chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen spleen severe left sided pain; Swollen spleen severe left sided pain; Swollen spleen severe left sided pain; muscle aches; lymph glands swollen left axillary large and very painful; lymph glands swollen left axillary large and very painful; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:30 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies : Penicillin " (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ABDOMINAL PAIN (non-serious), SPLEEN DISORDER (non-serious), SWELLING (non-serious) all with onset 02Jan2022, outcome "not recovered" and all described as "Swollen spleen severe left sided pain"; MYALGIA (non-serious) with onset 02Jan2022, outcome "not recovered", described as "muscle aches"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 02Jan2022, outcome "not recovered" and all described as "lymph glands swollen left axillary large and very painful". The events "swollen spleen severe left sided pain", "swollen spleen severe left sided pain", "swollen spleen severe left sided pain", "muscle aches", "lymph glands swollen left axillary large and very painful" and "lymph glands swollen left axillary large and very painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain, spleen disorder, swelling, myalgia, lymphadenopathy, axillary pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Skin lesion
Clinical narrative: Hand lesions; enlarged groin node; dose 1: 30Jul2021, dose 2: 08Aug2021 This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 08Aug2021 (Lot number: Fa7485) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Iodine, reaction(s): "Iodine allergy", notes: IV. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fa7485), administration date: 30Jul2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: SKIN LESION (disability) with onset 04Oct2021, outcome "not recovered", described as "Hand lesions"; LYMPHADENOPATHY (disability) with onset 04Oct2021, outcome "not recovered", described as "enlarged groin node"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Aug2021, outcome "unknown", described as "dose 1: 30Jul2021, dose 2: 08Aug2021". The events "hand lesions" and "enlarged groin node" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of skin lesion, lymphadenopathy. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received levothyroxine within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: I am three times vaccinated; have COVID right now; I am three times vaccinated/I tested positive; have COVID right now; I am three times vaccinated/I tested 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 62-year-old patient received COVID-19 Vaccine - Manufacturer Unknown, (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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "I am three times vaccinated"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have COVID right now; I am three times vaccinated/I tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: The patient tested on homecare and had tested positive. The patient has symptoms. He/she went to hospital to where he/she have been tested and it was negative (further not clarified). So, they said the patient probably have it but still have symptoms so, he/she will be isolating and taking all the precautions but have confusing data on his/her lab. The patient was not sure what that means for Xeljanz. The rheumatologist doesn't reach to the patient's calls whether the patient should continue taking it while sick. But truthfully, he/she just feel like he/she has very bad cold and the patient was three times vaccinated (further not clarified hence, suspect captured as unspecified vaccine). The patient was not feeling great.   The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: booster; Contracted Covid; Contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 43 years 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; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Contracted Covid".  Clinical Course: Optional Information: Covid symptoms include cough, congestion, sore throat and shortness of breath. Symptoms are mild-moderate. Description of Event: Contracted Covid approximately 6 weeks after booster shot of comirnaty.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Nasopharyngitis
Clinical narrative: Tested positive for Covid; Tested positive for Covid; mild Cold symptoms; Loss of taste/smell; Loss of taste/smell; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An elderly 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 patient was 60 something, and it was unknown weather she received booster dose. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "mild Cold symptoms"; ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "unknown" and all described as "Loss of taste/smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200028605 same drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; mild Cold symptoms; Loss of taste/smell; Loss of taste/smell; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An elderly 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 patient was 60 something, and it was unknown weather she received booster dose. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "mild Cold symptoms"; ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "unknown" and all described as "Loss of taste/smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200028605 same drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Headache, Immunisation, Migraine
