chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Gait disturbance, Inflammation, Pain
Clinical narrative: inflammatory reaction; burning; back pain; difficulty walking; having a lot of pain walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (ongoing), notes: her sister was in her 20s. The patient's concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "not recovered", described as "inflammatory reaction"; BURNING SENSATION (non-serious), outcome "not recovered", described as "burning"; BACK PAIN (non-serious), outcome "not recovered", described as "back pain"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "difficulty walking"; PAIN (non-serious), outcome "not recovered", described as "having a lot of pain walking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation, burning sensation, back pain, gait disturbance, pain.  Additional information: The reporter stated that for her it slowly started after the first vaccine, after the second dose over the next couple of months she became incapacitated. Brother (patient) had the same issue, x-rayed by doctor, and nothing was found wrong and was put on pain medications. The patient reported he was also having a lot of pain walking, states he could barely walk in the store, then over thanksgiving he spent the holiday with their other sister and she was having the same problems with the pain and the walking after her first dose as well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: inflammatory reaction; burning; back pain; difficulty walking; having a lot of pain walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (ongoing), notes: her sister was in her 20s. The patient's concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "not recovered", described as "inflammatory reaction"; BURNING SENSATION (non-serious), outcome "not recovered", described as "burning"; BACK PAIN (non-serious), outcome "not recovered", described as "back pain"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "difficulty walking"; PAIN (non-serious), outcome "not recovered", described as "having a lot of pain walking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation, burning sensation, back pain, gait disturbance, pain.  Additional information: The reporter stated that for her it slowly started after the first vaccine, after the second dose over the next couple of months she became incapacitated. Brother (patient) had the same issue, x-rayed by doctor, and nothing was found wrong and was put on pain medications. The patient reported he was also having a lot of pain walking, states he could barely walk in the store, then over thanksgiving he spent the holiday with their other sister and she was having the same problems with the pain and the walking after her first dose as well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Has bad body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Has bad body aches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: Patient has no health issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia
Clinical narrative: losing her voice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: current medical condition. Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. The following information was reported: APHONIA (non-serious), outcome "unknown", described as "losing her voice".  Additional information: The patient stated that she was exposed to COVID (Coronavirus Disease) and has been vaccinated but that she did seem to be losing her voice. She had reached out to her HCP (health care professional) and had not heard back yet.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heartbeats; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "Rapid heartbeats". The event "rapid heartbeats" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Hypoaesthesia oral
Clinical narrative: Recently afterwards the side of his tongue went numb; my daughter's dad have been losing our taste.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 32 year-old male patient received bnt162b2 (BNT162B2, solution for injection), administered in arm left (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "Recently afterwards the side of his tongue went numb"; AGEUSIA (non-serious), outcome "unknown", described as "my daughter's dad have been losing our taste.". Therapeutic measures were not taken as a result of hypoaesthesia oral, ageusia.  Additional information: This is the second case out of the 2 cases. Reporter stated, "Can you send me a package. Patient had a miscarriage from the Pfizer. Patient have a baby of 6 weeks old (Further clarification was unknown) and I just got the Pfizer and I think that's the cause of it. Do you need to send me some packet (Further clarification was unknown) or something to fill out or what you want me to do.  Patient had the miscarriage." When confirmed the name of the vaccine as Pfizer COVID-19 vaccine, Reporter stated, "Yeah,  got the vaccination, Pfizer COVID Vaccine with my daughter's dad, we got the number 2 series and then patient had a miscarriage of 6 weeks old on 17Jul and then me and my daughter's dad have been losing our taste. Are we going to get that back. Patient have all paper work and stuff, if you guys need that kind of stuff (Further clarification was unknown, hence checked as initial report). When paraphrased the concern, Reporter stated, "Will me and my daughter's dad get our taste back We are off eventually the vaccination so we can taste again. We are losing our taste from the Pfizer vaccination. When will the taste come back to our mouth? Me and my daughter's dad." Reporter was provided with the contact# for Pfizer Medical Information Department.   Follow-up attempts completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: Swollen lymph node left armpit; Itchy back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 12:00 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 11Feb2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 11Jan2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Dec2021 23:00, outcome "not recovered", described as "Swollen lymph node left armpit"; PRURITUS (non-serious) with onset 02Dec2021 23:00, outcome "not recovered", described as "Itchy back". Therapeutic measures were not taken as a result of lymphadenopathy, pruritus.  Additional information: No other vaccine in fourweeks. Not tested covid post vaccination. No known allergies.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Blood pressure measurement, Depression, Fatigue
