chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Lymph node pain
Clinical narrative: Moderate to severe arm soreness; low grade fever 100.1F/ 100.8 after NSAID; chills; weakness; headache; swollen and painful lymph nodes (Axillary and Supraclavicular); swollen and painful lymph nodes (Axillary and Supraclavicular); This is a spontaneous report from a contactable other HCP (patient). A 38-year-old non-pregnant female patient received second dose of bnt162b2 (Solution, injection; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 15Feb2021 09:30 as single dose (at the age of 38-years-old) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was a clinic. Medical history included metastatic breast cancer, diabetes mellitus and mild allergy to cefalexin. Concomitant medications included ibuprofen, fulvestrant, goserelin and metformin. The patient previously took cefalexin and experienced drug hypersensitivity. The patient previously took first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:00 as single dose for covid-19 immunisation. The patient did not receive any other vaccine in 4 weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. On 16Feb2021 at 08:00, patient experienced moderate to severe arm soreness and low grade fever 100.1f. After NSAIDS, fever was 100.8 and patient experienced chills, weakness, headache, swollen and painful lymph nodes (axillary and supraclavicular). Therapeutic measures were taken and patient was treated with ibuprofen. The outcome of the event moderate to severe arm soreness was not recovered while the outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Moderate to severe arm soreness; low grade fever 100.1F/ 100.8 after NSAID; chills; weakness; headache; swollen and painful lymph nodes (Axillary and Supraclavicular); swollen and painful lymph nodes (Axillary and Supraclavicular); This is a spontaneous report from a contactable other HCP (patient). A 38-year-old non-pregnant female patient received second dose of bnt162b2 (Solution, injection; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 15Feb2021 09:30 as single dose (at the age of 38-years-old) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was a clinic. Medical history included metastatic breast cancer, diabetes mellitus and mild allergy to cefalexin. Concomitant medications included ibuprofen, fulvestrant, goserelin and metformin. The patient previously took cefalexin and experienced drug hypersensitivity. The patient previously took first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:00 as single dose for covid-19 immunisation. The patient did not receive any other vaccine in 4 weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. On 16Feb2021 at 08:00, patient experienced moderate to severe arm soreness and low grade fever 100.1f. After NSAIDS, fever was 100.8 and patient experienced chills, weakness, headache, swollen and painful lymph nodes (axillary and supraclavicular). Therapeutic measures were taken and patient was treated with ibuprofen. The outcome of the event moderate to severe arm soreness was not recovered while the outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tuberculin test, Vaginal haemorrhage
Clinical narrative: vaginal bleeding; This is a spontaneous report from a contactable consumer reporting for herself. A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6201; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 16Feb2021 14:30 (at the age of 25-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications included none. The patient experienced vaginal bleeding on 17Feb2021. The patient underwent lab tests and procedures which included TB skin test with unknown result on 10Feb2021. It was reported that patient had a TB skin test last Wednesday at the time of this report. Caller received vaccine and then on morning of this report, had some vaginal bleeding. She wanted to know if this was a reported side effect. The patient was taking Pfizer-BioNTech as she works in a healthcare facility and stated she was a receptionist and does the billing. She got the first dose of the Pfizer BioNTech vaccine the day before this report. On 17Feb2021, the day of this report, she went to the restroom. And when she wiped, she had blood coming out. She has had her menstrual cycle this month. She was unsure if this was a side effect or if she needed to go get checked out. Physician address, phone and email are unknown to caller. There was one little spot on the pad. The blood comes out when she wipes. It was red in color. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer Suspect, investigation assessment or relevant Tests included none. AE did not require a visit to Emergency Room or Physician Office. Outcome of the event was not recovered and ongoing at the time of this report.