chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Inappropriate schedule of product administration, Obesity
Clinical narrative: Obese; High blood pressure; Middle of January and second end of January; This is a spontaneous report from a contactable consumer reporting for himself. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on Jan2021 (end of January) (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Jan2021 (middle of January) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced high blood pressure and was obese on unknown date in Jan2021. The patient stated that he got the vaccination, Pfizer, in middle of January and second end of January, was obese and high blood pressure, otherwise not in terrible shape. If it was recommended to get the booster what vaccine should he get. Caller started that, "he lived in a home of the idiots who do not want to get the shot and our numbers show it even though the governor blocked the daily reporting, such a wonderful man, hope karma rains down on him sometime. Anyhow sorry for the rant, just very upset". The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy, Fatigue, Headache, Insomnia
Clinical narrative: Caller wanted to report symptoms and some of the side effects. She is currently pregnant.; Improved, still a little swelling.; pain on her arm; really nauseous; Headache; feeling really tired; Dizzy; Insomnia; This is a spontaneous report from a contactable consumer (patient herself). This consumer or other non HCP reported information for both mother and fetus/baby. This is a maternal report. A 39-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0187; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in Arm Left on 28Jul2021 (at age of 39-years-old) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunization. The patient was pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included omeprazole (OMEPRAZOLE) taken for nausea, vomiting from an unspecified start date and ongoing. Patient's Medical History (including any illness at time of vaccination) was None. Family medical history relevant to AE(s) was no. Patient had not AE(s) following prior vaccinations. Patient had not additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not receive any other vaccines prior to COVID vaccinations (within 4 weeks). Mother did not smoke, drink alcohol and not using illicit drugs during this pregnancy. The patient experienced caller wanted to report symptoms and some of the side effects. she is currently pregnant on an unspecified date. It was reported that, she got the vaccine on Wednesday and on 28Jul2021 started feeling pain on her arm. Then at the end of the day she started feeling really nauseous, headache, really tired, and dizzy. She was not sleeping much, a couple of hours yesterday and today she was having insomnia (She tried to go to bed around 10 o'clock. She fell asleep around 4 or 5 am) as well. She had a question, she just got a new job and did not have enough time. Should she go to her Primary care for something showing that she was missing work due to COVID. The adverse events did not require emergency room or physician office visit. Therapeutic measures were taken as a result of pain on her arm, really nauseous, headache, feeling really tired and dizzy. Patient was using warm cloth and moving arm as treatment for pain on her arm it was improved, still a little swelling. She has been taking omeprazole for nauseous; taking it in the morning, due to her pregnancy and having nausea. Tylenol every six hours for headache. Patient was trying to rest (as treatment; started- 2 to 3 pm) as she was feeling really tired. Patient laid down and plenty of fluids (started - 2 to 3 pm) as treatment for dizzy. Patient did not receive any treatment for insomnia. Relevant tests was reported as none. The outcome of event pain in her arm was recovering, really nauseous, headache, feeling really tired, still a little swelling, insomnia was not resolved while it was unknown for dizzy.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Swelling
Clinical narrative: Caller wanted to report symptoms and some of the side effects. She is currently pregnant.; Improved, still a little swelling.; pain on her arm; really nauseous; Headache; feeling really tired; Dizzy; Insomnia; This is a spontaneous report from a contactable consumer (patient herself). This consumer or other non HCP reported information for both mother and fetus/baby. This is a maternal report. A 39-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0187; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in Arm Left on 28Jul2021 (at age of 39-years-old) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunization. The patient was pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included omeprazole (OMEPRAZOLE) taken for nausea, vomiting from an unspecified start date and ongoing. Patient's Medical History (including any illness at time of vaccination) was None. Family medical history relevant to AE(s) was no. Patient had not AE(s) following prior vaccinations. Patient had not additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not receive any other vaccines