chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she tested positive for COVID; she tested positive for COVID; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as DOSE 1, SINGLE (lot number: EL9262), on 23Mar2021 as DOSE 2, SINGLE (lot number: EL9262) and on 08Jan2022 as DOSE 3 (BOOSTER), SINGLE (lot number: 330308D) at the age of 64 years, for COVID-19 immunization. The patient's relevant medical history included: "Periventricular contractions benign" (unspecified if ongoing); "heart palpitations" (unspecified if ongoing); "panic attacks" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing). Concomitant medications included: TOPRAL [SULTOPRIDE HYDROCHLORIDE] taken for heart palpitations, periventricular contractions benign; PAXIL [PIROXICAM] taken for panic attacks, anxiety, and as antidepressant. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "she tested positive for COVID." The patient underwent the following laboratory tests and procedures: Covid-19 test (SARS-CoV-2 test): (Oct2022) Positive, notes: She called her doctor on Thursday and reported she tested positive for COVID. Therapeutic measures were taken as a result of Vaccination failure, Covid-19. It was reported that the patient had 1st 2 vaccines and 2 boosters of COVID-19 Vaccine by Pfizer. Caller was diagnosed with COVID prior to getting her next booster dose. The vaccine doses were off.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna: Dose number: 1 and 2; Pfizer / BioNTech - Dose number: 3 and 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162B2, BNT162B2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 29 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: 30155BA) for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Mar2021 as dose 1, single (Lot number: 029A21A) and on 03Apr2021 as dose 2, single (Lot number: 026B21A) for COVID-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN, start date:03Oct2022, stop date: 04Oct2022; IBUPROFEN, start date: 04Oct2022, stop date: 06Oct2022; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL], start date: 04Oct2022, stop date: 11Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna: Dose number: 1 and 2; Pfizer / BioNTech - Dose number: 3 and 4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: new positive test result occurred on Day 9; Positive, notes: tested positive on Day 5; Negative, notes: negative on Day 7; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Additional information: the patient was reported to have experienced a scratchy throat a day after a negative COVID test and several days after the cessation of symptoms and completion of a 5-day PAXLOVID course of treatment. She took a COVID test after the scratchy throat didn't resolve and received a positive result. This new positive test result occurred on Day 9 (with Day 1 being the first full day with symptoms and a positive COVID test result). She also tested positive on Day 5 and negative on Day 7. Her symptoms had mostly resolved by Days 3-4, though she still experienced fatigue.
Sex: F
Vaccine: COVID19
Symptoms: Bone marrow transplant
Clinical narrative: Bone marrow transplant; This is a spontaneous report received from a contactable reporter (Pharmacist) from Medical Information Team.  A 56-year-old female patient received BNT162b2 (BNT162B2), as DOSE 1, SINGLE (batch/lot number: unknown) and as DOSE 2, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE MARROW TRANSPLANT (medically significant), outcome "unknown." The event "bone marrow transplant" required physician office visit. The Caller is a pharmacist who stated that they have a patient who was completely done with COVID-19 primary series and has a bone marrow transplant, now, patient was recommended by her physician to restart her primary series to dose 1. Caller clarified that it did not happen yet. Caller was informed that per CDC, an individual is considered as fully vaccinated once he/she completed her/his primary series, not including the booster. Caller was referred to CDC contact number, to make sure that there is no recommendation, but caller declined. Question about the dosing of the COVID-19 vaccine was again reported. Caller on the line had a patient that already got the primary series and has had a bone marrow transplant. The patient is looking to get the COVID -19 vaccine. The physician told the patient they would need to restart the vaccine series.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event BONE MARROW TRANSPLANT and the vaccine (BNT162B2) cannot be excluded. "The impact of this report on the benefit/risk profile of the Pfizer product 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Pain, SARS-CoV-2 test, Skin discolouration
