chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anovulatory cycle, Intermenstrual bleeding
Clinical narrative: After I received my second dose. I couldn't ovulate on my own and was having unexplained spotting for a month. Then it happened again the next cycle; After I received my second dose. I couldn't ovulate on my own and was having unexplained spotting for a month. Then it happened again the next cycle; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. No medical history was included. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6198), dose 1 administered at arm left on 03Mar2021 at 14:30 as DOSE 1 for covid-19 immunisation. The patient's concomitant medications were not reported. 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. The patient stated that, "after I received my second dose. I couldn't ovulate on my own and was having unexplained spotting for a month. then it happened again the next cycle on 15Apr2021. Checked with my doctor and he couldn't fond anything wrong with my body". Outcome of the event was not recovered.  No additional details provided. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's mother) that: 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 NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced full body rash on an unspecified date and has been experiencing this from last couple of months. Reporter was provided with the number of Pfizer Medical Information Department. Product details (LOT#, Expiration Date, NDC# and UPC#) and other details could not be probed over the call as the reporter hung up abruptly. Hence, Limited information was available over the call. The outcome of event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Body temperature, Chills, Cough
Clinical narrative: A little bit of nausea, disturbance.; back pain; neck pain; Fever of 103.5.; Headache; A little bit of nausea, disturbance.; Chill; I started having abdominal muscle pain; Dry cough; I have kind of like a virus on my lip, kind of Herpes Zoster.; This is a spontaneous report from contactable consumer (patient). This female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she got the side effect or symptoms few months after getting both vaccines. She had started having abdominal muscle pain and back pain and neck pain, then she got fever of 103.5. She was experiencing all of that. She had headache and chill, a little bit of nausea, disturbance, dry cough and she had kind of like a virus on her lip kind of herpes zoster on the time of reporting this report. The patient underwent lab tests and procedure of body temperature and resulted as fever 103.5. The outcome of events was not recovered.  Information about lot/batch number had been requested.
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Headache, Herpes zoster, Nausea, Neck pain
Clinical narrative: A little bit of nausea, disturbance.; back pain; neck pain; Fever of 103.5.; Headache; A little bit of nausea, disturbance.; Chill; I started having abdominal muscle pain; Dry cough; I have kind of like a virus on my lip, kind of Herpes Zoster.; This is a spontaneous report from contactable consumer (patient). This female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she got the side effect or symptoms few months after getting both vaccines. She had started having abdominal muscle pain and back pain and neck pain, then she got fever of 103.5. She was experiencing all of that. She had headache and chill, a little bit of nausea, disturbance, dry cough and she had kind of like a virus on her lip kind of herpes zoster on the time of reporting this report. The patient underwent lab tests and procedure of body temperature and resulted as fever 103.5. The outcome of events was not recovered.  Information about lot/batch number had been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: A little bit of nausea, disturbance.; back pain; neck pain; Fever of 103.5.; Headache; A little bit of nausea, disturbance.; Chill; I started having abdominal muscle pain; Dry cough; I have kind of like a virus on my lip, kind of Herpes Zoster.; This is a spontaneous report from contactable consumer (patient). This female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she got the side effect or symptoms few months after getting both vaccines. She had started having abdominal muscle pain and back pain and neck pain, then she got fever of 103.5. She was experiencing all of that. She had headache and chill, a little bit of nausea, disturbance, dry cough and she had kind of like a virus on her lip kind of herpes zoster on the time of reporting this report. The patient underwent lab tests and procedure of body temperature and resulted as fever 103.5. The outcome of events was not recovered.  Information about lot/batch number had been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Tremor
Clinical narrative: Sore arm; Feeling really achy and shaky; Feeling really achy and shaky; This is a spontaneous report from a non-contactable consumer, the patient. A 17-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 in the left arm on 24Jun2021 at 09:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported to have gotten drunk the night before. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Jun2021 at 09:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 four weeks prior to the COVID vaccine. On 24Jun2021 at 22:00 the patient experienced sore arm and feeling really achy and shaky. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events sore arm and feeling really achy and shaky were not recovered at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest X-ray, Decreased appetite, Electrocardiogram normal, Palpitations
