this is not a normal occurrence for her.; "High Blood pressure" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Chronic venous insufficiency" (unspecified if ongoing); "stage 1 chronic kidney disease" (unspecified if ongoing). Concomitant medication(s) included: REBIF taken for multiple sclerosis; LISINOPRIL taken for hypertension; LISINOPRIL HCTZ taken for hypertension; HCTZ taken for hypertension; METOPROLOL SUCCINATE taken for hypertension; HYDRALAZINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose: 1, On 04Feb2021 she developed gout in her "left foot in her middle toe she reports it as swollen, red, painful to touch, it has improved but it is still painful."), administration date: 03Feb2021, when the patient was 70 years old, for Covid-19 immunisation, reaction(s): "Gout", "Sore arm", "tired". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; BLOOD URIC ACID INCREASED (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Her uric acid level was 7.8 on 01Mar2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood uric acid increased.  Additional information: Patient has arthritis but she is not taking anything for it. She has chronic venous insufficiency for which she wears compression socks for, she wore wraps initially and in the summers its hots. She used to have stage 1 chronic kidney disease but doesn't have it anymore, her kidneys are fine. It was reported that patient arm was a little sore after the second dose too. She is on colchicine because she cant be on any type of steroid after the shot. She did 2 weeks colchicine and that did nothing, her uric acid went down 1/10th of a point, she was almost vegan on a low purine diet, now having a little meat and poultry. She is now on allopurinol for 45 days which may be helping and they will do more blood work to see her uric acid levels. She wants to know if Nsaids are okay after the shot, she knows with the steroid it depends. She clarifies her outcome saying that when it comes to the uric acid levels she's not really better.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient got her first covid vaccine. Everything was great she only had a sore arm. She got the second one. She never perforated her skin. When she was driving she should have turned around and went back. There was a white liquid on her arm. She never perforated her arm.She went and showed them her card and they couldn't give her a shot because it said her shot was completed, but it's not because she never gave her the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: My sugar was up; it was like 215 in the morning and it is usually 107 or 110; my sugar went crazy after that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "insulin dependent diabetic" (unspecified if ongoing), notes: I am insulin dependent diabetic. The patient took concomitant medications. Past drug history included: Insulin for insulin dependent diabetic, notes: I am insulin dependent diabetic. Vaccination history included: Bnt162b2 (first dose), for Covid-19 Immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "My sugar was up; it was like 215 in the morning and it is usually 107 or 110; my sugar went crazy after that". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Additional information: The patient received second dose on Monday and day before report she noticed that her sugar was up. Since, the patient was insulin dependent diabetic hence, just wanted to inform. She read side effects and it was never mentioned elevation of sugar on the paper that she got. Patient took Insulin as treatment. The patient reported that, she do take her medication and do have high blood pressure but confused for the name of other medications as it could be the Irbesartan, or it could be the cholesterol, or it could be Atorvastatin since patient did not knew which one is for high blood pressure (further clarification unknown).  No follow up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: became severely depressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 13:15 (Lot number: EM9808) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Mild arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DEPRESSION (non-serious), outcome "unknown", described as "became severely depressed". Therapeutic measures were taken as a result of depression.  Additional information: currently patient was being treated for chronic migraine, panic disorder and major depressive disorder. Also have mild arthritis. After the first administration she became severely depressed, but this could have been a result of outside factors, had to change medications. There was no COVID prior to vaccination and COVID was not tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Skeletal injury, Vomiting
Clinical narrative: Headache; sick to stomach; throwing up; bones hurt in his body; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 14:00 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "sick to stomach"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; SKELETAL INJURY (non-serious), outcome "unknown", described as "bones hurt in his body"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Caller got the shot yesterday at 2 o'clock to keep from getting the coronavirus. He has had 45 clients who died from coronavirus who were not lucky enough to get it. All kinds of stuff are going on. Patient was wondering if it is safe. He even cuts peoples hair that work for Pfizer. He has heard the second shot is worse. He was wondering if he can take Tylenol or Aspirin for these side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Electrocardiogram normal, Haematocrit, Haematocrit increased