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Worsening tinnitus; This is a spontaneous report from a contactable physician (patient himself). A 52-year-old male patient received bnt162b2 (Pfizer, formulation: solution of injection; Lot number: EL1284), dose 1 via an unspecified route of administration administered in left arm on 04Jan2021 06:30 AM as dose 1, single for covid-19 immunisation. Medical history included allergies for Sulfa and hypertension (htn) from an unknown date and unknown if ongoing. Concomitant medication included amlodipine; colecalciferol (VITAMIN D [COLECALCIFEROL]) and famotidine; all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported worsening tinnitus in Feb2021. Patient did not receive any treatment for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Vomited x2 approx 12 hours after second dose; headache; body aches; low grade fever 99.9; This is a spontaneous report from a contactable Nurse. A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9265), via an unspecified route of administration, administered in arm left on 20Feb2021 at 10:00 AM (at the age of 38-year-old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, iron deficiency. Patient had no known drug it food allergies. The patient concomitant medications included fluticasone propionate (FLONASE), loratadine (CLARITIN), multivitamin (VITAMINS NOS) 1 a day. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL8982), via an unspecified route of administration, administered in arm left on 24Jan2021 at 02:00 PM as dose 1, single for COVID-19 immunization. The patient experienced vomited x2 approx 12 hours after second dose, headache, body aches, low grade fever 99.9, all on 20Feb2021 at 22:00 (10:00 PM). Adverse event: Vomited x2 approx 12 hours after second dose, headache, body aches, low grade fever 99.9. The patient underwent lab tests and procedures which included low grade fever was 99.9 on 20Feb2021. The patient did not receive treatment for the events. Outcome of the events was recovering.  Follow-up (PRD/SRD 22Jul2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: vaginal bleeding; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a female patient(Daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter reported that, Daughter (Patient) received covid vaccine on Thursday that morning and daughter was experiencing vaginal bleeding, but that did not look like blood from menstral cycle wanted to know if that was a normal reaction from receiving covid vaccine. The outcome of the event was unknown.  Information on the lot batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: shortness of breath/Heavy breathing; headache; dizzy; cough; chest pain; chills; This is a spontaneous case from a contactable consumer (patient's wife) or other non HCP via Medical Information Team.  A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 18Feb2021 as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. It was reported that the patient got tested positive for COVID on 06Jan2021, he later received first dose of vaccine on 18Feb2021. On an unknown date, patient experienced Headache, dizzy, cough, shortness of breath/heavy breathing, chest pain, and chills. The reporter would like to know if her husband should get the second dose of vaccine.The patient underwent lab test and procedure which include COVID positive on 06Jan2021.The outcome of the events was unknown at the time of reporting.  No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: shortness of breath/Heavy breathing; headache; dizzy; cough; chest pain; chills; This is a spontaneous case from a contactable consumer (patient's wife) or other non HCP via Medical Information Team.  A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 18Feb2021 as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. It was reported that the patient got tested positive for COVID on 06Jan2021, he later received first dose of vaccine on 18Feb2021. On an unknown date, patient experienced Headache, dizzy, cough, shortness of breath/heavy breathing, chest pain, and chills. The reporter would like to know if her husband should get the second dose of vaccine.The patient underwent lab test and procedure which include COVID positive on 06Jan2021.The outcome of the events was unknown at the time of reporting.  No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty and painful breathing developed 24 hours after injection of 2nd dose; This is a spontaneous report from a non-contactable Other-HCP (patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot unknown: True, lot unknown reason: Unable to locate or read the details), dose 2 via an unspecified route of administration, administered in Arm Left on 21Feb2021 15:00 PM (at the age of 35-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced difficulty and painful breathing developed 24 hours after injection of 2nd dose (non-serious) on 22Feb2021 16:00 PM. Adverse event: Difficulty and painful breathing developed 24 hours after injection of 2nd dose. Treatment was received for the adverse event was unknown. If COVID prior vaccination was unknown. If COVID tested post vaccination was provided as no. The outcome of event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary congestion, Vomiting