Clinical narrative: patient Still had slight heart flutter before palpitations all the time; heart palputations; loss of appetite for over two months; Hand shaking; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151), via an unspecified route of administration on 13Apr2021 at 17:45 (at the age of 73-year-old), as dose 2, single in left arm; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER2413), via an unspecified route of administration on 19Mar2021 at 03:15 (at the age of 73-year-old), as dose 1, single in left arm for COVID-19 immunization at Pharmacy or Drug Store. The patient's medical history included ongoing arthritis with back issues, ongoing hypertension, and ongoing blood cholesterol. Concomitant medications received within 2 weeks of vaccination included simvastatin, losartan potassium (LOSARTIN), meloxicam, calcium and multi vitamins all were taken for an unspecified indication, start and stop date were not reported. The patient previously experienced allergy to root beer and zest soao. 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 and after the vaccination, the patient had tested for COVID-19. Prior vaccinations were reported as none. On 03Apr2021, after vaccination, the patient experienced heart palpitations and loss of appetite for over two months. On an unspecified date in Apr2021, the patient experienced hand shaking. On an unspecified date, the patient still had slight heart flutter before palpitations all the time. 3 trips to emergency room for Electrocardiogram (EKG), chest X-rays were done and referred to cardiologist; and stress test were done. Numerous primary care visit was required. Event was reported as, hands shaking and still have slight tremor. Therapeutic measures were taken as a result of heart palpitations. For Loss appetite and hand shaking the treatment was not received. The events resulted in the, Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care (Emergency room and Physician office). Seriousness criteria for the event was reported as, Important medical event. The patient underwent lab tests and procedures which included chest X-ray: normal on an unspecified date at hospital, electrocardiogram: normal and ok on an unspecified date at hospital, and SARS-CoV-2 test: negative on an unspecified date at hospital. The clinical outcome of the heart palpitations and hand shaking were resolving and clinical outcome of the event loss of appetite for over two months was resolved in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: patient Still had slight heart flutter before palpitations all the time; heart palputations; loss of appetite for over two months; Hand shaking; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151), via an unspecified route of administration on 13Apr2021 at 17:45 (at the age of 73-year-old), as dose 2, single in left arm; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER2413), via an unspecified route of administration on 19Mar2021 at 03:15 (at the age of 73-year-old), as dose 1, single in left arm for COVID-19 immunization at Pharmacy or Drug Store. The patient's medical history included ongoing arthritis with back issues, ongoing hypertension, and ongoing blood cholesterol. Concomitant medications received within 2 weeks of vaccination included simvastatin, losartan potassium (LOSARTIN), meloxicam, calcium and multi vitamins all were taken for an unspecified indication, start and stop date were not reported. The patient previously experienced allergy to root beer and zest soao. 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 and after the vaccination, the patient had tested for COVID-19. Prior vaccinations were reported as none. On 03Apr2021, after vaccination, the patient experienced heart palpitations and loss of appetite for over two months. On an unspecified date in Apr2021, the patient experienced hand shaking. On an unspecified date, the patient still had slight heart flutter before palpitations all the time. 3 trips to emergency room for Electrocardiogram (EKG), chest X-rays were done and referred to cardiologist; and stress test were done. Numerous primary care visit was required. Event was reported as, hands shaking and still have slight tremor. Therapeutic measures were taken as a result of heart palpitations. For Loss appetite and hand shaking the treatment was not received. The events resulted in the, Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care (Emergency room and Physician office). Seriousness criteria for the event was reported as, Important medical event. The patient underwent lab tests and procedures which included chest X-ray: normal on an unspecified date at hospital, electrocardiogram: normal and ok on an unspecified date at hospital, and SARS-CoV-2 test: negative on an unspecified date at hospital. The clinical outcome of the heart palpitations and hand shaking were resolving and clinical outcome of the event loss of appetite for over two months was resolved in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise, Pain in extremity
Clinical narrative: Tiredness; not feeling well; diarrhea; arm sorbess; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 43-year-old non pregnant female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24Jun2021 17:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 43-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Seasonal asthma from an unknown date and unknown if ongoing and no known allergies. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient not diagnosed with COVID-19. The patient experienced Tiredness, not feeling well, diarrhea and arm sorbess on 24Jun2021 at 19:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events reported as recovering.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears /there is a another male patient (age not provided) who experianced it as well; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is one of two reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated there was another male patient (age not provided) who experienced it as well. The patient experienced ringing in the ears on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021783245 Same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Investigation, Mobility decreased