Clinical narrative: blood pressure was 180; woke up and her heart was going bananas; her Red Blood Cells, her HCT, and HGB were all high; her HCT were high; HGB were high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021268865.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sensitive to caffeine" (unspecified if ongoing). The patient took concomitant medications.The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "blood pressure was 180"; HEART RATE ABNORMAL (non-serious) with onset 10Mar2021, outcome "unknown", described as "woke up and her heart was going bananas"; RED BLOOD CELL COUNT INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "her Red Blood Cells, her HCT, and HGB were all high"; HAEMATOCRIT INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "her HCT were high"; HAEMOGLOBIN INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "HGB were high". The events "blood pressure was 180", "woke up and her heart was going bananas", "her red blood cells, her hct, and hgb were all high", "her hct were high" and "hgb were high" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that she took her Blood Pressure pill before she went, but the only other medication she took was her Cholesterol pill that evening, and both of those, the patient had been on for year. Patient had no idea if this was from the shot or not, but she was sensitive to things and any change in a medication like a change in the fillers of a pill, can cause a reaction. And she drank coffee and she was so sensitive and does not drink caffeine that much. Patient had no other vaccines on the same day as the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin increased, Heart rate abnormal, Positive airway pressure therapy, Red blood cell analysis, Red blood cell count increased
Clinical narrative: blood pressure was 180; woke up and her heart was going bananas; her Red Blood Cells, her HCT, and HGB were all high; her HCT were high; HGB were high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021268865.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sensitive to caffeine" (unspecified if ongoing). The patient took concomitant medications.The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "blood pressure was 180"; HEART RATE ABNORMAL (non-serious) with onset 10Mar2021, outcome "unknown", described as "woke up and her heart was going bananas"; RED BLOOD CELL COUNT INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "her Red Blood Cells, her HCT, and HGB were all high"; HAEMATOCRIT INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "her HCT were high"; HAEMOGLOBIN INCREASED (non-serious) with onset 10Mar2021, outcome "unknown", described as "HGB were high". The events "blood pressure was 180", "woke up and her heart was going bananas", "her red blood cells, her hct, and hgb were all high", "her hct were high" and "hgb were high" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that she took her Blood Pressure pill before she went, but the only other medication she took was her Cholesterol pill that evening, and both of those, the patient had been on for year. Patient had no idea if this was from the shot or not, but she was sensitive to things and any change in a medication like a change in the fillers of a pill, can cause a reaction. And she drank coffee and she was so sensitive and does not drink caffeine that much. Patient had no other vaccines on the same day as the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Fatigue, Feeling abnormal, Vaccination site pain
Clinical narrative: felt lightheaded and slightly dizzy; felt like he was floating; Blood Pressure was 188/84, rapid high level rise in his blood pressure.; Tired; hard pain in arm where injection was given and pain also covers his entire bicep on left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Mar2021 10:30 (Lot number: EN6199, Expiration Date: Jun2021) at the age of 70 years as 0.3 ml, dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Has had high blood pressure for 30-40 years. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 08Mar2021, outcome "recovered" (08Mar2021), described as "felt lightheaded and slightly dizzy"; FEELING ABNORMAL (non-serious) with onset 08Mar2021, outcome "recovered" (08Mar2021), described as "felt like he was floating"; BLOOD PRESSURE INCREASED (non-serious) with onset 08Mar2021, outcome "recovered" (08Mar2021), described as "Blood Pressure was 188/84, rapid high level rise in his blood pressure."; FATIGUE (non-serious) with onset 08Mar2021, outcome "recovered" (08Mar2021), described as "Tired"; VACCINATION SITE PAIN (non-serious) with onset 08Mar2021, outcome "recovering", described as "hard pain in arm where injection was given and pain also covers his entire bicep on left arm". The patient underwent the following laboratory tests and procedures: blood pressure increased: (08Mar2021) 188/84.  Additional Information: The information "Then shortly, a minute or so, after that he felt a rush to his body and he had to sit down" has been subsumed under the event of "Dizziness" (felt lightheaded and slightly dizzy). The patient stated that the nurse gave him some water and took his blood pressure. He has high blood pressure but has it under control and taking medication for years and it is usually 130/whatever is his normal. They took him outside in the breezeway and got fresh air and he felt ok but had to sit. The patient also stated that yesterday afternoon he had pain in his arm where injection was given, he understands this may be normal, but it was a a hard pain and still suffering from it now.The pain is larger than just at the injection site, he states that it covers his entire bicep on the left arm. This started four hours later after getting the vaccine. He reported he knows he is completely recovered from the high blood pressure reading because he checked it at his house with a blood pressure machine and it came back to normal, what is normal for him. Patient stated as treatment that he lounged around the house and didn't do anything all day.He checked it over a period of 3-4 hours. Prior Vaccinations (within 4 weeks): None; AE(s) following prior vaccinations: None.