Clinical narrative: 2 by 3 inch skin discoloration , similar to a skin burn; Extreme soreness; Scab has started to peel, showing pinkish skin color & dry; Scab has started to peel, showing pinkish skin color & dry; Scab has started to peel, showing pinkish skin color & dry; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 18:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies Latex" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: FK9895, Anatomical location: , Arm Left), administration date: 01Apr2022, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 301458A, Anatomical location: , Arm Left), administration date: 29Sep2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EN6206, Anatomical location: , Arm Left), administration date: 03Mar2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EN 9581, Anatomical location: , Arm Left), administration date: 10Feb2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 26Sep2022 at 08:00, outcome "recovering", described as "2 by 3 inch skin discoloration , similar to a skin burn"; PAIN (non-serious) with onset 26Sep2022 at 08:00, outcome "recovering", described as "Extreme soreness"; SKIN EXFOLIATION (non-serious), ERYTHEMA (non-serious), DRY SKIN (non-serious) all with onset 26Sep2022 at 08:00, outcome "recovering" and all described as "Scab has started to peel, showing pinkish skin color & dry". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin discolouration, pain, skin exfoliation, erythema, dry skin.  Additional information: The patient did not receive other vaccine in four weeks. Treatment included steroid cream & Zyrtec for reported events. The patient was not diagnosed with COVID prior to vaccination. Post vaccination, the patient was tested COVID.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: 2 by 3 inch skin discoloration , similar to a skin burn; Extreme soreness; Scab has started to peel, showing pinkish skin color & dry; Scab has started to peel, showing pinkish skin color & dry; Scab has started to peel, showing pinkish skin color & dry; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 18:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies Latex" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: FK9895, Anatomical location: , Arm Left), administration date: 01Apr2022, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 301458A, Anatomical location: , Arm Left), administration date: 29Sep2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EN6206, Anatomical location: , Arm Left), administration date: 03Mar2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EN 9581, Anatomical location: , Arm Left), administration date: 10Feb2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 26Sep2022 at 08:00, outcome "recovering", described as "2 by 3 inch skin discoloration , similar to a skin burn"; PAIN (non-serious) with onset 26Sep2022 at 08:00, outcome "recovering", described as "Extreme soreness"; SKIN EXFOLIATION (non-serious), ERYTHEMA (non-serious), DRY SKIN (non-serious) all with onset 26Sep2022 at 08:00, outcome "recovering" and all described as "Scab has started to peel, showing pinkish skin color & dry". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin discolouration, pain, skin exfoliation, erythema, dry skin.  Additional information: The patient did not receive other vaccine in four weeks. Treatment included steroid cream & Zyrtec for reported events. The patient was not diagnosed with COVID prior to vaccination. Post vaccination, the patient was tested COVID.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Lose of hearing in right ear.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 10:45 as dose 4 (booster), single (Lot number: GH9697) at the age of 61 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive any other vaccine in four weeks. The patient did not have Covid prior to vaccination. The patient was not Covid tested post vaccination. The patient had no known allergies. Vaccination history included: Covid-19 vaccine (Dose: 3 (1st booster), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The patient experienced lose of hearing in right ear in Oct2022. No treatment was received for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19, FLUX, HPVX, TDAP
Symptoms: Asthma, Expired product administered, Product use issue
Clinical narrative: Mild Asthma; 3 patients received Pfizer covid 19 vaccine orange cap past the expiration date.; Additional Vaccines Administered on Same Date of the Pfizer Suspect: T-DAP -Sanofi, HPV - Merck, Influenza -Sanofi; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID.  An 11-year-old female patient received BNT162b2 (BNT162B2), on 05Oct2022 at 16:30 as dose 1 (orange cap), 0.2 ml single (Lot number: FL8095, Expiration Date: 31Aug2022) at the age of 11 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA), on 05Oct2022 as dose 7, single (Lot number: UT7701KA, Expiration Date: 30Jun2023) intramuscular, in right deltoid for immunisation; hpv vaccine (HPV VACCINE), on 05Oct2022 as dose 1, single (Lot number: 1780878, Expiration Date: 02Dec2023) intramuscular, in right deltoid for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 05Oct2022 as dose 1, single (Lot number: U7461AA, Expiration Date: 12Jul2024) intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: She takes allergy meds but that was about it. The patient took concomitant medications. Vaccination history included: Influenza vaccine (Dose Number: 01, Sanofi), for Immunization; Influenza vaccine (Dose Number: 02, Sanofi), for Immunization; Influenza vaccine (Dose Number: 03, Sanofi), for Immunization; Influenza vaccine (Dose Number: 04, Sanofi), for Immunization; Influenza vaccine (Dose Number: 05, Sanofi), for Immunization; Influenza vaccine (Dose Number: 06, Sanofi), for Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 05Oct2022 at 16:30, outcome "unknown", described as "3 patients received Pfizer covid 19 vaccine orange cap past the expiration date."; PRODUCT USE ISSUE (non-serious) with onset 05Oct2022 at 16:30, outcome "unknown", described as "Additional Vaccines Administered on Same Date of the Pfizer Suspect: T-DAP -Sanofi, HPV - Merck, Influenza -Sanofi"; ASTHMA (non-serious), outcome "unknown", described as "Mild Asthma". Therapeutic measures were not taken as a result of asthma.  Additional information: The patient did not administer any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and no AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201223008 same reporter/drug/event, different patient;US-PFIZER INC-202201223295 same reporter/drug/event, different patient;
