chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Immunisation, Pain
Clinical narrative: The patient received the third/booster dose of BNT162b2; A very sore arm.; Full body aches; Chills, shivering; Headache; Woke up sweating intermittently throughout the night; Sweating intermittently; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via intramuscular route of administration in the left arm on 12Nov2021 at 09:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included norethisterone acetate/ethinylestradiol/ferrous fumarate (BLISOVI 24 FE), levocetirizine dihydrochloride (XYZAL) and fluticasone propionate (FLONASE); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the left arm on 28Jan2021 (at the age of 25-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the left arm on 18Feb2021 (at the age of 26-years-old); both as single doses for COVID-19 immunisation. On 12Nov2021 at 09:00, immediately after vaccination, the patient had a very sore arm. Approximately 12 hours after vaccination on 12Nov2021, the patient experienced full body aches, chills, shivering, and a headache. The patient was still experiencing these symptoms when she went to bed around 22:30, and woke up sweating intermittently throughout the night on an unspecified date in Nov2021. When the patient woke up the next morning she still had a headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache which included treatment with ibuprofen (ADVIL) and the patient felt back to normal once it had started working. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a very sore arm; approximately 12 hours after vaccination experienced full body aches, chills, shivering, and a headache; was still experiencing these symptoms when she went to bed around 22:30, and woke up sweating intermittently throughout the night; when the patient woke up the next morning she still had a headache was resolved on 13Nov2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: The patient received the third/booster dose of BNT162b2; A very sore arm.; Full body aches; Chills, shivering; Headache; Woke up sweating intermittently throughout the night; Sweating intermittently; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via intramuscular route of administration in the left arm on 12Nov2021 at 09:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included norethisterone acetate/ethinylestradiol/ferrous fumarate (BLISOVI 24 FE), levocetirizine dihydrochloride (XYZAL) and fluticasone propionate (FLONASE); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the left arm on 28Jan2021 (at the age of 25-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the left arm on 18Feb2021 (at the age of 26-years-old); both as single doses for COVID-19 immunisation. On 12Nov2021 at 09:00, immediately after vaccination, the patient had a very sore arm. Approximately 12 hours after vaccination on 12Nov2021, the patient experienced full body aches, chills, shivering, and a headache. The patient was still experiencing these symptoms when she went to bed around 22:30, and woke up sweating intermittently throughout the night on an unspecified date in Nov2021. When the patient woke up the next morning she still had a headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache which included treatment with ibuprofen (ADVIL) and the patient felt back to normal once it had started working. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a very sore arm; approximately 12 hours after vaccination experienced full body aches, chills, shivering, and a headache; was still experiencing these symptoms when she went to bed around 22:30, and woke up sweating intermittently throughout the night; when the patient woke up the next morning she still had a headache was resolved on 13Nov2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Polymenorrhoea
Clinical narrative: Changes in menstrual cycle (closer together); herpes outbreaks monthly; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 13:15 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. Medical history included herpes, but only one outbreak in the last 9 years. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and propranolol (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CD7534) via an unspecified route of administration in the left arm on 16Mar2021 at 15:00 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. On 08Jun2021 at 13:00, the patient experienced changes in menstrual cycle (closer together) and had herpes outbreaks monthly. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events changes in menstrual cycle (closer together) and herpes outbreaks monthly was not resolved at the time of this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation
Clinical narrative: Tiredness; Headache; Muscle and Joint aches; Muscle and Joint aches; Chills; Administration date 10Nov2021 at 10:15, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 10Nov2021 at 10:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical dystonia, wheat intolerance, allergies to casein and coffee, latex and adhesive sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR), losartan (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 56-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the patient experienced tiredness, headache, muscle and joint aches and chills. The events tiredness, headache, muscle and joint aches and chills did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events tiredness, headache, muscle and joint aches and chills. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, headache, muscle and joint aches and chills was resolved on an unknown date in Nov2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Tiredness; Headache; Muscle and Joint aches; Muscle and Joint aches; Chills; Administration date 10Nov2021 at 10:15, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 10Nov2021 at 10:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical dystonia, wheat intolerance, allergies to casein and coffee, latex and adhesive sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR), losartan (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 56-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the patient experienced tiredness, headache, muscle and joint aches and chills. The events tiredness, headache, muscle and joint aches and chills did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events tiredness, headache, muscle and joint aches and chills. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, headache, muscle and joint aches and chills was resolved on an unknown date in Nov2021.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Soreness at site of injection; Fatigue; This is a spontaneous report from a contactable other healthcare professional, the patient. A 20-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an intramuscular route of administration in the left arm on 09Jan2021 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an intramuscular route of administration in the left arm on 18Dec2020 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. On 10Jan2021, the patient experienced soreness at site of injection and fatigue, which were most noticeable 12 hours after the second vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, soreness at site of injection and fatigue was resolved on an unknown date in 2021. The patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an intramuscular route of administration in the left arm on 08Oct2021 (at the age of 21-year-old), as a single dose for COVID-19 immunisation.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic chalky bad taste in mouth that has continued to present day (7 months); This is a spontaneous report from a contactable pharmacist, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an intramuscular route of administration in the right arm on 27Apr2021 at 08:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an intramuscular route of administration in left arm on 06Apr2021 at 08:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 11:00, the patient experienced metallic chalky bad taste in mouth that had continued to present day (7 months). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic chalky bad taste in mouth that had continued to present day (7 months) was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Immunodeficiency
Clinical narrative: She experienced decreased immunity; I too had loss of energy; This is a spontaneous report from a contactable consumer reported for a 63-year-old female patient (reporter's mother) via Medical Information Team. A 63-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced decreased immunity and loss of energy. The clinical outcome of both the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinusitis; This is a spontaneous report from a contactable consumer or other non-health care professional (husband) reported for his wife. A female patient (Age: 58; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 16Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, reporter stated that his wife started antibiotic treatment for sinusitis and said his wife was experiencing some symptoms prior to first dose. Reporter asked if there was any drug interaction with antibiotics and vaccine. Patient has scheduled for second dose of vaccination on 09Mar2021. Therapeutic measures were taken as a result of sinusitis. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Headache, Heart rate
Clinical narrative: intense headaches; tired for a couple of days; soreness on arm; felt very cold; electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast; This is a spontaneous report from a contactable other hcp (Nurse). A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Mar2021 to an unknown date. Concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced intense headaches, tired for a couple of days, soreness on arm, felt very cold, electrical impulses all over her body started appearing and like her blood is running inside all over her body and heart rate went a little fast. The nurse reported that some of her co-workers, about 5 of them, had previous COVID diagnosis last March also received the vaccine were fine and experienced only intense headaches and tired for a couple of days. She mentioned that one person, until now has headaches and takes Tylenol for it. None of them reported the same side effects as her. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection. The patient underwent lab tests and procedures which included heart rate: heart rate went a little fast. Therapeutic measures were taken as a result of intense headaches, tired for a couple of days, soreness on arm, felt very cold, electrical impulses all over her body started appearing and like her blood is running inside all over her body and heart rate went a little fast which included Tylenol, albuterol and mucinex. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity
Clinical narrative: intense headaches; tired for a couple of days; soreness on arm; felt very cold; electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast; This is a spontaneous report from a contactable other hcp (Nurse). A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Mar2021 to an unknown date. Concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced intense headaches, tired for a couple of days, soreness on arm, felt very cold, electrical impulses all over her body started appearing and like her blood is running inside all over her body and heart rate went a little fast. The nurse reported that some of her co-workers, about 5 of them, had previous COVID diagnosis last March also received the vaccine were fine and experienced only intense headaches and tired for a couple of days. She mentioned that one person, until now has headaches and takes Tylenol for it. None of them reported the same side effects as her. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection. The patient underwent lab tests and procedures which included heart rate: heart rate went a little fast. Therapeutic measures were taken as a result of intense headaches, tired for a couple of days, soreness on arm, felt very cold, electrical impulses all over her body started appearing and like her blood is running inside all over her body and heart rate went a little fast which included Tylenol, albuterol and mucinex. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: 05Mar2021) via an unspecified route of administration, on 12Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on 02Mar2021, the patient experienced sinus. It was reported that patient got the Pfizer shot on 12 of February (clarified as 12Feb2021), the first one and due for the second one on Friday but have found out yesterday that he has a sinus infection, and he has given him antibiotics and prednisone (treatment). Patient was wondering if he can still get the shot on Friday. Patient got his 1st shot and due to get his 2nd dose on Friday 05Mar, was consulting if he is able to get his 2nd dose and mentioned he found out he has sinus infection and was prescribed antibiotics and steroids. (Cefdinir & Prednisone). Patient will start taking the medications today (03Mar2021), 2nd dose is scheduled more than 21 days from the 1st dose. Therapeutic measures were taken as a result of sinus infection with Cefdinir and Prednisone. The clinical outcome of the event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: head cold symptoms; runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 08Mar2021, as dose 1, single for covid-19 immunisation. Medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient stated that he got the Pfizer vaccine on 08Mar2021 Monday after 15 hours of vaccination, patient experienced head cold symptoms, runny nose, Patient went to fact sheet and did not see it listed there. He went to site and reported the information. Patient was thinking maybe he was just having a reaction due to warmer weather and season allergies. Patient stated, he usually take a zyrtec, yesterday he felt like he was at the peak day and took a zyrtec, he felt totally normal today. Therapeutic measures were taken received Zyrtec. The outcome of events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore Throat; Sore Throat; Runny Nose; symptoms of a cold such as sore throat and runny nose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration in arm left, on 10Mar2021 (last Wednesday) (age at vaccination: 27 years), as a dose 2, single for COVID-19 immunization/to prevent COVID. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration in arm left, on 17Feb2021, as a dose 1, single for COVID-19 immunization. On 14Mar2021 the patient stated that she has a sore throat and a runny nose and she thinks it was a cold. The patient reported that when she contacted her HR person, who the patient doesn't really know anything about it, they said to call the Health Department, they sent her to Pfizer. Caller wants to know does she need to get tested or quarantine or are these normal side effects. The patient stated that she was a home based therapist, so she needs to know because she doesn't want to spread anything. Reportedly as a corrective medication the patient received nyquil and Dayquil. On 16Mar2021 the outcome was recovered for the event runny nose. The outcome was not recovered for the event sore throat. The outcome was unknown for the other events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a contactable consumer (patient) communicated via regulatory authority.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: 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. On an unspecified date, the patient had sinus infection. It was reported that the patient wanted to know if it was okay to take second dose while she was on antibiotics for sinus infection on an unspecified date. The patient was received unspecified antibiotics treatment for the events. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This is a spontaneous report from a contactable consumer (Patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Jan2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced sinus infection. The patient was scheduled for her second dose 15Mar2021. The patient would like to verify her second dose schedule for tomorrow because patient was wondering why she received 2 emails for the confirmation of her appointment (first email is second dose appointment for Moderna) and (second email is second dose appointment for Pfizer). after the 1st dose and took 10 days antibiotics. Therapeutic measures were taken as a result of sinus infection. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nasopharyngitis
Clinical narrative: Feeling bad like he got a cold; Feeling bad like he got a cold; This is a spontaneous report from a contactable consumer. This consumer reported for 4 patients. This is 3rd of four reports. This consumer reported for a male patient (her husband's younger brother) of an unspecified age received unknown dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient did feel kind of bad, feeling bad like he got a cold. Caller states that her husband's younger brother took the same vaccine the same day as her husband. She adds that the younger brother reported that he did feel kind of bad and that he went to the pharmacy and got a medication to take. Caller does not know how the younger brother is feeling or how the younger brother is doing. Caller adds that nothing was prescribed, and that the medication was over the counter. Caller does not know anything else about this. She adds that she does not know if this was a one or two days affair. The clinical outcome of both the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: colds; This is a spontaneous report from a Pfizer sponsored program, a contactable consumer (Patient).   A 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration (at the age of 87 years old) on 26Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date the patient experienced colds. The patient received tylenol as treatment for cold. The patient reported that that 5 days before the second dose, patient took Tylenol to get rid of a cold. Patient took second dose on 19Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Malaise, Nasopharyngitis
