chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Ear pain, Lethargy, Pain
Clinical narrative: dizziness; body aches in almost all joints of body; body aches in almost all joints of body; earache; lethargy; heart palpitations/flutterings; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Jan2022 19:15 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: METHENAMINE. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, prev dose product: COVID 19, prev dose brand: Phizer , prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose administration date: 25May2021, prev dose vaccine location: Left arm), administration date: 25May2021, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, prev dose product: COVID 19, prev dose brand: Phizer , prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose administration date: 04May2021), administration date: 04May2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 06Jan2022, outcome "not recovered", described as "dizziness"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 06Jan2022, outcome "not recovered" and all described as "body aches in almost all joints of body"; EAR PAIN (non-serious) with onset 06Jan2022, outcome "not recovered", described as "earache"; LETHARGY (non-serious) with onset 06Jan2022, outcome "not recovered", described as "lethargy"; PALPITATIONS (non-serious) with onset 06Jan2022, outcome "not recovered", described as "heart palpitations/flutterings". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, pain, arthralgia, ear pain, lethargy, palpitations.  Additional information: The patient had no other vaccine in four weeks. No covid prior vaccination. The patient covid tested post vaccination. Covid test post vaccination: covid test type post vaccination: Nasal Swab, covid test name post vaccination: Rapid Test, covid test date: 05Jan2022, covid test result: Negative. Known allergies: No.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 antibody test
Clinical narrative: dizziness; body aches in almost all joints of body; body aches in almost all joints of body; earache; lethargy; heart palpitations/flutterings; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Jan2022 19:15 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: METHENAMINE. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, prev dose product: COVID 19, prev dose brand: Phizer , prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose administration date: 25May2021, prev dose vaccine location: Left arm), administration date: 25May2021, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, prev dose product: COVID 19, prev dose brand: Phizer , prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose administration date: 04May2021), administration date: 04May2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 06Jan2022, outcome "not recovered", described as "dizziness"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 06Jan2022, outcome "not recovered" and all described as "body aches in almost all joints of body"; EAR PAIN (non-serious) with onset 06Jan2022, outcome "not recovered", described as "earache"; LETHARGY (non-serious) with onset 06Jan2022, outcome "not recovered", described as "lethargy"; PALPITATIONS (non-serious) with onset 06Jan2022, outcome "not recovered", described as "heart palpitations/flutterings". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, pain, arthralgia, ear pain, lethargy, palpitations.  Additional information: The patient had no other vaccine in four weeks. No covid prior vaccination. The patient covid tested post vaccination. Covid test post vaccination: covid test type post vaccination: Nasal Swab, covid test name post vaccination: Rapid Test, covid test date: 05Jan2022, covid test result: Negative. Known allergies: No.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site; pain in the muscle; pain in the muscle & shoulder joint; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site"; MYALGIA (non-serious), outcome "unknown", described as "pain in the muscle"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain in the muscle & shoulder joint"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: very bad 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 05Jan2022 (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 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "very bad headache".  Additional information: First Name: withheld (Further not appropriately clarified hence captured Unknown in tab; Initial of First name clarified as I hence Patient Initials captured as withheld in Initials tab) Concern: Consumer stated, "I got the Pfizer booster (Further clarification unknown hence suspect captured as Unspecified Product) yesterday and I have a very bad headache and I must looking on there to see if I can take some Tylenol but they are saying that I cannot (Further clarification Unknown). All day (Incomplete Sentence)." When probed if patient has any query: Consumer further stated, "No, I just need to find out and see what I can take?" Consumer was informed about the role of the Pfizer Drug Safety. Consumer was informed about the Medical Information Department. Consumer stated, "Can you transfer me to that department?" Consumer was provided with the Pfizer Medical Information contact # as withheld and requested to press Option#3 and informed about timings from 9 am to 8 pm. Consumer stated, "This is so 'hard' for me, just please transfer me." The call got disconnected while transferring the call to Pfizer Medical Information department. Further probing could not be done. Transfer Incomplete. Product details (LOT#, Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed. Hence limited information available over the call.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, (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: MALAISE (non-serious), outcome "unknown", described as "did not feel well".  Updated Information included: Reporter was not sure about the manufacturer or the dosage received.   The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Inappropriate schedule of product administration, Migraine, Scoliosis