Age: 55.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Mass, Product use issue
Clinical narrative: Found painful lump between neck and collar bone; BNT162B2 and Flu Vax, drug start date: 08Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2022 at 11:00 as dose 1, single (Lot number: 6H90z) at the age of 55 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUVAX), on 08Oct2022 as unk unk, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "BP" (unspecified if ongoing), notes: other medications in two weeks: BP/ cholesterol; "Cholesterol" (unspecified if ongoing), notes: other medications in two weeks: BP/ cholesterol; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient took concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 08Oct2022, outcome "unknown", described as "BNT162B2 and Flu Vax, drug start date: 08Oct2022"; MASS (non-serious) with onset 09Oct2022, outcome "not recovered", described as "Found painful lump between neck and collar bone". The events "found painful lump between neck and collar bone" required emergency room visit.  Additional information: The patient received other vaccine in four weeks. The patient received other medications in two weeks for BP/ cholesterol. The patient was not diagnosed with covid prior to vaccination. Post vaccination the patient was not tested for covid.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Migraine, Peripheral swelling, Pyrexia
Clinical narrative: Migraine; Fever; Swollen arm 3 out of 4 times; Off balance for 3 days; 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 73-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Congenital heart defect" (unspecified if ongoing), notes: Congenital heart defect. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Migraine", "Fever"; Bnt162b2 (Dose 1, Swollen arm 3 out of 4 times), for COVID-19 immunization, reaction(s): "Swollen arm 3 out of 4 times"; Bnt162b2 (Dose 1, Off balance for 3 days), for COVID-19 immunization, reaction(s): "Off balance for 3 days"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Migraine", "Fever"; Bnt162b2 (Dose 2, Swollen arm 3 out of 4 times), for COVID-19 immunization, reaction(s): "Swollen arm 3 out of 4 times"; Bnt162b2 (Dose 2, Off balance for 3 days), for COVID-19 immunization, reaction(s): "Off balance for 3 days"; Bnt162b2 (Dose 3), for COVID-19 immunization, reaction(s): "Migraine", "Fever"; Bnt162b2 (Dose 3, Swollen arm 3 out of 4 times), for COVID-19 immunization, reaction(s): "Swollen arm 3 out of 4 times"; Bnt162b2 (Dose 3, Off balance for 3 days), for COVID-19 immunization, reaction(s): "Off balance for 3 days". The following information was reported: MIGRAINE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen arm 3 out of 4 times"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Off balance for 3 days".  Additional information: States she has had many side effects from her previous four doses of the Pfizer BioNTech COVID-19 Vaccine: "migraine, fever, swollen arm 3 out of 4 times, and feeling off balance for 3 days." Patient got first and second doses and the booster shot and after getting these vaccines patient had some reactions to the vaccines. Patient called to ask if the Pfizer COVID-19 Vaccine Bivalent Booster Shot has any different than the original shot or the original boosters; if the ingredients are different; and if this is a 2 in 1 shot. The doctor wants her to take this Pfizer COVID-19 Vaccine Bivalent Booster Shot but neither he nor the pharmacist knew the answers to her questions, so she called Pfizer. Patient had the first and second doses of the original shot and then 2 of the original boosters and experienced reactions to everything, all of those doses. Patient had already reported this previously, did it in the past when she did the first and second one and all the reactions are the same for everyone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Headache, Off label use, Product use issue, Vaccination site pain
