chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of taste; Loss of smell; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any other medications within two weeks prior to the vaccination. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 13:30, the patient experienced loss of taste and loss of smell 49.5 hours after taking the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events loss of taste and loss of smell was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Mobility decreased, Nausea
Clinical narrative: diarrhea; nausea; Arm would only move 30 degrees up; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had a history of allergy to peanuts. Concomitant medication included birth control (MANUFACTURER UNKNOWN) taken within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, on day of shot the patient was able to move arm only 30 degrees up. On 03Apr2021 i.e., on Saturday night, the patient experienced diarrhea and nausea and again on Monday all day. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutics measures were not taken as a result of the events. The clinical outcome of the events diarrhea, nausea and arm would only move 30 degrees up were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: severe stomach pain; spasms in stomach; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Apr2021 at 12:45 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included mTBI - post concussion syndrome. Concomitant medications included paracetamol (TYLENOL) for unspecified indication from one day before and day of (as reported). The patient previously took cefalexin (CEPHALEXIN) for unspecified indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, approximately 24 hours after the vaccine, the patient experienced very severe stomach pain and spasms in stomach and took 4 baths, switched positions constantly as it was hurting so bad. This lasted about 9 or 10 hours. The pain was very severe in the middle of stomach and was hurting to touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe stomach pain and spasms in stomach were recovered on 04Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384951 same reporter/event/drug, different patient
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Paraesthesia
Clinical narrative: Prolonged, pronounced joint pain.; On and off Pins and needles,; tingling in fingers arms legs and feet.; Sharp pains in legs and arms; Sharp pains in legs and arms; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732) via an unspecified route of administration in the arm left on 25Mar2021 at 15:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 16:00, the patient experienced prolonged, pronounced joint pain, on and off pins and needles, tingling in fingers, arms, legs and feet and the patient also experienced sharp pains in legs and arms on the same day. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events prolonged, pronounced joint pain, on and off Pins and needles, tingling in fingers arms legs and feet and sharp pains in legs and arms were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Photosensitivity reaction, Pyrexia
Clinical narrative: Fever; Chills; Muscle aches; Strong headache; Photosensitivity; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep7533) via an unspecified route of administration on an unknown date in 2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient experienced fever, chills, muscle aches, strong headache for duration of 24 hours and photosensitivity for the duration of 6 hours. The patient did not receive any treatment for the events. The clinical outcome of the events fever, chills and muscle aches were recovered on an unknown date in 2021 while the events strong headache and photosensitivity were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: pain in both feet; burning sensation in both feet; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8730) via an unspecified route of administration in the arm left on 02Apr2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications included hydrocortisone injection (CORTIZONE) in both feet for an unknown indication on 26Mar2021 and meloxicam (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6202) via an unspecified route of administration in the arm left on 12Mar2021 at 15:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 13:00 the patient experienced burning sensation and pain in both feet after having the COVID shot. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for the events. The patient was asking could this be reacting with the cortisone injection received on 26Mar2021. The clinical outcome of the events pain and burning sensation in both feet was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal
Clinical narrative: Chills; fatigue; decay; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 07Apr2021 20:00 (at the age of 38 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has no known allergies to medications, food, or other products. No other vaccine was administered in four weeks and no other medication within two weeks prior to vaccination. On 07Apr2021 21:00, the patient experienced chills, fatigue, decay. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.  Follow-up (07Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Chills, Pyrexia
Clinical narrative: Fever of 100.4; Chills; Aching joints; Stomach upset; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin and sulfa drugs from an unknown date. Concomitant medications included paracetamol (TYLENOL) taken for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, the patient experienced fever of 100.4, chills, aching joints and stomach upset. The patient's body temperature was found to be 100.4 (unit unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever, chills, aching joints and stomach upset was not recovered at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Cough, Dyspnoea, Influenza
