chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Headache, Lymph node pain, Tracheal pain
Clinical narrative: can not swallow or sip water; shortness of breath/difficulty breathing; pain in the trachea; pain in the gland; pain goes to the back of the brain; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 28Jul2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 25Jun2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization and experienced a lot of pain in the joints, the shoulder and the neck. On 29Jul2021, the patient experienced cannot swallow or sip water, shortness of breath/difficulty breathing, pain in the trachea, pain in the gland and pain goes to the back of the brain. The course of events was reported as follows: About 3 hours ago, in the morning, the patient started to experience some shortness of breath, difficulty breathing, pain in the trachea, pain in the gland, which was quite strong and the patient could not swallow or sip water. The pain went to the back of the brain. The patient wanted to know if these symptoms were normal. He was 100% sure that these were due to the vaccine, because he had never experienced anything like this. When he went to see his PCP the day before yesterday he told him that after the first dose of the vaccine he had a lot of pain in the joints, the shoulder and the neck, and the PCP stated that several of his patients also had those symptoms. The clinical outcomes of the events cannot swallow or sip water, shortness of breath/difficulty breathing, pain in the trachea, pain in the gland and pain goes to the back of the brain were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Rash, Vaccination site rash
Clinical narrative: small patch of rash around the injection site; she had a bright red kind of bumpy rash; This is a spontaneous report from a contactable consumer (patient). 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, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient of an unspecified age 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 an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced small patch of rash around the injection site and she had a bright red kind of bumpy rash. It was reported that the first day after the callers second shot of the Pfizer covid 19 vaccine she had a small patch of rash around the injection site, then two days after the second shot she had a bright red kind of bumpy rash that went down to the elbow, it lasted for 11 days. She talked to her pharmacist and they said yes it was definitely the vaccine. The last time she was tested for allergies she had 3 pages with 2 columns on each page of allergies. On an unspecified date, the patient underwent lab and procedure which included Allergy Test, last time she was tested for allergies, she had 3 pages with 2 columns on each page of allergies. Outcome of the events was recovered in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: She has a cough since two or three days before the first dose of the vaccine and it hasn't stopped; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (reporter's mother) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection),via an unspecified route of administration on an unknown date in 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient medical history included cough from an unknown date (has a cough since two or three days before the first dose of the vaccine). The patient's concomitant medications were not reported. The patient experienced she has a cough since two or three days before the first dose of the vaccine and it hasn't stopped on an unknown date in 2021. It was reported that reporter's mother who received the first dose of the Pfizer Covid-19 vaccine from this week, two weeks ago and it's her turn to get the second dose of the vaccine today or tomorrow. She had a cough since two or three days before the first dose of the vaccine and it hadn't stopped, it's not a flu, she mentions that the cough was not constant, but it was every day and especially at night. She would like to know if her mom should receive the second dose of the vaccine. The outcome for event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a rash in my right arm and both of my left and right foot; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had rash in right arm and both of left and right foot on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Dizziness, Headache
Clinical narrative: Headaches; Lightheadedness; lump under left armpit; This is a spontaneous report from a contactable nurse. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an intramuscular route of administration in the left arm on 27Jul2021 at 16:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The medical history included polycystic ovarian syndrome (PCOS), hypertension (HTN), obesity and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) and lisdexamfetamine mesilate (VYVANSE), all from unknown dates and for unspecified indications. On 27Jul2021, the patient experienced headaches, light-headedness and lump under left armpit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, light-headedness and lump under left armpit were unknown at the time of this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Muscle spasms, SARS-CoV-2 test, Swelling face
