chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore in the arm; This is a spontaneous report from a contactable consumer or other non hcp (parent) from a Pfizer-sponsored program Covax US Support. A contactable consumer reported for 19-Year-old patient (reporter's son). A 19-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Jun2021 (at the age of 19-year-old) at dose 1, single for covid-19 immunisation. Medical history included autism, lyme disease and allergic to gluten and silica related compound. Concomitant medications were not reported. On an unspecified date the patient experienced sore in the arm. Verbatim and Event Description: The reporter reported who has autism and lyme disease and is about to get his first dose of the covid-19 vaccine today, 22Jun2021but wanted to ask and clarify about the ingredients of the vaccine if containing any gluten and silica related compound which she suspected withheld to be allergic to. While getting information regarding withheld mentioned about her other son named withheld who she stated, got his first dose of the Pfizer covid-19 vaccine last Thursday, 17June2021 who had a sore in the arm. Created and submitted a manual AE form: due to concern mentioned related to the Caller's other son, who had an adverse event after getting the first dose of the vaccine but was not the main reason for the call. Outcome of the event was unknown.  Follow-up attempts are needed. Information on Lot/Batch number been requested.  Follow up (20Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Swollen lymph nodes on collarbone; Arm pain; Fever; Nausea; Neck pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 55-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 29Mar2021 at 11:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date 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 31Mar2021 at 15:00, the patient experienced swollen lymph nodes on collarbone, arm pain, fever and nausea, still had swollen lymph nodes and arm/neck pain. 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. The clinical outcome of the events swollen lymph nodes on collarbone, arm pain, neck pain, fever and nausea were resolved with sequelae.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Illness
Clinical narrative: Sick and couldn't walk so missed second dose of vaccine; Sick and couldn't walk so missed second dose of vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 83-years-old). The patient medical history and concomitant medications were not reported. It was reported that on 28May2021 the patient received the first dose of vaccine and stated that she was supposed to go to get her vaccine, but she was sick and couldn't walk on 18Jun2021, so missed second dose of vaccine. She called and they gave her another date. She can't remember the date when she was supposed to get the vaccine. She wanted to know if we could help her get the date. The outcome of the events was unknown.   Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Condition aggravated, Fatigue, Feeling of body temperature change
Clinical narrative: weak; hot and cold; Chills; Throat sore; Fatigue; Flu like symptoms; head is hurting; swollen at the site of the injection; Flu like symptoms; head is hurting; weak; hot and cold; Chills; Throat sore; Fatigue was reported as worsened.; a little heat around the injection site area; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 21Jun2021 (at the age of 44 years old) as dose 1, single for COVID-19 immunisation. Medical history included stroke (additional information for other conditions: in 2010 and one in Jan2021), blood pressure measurement (has blood pressure problems and had a stroke in January). The patient's concomitant medications were not reported. The patient experienced head is hurting, swollen at the site of the injection on 21Jun2021, flu like symptoms, weak, hot and cold, chills, throat sore, fatigue on 22Jun2021, flu like symptoms; head is hurting; weak; hot and cold; chills; throat sore; fatigue was reported as worsened, a little heat around the injection site area on an unspecified date on Jun2021. Event reported as, "the patient took the vaccine on monday and then 30 minutes afterwards her head started hurting. Then yesterday the patient symptoms were way worse and today it was worse. Today there was still a little heat around the injection site area. The caller's arm is still swollen a little bit but when the caller moves her arm it is not good, she can feel it still. The caller's throat is sore and she is fatigued. Tuesday is when everything started going down hill. Today the patient is in the bed and missing work because she can't work like this". Outcome of the event flu like symptoms, head is hurting, weak, hot and cold, chills, throat sore, fatigue was not recovered, recovering for swollen at the site of the injection, and unknown for flu like symptoms; head is hurting; weak; hot and cold; chills; throat sore; fatigue was reported as worsened, a little heat around the injection site area.  Information on lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Oropharyngeal pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: weak; hot and cold; Chills; Throat sore; Fatigue; Flu like symptoms; head is hurting; swollen at the site of the injection; Flu like symptoms; head is hurting; weak; hot and cold; Chills; Throat sore; Fatigue was reported as worsened.; a little heat around the injection site area; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 21Jun2021 (at the age of 44 years old) as dose 1, single for COVID-19 immunisation. Medical history included stroke (additional information for other conditions: in 2010 and one in Jan2021), blood pressure measurement (has blood pressure problems and had a stroke in January). The patient's concomitant medications were not reported. The patient experienced head is hurting, swollen at the site of the injection on 21Jun2021, flu like symptoms, weak, hot and cold, chills, throat sore, fatigue on 22Jun2021, flu like symptoms; head is hurting; weak; hot and cold; chills; throat sore; fatigue was reported as worsened, a little heat around the injection site area on an unspecified date on Jun2021. Event reported as, "the patient took the vaccine on monday and then 30 minutes afterwards her head started hurting. Then yesterday the patient symptoms were way worse and today it was worse. Today there was still a little heat around the injection site area. The caller's arm is still swollen a little bit but when the caller moves her arm it is not good, she can feel it still. The caller's throat is sore and she is fatigued. Tuesday is when everything started going down hill. Today the patient is in the bed and missing work because she can't work like this". Outcome of the event flu like symptoms, head is hurting, weak, hot and cold, chills, throat sore, fatigue was not recovered, recovering for swollen at the site of the injection, and unknown for flu like symptoms; head is hurting; weak; hot and cold; chills; throat sore; fatigue was reported as worsened, a little heat around the injection site area.  