Clinical narrative: chest was congested; kind of hard to breath; spitting out crud; This is a spontaneous report from a contactable consumer. A 78-year-old male patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiry Date: unknown), via an unspecified route of administration on arm left on 19Feb2021 11:00 AM (age at vaccination: 78 years) as dose 1, single for COVID-19 immunization at Heart hospital. The patient medical history included COPD diagnosed a few years ago, high blood pressure, allergic to penicillin and iodine. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. The patient Concomitant medications included Lasix for Blood pressure (His dose is either 10mg or 20mg, but he is not sure. He takes one tablet per day. He has been on it for a while). It was reported that, the patient got COVID shot on Friday and was good all day on Friday. He woke up on Saturday and was all congested. He started spitting out crud on Saturday. It was kind of hard to breath. Caller clarified that it was hard to breathe because his chest was congested. It was reported that he goes to a clinic and change the doctors frequently and he also goes to heart hospital. He has not been to the ER or to his physician's office. He goes back in two weeks for the second shot. The breath sounded like a popcorn. The patient woke up with congestion between 8:30AM and 9:00AM. The patient Wanting to know if difficulty breathing due to chest congestion is 'supposed to happen'. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast mass, Chills, Fatigue, Hypersomnia
Clinical narrative: lump on the inside of my wrist that was squishy; I Felt A Burning And Stinging Pain In My Left Wrist; Swelling wrist; vomiting; chills; severe body aches; fatigue; slept more than I have in years in one weekend; severe body aches (like I had fever); a baseball size lump formed under my armpit into my left breast; This is a spontaneous report from a contactable consumer.  A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route at Left arm, as dose 1 at a single dose for COVID-19 immunisation on 18Feb2021at 08:30 AM. The patient's medical and Concomitant medications was not reported. The Patients historic vaccine included BNT162B2 (lot no: unknown), dose 1 at Right arm on 28Jan2021 at 08:30 AM. The Patient did not take any other vaccine in four weeks nor other medications in two weeks. Approximately 9:45, patient Felt a Burning and Stinging Pain in Left Wrist, When she Pulled Up Sleeve her Wrist was swollen Up, From There The swelling went down on her wrist but, had a lump on the inside of wrist that was squishy, it has for the most part went away. on Friday a baseball size lump formed under armpit into left breast, the pain was terrible, it ran down my arm into my armpit my chest and shot back thru to her left shoulder blade, ibuprofen just took the edge off and did nothing for the swelling, Cold or Hot packs just seemed to irritate it more than anything. On top of that she had vomiting, chills, severe body aches (like she had fever) and fatigue she had slept more than I have in years in one weekend.no treatment was administered for events. The patient did not have covid prior vaccination nor tested covid post vaccination. The outcome of events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Vomiting
Clinical narrative: lump on the inside of my wrist that was squishy; I Felt A Burning And Stinging Pain In My Left Wrist; Swelling wrist; vomiting; chills; severe body aches; fatigue; slept more than I have in years in one weekend; severe body aches (like I had fever); a baseball size lump formed under my armpit into my left breast; This is a spontaneous report from a contactable consumer.  A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route at Left arm, as dose 1 at a single dose for COVID-19 immunisation on 18Feb2021at 08:30 AM. The patient's medical and Concomitant medications was not reported. The Patients historic vaccine included BNT162B2 (lot no: unknown), dose 1 at Right arm on 28Jan2021 at 08:30 AM. The Patient did not take any other vaccine in four weeks nor other medications in two weeks. Approximately 9:45, patient Felt a Burning and Stinging Pain in Left Wrist, When she Pulled Up Sleeve her Wrist was swollen Up, From There The swelling went down on her wrist but, had a lump on the inside of wrist that was squishy, it has for the most part went away. on Friday a baseball size lump formed under armpit into left breast, the pain was terrible, it ran down my arm into my armpit my chest and shot back thru to her left shoulder blade, ibuprofen just took the edge off and did nothing for the swelling, Cold or Hot packs just seemed to irritate it more than anything. On top of that she had vomiting, chills, severe body aches (like she had fever) and fatigue she had slept more than I have in years in one weekend.no treatment was administered for events. The patient did not have covid prior vaccination nor tested covid post vaccination. The outcome of events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Bunion operation, Heart rate decreased, Investigation
Clinical narrative: heart rate dropped; blood oxygen dropped; blood pressure dropped; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included her 8th surgery from an unknown date. The patient's concomitant medications were not reported. The patient experienced heart rate dropped, blood oxygen dropped, blood pressure dropped on an unspecified date. She stated a week after the vaccine she had a skin graft surgery on the top of her foot from where she had issues from a previous Lapiplasty, bunionectomy, that she had in October that a doctor screwed up. After the surgery in October a week into it her foot went purple and brown and she was in a boot and her foot went numb for 5 days. They went in and did a compartmental surgery. then they sent her to a vascular doctor and it was not vascular and then sent her to a wound care specialist and started doing hyperbaric