Clinical narrative: asthma; fever; chills; flu; coughing; body aches; could not breathe; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced asthma, fever, chills, coughing, body aches, could not breathe. She and her daughter got the first Pfizer covid vaccine on 09Apr. Nothing happened to her but her daughter, who is special needs and has asthma, has a fever, chills and it feels like she has the flu. She is coughing, has body aches and her lungs closed up and she could not breathe. Her doctors gave her prednisone, albuterol and budesonide as well as promethazine with codeine for her cough. She has a fever up and down. It's been going on for 72 hour now.Therapeutic measures were taken as a result of coughing. The outcome of all the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: asthma; fever; chills; flu; coughing; body aches; could not breathe; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced asthma, fever, chills, coughing, body aches, could not breathe. She and her daughter got the first Pfizer covid vaccine on 09Apr. Nothing happened to her but her daughter, who is special needs and has asthma, has a fever, chills and it feels like she has the flu. She is coughing, has body aches and her lungs closed up and she could not breathe. Her doctors gave her prednisone, albuterol and budesonide as well as promethazine with codeine for her cough. She has a fever up and down. It's been going on for 72 hour now.Therapeutic measures were taken as a result of coughing. The outcome of all the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes zoster, Pain
Clinical narrative: Developed shingles between the 1st and 2nd dose; Acute pain in my left upper back; Grew in intensity.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration, right arm on 17Mar2021 at 10:00 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included breast cancer from an unknown date and unknown if ongoing and arthritis diagnosed about 10 years ago from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. The concomitant medications of the patient were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 02Apr2021, the patient experienced acute pain in my left upper back, and it grew in intensity. On an unspecified date, she developed shingles between the 1st and 2nd dose. The patient visited emergency room as a result of acute pain in my left upper back. Therapeutic measures were taken as a result of events that included Valtrex as an antifungal and gabapentin for pain. The outcome of the events was reported as resolving.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Herpes zoster, Rash
Clinical narrative: arthritis; Shingles; I noticed a rash on my front trunk; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. Medical history included breast cancer, ongoing arthritis diagnosed about 10 years ago. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021, the patient returning from receiving 2nd dose, she noticed a rash on her front trunk (left side). It extended to her spine. She went to an Urgent Care facility on 08Apr2021and was diagnosed with shingles. She had shingles between the first and second doses of the vaccine, states on the online report she did not include something she should have, wanted to add that she has arthritis, diagnosed about 10 years ago. Is not reporting any additional events. The adverse event resulted her to visit emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and shingles with Valtrex as an antifugal and gabapentin for pain. Outcome of the event rash and shingles was resolving and for other was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: have a hard time breathing; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (at the age of 72 years age) (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Verbatim and Event Description: Patient called stated doctor office having problem calling in refill and wanted to know if can call in herself because "I'm out of it and I really need it." Also on call patient asked "I got my shots for the covid 19 was one of the side effects have a hard time breathing. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Hypopnoea
Clinical narrative: Chills; Fever; Body aches; Headache; weird shallowness when breathing; Elevated heart rate; Restless; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Apr2021 (at the age of 39-years) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) on 24Mar2021 for covid-19 immunisation. She had no side effects after the first vaccine. Caller had the second dose of the Pfizer covid19 vaccine on 17Apr2021 around 11:15 AM. A few hours after the vaccine she had chills, fever, body aches and a headache. That has subsided. Currently she has shortness of breath and an elevated heart rate. She felt uncomfortable when having a lengthy conversation or going up and down the stairs. She felt restless, and has weird shallowness when breathing. Caller stated she doesn't know if it is blood clot related or something else. Caller stated she already contacted her health care provider and was going to wait for them to call her back. She refused to complete the safety report. She was under the impression that she would get advice on what to do next. Clarified that we do not give advice, but she may contact MI for product side effects or ingredients. Advised her to contact her doctor for any medical advice. The outcome of the event restless was unknown; events elevated heart rate and short of breath were not recovered and recovering for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Restlessness