Information on lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain in calf; Pain in calf; Joint pain; This is a spontaneous report from a contactable healthcare professional. A 35-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Jun2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Other medical history reported as none. The patient had no known allergies to medications, food and other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 15Jun2021, the patient experienced swelling and pain in calf and joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events swelling and pain in calf and joint pain was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 11Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Mitral Valve Prolapse (MVP). The patient was allergic to penicillin. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 21Mar2021 at 09:30 (at the age of 60-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 18Apr2021, the patient experienced severe tinnitus. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severe tinnitus was not resolved at the time of report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vaccination site discomfort, Vaccination site mass
Clinical narrative: Discomfort at injection site with small lump present, more noticable with pressure (IE following side sleeping); Discomfort at injection site with small lump present, more noticable with pressure (IE following side sleeping); Pain throughout arm for 2-3 days; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, scoliosis, pain, headache and chronic sinus. The patient had known allergies to wasp sting and codeine. Concomitant medications included PRN for pain and headache, taken on an unknown date, unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 06Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. 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 COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, for second dose, the patient experienced pain throughout arm for 2-3 days, discomfort at injection site with small lump present, more noticeable with pressure (IE following side sleeping). It was reported that for first dose no adverse reactions. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. On 22Jun2021, the patient underwent rapid test (nasal Swab) and the result was negative. The clinical outcome of the events pain throughout arm for 2-3 days, discomfort at injection site with small lump present, more noticeable with pressure (IE following side sleeping) were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Her right hand was experiencing tremors. The tremors have persisted since then and progressed to the rest of her body as of today.; This is a spontaneous report from a contactable other healthcare professional. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0172) via intramuscular route of administration in the left arm on 18Jun2021 at 14:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient had reported any other health issues. It was unknown whether the patient had any known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0172) via intramuscular route of administration in the left arm on 28May2021 at 14:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 20Jun2021, three days after receiving her second vaccine, the patient experienced tremors in right hand. The tremors had persisted since then and progressed to the rest of the body. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event tremors in right hand and progressed to the rest of the body was not recovered at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: persistent increased heart rate at rest. (90 bpm); This is a spontaneous report received from a contactable consumer (patient). A 14-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unknown), via an unknown route of administration on an unknown date as dose 1, single and second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine , solution for injection, batch/lot number: unknown), via an unknown route of administration in right arm on an unknown date as dose 2, single for COVID-19 immunisation at public health clinic/veterans administration facility. The patient's medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both were taken foran unknown indication from an unknown date and take multivitamin. No other vaccine in four weeks. On 28May2021, the patient persistent increased heart rate at rest. (90 bpm); identified as "not looking well" at school and sent home resolved over time. did not seek additional medical support beyond school nurse. Event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination and no covid tested post vaccination. No treatment received. The outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence
Clinical narrative: Stomach cramps; Gas; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Er8737) via an unspecified route of administration on 17Apr2021 at 10:00 (at the age of 61-years-old) in left arm as a single dose for covid-19 immunization. Medical history included anxiety, hypertension, and penicillin allergy all from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications included lisinopril (LISINOPRIL) and propranolol (PROPRANOLOL) both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number=Ep6955) on 27Mar2021 at 10:00 in left arm for covid-19 immunization. The patient experienced stomach cramps, gas, and diarrhoea on 17Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated, and he was seeking treatment appt next Thursday. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased, SARS-CoV-2 test, Tachycardia