treatments that did not do a thing. The two toes were turning black, gangrene, and after a second opinion had to have 2 toes amputated right before holiday. Later, a third toe amputated where they put cadaver skin on it. She had a skin graft a week after the vaccine to replace this skin with skin from her thigh. In this surgery she was not sure if it was due to it being her 8th surgery or the anesthesiologist using something she had never ever used that she ended up having to be intubated because her heart rate dropped, and her blood oxygen dropped. She was fine. They did echos on her heart and kept a heart monitor on her for a week. After the surgery her blood pressure dropped, or is staying at a good rate, without any blood pressure medication within the last week and a half. She stated she wasn't even having to take her diabetes medication while she was in the hospital. She stated she was back to her for her diabetes but does not take shots. No other issues that she was out of surgery. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure dropped, bunion operation: foot issues (the top of her foot from where she had issues from a previous Lapiplasty, bunionectomy), heart rate decreased: heart rate dropped, investigation: foot issues (the top of her foot from where she had issues from a previous Lapiplasty, bunionectomy, oxygen saturation: her blood oxygen dropped) on an unspecified date. The outcome for all events was unknown.   Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: heart rate dropped; blood oxygen dropped; blood pressure dropped; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included her 8th surgery from an unknown date. The patient's concomitant medications were not reported. The patient experienced heart rate dropped, blood oxygen dropped, blood pressure dropped on an unspecified date. She stated a week after the vaccine she had a skin graft surgery on the top of her foot from where she had issues from a previous Lapiplasty, bunionectomy, that she had in October that a doctor screwed up. After the surgery in October a week into it her foot went purple and brown and she was in a boot and her foot went numb for 5 days. They went in and did a compartmental surgery. then they sent her to a vascular doctor and it was not vascular and then sent her to a wound care specialist and started doing hyperbaric treatments that did not do a thing. The two toes were turning black, gangrene, and after a second opinion had to have 2 toes amputated right before holiday. Later, a third toe amputated where they put cadaver skin on it. She had a skin graft a week after the vaccine to replace this skin with skin from her thigh. In this surgery she was not sure if it was due to it being her 8th surgery or the anesthesiologist using something she had never ever used that she ended up having to be intubated because her heart rate dropped, and her blood oxygen dropped. She was fine. They did echos on her heart and kept a heart monitor on her for a week. After the surgery her blood pressure dropped, or is staying at a good rate, without any blood pressure medication within the last week and a half. She stated she wasn't even having to take her diabetes medication while she was in the hospital. She stated she was back to her for her diabetes but does not take shots. No other issues that she was out of surgery. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure dropped, bunion operation: foot issues (the top of her foot from where she had issues from a previous Lapiplasty, bunionectomy), heart rate decreased: heart rate dropped, investigation: foot issues (the top of her foot from where she had issues from a previous Lapiplasty, bunionectomy, oxygen saturation: her blood oxygen dropped) on an unspecified date. The outcome for all events was unknown.   Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inflammation, Mass
Clinical narrative: Big lump, the size of egg that is hot and inflamed/described it as an inflamed area that is travelling down the length of the arm (not in neck)/size is about 2 inches wide and 4 inches long; Big lump, the size of egg that is hot and inflamed/described it as an inflamed area that is travelling down the length of the arm (not in neck)/size is about 2 inches wide and 4 inches long; Big lump, the size of egg that is hot and inflamed/described it as an inflamed area that is travelling down the length of the arm (not in neck)/size is about 2 inches wide and 4 inches long; This is a spontaneous report from a contactable consumer via medical information team. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on unknown date for COVID-19 immunisation. It was reported that patient received Pfizer-BioNTech COVID-19 Vaccine second dose last Monday, 22Feb2021, reported to have a big lump, the size of egg that is hot and inflamed. It was said that 72 hours since then it has decreased in size but is still there, described it as an inflamed area that is travelling down the length of the arm (not in neck) looks like someone took a paintbrush. It turns white when touched (redness fades) and it is warm. The size is about 2 inches wide and 4 inches long. The outcome for event was recovering for event big lump, the size of egg that is hot and inflamed while rest all events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: She had blood coming from her vagina; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she got the vaccine on 17th and last night she had blood coming from her vagina and she needed to know if she was okay. She was feeling better, and she was not bleeding anymore. The outcome of the event was recovered on an unknown date in 2021.   No follow-up attempts are possible, information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Malaise, Oral herpes