Clinical narrative: Chills; Fever; Body aches; Headache; weird shallowness when breathing; Elevated heart rate; Restless; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Apr2021 (at the age of 39-years) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) on 24Mar2021 for covid-19 immunisation. She had no side effects after the first vaccine. Caller had the second dose of the Pfizer covid19 vaccine on 17Apr2021 around 11:15 AM. A few hours after the vaccine she had chills, fever, body aches and a headache. That has subsided. Currently she has shortness of breath and an elevated heart rate. She felt uncomfortable when having a lengthy conversation or going up and down the stairs. She felt restless, and has weird shallowness when breathing. Caller stated she doesn't know if it is blood clot related or something else. Caller stated she already contacted her health care provider and was going to wait for them to call her back. She refused to complete the safety report. She was under the impression that she would get advice on what to do next. Clarified that we do not give advice, but she may contact MI for product side effects or ingredients. Advised her to contact her doctor for any medical advice. The outcome of the event restless was unknown; events elevated heart rate and short of breath were not recovered and recovering for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Blepharospasm, Fatigue, Headache, Pain
Clinical narrative: She was calling to see if she could get more info about side effects she is experiencing.; eye twitching; rash on her forehead, below her lip, on her leg; itching; pain; swelling in her arm; headache; fatigue; vaginal spotting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 14Mar2021 as DOSE 1 (age at vaccination: 41), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she was calling to see if she could get more info about side effects she is experiencing, eye twitching, rash on her forehead, below her lip, on her leg, itching, pain, swelling in her arm, headache, fatigue and vaginal spotting on an unspecified date. Caller asking if she should seek medical advice. Outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Vaginal haemorrhage
Clinical narrative: She was calling to see if she could get more info about side effects she is experiencing.; eye twitching; rash on her forehead, below her lip, on her leg; itching; pain; swelling in her arm; headache; fatigue; vaginal spotting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 14Mar2021 as DOSE 1 (age at vaccination: 41), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she was calling to see if she could get more info about side effects she is experiencing, eye twitching, rash on her forehead, below her lip, on her leg, itching, pain, swelling in her arm, headache, fatigue and vaginal spotting on an unspecified date. Caller asking if she should seek medical advice. Outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Headache, Oropharyngeal discomfort
Clinical narrative: shortness of breath; palpitations; scratchy throat; but had chills; cough; headache; This is a spontaneous report from AE Reporting. A contactable female patient of unspecified age received first dose and second dose  of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number & Expiry date were not provided) via unspecified route of administration on unspecified dates as single dose for COVID-19 Immunisation. Patient medical history include high blood pressure and concomitant medications were not reported. The patient has high blood pressure and takes medicine for it. It was reported that one week after patient had vaccine, she experienced shortness of breath, palpitations, scratchy throat on unspecified date. She went to ER  (Emergency room) was checked and no problems were found with her heart or lungs. Labs were normal. She had episodes a couple of more times then subsided.Patient had 2nd vaccine, symptoms were less severe, but had chills, cough, headache, etc. The Outcome of all events was unknown.       No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: shortness of breath; palpitations; scratchy throat; but had chills; cough; headache; This is a spontaneous report from AE Reporting. A contactable female patient of unspecified age received first dose and second dose  of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number & Expiry date were not provided) via unspecified route of administration on unspecified dates as single dose for COVID-19 Immunisation. Patient medical history include high blood pressure and concomitant medications were not reported. The patient has high blood pressure and takes medicine for it. It was reported that one week after patient had vaccine, she experienced shortness of breath, palpitations, scratchy throat on unspecified date. She went to ER  (Emergency room) was checked and no problems were found with her heart or lungs. Labs were normal. She had episodes a couple of more times then subsided.Patient had 2nd vaccine, symptoms were less severe, but had chills, cough, headache, etc. The Outcome of all events was unknown.       No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Muscle discomfort, Nasopharyngitis
Clinical narrative: After receiving the shot he experienced light cold, tiredness; After receiving the shot he experienced light cold, tiredness; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; his head is a little down, heart and lungs feels like there's something in it; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 04Apr2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient reported he got his first dose on 04Apr2021 and he experienced light cold, tiredness, but the second day those adverse event got away, however in the beginning of the second week after he got the shot adverse events started to happen again, his head is a little down, heart and lungs feels like there's something in it, difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever. He wanted to know if that was normal or okay. The outcome of all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: After receiving the shot he experienced light cold, tiredness; After receiving the shot he experienced light cold, tiredness; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; his head is a little down, heart and lungs feels like there's something in it; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 04Apr2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient reported he got his first dose on 04Apr2021 and he experienced light cold, tiredness, but the second day those adverse event got away, however in the beginning of the second week after he got the shot adverse events started to happen again, his head is a little down, heart and lungs feels like there's something in it, difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever. He wanted to know if that was normal or okay. The outcome of all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Dyspnoea, Malaise