Clinical narrative: feeling tired/started feeling really, really, tired on Friday (19Mar2021), Saturday (20Mar2021), and Sunday (21Mar2021), but paid no attention to her tiredness.; got her second COVID-19 Vaccine on 16Mar2021, and had been sick ever since then.; not feeling well; chills; cold; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that a 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:30 (78-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included depression (Stated she was diagnosed with depression back in the 1990s, and had been on medication for years) from an unspecified date in 1990 and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6205), via intramuscular administered in Arm Left on 25Feb2021 as dose 1, single for COVID-19 immunization. The patient had not received any vaccine within four weeks. No additional vaccines were administered on same date of the Pfizer Suspect. On 16Mar2021, the patient experienced illness. On 19Mar2021, the patient experienced fatigue. On an unspecified date in Mar2021, the patient experienced malaise, chills and cold. The patient reported she got her second COVID-19 Vaccine on 16Mar2021, and had been sick ever since then. She said she started feeling really, really, tired on Friday (19Mar2021), Saturday (20Mar2021), and Sunday (21Mar2021), but paid no attention to her tiredness. She said as time went on, she was very tired feeling, not feeling good, was cold, and had chills. The patient wanted to know how long the side effects can last. Therapeutic measures were taken as a result of chills (chills), cold(nasopharyngitis) using Naprosyn Sodium 220mg tablets (Lot Number: 1AE2412A, Expiration Date: Jul2022). The patient reported she put a sweater on when she was cold and had chills, and took some Tylenol (clarified as Naprosyn Sodium). She said she did not think there was anything else she could do for her symptoms. She said she told her friend about her symptoms, and her friend told her to report her symptoms to Pfizer. The patient reported sometimes she may take 2 Naprosyn Sodium 220mg tablets a day, and other days not take any at all. The patient reported her symptoms were no worse, but about the same. The patient asked if there was anything she can do for her symptoms. Adverse event did not require a visit to emergency room or physician office. The outcome of the event Illness was unknown while other events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infection; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as Dose 1, Single for Covid-19 immunisation. The patient medical history was not reported. Historical vaccination includes flu shot on an unspecific date and felt abnormality. On unspecified date in 2021 the patient experienced bladder infection. After getting first dose of the Pfizer BioNTech covid vaccine she developed a bladder infection and have been on antibiotics. The leaflet from the pharmacy states that she should not have immunizations while on the medication. Her urologist and internist both said that she should get the second dose of the vaccine when scheduled on 05Apr2021. Asking whether it is ok to get the second dose of the Pfizer vaccine and being on antibiotics. She was also on a blood thinner and a beta blocker. She had a flu shot earlier this year and felt a little something, but she didn't feel anything when she got the first dose of the Pfizer vaccine. Therapeutic measures were taken as a result of bladder infection includes administration of the antibiotics. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Headache, Hypoacusis, Malaise, Otitis media
Clinical narrative: otitis media; a bulging ear drum that can perforate at any moment; muffled hearing from the ear infection /can't hear very well; muffled hearing from the ear infection /can't hear very well; a stuffed head and pain; a stuffed head and pain; she still doesn't feel well; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 06Mar2021 14:30 (Age at Vaccination: 68 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Mar2021, the patient experienced Otitis media, a bulging ear drum that can perforate at any moment, muffled hearing from the ear infection /can't hear very well, a stuffed head and pain, and she still doesn't feel well. Caller wants to know if she is safe to get the second dose of the Pfizer Covid 19 vaccine from the side effects, she had from the first dose. The patient experienced otitis media and a bulging ear drum that can perforate at any moment since the 11Mar2021. She had muffled hearing a stuffed head and pain. She had finished a course of antibiotics on the 26Mar2021 due to the effects of the first dose and was also taking a decongestant. For treatment she had been on two different unknown antibiotics that she doesn't have with her to provide name or NDC/LOT/EXP from, and all sorts of decongestant meds, and her infection is gone but she still can't hear very well, and her head was completely full, and she still doesn't feel well. The outcome of the events otitis media, a bulging ear drum that can perforate at any moment was recovered on 11Mar2021; and other events were not recovered.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tympanic membrane perforation, Upper respiratory tract congestion
