chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: vomiting; sore arm; chills; Fever; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101864732 (Pfizer).  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Dec2021 13:45 (Batch/Lot number: unknown) at the age of 29 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: 1, Batch/Lot No: Unknown. Misplaced/discarded), administration date: 22May2021, when the patient was 29 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded), administration date: 19Jun2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Dec2021 13:45, outcome "unknown", described as "booster"; VOMITING (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "vomiting"; PAIN IN EXTREMITY (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "sore arm"; CHILLS (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information : Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events Reported: Fever, sore arm, chills, vomiting. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; sore arm; chills; Fever; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101864732 (Pfizer).  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Dec2021 13:45 (Batch/Lot number: unknown) at the age of 29 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: 1, Batch/Lot No: Unknown. Misplaced/discarded), administration date: 22May2021, when the patient was 29 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded), administration date: 19Jun2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Dec2021 13:45, outcome "unknown", described as "booster"; VOMITING (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "vomiting"; PAIN IN EXTREMITY (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "sore arm"; CHILLS (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information : Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events Reported: Fever, sore arm, chills, vomiting. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Severe pain and swelling under arm (same arm as vaccine); Severe pain and swelling under arm (same arm as vaccine); chills; fever; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 17:15 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfa antibiotis" (unspecified if ongoing), notes: known allergies: Sulfa antibiotis. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 21Mar2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "No events after first dose"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "Severe pain and swelling under arm (same arm as vaccine): Same symptoms after second", "Severe pain and swelling under arm (same arm as vaccine): Same symptoms after second", "chills: Same symptoms after second", "Fever: Same symptoms after second". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 17:15, outcome "unknown", described as "dose received: 3"; SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 23Dec2021 14:00, outcome "recovering" and all described as "Severe pain and swelling under arm (same arm as vaccine)"; CHILLS (non-serious) with onset 23Dec2021 14:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 23Dec2021 14:00, outcome "recovering", described as "fever". Therapeutic measures were not taken as a result of swelling, pain in extremity, chills, pyrexia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Severe pain and swelling under arm (same arm as vaccine), fever, chills. Same symptoms after second and third vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation
Clinical narrative: I got my booster shot yesterday; I had a chill last night; I got a headache; 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 23Dec2021 (Lot number: FJ8757) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "I got my booster shot yesterday"; CHILLS (non-serious) with onset 23Dec2021, outcome "unknown", described as "I had a chill last night"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "I got a headache".  Additional information: Consumer stated, "I can't find information. I got my booster shot yesterday and I had a chill last night and I got a headache and I am wondering my great grandchildren are supposed to come over. Are they not safe? Is it not safe for them to come over seeing that I had these side effects."  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass, Furuncle, Immunisation
Clinical narrative: large painful boils and lumps in my armpits and under breasts; large painful boils and lumps in my armpits and under breasts; large painful boils and lumps in my armpits and under breasts; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 16:00 (Lot number: FJ1620) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, lot number: EW0176, administration time: 04:00PM, location: Left arm,), administration date: 27Apr2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, lot number: ER8737, administration time: 02:00PM, location: Left arm), administration date: 06Apr2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 16:00, outcome "unknown", described as "dose number=3"; FURUNCLE (non-serious), AXILLARY MASS (non-serious), BREAST MASS (non-serious) all with onset 13Dec2021 12:00, outcome "not recovered" and all described as "large painful boils and lumps in my armpits and under breasts".  Additional information: After 3 dose (booster) patient have been experiencing large painful boils and lumps in her armpits and under breasts. Patient has not suffered from covid prior vaccination and has not been tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Inappropriate schedule of product administration, Off label use
Clinical narrative: Booster; received the booster Pfizer covid vaccine dose on 27 Dec 2021,  5 months after the second doses which she received on 30 July 2021; received the booster Pfizer covid vaccine dose on 27 Dec 2021,  5 months after the second doses which she received on 30 July 2021; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 46 -old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 (Lot number: FD7218, Expiration Date: May2022) at the age of 46 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose , Date: 09Jul2021, NDC: 59267-1000-01, Lot: EW0196, Expiration: Sep2021, Site: Right arm), administration date: 09Jul2021, when the patient was 45 years old, for Covid-19 Immunization; Bnt162b2 (Second dose, Date: 30Jul2021, NDC: 59267-1000-01, Lot: FA7485, Expiration: Oct2021, Site: Right arm), administration date: 30Jul2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 27Dec2021, outcome "unknown" and all described as "received the booster Pfizer covid vaccine dose on 27 Dec 2021,  5 months after the second doses which she received on 30 July 2021".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Drug intolerance, Immunisation, Malaise