Clinical narrative: she sees her neurologist every 3 months for migraines; shot in Jan2021 and in early Feb2021 and got boostered in Jul2021; scoliosis; fibromyalgia; 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 69 year-old female patient received bnt162b2 (COMIRNATY), administration date Jul2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "INFLUENZA VACCINE" (unspecified if ongoing), notes: gets the flu shot every year and other boosters. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 2), administration date: Feb2021, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "she sees her neurologist every 3 months for migraines"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "shot in Jan2021 and in early Feb2021 and got boostered in Jul2021"; SCOLIOSIS (non-serious) with onset 2021, outcome "unknown", described as "scoliosis"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "fibromyalgia".  Additional Information: Caller states she had her shot in Jan2021 and in early Feb2021 and got boostered in Jul2021. Caller would like to know if there is any information regarding emergency authorization for a second booster? Caller states it has been 6 months and she believes in these shots. Caller states she gets the flu shot every year and other boosters. Caller states she side effects to any of the vaccines. Caller states she sees her neurologist every 3 months for migraines and has a primary care doctor and orthopedics. Caller states she is in a location where she believes we were doing some research in which is 20 miles from her house. Caller states she is willing to go into a testing protocol. Caller states she would be more than happy to be a test subject but states she does not want the placebo and she wants the real thing. Caller states she is willing to be a participant in the clinical trial? Description of Potential AE I live in (State and city name) and I got my Pfizer Covid vaccine very early last year and got my booster in July. I want to know if there will be a second booster. I want to get in a trial if there is one. I have migraines, scoliosis and fibromyalgia. I have done a trial before for migraines and I think that big pharma helps but I think the government is trying to scare everyone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeding disorder, Feeling abnormal, Headache, Vomiting
Clinical narrative: Yesterday was really weird; Today she is not eating; Vomiting; Stomach pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Yesterday was really weird"; FEEDING DISORDER (non-serious), outcome "unknown", described as "Today she is not eating"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pain"; HEADACHE (non-serious), outcome "unknown", described as "Headache".    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Hardness in the arm, stiff arm that was fine; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovered", described as "Hardness in the arm, stiff arm that was fine".  Additional information: Patient had been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Tachycardia
Clinical narrative: tachycardia; Too bad with asthma; This is a spontaneous report received from 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 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: TACHYCARDIA (non-serious), outcome "unknown", described as "tachycardia"; ASTHMA (non-serious), outcome "unknown", described as "Too bad with asthma". Therapeutic measures were taken as a result of tachycardia.  Additional information: The patient had horrible tachycardia due to which the patient had to use half a dose with distilled water and so I tolerate it a little. The patient was shot by that asthma monster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: I contracted dermatographia; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jun2021 (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: MECHANICAL URTICARIA (non-serious) with onset Jul2021, outcome "unknown", described as "I contracted dermatographia".  Additional information: Patient had COVID-19 vaccine in late Jun2021 and beginning early Jul2021 and contracted dermatographia. Patient was just seeing if anyone else had been experiencing these side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: gotten Covid at some point prior to this report; gotten Covid at some point prior to this report; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult 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: Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "gotten Covid at some point prior to this report"; COUGH (non-serious), outcome "recovering", described as "Had a rough sounding cough".  She stated was "recovering" in office (i am a contract worker), believe was referring to recovering from Covid. Had a rough sounding cough. Most people in the office are at least fully vaccinated, though I do not know which vaccine has received. Probably in late 30s or 40s for age. Do not know year but date is 30Jul I haven't gotten specific follow-up at this time, but [Name] from what I heard seems to have gotten Covid at some point prior to this report submission and was recovering. They were in the office space (as they were probably well enough to do so and past contagious point). Most people in the office are vaccianted, so I believe she is too.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: doesn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Formulation: solution for injection, 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: MALAISE (non-serious), outcome "unknown", described as "doesn't feel well".  Follow-up attempts are possible. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200038504 Same reporter/drug, different drugpatient, and similar event