Clinical narrative: Tachycardia/My resting heart rate is mid 50s bpm. After the second vaccine, I was hitting 100+ bpm even during minimal motion.; abnormally fast heart rate (if I moved or stood up); tightness in chest; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 14Apr2021 09:45 (Batch/Lot Number: EW0158) as DOSE 2 (Age at vaccination: 56-years-old), SINGLE for COVID-19 immunisation. Patients Medical history: ongoing insomnia and ongoing seasonal allergy. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) taken via oral route for seasonal allergy from an unspecified start date and ongoing; ibuprofen taken for an unspecified indication, start and stop date were not reported and zolpidem taken via oral route of administration for insomnia from an unspecified start date and ongoing. The patient was not pregnant at vaccination. Historical vaccine included as bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm left on 24Mar2021 at 04:15 AM (Batch/Lot Number: EW0158) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no Covid prior vaccination and not tested for COVID post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced abnormally fast heart rate (if I moved or stood up) and tightness in chest. Her resting heart rate was mid 50s bpm. On 14Apr2021 06:30 PM, After the second vaccine, she was hitting 100+ bpm even during minimal motion. Tachycardia symptoms started in the afternoon following second covid-19 vaccine dose in the morning if she moved from bed/resting position. my heart rate shot up to over 100bpm. the high heart rate was sustained until complete physical in action. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021 Nasal Swab 3x/wk (ended 24May2021) testing PCR,covid test result=Negative,heart rate: abnormally fast heart rate on abnormally fast heart rate (if I moved or stood up). The outcome of the event (tachycardia, chest discomfort and heart rate increased) was recovered on Apr2021.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Limb discomfort, Muscular weakness, Pain
Clinical narrative: Feeling pain on left side below the nipples; Sometimes would feel a bit dizzy; Feel uncomfortable on left side; Left arm would give pain mixed with a lot of discomfort; Left arm would give pain mixed with a lot of discomfort; Feeling weak in legs; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Jun2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or any other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Jun2021, the patient started feeling pain on left side below the nipples, felt uncomfortable on his left side and sometimes would feel a bit dizzy. The patient's left arm would give him pain mixed with a lot of discomfort and this would prevent him from focusing on what he was doing. Patient did not know what to do about this, and went to the gym to see if that would help and it helped for a day and came back the next day. Most of the time, this issue happened when patient woke up and was getting ready for work. He started feeling weak in his legs and started having pain on his left side. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events feeling pain on left side below the nipples, feel uncomfortable on left side, left arm would give pain mixed with a lot of discomfort and feeling weak in legs which included treatment with ibuprofen (MANUFACTURER UNKNOWN) and it seemed to help the patient so far. It was unknown whether any therapeutic measures were taken as a result of the event sometimes would feel a bit dizzy. The clinical outcome of the events feeling pain on left side below the nipples, feel uncomfortable on left side, sometimes would feel a bit dizzy, left arm would give pain mixed with a lot of discomfort and feeling weak in legs were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Feeling pain on left side below the nipples; Sometimes would feel a bit dizzy; Feel uncomfortable on left side; Left arm would give pain mixed with a lot of discomfort; Left arm would give pain mixed with a lot of discomfort; Feeling weak in legs; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Jun2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or any other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Jun2021, the patient started feeling pain on left side below the nipples, felt uncomfortable on his left side and sometimes would feel a bit dizzy. The patient's left arm would give him pain mixed with a lot of discomfort and this would prevent him from focusing on what he was doing. Patient did not know what to do about this, and went to the gym to see if that would help and it helped for a day and came back the next day. Most of the time, this issue happened when patient woke up and was getting ready for work. He started feeling weak in his legs and started having pain on his left side. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events feeling pain on left side below the nipples, feel uncomfortable on left side, left arm would give pain mixed with a lot of discomfort and feeling weak in legs which included treatment with ibuprofen (MANUFACTURER UNKNOWN) and it seemed to help the patient so far. It was unknown whether any therapeutic measures were taken as a result of the event sometimes would feel a bit dizzy. The clinical outcome of the events feeling pain on left side below the nipples, feel uncomfortable on left side, sometimes would feel a bit dizzy, left arm would give pain mixed with a lot of discomfort and feeling weak in legs were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: numbness to her tongue; numbness under her lip; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient 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 (at the age of 65-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced numbness to her tongue, numbness under her lip on an unspecified date. Reporter is a pharmacist who is calling to report a patient who received the Pfizer Covid vaccine today and is 15 minutes after the dose is experiencing numbness to her tongue. Reporter wants to know if this has been reported and is a side effect of the vaccine. After hanging up with caller document found that was specific to Paresthesia. Called provider back and informed her of updated information. As of 31Dec2020, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed that we have received spontaneous reports of dental paresthesia, paresthesia, paresthesia oral, paresthesia mucosal, intranasal paresthesia, pharyngeal paresthesia, paresthesia ear and vaccination site paresthesia since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. Calling about Pfizer COVID vaccine. She just gave the vaccine to a patient and within 15 minutes started having numbness under her lip, is that normal. Outcome of the events was unknown.  Information regarding the Lot/Batch number has been requested.  Follow-Up (PRD/SRD 20Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Confusional state