prior to COVID vaccinations (within 4 weeks). Mother did not smoke, drink alcohol and not using illicit drugs during this pregnancy. The patient experienced caller wanted to report symptoms and some of the side effects. she is currently pregnant on an unspecified date. It was reported that, she got the vaccine on Wednesday and on 28Jul2021 started feeling pain on her arm. Then at the end of the day she started feeling really nauseous, headache, really tired, and dizzy. She was not sleeping much, a couple of hours yesterday and today she was having insomnia (She tried to go to bed around 10 o'clock. She fell asleep around 4 or 5 am) as well. She had a question, she just got a new job and did not have enough time. Should she go to her Primary care for something showing that she was missing work due to COVID. The adverse events did not require emergency room or physician office visit. Therapeutic measures were taken as a result of pain on her arm, really nauseous, headache, feeling really tired and dizzy. Patient was using warm cloth and moving arm as treatment for pain on her arm it was improved, still a little swelling. She has been taking omeprazole for nauseous; taking it in the morning, due to her pregnancy and having nausea. Tylenol every six hours for headache. Patient was trying to rest (as treatment; started- 2 to 3 pm) as she was feeling really tired. Patient laid down and plenty of fluids (started - 2 to 3 pm) as treatment for dizzy. Patient did not receive any treatment for insomnia. Relevant tests was reported as none. The outcome of event pain in her arm was recovering, really nauseous, headache, feeling really tired, still a little swelling, insomnia was not resolved while it was unknown for dizzy.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache and then he ended up at the hospital.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient experienced headache on an unspecified date in Mar2021. The patient already had both of his Pfizer vaccine doses (19Jan2021 and 09Feb2021) and then 5 weeks later he experienced side effects, one example is headache and then he ended up at the hospital on an unspecified date in Mar2021. The patient wanted to know how is it possible that you received the Pfizer Vaccine and you can still feel side effects even if it's 5 weeks later and asked how long from the vaccine shot can you get a reaction. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified, age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient reported their heart felt like it was beating faster (pounding); and had shortness of breath. Patient reported, about two weeks ago, they got the shot of the Pfizer vaccine shot. It was the first dose. About 24 hours later, their heart started beating faster and pounding. They had shortness of breath. Patient was supposed to get a next Pfizer shot next Wednesday. The outcome of events: unknown. Information on lot/batch number requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Overdose, Weight
Clinical narrative: Headache; OVERDOSE; This is a spontaneous report from a contactable consumer (patient's wife). A 35-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: 042B21A, Expiry date: 05Oct2021), via an unspecified route of administration on 17Apr2021 (at age of 35-years-old) as dose 2, 0.5 ml single for covid-19 immunisation. Medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse event was none. There were no concomitant medications. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 036A21A, Expiration Date: 26Aug2021), via an unspecified route of administration on 20Mar2021 (at age of 35-years-old) as dose 1, 0.5 ml single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks.On 17Apr2021, the patient had an overdose of bnt162b2 vaccine (0.5 ml dose was administered). On 18Apr2021 after second dose, the patient experienced headache and went away, lasted a couple of days. The caller reported that her son was perfectly fine and her husband was fine but he had a headache with the second dose. Not sure if it was bnt162b2. Caller agreed to complete a report on behalf of her husband. The patient woke up with a headache on the 18Apr2021, he was going to go to work at 6 in the morning. Additional vaccines administered on same date of the bnt162b2 suspect were none. Adverse events following prior vaccinations were none. The patient was taking Tylenol. The adverse event did not required visit to emergency room or visit to physician's office. The patient underwent lab tests and procedures which included weight: 156 or 157 on an unspecified date. Relevant test was reported as none. Therapeutic measures were taken as a result of the event. The outcome of the events was recovered on 20Apr2021.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: unknown) via unspecified route on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the Pfizer-BioNTech COVID-19 vaccine 2 months ago and got COVID-19 and was in a hospital. Reporter stated that she is not sure if the patient was hospitalized due to COVID-19 or due to other ailments. Reporter inquired if they should revaccinate the patient. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up. Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Pain, Pyrexia