Clinical narrative: second vaccine I had that too and had a similar reaction but I had an additional situation with anxiety and depression; put me in the bed for about 2 weeks with just symptomatic stuff; no energy; couldn''t get it together; I am depressed; Fatigue; second vaccine I had that too and had a similar reaction but I had an additional situation with anxiety and depression; 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), administration date 12Feb2021 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot No: EL3247), administration date: 21Jan2021, for COVID-19 Immunization, reaction(s): "tired". The following information was reported: DEPRESSION (non-serious), ANXIETY (non-serious) all with onset 2021, outcome "unknown" and all described as "second vaccine I had that too and had a similar reaction but I had an additional situation with anxiety and depression"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "put me in the bed for about 2 weeks with just symptomatic stuff; no energy; couldn''t get it together; I am depressed"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of depression, asthenia, fatigue, anxiety.  Additional information: The second vaccine I had that too and had a similar reaction but I had an additional situation with anxiety and depression something, I yes, I had anxiety. We all know, we all got that right now but I don't usually have depression and that put me in the bed for about 2 weeks with just symptomatic stuff like that no energy, fatigue and couldn't quite get it together. The patient had always have low blood pressure whole life. Just after the vaccine the patient went to see with doctor to get the regular check up, the patient was given very low dose of blood pressure medication for the first time in my life. So, you know this is not going to work for me.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101721333 similar report from same reporter
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo, Visual impairment, Vomiting
Clinical narrative: Headache; Vomiting; Difficult seeing; Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 (Lot number: FC3180) at the age of 57 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, lot no: FC3180, anatomical location: Arm Left), administration date: 25May2021, for covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "Headache"; VOMITING (non-serious) with onset 26Aug2021, outcome "recovered" (27Aug2021), described as "Vomiting"; VISUAL IMPAIRMENT (non-serious) with onset 26Aug2021, outcome "recovered with sequelae" (27Aug2021), described as "Difficult seeing"; VERTIGO (non-serious) with onset 26Aug2021, outcome "recovering", described as "Vertigo". The events "headache", "vomiting", "difficult seeing" and "vertigo" were evaluated at the emergency room visit.  Additional information: It was reported that Caller states that according to the doctor, he thinks her issues were related to the vaccination. Calle reports that she had a headache, like a knifepick in her head, and it was a debilitating, stabbing pain. Caller also reports she had vomiting, difficulty seeing and vertigo. Caller confirms that she did not have a stroke and was released from the emergency room. Adverse Event: all occurred after second vaccine. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). No, other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Limb discomfort, Pain
Clinical narrative: Dull pain; Pressure in head (especially behind eyeballs); Pressure formed and released in several places such as legs and arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 14:00 (Lot number: EW0180) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Allergy: Onions" (unspecified if ongoing), notes: Allergy: Onions; "possible PMDD" (unspecified if ongoing), notes: possible PMDD; "Neck injury" (unspecified if ongoing), notes: Neck injury; "Allergy: Cinnamon" (unspecified if ongoing), notes: Allergy: Cinnamon; "Allergy: Sulfa drugs (IV)" (unspecified if ongoing), notes: Allergy: Sulfa drugs (IV). Concomitant medication(s) included: ASPIRIN; VITAMIN C; CALCIUM. The following information was reported: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Dull pain"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "recovering", described as "Pressure in head (especially behind eyeballs)"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "recovering", described as "Pressure formed and released in several places such as legs and arm". The events "dull pain", "pressure in head (especially behind eyeballs)" and "pressure formed and released in several places such as legs and arm" were evaluated at the physician office visit and emergency room visit. No follow-up attempts are possible. No further information is expected.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperacusis
Clinical narrative: I had intense headaches with extreme sound sensitivity to all 3 vaccines; I had intense headaches with extreme sound sensitivity to all 3 vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 12:00 (Lot number: ER8730) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ITP (idiopathic thrombocytopenia)" (unspecified if ongoing), notes: ITP (idiopathic thrombocytopenia); "Known allergies: Cioro" (unspecified if ongoing), notes: Known allergies: Cioro. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), HYPERACUSIS (non-serious) all with onset 2021, outcome "unknown" and all described as "I had intense headaches with extreme sound sensitivity to all 3 vaccines".  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting 40 hours after dose 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 17:00 (Lot number: Fl0007) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk5127, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Nov2021, for COVID-19 Immunization. The following information was reported: VOMITING (non-serious) with onset 05Dec2021 09:00, outcome "recovering", described as "Vomiting 40 hours after dose 2". Therapeutic measures were not taken as a result of vomiting. Additional Information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: paresthesia of left shin and foot/paresthesia has continued intermittently to bilateral arms and shins to this date; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Nov2021 14:45 (Lot number: 330308D) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: Sulfa" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: Multivitamins, ZINC; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Past drug history included: Zithromax for product used for unknown indication, reaction(s): "Known allergies: Zithromax". The following information was reported: PARAESTHESIA (non-serious) with onset 26Nov2021, outcome "not recovered", described as "paresthesia of left shin and foot/paresthesia has continued intermittently to bilateral arms and shins to this date"; DIZZINESS (non-serious) with onset 26Nov2021, outcome "unknown", described as "dizziness". Therapeutic measures were not taken as a result of paraesthesia, dizziness.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2020 (Batch/Lot number: unknown) as dose 1, single and administered in arm right, administration date 2020 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar disorder" (unspecified if ongoing), notes: Verbatim: Bipolar disorder; "Thyroid cancer", start date: 1997 (unspecified if ongoing), notes: Since 1997 thyroid cancer; "GERD" (unspecified if ongoing), notes: I take an Omeprazole which is for GERD its for stomach if you had acid reflux.; "having trouble sleeping" (unspecified if ongoing), notes: having trouble sleeping; "some mental condition" (unspecified if ongoing), notes: I have some mental condition. Concomitant medication(s) included: GABAPENTIN; SYNTHROID; OMEPRAZOLE taken for gastrooesophageal reflux disease; XANAX taken for initial insomnia; NEURONTIN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "A little arm pain".  Additional information: Patient's arm was really bad she could hardly lift it.Expiry Date of COVID-19 Vaccine: 28Feb2022.Patient got her booster in morning at about 10 O'clock. She had thyroid cancer history but that's been gone since 1997.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 16:00 (Lot number: EW0170) at the age of 33 years as dose 2, single and administered in arm left, administration date 02Apr2021 08:30 (Lot number: ER8734) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of pain in extremity, fatigue. Additional information: The patient would like to mention after my 1st and 2nd dose I had almost no side effects. Just a sore arm and tiredness. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. The patient had no known allergies. The patient received iron supplements 25 mg within two weeks of vaccination. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: painful swollen lymph node(s) in my right arm pit; painful swollen lymph node(s) in my right arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Apr2021 12:00 (Lot number: ER8735) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Known allergies: bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 04Apr2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 26Apr2021, outcome "recovered" (Apr2021) and all described as "painful swollen lymph node(s) in my right arm pit". The event "painful swollen lymph node(s) in my right arm pit" and "painful swollen lymph node(s) in my right arm pit" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and receive vitamins, supplements within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue; her arm ached; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Amlyodosis" (unspecified if ongoing), notes: Patient has amlyodosis and had stem cell transplant 6 years ago; "Stem cell" (unspecified if ongoing), notes: Patient has amlyodosis and had stem cell transplant 6 years ago. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm ached".  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: Vaccination site bruising