Clinical narrative: Arm was just a little sore actually both arms because chose one arm for the Pfizer booster and one arm for the Flu shot; Headache; got a Flu shot (Unspecified Flu shot) and the Pfizer, the third booster (Clarified as Pfizer COVID 19 Vaccine) today, 11Oct2022; got a Flu shot (Unspecified Flu shot) and the Pfizer, the third booster (Clarified as Pfizer COVID 19 Vaccine) today, 11Oct2022; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 11Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Manufacturer unknown), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Oct2022, outcome "unknown" and all described as "got a Flu shot (Unspecified Flu shot) and the Pfizer, the third booster (Clarified as Pfizer COVID 19 Vaccine) today, 11Oct2022"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm was just a little sore actually both arms because chose one arm for the Pfizer booster and one arm for the Flu shot"; HEADACHE (non-serious), outcome "unknown". Additional Information: The patient got a Flu shot (Unspecified Flu shot) and the Pfizer, the third booster (Clarified as Pfizer COVID 19 Vaccine) today, 11Oct2022. Arm was just a little sore actually both arms because chose one arm for the Pfizer booster and one arm for the Flu shot and also got little headache.  Stated that his/her arm was sore and it was the same symptoms that he/she had in the past (further clarification unknown). It was reported that patient was told when he/she got the earlier series of vaccine that he/she could take a couple of Tylenol if arm was achy. Reporter was querying if he can take a couple of Tylenol to see if that helps with the achy arm and the slight headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breastfeeding" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of Covid- 11 days post treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 26Sep2022 to 30Sep2022. Additional information: The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Mast Cell Activation" (unspecified if ongoing); "POTS" (unspecified if ongoing); "Paralyzed right hemi diaphragm" (unspecified if ongoing); "restrictive airway disease" (unspecified if ongoing); "Multiple drug allergies/hyper sensitivities" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Paxlovid Covid Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated for COVID-19 with anti-viral drug from 28Sep2022 to 03Oct2022. Patient took other medication in 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Oct2022 to 08Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN; Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2 SINGLE; MANUFACTURER UNKNOWN; Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN; Lot number: unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm is still sore". Additional information: Caller stated that he got the 4th shot, the booster, the Pfizer, caller then clarified that he got the 4th dose of the Pfizer Covid vaccine. He wanted to ask a question. His arm was still sore but its was getting better, he would like to know how long would he be susceptible to somebody that has covid and how long does the vaccination take before he was fully covered. Caller confirmed he was trying to find out how long it would take to have immunity. Caller further clarified that he had just been informed that a person that he was potentially going to see today has been exposed to covid, but it had not been confirmed yet if that person has the virus. Caller declined safety report stating that he is only calling for his question. Caller was probed when did he received his 4th dose, caller stated that he was not exactly sure but he thinks it's been exactly a week. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in jaw, Pyrexia
Clinical narrative: Swollen painful lymph nodes both sides of neck and under left arm in armpit; jaw pain right side; Body aches; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 11:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa intolerance" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Right), administration date: 10Apr2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FF2593), administration date: 30Oct2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 10Oct2022 at 21:00, outcome "not recovered", described as "Body aches"; PYREXIA (non-serious) with onset 10Oct2022 at 21:00, outcome "not recovered", described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 10Oct2022 at 21:00, outcome "not recovered", described as "Swollen painful lymph nodes both sides of neck and under left arm in armpit"; PAIN IN JAW (non-serious) with onset 10Oct2022 at 21:00, outcome "not recovered", described as "jaw pain right side". Therapeutic measures were not taken as a result of lymphadenopathy, pain in jaw, pain, pyrexia. Additional information: It was unknown if the patient had COVID-19 prior vaccination and was not tested for COVID-19 post vaccination.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 22 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus. Concomitant medication(s) included: PROZAC; HYDROXYCHLOROQUINE; LAMICTAL; WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication taken in 2 weeks was Ventura Birth Control Pill. Therapeutic measures taken was Paxlovid from 30Sep2022 to 05Oct2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: four earlier Pfizer COVID vaccines, I had fevers the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP6955) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: she just takes an unspecified thyroid medication. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 19Mar2021, outcome "unknown", described as "four earlier Pfizer COVID vaccines, I had fevers the next day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no investigations and relevant tests. Caller denied any other medications, medical conditions, labs, testing, or treatments relevant to these events. Caller stated that she just taken an unspecified thyroid medication and did not think it was relevant. The patient had no additional vaccines administered on same date of the Pfizer Suspect. It was reported that the patient recently received our bivalent booster shot and experienced no side effects.  The odd thing was, for all four earlier Pfizer COVID vaccines, patient had fevers the next day.  They ranged from 100 to 101 degrees. Caller was asking about why she had no side effects with this most current vaccine.  Caller has agreed to report on her side effects she had after the first 4 doses of the COVID Vaccines. Caller stated that her fevers actually ranged from 100-101.5 degrees. The event did not requited a visit to Emergency Room or Physician Office.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Blood test, Infection, Pruritus, Rash
