chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; 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 male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Pain at the injection site". Additional information: The patient had the first dose of vaccine on Tuesday, 16Mar2021, and the person who administered the vaccine mentioned not to take any aspirin after getting the vaccine. The patient experienced pain at the injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Malaise, Myalgia
Clinical narrative: temperature reached 100.02; muscle pain; not totally feeling well; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "he got the virus", start date: Jul2020 (not ongoing), notes: The caller stated that he got the virus last July 2020 and recovered from it. The patient's concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "temperature reached 100.02"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; MALAISE (non-serious), outcome "unknown", described as "not totally feeling well". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: after he got the 1st dose of the vaccine, he stated that his temperature reached 100.02, and he had muscle pain and he is not totally feeling well. He wants to know what he can do to get better.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: weak; headache; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Apr2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "weak"; HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills". Additional information: 17Mar2021 was the first dose of the COVID vaccine and the second is scheduled for 15Apr2021. He experienced weak, headache and chills. He felt the same when he had COVID in Apr2020. He was wondering if he still needed to get the second dose because he had COVID in the past and because he had a reaction to the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: leg cramps; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "leg cramps". Additional information: The patient received the second dose of Pfizer COVID 19 vaccine about a week ago. After receiving the second dose of Pfizer COVID 19 vaccine, the patient started to have leg cramps at night and every other night.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling sick as a dog; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "recovering", described as "feeling sick as a dog". Additional information: Patient reported feeling "sick as a dog" the day after the second dose of the vaccine and 70% better on the second day following.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: had severe pain after the shot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent (mother).  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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: PAIN (non-serious) with onset 19Mar2021, outcome "unknown", described as "had severe pain after the shot". Therapeutic measures were not taken as a result of pain. Additional information: the nurse informed them not to take any medicines and the reporter (mother) wanted to confirm if that information is true.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: Pain at injection site radiated down into her hand and fingers; Pain at injection site radiated down into her hand and fingers; hand and fingers began; Hand and fingers with a severe, intolerable burning, and pressure sensation; Hand and fingers with a severe, intolerable burning, and pressure sensation; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 20Apr2021 15:00 (Lot number: EW0161) at the age of 46 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Allergies to nuts" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE HYDROCHLORIDE; SINGULAIR. Past drug history included: Cipro, reaction(s): "Drug allergy". Vaccination history included: BNT162B2 (DOSE 1; Lot Number: ER8730; left arm; 04:00 PM), administration date: 30Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Apr2021 20:00, outcome "recovered", described as "Pain at injection site radiated down into her hand and fingers"; PAIN IN EXTREMITY (non-serious) with onset 20Apr2021 20:00, outcome "recovered", described as "Pain at injection site radiated down into her hand and fingers; hand and fingers began"; BURNING SENSATION (non-serious), DISCOMFORT (non-serious) all with onset 20Apr2021 20:00, outcome "recovered" and all described as "Hand and fingers with a severe, intolerable burning, and pressure sensation". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, burning sensation, discomfort.  Additional Information: No other vaccine was administered in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-up (13Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: Booster; I got my three Pfizer shots and my symptoms are very mild/his Covid breakthrough infection; I got my three Pfizer shots and my symptoms are very mild/his Covid breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "I got my three Pfizer shots and my symptoms are very mild/his Covid breakthrough infection". It was unknown if therapeutic measures were taken as a result of suspected covid-19. Clinical course: It was unknown if patient had COVID prior to vaccination or COVID tested post vaccination. The patient had a breakthrough infection with mild symptoms and he was boosted.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Heavy menstrual bleeding, Herpes zoster, Lymph node pain