Clinical narrative: 3rd dose (booster) of comirnaty.; dizziness; headaches/has had more than normal headaches since booster; She is susceptible to migraines but complains that she has had more than normal; She is susceptible to migraines but complains that she has had more than normal; swelling under her armpit; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (COMIRNATY) (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), for COVID-19 Immunization; Bnt162b2 (Dose:2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "3rd dose (booster) of comirnaty."; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headaches/has had more than normal headaches since booster"; MIGRAINE (non-serious), outcome "unknown", CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "She is susceptible to migraines but complains that she has had more than normal"; SWELLING (non-serious), outcome "recovered", described as "swelling under her armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: 3rd dose (booster) of comirnaty.; dizziness; headaches/has had more than normal headaches since booster; She is susceptible to migraines but complains that she has had more than normal; She is susceptible to migraines but complains that she has had more than normal; swelling under her armpit; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (COMIRNATY) (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), for COVID-19 Immunization; Bnt162b2 (Dose:2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "3rd dose (booster) of comirnaty."; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headaches/has had more than normal headaches since booster"; MIGRAINE (non-serious), outcome "unknown", CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "She is susceptible to migraines but complains that she has had more than normal"; SWELLING (non-serious), outcome "recovered", described as "swelling under her armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Immunisation, Lymphadenopathy, Migraine
Clinical narrative: Extreme pain in joints; chills; fever; migraine; swollen lymph nodes in underarm and groin; booster of Pfizer vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 16:45 (Lot number: FJ8762) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm right, administration date 05Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: other medical history: Asthma allergies heart murmur; "heart murmur" (unspecified if ongoing); "Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies; "Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies; "Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies; "known allergies: Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; SINGULAIR; NASONEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0169, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 19Apr2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 29Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 16:45, outcome "unknown", described as "booster of Pfizer vaccines"; ARTHRALGIA (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "Extreme pain in joints"; CHILLS (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "fever"; MIGRAINE (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "migraine"; LYMPHADENOPATHY (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "swollen lymph nodes in underarm and groin". Therapeutic measures were not taken as a result of arthralgia, chills, pyrexia, migraine, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme pain in joints; chills; fever; migraine; swollen lymph nodes in underarm and groin; booster of Pfizer vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 16:45 (Lot number: FJ8762) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm right, administration date 05Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: other medical history: Asthma allergies heart murmur; "heart murmur" (unspecified if ongoing); "Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies; "Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies; "Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies; "known allergies: Walnuts latex bees seasonal allergies" (unspecified if ongoing), notes: known allergies: Walnuts latex bees seasonal allergies. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; SINGULAIR; NASONEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0169, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 19Apr2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 29Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 16:45, outcome "unknown", described as "booster of Pfizer vaccines"; ARTHRALGIA (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "Extreme pain in joints"; CHILLS (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "fever"; MIGRAINE (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "migraine"; LYMPHADENOPATHY (non-serious) with onset 05Jan2022 22:00, outcome "recovering", described as "swollen lymph nodes in underarm and groin". Therapeutic measures were not taken as a result of arthralgia, chills, pyrexia, migraine, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: Tested positive for Covid recently and had mild cold symptoms and loss of taste/smell. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200028500 same drug/event, different patient
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Breakthrough case./Covid test -Positive; Breakthrough case./Covid test -Positive; DOSE 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 02Mar2021 (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) with onset 11Oct2021, outcome "unknown", described as "DOSE 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "Breakthrough case./Covid test -Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were not taken as a result of covid-19. The patient did not receive any other vaccines in four weeks. Patient did not diagnosed with covid prior to vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: then tested Covid positive 30Dec, and again positive on 05Jan; then tested Covid positive 30Dec, and again positive on 05Jan; dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) at the age of 23 years as dose 3 (booster), single, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Celiac" (unspecified if ongoing); "known allergies Gluten allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant) with onset 28Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 28Dec2021, outcome "recovering" and all described as "then tested Covid positive 30Dec, and again positive on 05Jan". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive; (05Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19. Clinical course: Sore throat, head cold symptoms, aches and cough on 28Dec2021, then tested Covid positive 30Dec2021, and again positive on 05Jan2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bell's palsy, Hypoaesthesia, Illness, SARS-CoV-2 test