Clinical narrative: autoimmune disease that is not going away and screwed up her immune; itching so bad; blood cells are elevated because of infection in her body; rash that turned into lesions from her neck to her toes.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: EN6207), administration date: 11Mar2021, when the patient was 68-year-old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot: EP7533), administration date: 2021, when the patient was 68 years old, for Covid-19 immunization. The patient received 3 doses of the Pfizer Covid-19 vaccine and after the third dose which was the booster shot and 2 weeks after the dose (Oct2021), she experienced a rash that turned into lesions from her neck to her toes, on top of her feet and was lingering for one year and she had been in pants and shirts all summer and she never had a problem before and she had pictures since Oct2021 and every month and she has seen 4 Dermatologists. She had been to the Emergency room and hospital and went to a university last month asking what to do and the vaccine made her have an autoimmune disease that was not going away and screwed up her immune and the booster did it to her and she was tortured with lesions all over her body, legs, thighs, arms, chest and everywhere. The patient described the rash as starting 2 weeks after booster as little dots all over her body and then came big rashes and then lesions and she has tried 500 different medications and not internally but externally.  When it first started she went to the Emergency Room because the itching so bad she was going out of her mind and thought she would have a nervous breakdown and they gave her intravenous prednisone and told her to see an infectious disease Doctor and they said they cannot do anything and then she went to Dermatologist 1, then Dermatologist 2, then Dermatologist 3, and Dermatologist 4. She had bloodwork and showed constantly her blood cells are elevated because of infection in her body. Her Dermatologist put her on dupilumab (DUPIXENT) and burning and shots and creams and she had been to 500 drugs stores and all over country and nothing was helping and this is the last resort. The patient received the following medications as treatment: doxycycline, hydroxyzine tablets for itching, mupirocin, prednisolone 5 times since Jan2022 and clobetasol. The outcome of "rash that turned into lesions from her neck to her toes" and "itching so bad" was not recovered while unknown for the other events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201227099 same patient/product, different dose/events;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: autoimmune disease that is not going away and screwed up her immune; itching so bad; blood cells are elevated because of infection in her body; rash that turned into lesions from her neck to her toes.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: EN6207), administration date: 11Mar2021, when the patient was 68-year-old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot: EP7533), administration date: 2021, when the patient was 68 years old, for Covid-19 immunization. The patient received 3 doses of the Pfizer Covid-19 vaccine and after the third dose which was the booster shot and 2 weeks after the dose (Oct2021), she experienced a rash that turned into lesions from her neck to her toes, on top of her feet and was lingering for one year and she had been in pants and shirts all summer and she never had a problem before and she had pictures since Oct2021 and every month and she has seen 4 Dermatologists. She had been to the Emergency room and hospital and went to a university last month asking what to do and the vaccine made her have an autoimmune disease that was not going away and screwed up her immune and the booster did it to her and she was tortured with lesions all over her body, legs, thighs, arms, chest and everywhere. The patient described the rash as starting 2 weeks after booster as little dots all over her body and then came big rashes and then lesions and she has tried 500 different medications and not internally but externally.  When it first started she went to the Emergency Room because the itching so bad she was going out of her mind and thought she would have a nervous breakdown and they gave her intravenous prednisone and told her to see an infectious disease Doctor and they said they cannot do anything and then she went to Dermatologist 1, then Dermatologist 2, then Dermatologist 3, and Dermatologist 4. She had bloodwork and showed constantly her blood cells are elevated because of infection in her body. Her Dermatologist put her on dupilumab (DUPIXENT) and burning and shots and creams and she had been to 500 drugs stores and all over country and nothing was helping and this is the last resort. The patient received the following medications as treatment: doxycycline, hydroxyzine tablets for itching, mupirocin, prednisolone 5 times since Jan2022 and clobetasol. The outcome of "rash that turned into lesions from her neck to her toes" and "itching so bad" was not recovered while unknown for the other events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201227099 same patient/product, different dose/events;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Blood test, Infection, Pruritus, Rash