Clinical narrative: heavy heavy Menstrual bleeding with golf ball size clots. had to go to ER because was bleeding through pads in less than an hour; heavy heavy Menstrual bleeding with golf ball size clots. had to go to ER because was bleeding through pads in less than an hour; cough; cold; shingles; headache; Swollen and painful lymph nodes; Swollen and painful lymph nodes; 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 30Nov2021 16:00 (Lot number: FJ1611) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 08Dec2021, outcome "recovering" and all described as "heavy heavy Menstrual bleeding with golf ball size clots. had to go to ER because was bleeding through pads in less than an hour"; COUGH (non-serious) with onset 08Dec2021, outcome "recovered", described as "cough"; NASOPHARYNGITIS (non-serious) with onset 08Dec2021, outcome "recovered", described as "cold"; HERPES ZOSTER (non-serious) with onset 08Dec2021, outcome "recovering", described as "shingles"; HEADACHE (non-serious) with onset 08Dec2021, outcome "recovered", described as "headache"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 08Dec2021, outcome "recovered" and all described as "Swollen and painful lymph nodes". The events "heavy heavy menstrual bleeding with golf ball size clots. had to go to er because was bleeding through pads in less than an hour", "heavy heavy menstrual bleeding with golf ball size clots. had to go to er because was bleeding through pads in less than an hour", "cough", "cold", "shingles", "headache", "swollen and painful lymph nodes" and "swollen and painful lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Swollen and painful lymph nodes, cough, headache and cold which had lasted for a month, heavy heavy Menstrual bleeding with golf ball size clots, had to go to ER because was bleeding through pads in less than an hour, shingles. It is unknown if the patient had covid prior vaccination. The patient had tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. known allergies and other medical history was none.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Menstrual disorder, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: heavy heavy Menstrual bleeding with golf ball size clots. had to go to ER because was bleeding through pads in less than an hour; heavy heavy Menstrual bleeding with golf ball size clots. had to go to ER because was bleeding through pads in less than an hour; cough; cold; shingles; headache; Swollen and painful lymph nodes; Swollen and painful lymph nodes; 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 30Nov2021 16:00 (Lot number: FJ1611) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 08Dec2021, outcome "recovering" and all described as "heavy heavy Menstrual bleeding with golf ball size clots. had to go to ER because was bleeding through pads in less than an hour"; COUGH (non-serious) with onset 08Dec2021, outcome "recovered", described as "cough"; NASOPHARYNGITIS (non-serious) with onset 08Dec2021, outcome "recovered", described as "cold"; HERPES ZOSTER (non-serious) with onset 08Dec2021, outcome "recovering", described as "shingles"; HEADACHE (non-serious) with onset 08Dec2021, outcome "recovered", described as "headache"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 08Dec2021, outcome "recovered" and all described as "Swollen and painful lymph nodes". The events "heavy heavy menstrual bleeding with golf ball size clots. had to go to er because was bleeding through pads in less than an hour", "heavy heavy menstrual bleeding with golf ball size clots. had to go to er because was bleeding through pads in less than an hour", "cough", "cold", "shingles", "headache", "swollen and painful lymph nodes" and "swollen and painful lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Swollen and painful lymph nodes, cough, headache and cold which had lasted for a month, heavy heavy Menstrual bleeding with golf ball size clots, had to go to ER because was bleeding through pads in less than an hour, shingles. It is unknown if the patient had covid prior vaccination. The patient had tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. known allergies and other medical history was none.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypersensitivity, Immunisation
Clinical narrative: felt warm on my neck and face; skin was red; similar to a sunburn and likely an allergic reaction; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 15:45 (Lot number: FJ8757) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: contrast dye" (unspecified if ongoing). Concomitant medication(s) included: QUERCETIN in two weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 07May2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0169, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 16Apr2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: FEELING HOT (medically significant) with onset 03Jan2022 16:00, outcome "unknown", described as "felt warm on my neck and face"; ERYTHEMA (medically significant) with onset 03Jan2022 16:00, outcome "unknown", described as "skin was red"; HYPERSENSITIVITY (medically significant) with onset 03Jan2022 16:00, outcome "unknown", described as "similar to a sunburn and likely an allergic reaction"; IMMUNISATION (non-serious) with onset 03Jan2022 15:45, outcome "unknown", described as "booster". Therapeutic measures were taken as a result of feeling hot, erythema, hypersensitivity with Prilosec and Benadryl. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and did not test for covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, SARS-CoV-2 test, Thrombosis