Clinical narrative: Face swelling; Lips swelling; Leg cramps; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the left arm on 23Jul2021 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not have any concomitant medications. On 23Jul2021, after1 hour of vaccination the patient experienced face swelling, lips swelling and leg cramps. Therapeutic measures were taken as a result of events and included treatment with prescribed steroids and Benadryl. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 29Jul2021, the patient underwent nasal Swab, SARS CoV-2 test and the result was negative.  Since the vaccination, the patient had  been tested for COVID-19. The clinical outcome of face swelling, lips swelling and leg cramps were recovered on Jul2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report from a Pfizer-sponsored program received via a contactable consumer or other non-health care professional (patient). A 70-years-old female patient 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 Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On and unspecified date in Apr2021, the patient after receiving 1st shot experienced not feeling well. She stated that she received her 1st Pfizer Covid 19 vaccine at the end of Apr, 2nd vaccine was scheduled on 04May and was opted not to go back because she was feeling unwell after receiving 1st shot (did not go in to detail regarding symptoms). She would now like to know what the efficacy of the 1st shot is, if she can still get her 2nd shot or if she needs to begin the vaccination series again. She wanted to know if there will be a need to retake the entire vaccination series of the Pfizer BioNTech Covid-19 Vaccine if there 3 weeks dosing interval of the first and the second dose was not observed. She was advised by her doctor to not take the 2nd dose because she was not feeling well. She wanted to know the risks associated after receiving a dose of the Pfizer BioNTech Covid-19 Vaccine. She wanted to know the efficacy of the Pfizer BioNTech covid-19 vaccine after one dose and wanted to know if she will be contraindicated in getting the second dose of the Pfizer BioNTech Covid-19 Vaccine. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Can't sleep or stay sleep; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old, non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Jul2021 at 16:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications included paracetamol (TYLENOL) for unknown indication from an unknown date. The patient previously received morphine (MANUFACTURER UNKNOWN) and linaclotide (LINZESS) for unknown indication on an unknown date and experienced drug allergy. 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. On 29Jul2021, the patient could not sleep or stay sleep. 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 could not sleep or stay sleep was unknown at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Lethargy, Pain, Paranasal sinus discomfort, Productive cough
Clinical narrative: 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: FA7484) via an unspecified route of administration in the left arm on 23Jul2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and high cholesterol. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jul2021, the patient experienced mildly lethargic. On 25Jul2021 at 17:00, the patient experienced dry coughing, deep, dry cough persisted for two days. On 27Jul2021, the patient felt legitimately ill with coughing (semi productive with mucus), body aches and sinus pressure. The patient had no fever at any point. On 28Jul2021, the patient had more sinus drip than he had ever had in his life. He went through a box and a half of Kleenex in 24 hours. The patient had to stand in shower and let nose just run, several times throughout the day and experienced lots of vigorous sneezing, coughing largely subsided by that point. On 29Jul2021, the patient's sinuses began to clear up but the patient woke up at night in an aggressive, unexplained fit of coughing that persisted for about 30 minutes. On 30Jul2021, the patient felt he was on the mend and symptoms were finally subsiding. The patient had scheduled an appointment with his doctor for next Wednesday for antibody test. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 28Jul2021, the patient underwent coronavirus (COVID-19) YHL test and the result was negative. The clinical outcome of the events vigorous sneezing, mildly lethargic, dry coughing, legitimately ill with coughing (semi productive with mucus), body aches, sinus pressure and sinus drip was resolving at the time of this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Sneezing, Upper-airway cough syndrome
Clinical narrative: 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: FA7484) via an unspecified route of administration in the left arm on 23Jul2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and high cholesterol. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jul2021, the patient experienced mildly lethargic. On 25Jul2021 at 17:00, the patient experienced dry coughing, deep, dry cough persisted for two days. On 27Jul2021, the patient felt legitimately ill with coughing (semi productive with mucus), body aches and sinus pressure. The patient had no fever at any point. On 28Jul2021, the patient had more sinus drip than he had ever had in his life. He went through a box and a half of Kleenex in 24 hours. The patient had to stand in shower and let nose just run, several times throughout the day and experienced lots of vigorous sneezing, coughing largely subsided by that point. On 29Jul2021, the patient's sinuses began to clear up but the patient woke up at night in an aggressive, unexplained fit of coughing that persisted for about 30 minutes. On 30Jul2021, the patient felt he was on the mend and symptoms were finally subsiding. The patient had scheduled an appointment with his doctor for next Wednesday for antibody test. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 28Jul2021, the patient underwent coronavirus (COVID-19) YHL test and the result was negative. The clinical outcome of the events vigorous sneezing, mildly lethargic, dry coughing, legitimately ill with coughing (semi productive with mucus), body aches, sinus pressure and sinus drip was resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma, SARS-CoV-2 test
