chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: toothache; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) reported for himself.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient asked if it's okay to take Amoxicillin before the 2nd dose scheduled on 13APR2021. He went to the dentist today (12Apr2021) because of a toothache. He received the 1st dose of covid-19 vaccine last 23Mar2021. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) from Pfizer. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (lot number and expiration date: unknown) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 25Mar2021 and subsequently tested positive for COVID on an unknown date in 2021. The patient was seeking to reschedule the appointment for the second dose. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: her friend also had insomnia when she took the vaccine; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter shared that her friend also had insomnia when she took the vaccine. The outcome of the event was unknown. The report was not serious.   Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: diarrhea; fatigue; sore arm; This is a spontaneous report from a contactable consumer (patient wife). A 50 years old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 Immunization. The patient (husband) experienced diarrhea, fatigue, sore arm in Apr2021.  Outcome of event was unknown. It was reported reporter's son (16 years old) also received 2nd dose of the Pfizer covid vaccine on Sat 10Apr2021 and experienced fatigue, insomnia, chills, slight temp (99.7 F).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Insomnia, Pyrexia
Clinical narrative: slight temp; fatigue; insomnia; chills; This is a spontaneous report from a contactable female consumer reported for her son. A 16-years-old male patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 10Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced fatigue, insomnia, chills, slight temp (99.7 F) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little pain; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6204 and expiration date not provided), via an unspecified route of administration, on 13Mar2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported patient had not yet been administered second dose over 4 weeks later of the first dose of vaccine. Patient reported he didn't have any adverse effects from the first dose of vaccine other than a little pain the next day, on 14Mar2021, but that had gone away. The outcome of the event was recovered in 2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I have been so sick from the 1st dose; 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), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has been so sick from the 1st dose  on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: strong soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) in Mar2021 14:30 in left arm at single dose for COVID-19 immunization. Medical history included high cholesterol, high blood pressure. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the first dose, patient experienced strong soreness at injection site. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Headache; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 50-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) via an unspecified route of administration, administered in arm left on 23Mar2021  (at the age of 50-years-old) as a single dose for covid-19 immunisation. The patient medical history included mitral valve repaired in 2017 (reported as 4 years ago). The patient had no known allergies. The patient's concomitant medications were not reported. The patient had no other vaccines within four weeks. The patient experienced headache on 10Apr2021 15:00 (03:00PM). The event resulted in physician or other health professional office visit, disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Apr2021. The patient received treatment for the event as doxycycline and prednisone were provided. The outcome of the event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of headache due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (reporter's father and mother). This is first of two reports.  A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in Jan2021 (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 stated that his parents received the first dose of the Pfizer COVID vaccine in Jan2021 and then was diagnosed with COVID-19 and could not receive the second dose of the vaccine. He had been told conflicting things regarding if and when they should receive the second dose. He was originally told they had to wait 90 days to receive the second dose and then he was told they had to restart the series and not just receive the second dose. He would like to know what the correct guidance for his parents is. He would like to know if the first and second dose is the same composition and quantity. He stated the vaccination facility where his parents received the first dose of the vaccine ran out Pfizer COVID vaccines so he was wondering if he could go to another location that had Pfizer COVID vaccines. He would like to know if the vaccine will be still as effective if given greater than 90 days apart from the first dose. He was trying to get answers regarding the Covid-19 vaccine. His parents received the first dose of the vaccine in Jan2021. Between the first and second dose they had Covid and was unable to get the second dose. They were told they had to wait 90 days and start over. After 90 days was told only the second dose was needed. He tried to schedule the vaccine and was told they had to start over. He kept getting the back and forth.  Case was reported as non-serious. Outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021414637 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: anxiety; dizziness and lightheadedness; dizziness and lightheadedness; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer (patient). A 67-year-old female patient received first dose BNT162B2 of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an intramuscular route, on 26Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient previously took flu shot for immunization and was sick for 34 days afterwards. The patient experienced anxiety, dizziness and lightheadedness on an unknown date in 2021 after first dose. She was concerned about receiving the second dose because of the side effects. She also asked about the vaccine not being FDA approved and wants to know if it was safe for her to receive it. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Received 2 pfizer vaccines, exactly 21 days apart. As of yesterday I was diagnosed positive for covid with symptoms; Received 2 pfizer vaccines, exactly 21 days apart. As of yesterday I was diagnosed positive for covid with symptoms; This is a spontaneous report from a contactable other health professional. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via intramuscular, administered in Arm Left on 12Jan2021 at 18:00 (Batch/Lot Number: EL1284) as single dose, then dose 2 on 02Feb2021 (Batch/Lot Number: Unknown), as single dose for COVID-19 immunization. The patient had known allergies. The patient's concomitant medications were not reported. The patient experienced received 2 Pfizer vaccines, exactly 21 days apart. As of 11Apr2021 (reported as yesterday), the patient was diagnosed positive for covid with symptoms.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021 (Rapid covid test). The outcome of the events was recovering. The patient did not had COVID prior to vaccination and the patient was tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 virus test positive  cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Influenza like illness, Malaise, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: her doctor said it may have been during incubation period so she should take a test again.; her doctor said it may have been during incubation period so she should take a test again.; not feeling well; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that she was not feeling well and want to know if she needed to reschedule the 2nd dose (scheduled for 15Apr2021). The patient reported flu like symptoms.  The patient underwent lab test and procedures which included a PCR test done (rapid test) it was negative but her doctor said it may have been during incubation period so she should take a test again. The patient outcome of the events was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 101; This is a spontaneous report from Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received second dose of BNT162B2 (Pfizer Covid vaccine, Solution for injection) via unspecified route of administration on an unknown date at a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient got second one and had a fever of 101 on an unspecified date. Her husband and son get the vaccine and she wants to know if they would be able to take anything if they experience aches or fevers like Tylenol- Cold. The outcome of the event fever was unknown.  Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Lower back pain; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient).   A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced lower back pain. The case was assessed as serious as the patient reported "I'm supposed to get a shot for lower back pain". Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient tested positive for COVID after receiving the first dose; patient tested positive for COVID after receiving the first dose; This is a spontaneous report received from a contactable pharmacist (patient). A patient of unspecified age and gender received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient tested positive for COVID after receiving the first dose. The patient underwent COVID test and showed positive on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had a reaction from first shot, she ran a fever; This is a spontaneous report received from a contactable consumer (patient's father) via a Pfizer-sponsored program. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 13Apr2021 (at the age of 39-year-old) at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a reaction from first shot, she ran a fever in Apr2021. The caller stated that patient got the first dose of Pfizer COVID-19 vaccine on 13Apr2021 and wanted to confirm how long can she take second dose, because may be leaving town at 3-weeks. Caller then mentioned they were afraid on the second shot she would get more side effects. He also mentioned She is a single mom, had a reaction from first shot, she ran a fever. Also asked if there is an interaction between the Covid vaccine and a patient with seizure and taking seizure medication. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Bilateral lower back pain; Muscle Stiffness; Muscle. Stiffness ans pain for 5/6 days.; This is a spontaneous report from Pfizer colleague from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced Bilateral lower back pain, muscle stiffness ans pain for 5/6 days; all from 10Apr2021. Event took place after use of product. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. The female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body aches on an unspecified date. The patient  wanted to know if she can take tylenol or advil for it. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, headache, and fatigue. Event took place after use of product. The outcomes of events were unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Vaccination site pain