Clinical narrative: fatigue; body and joint aches and pains; scratchy throat; cold sores; malaise; body and joint aches and pains; Severe Brain fog; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) second dose via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. Medical history included lupus from an unknown date and unknown if ongoing. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for lupus cystitis from an unspecified start date and ongoing; influenza vaccine (FLU) taken for immunisation, start and stop date were not reported. The patient experienced fatigue, malaise, scratchy throat, cold sores beginning 3 days after shot and body joint aches and pains, cold sores, and severe brain fog on an unspecified date. The reporter stated that long-standing history of lupus. Developed severe fatigue, body and joint aches and pains about 6 hours post 2nd vaccination with COVID vaccine. Resolved in about 36 hours after Tylenol Motrin combo. Severe brain fog for about 8 hours. Has similar but not as severe symptoms post flu shot. Was advised by rheumatologist to take the vaccine as the benefits outweighs the risks. Would take it again but would make sure to have a day off to recuperate. Therapeutic measures were taken as a result of fatigue, body and joint aches and pains, scratchy throat, cold sores, malaise, body and joint aches and pains and treatment included tylenol motrin combo. The outcome of the events was reported as resolved on an unspecified date.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Throat irritation
Clinical narrative: fatigue; body and joint aches and pains; scratchy throat; cold sores; malaise; body and joint aches and pains; Severe Brain fog; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) second dose via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. Medical history included lupus from an unknown date and unknown if ongoing. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for lupus cystitis from an unspecified start date and ongoing; influenza vaccine (FLU) taken for immunisation, start and stop date were not reported. The patient experienced fatigue, malaise, scratchy throat, cold sores beginning 3 days after shot and body joint aches and pains, cold sores, and severe brain fog on an unspecified date. The reporter stated that long-standing history of lupus. Developed severe fatigue, body and joint aches and pains about 6 hours post 2nd vaccination with COVID vaccine. Resolved in about 36 hours after Tylenol Motrin combo. Severe brain fog for about 8 hours. Has similar but not as severe symptoms post flu shot. Was advised by rheumatologist to take the vaccine as the benefits outweighs the risks. Would take it again but would make sure to have a day off to recuperate. Therapeutic measures were taken as a result of fatigue, body and joint aches and pains, scratchy throat, cold sores, malaise, body and joint aches and pains and treatment included tylenol motrin combo. The outcome of the events was reported as resolved on an unspecified date.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The second day it felt like a Marble at the injection site; the third day (today) it is swollen to the size of a golfball and bright red with heat and pain to touch; the third day (today) it is swollen to the size of a golfball and bright red with heat and pain to touch; the third day (today) it is swollen to the size of a golfball and bright red with heat and pain to touch; the third day (today) it is swollen to the size of a golfball and bright red with heat and pain to touch; This is a spontaneous report from a contactable Other Health care Professional (Patient, reported for self). A 34-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date were UNKNOWN), via an unspecified route of administration, administered in Arm Right on 24Feb2021 16:45 (at the age of 34 years) as dose 1, single for COVID-19 immunisation. (lot unknown reason: Not available/provided to reporter at the time of report completion). Patient's medical history included congestive heart failure, lupus, cardiomyopathy, sjogrens, inappropriate sinus tach, raynauds, fibromyalgia, rheumatoid arthritis. Known allergies include allergy to Penicillin, iodine, paper tape. Prior vaccination patient had COVID-19 from an unknown date and unknown if ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Prescription medications. Request list. The patient reported that the second day, on 25Feb2021 08:00 patient felt like a marble at the injection site, the third day (today) it was swollen to the size of a golfball and bright red with heat and pain to touch. Patient was not tested for COVID post vaccination. No treatment received. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Genital herpes, Headache, Influenza like illness, Neck pain