Clinical narrative: Bruising 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 (COMIRNATY), administered in arm left, administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 15Nov2021. Vaccination history included: Bnt162b2 (Dose 1, single, Location of injection: Arm Left), administration date: 09Nov2021, when the patient was 9 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 03Dec2021, outcome "recovering", described as "Bruising at injection site". Therapeutic measures were not taken as a result of vaccination site bruising.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain with all three doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 05Feb2021 (Lot number: EL9269) at the age of 67 years as dose 1, single and administered in arm left, administration date 26Feb2021 (Lot number: EN6202) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovering", described as "injection site pain with all three doses".  Additional information: The patient has not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine, and patient has not administered additional Vaccines on same date of the Pfizer suspect. Is report related to a study or programme- Yes.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 13:15 (Lot number: ER8727) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN; VITAMIN D 2000. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 27Feb2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue". Additional information: The lymph node adverse event was new, After my 2nd dose & 3rd dose I had chills, and fatigue that lasted less then 24 hours.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Arm soreness at injection site; Fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 8 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injection site"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Heart rate increased
Clinical narrative: Fast heartbeat; Stomach pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 11:00 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Innocent Heart murmur/abnormality as baby" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 05Dec2021 18:15, outcome "unknown", described as "Fast heartbeat"; ABDOMINAL PAIN UPPER (non-serious) with onset 05Dec2021 18:15, outcome "unknown", described as "Stomach pain". Therapeutic measures were not taken as a result of heart rate increased, abdominal pain upper. No follow-up attempts are possible. No further information is expected.  Additional Information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, was the patient diagnosed with COVID-1.Since the vaccination, the patient has not been tested for COVID-19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: it was not even as sore as before with the other shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 73 years as dose 1, single and administered in arm left, administration date 18Mar2021 (Lot number: EN6207, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE taken for arthritis. Vaccination history included: Flu shot (Caller reports she takes flu shots every year and no reactions to report). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "it was not even as sore as before with the other shots".  Additional information:Investigation Assessment was no.It was reported that  the soreness lasted a few days but it was not even as sore as before with the other shots though that might had been because she is taking prednisone due to arthritis. Patient  reports she takes flu shots every year and no reactions to report.Additional Vaccines Administered on Same Date of the Pfizer Suspect was  none. Emergency Room and Physician Office visit was no.AE(s) following prior vaccinations: sore arm, tired.Relevant Tests were none.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm for 5days; 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), administered in arm right, administration date 03Mar2021 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "Cholesterol" (unspecified if ongoing), notes: Cholesterol; "High blood" (unspecified if ongoing), notes: High blood; "prostate" (unspecified if ongoing), notes: prostate. Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus (ongoing); SIMVASTATIN taken for blood cholesterol abnormal (ongoing); TAMSULOSIN taken for prostate infection (ongoing); LISINOPRIL taken for hypertension (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "unknown", described as "Sore Arm for 5days". No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with Covid vaccine that lasted 45 minutes.; Temperature excursion with Covid vaccine that lasted 45 minutes.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "Temperature excursion with Covid vaccine that lasted 45 minutes.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinusitis
Clinical narrative: I have got a little head cold/I got cold; I have got my sinus; 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) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I have got a little head cold/I got cold"; SINUSITIS (non-serious), outcome "unknown", described as "I have got my sinus".  Additional Information: Consumer stated, "I have got an appointment this morning at 9:00 and it is 07:30 here, I made an appointment last week, I have got a little head cold, this is normal. So, I was wondering, will they stop me from getting my shot? I am taking my booster shot today at 09:00." (Head cold-captured as event since further clarification about if consumer was experiencing head cold after getting first and second vaccine shot was unknown).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Haemoglobin, Haemoglobin decreased, Inappropriate schedule of product administration, Menstrual disorder