Clinical narrative: In a constant mental fog; I have no short-term memory; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0180) via an unspecified route of administration in the arm left on 22Jun2021 at 16:00 as a single dose(at the age of 47-years-old) for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient had no known allergies. Prior to the vaccination the patient had not been 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. On 22Jun2021, the patient reported that he was in a constant mental fog and had no short-term memory. 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 outcome of the event in a constant mental fog and short term memory loss was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Somnolence
Clinical narrative: Swelling in arm; sleeping more than 4 hours; This is a spontaneous report from a contactable consumer, the patient. A 14-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 23Jun2021 at 12:15 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. 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 23Jun2021 at 13:00, the patient experienced swelling in arm and was sleeping more than four hours. 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 outcome of the events swelling in arm and sleeping more than 4 hours was resolving at the time of this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Maternal exposure during pregnancy, Speech disorder
Clinical narrative: Hoarse throat; can barely speak; Pregnancy, 14 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Jun2021 at 11:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient delivery date is on 22Dec2021. She was 14weeks pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included doxylamine succinate (UNISOM), prenatal vitamins (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and pyridoxine hydrochloride  (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 17:30, the patient experienced hoarse throat and barely speak. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hoarse throat and can barely speak were not resolved at the time of the report.  No follow-up attempts are possible. No further information is expected
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Formication, Pruritus, Rash
Clinical narrative: itching all over; series of rashes on my torso; blister type itchy bumps; my skin is crawling; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ;Lot Number: EW0178) via an unspecified route of administration in the left arm on 05May2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included severe reaction to H1N1 vaccination (allergy to vaccine) in 2010. 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 concomitant medications within two weeks of the COVID vaccine. The patient was allergic to fluoroquinolones and clobetasol (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on an unknown date at 08:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Jun2021 at 08:00 the patient experienced itching all over, series of rashes on torso, blister type itchy bumps, skin crawling . The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the reported events. The clinical outcome of the event itching all over, series of rashes on torso, blister type itchy bumps, skin crawling were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: after my vaccine I started spotting. In the 3 years I had the MIRENA IUD, I did not have spotting or a period once.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: was not reported, Expiry date: unknown, at the age of 34 years), dose 1 via an unspecified route of administration on 21May2021 11:30 as dose 1, single for covid-19 immunisation. Medical history included MIRENA IUD from an unspecified date in 2018 (I had a MIRENA IUD at time of my vaccination (since 2018) - after my vaccine I started spotting) and MIRENA IUD removed (I had my MIRENA IUD removed 18Jun2021). The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported after her vaccine she started spotting. In the 3 years she had the Mirena iud, she did not have spotting or a period once. The spotting began after her first vaccine dose and the spotting has continued since then. The patient underwent lab tests and procedures which included blood test: normal (Her ob/gyn administered a blood test and the results came back normal, she was concerned the vaccine has affected her cycle) on an unspecified date, sars-cov-2 test: negative on 21May2021. The patient did not receive any treatment for the event. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The reporter assessed the events as non-serious. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Broke out with shingles; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 05Jun2021 at 14:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included ulcerative colitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Jun2021 at 01:00, the patient reported that he broke out with shingles. Since the vaccination, the patient had not been tested for COVID-19. The event 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 adverse event and included treatment with valacyclovir. The clinical outcome of the event broke out with shingles was resolving at the time of this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: After both the first and second dose I received my period for an extended period (longer than normal). The bleeding was a bit heavier than normal as well; This is a spontaneous report from a contactable consumer (patient herself). A 23-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: ew0164) as DOSE 2, SINGLE; via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: er8736) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history included acne. Concomitant medication(s) included spironolactone. The patient was vaccinated in a hospital. The patient did not have no known allergies. On 21Apr2021, the patient after both the first and second dose she received her period for an