Clinical narrative: dry cough/ coughing; not feeling well; booster shot; too strong for her body; physically weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 24Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "wife's immune is kind of slower" (unspecified if ongoing), notes: States his wife's immune is kind of slower. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Dec2021, outcome "unknown", described as "booster shot"; COUGH (non-serious) with onset 26Dec2021, outcome "not recovered", described as "dry cough/ coughing"; MALAISE (non-serious) with onset 26Dec2021, outcome "not recovered", described as "not feeling well"; ASTHENIA (non-serious) with onset Dec2021, outcome "not recovered", described as "physically weak"; DRUG INTOLERANCE (non-serious) with onset 24Dec2021, outcome "unknown", described as "too strong for her body".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Tinnitus
Clinical narrative: his closest friend who got the Moderna mRNA second dose/had a booster; Off Label Use; his friend had a booster; friend had a booster it worsened his tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing), notes: he knows someone who had tinnitus already. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Moderna vaccine (Dose: 2, got the Moderna mRNA second dose and lost hearing a couple of days after that in his left ear), for Covid-19 Immunization, reaction(s): "lost hearing a couple of days after that in his left ear". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "his closest friend who got the Moderna mRNA second dose/had a booster"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off Label Use"; IMMUNISATION (non-serious), outcome "unknown", described as "his friend had a booster"; TINNITUS (non-serious), outcome "unknown", described as "friend had a booster it worsened his tinnitus".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Influenza like illness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Booster; Minor flu like symptoms; Swelling in the arm; pain; Minor fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovering", described as "Minor flu like symptoms"; PERIPHERAL SWELLING (non-serious), outcome "recovering", described as "Swelling in the arm"; PAIN (non-serious), outcome "recovering", described as "pain"; PYREXIA (non-serious), outcome "recovering", described as "Minor fever".  Additional information: The report was not related to a study or programme. NDC number, expiry date and investigation assessment were not provided. The patient had minor flu like symptoms, which started two days later. Ten hours later he got minor fever, swelling in the arm, and pain. After two days, 48 hours, he was like 80-90% recovered. He thought he was ok.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: injection arm hurts really bad; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 24Dec2021 (Lot number: 331308A) 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 2, lot number ER8729), administration date: 21Apr2021, for Covid-19 immunization, reaction(s): "Covid"; Bnt162b2 (Dose 1, lot number ER8733), administration date: 24Mar2021, for Covid-19 immunization, reaction(s): "Covid".  The following information was reported: IMMUNISATION (non-serious) with onset 24Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection arm hurts really bad".
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Peripheral coldness
Clinical narrative: feels the injection is "breaking the bones" in her arm,; hands and feet are cold; 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 61 year-old female patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "osteoporosis" (unspecified if ongoing), notes: Caller was diagnosed with osteoporosis six years ago. The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "feels the injection is "breaking the bones" in her arm,"; PERIPHERAL COLDNESS (non-serious) with onset Dec2021, outcome "unknown", described as "hands and feet are cold".  Additional info: Caller would like to know whether she can take Aleve for pain symptoms following Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Bone pain, Pain in extremity, Peripheral coldness, Vaccination site movement impairment
Clinical narrative: feels the injection is "breaking the bones" in her arm,; hands and feet are cold; 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 61 year-old female patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "osteoporosis" (unspecified if ongoing), notes: Caller was diagnosed with osteoporosis six years ago. The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "feels the injection is "breaking the bones" in her arm,"; PERIPHERAL COLDNESS (non-serious) with onset Dec2021, outcome "unknown", described as "hands and feet are cold".  Additional info: Caller would like to know whether she can take Aleve for pain symptoms following Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Neck pain, Pyrexia
Clinical narrative: dose number 3; had high fevers; suffered neck and joint pain; suffered neck and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received bnt162b2 (BNT162B2), administration date 28Nov2021 (Batch/Lot number: unknown) 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. , The patient had high fevers after each dose of the vaccine.), for COVID-19 immunization, reaction(s): "had high fever"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , The patient had high fevers after each dose of the vaccine.), for COVID-19 immunization, reaction(s): "had high fever". The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021, outcome "unknown", described as "dose number 3"; PYREXIA (non-serious) with onset 28Nov2021, outcome "recovered" (29Nov2021), described as "had high fevers"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 28Nov2021, outcome "recovered" (30Nov2021) and all described as "suffered neck and joint pain".  Clinical course: The patient had high fevers after each dose of the vaccine.  The third dose had the worst fevers that lasted a day. The patient also suffered neck and joint pain for two days since the third dose was injected. Reporter assessed case as non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Urticaria
Clinical narrative: Hives; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 03Dec2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9810), administration date: 04Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248), administration date: 12Jan2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; URTICARIA (non-serious) with onset 24Dec2021, outcome "not recovered", described as "Hives". Therapeutic measures were not taken as a result of urticaria.  Additional Information: 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. No COVID-19 tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Immunisation