Clinical narrative: Flu like symptoms; headache; neck and body ache; radiating pain; swelling into my left shoulder arm and hand with joint pain and swelling in left hand; severe genital herpes outbreak; swelling into my left shoulder arm and hand with joint pain and swelling in left hand; This is a spontaneous report from a contactable other hcp (patient). A 56-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration, in left arm on 11Feb2021 at 19:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included genital herpes from an unknown date and unknown if ongoing and hiv infection from an unknown date and unknown if ongoing. The patient was allergic to heparin. The concomitant medications of the patient were not reported. 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. After the vaccination, the patient had been tested with covid-19. The patient reported that after first dose he experienced Flu like symptoms for 1-2 days including headache, neck and body ache, radiating pain and swelling into my left shoulder arm and hand with joint pain and swelling in left hand. Then for the next 2 and more weeks, severe genital herpes outbreak (no outbreaks in prior 2 years). The patient underwent lab tests and procedures which included Nasal swab: negative on 08Jan2021. Therapeutic measures were taken as a result of severe genital herpes outbreak that included Valtrex medication for herpes outbreak. The patient recovered from the events on an unknown date .  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Flu like symptoms; headache; neck and body ache; radiating pain; swelling into my left shoulder arm and hand with joint pain and swelling in left hand; severe genital herpes outbreak; swelling into my left shoulder arm and hand with joint pain and swelling in left hand; This is a spontaneous report from a contactable other hcp (patient). A 56-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration, in left arm on 11Feb2021 at 19:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included genital herpes from an unknown date and unknown if ongoing and hiv infection from an unknown date and unknown if ongoing. The patient was allergic to heparin. The concomitant medications of the patient were not reported. 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. After the vaccination, the patient had been tested with covid-19. The patient reported that after first dose he experienced Flu like symptoms for 1-2 days including headache, neck and body ache, radiating pain and swelling into my left shoulder arm and hand with joint pain and swelling in left hand. Then for the next 2 and more weeks, severe genital herpes outbreak (no outbreaks in prior 2 years). The patient underwent lab tests and procedures which included Nasal swab: negative on 08Jan2021. Therapeutic measures were taken as a result of severe genital herpes outbreak that included Valtrex medication for herpes outbreak. The patient recovered from the events on an unknown date .  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Oxygen saturation, Tremor
Clinical narrative: trouble breathing; tremors/extremely shaky; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program COVAX US Support. A female patient (wife) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated, his wife got the 1st dose today 22Feb and now she was experienced an adverse reaction after the first dose. She was having trouble breathing, tremors, extremely shaky (2021). Her heartbeat was 87bpm and oxygen 93. The patient underwent lab tests and procedures which included Heartbeat: 87 bpm, Oxygen: 93. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pain in extremity, Pharyngeal hypoaesthesia
Clinical narrative: she had pain in arm, SOB, throat closing, and lightheaded.; she had pain in arm, SOB, throat closing, and lightheaded.; she had pain in arm, SOB, throat closing, and lightheaded.; she had pain in arm, SOB, throat closing, and lightheaded.; This is a spontaneous report from a contactable consumer.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route, as dose 1 at a single dose for COVID-19 immunisation. The patient's medical and Concomitant medications was not reported. on an unspecified date the patient experienced pain in arm, SOB, throat closing, and lightheaded after the first dose of vaccine. pain in arm, SOB, throat closing, and lightheaded. The outcome of events was reported as recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Headache, Pain in extremity, Pyrexia, Vaginal haemorrhage
Clinical narrative: Typical Fever; Headache; Body aches; spotting; had constipation; This is a spontaneous report from a contactable pharmacist, the patient. A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Left on 26Feb2021 15:00 (at the age of 30-years-old) as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 17:00 (at the age of 30-years-old) as a single dose for covid-19 immunization. Medical history included orthostatic hypotension, postural orthostatic tachycardia syndrome, pneumothorax spontaneous, irritable bowel syndrome. The patient had known allergies with hydrocodone, codeine, latex, triptans, adhesives. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) in two weeks included propranolol, folic acid, prenatal vitamins, omeprazole. On 26Feb2021, she had constipation the day of and day after. On 28Feb2021 11:00, the patient experienced along with the typical fever, headache, and body aches on the day after, had some spotting about 36 hours post-vaccination. My menstrual cycle had ended 4 days prior, so she know it wasn't part of her cycle. It never showed up on a panty liner, it was only when she wiped. Occurred after urination twice within 5 hours. The patient did not receive any treatment. Outcome of the event was recovered, at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival bleeding, Lymphadenopathy