Clinical narrative: otitis media; a bulging ear drum that can perforate at any moment; muffled hearing from the ear infection /can't hear very well; muffled hearing from the ear infection /can't hear very well; a stuffed head and pain; a stuffed head and pain; she still doesn't feel well; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 06Mar2021 14:30 (Age at Vaccination: 68 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Mar2021, the patient experienced Otitis media, a bulging ear drum that can perforate at any moment, muffled hearing from the ear infection /can't hear very well, a stuffed head and pain, and she still doesn't feel well. Caller wants to know if she is safe to get the second dose of the Pfizer Covid 19 vaccine from the side effects, she had from the first dose. The patient experienced otitis media and a bulging ear drum that can perforate at any moment since the 11Mar2021. She had muffled hearing a stuffed head and pain. She had finished a course of antibiotics on the 26Mar2021 due to the effects of the first dose and was also taking a decongestant. For treatment she had been on two different unknown antibiotics that she doesn't have with her to provide name or NDC/LOT/EXP from, and all sorts of decongestant meds, and her infection is gone but she still can't hear very well, and her head was completely full, and she still doesn't feel well. The outcome of the events otitis media, a bulging ear drum that can perforate at any moment was recovered on 11Mar2021; and other events were not recovered.  No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; general fatigue lasting four hours; No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; headache; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration, administered in left arm as dose 2, single on 12Feb2021 02:00 (at the age of 77-year-old) for covid-19 immunisation. Medical history included heart condition aneurism and leaking valve both from an unknown date and unknown if ongoing. Patient had known allergy to penicillin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on unspecified date (at the age of 77-year-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Concomitant medication within 2 weeks of vaccination included losartan potassium taken for an unspecified indication, start and stop date were not reported. On unspecified date in Feb2021 12:00 PM, patient experienced chills, headache, feverish, legs aching and general fatigue lasting four hours chills with shaking like he was in an ice box naked and went to doctor found nothing and had no reaction until 10 days after vaccine. No further side effects until Apr2021 (as reported today) same exact side effects chills with shaking fatigue, legs hurt and slight headache. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse event. At the time of this report, the outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; general fatigue lasting four hours; No reaction until 10 days after vaccine chills feverish legs aching and general fatigue lasting four hours chills with shaking like I'm in an ice box naked....went to dr found nothing No further side; headache; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration, administered in left arm as dose 2, single on 12Feb2021 02:00 (at the age of 77-year-old) for covid-19 immunisation. Medical history included heart condition aneurism and leaking valve both from an unknown date and unknown if ongoing. Patient had known allergy to penicillin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on unspecified date (at the age of 77-year-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Concomitant medication within 2 weeks of vaccination included losartan potassium taken for an unspecified indication, start and stop date were not reported. On unspecified date in Feb2021 12:00 PM, patient experienced chills, headache, feverish, legs aching and general fatigue lasting four hours chills with shaking like he was in an ice box naked and went to doctor found nothing and had no reaction until 10 days after vaccine. No further side effects until Apr2021 (as reported today) same exact side effects chills with shaking fatigue, legs hurt and slight headache. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse event. At the time of this report, the outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Pain in extremity, Pharyngeal erythema, Urticaria
Clinical narrative: very sore arm for less than 24 hours; developed pimples/hives inside of mouth/hives all over the patient torso; developed pimples/hives inside of mouth; red throat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6208, Expiry Date: Not Reported), via an unspecified route of administration, administered in left arm on 14Mar2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included environmental allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. The patient took other medications (concomitant therapy) in two weeks of vaccination. Historical vaccine included, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL9266, Expiry Date: Not Reported), via an unspecified route of administration, administered in left arm on 21Feb2021 (at the age of 57-year-old) at 10:30 as dose 1, single for covid-19 immunization and experienced extremely tired on day 3. The patient was not diagnosed with covid prior vaccination. The patient was not tested for covid post vaccination. On an unknown date Mar2021, at 8:00 after the second dose the patient experienced very sore arm for less than 24 hours, a few days later developed pimples/hives inside of mouth and had a very red throat, non-painful throat. Pimple come and go, 4 Weeks later woke up to hives all over the patient torso along with the pimples in mouth. Hive went away after about a week. Redness in throat was at a minimum but still getting a smaller pimple almost every day. Saw ENT and Dentist about throat not linking the possible connection to the vaccine. Both felt there was nothing serious to be concerned with. The Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Outcome of the event sore arm was recovered in 2021 and for rest all events outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.