Clinical narrative: Lymphoma; This is a spontaneous report from a contactable nurse. An 85-year-old female patient not pregnant received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Jul2021 the patient experienced lymphoma. The patient was hospitalized for lymphoma for 5 days. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Therapeutic oncology measures were taken as a result of lymphoma. Patient did not have COVID prior vaccination, patient was tested for COVID post vaccination with Nasal Swab result was negative on unknown date. Patient had not recovered from the event, at the time of the report.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events "lymphoma" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Vaccination site pain
Clinical narrative: pain; lymph nodes popping out under her left armpit and side of her left breast; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old female 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 29Jul2021 14:35 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 30Jul2021 03:00 the patient experienced pain, lymph nodes popping out under her left armpit and side of her left breast, injection site pain. Reporter, female, aged 63, received first dose of the Pfizer BioNTech Covid 19 vaccine yesterday on 29Jul2021 at 2:35pm-2:40pm. This morning on 30Jul2021 around 3am she woke up with pain and noticed lymph nodes popping out under her left armpit and side of her left breast. She says the lumps her real bad. She received the shot on the right side but has no pain on the right side, just injection site pain if she presses on it but nothing severe. While on the phone she noticed she has a swollen one on her neck as well. Is this a side effect of the vaccine. Question: She has an upcoming biopsy bladder surgery on Wednesday, is it still okay to do. Outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (23Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Lymphoedema, Neck pain, Pain, Peripheral swelling
Clinical narrative: Lymphedema / swelling of  lower left leg; Lymphedema / swelling of  lower left leg; Body aches, back pain and neck pain for following week.; Body aches, back pain and neck pain for following week.; Body aches, back pain and neck pain for following week.; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old male 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 23Jul2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient previously had tree nuts and experienced allergy to nuts. The patient also had peach previously and experienced fruit allergy. The patient did not have any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 02Jul2021 at 11:00 (at the age of 38-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 23Jul2021 at 19:00, the patient experienced lymphedema / swelling of  lower left leg. The patient also experienced body aches, back pain and neck pain for following week on 23Jul2021 at 19:00. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events lymphedema / swelling of  lower left leg; body aches, back pain and neck pain for following week was resolved with sequelae on an unknown date in Jul2021.   No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: severe pain, tingling sensation in both feet/not able to walk/neurologist suspects neuropathy; I am not able to walk/I have to use crutches to walk; severe pain; Tingling sensation in both feet; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 06Jun2021 16:00 (at the age of 14-years-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0177), via an unspecified route of administration, administered in right arm on 16May2021 at 04:00 PM (at the age of 14-years-old) as single dose for COVID-19 immunisation. The patient stated 4 weeks after booster dose, on 06Jul2021 at 08:00, he woke up one morning with severe pain, tingling sensation in both feet. He was not able to walk, he saw a podiatrist who referred me to a neurologist and the neurologist suspects neuropathy. He has to use crutches to walk and was on gabapentin. She has had these indications for 3 weeks now, its not getting better. Patient is otherwise very healthy with no other medical issues. Therapeutic measures were taken with gabapentin as a result of all event. The outcome of all event was not recovered.  Follow-Up (03Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, Magnetic resonance imaging, Metabolic function test
