chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Ocular hyperaemia
Clinical narrative: my left eye gets very blood shot and a little irritated; my left eye gets very blood shot and a little irritated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 02:00 (Lot number: EW0170) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP7533, Administration time: 2 PM, Vaccine location: Left arm), administration date: 05Apr2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: OCULAR HYPERAEMIA (non-serious), EYE IRRITATION (non-serious) all with onset 01Dec2021, outcome "recovering" and all described as "my left eye gets very blood shot and a little irritated". Therapeutic measures were not taken as a result of ocular hyperaemia, eye irritation.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild tenderness at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: being slightly immunocompromised. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "mild tenderness at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Nausea, Vaccination site pain
Clinical narrative: mild tenderness at the injection site; nausea; tiredness; feeling under the weather like she was catching a cold or the beginning of a flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: Caller reports history of her and her husband being slightly immunocompromised. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "mild tenderness at the injection site"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feeling under the weather like she was catching a cold or the beginning of a flu". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Culture, Fatigue, Influenza, Malaise
Clinical narrative: runny nose; feeling sick/He felt off; Diagnosed with flu; sore throat; coughing/bad cough; congestion; low grade fever; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101714020 (PFIZER).  A 9 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Nov2021 17:00 (Lot number: fk5618) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Time: 16:00, Anatomical site: Left arm,, Intramuscular, Lot number: fk5127), administration date: 08Nov2021, when the patient was 9 years old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 30Nov2021, outcome "recovered" (06Dec2021), described as "coughing/bad cough"; OROPHARYNGEAL PAIN (non-serious) with onset 01Dec2021, outcome "recovered" (03Dec2021), described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; INFLUENZA (non-serious) with onset 02Dec2021, outcome "recovered" (05Dec2021), described as "Diagnosed with flu"; NASAL CONGESTION (non-serious) with onset 30Nov2021, outcome "unknown", described as "congestion"; MALAISE (non-serious), outcome "unknown", described as "feeling sick/He felt off"; PYREXIA (non-serious) with onset 30Nov2021, outcome "recovered" (04Dec2021), described as "low grade fever"; FATIGUE (non-serious) with onset 30Nov2021, outcome "recovered", described as "feeling tired". The events "coughing/bad cough", "sore throat", "runny nose", "feeling sick/he felt off", "low grade fever" and "feeling tired" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient got his second covid vaccine shot on Monday 29Nov. He felt off while at school on Tuesday and developed a fever in the evening on 30Nov and kept him home on Wednesday and gave him Tylenol and fluids, while the fever persisted and also complained of fatigue, runny nose and had a bad cough. On Thursday, 02Dec, he woke up complaining of a sore throat. We called his doctor and she said to bring him in for a strep test. Apparently, it's going around. The rapid strep test came back negative, so the doctor also did a rapid flu test. That came back positive and had not been vaccinated for flu yet this season.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Streptococcus test
Clinical narrative: runny nose; feeling sick/He felt off; Diagnosed with flu; sore throat; coughing/bad cough; congestion; low grade fever; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101714020 (PFIZER).  A 9 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Nov2021 17:00 (Lot number: fk5618) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Time: 16:00, Anatomical site: Left arm,, Intramuscular, Lot number: fk5127), administration date: 08Nov2021, when the patient was 9 years old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 30Nov2021, outcome "recovered" (06Dec2021), described as "coughing/bad cough"; OROPHARYNGEAL PAIN (non-serious) with onset 01Dec2021, outcome "recovered" (03Dec2021), described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; INFLUENZA (non-serious) with onset 02Dec2021, outcome "recovered" (05Dec2021), described as "Diagnosed with flu"; NASAL CONGESTION (non-serious) with onset 30Nov2021, outcome "unknown", described as "congestion"; MALAISE (non-serious), outcome "unknown", described as "feeling sick/He felt off"; PYREXIA (non-serious) with onset 30Nov2021, outcome "recovered" (04Dec2021), described as "low grade fever"; FATIGUE (non-serious) with onset 30Nov2021, outcome "recovered", described as "feeling tired". The events "coughing/bad cough", "sore throat", "runny nose", "feeling sick/he felt off", "low grade fever" and "feeling tired" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient got his second covid vaccine shot on Monday 29Nov. He felt off while at school on Tuesday and developed a fever in the evening on 30Nov and kept him home on Wednesday and gave him Tylenol and fluids, while the fever persisted and also complained of fatigue, runny nose and had a bad cough. On Thursday, 02Dec, he woke up complaining of a sore throat. We called his doctor and she said to bring him in for a strep test. Apparently, it's going around. The rapid strep test came back negative, so the doctor also did a rapid flu test. That came back positive and had not been vaccinated for flu yet this season.  No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Headache; fever; chills; sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 14:30 (Lot number: Fk5618) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 15Nov2021, stop date: 15Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk5127, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 08Nov2021, when the patient was 10 years old, for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Nov2021 21:00, outcome "recovered" (2021), described as "sore arm at injection site"; HEADACHE (non-serious) with onset 30Nov2021, outcome "recovered" (2021), described as "Headache"; PYREXIA (non-serious) with onset 30Nov2021, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset 30Nov2021, outcome "recovered" (2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, headache, pyrexia, chills.  Additional information: Event of sore arm at injection site and headache (mild) had occurred 6-8 hours after second dose and fever, chills and headache (moderate) had occurred 12 hours after second dose. Patient was treated with motrin and tylenol. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Nausea, Vaccination site pain