Clinical narrative: a metallic taste in his mouth; a little sore on injection arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on 23Mar2021 as single dose administered in arm for covid-19 immunization at the age of 59-year-old. The patient medical history and concomitant medications were not reported. The patient experienced a little sore on injection arm in Mar2021. The patient also reported a metallic taste in his mouth when he got the vaccine on 23Mar2021. The outcome of events is unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheaded; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 25Feb2021 (79-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing type 2 diabetes. Concomitant medications were not reported. With the first COVID-19 vaccine the patient was lightheaded (from 25Feb2021) for 2 days then she was great. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: she had a 103.5 temperature and her reaction was severe; This is a spontaneous report from a contactable consumer (patient's friend).   A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Apr2021 at age of 62 years old (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Reporter stated that My friend received the Pfizer/Biontech COVID-19 vaccine yesterday, 10Apr2021. Today(11Apr2021) she sent me a text message saying she had a 103.5 temperature and her reaction was severe. Outcome for event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site is hurting/aching; This is a spontaneous report from a contactable consumer (patient) via Pfizer- sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer Covid 19 Vaccine), dose 1 via an unspecified route of administration on 08Apr2021 (Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced injectionis hurting/aching, so put Arnicare Pain Relieving Gel. The event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: four or five days later the psoriasis had disappered; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that 62-year-old female patient received he her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunisation. Medical history included psoriasis and pre diabetic. The patient's concomitant medications were not reported. The patient had psoriasis didn't take any medication for it and was pre diabetic. She received her first vaccine on April 6th and four or five days later the psoriasis had disappeared in Apr2021. AE due to psoriasis clearing up after first vaccine. The outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pyrexia, Swelling face
Clinical narrative: Low fever 99; Swollen facial fillers; fatigue; flu-like; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 36-years, on 09Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low fever 99, swollen facial fillers, fatigue-flu-like on Apr2021. Events took place after use of product. Events outcome was unknown.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe pain in both of his upper arms; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er0734), via an unspecified route of administration, administered in arm left on 11Apr2021 11:30 AM (at the age of 68-years-old) as a single dose for covid-19 immunisation. The vaccine administered at the Pharmacy/drug store. The patient had known allergies with penicillin. Concomitant medications included benazepril; celecoxib; duloxetine; and hydrochlorothiazid; all were taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ep7534), administered in left arm on 22Mar2021 12:00 AM (at the age of 68-years-old) for covid-19 immunization. On 13Apr2021 20:00 (08:00 PM) about 32 hours after his second shot, he started getting severe pain in both of his upper arms. It started in the middle of both of his humeri and radiated up to his shoulders. It was severe pain that lasted for about 30 minutes and then started to reduce in severity. Within a couple of hours the pain was mostly gone in his right arm and some pain remained in the left arm which was where he got the shot. The event resulted in disability or permanent damage. The patient did not received any treatment for the event. The outcome of the event was recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event of pain in extremity, a possible contribution of the drug to the event cannot be excluded.  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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Headache, Insomnia, Limb discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient (unknown if was pregnant) received bnt162b2 (BNT162B2), dose 2 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. The patient experienced her limbs felt heavy on an unknown date, aching joints, severe headache, nausea, congestion, difficulty sleeping, was laying on her chest on 11Apr2021. Reported as: Reporter says that patient experience symptoms after 2nd dose of Comirnaty. Her limbs felt heavy, aching joints, severe headache, nausea and congestion. She had difficulty sleeping because it felt like something was laying on her chest. Her symptoms lasted for over 24 hours. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient (unknown if was pregnant) received bnt162b2 (BNT162B2), dose 2 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. The patient experienced her limbs felt heavy on an unknown date, aching joints, severe headache, nausea, congestion, difficulty sleeping, was laying on her chest on 11Apr2021. Reported as: Reporter says that patient experience symptoms after 2nd dose of Comirnaty. Her limbs felt heavy, aching joints, severe headache, nausea and congestion. She had difficulty sleeping because it felt like something was laying on her chest. Her symptoms lasted for over 24 hours. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Investigation, Myalgia
Clinical narrative: severe muscle pain, leg and neck; This is a spontaneous report from a contactable consumer (patient). A 67-year-old patient of an unspecified gender received the second dose of bnt162b2 (PFIZER/BIOTECH COVID-19 VACCINE), intramuscularly administered in Left upper arm at the age of 67 years old, on 01Mar2021 14:00 (Batch number: BUD 1540, Lot Number: EN6205) at single dose for Covid-19 immunisation. Vaccination Facility Type: Public Health Clinic. Medical history included heart attack from Jun2019, Quadruple bypass, liver failure from Jan2003 and ongoing, liver transplant in Jan2003. Concomitant medication included tacrolimus (PROGRAF) taken for liver transplant from Jan2003 and ongoing. There were no other vaccines with 4 weeks prior vaccination. The patient previously received the first dose of bnt162b2 (Batch number: BUD 1005, Lot number: EL9269) on 08Feb2021, 9:00 AM intramuscularly on Left upper arm at single dose for covid-19 immunisation. The patient experienced severe muscle pain leg and neck 10-12 days after the 2nd dose. The patient performed multiple tests from 2000 to 2003, with result: Liver failure, on transplant list for 2 years; Cardiogram on 23Jun2019 with result: blocked arteries, comments: Quadruple bypass. No treatment was received, the event didn't require the initiation of new medication /other treatment / procedure. The outcome of the event was unknown. Seriousness Criteria was Not serious.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; headache; extreme fatigue; This is a spontaneous case received from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via intramuscular, at left arm on 04Mar2021 at 09:30 (60-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via intramuscular, at left arm on 11Feb2021, at 09:30 (60-year-old at time of vaccination), at single dose, for COVID-19 immunization and experienced headache, bodyaches, chills, night sweats, fatigue, nausea, and fever. No other prior vaccinations. The patient experienced chills, headache, and extreme fatigue on 05Mar2021 at 01:00. The events were assessed as non-serious. The outcome of the event was recovered on 06Mar2021 at 07:00.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Pyrexia, Urine output decreased