Clinical narrative: he cant get out of bed and he is going crazy; fatigue and joint pain; fatigue and joint pain; he cant get out of bed and he is going crazy; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Feb2021 patient experienced fatigue and joint pain, he could not get out of bed and he was going crazy. It was reported that the patient had received both vaccines and has had side effects starting in February. The patient had fatigue and joint pain and they were 99.9 percent sure they would rather have that then death. She states that he is a strong hardworking man and he could not get out of bed and he was going crazy. They had been to the doctors and he has had every test known to man and have all come back normal. The caller wanted to know if there is any information on how to help get rid of the side effects. Caller wanted to know how she can get her husband involved with the clinical trials. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Arm has swollen up; Rash that is on my arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose number unknown via an unspecified route of administration, on 17Jun2021 as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient reported, She was at work. Her arm has swollen up. It has swollen up bad. She was concerned about the rash that is on her arm on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inner ear inflammation, Vomiting
Clinical narrative: Callers sister had taken the first dose of the covid vaccine, and her inner ear has inflammation; experiencing vomiting; dizziness; This is a spontaneous report from a contactable consumer or other non-healthcare professional via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunization. Medical history included face paralysis. The patient's concomitant medications were not reported. It was reported that patient had taken the first dose of the covid vaccine, and on an unknown date her inner ear has inflammation, and she also experienced vomiting and dizziness and scared to take the second dose because she might go back to having face paralysis and wanted to know what to do. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Swelling face
Clinical narrative: Fever of 101.3 on the second day after receiving the vaccine.; Facial swelling on the second and third day of receiving the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 22-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 in the arm left on 23Jun2021 at 14:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pineapple and penicillin. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) from an unknown date for birth control. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Jun2021 at 16:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 four weeks prior to the vaccination. On 24Jun2021 the second day after receiving the vaccine, the patient experienced fever of 101.3 and facial swelling on the second and third day of receiving the vaccine. The patient reported that she did not have any dental fillers that would cause the events. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 24Jun2021, the patient underwent body temperature test and tested with 101.3(unspecified units).  The clinical outcome of the event fever of 101.3 and facial swelling was recovering at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: experiencing severe soreness and aching on the entire right side of her body; This is a spontaneous report from a Pfizer-sponsored program. 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 2 via an unspecified route of administration, administered in Arm Right on 24Jun2021 (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's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient on an unspecified date in Jun2021, experienced severe soreness and aching on the entire right side of her body. The patient would like to know whether she could take ADVIL for pain. The clinical outcome for the event was unknown.  Information about Lot/Batch number requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Skin tightness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 44-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0180), at the age of 44, via an unspecified route of administration, left arm, on Jun 22, 2021, at 11:30, single dose, for COVID-19 immunisation. The patient has no known allergies. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 44, via an unspecified route of administration, left arm, on Jun 1, 2021, at 11:30, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Jun 23, 2021, patient felt tightness under armpit and sore all around arm as patient lifted. On Jun 24, 2021, patient developed a swollen lymph. No therapeutic measures taken as a result of the events. The outcome of tightness under armpit, sore all around arm and swollen lymph: not resolved (at the time of this report).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable consumer or other non healthcare professional reporting for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, receiving the first injection of the Pfizer covid-19 vaccine yesterday (24Jun2021) and then experiencing arm pain, approximately on Jun2021 which she treated with ibuprofen. Reporter wanted to know was it ok to take ibuprofen after getting the Pfizer covid-19 vaccine. Therapeutic measures were taken as a result of arm pain; treatment included Ibuprofen. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Inflammation, Insomnia, Rotator cuff syndrome