Clinical narrative: cant' taste; loss of smell/I have hard time in smelling/cant' smell; low-grade fever/fever; body aches; fatigue; This is a spontaneous report from a contactable consumer (patient).     A 23-years-old male patient received first dose of bnt162b2 (BNT162B2; Batch/Lot Number: FA7484), via an unspecified route of administration, administered in Arm Right on 27Jul2021 17:00 (at the age of 23-year-old) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient experienced cant' taste (ageusia) (medically significant) on 30Jul2021 with outcome of not recovered, body aches (non-serious) on 28Jul2021 with outcome of recovered, low-grade fever (non-serious) on 29Jul2021 with outcome of recovered, loss of smell (anosmia) (non-serious) on 30Jul2021 with outcome of not recovered , fatigue (non-serious) on Jul2021 with outcome of recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 23Jul2021, sars-cov-2 test: negative on 26Jul2021.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: cant' taste; loss of smell/I have hard time in smelling/cant' smell; low-grade fever/fever; body aches; fatigue; This is a spontaneous report from a contactable consumer (patient).     A 23-years-old male patient received first dose of bnt162b2 (BNT162B2; Batch/Lot Number: FA7484), via an unspecified route of administration, administered in Arm Right on 27Jul2021 17:00 (at the age of 23-year-old) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient experienced cant' taste (ageusia) (medically significant) on 30Jul2021 with outcome of not recovered, body aches (non-serious) on 28Jul2021 with outcome of recovered, low-grade fever (non-serious) on 29Jul2021 with outcome of recovered, loss of smell (anosmia) (non-serious) on 30Jul2021 with outcome of not recovered , fatigue (non-serious) on Jul2021 with outcome of recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 23Jul2021, sars-cov-2 test: negative on 26Jul2021.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Echocardiogram, Pruritus, Pulmonary mass
Clinical narrative: Find a nodule on his lungs; Rashes; scratches; itchiness on legs and arms; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 20Jan2021 (at the age of 77-years-old) at dose 2, single for COVID-19 immunisation. Medical history included overweight, but patient had been on lockdown, and osteoporosis. Concomitant medications included atorvastatin calcium (LIPITOR) and morniflumate (FLOMAX). The patient received the first dose of BNT162b2 on 29Dec2020, at the age of 77-years-old, for COVID-19 immunisation. Patient had the 2nd dose which he had rashes, scratches and itchiness on legs and arms, in 2021. He had the chest X-ray in May2021 and they saw something suspicious on it. Then he had a CT scan within a week to 10 days, in 2021, and that was when they found the nodule on his lungs. The doctor compared it to one he had done 18 months before, in Nov2019 and the nodule was not there then. He wanted to know if this had been a reported side effects of the vaccine. He said this side effects about the nodule was all over the internet and he wanted to know if it was true. They were wanting him to see a pulmonologist and he wanted to know if it was related or not, so he knew how to go forward. He was not sure if it was related but they were wanting him to see a pulmonologist and do all these test and follow up. He had also had an echocardiogram recently, in 2021, and did not do well on it so he had to have a follow up for that also. He was most concerned about the nodule in his lung and did not know that any of this was related to the reason for the call. This could be cause by his atorvastatin calcium, maybe the dose needed to be adjusted. He heard someone else mentioning this and so he was calling to see if this was related. The outcome of the events was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Scratch
Clinical narrative: Find a nodule on his lungs; Rashes; scratches; itchiness on legs and arms; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 20Jan2021 (at the age of 77-years-old) at dose 2, single for COVID-19 immunisation. Medical history included overweight, but patient had been on lockdown, and osteoporosis. Concomitant medications included atorvastatin calcium (LIPITOR) and morniflumate (FLOMAX). The patient received the first dose of BNT162b2 on 29Dec2020, at the age of 77-years-old, for COVID-19 immunisation. Patient had the 2nd dose which he had rashes, scratches and itchiness on legs and arms, in 2021. He had the chest X-ray in May2021 and they saw something suspicious on it. Then he had a CT scan within a week to 10 days, in 2021, and that was when they found the nodule on his lungs. The doctor compared it to one he had done 18 months before, in Nov2019 and the nodule was not there then. He wanted to know if this had been a reported side effects of the vaccine. He said this side effects about the nodule was all over the internet and he wanted to know if it was true. They were wanting him to see a pulmonologist and he wanted to know if it was related or not, so he knew