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: was "not right" 6 days after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "was "not right" 6 days after receiving the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: had 3 "rough days"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Guillain-Barre syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "had 3 "rough days"".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphoedema, Pain, Pain in extremity, Weight
Clinical narrative: I had severe pain in my opposite arm; My arm with lymphedema started paining terribly, it was so bad I couldn't move it, I couldn't drive my car; The pain was excruciating I could not move my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6202) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "I have slightly raised blood pressure" (unspecified if ongoing), notes: I have slightly raised blood pressure; "lymphedema", start date: 1995 (ongoing), notes: I have had lymphedema since 1995; "Breast lumpectomy" (unspecified if ongoing), notes: I had a breast lumpectomy and the severe pain I had in the entire arm was unbearable.; "15 lymph nodes removed" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; DIGOXIN; FUROSEMIDE; METOPROLOL; VALSARTAN; ATORVASTATIN; METOPROLOL SUCCINATE. The following information was reported: LYMPHOEDEMA (non-serious) with onset 08Mar2021, outcome "recovering", described as "My arm with lymphedema started paining terribly, it was so bad I couldn't move it, I couldn't drive my car"; PAIN (non-serious) with onset 08Mar2021, outcome "recovering", described as "The pain was excruciating I could not move my arm"; PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "recovering", described as "I had severe pain in my opposite arm". Relevant laboratory tests and procedures included Blood test: unknown result and Weight:125 or 126 on an unspecified date. Therapeutic measures were taken as a result of lymphoedema, pain, pain in extremity and treatment included with she took was 1 Tylenol in the morning and one Tylenol at night.  Additional information: On 05Mar she had her first Pfizer vaccine and it was fine, she had no problem at all, no soreness no nothing. However, 3 days later on the 08Mar2021, she have to back track a little bit, she had her vaccine in her left arm which she have all her vaccines in because she have lymphedema in her right arm. So now 3 days after she had the vaccine her arm with lymphedema started paining terribly, it was so bad she couldn't move it, she couldn't drive her car and she have never had any pains in that arm, she have had lymphedema since 1995 so she never had any pain in it but it lasted until yesterday. It was very very painful so she began to wonder if she should have another vaccine or she shouldn't have the second vaccine." Very lightly, it feels like it's almost gone. She  just roll her shoulder now to try, She kept trying to move it, to get rid of it but it took a long time.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Weight, Weight decreased
Clinical narrative: terrible diarrhea; lost 5 pounds; she is not as tired as she was; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EV6204) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 13Mar2021, outcome "recovered" (18Mar2021 06:00), described as "terrible diarrhea"; WEIGHT DECREASED (non-serious) with onset Mar2021, outcome "unknown", described as "lost 5 pounds"; FATIGUE (non-serious) with onset Mar2021, outcome "recovering", described as "she is not as tired as she was". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea.  Additional information: She said that Saturday late afternoon she had diarrhea which she didn't pay it attention and didn't connect it, but then Sunday through Tuesday she had the worst diarrhea of her life and she would be 80 in a month, to where she barely got to the toilet and it poured out of her all day and during the night. Her husband got her Imodium, which made it more controlled and she could get to the toilet, and the diarrhea continued to last night though not as bad, it was still pouring out. She said this morning she took Imodium and had only went one time at 06:00AM, and she has not had any since. She said she dropped 5 pounds, she thinks she was pooping everything out, it was the craziest thing. She said she was not as tired as she was, but she also didn't know if she should continue taking Imodium to treat the symptom. She said she was better now. Reporter said that there were 24 tablets in pack, and was supposed to take two the first time she believes, it said take two tabs after the first loose stool, and one for each occurrence after that and no more than 4 in 24 hours, which she stuck to that.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injury, Pain