Clinical narrative: Bell''s palsy; Weakness; left side of her face of being numb; She was also ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant) with onset 07Jan2022, outcome "unknown", described as "Bell''s palsy"; ASTHENIA (non-serious) with onset 07Jan2022, outcome "unknown", described as "Weakness"; HYPOAESTHESIA (non-serious) with onset 07Jan2022, outcome "unknown", described as "left side of her face of being numb"; ILLNESS (non-serious) with onset 07Jan2022, outcome "unknown", described as "She was also ill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results. Clinical course: Reporter stated, my daughter was diagnosed today with Bell's palsy and she is still awaiting her COVID test but she did get the vaccination and there after she was starting to have more like weakness and then today she came to nursing office at her school with left side of her face being numb and she was also ill so I just want to report because I am concerned it may be a reaction from the vaccine. Reporter stated, She is going to be getting steroids today. She is going to, I am going to pick in few minutes. As long as its reported I know its still new for kids she is 10 year old so, I just want to make sure you guys know. I will probably going to 'hang' off from the booster (further not clarified). Reporter was unwilling to share information and complete the report. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: After my first two shots, my period was approx. 30 days late; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 15:00 (Lot number: EN6204) at the age of 38 years as dose 2, single and administered in arm right, administration date 04Mar2021 09:00 (Lot number: EN6202) 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: MENSTRUATION DELAYED (disability) with onset Mar2021, outcome "recovered" (Mar2021), described as "After my first two shots, my period was approx. 30 days late". The event "after my first two shots, my period was approx. 30 days late" was evaluated at the physician office visit. Additional information: The patient stated, "I believe after the second occurrence the vaccines are to blame for my missed periods and continued lack of menstruation." The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200028757 same reporter/patient, different vaccine dose/event
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive PCR test for COVID-19.; sore throat; Positive PCR test for COVID-19.; dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: FD0810) at the age of 46 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 05Apr2021 (Lot number: ER8735) as dose 2, single and intramuscular, administered in arm left, administration date 14Mar2021 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "dose 3"; COVID-19 (medically significant) with onset 06Jan2022, outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Positive PCR test for COVID-19."; OROPHARYNGEAL PAIN (non-serious) with onset 06Jan2022, outcome "recovering", described as "sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: Nasal Swab; (05Jan2022) negative, notes: Nasal Swab; (07Jan2022) negative, notes: Nasal Swab; (08Jan2022) positive, notes: Nasal Swab; (08Jan2022) negative, notes: Nasal Swab; (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, oropharyngeal pain.  Clinical course: Positive PCR test for COVID-19. Symptoms: sore throat. Date below reflects date of first symptoms. Date of PCR test was 08Jan2022. Test results received 09Jan2022.  Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive covid 19 nasal test; positive covid 19 nasal test; dose 3; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 15:30 (Lot number: FD0809) at the age of 58 years as dose 3 (booster), single, intramuscular, administration date 10Apr2021 10:00 (Lot number: EP6955) as dose 2, single and intramuscular, administration date 20Mar2021 10:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. The patient took concomitant medications.  The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021 15:30, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant) with onset 09Jan2022 11:15, outcome "unknown", COVID-19 (medically significant) with onset 09Jan2022 11:15, outcome "recovering" and all described as "positive covid 19 nasal test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Ag test on 09Jan2022 at home is positive; Ag test on 09Jan2022 at home is positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EL3247) at the age of 40 years as dose 2, single and administration date 03Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 08Jan2022, outcome "recovering" and all described as "Ag test on 09Jan2022 at home is positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19. Reported Event: exposure 07Jan-08Jan overnight to COVID positive person then + symptoms 08Jan at 10:30pm ST and slight cough + Ag test on 09Jan2022 at home. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, a causal association between reported events Vaccination failure, covid 19 with BNT162B2 is possible.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Immunisation, Nausea, SARS-CoV-2 test
Clinical narrative: PCR positive COVID; PCR positive COVID; then intractable nausea; sick; dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FF2589) at the age of 53 years as dose 3 (booster), single, administration date 27Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) 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) with onset 12Nov2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "PCR positive COVID"; ILLNESS (non-serious) with onset 04Jan2022, outcome "unknown", described as "sick"; NAUSEA (non-serious) with onset 06Jan2022, outcome "unknown", described as "then intractable nausea". The event "pcr positive covid" and "pcr positive covid" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative, notes: Unknown; (06Jan2022) positive, notes: Unknown.  Clinical course: It was reported that daughter was sick on 04Jan and covid and then intractable nausea on 06Jan and hospital visit for treatment and PCR positive COVID. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. And since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Immunisations, Vaccination failure, COVID-19 cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: PCR positive COVID; PCR positive COVID; then intractable nausea; sick; dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FF2589) at the age of 53 years as dose 3 (booster), single, administration date 27Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) 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) with onset 12Nov2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "PCR positive COVID"; ILLNESS (non-serious) with onset 04Jan2022, outcome "unknown", described as "sick"; NAUSEA (non-serious) with onset 06Jan2022, outcome "unknown", described as "then intractable nausea". The event "pcr positive covid" and "pcr positive covid" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative, notes: Unknown; (06Jan2022) positive, notes: Unknown.  Clinical course: It was reported that daughter was sick on 04Jan and covid and then intractable nausea on 06Jan and hospital visit for treatment and PCR positive COVID. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. And since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Immunisations, Vaccination failure, COVID-19 cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Autoimmune thyroiditis, Hair disorder, Immunisation, Skin disorder