extended period. The bleeding was a bit heavier than normal and the timing was in line with the vaccine. The patient had an intrauterine device (IUD) and didn't have a period for 3 months before the vaccine. She was on medication for acne, and noticed that has thrown my period off as well. The patient on 29May2021, underwent sars-cov-2 test (nasal swab) which was negative. The patient did not receive other vaccine in four weeks. The patient did not receive any treatment for the adverse event. The patient did not have covid before vaccination. The outcome of the event was recovered on an unknown date in 2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: bloating; bleeding; Spotting between period; Extended period circle from 3 days to 7 days; My cycle have changed with increased pain/Excruciating pain and cramps; This is a spontaneous report from a contactable other health care professional (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration in right arm on 21May2021 at 17:30 (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0162), via an unspecified route of administration in left arm on 04Apr2021 at 17:30 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation and experienced menstrual disorder. The patient had no known allergies. No covid prior vaccination and no covid tested post vaccination. 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. It was reported that her cycle has changed with increased pain, bloating and bleeding on 21Jun2021 at 09:00. She has had 2 cycles within her first dose and last dose of the vaccine. On an unknown date in May2021, spotting between periods, extended period circle from 3 days to 7 days, excruciating pain, and cramps. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Lymphoedema
Clinical narrative: Lymphedema after second dose; Arm hung down 12 to 18 inches; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of 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 at dose 2, single for covid-19 immunisation. Medical history was not reported. Concomitant medication included Lasix. Patient previously received first dose of BNT162B2 on an unspecified date at dose 1, single for COVID-19 immunization. On an unspecified date the patient experienced lymphedema after second dose, arm hung down 12 to 18 inches. Stated reporter was a consumer that received paperwork for an adverse event she had after her second dose of Pfizer Covid-19 Vaccine. Reporter had a question about the form. It was 5 to 7 days after her second dose, she developed lymphedema and they had to increase her Lasix. She has questions about the paperwork she received. She also said she had to go through Occupational Therapy because of this. While reporting on herself, reporter stated that when she signed in for Physical Therapy, the girl told her that about 30 percent of her patients were all from the second Covid vaccine and it all happened within the same time frame as the callers (within 5-7 days after the second COVID Vaccine). All of these people had lymphedema, and another thing they had in common was that they all had radiation treatment for cancer. She is just wondering if Pfizer's studies included any people who had radiation treatments because it seems like the 30% in the physical therapy class that had the Pfizer vaccine all had radiation. Reporter stated that one lady's arm hung down 12 to 18 inches and that was from the Covid vaccine. This report is in regard to the lady whose arm hung down 12 to 18 inches. Outcome of the events was unknown. Communication: No further information was provided or obtained. This is Report 3 of 3. MI filed on Report 1. Information about lot/batch number has been requested.  Follow up (20Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: Lymphedema after second dose; This is a spontaneous report from a contactable consumer reported for female patient (lady) that is also a patient in physical therapy. A female patient of unspecified age received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: Unknown, Expiry date: Not provided), via an unspecified route on an unspecified date, as a single dose for covid-19 immunization. Medical history included breast cancer. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection), as a single dose for covid-19 immunization. On an unknown date, 5 to 7 days after second dose, patient developed lymphedema and they had to increase her Lasix. Reporter stated that when she signed in for Physical Therapy, the girl told her that about 30 percent of her patients were all from the second Covid vaccine and it all happened within the same time frame (within 5-7 days after the second COVID Vaccine). All of these people had lymphedema, and another thing they had in common was that they all had radiation treatment for cancer. Reporter was just wondering if Pfizer's studies included any people who had radiation treatments because it seems like the 30% in the physical therapy class that had the Pfizer vaccine all had radiation. Reporter has questions about the paperwork she received. She said she had to go through Occupational Therapy because of this. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fatigue; Headache; Chills; Fever; Sore arm; This is a spontaneous report from a contactable consumer (Patient). A 74 (units unspecified) female patient of an unspecified age received bnt162b2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration on 22Apr2021 as dose 1, single and bnt162b2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration on 13May2021 as dose 2, single for COVID-19 immunization. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medications included olmesartan taken for blood pressure measurement, start and stop date were not reported (dose was not clarified. Reporter think it was 40-25 mg). After the first and second dose the patient experienced fatigue, headache, chills, fever and sore arm on unspecified date in Apr2021. Reporter wanted to report it, but she wanted to report it to someone who was going to have records with CDC, and she guess that you don't have that. You do not report to CDC. Pfizer does not report the side effects to the CDC. Lab tests was not provided, but reporter saw her doctor after all this. Patient did not receive any treatment for events. Reporter stated that she was not having any problems (not clarified further). The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.