Clinical narrative: if she can take Ibuprofen to ease the pain for her injury; if she can take Ibuprofen to ease the pain for her injury; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021305533 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), INJURY (non-serious), outcome "unknown" and all described as "if she can take Ibuprofen to ease the pain for her injury". Therapeutic measures were taken as a result of pain (Tylenol (14Mar2021)).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: 2nd dose of bnt162b2 was scheduled on 03Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Prior to second dose she needs to take antibiotics for tooth infection and tooth extraction; taking antibiotic if affect second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH INFECTION (non-serious), outcome "unknown", described as "Prior to second dose she needs to take antibiotics for tooth infection and tooth extraction; taking antibiotic if affect second dose".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: had some weird feelings during the night/ was a very strange feeling"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "had some weird feelings during the night/ was a very strange feeling  Additional information: Patient had the 2nd shot from the Pfizer vaccine and reported an adverse event regarding the Pfizer-BioNTech Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: seemed confused; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "seemed confused".  Additional information: The patient said that she had her 1st dose of the covid-19 vaccine the following week, and stated the she went to the vaccination site the on day of reporting morning to receive the second dose. The patient stated that no one was there and she was supposed to come back on the day of reporting for second vaccine and the patient seemed confused.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Mobility decreased, Vaccination site joint pain, Vaccination site nerve damage, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset Mar2021, described as "given the vaccine at the top of her shoulder, way up on her arm"; NEURALGIA (non-serious) with onset Mar2021, described as "vaccine may have hit nerve or went in to joint"; MOBILITY DECREASED (non-serious) with onset Mar2021, described as "unable to move her arm and not from soreness"; VACCINATION SITE JOINT PAIN (non-serious) with onset Mar2021, described as "extreme pain vaccine may have hit nerve or went in to joint". Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Reporter states that her mother received 1st dose of Covid vaccine about 2 weeks ago. She states that her mother was given the vaccine at the top of her shoulder, way up on her arm. After the vaccine her mother was unable to move her arm and not from soreness. Now 13 days later mother is in extreme pain. They are wondering if the vaccine was given in shoulder, will that decrease efficacy of vaccine and wondering if this pain will resolve itself or will this be a lifelong thing. Thinks vaccine may have hit nerve or went in to joint. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information was No. Information on lot/batch number has been requested. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue, Hot flush, Hyperhidrosis, Lymphoedema
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396). The reporter is the patient. A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTICS taken for lymphoedema. The following information was reported: HOT FLUSH (non-serious), outcome "unknown", described as "lots and lots of hot flashes"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; LYMPHOEDEMA (non-serious), outcome "unknown", described as "lymphedema"; FATIGUE (non-serious), outcome "unknown", described as "tired days"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "she gets sad sometimes". Therapeutic measures were taken as a result of lymphoedema. Additional information: Patient stated she went off Ibrance for 3 weeks, so that she could get the COVID vaccine and also stated she has had both shots and was grateful. Further shared Adverse events she experienced and gets MDL treatment for lymphedema in which the affected area of her body was purified, and wonders how much time she has left. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 57-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "type 1 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, single, lot number: EK9231, administered in arm left), administration date: 08Jan2021, for COVID-19 immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "12 hours of high sugars". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), ARTHRITIS (non-serious), outcome "unknown" and all described as "a friend of her also developed pain in the elbows and also inflammation in her wrists". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Severe headache"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Feeling sick, She is not doing well"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "I just vomited like five times"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain". The event "pain" was evaluated at the physician office visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the  Information Team. The reporter is the patient. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Jan2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391297 Same reporter and suspect drug; different patient.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer from medical information team. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Jan2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391253 same reporter, same suspect drug, similar events, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Severe headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223465 same patient/drug, different dose/event.