Clinical narrative: flare up of hashimotos hypothyroid; Significant and rapid hair loss; including skin and hair issues; including skin and hair issues; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:45 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's Thyroid" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; AMBIEN; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (dose 2, lot number: ER8737, administration time: 04:00 PM , vaccine location: left arm), administration date: 29Mar2021, when the patient was 43 years old, for Covid-19 immunization, reaction(s): "chills", "fever/low grade fever", "head/body ache", "fatigue", "swelling/redness and pain at injection site", "disrupted menstrual cycle", "heavy/longer than usual menstrual period", "flare up of hashimotos hypothyroid", "skin and hair issues at this time", "hair loss"; Pertussis vaccine, reaction(s): "Known allergies: pertussis vaccine". These occurred after second dose and lasted 6 months. Her hair was starting to regrow and then after booster began to fall out again. She experienced significant and rapid hair loss. Never had hair loss prior, it was sudden significant, and resulted in a thinning across the scalp particularly in the top of head and temple area. Estimate1/4 reduction of volume in this area. Have also experienced flare up of hashimotos hypothyroid including skin and hair issues at this time. Had been stable with medication for more than 5 years prior. The events "booster", "flare up of hashimotos hypothyroid", "significant and rapid hair loss", "including skin and hair issues" and "including skin and hair issues" were evaluated at the physician office visit. Therapeutic measures taken as a result of events included adjustment of thyroid medication. The patient had not recovered from flare up of hashimotos hypothyroid, significant and rapid hair loss, skin and hair issues. No covid prior to vaccination and was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Autoimmune thyroiditis, Body temperature, Chills, Condition aggravated
Clinical narrative: flare up of hashimotos hypothyroid; Significant and rapid hair loss; including skin and hair issues; including skin and hair issues; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:45 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's Thyroid" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; AMBIEN; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (dose 2, lot number: ER8737, administration time: 04:00 PM , vaccine location: left arm), administration date: 29Mar2021, when the patient was 43 years old, for Covid-19 immunization, reaction(s): "chills", "fever/low grade fever", "head/body ache", "fatigue", "swelling/redness and pain at injection site", "disrupted menstrual cycle", "heavy/longer than usual menstrual period", "flare up of hashimotos hypothyroid", "skin and hair issues at this time", "hair loss"; Pertussis vaccine, reaction(s): "Known allergies: pertussis vaccine". These occurred after second dose and lasted 6 months. Her hair was starting to regrow and then after booster began to fall out again. She experienced significant and rapid hair loss. Never had hair loss prior, it was sudden significant, and resulted in a thinning across the scalp particularly in the top of head and temple area. Estimate1/4 reduction of volume in this area. Have also experienced flare up of hashimotos hypothyroid including skin and hair issues at this time. Had been stable with medication for more than 5 years prior. The events "booster", "flare up of hashimotos hypothyroid", "significant and rapid hair loss", "including skin and hair issues" and "including skin and hair issues" were evaluated at the physician office visit. Therapeutic measures taken as a result of events included adjustment of thyroid medication. The patient had not recovered from flare up of hashimotos hypothyroid, significant and rapid hair loss, skin and hair issues. No covid prior to vaccination and was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: flare up of hashimotos hypothyroid; Significant and rapid hair loss; including skin and hair issues; including skin and hair issues; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:45 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's Thyroid" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; AMBIEN; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (dose 2, lot number: ER8737, administration time: 04:00 PM , vaccine location: left arm), administration date: 29Mar2021, when the patient was 43 years old, for Covid-19 immunization, reaction(s): "chills", "fever/low grade fever", "head/body ache", "fatigue", "swelling/redness and pain at injection site", "disrupted menstrual cycle", "heavy/longer than usual menstrual period", "flare up of hashimotos hypothyroid", "skin and hair issues at this time", "hair loss"; Pertussis vaccine, reaction(s): "Known allergies: pertussis vaccine". These occurred after second dose and lasted 6 months. Her hair was starting to regrow and then after booster began to fall out again. She experienced significant and rapid hair loss. Never had hair loss prior, it was sudden significant, and resulted in a thinning across the scalp particularly in the top of head and temple area. Estimate1/4 reduction of volume in this area. Have also experienced flare up of hashimotos hypothyroid including skin and hair issues at this time. Had been stable with medication for more than 5 years prior. The events "booster", "flare up of hashimotos hypothyroid", "significant and rapid hair loss", "including skin and hair issues" and "including skin and hair issues" were evaluated at the physician office visit. Therapeutic measures taken as a result of events included adjustment of thyroid medication. The patient had not recovered from flare up of hashimotos hypothyroid, significant and rapid hair loss, skin and hair issues. No covid prior to vaccination and was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.