Clinical narrative: booster; her girlfriend may never walk again from this; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "her girlfriend may never walk again from this".  Additional information: Reporter wants to know when Pfizer is going to say that Pfizer shots are not wonderful. Mentioned that she knows people got paralyzed and blood clots as soon as they took a booster shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation
Clinical narrative: she received her COVID Booster; Fatigue; Chills; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose number Unknown), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "she received her COVID Booster"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Immunisation, Tinnitus
Clinical narrative: I have a terrible ringing in my ear and a bad pain in my ear; I have a terrible ringing in my ear and a bad pain in my ear; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old male patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Lot number: FD7218) at the age of 23 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "booster"; EAR PAIN (non-serious), TINNITUS (non-serious) all with onset 28Dec2021, outcome "unknown" and all described as "I have a terrible ringing in my ear and a bad pain in my ear". Therapeutic measures were taken as a result of ear pain, tinnitus.  Additional information: Consumer stated, "he like to report an adverse side effect from, have the question about it, he got booster shot yesterday and now he had a terrible ringing in his ear and a bad pain in his ear and he didn't know that was the common, he couldn't find anything online about that being a side effect so he wanted to see if that side effect was reported before or it was anything known about that." Consumer stated that he wanted to know if that's a common side effect, if not he would like to report it.The patient took Ibuprofen, like over a counter pain medication. Consumer didn't see the expiration date on vaccine card. Consumer stated he had no underline conditions and I take no medications." Further probing was not done. Hence, limited information was available over the call. Patient had no family history.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Immunisation, Swelling
Clinical narrative: Extreme swelling in arm pit and breast area; hot to touch areas swollen; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient received BNT162b2 (BNT162B2), administered in arm right, administration date 27Dec2021 14:00 (Lot number: FE3594) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 01May2021, when the patient was 47 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 10Apr2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 14:00, outcome "unknown", described as "Dose Number: 3"; SWELLING (non-serious) with onset 28Dec2021 12:00, outcome "not recovered", described as "Extreme swelling in arm pit and breast area"; FEELING HOT (non-serious) with onset 28Dec2021 12:00, outcome "not recovered", described as "hot to touch areas swollen". It was unknown if therapeutic measures were taken as a result of swelling, feeling hot.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID prior to vaccination and since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Immunisation, Pain
Clinical narrative: Diarrhea; chills; low grade fever; body aches; fatigue; Dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 11:45 (Lot number: FD7218) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Known allergies: Sugar" (unspecified if ongoing); "Known allergies: wheat, corn" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; SUMATRIPTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left), administration date: 12Apr2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 11:45, outcome "unknown", described as "Dose number = 3"; DIARRHOEA (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "Diarrhea"; CHILLS (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "low grade fever"; PAIN (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of diarrhoea, chills, pyrexia, pain, fatigue.  Additional Information : Prior to vaccination and since the vaccination the patient had not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received multivitamin within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; chills; low grade fever; body aches; fatigue; Dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 11:45 (Lot number: FD7218) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Known allergies: Sugar" (unspecified if ongoing); "Known allergies: wheat, corn" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; SUMATRIPTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left), administration date: 12Apr2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 11:45, outcome "unknown", described as "Dose number = 3"; DIARRHOEA (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "Diarrhea"; CHILLS (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "low grade fever"; PAIN (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 27Dec2021 17:45, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of diarrhoea, chills, pyrexia, pain, fatigue.  Additional Information : Prior to vaccination and since the vaccination the patient had not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received multivitamin within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Night sweats
Clinical narrative: received the Pfizer/BioNTech booster; Night sweats; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 45 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: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "received the Pfizer/BioNTech booster"; NIGHT SWEATS (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "Night sweats"; CHILLS (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "Chills". Therapeutic measures were not taken as a result of night sweats, chills.  Additional Information:  Reported Event: Middle aged female who received the Pfizer/BioNTech booster developed sweating (PT Night sweats) and chills (PT Chills) in the middle of the night. Patient recovered from the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  No Hospitalization Prolonged. Facility where the most recent COVID-19 vaccine was administered was Unknown. Serious was reported as No. Seriousness criteria Results in death, Life threatening was no. Seriousness criteria Caused/prolonged hospitalization was no. Seriousness criteria Disabling/Incapacitating was no. Seriousness criteria Congenital anomaly/birth defect was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Muscular weakness, Neuralgia, Pain