how to go forward. He was not sure if it was related but they were wanting him to see a pulmonologist and do all these test and follow up. He had also had an echocardiogram recently, in 2021, and did not do well on it so he had to have a follow up for that also. He was most concerned about the nodule in his lung and did not know that any of this was related to the reason for the call. This could be cause by his atorvastatin calcium, maybe the dose needed to be adjusted. He heard someone else mentioning this and so he was calling to see if this was related. The outcome of the events was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: shortness of breath; random light headedness; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ew0186), administered in left arm on 29Jun2021 12:00 PM (at the age of 32-year-old) as dose 2, single for COVID-19 immunization. Vaccination facility type was reported as pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ew0180), administered in left arm on 08Jun2021 12:00 PM (at the age of 32-year-old) as dose, 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jul2021 the patient experienced random light headedness and shortness of breath both reported as non-serious. No treatment was received due to the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was not resolved.  Follow-up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypoaesthesia, Insomnia, Muscle atrophy, Vaccination site pain
Clinical narrative: Patient was having a stroke; Its hard to sleep on the patient arm; the muscle at the very top of his shoulder feels like its numb; left upper muscle of his left arm collapsed and patient is not able to use it; sharp pain in his arm where patient got the vaccine; This is a spontaneous report from a contactable consumer (Reported for himself). A 60-years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0158/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 12Apr2021 (at the age of 59-years-old) as dose 2, single for covid-19 immunisation. Medical history included blood pressure measurement (Diagnosed to 12-14 years ago). The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER2613/Batch number was not reported), dose 1 via an unspecified route of administration on 17Mar2021 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation. The patient experienced upper muscle of his left arm collapsed and patient is not able to use it on an unspecified date in Apr2021, patient was having a stroke, it's hard to sleep on the patient arm, sharp pain in his arm where patient got the vaccine and the muscle at the very top of his shoulder feels like its numb on an unspecified date. Outcome of left upper muscle of his left arm collapsed and patient is not able to use it and sharp pain in his arm where patient got the vaccine was resolving and other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Lip blister, Oral discomfort, Oral mucosal blistering, Oral pain
Clinical narrative: Hard to breathe; Blisters in mouth; Blisters in mouth lips; below eyes swollen; increased sensitivity to coffee, spicy foods, soda drinks; burn really bad in mouth; burn really bad in mouth and going down throat; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FA6780), administered in arm right, on 25Jul2020 at 11:30 (at the age of 56-years-old) at dose 1, single for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included amlodipine, lisinopril, cetirizine, aspirin (acetylsalicylic acid), omeprazole (OMEPRAZ); all reported as medications that patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jul2021 at 05:00 AM, the patient experienced blisters in mouth, lips and below eyes swollen; increased sensitivity to coffee, spicy foods, soda drinks; burn really bad in mouth and going down throat. Since COVID, he had always rinsed mouth with mouthwash before bed and when he got up. Currently it was unbearable to do because it burned. Hard to breathe. No treatment was received for the events. The patient had not recovered from the events.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling, Throat irritation
Clinical narrative: Hard to breathe; Blisters in mouth; Blisters in mouth lips; below eyes swollen; increased sensitivity to coffee, spicy foods, soda drinks; burn really bad in mouth; burn really bad in mouth and going down throat; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FA6780), administered in arm right, on 25Jul2020 at 11:30 (at the age of 56-years-old) at dose 1, single for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included amlodipine, lisinopril, cetirizine, aspirin (acetylsalicylic acid), omeprazole (OMEPRAZ); all reported as medications that patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jul2021 at 05:00 AM, the patient experienced blisters in mouth, lips and below eyes swollen; increased sensitivity to coffee, spicy foods, soda drinks; burn really bad in mouth and going down throat. Since COVID, he had always rinsed mouth with mouthwash before bed and when he got up. Currently it was unbearable to do because it burned. Hard to breathe. No treatment was received for the events. The patient had not recovered from the events.   Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Polymenorrhoea, Vaccination site pain