Clinical narrative: frequent low volume urination; fatigue; chills; low fever (99.7); stomachache; This is a spontaneous report from a contactable consumer.   A 47-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  Medical history included Kidney transplant: Nov2019, Nephrectomy: 04Dec2020, laminectomy: 07Jan2021, craniotomy: 23Jan2021.   The patient's concomitant medications were not reported.  The patient experienced Potential COVID-19 vaccine reaction six days after first dose: frequent low volume urination, fatigue, chills, low fever (99.7), stomachache.  Outcome for events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller just got out of the hospital after having Covid along with her husband and they both got their 1st dose.; Caller just got out of the hospital after having Covid along with her husband and they both got their 1st dose.; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. This consumer reported same events for two patients (for herself and for her husband). This is the first of two reports.   A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient just got out of the hospital after having COVID along with her husband on an unspecified date and they both got their first dose of the vaccine. She wanted to know if they have to get their second dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412079 same reporter, drug, and event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: pharmacist gave an Expired dose of covax; This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. First time caller was a pharmacist gave an Expired dose of covax, they were following medera guidelines and administered to patient puntured vial 12 hrs since recontitution. This was a Pfizer covax. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller just got out of the hospital after having Covid along with her husband and they both got their 1st dose.; Caller just got out of the hospital after having Covid along with her husband and they both got their 1st dose.; This is a spontaneous report from a contactable consumer received from a Pfizer sponsored program . This consumer reported same events for two patients (for herself and for her husband). This is the second of two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient just got out of the hospital after having COVID along with her husband and on an unspecified date and they both got their first dose of the vaccine. She wanted to know if they have to get their second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412064 same reporter, drug, and event, different patient
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: small amount of blood in the bandage a little smaller than a dime/there's blood on his arm/with his second dose, there was blood at the injection site; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 40 years of age), dose 2 via an unspecified route of administration, administered in arm left on 14Apr2021 10:20 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Historical vaccine included BNT162B2 (at 40 years of age), dose 1 in the left arm on 23Mar2021 for COVID-19 immunisation, wherein he experienced sore arm after first vaccine. He had no other vaccines within four weeks before covid vaccine. It was reported that the patient got the second dose of the vaccine today (14Apr2021) and there was blood on his arm, the first time he got the shot for the first dose there was no bleeding. He added that with his first dose he had no blood at the injection site, he only had a sore arm the next day and that was it. He stated that today, with his second dose, there was blood at the injection site. He asked if this was something he had to concerned about. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: injecting the vaccine too high/ the side effect that she is experiencing may not be directly contributed to the vaccine itself but to incorrect vaccine administration technique.; shoulder pain and elbow pain; Experienced aching in the arm; This is a spontaneous report from a contactable Nurse (patient). This 63-year-old female nurse received the first dose of BNT162B2 (Lot number ER8734) intramuscular at single dose for COVID-19 immunisation on 07Apr2021. Relevant history included Hyperthyroidism and Pott's disease. Relevant concomitant drug included carvedilol, ivabradine hydrochloride (CORLANOR) and levothyroxine sodium (SYNTHROID). The patient and her husband had their first dose of Covid 19 vaccine on 07Apr2021, both of them had experienced aching in the arm for a week and one of the main reason why was calling now was because of a lady who helped them she said that she was not sure if that's a nurse or a doctor it's just a pharmacist that person did not know what she was doing because that person was like injecting the vaccine too high and it's like so much into the shoulder and told to that person if you are going to vaccinatedus too high it might cause shoulder injury she was asking if she was okay to take it in legs because it is also an intramuscular injection so it doesn't matter it's in arms or legs the person the pharmacist said to her is like this. The patient said that after the shot she experienced severe pain on her shoulder (back side of the humerus). Also, the caller said that she was afraid that this might affect Pfizer on another note as the side effect that she is experiencing may not be directly contributed to the vaccine itself but to incorrect vaccine administration technique. She also mentioned that the administrator of the vaccine have to massage her arm very furiously post vaccination. The patient also experienced aching in the arm and Elbow pain. She was still having some shoulder pain and elbow pain and she thought it had nothing to do with the vaccine she thought it had to do with poor administration too high up on the shoulder instead of down in the muscle. No treatment was received, she just been trying to rest her arm and hope it will go away. The patient was resolving (improved).    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423506 same reporter, same drug, similar event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Malaise, Neck pain