Clinical narrative: raised rash; nerve psi / Nerve pain; Arm weakness; Body aches; Rash turned into large red patch before fading; Rash turned into large red patch before fading; 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 21Dec2021 10:45 (Lot number: FL3197) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 20Apr2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 30Mar2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 10:45, outcome "recovered", described as "3rd dose"; RASH PAPULAR (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "raised rash"; NEURALGIA (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "nerve psi / Nerve pain"; MUSCULAR WEAKNESS (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "Arm weakness"; PAIN (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "Body aches"; RASH (non-serious), ERYTHEMA (non-serious) all with onset 21Dec2021 18:00, outcome "recovered" and all described as "Rash turned into large red patch before fading". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of immunisation, rash papular, neuralgia, muscular weakness, pain, rash, erythema. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The AE treatment was given with gabapentin.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, SARS-CoV-2 test
Clinical narrative: raised rash; nerve psi / Nerve pain; Arm weakness; Body aches; Rash turned into large red patch before fading; Rash turned into large red patch before fading; 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 21Dec2021 10:45 (Lot number: FL3197) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 20Apr2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 30Mar2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 10:45, outcome "recovered", described as "3rd dose"; RASH PAPULAR (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "raised rash"; NEURALGIA (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "nerve psi / Nerve pain"; MUSCULAR WEAKNESS (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "Arm weakness"; PAIN (non-serious) with onset 21Dec2021 18:00, outcome "recovered", described as "Body aches"; RASH (non-serious), ERYTHEMA (non-serious) all with onset 21Dec2021 18:00, outcome "recovered" and all described as "Rash turned into large red patch before fading". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of immunisation, rash papular, neuralgia, muscular weakness, pain, rash, erythema. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The AE treatment was given with gabapentin.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Disorientation, Dizziness, Immunisation, Productive cough
Clinical narrative: 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 78 year-old male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 78  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-1, The first and second doses of the vaccine he and his wife had no problems), for Covid-19 immunization, reaction(s): "no problems"; Bnt162b2 (DOSE-2, The first and second doses of the vaccine he and his wife had no problems), for Covid-19 immunization, reaction(s): "no problems". The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "unknown", described as "booster"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DISORIENTATION (non-serious), outcome "unknown", described as "Disoriented"; PRODUCTIVE COUGH (non-serious), COUGH (non-serious), outcome "unknown" and all described as "Coughing up Phlegm". Additional information: It was reported that patient and his wife, began feeling dizzy, disoriented and coughing up phlegm since being administered the Pfizer booster dose and want to know has this been reported by other. After the first and second doses of the vaccine he and his wife had no problems but began to experience symptoms after receiving the booster dose. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202101878726 different patient, same drug and event.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Immunisation, Musculoskeletal discomfort, SARS-CoV-2 test
Clinical narrative: hard and tight pressure on the right side of my chest; pressure also on my right back; Booster; 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Dec2021 17:00 (Lot number: 331308A) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient had no known allergies. The patient had no other medical history. Concomitant medication(s) included: ZYTREC; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer-Biontech,, prev dose brand unknown=False,, prev dose lot number=EW0168,, prev dose lot unknown=False,, prev dose administration date=04May2021,, prev dose dose number=2), administration date: 04May2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer-Biontech,, prev dose brand unknown=False,, prev dose lot number=ER8731,, prev dose lot unknown=False,, prev dose administration date=13Apr2021, prev dose dose number=1), administration date: 13Apr2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 17:00, outcome "unknown", described as "Booster"; CHEST DISCOMFORT (non-serious) with onset 23Dec2021, outcome "recovering", described as "hard and tight pressure on the right side of my chest"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 23Dec2021, outcome "recovering", described as "pressure also on my right back". The events "hard and tight pressure on the right side of my chest" and "pressure also on my right back" 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 not taken as a result of chest discomfort, musculoskeletal discomfort.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Immunisation, Paraesthesia
Clinical narrative: 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 24 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "booster dose"; FEELING COLD (non-serious) with onset 28Dec2021, outcome "unknown", described as "feet and legs as well as hands and arms feel cool"; PARAESTHESIA (non-serious) with onset 28Dec2021, outcome "unknown", described as "she got pins and needles sensation". Additional information: Patient received Comirnaty booster dose on Monday and day before reporting got pins and needles sensation and her feet and legs as well as he hands, and arms feel cool. Patient did not know whether these were normal and already called the doctor and was told to Pfizer. The lot number for bnt162b2 was not provided and will be requested during follow up.