Clinical narrative: severe pain, tingling sensation in both feet/not able to walk/neurologist suspects neuropathy; I am not able to walk/I have to use crutches to walk; severe pain; Tingling sensation in both feet; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 06Jun2021 16:00 (at the age of 14-years-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0177), via an unspecified route of administration, administered in right arm on 16May2021 at 04:00 PM (at the age of 14-years-old) as single dose for COVID-19 immunisation. The patient stated 4 weeks after booster dose, on 06Jul2021 at 08:00, he woke up one morning with severe pain, tingling sensation in both feet. He was not able to walk, he saw a podiatrist who referred me to a neurologist and the neurologist suspects neuropathy. He has to use crutches to walk and was on gabapentin. She has had these indications for 3 weeks now, its not getting better. Patient is otherwise very healthy with no other medical issues. Therapeutic measures were taken with gabapentin as a result of all event. The outcome of all event was not recovered.  Follow-Up (03Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Pain, Pain in extremity, Paraesthesia
Clinical narrative: severe pain, tingling sensation in both feet/not able to walk/neurologist suspects neuropathy; I am not able to walk/I have to use crutches to walk; severe pain; Tingling sensation in both feet; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 06Jun2021 16:00 (at the age of 14-years-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0177), via an unspecified route of administration, administered in right arm on 16May2021 at 04:00 PM (at the age of 14-years-old) as single dose for COVID-19 immunisation. The patient stated 4 weeks after booster dose, on 06Jul2021 at 08:00, he woke up one morning with severe pain, tingling sensation in both feet. He was not able to walk, he saw a podiatrist who referred me to a neurologist and the neurologist suspects neuropathy. He has to use crutches to walk and was on gabapentin. She has had these indications for 3 weeks now, its not getting better. Patient is otherwise very healthy with no other medical issues. Therapeutic measures were taken with gabapentin as a result of all event. The outcome of all event was not recovered.  Follow-Up (03Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Oropharyngeal pain
Clinical narrative: low temperature last night; sore throat; This is a spontaneous report from a contactable Consumer (patient) that. A 12-years-old male patient received BNT162B2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection), via an unspecified route of administration on 27Jul2021 (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. Caller asks about if the vaccine could cause a sore throat as a side effect for a 12-year-old because her grandson went swimming yesterday and had a low temperature last night but complained of a sore throat on an unspecified date in Jul2021. Caller states she didn't know if it was the pool that was treated the day before with chlorine or would it be the vaccine. Caller asks if it is known which manufacturer is suitable for a heroin or opioid addict or is it recommended, they get the vaccine? Caller asks if there is a specified time that an addict stop using before receiving the vaccine such as five days or ten days? Caller states the person she is calling about does not have any health issues other than he has used before. Caller states she can't believe that after developing the vaccine that his question hasn't arisen to as to how it would affect someone on heroin or opioids because this had to have been a concern and been in a clinical trial or something. The patient underwent lab tests and procedures which included body temperature: low on Jul2021. The event outcome was Unknown.  Provided disclaimer that Pfizer cannot provide individual treatment recommendations.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Electromyogram, Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; diffuse weakness; This is a spontaneous report from a contactable physician (Neurologist). A 64-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 25Mar2021 (Lot number was not reported) as single dose (age at vaccination: 64-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. It was unknown about any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date patient experienced guillain barre syndrome and diffuse weakness. Events resulted in Emergency Room and Physician Office visit. The reporting Neurologist stated that he saw a patient this week and wanted to report the patient presented with guillain barre syndrome (GBS) approximately 2 weeks after receiving the vaccine. He clarifies that within 2 weeks after receiving the vaccine, the patient presented to the Emergency room with diffuse weakness and Guillain-Barre syndrome. Caller is wanting to know what the appropriate way to follow-up is. He clarifies he knows how to treat Guillain-Barre, he is a neurologist, he knows what to do, he just really wanted to know what channels to go through to log the adverse event. Reporter stated he had rules about HIPAA. He had yet to contact the patient to discuss the possibility of sharing their information. Reporter stated that the patient had knee surgery 2 days before the onset of weakness. The surgery date was 06Apr2021. The patient had electrodiagnostic testing done, clarified as an electromyogram (EMG). An EMG makes the diagnosis of GBS on unknown date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided regarding, the causal association between the event Guillain Barre syndrome and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: My mom had a stroke with in a month or two after getting vaccine.