chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: neuropathy; had a bad fall twice; tingling sensations; had really cold toes and fingers; had problems with swallowing; felt dizzy; feels like she would choke.; On her left foot, she said it felt like she stepped on shards of glass and cut her toes.; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received bnt162b2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on Mar2021 as dose 1, single and via an unspecified route of administration on Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient said she received her 1st and 2nd doses last Mar2021. Months after the 1st dose, she said she felt dizzy. She also mentioned that she is currently dizzy, and feels "dizzy to the left." However, she isn't sure whether if it was because of the vaccine or if it was because she's recently had a bad fall twice. A month, 2, or 3 months after her 1st dose (2021), she said she had neuropathy. She had tingling sensations, and had really cold toes and fingers. On her left foot, she said it felt like she stepped on shards of glass and cut her toes. She also said she had problems with swallowing, and feels like she would choke. She wants to know if these were symptoms of the vaccine. Outcome of the event dizzy was not recovered while unknown for the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Facial paralysis, Muscular weakness
Clinical narrative: he next day I woke up With facial Paralysis; rigth after 5 month I still can talk right and have weakness in my right arm am; it course verry Sever anxaity and depression; it course verry Sever anxaity and depression; This is a Spontaneous report from a contactable consumer. This 46-year-old female consumer reported for herself that:   A 46-years-old non-pregnant female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Formulation; Solution for Injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, Administered in Arm Right on 11Jun2021  (at 16:45) (at the age of 46-year-old) as Dose 1, Single for Covid-19 Immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and in two weeks. The patient did not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient experienced He next day i woke up with facial paralysis, Right after 5 month i still can talk right and have weakness in my right arm, It course very sever anxiety and depression, It cause very severe anxiety and depression on 12Jun2021 (at 09:00). The patient was hospitalized for the events. Therapeutic measures were taken as Steroids a result of the events. The events were assessed as hospitalization, life threatening illness (immediate risk of death from the event),disability or permanent damage.The outcome for all the events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a non-contactable consumer (niece). A male patient (reporter's uncle) of an unspecified age received bnt162b2 (COVID vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced heart attack. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart attack
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had the second dose of the Pfizer Covid-19 vaccine and felt like she had Covid-19 afterwards; had the second dose of the Pfizer Covid-19 vaccine and felt like she had Covid-19 afterwards; This is a spontaneous report from a contactable consumer or other non-HCP (reporter who was also a patient reported for her Niece). A 66-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE (Age of vaccination: Unknown) for COVID-19 immunization. Medical history and concomitant mediocations were not reported. Her (patient's) whole family had COVID-19. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single (Age of vaccination: Unknown) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient received the second dose of the Pfizer covid-19 vaccine and felt like she had covid-19 afterwards. Therapeutic measures were taken as a result of the events, took Tylenol. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: died from Covid 5 days after diagnosis; died from Covid 5 days after diagnosis; This is a spontaneous report from a non-contactable consumer or other non hcp. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A healthy patient died from Covid 5 days after diagnosis even though she had both Pfizer vaccine shots. Event took place after use of product. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died from Covid 5 days after diagnosis; died from Covid 5 days after diagnosis
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Off label use, Pain in extremity, Uterine infection
Clinical narrative: uterine infection; arm was a little red and sore; arm was a little red and sore; booster dose; booster dose; This is a spontaneous report from a contactable consumer (patient) via a regulatory authority. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on unspecified dates for covid-19 immunization. The patient developed uterine infection on an unspecified date the day after the injection. The patient asked if it was a side effect that has been reported. The patient also reported that her arm was a little red and sore, not bad on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died as a result of the COVID-19 vaccine shot; This is a spontaneous report from a contactable a consumer reporting same event under the same suspect product for twenty patients.   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 single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter personally knows of 20 people who have died as a result of the COVID-19 vaccine shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101393431 same reporter, product/event; different patient; Reported Cause(s) of Death: died as a result of the COVID-19 vaccine shot
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chest pain, Chills, Condition aggravated, Headache
Clinical narrative: stronger after 2nd dose; left chest compression like pain; left arm extension pain; lung scarification; headache; erratic fever; Chills; Balance issue; stiff joints of  elbow ,knee +wrist; left arm pain arms shot area; This is a spontaneous report from a contactable consumer (patient). This 70-year-old male patient received dose 2 of BNT162B2 (lot number EN6207) intramuscular on 12Mar2021 at 09:00 as a single dose in the left upper arm for COVID-19 immunization. Medical history included COVID-19 from 22May2020 to 19Jun2020 (tested positive 22May2020 and tested negative 19Jun2020). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were none. The patient previously received dose 1 of BN162B2 (lot number EN6198) intramuscular on 19Feb2021 at 09:00 as a single dose in the left upper arm for COVID-19 immunization and experienced light headedness, off balance, extreme tiredness, constant headache, extreme muscle pain in left arm, extreme joint pain, left chest compression-like pain, left arm pain arms shot area, erratic fever/chills, and stiff joints of elbow, knee and wrist. On 12Mar2021 at 15:00 (as reported) for two days following each of the vaccination shots the patient experienced the common symptoms most people experienced: severe and constant headache, left arm pain arm's shot area, erratic fever/chills, balance issue. He also had extreme stiff joints of elbow, knee, and wrist. On the third day after shots these symptoms diminished to near zero although there were 2 symptoms not mentioned yet. The patient had  awful left chest compression-like pain and left arm extension pain. These 2 pains lessened between shots but became stronger after the 2nd shot. They lessened since the 2nd shot nearly 2 months later. The patient notified his doctor after the first show and his doctor assured him the symptoms were not allergic reactions. They were confident the heart was not the source of chest pain. A magnetic resonance imaging (MRI) of chest showed lung scarification. The patient had a future test for left arm extension pain. The events were reported as serious for persistent/significant disability/incapacity. The patient did not receive any treatment for the events. The outcomes of headache, left arm pain arm's shot area, erratic fever/chills, balance issue, stiff joints, left chest compression-like pain, left arm extension pain, and lung scarification were recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021206053 Same patient and suspect product, different dose and event.
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Magnetic resonance imaging, Pain in extremity, Pulmonary fibrosis, Pyrexia
Clinical narrative: stronger after 2nd dose; left chest compression like pain; left arm extension pain; lung scarification; headache; erratic fever; Chills; Balance issue; stiff joints of  elbow ,knee +wrist; left arm pain arms shot area; This is a spontaneous report from a contactable consumer (patient). This 70-year-old male patient received dose 2 of BNT162B2 (lot number EN6207) intramuscular on 12Mar2021 at 09:00 as a single dose in the left upper arm for COVID-19 immunization. Medical history included COVID-19 from 22May2020 to 19Jun2020 (tested positive 22May2020 and tested negative 19Jun2020). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were none. The patient previously received dose 1 of BN162B2 (lot number EN6198) intramuscular on 19Feb2021 at 09:00 as a single dose in the left upper arm for COVID-19 immunization and experienced light headedness, off balance, extreme tiredness, constant headache, extreme muscle pain in left arm, extreme joint pain, left chest compression-like pain, left arm pain arms shot area, erratic fever/chills, and stiff joints of elbow, knee and wrist. On 12Mar2021 at 15:00 (as reported) for two days following each of the vaccination shots the patient experienced the common symptoms most people experienced: severe and constant headache, left arm pain arm's shot area, erratic fever/chills, balance issue. He also had extreme stiff joints of elbow, knee, and wrist. On the third day after shots these symptoms diminished to near zero although there were 2 symptoms not mentioned yet. The patient had  awful left chest compression-like pain and left arm extension pain. These 2 pains lessened between shots but became stronger after the 2nd shot. They lessened since the 2nd shot nearly 2 months later. The patient notified his doctor after the first show and his doctor assured him the symptoms were not allergic reactions. They were confident the heart was not the source of chest pain. A magnetic resonance imaging (MRI) of chest showed lung scarification. The patient had a future test for left arm extension pain. The events were reported as serious for persistent/significant disability/incapacity. The patient did not receive any treatment for the events. The outcomes of headache, left arm pain arm's shot area, erratic fever/chills, balance issue, stiff joints, left chest compression-like pain, left arm extension pain, and lung scarification were recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021206053 Same patient and suspect product, different dose and event.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: stronger after 2nd dose; left chest compression like pain; left arm extension pain; lung scarification; headache; erratic fever; Chills; Balance issue; stiff joints of  elbow ,knee +wrist; left arm pain arms shot area; This is a spontaneous report from a contactable consumer (patient). This 70-year-old male patient received dose 2 of BNT162B2 (lot number EN6207) intramuscular on 12Mar2021 at 09:00 as a single dose in the left upper arm for COVID-19 immunization. Medical history included COVID-19 from 22May2020 to 19Jun2020 (tested positive 22May2020 and tested negative 19Jun2020). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were none. The patient previously received dose 1 of BN162B2 (lot number EN6198) intramuscular on 19Feb2021 at 09:00 as a single dose in the left upper arm for COVID-19 immunization and experienced light headedness, off balance, extreme tiredness, constant headache, extreme muscle pain in left arm, extreme joint pain, left chest compression-like pain, left arm pain arms shot area, erratic fever/chills, and stiff joints of elbow, knee and wrist. On 12Mar2021 at 15:00 (as reported) for two days following each of the vaccination shots the patient experienced the common symptoms most people experienced: severe and constant headache, left arm pain arm's shot area, erratic fever/chills, balance issue. He also had extreme stiff joints of elbow, knee, and wrist. On the third day after shots these symptoms diminished to near zero although there were 2 symptoms not mentioned yet. The patient had  awful left chest compression-like pain and left arm extension pain. These 2 pains lessened between shots but became stronger after the 2nd shot. They lessened since the 2nd shot nearly 2 months later. The patient notified his doctor after the first show and his doctor assured him the symptoms were not allergic reactions. They were confident the heart was not the source of chest pain. A magnetic resonance imaging (MRI) of chest showed lung scarification. The patient had a future test for left arm extension pain. The events were reported as serious for persistent/significant disability/incapacity. The patient did not receive any treatment for the events. The outcomes of headache, left arm pain arm's shot area, erratic fever/chills, balance issue, stiff joints, left chest compression-like pain, left arm extension pain, and lung scarification were recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021206053 Same patient and suspect product, different dose and event.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died as a result of the COVID-19 vaccine shot; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for twenty patients.   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 single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter personally knows of 20 people who have died as a result of the COVID-19 vaccine shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101393431 same reporter, product/event; different patient; Reported Cause(s) of Death: died as a result of the COVID-19 vaccine shot
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died as a result of the COVID-19 vaccine shot; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for twenty patients. This is one of twenty reports.  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 single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter personally knows of 20 people who have died as a result of the COVID-19 vaccine shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101393431 same reporter, product/event; different patient; Reported Cause(s) of Death: died as a result of the COVID-19 vaccine shot
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died as a result of the COVID-19 vaccine shot; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for twenty patients. This is one of twenty reports.  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 single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter personally knows of 20 people who have died as a result of the COVID-19 vaccine shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s): PFIZER INC-202101393431 same reporter, product/event; different patient; Reported Cause(s) of Death: died as a result of the COVID-19 vaccine shot
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died as a result of the COVID-19 vaccine shot; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for twenty patients. This is one of twenty reports.  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 single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter personally knows of 20 people who have died as a result of the COVID-19 vaccine shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101393431 same reporter, product/event; different patient; Reported Cause(s) of Death: died as a result of the COVID-19 vaccine shot
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue for 5 days; The initial case was missing the following minimum criteria: of an adverse event. Upon receipt of follow-up information on (24Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer Sponsored Program. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL0142; Expiration Date: Mar2021) via an unspecified route of administration, administered in arm left on 27Jan2021 15:45 (at the age of 66-year-old) at dose 1, single for covid-19 immunisation. Medical history included ongoing cholesterol and ongoing sinus disorder. Concomitant medication simvastatin via an unspecified route of administration from an unspecified date (Lot Number: 866082) and ongoing, at 20 mg, daily (For Example, 20 Mg Once a Day, 10 Mg Twice a Day), Date Started (Or Best estimated Period): 7 years ago for cholesterol; cetirizine hydrochloride (ZIRTEK), via an unspecified route of administration from an unspecified date (Lot Number: 843130) and ongoing, at 10 mg, daily (For Example,20 Mg Once a Day,10 Mg Twice a Day) Date Started (Or Best estimated Period): 2 years ago for sinus. On an unspecified date in 2021 the patient experienced fatigue for 5 days. Patient did not visited to emergency room. Reporter just had her 1st dose today. Reporter is asking if it is okay to take her everyday medication like Simvastatin and Zirtek. Outcome of the event was reported as resolved on an unspecified date in 2021.   Information about Lot/Batch has been requested.  Follow-up (24Feb2021): This is a follow-up spontaneous report received from a contactable Consumer. This 66-year-old female consumer (patient) reported in response to non-HCP letter sent that included the following: Patient date of birth, age and age at vaccination 66-year, relevant Medical History cholesterol, sinus added. bnt162b2 details and concomitant medication details added. Event changed to fatigue for 5 days and clinical information was updated.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Gait disturbance, Muscular weakness
Clinical narrative: Very weak the following day/leg weakness; Nausea; leg weakness; Temp 99.3; difficulty ambulating; Woke up during the night with chills; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via intramuscularly, administered in left arm (deltoid) on 16Feb2021 at 10:30 AM (age at the time of vaccination: 74-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262) via intramuscularly, administered in left deltoid on 09Mar2021 at 09:30 AM as DOSE 2, SINGLE for COVID-19 immunization. Medical history included COVID 19. Patient had no allergies. Concomitant medications included vitamin C [ascorbic acid], colecalciferol (VITAMIN D [COLECALCIFEROL]), flaxseed oil [linum usitatissimum seed oil] and probiotics. On 17Feb2021 01:00 AM, patient woke up during the night with chills. On the same day, at 02:AM she had difficulty ambulating and at 09:00 AM felt very weak the following day/leg weakness and nausea. The patient was also reported with temperature 99.3 (unspecified units). No further chills. The following day patient felt fine. No treatment was received as a result of events. Patient had not received any other vaccine within four weeks and neither tested with COVID, post vaccination. As per the follow-up (17feb2021), new event nausea was added, event onset times were corrected. Route of administration for both the doses was updated. The outcome of woke up during the night with chills, very weak the following day/leg weakness and nausea was recovered on the same day (17Feb2021) whereas the event difficulty ambulating, temperature 99.3 was recovered on an unspecified date.  Information about lot/Batch number has been requested.  Follow-up (17May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for herself in response to non-HCP letter sent which included details like age at vaccination, event onset times, recovery dates and route of drug administration. Drug lot number and expiration date.  Follow-up (28MAY2021): Follow-up attempts completed. No further information expected.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Very weak the following day/leg weakness; Nausea; leg weakness; Temp 99.3; difficulty ambulating; Woke up during the night with chills; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via intramuscularly, administered in left arm (deltoid) on 16Feb2021 at 10:30 AM (age at the time of vaccination: 74-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262) via intramuscularly, administered in left deltoid on 09Mar2021 at 09:30 AM as DOSE 2, SINGLE for COVID-19 immunization. Medical history included COVID 19. Patient had no allergies. Concomitant medications included vitamin C [ascorbic acid], colecalciferol (VITAMIN D [COLECALCIFEROL]), flaxseed oil [linum usitatissimum seed oil] and probiotics. On 17Feb2021 01:00 AM, patient woke up during the night with chills. On the same day, at 02:AM she had difficulty ambulating and at 09:00 AM felt very weak the following day/leg weakness and nausea. The patient was also reported with temperature 99.3 (unspecified units). No further chills. The following day patient felt fine. No treatment was received as a result of events. Patient had not received any other vaccine within four weeks and neither tested with COVID, post vaccination. As per the follow-up (17feb2021), new event nausea was added, event onset times were corrected. Route of administration for both the doses was updated. The outcome of woke up during the night with chills, very weak the following day/leg weakness and nausea was recovered on the same day (17Feb2021) whereas the event difficulty ambulating, temperature 99.3 was recovered on an unspecified date.  Information about lot/Batch number has been requested.  Follow-up (17May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for herself in response to non-HCP letter sent which included details like age at vaccination, event onset times, recovery dates and route of drug administration. Drug lot number and expiration date.  Follow-up (28MAY2021): Follow-up attempts completed. No further information expected.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy/Lymphadenopathy in neck persisting more than 10 days.; This is a spontaneous report from a contactable Other Health Care Professional (patient) via Medical Information Team. A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318), via an unspecified route of administration, administered in arm left on 01Feb2021 at 08:45 (age at vaccination was 28-year-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. On 07Feb2021, the patient experienced lymphadenopathy/ lymphadenopathy in neck persisting for more than 10 days as it was still there as of 19Feb2021.The patient reported that she saw in the study that participants experienced this adverse event for around 10 days with some still experiencing the event. Wondering if you had follow-up data about those participants if they had recovered and the time frame. The patient had submitted an adverse drug reaction (ADR) report via your website already. Since the vaccination, the patient had not tested for COVID-19. No treatment medication was received for the event. The outcome of the event was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Wrong technique in product usage process
Clinical narrative: received COVID-19 Vaccine second dose with 25 gauge needles. Was advised by Pfizer the needle had to be 21 gauge or narrower; sore afterwards; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9267), via an unspecified route of administration on 18Feb2021 (at the age of 75-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure and high cholesterol increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient reported that she and her husband received the COVID-19 vaccine with the 25-gauge needle. Patient did not feel the COVID-19 vaccine when it was administered and was sore afterwards (Feb2021), it was advised by Pfizer the needle had to be 21 gauge or narrower and did not know if the second dose would be ok or not. The clinical outcome for the events was unknown.  No follow-up attempts are possible, No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021215248 same reporter, product, and event, different patient;US-PFIZER INC-2021215900 same reporter, product, and event, different patient
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This is a spontaneous report received from a contactable consumer or other health care professional reported herself. A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3247), via an unspecified route of administration, in left arm on 22Feb2021 at 09:30 (at the age of 62-year-old) as dose 1, single for covid-19 immunization at workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included HBP and Latex Known allergies latex: allergies to medications, food, or other products reported as yes. Concomitant medications included lisinopril, Pantoprazole, Vitamin D and tocopherol (VITAMIN E), patient received any other medications within two weeks of vaccination was reported as yes. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021, patient experienced the headache and nausea the day after she received the vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were reported as no. The outcome of the events was reported as recovering, since everything was good and fine on 24Feb2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This is a spontaneous report from a contactable Consumer (patient). A 77-years-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 18Feb2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Feb2021 patient stated that she started experiencing a severe headache on Saturday after receiving the vaccine and still had this severe headache. The headache was worse when she was standing up and feels a little better when she was lying down. She wants to know if this was a normal side effect after receiving the Pfizer COVID-19 vaccine and how long it was going to last. patient had not spoken with her HCP about these symptoms yet. She also states that her boyfriend received the first dose of the Pfizer COVID-19 vaccine on the same day and he has not had any adverse reactions after receiving his vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paranasal sinus discomfort
Clinical narrative: headache; sinus pressure; This is a spontaneous report from a contactable consumer or other non health-care professional. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution For Injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient states she took one Advil before first dose. Looking for quantitative efficacy information. The patient experienced headache, sinus pressure on an unspecified date following first dose. Outcome of both the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she is having pain from her shoulder to fingers tips in the right arm; This is a spontaneous report from a contactable nurse. A female patient (Age: 75; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,Lot number was EN6201,Expiration Date: 30Jun2021) dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 as DOSE 1,SINGLE for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine taken, ascorbic acid, retinol, tocopherol (OCUVITE [ASCORBIC ACID,RETINOL,TOCOPHEROL]), losartan, amlodipine besylate, furosemide (LASIX [FUROSEMIDE]), krill oil, vitamin D3 taken for an unspecified indication, start and stop date were not reported. On 10Feb2021, Caller stated she received the Pfizer covid vaccine and 10 days later she was having pain from her shoulder to fingers tips in the right arm, but her vaccination site is left arm. She said she takes Tylenol PM at night and takes 2 Bayer's aspirin in the morning. I woke at about 4:30 in the morning and it was such excruciating pain. Therapeutic measures were taken as she had been taken Tylenol and 2 Aspirins, she took Tylenol one time and the next time she was taking 2 aspirins. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head cold; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age (Age: 53; Unit: Unknown) received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on 04Feb2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced head cold on un unspecified date. Patient reported that, she would like to know whether she may receive her 2nd dose of the covid vaccine if she is currently experiencing symptoms of a head cold. Patient said, she received her 1st dose of the Pfizer covid vaccine 04Feb2021 and is due to get the 2nd dose 25Feb2021. She has had symptoms of a head cold which she does not associate to covid. She thought she got it from her boyfriend since he had a head cold 5 days prior to her receiving her vaccine and he did not receive the vaccine. She had energy, had been working and working out. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head cold; This is a spontaneous report from a contactable Consumer (patient herself).   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, on 04Feb2021, as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient called about the Pfizer BioNtech Covid Vaccine. She is a first responder in (city)a high-risk area. She got the first dose on 04Feb2021. She is due to get the second dose on Thursday 25FEB2021. Since that time, on 19Feb2021 she has developed a head cold, there is no indication or anything other than a head cold. She is due to get the second vaccine, before getting the vaccine, they ask questions via paperwork like do you have a runny nose etc. She stated that she does have a runny nose, she is trying to get to the right place for her question and asked if she still okay to get the second dose.  The patient declined safety report, stating that her symptoms did not have anything to do with the vaccine, it is the common cold. She is concerned because they make her fill out paperwork and she would select yes for runny nose question and asked is she not supposed to have a runny nose at the time of being vaccinated. Outcome of the event was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Retching
Clinical narrative: dizziness; little nausea, like vertigo; little nausea; Chills; Fatigue; dry heaves; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6201, expiration date: not reported) dose 2 via an unspecified route of administration on 20Feb2021 at 09:21 (at the age of 68 years) single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN5318, expiration date: not reported) dose 1 via an unspecified route of administration on 29Jan2021 single for covid-19 immunization. On 22Feb2021 she experienced 3 episodes of dizziness and one being severe. When it happened, she needed to sit down, or she was going to fall down. She asked if dizziness a symptom or an after effect. The dizziness did not occur until 48 hours later. She experienced chills and fatigue which she expected. The first day she was fine she got it around 9 in the morning and the rest of that day, Saturday she was perfect. In the middle of the night, she got some chills, not bad and she expected that then fatigue, Sunday afternoon she had to nap then she was fine but Monday she started experiencing dizziness and a little nausea, like vertigo. She was healthy, she has never experienced dizziness, this was to the point that she had sit or lay down or she would have fallen. She is a pusher, she is active prior to the COVID pandemic she was at the gym 5 days week, she is a runner she is healthy, she is not on any meds. She went with her husband to purchase plants in and on the way back she got dizzy. If she had been driving it would not have been a good circumstance. That was one concern that there was no precaution about driving, she says it seems like this was a rare instance from what she can find online, but she was nervous about it. She does not really know there was no predisposition of what happened before the episode. When she was in the car she does not know if that motion impediment but she was pretty energetic, she moves around fast and yesterday morning she was just changing the linens on the bed and she got extremely dizzy and had to lay on the bed, that passed and she decided to push through and go to get plants with her husband and on the way back in the car experienced it was like an earthquake the roads were curving badly it lasted about 5 seconds but then she got the dry heaves and then it passed. Clinical outcome of all the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: dizziness; little nausea, like vertigo; little nausea; Chills; Fatigue; dry heaves; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6201, expiration date: not reported) dose 2 via an unspecified route of administration on 20Feb2021 at 09:21 (at the age of 68 years) single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN5318, expiration date: not reported) dose 1 via an unspecified route of administration on 29Jan2021 single for covid-19 immunization. On 22Feb2021 she experienced 3 episodes of dizziness and one being severe. When it happened, she needed to sit down, or she was going to fall down. She asked if dizziness a symptom or an after effect. The dizziness did not occur until 48 hours later. She experienced chills and fatigue which she expected. The first day she was fine she got it around 9 in the morning and the rest of that day, Saturday she was perfect. In the middle of the night, she got some chills, not bad and she expected that then fatigue, Sunday afternoon she had to nap then she was fine but Monday she started experiencing dizziness and a little nausea, like vertigo. She was healthy, she has never experienced dizziness, this was to the point that she had sit or lay down or she would have fallen. She is a pusher, she is active prior to the COVID pandemic she was at the gym 5 days week, she is a runner she is healthy, she is not on any meds. She went with her husband to purchase plants in and on the way back she got dizzy. If she had been driving it would not have been a good circumstance. That was one concern that there was no precaution about driving, she says it seems like this was a rare instance from what she can find online, but she was nervous about it. She does not really know there was no predisposition of what happened before the episode. When she was in the car she does not know if that motion impediment but she was pretty energetic, she moves around fast and yesterday morning she was just changing the linens on the bed and she got extremely dizzy and had to lay on the bed, that passed and she decided to push through and go to get plants with her husband and on the way back in the car experienced it was like an earthquake the roads were curving badly it lasted about 5 seconds but then she got the dry heaves and then it passed. Clinical outcome of all the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Persistent right sided headache, radiating over right eye to behind the ear; This is a spontaneous report from a contactable pharmacist. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN5318 ) via an unspecified route of administration, administered in left arm on 26Jan2021 (at the age of 29-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient had no known allergies. Historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EL0140) via an unspecified route of administration, administered in Arm Left on 04Jan2021 as dose 1, single for COVID-19 immunization. Patient received vaccine at hospital. The patient had not received any other vaccine in four weeks. The patient did not received any other medications in two weeks. The patient did not had covid prior vaccination and did not tested COVID post vaccination. On 01Feb2021, patient experienced persistent right sided headache, radiating over right eye to behind the ear. The patient did not received treatment for adverse event. The outcome of event was not recovered.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.