Clinical narrative: First dose was received on 26Jul2021 and second dose was received on 14Oct2021; I have been bleeding so much too, it lowered my hemoglobin; heavy menstrual cycle lasting over 17 days; Almost got me a block heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (004756). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Oct2021 03:00 (Lot number: EW0151) at the age of 31 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 was 2 O' clock), administration date: 26Jul2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "heavy menstrual cycle lasting over 17 days"; ATRIOVENTRICULAR BLOCK (non-serious) with onset 2021, outcome "unknown", described as "Almost got me a block heart"; HAEMOGLOBIN DECREASED (non-serious) with onset Oct2021, outcome "unknown", described as "I have been bleeding so much too, it lowered my hemoglobin"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "First dose was received on 26Jul2021 and second dose was received on 14Oct2021". The events "heavy menstrual cycle lasting over 17 days", "almost got me a block heart" and "i have been bleeding so much too, it lowered my hemoglobin" 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 menstrual disorder.  Additional information included: The patient did not start missing it, she had very strong menstrual heavy cycle for over 17 days. She was bleeding for atleast 10 days. It real came back to the point that she ended up in the hospital. She was put on a medication (Tranexamic acid 650mg, NDC number - 255926530, three times a day, medication for 5 days) to try and stop the heavy menstrual cycle which did not work, which almost got her a block heart. She was bleeding so much too, it lowered her hemoglobin. So, that's why she was trying to figure out what's actually in the vaccine because she had an appointment with her OB-GYN at 1:30. So, she could discuss with him the ingredients that was actually in the Pfizer so, doctor could treat her accordingly. The patient did not take any prior vaccination (4 Weeks).  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Physical examination
Clinical narrative: First dose was received on 26Jul2021 and second dose was received on 14Oct2021; I have been bleeding so much too, it lowered my hemoglobin; heavy menstrual cycle lasting over 17 days; Almost got me a block heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (004756). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Oct2021 03:00 (Lot number: EW0151) at the age of 31 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 was 2 O' clock), administration date: 26Jul2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "heavy menstrual cycle lasting over 17 days"; ATRIOVENTRICULAR BLOCK (non-serious) with onset 2021, outcome "unknown", described as "Almost got me a block heart"; HAEMOGLOBIN DECREASED (non-serious) with onset Oct2021, outcome "unknown", described as "I have been bleeding so much too, it lowered my hemoglobin"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "First dose was received on 26Jul2021 and second dose was received on 14Oct2021". The events "heavy menstrual cycle lasting over 17 days", "almost got me a block heart" and "i have been bleeding so much too, it lowered my hemoglobin" 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 menstrual disorder.  Additional information included: The patient did not start missing it, she had very strong menstrual heavy cycle for over 17 days. She was bleeding for atleast 10 days. It real came back to the point that she ended up in the hospital. She was put on a medication (Tranexamic acid 650mg, NDC number - 255926530, three times a day, medication for 5 days) to try and stop the heavy menstrual cycle which did not work, which almost got her a block heart. She was bleeding so much too, it lowered her hemoglobin. So, that's why she was trying to figure out what's actually in the vaccine because she had an appointment with her OB-GYN at 1:30. So, she could discuss with him the ingredients that was actually in the Pfizer so, doctor could treat her accordingly. The patient did not take any prior vaccination (4 Weeks).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: after her first dose of the vaccine she had a super sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: ER2613) 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: PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "after her first dose of the vaccine she had a super sore arm".  Additional information: Patient side effects began either the next day or that evening, it wasn't immediate. patient says that she couldn't sleep that evening because patient couldn't sleep on that side that night, so it must have begun that evening on 23Mar2021. It lasted about 3 days. Patient second dose of the vaccine on 13Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on left Arm around shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 08:00 (Lot number: EW0150) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, Batch/Lot No: ER2613 , Location of injection: Arm Left , Vaccine Administration Time: 08:00 AM), administration date: 17Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 09Apr2021 08:00, outcome "recovered" (17Apr2021 08:00), described as "Rash on left Arm around shot". Therapeutic measures were not taken as a result of vaccination site rash.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: a little dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 10Mar2021 (Lot number: EN6200) at the age of 62 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: DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "a little dizziness".  Additional information: Other Products: No. Patient History: No. Investigation Assessment: No. Reporter and his wife took the booster dose of Pfizer COVID-19 vaccine and are experiencing adverse events. Pfizer COVID-19 vaccine: Reporter says his wife's first dose was 10Mar2021 of LOT: EN6200, and second dose was 01Apr2021 of EN6206. He says NDC/EXP was not provided for any of her doses. Reporter says they are both pretty fit, and his wife works out 4 days a week, and he lifts 4 times at least a week. He says they can both get on a trail and hike 15 miles and be fine, they are in the upper percentages of health for their age. He says after their first vaccine dose they both had a little dizziness that was not bad, they were fine. Concomitant Medications: Reporter says his wife takes no medications, she was very fit.  Follow-up attempts are completed. No further information is expected.