Clinical narrative: blood clots both lungs; received the third dose of BNT162B2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=pfizer, 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 dose number=2), for Covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=pfizer,, 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 dose number=1), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 20Dec2021, outcome "unknown", described as "received the third dose of BNT162B2"; THROMBOSIS (hospitalization) with onset 03Jan2022 06:00, outcome "not recovered", described as "blood clots both lungs". The patient was hospitalized for thrombosis (hospitalization duration: 1 day(s)); the patient was hospitalized for immunisation (hospitalization duration: 1 day(s)). The event "blood clots both lungs" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) negative, notes: type post vaccination: Unknown. Therapeutic measures were taken as a result of thrombosis. Addition information: Other vaccine in four weeks was none. Other medications in two weeks was none. Covid prior vaccination was none. Covid tested post vaccination. Ae treatment included Eliquis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Breakthrough COVID illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Drug ineffective"; COVID-19 (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Breakthrough COVID illness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient did not take other vaccine in four weeks. Patient had no covid prior vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got a positive test for COVID-19; Got a positive test for COVID-19; 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 47-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got a positive test for COVID-19". The patient had her two primary doses of the Pfizer Biontech COVID-19 vaccine and was now (as of 04Jan2022) overdue for her booster shot. Last Sunday (on an unspecified date) she got a positive test for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID test; COVID symptoms; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 17Dec2021 (Lot number: 331308A) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Route of Administration: Intramuscular), administration date: 19Mar2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9266, Route of Administration: Intramuscular), administration date: 25Feb2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 17Dec2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant) with onset 25Dec2021, outcome "recovered", described as "positive COVID test"; COVID-19 (medically significant) with onset 24Dec2021, outcome "recovered", described as "COVID symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive, notes: Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Vaccination site pain
Clinical narrative: Cataracts in both eyes; Arm was a little sore after the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: EW0162 or EWD162) at the age of 60 years as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: for approximately 10 years; "Diabetes" (unspecified if ongoing), notes: for approximately 10 years; "Bifocals eyeglass wearer" (ongoing). Family history included: "Cataracts run in her family" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CATARACT (medically significant) with onset 2021, outcome "not recovered", described as "Cataracts in both eyes"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Arm was a little sore after the vaccine". Therapeutic measures were not taken as a result of vaccination site pain. Clinical course: The patient's arm was a little sore after the vaccine but she didn't need to take anything. After the patient got the vaccines, she felt like she had cataracts and really noticed them at that time. The patient doesn't think her cataracts were related to the vaccine, as they run in her family and she knew she would have them. The patient stated that she knew her eyes were getting worse. She was wearing her bifocals and thought she needed stronger ones however she was diagnosed with cataracts. The doctor said her eyes were really bad.  She has cataracts in both eyes and needed to have cataract surgery. She was scheduled to have cataract surgery on 25Jan2022, and they won't do it unless she gets the booster shot. The patient received 2 doses of the Pfizer COVID-19 vaccine and she was seeking out the booster dose. She lost her vaccination card and the vaccination sites are refusing to vaccinate her with the booster because she lost her vaccine card. It was also reported that the patient received her vaccine on "20Oct2021" (not further specified).    The reporter considered "cataract" not related to bnt162b2. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known disease pathophysiology, the event of cataract is assessed as not related to BNT162B2, and more likely due to factors like familial history .