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Endoscopy, Oesophageal ulcer
Clinical narrative: esophagus ulcer; Initial information regarding this unsolicited valid courtesy non serious case received from Regulatory Authority from Other Health Care Professional via Pfizer (US-SA-SAC20211126000608) and transmitted to Sanofi on 23-NOV-2021.  This case involved 75 years old male patient who experienced esophagus ulcer while receiving vaccines COVID-19 VACCINE and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and while treated with clopidogrel bisulfate.  The patient's past medical history included Eyelid ptosis on 03-JAN-2020.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Hypertension on 03-JAN-2020.  Concomitant medications included atenolol (tenormin) for hypertension; famotidine (pepcid ac); and atorvastatin calcium (lipitor).  In August 2020, the patient started taking clopidogrel bisulfate unknown 25 mg daily via unknown route unknown (with an unknown batch number and expiry date not reported) for Prophylaxis. On an unknown date, the patient received dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported and expiry date not reported) for prophylactic vaccination.  On 06-Oct-2021, the patient received dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot 30155BA via unknown route in the left deltoid for prophylactic vaccination.  On an unknown date the patient experienced serious esophagus ulcer (oesophageal ulcer) following the first dose intake and following the last dose intake of clopidogrel bisulfate. This event was assessed as medically significant. The patient was hospitalized for this event. On an unknown date the patient developed a serious esophagus ulcer (oesophageal ulcer) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and (unknown latency) following the administration of COVID-19 VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Relevant laboratory test results included: Endoscopy - On 23-Oct-2021:  [Unknown]  clopidogrel bisulfate was discontinued in October 2020.  It was not reported if the patient received any corrective treatment for the event  At time of reporting, the patient recovered from the event.  No further information was provided; Sender's Comments: Sanofi company comment dated 03-Dec-2021: Considering the positive temporal relationship between the unlisted event and the suspect drug, the contributory role of the drug cannot be excluded. However, contributory role of underlying medical conditions from past medical history and concomitant medications cannot be denied either.
Sex: F
Vaccine: FLUX
Symptoms: Chronic fatigue syndrome, Fibromyalgia, Herpes zoster, Illness, Pain
Clinical narrative: shingles; debilitating with extreme pain episodes; acute pancreatitis; fibromyalgia; chronic fatigue syndrome; restless leg syndrome; illnesses; Initial information was received on 28-Nov-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional under reference number US-SA-SAC20211201000141.  This case involves Adult female patient who experienced shingles (herpes zoster), debilitating with extreme pain episodes (pain), acute pancreatitis (pancreatitis acute), fibromyalgia, chronic fatigue syndrome, restless leg syndrome (restless legs syndrome) and illness, after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PREGABALIN (LYRICA) for Fibromyalgia.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious shingles (herpes zoster), debilitating with extreme pain episodes (pain), acute pancreatitis (pancreatitis acute), fibromyalgia, chronic fatigue syndrome, restless leg syndrome (restless legs syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  On an unknown date the patient developed a non-serious illness (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for event.  At the time of reporting, outcome of all the events were unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case involves adult female patient who experienced herpes zoster, pain, pancreatitis acute, fibromyalgia, chronic fatigue syndrome, restless legs syndrome and illness after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is not known. However, patient's medical condition at time of vaccination, Lab data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the individual vaccines cannot be assessed.