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Hot flush, Menopausal symptoms, Product use issue
Clinical narrative: menstrual stopped completely; hot flashes; pre menopausal symptom; Other vaccine same date vaccine date 15Oct2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Oct2021 (Lot number: Fe3592) at the age of 51 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Muscle spasms" (unspecified if ongoing); "anemia" (unspecified if ongoing); "mitral valve" (unspecified if ongoing); "prolapse" (unspecified if ongoing), notes: mitral valve prolapse. Concomitant medication(s) included: FLU, administration date 15Oct2021; VITAMIN D3; TYLENOL; ZINC; BACLOFEN. Past drug history included: Flagyl, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8732, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6204, Location of injection: Arm Right), administration date: 05Mar2021, when the patient was 51 years old, for Covid-19 Immunization. The following information was reported: AMENORRHOEA (non-serious) with onset 15Oct2021, outcome "not recovered", described as "menstrual stopped completely"; HOT FLUSH (non-serious) with onset 15Oct2021, outcome "not recovered", described as "hot flashes"; MENOPAUSAL SYMPTOMS (non-serious) with onset 15Oct2021, outcome "not recovered", described as "pre menopausal symptom"; PRODUCT USE ISSUE (non-serious) with onset 15Oct2021, outcome "not recovered", described as "Other vaccine same date vaccine date 15Oct2021". The events "menstrual stopped completely", "hot flashes", "pre menopausal symptom" and "other vaccine same date vaccine date 15oct2021" were evaluated at the physician office visit. Therapeutic measures were taken as a result of amenorrhoea, hot flush, menopausal symptoms, product use issue.  Additional information: Patient was advised to take magnesium for hot flashes. The patient was not diagnosed with covid prior to vaccination. The patient was not tested for covid post vaccination. patient did not receive other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in the armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 31 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Jan2022 (Lot number: FE3594) at the age of 31 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: 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: LYMPHADENOPATHY (non-serious) with onset 07Jan2022, outcome "unknown", described as "Swollen lymph node in the armpit".  Additional information: The patient received the booster dose of the vaccine this past Friday (07Jan2022) and has had a swollen lymph node in that arm since then.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Saw Cardiologist after receiving second dose Pfizer Covid Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A male 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: Covid-19 vaccine (DOSE 1, SINGLE., Manufacturer unknown), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Saw Cardiologist after receiving second dose Pfizer Covid Vaccine". The event "saw cardiologist after receiving second dose pfizer covid vaccine" was evaluated at the physician office visit.  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: Body temperature, Headache, Interchange of vaccine products, Off label use, Pain
Clinical narrative: patient has the Pfizer vaccine for her primary series. The patient has the Modera vaccine for a booster dose.; patient has the Pfizer vaccine for her primary series. The patient has the Modera vaccine for a booster dose.; general body aches; headaches; low fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (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 1, he patient experienced no adverse reactions to the first Pfizer vaccine.), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "patient has the Pfizer vaccine for her primary series. The patient has the Modera vaccine for a booster dose."; PAIN (non-serious), outcome "unknown", described as "general body aches"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; PYREXIA (non-serious), outcome "unknown", described as "low fever". 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: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: patient has the Pfizer vaccine for her primary series. The patient has the Modera vaccine for a booster dose.; patient has the Pfizer vaccine for her primary series. The patient has the Modera vaccine for a booster dose.; general body aches; headaches; low fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (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 1, he patient experienced no adverse reactions to the first Pfizer vaccine.), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "patient has the Pfizer vaccine for her primary series. The patient has the Modera vaccine for a booster dose."; PAIN (non-serious), outcome "unknown", described as "general body aches"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; PYREXIA (non-serious), outcome "unknown", described as "low fever". 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: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Pain, SARS-CoV-2 test
Clinical narrative: Asthma; Cough; Really bad body aches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FF2589) as dose 3 (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 2; MANUFACTURER UNKNOWN; Lot number: unknown; Route of administration: unspecified), for COVID-19 immunisation, reaction(s): "Drug ineffective"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN; Lot number: unknown; Route of administration: unspecified), for COVID-19 immunisation, reaction(s): "Drug ineffective". The following information was reported: COUGH (non-serious) with onset 09Jan2022, outcome "unknown", described as "Cough"; PAIN (non-serious) with onset 09Jan2022, outcome "unknown", described as "Really bad body aches"; ASTHMA (non-serious) with onset 10Jan2022, outcome "unknown", described as "Asthma". The events "cough", "really bad body aches" and "asthma" 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 asthma. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Headache, Weight