Clinical narrative: Mild tenderness at the injection site; She felt nausea; Tiredness; Flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: slightly immunocompromised. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01, first two doses where she and her husband both experienced side effects with the second dose being even stronger. She did report mild tenderness at the injection site.), for COVID-19 immunization, reaction(s): "mild tenderness at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild tenderness at the injection site"; INFLUENZA (non-serious), outcome "recovered" (2021), described as "Flu"; NAUSEA (non-serious), outcome "unknown", described as "She felt nausea"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional information: Caller reports no side effects (no body aches, fever, tiredness, nothing) after the booster dose as compared to the first two doses where she and her husband both experienced side effects with the second dose being even stronger. She did report mild tenderness at the injection site. Caller concerned that the vaccine may not be working or she could have gotten the wrong dose since she did not experience any side effects. after the second dose, they both had flu that lasted for 3 days. he felt nausea, tiredness similar to feeling under the weather like she was catching a cold or the beginning of a flu. Caller stated the second vaccine had stronger effects than the first one. she felt the side effects of the second vaccine every other day for 3 to 4 days.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Injection site pain, Nasal congestion, Nausea
Clinical narrative: Stomach ache; nausea; slight stuffy nose; soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Nov2021 18:30 (Lot number: FK5612) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing). Concomitant medication(s) included: XYZAL taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Left shoulder, Route of administration: Intramuscular, Vaccine Administration Time: 06:30PM), administration date: 09Nov2021, when the patient was 9 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 01Dec2021 13:00, outcome "recovered" (02Dec2021), described as "Stomach ache"; NAUSEA (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "nausea"; NASAL CONGESTION (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "slight stuffy nose"; INJECTION SITE PAIN (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "soreness at injection site". Therapeutic measures were not taken as a result of abdominal pain upper, nausea, nasal congestion, injection site pain.  Additional information: Patient did not receive any other vaccine in four weeks, did not have covid prior vaccination and not tested covid post vaccination. Patient did not have any prior vaccination within 4 weeks. Patient did not have any known allergies. The patient received (ongoing) immunotherapy injection for allergy shot on 24Nov2021 as concomitant medication.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 26Jan2021 15:00 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "Injection site soreness". Therapeutic measures were not taken as a result of fatigue, vaccination site pain. Additional information:Comments/Narrative: There was no error, only that I received my 2nd dose approx., 10 months after my first, that is all. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: she couldn't put her arm down all day; it was swollen and painful underneath the arm; it was swollen and painful underneath the arm; cramp in her upper right arm; First dose: given on 16Sep2021/Second dose: Given on 23Nov2021; at least three very large swollen lymph nodes under the right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Nov2021 (Lot number: FH8028) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Additional Information for Concomitant Products Bystolic: She has been on it years. Concomitant medication(s) included: BYSTOLIC taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (Dose Number:01, Lot number: FD8448), administration date: 16Sep2021, when the patient was 52 years old, for Covid-19 Immunization, reaction(s): "she thinks it did something to her heart rate/Her heart rate is usually 80 to 100 and it was around 50", "she still felt really tired". The following information was reported: MUSCLE SPASMS (non-serious) with onset 24Nov2021, outcome "not recovered", described as "cramp in her upper right arm"; LIMB DISCOMFORT (non-serious) with onset 25Nov2021, outcome "unknown", described as "she couldn't put her arm down all day"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 25Nov2021, outcome "unknown" and all described as "it was swollen and painful underneath the arm"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "at least three very large swollen lymph nodes under the right arm"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "First dose: given on 16Sep2021/Second dose: Given on 23Nov2021". The events "cramp in her upper right arm", "she couldn't put her arm down all day", "it was swollen and painful underneath the arm", "it was swollen and painful underneath the arm" and "at least three very large swollen lymph nodes under the right arm" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle spasms.  Additional information: After the first shot she thinks it did something to her heart rate. She can't prove it. It was a few weeks after the first shot that she noticed she still felt really tired. She checks her blood pressure on a regular basis because she is on blood pressure medicine. Her heart rate is usually 80 to 100 and it was around 50. She went to the emergency room and they did heart test. Nothing came back. Everything seems ok now. They will do a stress test in the future on 23Dec2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular examination, Fatigue, Heart rate, Heart rate decreased