Clinical narrative: Any time she has to pee, she has something brown/ small spots when she pees/ she can see on the water brown spots/ anytime she goes to pee she sees something like brown/ brown blood; Pain in her left arm where she took the shot; symptom of menstrual cycle changes/ she was in the middle of her cycle and her period didn't have to come in 15 days; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jul2021 (at the age of 27-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received her first dose the day before the present report (29Jul2021) then she had pain on left arm where she received the shot. Caller (patient) was currently in the middle of her menstrual cycle, she said that any time she had to pee, she had something brown as if the menstrual cycle is beginning or ending. Caller wanted to know if side effect was normal. She said that she found that pain on left arm is regular side effect of the vaccine. She thought that her symptom of menstrual cycle changes may be a side effect, but she couldn't find it on google and that this never happened to her. She added that it was not like bleeding bleeding (as reported) and that she saw small spots when she pees. Reiterated that she was in the middle of her cycle and her period didn't have to come in 15 days. Every time she went to pee, she could see on the water brown spots. She was concerned about what she was experiencing. She thought it was related to the vaccine and she got the first shot the day before the present report (29Jul2021) and she had a pain in her left arm where she took the shot. She had been having not like menstrual bleeding, she was in the middle of her cycle but since the day before the present report (29Jul2021) anytime she went to pee she saw something like brown. As if it was her menstrual cycle in the beginning or finishing, brown blood. She didn't know if this is a side effect because it never happened to her. She did do research on google and she hadn't seen anything. It hadn't happened to her before. The outcome of the events was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Cardiac output, Cardiac output decreased, Dyspnoea
Clinical narrative: Tests revealed that my cardiac output was 20%.; AFib; Congestive Heart Failure; Shortness of breath; inappropriate schedule of vaccine administered; 31Dec2020, dose_number=1/31Dec2020 dose_number=2; This is a spontaneous report from a contactable consumer (patient). An 84-year-old non-pregnant female patient received the first (lot number: EL3246) and the second dose (lot number: EL9861) of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), both administered in left arm on 31Dec2020 (at the age of 84-years-old) 1st dose at dose 1, single and 2nd dose at dose 2, single for COVID-19 immunisation. Medical history included rheumatoid arthritis, Grave's disease, osteoporosis, scoliosis, high blood pressure (BP). Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took morphine and experienced allergy. The patient experienced shortness of breath, starting in about Feb2021 and it got progressively worse, leading to being sent to emergency room (ER) on 09Jun2021 with atrial fibrillation (AFib) and congestive heart failure, started in Feb2021. The events AFib and congestive heart failure were reported as serious due to hospitalization, disability and important medical events; the event shortness of breath was reported as serious due to hospitalization and disability. Tests revealed that her cardiac output was 20%, in 2021. The patient was hospitalized from 10Jun2021 and was not discharged until 17Jun2021; the hospitalization lasted for 7 days. Much difficulty in getting heart rate under control. This was still causing a lot of problems. The adverse events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care. The treatment received for the adverse events included cardiac ablation, many medications, both intravenous (IV) and oral (PO). The patient was recovering from shortness of breath, congestive heart failure and AFib; the outcome of the other event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Overdose
Clinical narrative: Tests revealed that my cardiac output was 20%.; AFib; Congestive Heart Failure; Shortness of breath; inappropriate schedule of vaccine administered; 31Dec2020, dose_number=1/31Dec2020 dose_number=2; This is a spontaneous report from a contactable consumer (patient). An 84-year-old non-pregnant female patient received the first (lot number: EL3246) and the second dose (lot number: EL9861) of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), both administered in left arm on 31Dec2020 (at the age of 84-years-old) 1st dose at dose 1, single and 2nd dose at dose 2, single for COVID-19 immunisation. Medical history included rheumatoid arthritis, Grave's disease, osteoporosis, scoliosis, high blood pressure (BP). Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took morphine and experienced allergy. The patient experienced shortness of breath, starting in about Feb2021 and it got progressively worse, leading to being sent to emergency room (ER) on 09Jun2021 with atrial fibrillation (AFib) and congestive heart failure, started in Feb2021. The events AFib and congestive heart failure were reported as serious due to hospitalization, disability and important medical events; the event shortness of breath was reported as serious due to hospitalization and disability. Tests revealed that her cardiac output was 20%, in 2021. The patient was hospitalized from 10Jun2021 and was not discharged until 17Jun2021; the hospitalization lasted for 7 days. Much difficulty in getting heart rate under control. This was still causing a lot of problems. The adverse events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care. The treatment received for the adverse events included cardiac ablation, many medications, both intravenous (IV) and oral (PO). The patient was recovering from shortness of breath, congestive heart failure and AFib; the outcome of the other event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: SOB; Heart palpations; arm hurt; headache; hurt all over; Had trouble doing my regular exercise class this morning; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Expiration date: Not reported, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Left on 29Jul2021 16:30 (Age at vaccination 64-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included pneumococcal vaccine (PNEUMONIA SHOT) taken for pneumococcal immunisation from 23Jul2021 to 23Jul2021. Prior to vaccination, was the patient diagnosed with COVID-19 was No. On 29Jul2021 the patient experienced SoB, Heart palpations, arm hurt, headache, hurt all over. Had trouble doing my regular exercise class this morning. Since the vaccination, has the patient been tested for COVID-19 was No. Treatment received was no for all events. Outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: SOB; Heart palpations; arm hurt; headache; hurt all over; Had trouble doing my regular exercise class this morning; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Expiration date: Not reported, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Left on 29Jul2021 16:30 (Age at vaccination 64-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included pneumococcal vaccine (PNEUMONIA SHOT) taken for pneumococcal immunisation from 23Jul2021 to 23Jul2021. Prior to vaccination, was the patient diagnosed with COVID-19 was No. On 29Jul2021 the patient experienced SoB, Heart palpations, arm hurt, headache, hurt all over. Had trouble doing my regular exercise class this morning. Since the vaccination, has the patient been tested for COVID-19 was No. Treatment received was no for all events. Outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Dehydration, Dizziness, Hypotension
Clinical narrative: she passed out in the chair. She eats well and drinks water.; her blood pressure was so low; dizzy; lost all color in her face and lips; dehydrated; This is a spontaneous report from received from a contactable consumer (patient's parent). A 14-year-old non-pregnant female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 02Jul2021 02:30 PM (at the age of 14-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient's medical history was not reported. No concomitant medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the next morning (03Jul2021). Her daughter woke up and they went to the (privacy) within 45 mins of waking up. 30 minutes later she passed out in the chair. She eats well and drinks water. They had to be transported in an ambulance because her blood pressure was so low, she was dizzy and lost all color in her face and lips. They spent three hours in the hospital and all the blood work came back good, but her body was dehydrated for some reason. So they pumped her with fluids. Onset date of events was reported as 03Jul2021 at 12:00. The events resulted in emergency room/department or urgent care visit. Treatment (pumped her with fluids) was received due to dehydration while it was unknown if treatment was received due to other events. The case was reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was resolving.  Information about lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pallor
Clinical narrative: she passed out in the chair. She eats well and drinks water.; her blood pressure was so low; dizzy; lost all color in her face and lips; dehydrated; This is a spontaneous report from received from a contactable consumer (patient's parent). A 14-year-old non-pregnant female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 02Jul2021 02:30 PM (at the age of 14-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient's medical history was not reported. No concomitant medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the next morning (03Jul2021). Her daughter woke up and they went to the (privacy) within 45 mins of waking up. 30 minutes later she passed out in the chair. She eats well and drinks water. They had to be transported in an ambulance because her blood pressure was so low, she was dizzy and lost all color in her face and lips. They spent three hours in the hospital and all the blood work came back good, but her body was dehydrated for some reason. So they pumped her with fluids. Onset date of events was reported as 03Jul2021 at 12:00. The events resulted in emergency room/department or urgent care visit. Treatment (pumped her with fluids) was received due to dehydration while it was unknown if treatment was received due to other events. The case was reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was resolving.  Information about lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Electrocardiogram, Fatigue