Clinical narrative: sharp pains in her head/sharp pains in head was reported as worsened; 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 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Lot number: 330308D) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Headache" (unspecified if ongoing), notes: she suffered from headaches prior to the booster. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single; Batch/Lot Number: ER8735), administration date: 07Apr2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Single; Batch/Lot Number: EN6205, Caller states the lot number is hard to read because they did not have good handwriting.), administration date: 10Mar2021, when the patient was 67 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "sharp pains in her head/sharp pains in head was reported as worsened". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated she received a Comirnaty booster dose on 29Oct2021 and since then she has been getting sharp pains in hear head in the morning and it lasts for about half an hour and sometimes it woke her up at night as well. She wanted to know if anyone else has reported that. Caller said that this was harrowing for her. Caller asked if this has anything to do with the dose and a possible error in administration.Reporter stated she could not recall the exact date it started, but it started after the booster. After the booster, she had headache and all the symptoms then was fine. Then the sharp pains started happening. The sharp pains occur every day. Sharp pains in head was reported as worsened. She had a flu shot but that was from her doctor that retired. She was not sure of the exact date. She did not have the lot number or information for the flu shot. Reporter stated that she did not want to give her medical information out.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Scratch, Urticaria
Clinical narrative: I scratch it to death; it itches like the 'dickens'; inside of her arms and hands started to breakout in hives; rash inside her arm/skin rash; 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 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 14:20 (Lot number: 330308D) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heartburn" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for dyspepsia. Vaccination history included: Bnt162b2 (DOSE 1, Lot: EL9264), administration date: 30Jan2021, for covid-19 immunization; Bnt162b2 (DOSE 2, Lot: EN6201), administration date: 20Feb2021, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "inside of her arms and hands started to breakout in hives"; RASH (non-serious) with onset 15Dec2021, outcome "not recovered", described as "rash inside her arm/skin rash"; SCRATCH (non-serious), outcome "unknown", described as "I scratch it to death"; PRURITUS (non-serious), outcome "not recovered", described as "it itches like the 'dickens'". The events "inside of her arms and hands started to breakout in hives", "rash inside her arm/skin rash" and "it itches like the 'dickens'" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of urticaria, rash, scratch, pruritus.  Additional information: Patient showed no reaction to any of the doses in the primary series (hardly any sore). She had no issues with the booster until 15Dec2021 where she started experiencing hives/rash inside of her arm. This recurring, random hives inside of her hands and arms, comes and goes and they appear in different parts of her arm. the rash is not debilitating but she wants to make it stop. she is not taking any antihistamine nor is using any itch creams. and she has not change anything in her routine prior to receiving the booster dose (no new lotion or perfume). she has visited a dermatologist and the derma has confirm that she has seen the rash with patients who have received the Pfizer BioNTech vaccine. She is asking why is it not on the top of her arms and hands but instead on the inside of her arms and hands, which is weird. It is persisting. Sometimes its really bad and it is a big old swath of it. This morning she had it and it is already gone, it was the size of a quarter. Patient did not received treatment, and said just don't feel like I need to be taken a antihistamine every day. I just don't take medicine at all, I don't take medicine. So, I am not doing anything, I am not rubbing any cream on it, any cortisone cream or any itch cream. I am not doing anything, it just comes at random.  Follow-up (18JAN2022): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Immunisation, Malaise, Vaccination site pruritus
Clinical narrative: Day after covid booster; malaise; general feeling of being unwell; swelling and lump at injection site; headache; warmth; itching at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 05:30 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), administered in deltoid right, administration date 04Jan2022 (Batch/Lot number: unknown) as unk unk, single. Relevant medical history included: "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported.  Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "Day after covid booster"; MALAISE (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "malaise"; MALAISE (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "general feeling of being unwell"; VACCINATION SITE SWELLING (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "swelling and lump at injection site"; HEADACHE (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "headache"; FEELING HOT (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "warmth"; VACCINATION SITE PRURITUS (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "itching at injection site". Therapeutic measures were not taken as a result of immunisation, malaise, malaise, vaccination site swelling, headache, feeling hot, vaccination site pruritus. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Day after covid booster; malaise; general feeling of being unwell; swelling and lump at injection site; headache; warmth; itching at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 05:30 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), administered in deltoid right, administration date 04Jan2022 (Batch/Lot number: unknown) as unk unk, single. Relevant medical history included: "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported.  Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "Day after covid booster"; MALAISE (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "malaise"; MALAISE (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "general feeling of being unwell"; VACCINATION SITE SWELLING (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "swelling and lump at injection site"; HEADACHE (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "headache"; FEELING HOT (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "warmth"; VACCINATION SITE PRURITUS (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "itching at injection site". Therapeutic measures were not taken as a result of immunisation, malaise, malaise, vaccination site swelling, headache, feeling hot, vaccination site pruritus. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Malaise, Pyrexia, Vaccination site erythema
Clinical narrative: Swollen, hard, really red, and very sore just below injection site; Swollen, hard, really red, and very sore just below injection site; Swollen, hard, really red, and very sore just below injection site; Injection site has a temperature of 102; Low grade fever; Doesn''t feel well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date Jan2022 (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 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Jan2022, outcome "unknown" and all described as "Swollen, hard, really red, and very sore just below injection site"; BODY TEMPERATURE INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "Injection site has a temperature of 102"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Low grade fever"; MALAISE (non-serious) with onset Jan2022, outcome "unknown", described as "Doesn''t feel well at all". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: caller had the booster shot on Saturday afternoon. Monday evening, arm started turning really red just below the injection site. It was swollen, hard, and very sore. She put a temperature gun over the injection site and it was reading 102. Caller was also running a low-grade fever. She called and was told to make an appointment. She made an appointment today with clinic at 4:30PM. However, caller was just informed that her appointment had been filled and she cannot be seen until 26Jan2022. Wants to go find the doctor and get this taken care of. she did not feel well at all.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen, hard, really red, and very sore just below injection site; Swollen, hard, really red, and very sore just below injection site; Swollen, hard, really red, and very sore just below injection site; Injection site has a temperature of 102; Low grade fever; Doesn''t feel well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date Jan2022 (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 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Jan2022, outcome "unknown" and all described as "Swollen, hard, really red, and very sore just below injection site"; BODY TEMPERATURE INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "Injection site has a temperature of 102"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Low grade fever"; MALAISE (non-serious) with onset Jan2022, outcome "unknown", described as "Doesn''t feel well at all". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: caller had the booster shot on Saturday afternoon. Monday evening, arm started turning really red just below the injection site. It was swollen, hard, and very sore. She put a temperature gun over the injection site and it was reading 102. Caller was also running a low-grade fever. She called and was told to make an appointment. She made an appointment today with clinic at 4:30PM. However, caller was just informed that her appointment had been filled and she cannot be seen until 26Jan2022. Wants to go find the doctor and get this taken care of. she did not feel well at all.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Diarrhoea, Hypoaesthesia
Clinical narrative: Diarrhea; chills; Numbness in feet; stabbing lower back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 11:00 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 22Mar2021, when the patient was 20 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 05Apr2021, when the patient was 20 years old, for COVID-19 Immunization, reaction(s): "dose number=2: administration date=05Apr2021; dose number=1, administration date=22Mar2021". The following information was reported: DIARRHOEA (non-serious) with onset 12Jan2022 14:00, outcome "recovering", described as "Diarrhea"; CHILLS (non-serious) with onset 12Jan2022 14:00, outcome "recovering", described as "chills"; HYPOAESTHESIA (non-serious) with onset 12Jan2022 14:00, outcome "recovering", described as "Numbness in feet"; BACK PAIN (non-serious) with onset 12Jan2022 14:00, outcome "recovering", described as "stabbing lower back pain". The events "diarrhea", "chills", "numbness in feet" and "stabbing lower back pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of diarrhoea, chills, hypoaesthesia, back pain. The lot number for bnt162b2 was not provided and will be requested during follow up.  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, the patient was diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. Case was reported as non serious. Hospitalization prolonged was reported as no.  No follow-up attempts are possible. No further information is expected.