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a female patient (reporters mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporters mother had a stroke within a month or two after getting vaccine on an unspecified date. She was fine now and the doctors found no indication of legs or other area throwing off clot. Reporter's friend's brother had same issue. Reporter was suggesting to make inquiry on both cases. She told anyone can contact to her she would be trying to help. The outcome of event was recovered on an unspecified date.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke with in a month or two after getting vaccine.; This is a spontaneous report from a Pfizer sponsored program- General Company Information.   A contactable consumer reported for a male patient (reporter's friend's brother) that: A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, unknown dose (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. His mom had a stroke within a month or two after getting vaccine. She was fine now, and the doctors found no indication of legs or other area throwing off clot. A friend of his brother had same issue. He would suggest you make and inquiry on both cases. Contact his if you want. Just trying to help. Outcome of event was unknown.    The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart is racing; This is a spontaneous report from a contactable consumer, the patient. A 64- year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0186) via an unspecified route of administration in the left arm on 29Jul2021 at 16:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol, anxiety and menopause. 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. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and atorvastatin calcium (LIPITOR); all for unknown indication on unknown date, unknown if ongoing. Patient did not know of any allergies to food, medication or other products. On 30Jul2021 at 06:30, the patient experienced heart racing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse event heart racing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart racing was not recovered at the time of this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Joint swelling, Neck pain, Systemic lupus erythematosus
Clinical narrative: Neck pain; knee pain; Swollen knee; autoimmune disease-most likely lupus; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration, administered right arm on 04Mar2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number: EN6199) on an unspecified date in 2021. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Medical history included childhood epilepsy and migraines. The patient was not diagnosed with COVID-19 prior vaccination and since the vaccination she was not tested for COVID-19. Concomitant medication included sumatriptan taken for an unspecified indication, start and stop date were not reported. The patient reported that on 21May2021 (also reported about 2 months after 2nd dose) she experienced neck pain that has migrated down to her left knee. Left knee swelled up and remained swollen for 2 months. Blood tests indicated likely autoimmune disease-most likely lupus. The events were reported as serious (disability). The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. The events were treated with Prednisone and hydroxychloroquine. The outcome of events was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Feeling abnormal, Hypersensitivity
Clinical narrative: stomach ache; dizzy; Migraine; Head was really foggy  she could not concentrate; experienced some allergic reactions; itchiness all over the body; diarrhea; body ache; 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, lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included allergic to Sulfa (almost died when she had it) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unknown date in 2021, the patient experienced some allergic reactions like itchiness all over the body, diarrhea, body ache, stomachache, was dizzy, had migraine for 3 weeks, and head was really foggy she could not concentrate. When patient went to get the second dose of the vaccine, the pharmacist told her that due to her allergies, she should not had gotten the first dose because sulfur was a component of the vaccine and would not give the patient her second dose. The patient wanted to know if sulfur was a component of the vaccine. Response from Pfizer mentioned that Sodium Chloride is listed as an ingredient of the Pfizer BioNTech COVID-19 vaccine and Sodium Chloride may contain trace amount of sulphate which can be converted to sulphite. The patient wanted to know if she can get the second dose of the Pfizer COVID-19 vaccine considering her allergy to sulfur drugs and her experience (some allergic reaction) with the first dose of the vaccine. The outcome of the events migraine and head was really foggy she could not concentrate was resolved on an unknown date in 2021. The outcome for the other events was unknown. The patient declined to make a report.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pruritus
Clinical narrative: stomach ache; dizzy; Migraine; Head was really foggy  she could not concentrate; experienced some allergic reactions; itchiness all over the body; diarrhea; body ache; 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, lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included allergic to Sulfa (almost died when she had it) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unknown date in 2021, the patient experienced some allergic reactions like itchiness all over the body, diarrhea, body ache, stomachache, was dizzy, had migraine for 3 weeks, and head was really foggy she could not concentrate. When patient went to get the second dose of the vaccine, the pharmacist told her that due to her allergies, she should not had gotten the first dose because sulfur was a component of the vaccine and would not give the patient her second dose. The patient wanted to know if sulfur was a component of the vaccine. Response from Pfizer mentioned that Sodium Chloride is listed as an ingredient of the Pfizer BioNTech COVID-19 vaccine and Sodium Chloride may contain trace amount of sulphate which can be converted to sulphite. The patient wanted to know if she can get the second dose of the Pfizer COVID-19 vaccine considering her allergy to sulfur drugs and her experience (some allergic reaction) with the first dose of the vaccine. The outcome of the events migraine and head was really foggy she could not concentrate was resolved on an unknown date in 2021. The outcome for the other events was unknown. The patient declined to make a report.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Compression fracture, Computerised tomogram, X-ray
Clinical narrative: Had a fall fractured L-2 vertebrae, fine now; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202; Expiration Date: Jun2021), dose 2 intramuscular, administered in Left upper arm on 26Mar2021 11:00 as dose 2, single (69-years-old) for covid-19 immunisation. Medical history included , ongoing osteoporosis (drug name: vitamin d, reason for use: osteoporosis ongoing: yes), ongoing allergies (drug name: Claritin, reason for use: allergies ongoing: yes), ongoing acid reflux (drug name: pantoprazole sodium, reason for use: acid reflux ongoing: yes). Concomitant medication(s) included colecalciferol (VITAMIN D) taken for osteoporosis from 2018 and ongoing; loratadine (CLARITIN) taken for allergies from 2017 and ongoing; pantoprazole sodium taken for acid reflux from 2016 and ongoing. Patient previous took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810; Expiration Date: Jun2021), dose 1 intramuscular, administered in Left upper arm on 05Feb2021 11:00 as dose 1, single (69-years-old) for covid-19 immunisation. On 05May2021, patient had a fall fractured l-2 vertebrae and fine at the time of reporting. The patient underwent lab tests and procedures which included computerised tomogram: stomach ok on 03Mar2021 Had stomach pain, x-ray: compression fracture on 05May2021 Had a fall-fractured L-2 vertebrae, fine now. The outcome of the event was recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Electrocardiogram, Heart rate
Clinical narrative: bradycardia; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single, and second dose via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient reported that he had both doses of the Pfizer BioNTech Covid-19 vaccine in Mar2021, and has been experiencing bradycardia in the 30s. He stated that nothing has changed in his dietary or fitness habits, but there has been a marked change in bradycardia since the shots according to his fitness watch. Has been to his HCP and had an EKG done. Also reported that he couldn't get in to see a cardiologist until Nov2021. At times the patient's resting heart rate has dropped into the 30s. This event correlates shortly after the vaccine. The caller did not know if this is from the vaccine or not. The outcome of event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Tremor
Clinical narrative: Shaking in the left hand/actual hand shakes; Twitching/left arm twitching and shaking in certain positions; Numbness in her leg; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 24-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0198), via an unspecified route of administration, administered in Arm Left on 27Jul2021 (at the age of 24-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE) taken for an unspecified indication, start and stop date were not reported. Caller said that she has another med that she takes has another medication that was already approved by her eye specialist for an eye condition, and she approved for her to get vaccine and said that med was ok and CDC said approved. She said she does not think that the medication was relevant, it was Mycophenolate. No further details provided about this medication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0198) via an unknown route of administration on 06Jul2021 (at the age of 24-years-old) as dose 1, single for COVID-19 immunisation. Consumer calling about Pfizer-BioNTech COVID-19 vaccine, who said she recently got her second dose on 27Jul, which was about 3 days ago. She said that last night or early this morning she noticed on Jul2021, her arm was twitching and shaking when she would hold it in certain positions, and that her actual hand shakes, and she has never experienced that before. Caller was asking for any recommendations on treatment. Caller said it seems like the twitching and shaking has stayed about the same. though it was twitching and shaking more frequently when she holds her hand in that position. She said it started now randomly in middle of the night or early this morning between 01:00 to 02:00. Therapeutic measures were taken as a result of shaking in the left hand/actual hand shakes, twitching/left arm twitching and shaking in certain positions. Caller further stated that she had done no treatment since she did not know what to do which was why she called. She said she has been taking Tylenol. No further details provided about this medication. The outcome of the events was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.