Clinical narrative: high cholesterol; could not breathe well; did not feel well; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH, COVID-19, solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated she received first dose. She wanted to know what will happen if she did not get second dose. She had high cholesterol. She could not breathe well and did not feel well with first dose. She was afraid to feel worse with second dose. The patient underwent lab tests and procedures which included blood cholesterol: high on an unspecified date. The clinical outcome of the events was unknown at the time of report.  No Follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Oedema, Pain in extremity, Vaccination site reaction
Clinical narrative: seeing fluid under her skin and having a "black and blue" where the injection was given; was concerned about the soreness to her arm; seeing fluid under her skin and having a "black and blue" where the injection was given; when she received the injection she is convinced that it was given subcutaneously versus in the muscle; This is a spontaneous report from a contactable other hcp (patient) via Pfizer sponsored program. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: en6205) via subcutaneous on 20Mar2020 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a registered nurse and stated that she received her first vaccine dose on 20Mar2021 at clinic but when she received the injection, she was convinced that it was given subcutaneously versus in the muscle. She reported that afterwards she remembers seeing fluid under her skin and having "black and blue" where the injection was given. She had gone to see her HCP because afterwards she was concerned about the soreness to her arm along with the fact that she didn't think she got the injection performed appropriately. She received her second injection on 10Apr2021 in muscle (Lot: er8727) and it went fine but was worried as she was not fully protected and was wondering if she should do a booster. She asked what to be done about an invalid dose and also asked about the studies being done on the efficacy after receiving 1 dose and what type of tests regarding antibodies for the covid vaccine are recommended to check for immunity. She asked If there was any plan to train people further or better qualifying people on giving an IM injection. 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: Breast mass, Chills
Clinical narrative: Lump on my left boob like on top and it hurt; Chill; This is a spontaneous report from a contactable consumer (Patient). A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158; Expiry Date: unknown), via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 22-years-old) as dose 1, single for covid-19 immunisation. The patient medical and concomitant medications were not reported. It was reported No investigation assessment and patient history. On 15Apr2021, the patient experienced "lump on my left boob like on top and it hurt" and chill. Treatment was given with Tylenol for the events. Reporter seriousness for both the event was unspecified. NDC number and UPC number of Covid vaccine was unknown. It was reported that the patient got her vaccine yesterday and she had a lump on her left boob like on top and it hurt and she had chill also. It was quick but its just here still there, it doesn't hurt to breathe but like lump. Consumer stated, The expiration its April15, no she got her shot on this. The date for second dose was provided as 06May2021. The patient confirmed she hadn't had any lab test. When probed for the condition is worsened, improved or persisting, consumer stated, "yeah." Outcome of the events were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Pollakiuria
Clinical narrative: Couldn't breath; went to the restroom and peed 4 times, too much the first night; something happened to her heart; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:50 (age at vaccination 54 years) as dose 1, single for covid-19 immunisation. Medical history included ongoing high blood pressure. Concomitant medication(s) included amlodipine (AMLODIPINE) 5mg by mouth one time daily taken for hypertension and ongoing (started at 39 years old, increased to 10mg, then back to 5 mg; unspecified water pill (started one year ago) and ongoing taken for blood pressure was too high, fluoxetine (FLUOXETINE) 40mg, one tablet by mouth one time per day (started 3-4 years ago. Maybe 2016. Patient cannot remember). The patient previously took amoxicillin and experienced allergy (She has severe allergy to amoxicillin). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 the patient experienced couldn't breathe, went to the restroom and peed 4 times, too much the first night on 20Apr2021, something happened to her heart on 17Apr2021. Patient stated, she experienced a strange thing. Last night and the night before. she is overweight. 2 nights ago, she was sleeping and woke up and couldn't breathe. Her nose and mouth were stuck, and she drank water, and she was ok. It happened 2 times where she felt she couldn't breathe. It was horrible, she had to drink a little bit of water to get better. Her mouth and nose were closed and she doesn't know how it happened. It happened 2 nights ago, 4 times total. It occurred 3 times the first night and last night she didn't drink water, but the first times she needed water. Reporter added the breathing is improving but doesn't know if it will occur tonight. She traveled too long to receive her vaccination. She did not take her water pill yesterday, because she finished the medicine. she have to wait now for like 1 week. The name of the medicine starts with Tr and she cannot remember. She is a engineer, a designer. She was abused at work. They didn't expect a broken English speaking and a woman in their department. She was good at her job. After surviving 6 months, she started taking Fluoxetine. The outcome of event Couldn't breath was resolving, Frequency urination was resolved on 20Apr2021, something happened to her heart was resolved on 17Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaginal haemorrhage