Clinical narrative: she thinks it did something to her heart rate/Her heart rate is usually 80 to 100 and it was around 50; she still felt really tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Sep2021 (Lot number: FD8448) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC taken for hypertension. The following information was reported: HEART RATE DECREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "she thinks it did something to her heart rate/Her heart rate is usually 80 to 100 and it was around 50"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "she still felt really tired". The events "she thinks it did something to her heart rate/her heart rate is usually 80 to 100 and it was around 50" and "she still felt really tired" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concomitant products bystolic she has been on it for years. AE(s) following prior vaccinations were none. Family medical history relevant to AE(s) were none. After the first shot she thinks it did something to her heart rate. She can't prove it. It was a few weeks after the first shot that she noticed she still felt really tired. She checks her blood pressure on a regular basis because she is on blood pressure medicine. Her heart rate is usually 80 to 100 and it was around 50. She went to the emergency room and they did heart test. Nothing came back. Everything seems ok now. They will do a stress test in the future on 23Dec2021.   No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 102.3 temperature taken at 11:15PM; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 16:30 (Lot number: FK 5127) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 01Dec2021 21:00, outcome "unknown", described as "102.3 temperature taken at 11:15PM". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. It was reported that the patient was having 102.3 temperature which was taken at 11:15PM, the day after vaccination. The patient was sleeping and will wait till he wakes up to take further action.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Lymphadenopathy, Skin swelling, Swelling face
Clinical narrative: Woke up with my whole face swollen; Right side of face is like puffy; My lips is big; My nodes is just swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: PH8028) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Albuterol for Asthma, notes: I have not taken my Albuterol since 2 months, Expiration date of Albuterol: Consumer stated, "Jan2022., LOT#: 9G4N. The following information was reported: SWELLING FACE (non-serious) with onset 01Dec2021, outcome "unknown", described as "Woke up with my whole face swollen"; SKIN SWELLING (non-serious) with onset 01Dec2021, outcome "unknown", described as "Right side of face is like puffy"; LIP SWELLING (non-serious) with onset 01Dec2021, outcome "unknown", described as "My lips is big"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "unknown", described as "My nodes is just swollen".  Additional information: Patient took the vaccine yesterday. And had a side effect from the vaccine. Patient just woke up in the afternoon and when she woke up and went to the bathroom to look at her face and her face was swollen. So her sister said to call and report it. But she was going to her Doctor office to take a look and to make sure that she was not having an allergic reaction or something because her face was swollen. And one side of her face, the right side of her face was like puffy. Her nodes was just swollen to the point that it is was and her lips were big. No Prior vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 14:30 (Lot number: Fk5127) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, start date: 15Nov2021, stop date: 15Nov2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "sore arm".  Additional information:  The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Influenza like illness, Nausea
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. A 60 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: husband being slightly immunocompromised. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "tiredness", "flu like symptoms", "Nausea". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu/like catching a cold or the beginning of a flu/felt the same symptoms"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "with the second dose being even stronger". Additional information: Reporter stated that she and her husband are around 60 years old and received their third booster dose of the Pfizer BioNTech Covid-19 vaccine on 22Oct2021, 6 months after her primary series. Reporter reports history of her and her husband being slightly immunocompromised. Reporter reports no side effects (no body aches, fever, tiredness, nothing) after the booster dose as compared to the first two doses where she and her husband both experienced side effects with the second dose being even stronger. She did report mild tenderness at the injection site. Reporter concerned that the vaccine may not be working or she could have gotten the wrong dose since she did not experience any side effects. Reporter also mentioned that she read people with arthritis and inflammatory diseases are feeling side effects. Second dose: Unspecified Dates for Unspecified effects, after first vaccine: (From: Unspecified To: Unspecified) Reporter seriousness for Unspecified effects, after first vaccine: Unspecified Dates for Mild, warm tingling sensation at the injection site after booster: (From: Unspecified To: Unspecified) Reporter seriousness for Mild, warm tingling sensation at the injection. Reporter specified that after the second dose, they both had flu that lasted for 3 days. With the first two doses her and her husband felt mild side effects. Reporter stated that after the second dose of vaccine, she felt nausea, tiredness similar to feeling under the weather like she was catching a cold or the beginning of a flu. Reporter stated the