Clinical narrative: inability to function; blood pressure which is usually 130/80 spiked for several weeks at consistently 200; rash that moved all over my neck arms and legs which was extremely painful and I still have small rashes on arms 11 weeks later; Extremely fatigues; almost lost ability to walk; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15May2021 at 17:00 (at the age of 59-years-old) at dose number unknown, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were reported as none. Patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 19May2021 at 16:00, the patient had a rash that moved all over her neck, arms and legs which was extremely painful and she still had small rashes on arms 11 weeks later. Blood pressure which was usually 130/80 spiked for several weeks at consistently 200, since 19May2021 at 16:00. Patient had to be hospitalized in 2021 due to inability to function, on 19May2021 at 16:00. Extremely fatigues and almost lost ability to walk, on 19May2021 at 16:00. The events were reported as non-serious. The events resulted in emergency room/department or urgent care visit. A treatment was received in response to the events. The patient underwent lab tests and procedures, which included X-ray, EKG and bloodwork in 2021, all with unknown results. The patient had recovered from the events in 2021.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Loss of personal independence in daily activities, Rash, X-ray
Clinical narrative: inability to function; blood pressure which is usually 130/80 spiked for several weeks at consistently 200; rash that moved all over my neck arms and legs which was extremely painful and I still have small rashes on arms 11 weeks later; Extremely fatigues; almost lost ability to walk; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15May2021 at 17:00 (at the age of 59-years-old) at dose number unknown, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were reported as none. Patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 19May2021 at 16:00, the patient had a rash that moved all over her neck, arms and legs which was extremely painful and she still had small rashes on arms 11 weeks later. Blood pressure which was usually 130/80 spiked for several weeks at consistently 200, since 19May2021 at 16:00. Patient had to be hospitalized in 2021 due to inability to function, on 19May2021 at 16:00. Extremely fatigues and almost lost ability to walk, on 19May2021 at 16:00. The events were reported as non-serious. The events resulted in emergency room/department or urgent care visit. A treatment was received in response to the events. The patient underwent lab tests and procedures, which included X-ray, EKG and bloodwork in 2021, all with unknown results. The patient had recovered from the events in 2021.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain began in left elbow in May and continues; then in June it started in right wrist but has subsided for the most part; and in July it startedin the knuckles of my right hand and continues.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 25Apr2021 at 14:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included GERD (gastroesophageal reflux disease). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other concomitant medications within two weeks of the vaccination which are unspecified. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 04Apr2021 at 13:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. On 02May2021 at 09:00 the patient experienced joint pain which began in left elbow in May2021 and continues, then in June2021 it started in right wrist but subsided for the most part and in July2021 it started in the knuckles of the right hand and continues. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joint pain was not resolved at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Vital signs measurement
Clinical narrative: visible red skin in areas of last sunburn; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date in 2021 (30-year-old ) as a single dose for COVID-19immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On an unknown date in 2021, the patient drank glass of wine two weeks post the second shot and experienced visible red skin in areas of last sun burn, no ability to know except in the mirror. There were no other symptoms. On an unknown date the patient underwent lab tests and procedures which included body temperature and vitals measurement which had no abnormalities. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event visible red skin in areas of last sun burn was unknown at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.