Clinical narrative: feverish; chills; neck pain; Bad headache; patient had not been feeling great; sick; This is a spontaneous report from a contactable consumer (patient's Mother). A 28-years-old male 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 SINGLE DOSE for covid-19 immunisation. Medical history included headache. The patient's concomitant medications were not reported. It was reported that patient took the first dose of the Pfizer Covid vaccine and developed feverish and chills, and neck pain are these symptoms, should he take the second dose our doctor told us his opinion, but reporter want to know about company. Caller reported that her youngest son, the patient, had the Pfizer Covid-19 vaccine last week. Caller reported that the patient had not been feeling great and that the patient had been sick with something a few weeks prior. Caller reported that she thought that the patient called his doctor and the patient's doctor informed him that he was ok to receive the Covid-19 vaccine. Caller reported that after the patient had the Covid-19 vaccine, he woke up the following morning with chills and a bad headache. Caller reported that the patient gets headaches but said that the headache he got after the Covid-19 vaccine was the worst. Caller reported that the patient's headache went away and then went into his neck. Caller reported that the patient became feverish. Caller reported that the patient would get up, go to work, and then come home. Caller reported that the patient experienced side effects for 2 days in a row after he received the Covid-19 vaccine. Caller reported that the patient played basketball after he got the Covid-19 vaccine, which he normally did not do, and that her son physically exerted himself. Caller reported she does not know if the patient had Covid-19 when the patient was sick a few weeks ago or what might have caused his illness. Caller reported that the patient received his first dose of the Covid-19 vaccine and now he was going to need the second dose. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feverish; chills; neck pain; Bad headache; patient had not been feeling great; sick; This is a spontaneous report from a contactable consumer (patient's Mother). A 28-years-old male 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 SINGLE DOSE for covid-19 immunisation. Medical history included headache. The patient's concomitant medications were not reported. It was reported that patient took the first dose of the Pfizer Covid vaccine and developed feverish and chills, and neck pain are these symptoms, should he take the second dose our doctor told us his opinion, but reporter want to know about company. Caller reported that her youngest son, the patient, had the Pfizer Covid-19 vaccine last week. Caller reported that the patient had not been feeling great and that the patient had been sick with something a few weeks prior. Caller reported that she thought that the patient called his doctor and the patient's doctor informed him that he was ok to receive the Covid-19 vaccine. Caller reported that after the patient had the Covid-19 vaccine, he woke up the following morning with chills and a bad headache. Caller reported that the patient gets headaches but said that the headache he got after the Covid-19 vaccine was the worst. Caller reported that the patient's headache went away and then went into his neck. Caller reported that the patient became feverish. Caller reported that the patient would get up, go to work, and then come home. Caller reported that the patient experienced side effects for 2 days in a row after he received the Covid-19 vaccine. Caller reported that the patient played basketball after he got the Covid-19 vaccine, which he normally did not do, and that her son physically exerted himself. Caller reported she does not know if the patient had Covid-19 when the patient was sick a few weeks ago or what might have caused his illness. Caller reported that the patient received his first dose of the Covid-19 vaccine and now he was going to need the second dose. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Very strong fatigue; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (Pfizer/ BioNTech COVID-19 vaccine, lot number: EM9810), intramuscularly in deltoid right on 10Feb2021 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer from 1989 and ongoing, gastrooesophageal reflux disease (GERD) from 2010 and ongoing, osteoporosis from 1989 and ongoing, macular degeneration (MAC. degeneration), and allergies. Concomitant medications included anastrozole (ARIMIDEX) for breast cancer from 1998 and ongoing, famotidine for GERD from 2018 and ongoing, calcium carbonate/colecalciferol (VITAMIN D 2000) for osteoporosis from 2010 and ongoing, ascorbic acid/tocopheryl acetate/xantofyl/zeaxanthin/zinc (AREDS) for MAC. degeneration from 2015 and ongoing, and cetirizine hydrochloride (ZYRTEC ALLERGY) for allergies. Patient received the first dose of BNT162B2 (lot number: EL3247), intramuscularly in right deltoid on 20Jan2021 17:00 for COVID-19 immunisation and experienced severe headache, and fatigue. When patient received the first dose, some of the vaccine was flowing down her arm and she worried that she did not receive the whole dose and would like to check if she had antibodies. The patient experienced very strong fatigue on 11Feb2021. Treatment was not received for this event. Outcome of the event was resolved on 18Feb2021.  No follow-up attempts are needed. No further information is expected.