second vaccine had stronger effects than the first one. Reporter stated she felt the side effects of the second vaccine every other day for 3 to 4 days. Reporter stated her husband felt the same symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: She is having numbness and tingling in her arm that they gave the dose. She also experienced it in her ''quadrants'' and part on her leg as well as in her other arm/The numbness and tingling or the left, sorry the left; She is having numbness and tingling in her arm that they gave the dose. She also experienced it in her ''quadrants'' and part on her leg as well as in her other arm/The numbness and tingling or the left, sorry the left; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 18:00 (Lot number: FG3527) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 01Dec2021, outcome "unknown" and all described as "She is having numbness and tingling in her arm that they gave the dose. She also experienced it in her ''quadrants'' and part on her leg as well as in her other arm/The numbness and tingling or the left, sorry the left". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia.  Follow-up (08Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Pain
Clinical narrative: High Heart rate; Fatigue; bad headache; achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EN6200) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (ongoing); "Bones" (ongoing); "Sleep" (ongoing); "Headaches" (ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol (ongoing); CALCIUM taken for bone disorder (ongoing); ZOLPIDEM taken for sleep disorder; VITAMIN D taken for bone disorder (ongoing); ALEVE taken for headache. Vaccination history included: Bnt162b2 (Dose: 01, Caller states that she had all 3 doses on her Left arm., states that it might be R19265 or E19265 but she more so thinks it's E19265), administration date: 04Feb2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 23Feb2021, outcome "recovered" (Nov2021), described as "High Heart rate"; FATIGUE (non-serious) with onset 23Feb2021, outcome "recovered" (Nov2021), described as "Fatigue"; HEADACHE (non-serious) with onset 23Feb2021, outcome "recovered" (Nov2021), described as "bad headache"; PAIN (non-serious) with onset 23Feb2021, outcome "recovered" (Nov2021), described as "achy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the vaccine she had a high heart rate, she was achy and fatigued. This was after the booster and after the second dose. It started the very same day as getting the second dose, but later in the day. The high heart rate, achy and fatigue subsided a couple days later. Allergies were none. Vaccination facility type was pharmacy or drug store. Prior vaccinations were none.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Immunisation, Lymphadenopathy, Pain
Clinical narrative: red 1" painful circular area developed / Near but not including actual injection site; red 1" painful circular area developed / Near but not including actual injection site; red 1" painful circular area developed / Near but not including actual injection site; initial red area turned purple and lighter red area; Painful and itchy; Painful and itchy; Lymphadenopathy in armpit; shaking; chills; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 11:15 (Lot number: FJ1620) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Past drug history included: Amoxycillin for Known allergies: Amoxycillin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 31Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 10Mar2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 11:15, outcome "unknown", described as "booster dose"; ERYTHEMA (non-serious), PAIN (non-serious), VACCINATION SITE REACTION (non-serious) all with onset 01Dec2021, outcome "not recovered" and all described as "red 1" painful circular area developed / Near but not including actual injection site"; SKIN DISCOLOURATION (non-serious) with onset 01Dec2021, outcome "not recovered", described as "initial red area turned purple and lighter red area"; PAIN (non-serious), PRURITUS (non-serious) all with onset 01Dec2021, outcome "not recovered" and all described as "Painful and itchy"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Lymphadenopathy in armpit"; TREMOR (non-serious) with onset 01Dec2021, outcome "not recovered", described as "shaking"; CHILLS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "chills". The events "red 1" painful circular area developed / near but not including actual injection site", "red 1" painful circular area developed / near but not including actual injection site", "red 1" painful circular area developed / near but not including actual injection site", "initial red area turned purple and lighter red area", "painful and itchy", "painful and itchy", "lymphadenopathy in armpit", "shaking" and "chills" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of erythema, pain, vaccination site reaction, skin discolouration, pain, pruritus, lymphadenopathy, tremor, chills.  Additional information: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Sleep talking
Clinical narrative: Chills; 102.3 temperature; vomiting; headache; talking in sleep due to fever; pain on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 14:15 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR. The following information was reported: CHILLS (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "102.3 temperature"; VOMITING (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "headache"; SLEEP TALKING (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "talking in sleep due to fever"; VACCINATION SITE PAIN (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "pain on the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, vomiting, headache, sleep talking, vaccination site pain.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Chills; 102.3 temperature; vomiting; headache; talking in sleep due to fever; pain on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 14:15 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR. The following information was reported: CHILLS (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "102.3 temperature"; VOMITING (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "headache"; SLEEP TALKING (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "talking in sleep due to fever"; VACCINATION SITE PAIN (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "pain on the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, vomiting, headache, sleep talking, vaccination site pain.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain, Rash, Urticaria