Clinical narrative: Experienced heavy bleeding coming out of the vagina this morning.; This is a spontaneous report from a contactable consumer or other non hcp.    A 63-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 12:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 81 mg for an unspecified indication. Medical history included and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced heavy bleeding coming out of the vagina this morning on 24Apr2021 07:00 with outcome of recovered with sequelae. No treatment was received.  Follow-up (24Jun2021): This is a follow up-spontaneous report from a contactable Consumer. This Consumer reported for the female patient in response to Non-HCP letter via follow-up letter which included the information.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: very unusual, heavy vaginal bleeding that lasted through the day, overnight, and into sunday morning; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in right arm on 23Apr2021 at 17:00 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization.The patient medical history was not reported. The patient had no allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), estradiol (VIVELLE-DOT), guaifenesin and ibuprofen. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: ER8730), via an unspecified route of administration, administered in right arm on 26Mar2021 at 12:30 as first dose for COVID-19 immunization. The patient experienced very unusual, heavy vaginal bleeding that lasted through the day, overnight, and into Sunday morning on 24Apr2021 at 09:00. Since the vaccination, the patient had not been tested for COVID. The patient visited to emergency room/department or urgent care. The patient did not receive any treatment as a result of event. The outcome of the event was resolving.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gingival bleeding
Clinical narrative: her husband's gums are bleeding; This is a spontaneous report from a Pfizer sponsored program support received from a contactable consumer (patient's wife).  A male patient of an unknown age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) dose 1 via an unknown route of administration on 23Apr2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced her husband's gums are bleeding. It was unknown whether the Reporter a Healthcare Professional (HCP) or prescribing HCP. The reporter's contact information available to you or a sub-contracted party was unknown. It was reported that patient was scheduled to return on 14 May for the second dose. The outcome of the event was reported as unknown.   No follow-up attempts were possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: a little sore arm; some fatigue; This is a spontaneous report from a contactable consumer (patient), from a Pfizer-sponsored program. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 23Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization and developed chills and loss of appetite and went to the emergency room, Was ill for nine days. The patient reports that she had her second dose of the Pfizer-Biontech Covid19 vaccine on Friday (23Apr2021) and all she ended up with was some fatigue and a little sore arm. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from a Pfizer Sponsored program. A contactable male consumer of an unspecified age (reported for himself) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), first dose via an unspecified route of administration on 22Apr2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient received his 1st dose of the vaccine yesterday (on 23Apr2021 as reported) and when he woke up today (unspecified date),  it was hard for him to breathe and had shortness of breath. the outcome of the event shortness of breath  was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: She had heavy bleeding from her vagina; This is a spontaneous report received from a contactable consumer. This consumer reported for female patient (wife) that: A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Patient had first shot of vaccine and had heavy bleeding from her vagina. So don't know if this had something to do with it, also patient is 63 years old and highly unlikely that she is having periods. Reporter concern "I don't know about it and I want to know if there are people who have experienced similar situations or did anyone report to you about the similar condition. Also, I want to know, is there any solution to the problem?". The outcome of the vent was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Balanoposthitis, Mouth ulceration
Clinical narrative: Mouth ulcers; Balanitis; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, post-traumatic stress disorder, herniated disc, migraine, COVID-19 and tinnitus from an unspecified date, allergy to walnut. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), thc (MANAFACTURER UNKNOWN) and clonazepam (KLONOPIN) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left  arm on 12Mar2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient underwent lab tests and procedures, which included COVID-19 virus test on unknown date and tested positive. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 the patient experienced mouth ulcers and balanitis. The patient received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event mouth ulcer and balanitis were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.