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Apnoea, Electrocardiogram, Immunisation, Loss of consciousness, Seizure
Clinical narrative: unconscious; seizure; stopped breathing; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jan2022 10:30 (Lot number: 330368D) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0169, Location of injection: Arm Right), administration date: 29Apr2021, when the patient was 16 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Right), administration date: 04Apr2021, when the patient was 16 years old, for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 02Jan2022 10:45, outcome "unknown", described as "unconscious"; SEIZURE (medically significant) with onset 02Jan2022 10:45, outcome "unknown", described as "seizure"; APNOEA (medically significant) with onset 02Jan2022 10:45, outcome "unknown", described as "stopped breathing"; IMMUNISATION (medically significant) with onset 02Jan2022, outcome "unknown", described as "booster". The events "unconscious", "seizure", "stopped breathing" and "booster" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: normal. Therapeutic measures were taken as a result of loss of consciousness, seizure, apnoea, immunisation. Additional Information:  No other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not covid tested post vaccination. No Known allergies.  During 15-minute wait period after receiving third vaccine Patient experienced events. Emergency medical service responded. He has never before had a seizure or passed out. EEG scheduled for tomorrow (unspecified date).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 69 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". She is currently in quarantine and does not know when she has to take the booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: has covid; has covid; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old 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), for COVID-19 Immunization; Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: IMMUNISATION (prolonged hospitalization, medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "has covid". The patient was hospitalized for drug ineffective, covid-19 (start date: 30Dec2021). The event "has covid" and "has covid" was evaluated at the physician office visit.  Clinical course was reported as: Patient stated she was in quarantine. She was feeling lousy, fever, vomit and achy after receiving a booster. She went to the clinic on 28Dec and found out she has an infection. Patient was getting worst 30Dec patient went to hospital and doctor told patient has covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cataract, Vision blurred
Clinical narrative: cataracts; foggy vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2, solution for injection), administered in arm right, administration date 27Apr2021 11:00 (Lot number: EW0153) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Really high eye pressure", start date: 2008 (ongoing). Concomitant medication(s) included: LATANOPROST taken for eye pain. Vaccination history included: Bnt162b2 (First dose: 06APR2021 , Lot: EP6955, NDC: Unknown , Expiration: Unknown , Route of administration: right shoulder), administration date: 06Apr2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "foggy vision". The following information was reported: CATARACT (medically significant), outcome "unknown", described as "cataracts"; VISION BLURRED (non-serious) with onset Apr2021, outcome "unknown", described as "foggy vision". The events "cataracts" and "foggy vision" were evaluated at the physician office visit.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dizziness, Drug ineffective, Fatigue
Clinical narrative: Drug ineffective; COVID 19 positive; headache; fatigue; some dizziness; mild sore throat; some mild congestion; some variable mild coughing; Booster; 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 Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (ongoing); "celiac" (ongoing); "Hashimoto's" (ongoing). Concomitant medication(s) included: INSULIN (ongoing); LEVOTHYROXINE (ongoing). Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 03Jan2022, outcome "unknown", described as "COVID 19 positive"; IMMUNISATION (medically significant) with onset Sep2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 31Dec2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 31Dec2021, outcome "unknown", described as "fatigue"; DIZZINESS (non-serious) with onset 31Dec2021, outcome "unknown", described as "some dizziness"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021, outcome "unknown", described as "mild sore throat"; NASAL CONGESTION (non-serious) with onset 31Dec2021, outcome "unknown", described as "some mild congestion"; COUGH (non-serious) with onset 31Dec2021, outcome "unknown", described as "some variable mild coughing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2021) positive, notes: COVID 19 positive via rapid test yesterday 03Jan2022. Clinical course: COVID 19 positive via rapid test yesterday 03Jan2022 and symptoms starting Friday prior. Have been vaccinated and had the booster end of Sep2021. So far COVID symptoms mild (headache, fatigue, some dizziness, mild sore throat, some mild congestion, some variable mild coughing). Optional Information: Type 1 diabetes, celiac, hashimoto's are underlying conditions. Currently taking insulin and levothyroxine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Immunisation, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 positive; headache; fatigue; some dizziness; mild sore throat; some mild congestion; some variable mild coughing; Booster; 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 Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (ongoing); "celiac" (ongoing); "Hashimoto's" (ongoing). Concomitant medication(s) included: INSULIN (ongoing); LEVOTHYROXINE (ongoing). Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 03Jan2022, outcome "unknown", described as "COVID 19 positive"; IMMUNISATION (medically significant) with onset Sep2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 31Dec2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 31Dec2021, outcome "unknown", described as "fatigue"; DIZZINESS (non-serious) with onset 31Dec2021, outcome "unknown", described as "some dizziness"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021, outcome "unknown", described as "mild sore throat"; NASAL CONGESTION (non-serious) with onset 31Dec2021, outcome "unknown", described as "some mild congestion"; COUGH (non-serious) with onset 31Dec2021, outcome "unknown", described as "some variable mild coughing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2021) positive, notes: COVID 19 positive via rapid test yesterday 03Jan2022. Clinical course: COVID 19 positive via rapid test yesterday 03Jan2022 and symptoms starting Friday prior. Have been vaccinated and had the booster end of Sep2021. So far COVID symptoms mild (headache, fatigue, some dizziness, mild sore throat, some mild congestion, some variable mild coughing). Optional Information: Type 1 diabetes, celiac, hashimoto's are underlying conditions. Currently taking insulin and levothyroxine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Patient tested positive for COVID after receiving the 3rd dose of the vaccine; Patient tested positive for COVID after receiving the 3rd dose of the vaccine; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 28Nov2021 (Lot number: 320308D) at the age of 40 years as dose 3 (booster), single, administration date 23Apr2021 (Lot number: EW0161) as dose 2, single and administration date 31Mar2021 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 04Jan2022, outcome "recovering" and all described as "Patient tested positive for COVID after receiving the 3rd dose of the vaccine"; IMMUNISATION (medically significant) with onset 28Nov2021, outcome "unknown", described as "Booster". The event "patient tested positive for covid after receiving the 3rd dose of the vaccine" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: Inteliswab test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He got COVID a week after her; He got COVID a week after her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: EP6955) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2021, outcome "unknown" and all described as "He got COVID a week after her". The patient's wife was diagnosed with COVID on 01Apr2021. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Apr2021) positive, notes: He got COVID a week after her because he drank after her.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Poor quality product administered, Product temperature excursion issue
Clinical narrative: questioning lack of efficacy; administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 70 year-old patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 22Dec2021 10:45 (Lot number: FH8030, Expiration Date: 28Feb2022) 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: DRUG INEFFECTIVE (medically significant) with onset 28Dec2021, outcome "unknown", described as "questioning lack of efficacy"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 22Dec2021 10:45, outcome "unknown" and all described as "administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days".  Additional information: Caller stated that she reported that it was in the freezer too long. Stated that it was stored within normal temperature in the fridge. Stated that it was in the refrigerator for seven days before it was administered during a vaccination clinic to eight separate patients as a booster dose. Provided a case number of 524685. Stated that she did not know a lot of fine details but through root cause analysis that she has come up with a lot more information. Stated that she did not complete reports on the patients. Stated that she has not gotten an email yet. Clarified that the vaccine came from district health, and they put it in their freezer, and it is kept between 25 degrees below Celsius and -15 degrees Celsius. Stated that it was at the normal temperature up to two weeks and was extended to 17 days per Pfizer from the other phone call. Count for which of the 8 patients received the Pfizer purple top vial pediatric dose not provided. Later clarified that they were not all booster doses. Patient stated that she is not aware of any antipyretic use around the date of vaccination. There were no predisposing factors. No culture performed. Relevant Tests was none. Questioned lack of efficacy on 28Dec when they discovered the mistake. Stated that they stopped questioning efficacy after they called Pfizer. Later clarified that she is still questioning the efficacy.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200010841 as same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a company representative. The reporter is the patient.  An 85 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient reported they are an 85 years old female with some underline problems and they tested positive for COVID-19, their doctor tried to order Taxlozid (as reported) for her. The patient was fully vaccinated.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid positive; Covid positive; 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 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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. It was reported as, Suspect Product(s) (provide Name / Indication/Dosage/Start and Stop date where possible) was Fludarabine. The patient has a family member that was battling leukemia and they needed the drug for her family member to live. She was asking how they can obtain the drug (Fludarabine) since the area where her family member lives doesn't have the drug. Also, the Reporter mentioned she was Covid positive but did not specify what brand of vaccine was administered to her.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: has contracted covid; has contracted covid; 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 number unknown , single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PAXLOVID. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has contracted covid". The patient had contracted covid, take Paxlovid. Caller wants to know if it was a safe option since his husband has other illnesses and wants to know if it is available in (place name). Caller mentioned that they both took the Pfizer covid vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.