Clinical narrative: He kind of had like a little hives underneath; Rash; Achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Lot number: FK5618) at the age of 5 years as dose number unknown, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 02Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset Dec2021, outcome "unknown", described as "He kind of had like a little hives underneath"; RASH (non-serious) with onset Dec2021, outcome "unknown", described as "Rash"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Achy". Therapeutic measures were not taken as a result of urticaria, rash, pain.  Additional info: Anatomical site of vaccination: Reporter stated, I believe it was on the left side and flu shot was on the right side. I think the flu shot was given at the bottom where he had rashes.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: chills; fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Dec2021 11:45 (Lot number: FK5618) at the age of 7 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for influenza, administration date 14Nov2021, administration date 20Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM/ 11:45, Route of Administration: Intramuscular, Dose: 1st, Date/ time: , Date: 13Nov2021, Time: 11:45 , Site and route of injection:, Anatomical Site of Injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: FK5127), administration date: 13Nov2021, when the patient was 7 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 05Dec2021 03:00, outcome "recovered" (05Dec2021), described as "chills"; PYREXIA (non-serious) with onset 05Dec2021 03:00, outcome "recovered" (05Dec2021), described as "fever"; HEADACHE (non-serious) with onset 05Dec2021 03:00, outcome "recovered" (05Dec2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, headache.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was reported as available. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported no. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Relevant tests was reported as no. Specific relevant test was reported as no. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 10-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FJ1620),  Dec 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pyrexia (slight fever), peripheral swelling (arm is kind of swollen), and burning sensation (kind of burning-up), with outcome of unknown. Additional information: Reporter stated, "I am calling because my granddaughter said she was having a slight fever. She just got the Pfizer COVID-19 vaccine yesterday. She was kind of burning-up but her arm was kind of swollen." When paraphrased the concern, reporter stated, "Yes, her arm is kind of swollen." No follow-up attempts possible. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenitis, Pyrexia
Clinical narrative: I was really tired and I could not leave the bed; shiver and chill and may be low fever; I had very bad collar bone and lymph node in my neck swollen; I have a joint pain like my knee hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EW0150) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1, Pfizer covid-19 vaccine: Yes, Batch/Lot Number:EN6208), administration date: 17Mar2021, when the patient was 33 years old, for Covid 19 immunization, reaction(s): "Sick". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I was really tired and I could not leave the bed"; PYREXIA (non-serious), outcome "unknown", described as "shiver and chill and may be low fever"; LYMPHADENITIS (non-serious), outcome "unknown", described as "I had very bad collar bone and lymph node in my neck swollen"; ARTHRALGIA (non-serious), outcome "unknown", described as "I have a joint pain like my knee hurts". Therapeutic measures were not taken as a result of fatigue, pyrexia, lymphadenitis, arthralgia.  Additional information: After the second shot, the second day of second shot, I was really tired and I could not leave the bed but then all the symptoms were gone on the third day afternoon.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101727151 Same patient and drug, different dose;US-PFIZER INC-202101727462 Same patient and drug, different dose
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: I've experienced headaches that last 2-3 days on and off the last several months since taking the vaccine.; I also feel arm soreness once in awhile at the site the injections were made.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 08May2021 (Lot number: EW0179) at the age of 50 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0170, Anatomical site: left arm), administration date: 17Apr2021, when the patient was 50 years old, for COVID-19 immunisation, reaction: "Vaccination site pain".   The following information was reported: HEADACHE (non-serious) with onset 08May2021, outcome "not recovered", described as "I've experienced headaches that last 2-3 days on and off the last several months since taking the vaccine"; VACCINATION SITE PAIN (non-serious) with onset 08May2021, outcome "not recovered", described as "I also feel arm soreness once in awhile at the site the injections were made". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache and vaccination site pain.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The headaches were new, the patient did not have them prior to taking the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.Have not had any blood tests. Only know that have had headache almost weekly since getting vaccine. Otc pill, Advil, Tylenol, and aspirin does not help them. They last a day or two which is unsuccessful.   Follow-Up (14Dec2021):Follow-up attempts are completed. No further information is expected.  Follow-up (14Feb2022): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP letter sent which included that: Narrative updated.   Follow-up attempts are completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101756922 similar report from same reporter