Clinical narrative: developed sore left and right shoulders; knee started hurting; Shoulders had rotator cuff tendinitis; Knee had bad inflammation; Can not sleep; Limping; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Mar2021 at 13:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included prior arthroscopic surgeries on right shoulder and knee. The patient was allergic to penicillin. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took erythromycin and experienced drug allergy. Prior to the 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 four weeks prior to the vaccination. On 23Mar2021, at 16:00, within one day of first vaccination, the patient developed soreness in left and right shoulders. On an unknown date in 2021, within 2 weeks, the patient's knee started hurting. On an unknown date in 2021, at 4 weeks, the patient went to the doctor who informed that both the shoulders had rotator cuff tendinitis and knees had bad inflammation. On an unknown date in 2021, the patient also experienced lots of pain, could not sleep and was limping. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all reported events and included treatment with prednisone. The clinical outcome of the events sore shoulders, rotator cuff tendinitis, knee inflammation, lots of pain, could not sleep and limping were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: woke up with rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 29Apr2021 at 11:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and post-traumatic stress disorder (PTSD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food and other products. Concomitant medications included escitalopram oxalate (LEXAPRO) for unknown indication, from an unknown date. Prior to the vaccination, it was unknown whether the patient had received any other vaccines within four weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 10:00 the patient woke up with rapid heart rate every morning and it picks up the patient at random times of the day, the patient also got a weird sensation at random times that her heart is beating harder than usual. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event woke up with rapid heart rate was not recovered at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Really sore arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 23Jun2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism for which patient hadn't taken any medicines for a while. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 19:45, the patient experienced really sore arm, especially on the first day. The patient stated that the vaccine was magnetic, a friend came up to the patient with a magnet and said they heard from somewhere that it was magnetic. To the patient's surprise the magnet stuck to the injection site, she quickly jerked it off because it felt really funny like it was pulling something out and it hurt a little. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event really sore arm was unknown at the time of this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Fatigue
Clinical narrative: Headache; Feeling unwell; Fever 102.8,; Extreme Chills; Muscle pain; joint pain; weakness; Nausea; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 23Jun2021 at 18:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Aug2020. Patient had no known allergies. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on an unspecified date in Jun2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 four weeks prior to the vaccination. On 24Jun2021 at 07:00, the patient experienced fever 102.8, extreme chills, muscle and joint pain, weakness, headache, nausea, tiredness. Patient stated that previously he had COVID- 19 in Aug2020 for a period of 3-4 hours the following day after dose 2 of the COVID vaccine his symptoms were worse than when he had COVID. He continued to experience a headache and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL, ibuprofen, and bed rest. On 24Jun2021, the patient underwent Body temperature and the result was 102.8 (UNSPECIFIED UNITS). The clinical outcome of the events fever 102.8, extreme chills, muscle and joint pain, weakness, headache, nausea, tiredness, and feeling unwell was recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache; Feeling unwell; Fever 102.8,; Extreme Chills; Muscle pain; joint pain; weakness; Nausea; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 23Jun2021 at 18:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Aug2020. Patient had no known allergies. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on an unspecified date in Jun2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 four weeks prior to the vaccination. On 24Jun2021 at 07:00, the patient experienced fever 102.8, extreme chills, muscle and joint pain, weakness, headache, nausea, tiredness. Patient stated that previously he had COVID- 19 in Aug2020 for a period of 3-4 hours the following day after dose 2 of the COVID vaccine his symptoms were worse than when he had COVID. He continued to experience a headache and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL, ibuprofen, and bed rest. On 24Jun2021, the patient underwent Body temperature and the result was 102.8 (UNSPECIFIED UNITS). The clinical outcome of the events fever 102.8, extreme chills, muscle and joint pain, weakness, headache, nausea, tiredness, and feeling unwell was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported she received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA 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. The patient had an ear infection on unspecified date in 2021; with outcome of unknown. Information on the batch/lot number requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia
Clinical narrative: a heavy metal taste in mouth; Just tip over and would have to stop and plant both feet so I wouldn't fall.; This is a spontaneous report from a contactable consumer, the patient. A 62-total-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 02Apr2021 at 08:45 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies. Concomitant medications included dietary supplements and camellia sinensis (GREEN TEA) from an unknown date, for unknown indication and unknown if ongoing. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021 at 10:45 the patient experienced a heavy metal taste in mouth, just a tip over and would have to stop and plant both feet so wouldn't fall. No therapeutic measures were taken as a result of reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event a heavy metal taste in mouth,  just a tip over and would have to stop and plant both feet so wouldn't fall was not recovered at the time of report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Entire body pain (muscle ache); This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 03Jun2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypertension. Patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), amlodipine besilate (AMLODIPINE), ibuprofen (MOTRIN) and glycopyrronium bromide, formoterol fumarate, budesonide (BREZTRI) on an unknown dates for unknown indications and unknown if ongoing. Prior to the 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 four weeks prior to the COVID vaccine. On 18Jun2021 at 18:00, the patient experienced entire body pain (muscle ache). No therapeutics were taken as a result of the reported event. The clinical outcome of the event entire body pain (muscle ache) was not resolved at the time of reporting. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 24Jun2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Had sever cough that the patient couldnt really sleep; Itchy throat; Coughing; Pain; Sore throat; Nasal discharge (yellow mucus); Tiredness; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 45-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 in the left arm on 22Jun2021 at 10:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) on an unknown date and unknown if ongoing. The patient was not allergic to medications, food, or other products. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. 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 previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Jun2021 at 17:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 23Jun2021 at 23:00, the patient had common symptoms like pain, tiredness, chills and fever for 1 day. The patient also had some sore throat and nasal discharge (yellow mucus). On 24Jun2021, most symptoms disappeared except for sore throat, nasal discharge and instead the patient had new symptoms including itchy throat and coughing. On 25Jun2021 night, the patient had sever cough that the patient could not really sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, tiredness, chills and fever was recovered on 24Jun2021 after the duration of 1 day. The clinical outcome of the events sore throat, nasal discharge (yellow mucus), coughing, itchy throat and had sever cough that the patient could not really sleep was not recovered at the time of this report.   The lot/batch numbers for BNT162b2, were not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia, Rhinorrhoea, Throat irritation
Clinical narrative: Had sever cough that the patient couldnt really sleep; Itchy throat; Coughing; Pain; Sore throat; Nasal discharge (yellow mucus); Tiredness; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 45-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 in the left arm on 22Jun2021 at 10:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) on an unknown date and unknown if ongoing. The patient was not allergic to medications, food, or other products. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. 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 previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Jun2021 at 17:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 23Jun2021 at 23:00, the patient had common symptoms like pain, tiredness, chills and fever for 1 day. The patient also had some sore throat and nasal discharge (yellow mucus). On 24Jun2021, most symptoms disappeared except for sore throat, nasal discharge and instead the patient had new symptoms including itchy throat and coughing. On 25Jun2021 night, the patient had sever cough that the patient could not really sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, tiredness, chills and fever was recovered on 24Jun2021 after the duration of 1 day. The clinical outcome of the events sore throat, nasal discharge (yellow mucus), coughing, itchy throat and had sever cough that the patient could not really sleep was not recovered at the time of this report.   The lot/batch numbers for BNT162b2, were not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dry skin, Headache
Clinical narrative: Became sick; Sick with overnight cold lots of mucus and chills; Chills; Coughing; Headache; Body pain; Shallow breathing; No energy; Lots of mucus; Sinus ran on; Felt like I was sweating but when I touched the skin it was dry.; Slept for long periods if time.; This is a spontaneous report from a contactable consumer, the patient. A 56-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 13Jun2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, neuropathy and acute migraine. The patient had known allergies to Xray dye. Concomitant medications included metformin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BAYER ASPIRIN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 23May2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Prior to the 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 four weeks prior to the vaccination. On 14Jun2021 at 08:00, the patient experienced sick with overnight cold, lots of mucus and chills, coughing, headache for 4 days then some of mucus cleared up but headache and sinus ran on, body pain, shallow breathing, felt like she was sweating but when touched the skin it was dry, no energy, slept for long periods of time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sick with overnight cold, lots of mucus, chills, coughing, headache, sinus ran on, body pain, shallow breathing, no energy and slept for long periods of time were resolving at the time of this report.    The batch/lot number for BNT162b2 was not provided and will be requested during follow up.