Clinical narrative: swollen and very sore lymph nodes in armpits, neck and groin area; bleeding gums; This is a spontaneous report from a contactable pharmacist (patient). A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 10:30 as DOSE 2 (Age at Vaccination: 46), SINGLE for covid-19 immunisation. Medical history included mastectomy (2010 to an unknown date). The patient had no known allergies. There were no concomitant medications. The patient received dose 1 of bnt162b2 on 03Feb2021 for covid-19 immunisation (vaccine location: Left arm, lot number: EL9264). 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 has not been tested for COVID-19. The patient experienced swollen and very sore lymph nodes in armpits, neck and groin area and bleeding gums on 25Feb2021 at 02:00. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of both the events was not recovered.  Information about Lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Diarrhoea, Fatigue, Headache
Clinical narrative: diarrhea on the third day; When given the shot, a sensation ran up the left side of my neck; my arm hurt; felt ill within an hour; achy; headache; fatigue; increased blood pressure; felt unwell and had a headache for three days; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration in arm left on 26Feb2021 at 09:15 (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included type 2 diabetes mellitus (MODY diabetic, 40 years), blood cholesterol (medicated for cholesterol), hypothyroidism (underactive thyroid) from an unknown date and unknown if ongoing. Concomitant medications in two weeks included glimepiride (GLIMEPIRIDE), metformin (METFORMIN) taken for type 2 diabetes mellitus; levothyroxine (LEVOTHYROXINE) taken for hypothyroidism; atorvastatin (ATORVASTATIN) taken for blood cholesterol, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity (known allergies: codeine). Patient had no other vaccine in four weeks. Patient had COVID prior vaccination and not tested for covid post vaccination. The patient experienced when given the shot, a sensation ran up the left side of her neck, arm hurt, felt ill within an hour, achy, headache, fatigue, increased blood pressure, felt unwell and had a headache for three days on 26Feb2021 at 10:00, diarrhea on the third day on 28Feb2021. The patient underwent lab tests and procedures which included mild COVID-19- tested positive on 10Dec2020; blood pressure measurement: 155/86, which is high for patient on 26Feb2021. When given the shot, a sensation ran up the left side of her neck. The sensation lasted all day; patient arm hurt and felt ill within an hour; achy, headache, fatigue; increased blood pressure (155/86, which is high for patient); felt unwell and had a headache for three days; diarrhea on the third day. No treatment was received. Clinical outcome of the event fatigue was recovered on 28Feb2021 and all other events were recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: diarrhea on the third day; When given the shot, a sensation ran up the left side of my neck; my arm hurt; felt ill within an hour; achy; headache; fatigue; increased blood pressure; felt unwell and had a headache for three days; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration in arm left on 26Feb2021 at 09:15 (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included type 2 diabetes mellitus (MODY diabetic, 40 years), blood cholesterol (medicated for cholesterol), hypothyroidism (underactive thyroid) from an unknown date and unknown if ongoing. Concomitant medications in two weeks included glimepiride (GLIMEPIRIDE), metformin (METFORMIN) taken for type 2 diabetes mellitus; levothyroxine (LEVOTHYROXINE) taken for hypothyroidism; atorvastatin (ATORVASTATIN) taken for blood cholesterol, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity (known allergies: codeine). Patient had no other vaccine in four weeks. Patient had COVID prior vaccination and not tested for covid post vaccination. The patient experienced when given the shot, a sensation ran up the left side of her neck, arm hurt, felt ill within an hour, achy, headache, fatigue, increased blood pressure, felt unwell and had a headache for three days on 26Feb2021 at 10:00, diarrhea on the third day on 28Feb2021. The patient underwent lab tests and procedures which included mild COVID-19- tested positive on 10Dec2020; blood pressure measurement: 155/86, which is high for patient on 26Feb2021. When given the shot, a sensation ran up the left side of her neck. The sensation lasted all day; patient arm hurt and felt ill within an hour; achy, headache, fatigue; increased blood pressure (155/86, which is high for patient); felt unwell and had a headache for three days; diarrhea on the third day. No treatment was received. Clinical outcome of the event fatigue was recovered on 28Feb2021 and all other events were recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected