chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: I received a rash; I have mouth sores; I have swelling in my legs; I was tired; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (non-pregnant) received BNT162B2, first dose via an unspecified route of administration at left arm on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at age of 46-year-old (non-pregnant). The patient medical history included covid prior vaccination. Concomitant drugs were not reported. The patient had Rash, Mouth sores, swelling in her legs, was tired and headache on 10Apr2021. The events resulted to visit doctors or other Healthcare professional office/ Clinic visit, Emergency room, department or Urgent care and hospitalization for 2 days. The patient received creams as treatment for rash. The patient had Covid test on 27May2021 and Covid test result was negative. Outcome of the events was not recovered. The patient received second dose of bnt162b2 on 26Apr2021 at left arm later.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Cellulitis
Clinical narrative: Cellulitis aggravated; Back pain; This is a solicited report from an unspecified marketing program received from a contactable consumer. A 67-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for psoriatic arthritis and moderate to severe chronic plaque psoriasis. Medical history included cellulitis from an unknown date. The patient's concomitant medications were not reported.  The patient experienced cellulitis aggravated and back pain. The action taken in response to the events for bnt162b2 adalimumab was unknown. The event back pain was not recovered and unknown outcome for the event Cellulitis aggravated. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Follow-up attempts are possible; information about lot/batch number not available.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes 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 Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hypothermia
Clinical narrative: her body temperature (90F to 95F); This is a spontaneous report from a contactable consumer received via Pfizer- sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose of COMIRNATY on 01Apr2021 (Batch/lot: unknown) for Covid-19 immunisation. The patient experienced her body temperature was (90F to 95F) because the vaccine regulates her temperature. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Severe shoulder joint pain and loss of articulation of the left arm.; Severe shoulder joint pain and loss of articulation of the left arm.; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm Left on 18Mar2021 09:45 (Batch/Lot Number: en6204) as 1ST DOSE, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported. On 25Mar2021, the patient had severe shoulder joint pain and loss of articulation of the left arm. Events were considered as serious (disability or permanent damage). Prior to vaccination, the patient was no diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. The patient was recovering from the events.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, SARS-CoV-2 test, Tinnitus
Clinical narrative: Hearing loss in my left ear along with tinnitus; Hearing loss in my left ear along with tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:00 (Batch/Lot Number: EW0158) as 1st dose, single; dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 16:00 (Batch/Lot Number: EW0176) as 2nd dose, single for COVID-19 immunization. Medical history included SARS-CoV-2 pneumonia. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not have other vaccines in the last four weeks nor other medications in two weeks. The event the patient had and was still experiencing was hearing loss in his left ear along with tinnitus on 17Apr2021 (also reported as beginning after the 2nd shot) which resulted in doctor or other healthcare professional office/clinic visit. The patient received antibiotics (amoxicillin) as treatment. He was not tested for COVID post vaccination. The outcome of the event was not recovered. The case was reported as non-serious.  Follow-up attempts are needed. Further information is requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Illness, Malaise, Migraine, Night sweats
Clinical narrative: night sweats; Sick; got an infected salivary gland. Also experienced night sweats without fever and fever from time to time; got an infected salivary gland. Also experienced night sweats without fever and fever from time to time; malaise; body aches; migraine; bladder infection right after infection.; This is a spontaneous report from a contactable consumer (patient).  A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Apr2021 08:00 (Batch/Lot number was not reported), age at vaccination of 35-years-old, as single dose, for covid-19 immunisation.  Medical history was none; the patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Left arm on 14Mar2021 08:00 , age at vaccination of 34-years-old, for covid-19 immunisation. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   On 21Apr2021 (07:00) the patient experienced malaise, body aches, migraine, bladder infection right after infection fever from time to time, sick with bladder infection for a month even with antibiotics. After bladder infection went away, the patient got an infected salivary gland. The patient also experienced night sweats without fever on an unspecified date. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient was treated with bactrim, prednisone (poison ivy) and cipro. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event bladder infection on an unspecified date while was recovering from the other events.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sialoadenitis
Clinical narrative: night sweats; Sick; got an infected salivary gland. Also experienced night sweats without fever and fever from time to time; got an infected salivary gland. Also experienced night sweats without fever and fever from time to time; malaise; body aches; migraine; bladder infection right after infection.; This is a spontaneous report from a contactable consumer (patient).  A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Apr2021 08:00 (Batch/Lot number was not reported), age at vaccination of 35-years-old, as single dose, for covid-19 immunisation.  Medical history was none; the patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Left arm on 14Mar2021 08:00 , age at vaccination of 34-years-old, for covid-19 immunisation. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   On 21Apr2021 (07:00) the patient experienced malaise, body aches, migraine, bladder infection right after infection fever from time to time, sick with bladder infection for a month even with antibiotics. After bladder infection went away, the patient got an infected salivary gland. The patient also experienced night sweats without fever on an unspecified date. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient was treated with bactrim, prednisone (poison ivy) and cipro. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event bladder infection on an unspecified date while was recovering from the other events.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait inability, Intervertebral disc protrusion, Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: Intractable back pain; Couldnt walk; Stiffness; Herniated disk l4/l5; this vaccine caused swelling; This is a spontaneous report from a contactable consumer (patient)    A 47-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (at the age of 47) on 21May2021 17:00 (Batch/Lot Number: EW0176) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity to PNC, allopurinol (ELEVIL), cymbalta. No other vaccine was received in four weeks. Concomitant medications were received but not specified. The patient experienced intractable back pain on 21May2021 19:00, couldnt walk on 21May2021 19:00, stiffness on 25May2021, herniated disk l4/l5 on 21May2021 19:00, this vaccine caused swelling on 21May2021 19:00. The patient was hospitalized for 3 days for intractable back pain and couldnt walk. Patient received unspecified treatment. No Covid prior vaccination, or Covid tested post vaccination. The patient underwent lab tests and procedures which included magnetic resonance imaging: no underlying issues, herniated disk l4/l5 also a fracture of her hip.  The events outcome was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Intractable back pain; Couldnt walk; Stiffness; Herniated disk l4/l5; this vaccine caused swelling; This is a spontaneous report from a contactable consumer (patient)    A 47-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (at the age of 47) on 21May2021 17:00 (Batch/Lot Number: EW0176) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity to PNC, allopurinol (ELEVIL), cymbalta. No other vaccine was received in four weeks. Concomitant medications were received but not specified. The patient experienced intractable back pain on 21May2021 19:00, couldnt walk on 21May2021 19:00, stiffness on 25May2021, herniated disk l4/l5 on 21May2021 19:00, this vaccine caused swelling on 21May2021 19:00. The patient was hospitalized for 3 days for intractable back pain and couldnt walk. Patient received unspecified treatment. No Covid prior vaccination, or Covid tested post vaccination. The patient underwent lab tests and procedures which included magnetic resonance imaging: no underlying issues, herniated disk l4/l5 also a fracture of her hip.  The events outcome was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: thyroid pain; low grade fever; joint pain; headache; acute thyroid inflammation; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201) via an unspecified route of administration in arm (unclear whether left or right) on 30Jan2021 03:30 PM at single dose for COVID-19 immunisation. It was unclear whether the patient received the first or second dose. Relevant medical history included allergy to penicillin and sulfur drugs, breast cancer in 2018, surgery, chemo and radiation. The patient had no COVID prior to vaccination. The patient did not receive any other vaccine in four weeks. Concomitant medications included anastrozole (ARIMIDEX) and multimineral supplement. The patient developed acute thyroid inflammation 10 days after her second shot with thyroid pain (thought it was a sore throat), low grade fever, joint pain and headache. It lasted for 3 weeks, diagnosis was made two weeks after onset of symptoms. Onset date for acute thyroid inflammation was Feb2021, while onset for the other events was 23Feb2021. No treatment was received. Acute thyroid inflammation was serious due to disability, while other events were non-serious. The patient was tested for COVID post vaccination: nasal swab was negative on 05Mar2021. The events resolved with sequelae (lasting effects).  Information on Lot/Batch number was available. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid pain, Thyroiditis acute
Clinical narrative: thyroid pain; low grade fever; joint pain; headache; acute thyroid inflammation; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201) via an unspecified route of administration in arm (unclear whether left or right) on 30Jan2021 03:30 PM at single dose for COVID-19 immunisation. It was unclear whether the patient received the first or second dose. Relevant medical history included allergy to penicillin and sulfur drugs, breast cancer in 2018, surgery, chemo and radiation. The patient had no COVID prior to vaccination. The patient did not receive any other vaccine in four weeks. Concomitant medications included anastrozole (ARIMIDEX) and multimineral supplement. The patient developed acute thyroid inflammation 10 days after her second shot with thyroid pain (thought it was a sore throat), low grade fever, joint pain and headache. It lasted for 3 weeks, diagnosis was made two weeks after onset of symptoms. Onset date for acute thyroid inflammation was Feb2021, while onset for the other events was 23Feb2021. No treatment was received. Acute thyroid inflammation was serious due to disability, while other events were non-serious. The patient was tested for COVID post vaccination: nasal swab was negative on 05Mar2021. The events resolved with sequelae (lasting effects).  Information on Lot/Batch number was available. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Got anaphylaxis 24 hours later; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0164) via an unspecified route of administration administered in left arm on 20Apr2021 at 14:15 (at 34 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included mast cell activation disorder from unspecified date. "Known allergies: with mast cell disorders possible everything and nothing" (as reported). The patient's concomitant medications were not reported. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient got anaphylaxis about 24 hours later, which was considered serious medically significant on 21Apr2021 at 03:00 requiring emergency room visit. The patient reported he had mast cell activation disorder and got anaphylaxis about 24 hours later. The patient suspected to have more than one tryptase alpha/beta 1 (TPSAB1) gene need genetic testing to confirm thus more hemagglutinin receptors that the spike protein attached to. Outcome of the event was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Loss of consciousness, Pain, Pyrexia
Clinical narrative: Passing out; Feeling very faint; high fever (103 degrees Fahrenheit); Body aches; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27May2021 16:00 (at the age of 17years) (Batch/Lot number was not reported) as unknown, single for Covid-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder) and known allergies to Sulfate. Concomitant medication included tilactase (LACTAID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021 12:00, the patient experienced very high fever (103 degrees Fahrenheit) for at least more than 2 days, body aches, feeling very faint, passing out whenever she stands up for more than a couple of minutes. There was no treatment received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension
Clinical narrative: Blood pressure dropped to 75/45; This is a spontaneous report from a contactable consumer (Patient, reported for self).  A 63-Years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number: Ew0187; Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 25May2021 at 15:45 (at 63-Years-old) as single dose for COVID-19 immunization. Patient medical history included lupus (Name of Drug as Reported :No) from an unspecified date and unspecified if ongoing. Patient was diagnosed positive with COVID prior to vaccination on an unspecified date. Patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Reaction/event as reported by primary source: On 28May2021 at 12:00, Blood pressure dropped to 75/45 on the 3rd after shot. stayed that low most of the 3rd day. Came back up on the 4th day. The patient was not tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included Blood pressure measurement of 75/45 (units not reported) on 28May2021. No Hospitalization Prolonged. The outcome of event was recovered on 29May2021.   Information on Lot/Batch number was available. Additional information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Legally blind/I could no longer see the lights in my house; This is a spontaneous report from a contactable consumer (Patient).  A 59-years-old patient of an unspecified gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on an unspecified date as 2nd DOSE, SINGLE for covid-19 immunization Medical history included hypertension. The patient's concomitant medications included Hypertension medications . Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Consumer and secondary reporter(a friend of patient) both on the call. Consumer reported that since last 4 days after second Pfizer shot after the fourth day, patient was already legally blind. Patient could no longer see the lights in house. The outcome of event was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Blood glucose, Blood test, Computerised tomogram, Fall
Clinical narrative: She has fainted and pass out; She has fainted and pass out; She fell down and hit her head and all of her left eye; She fell down and hit her head and all of her left eye; she was like in pain; she needs help with her balance, walking; This is a spontaneous report from a contactable consumer (patient's grandfather). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 17 years of age), dose 1 via an unspecified route of administration, administered in arm right on 27May2021 17:15 (Batch/Lot Number: EW0187) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history was none. Family history included her grandmother had diabetes. The patient's concomitant medications were not reported. It was unknown if the patient was pregnant. The patient did not have any prior vaccines. It was reported that the patient received Pfizer vaccine. She was under 18, she was 17 and she had a very bad side effect from it. She got her first dose yesterday (27May2021) and she had a bad reaction and was rushed to the emergency room. She fainted and passed out and she was like in pain and she was out like about four minutes. Just all of a sudden and then after she got out of it and then they needed to rush into the emergency room. She fell down and hit her head and all of her left eye. They took her to the emergency room. They did every test, they checked everything, and they said it was a bad side effect from the vaccine. She got her vaccine around, it was like about 5:15 pm in the afternoon and the incident happened like about 7:20, 7:30. She was trying to recover, she needed help with her balance, walking. She was trying to rest. The doctor in emergency room said that she had to rest, if side effects continue or happen again then she had to go back to the emergency room. Not really. They did some lab tests yesterday (27May2021) in the hospital. They don't know what they did. There was complete blood, there was CBC done. They did CT scan of her head, X-rays for her arm. They have here PMP, the reporter was not sure as they have different kind of blood test. They have calcium level 1, glucose level, there are so many different test names such as WBC and RBC. When asked about treatment it was reported that 'No, they did not prescribe her any medicine'. They told her for any pain, from the fall she found hit her head she could take Tylenol regular'. The events occurred on 27May2021. The outcome of 'fainted and pass out' was recovered on 27May2021 (she was out like about four minutes); 'she needs help with her balance, walking' was not recovered; while outcome of other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Gait disturbance, Head injury, Loss of consciousness, Pain
Clinical narrative: She has fainted and pass out; She has fainted and pass out; She fell down and hit her head and all of her left eye; She fell down and hit her head and all of her left eye; she was like in pain; she needs help with her balance, walking; This is a spontaneous report from a contactable consumer (patient's grandfather). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 17 years of age), dose 1 via an unspecified route of administration, administered in arm right on 27May2021 17:15 (Batch/Lot Number: EW0187) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history was none. Family history included her grandmother had diabetes. The patient's concomitant medications were not reported. It was unknown if the patient was pregnant. The patient did not have any prior vaccines. It was reported that the patient received Pfizer vaccine. She was under 18, she was 17 and she had a very bad side effect from it. She got her first dose yesterday (27May2021) and she had a bad reaction and was rushed to the emergency room. She fainted and passed out and she was like in pain and she was out like about four minutes. Just all of a sudden and then after she got out of it and then they needed to rush into the emergency room. She fell down and hit her head and all of her left eye. They took her to the emergency room. They did every test, they checked everything, and they said it was a bad side effect from the vaccine. She got her vaccine around, it was like about 5:15 pm in the afternoon and the incident happened like about 7:20, 7:30. She was trying to recover, she needed help with her balance, walking. She was trying to rest. The doctor in emergency room said that she had to rest, if side effects continue or happen again then she had to go back to the emergency room. Not really. They did some lab tests yesterday (27May2021) in the hospital. They don't know what they did. There was complete blood, there was CBC done. They did CT scan of her head, X-rays for her arm. They have here PMP, the reporter was not sure as they have different kind of blood test. They have calcium level 1, glucose level, there are so many different test names such as WBC and RBC. When asked about treatment it was reported that 'No, they did not prescribe her any medicine'. They told her for any pain, from the fall she found hit her head she could take Tylenol regular'. The events occurred on 27May2021. The outcome of 'fainted and pass out' was recovered on 27May2021 (she was out like about four minutes); 'she needs help with her balance, walking' was not recovered; while outcome of other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count, Syncope, White blood cell count, X-ray
Clinical narrative: She has fainted and pass out; She has fainted and pass out; She fell down and hit her head and all of her left eye; She fell down and hit her head and all of her left eye; she was like in pain; she needs help with her balance, walking; This is a spontaneous report from a contactable consumer (patient's grandfather). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 17 years of age), dose 1 via an unspecified route of administration, administered in arm right on 27May2021 17:15 (Batch/Lot Number: EW0187) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history was none. Family history included her grandmother had diabetes. The patient's concomitant medications were not reported. It was unknown if the patient was pregnant. The patient did not have any prior vaccines. It was reported that the patient received Pfizer vaccine. She was under 18, she was 17 and she had a very bad side effect from it. She got her first dose yesterday (27May2021) and she had a bad reaction and was rushed to the emergency room. She fainted and passed out and she was like in pain and she was out like about four minutes. Just all of a sudden and then after she got out of it and then they needed to rush into the emergency room. She fell down and hit her head and all of her left eye. They took her to the emergency room. They did every test, they checked everything, and they said it was a bad side effect from the vaccine. She got her vaccine around, it was like about 5:15 pm in the afternoon and the incident happened like about 7:20, 7:30. She was trying to recover, she needed help with her balance, walking. She was trying to rest. The doctor in emergency room said that she had to rest, if side effects continue or happen again then she had to go back to the emergency room. Not really. They did some lab tests yesterday (27May2021) in the hospital. They don't know what they did. There was complete blood, there was CBC done. They did CT scan of her head, X-rays for her arm. They have here PMP, the reporter was not sure as they have different kind of blood test. They have calcium level 1, glucose level, there are so many different test names such as WBC and RBC. When asked about treatment it was reported that 'No, they did not prescribe her any medicine'. They told her for any pain, from the fall she found hit her head she could take Tylenol regular'. The events occurred on 27May2021. The outcome of 'fainted and pass out' was recovered on 27May2021 (she was out like about four minutes); 'she needs help with her balance, walking' was not recovered; while outcome of other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Suicide attempt, Tinnitus
Clinical narrative: Ringing in ears; committed suicide; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient committed suicide because of the ringing in his ears. 6 months after the patient got the vaccine, he committed suicide because the ringing in his ears drove him crazy. The patient received the Pfizer covid vaccine. The outcome of the events was unknown.   Information about batch/ lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Illness, Parkinson's disease
Clinical narrative: worsening neurological features of Parkinson's; very sick for several days; This is a spontaneous report from a non-contactable consumer (patient). This report was received via a sales representative. A female patient of an unspecified age (Patient is a female late 70s-80s). received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included parkinson's disease and patient also has Parkinson's related dementia, including some memory loss, dementia. Diagnosed with Parkinson's. The patient's concomitant medications were not reported. Patient said they were very sick for several days after receiving the second dose of the vaccine. Patient also said they are currently experiencing worsening neurological features of Parkinson's since receiving the second dose. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Dyspnoea
Clinical narrative: heart pain within a day of the shot and continuing now to 1 week after; Tightness of chest; Shortness of breath, especially with mild/normal activity; This is a spontaneous report from a non-contactable consumer or other non hcp. A 39-year-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration, administered on Arm Left on 22May2021 14:15 at SINGLE dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included None, except maybe PMDD. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included fluoxetine 5 mg daily (FLUOXETINE). On 23May2021 the patient experienced heart pain within a day of the shot and continuing now to 1 week after, tightness of chest, shortness of breath, especially with mild/normal activity. Patient did not receive any treatment. Since the vaccination and post vaccination, patient has not been tested for COVID-19. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Condition aggravated, Gait disturbance
Clinical narrative: I had torn meniscus surgery on my left knee.  The vaccine caused an extreme flare and extreme pain in the joints; I had torn meniscus surgery on my left knee.  The vaccine caused an extreme flare and extreme pain in the joints; The second dose caused a flare and my knee is now very weak; I am limping and will seek a Dr.The joint pain and flares were not there prior to this vaccine.; This is a spontaneous report from a contactable consumer who reported for herself. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0165), dose 1 via an unspecified route of administration on 10Apr2021 as 1st dose, single dose, dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot Number: EW0162) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. She stated that she had torn meniscus surgery on her left knee. The vaccine caused an extreme flare and extreme pain in the joints. The second dose caused a flare and her knee was now very weak and she was limping and will seek a Doctor. The joint pain and flares were not there prior to this vaccine. The outcome of the events was reported as not recovered.  Follow-up attempts are needed. further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cataract, Ophthalmological examination
Clinical narrative: Bilateral cataracts; This is a Non-Interventional study (solicited report) based on the information received by Pfizer . (MFR Control No. # 21K-163-3911539-00). A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2) intramuscular on 26Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, and second dose intramuscular on 27Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization and adalimumab (HUMIRA), subcutaneous from Sep2014 (Batch/Lot number was not reported) and ongoing,  (40 mg,1 in 2 wk) for rheumatoid arthritis. Medical history included non-smoker, abstains from alcohol, chronic obstructive pulmonary disease, arthritis, diuretics, high cholesterol, high blood pressure and neuropathy from an unknown date and unknown if ongoing. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease, methotrexate (METHOTREXATE) taken for arthritis, prednisone (PREDNISONE) taken for arthritis, furosemide (FUROSEMIDE) taken for polyuria, lovastatin (LOVASTATIN) taken for blood cholesterol increased, isosorbide (ISOSORBIDE) taken for hypertension, clopidogrel (CLOPIDOGREL) taken for hypertension, metoprolol (METOPROLOL) taken for hypertension, potassium (POTASSIUM) taken for an unspecified indication, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension, folic acid (FOLIC ACID) taken for arthritis, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for hypertension, gabapentin (GABAPENTIN) taken for neuropathy peripheral and ipratropium bromide, salbutamol sulfate (COMBIVENT) taken for chronic obstructive pulmonary disease. The patient experienced bilateral cataracts on 30Mar2021. It was reported that on 27Apr2021, the patient underwent out patient cataract surgery on left eye  and on 11May2021 on right eye, due to blurry vision. The symptom blurry vision  was improved. The patient underwent lab tests and procedures which included ophthalmological examination: cataract on Mar2021 (Confirmed patient has cataract that causes blurry vision in left and right side of the eye).  The action taken for adalimumab was unknown.  Therapeutic measures were taken as a result of bilateral cataracts. Outcome of the event was recovering. Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of CATARACT ON LEFT AND RIGHT SIDE OF EYE with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The reported cataract is likely an intercurrent medical condition and unrelated to BNT162B2. Case will be reassess once additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have to wait nine months for my second dose . (referring to vaccine). Later on, she stated: " I caught it twice; I have to wait nine months for my second dose . (referring to vaccine). Later on, she stated: " I caught it twice; This is a spontaneous report from a contactable consumer.   A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose, for COVID-19 immunisation.  The patient medical history included "I caught it back in October of last year (COVID-19; Oct2020)". Concomitant medications were not reported.  The patient stated, "I have to wait nine months for my second dose (referring to vaccine). Later on, she stated: I caught it twice (covid-19)". The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fall, Headache, Rib fracture
Clinical narrative: Rib fracture; Headache; Fall; This is a solicited report based on the information received by Pfizer from AbbVie (Mfr. Control Number: 21K-163-3907099-00). A contactable consumer (patient) reported that a 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 and dose 2 both intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date (Batch/Lot number was not reported, Citrate Free) to an unspecified date for colitis ulcerative and Crohn's disease. No known allergies. No relevant medical history. The patient concomitant medications were not reported. The patient experienced rib fracture, headache, fall on an unspecified date. The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date. The outcome of events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the available information, no evidence of a drug to event temporal association was provided. The Company considered there was not a reasonable possibility that the reported events rib fracture, headache   and fall were  related to the suspect  vaccine BNT162B2 (PFIZER-BIONTECH COVID-19).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have COVID-19, I got it even after I got the vaccine; I have COVID-19, I got it even after I got the vaccine; This is a spontaneous report from a contactable nurse and consumer (patient). A 54-year-old female patient (unknown if pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis. Concomitant medications included tofacitinib citrate (XELJANZ XR) taken for rheumatoid arthritis from 01Feb2021 to Feb2021, adalimumab (HUMIRA), celecoxib (CELEBREX), calcium carbonate, colecalciferol (VITAMIN D 400), magnesium oxide, pyridoxine hydrochloride (MAGNESIUM + B6), methotrexate, ospemifene (OSPHENA), estrogens conjugated (PREMARIN), prednisone, and sulfasalazine (SULFASALAZINE (ENTERIC COATED)); all taken for unspecified indications, start and stop dates were not reported. The patient reported "My Dr took me off the Xeljanz for 2 weeks I have COVID-19, I got it even after I got the vaccine." MD aware. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. The outcome of the event was unknown. The event was considered as serious (medically significant).  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events COVID-19 and Drug Ineffective and the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up in finger; BODYACHES; Headache; tiredness; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer. A contactable consumer (patient) reported that a 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; upadacitinib (RINVOQ) oral from an unspecified date at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 via intramuscular on an unspecified date for COVID-19 immunisation. The patient had flare in finger after BNT162B2 lasted three days and caused her headache, tiredness, body aches on an unspecified date. The action taken in response to the events for upadacitinib was unknown. The outcome of events was recovered.    The reporter's causality for the events of body aches, headache and rheumatoid arthritis flare up in finger with upadacitinib was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the current limited available information and the drug-event plausible association, a possible contributory role of the suspect product BNT162B2 to the development of events of rheumatoid arthritis flare up, body aches, headache and pain cannot be totally excluded/assessed.  Moreover, case assessment for causal association is confounded due to presence of co-suspect product upadacitinib (RINVOQ). The case will be reassessed if additional information becomes 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 Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested positive for COVID19; tested positive for COVID19; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for mother. An 84-years-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient past medical history and concomitant medication was not reported. On an unspecified date It was reported that after the administered of first dose the patient tested positive for COVID-19 and her 2nd dose was scheduled on 24Feb2021. Eventually 2nd dose was not successfully given due to the positive result to COVID19 test conducted. Her physician advised her to get a monoclonal antibody and had to wait 90 days to get her 2nd dose. Reporter has been getting conflicting information from their physicians regarding the number of doses to be administered following a monoclonal AB administration. The patient underwent lab tests and procedures which included covid-19: positive in Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested. further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chronic lymphocytic leukaemia
Clinical narrative: Chronic Lymphocytic Leukemia; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included obinutuzumab (GAZYVA) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced chronic lymphocytic leukemia. The patient underwent lab tests and procedures which included antibody test: no antibodies on an unspecified date. The outcome of the event was unknown.   Information about the lot/batch number has been requested.