Clinical narrative: She got Covid anyway; She got Covid anyway; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), in 2021 as dose 2, single (Lot number: EP7533) and on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years for COVID-19 immunisation. The patient's relevant medical history included: "Itching" (unspecified if ongoing). Concomitant medications included: CLOBETASOL; DOXYCYCLINE; HYDROXYZINE taken for pruritus; MUPIROCIN; PREDNISOLONE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She got Covid anyway". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: She got Covid anyway. Caller said got Covid sometime a few months after. Clinical course: The patient had no additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room, physician office, and hospitalization. There were no adverse events prior vaccinations.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224766 same patient/product, different dose/events;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: She got Covid anyway; She got Covid anyway; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), in 2021 as dose 2, single (Lot number: EP7533) and on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years for COVID-19 immunisation. The patient's relevant medical history included: "Itching" (unspecified if ongoing). Concomitant medications included: CLOBETASOL; DOXYCYCLINE; HYDROXYZINE taken for pruritus; MUPIROCIN; PREDNISOLONE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She got Covid anyway". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: She got Covid anyway. Caller said got Covid sometime a few months after. Clinical course: The patient had no additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room, physician office, and hospitalization. There were no adverse events prior vaccinations.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224766 same patient/product, different dose/events;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got Covid; Got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), Suspected COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid".  Additional information: the reporter/ caller is the daughter of the patient. During report caller states that her dad got the Pfizer Covid 19 vaccine and the booster and got Covid. Also had a mild form or reactive arthritis and that went away.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225214 same patient/ reporter, different event/ dose;
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Memory impairment
Clinical narrative: headaches; feel fatigue; Asks if Vaccine could cause a little bit of lapse of memory for short period of time.; 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 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9693) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series Completed, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; FATIGUE (non-serious), outcome "unknown", described as "feel fatigue"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Asks if Vaccine could cause a little bit of lapse of memory for short period of time.".  Additional information: Can get headaches and feel fatigue. Which is normal. Would the Pfizer MRNA Vaccine BA.4-BA.5 cause a little bit of lapse of memory for short period of time? The symptoms patient had didn't last long, wondering how normal the symptoms were? The patient mentioned that he had to go to another room since the music was driving him crazy. Mentioned that he did not normally fear for the virus but he wanted to know since he will be going to a nursing home. He mentioned that he will have a risk of exposure. The person at the nursing home has the virus. He will go to a nursing home to sign paperwork. It was reported that the staff may have transmitted it to the person. Lot: GH9693 Caller also stated that he had headaches and felt tired. There were a few things he couldn't remember clearly after receiving the vaccine. Caller stated that he is 70y/o. Caller later mentioned that on the day the he received the vaccine, he had trouble remembering some things. Caller mentioned that it may be caused by him feeling fatigue or having headaches. Caller stated that he has been very lucky during the early stages when there were still no vaccines. Caller mentioned that he was exposed to people. Caller mentioned that another person, their mom, and their baby got it. Caller mentioned that he never got it. Caller mentioned that he had read it will take 2 weeks for the vaccine to take full effect. Caller mentioned that he can be corrected if he's wrong. Caller mentioned that he is very active. Caller mentioned that he took a very physical job deliberately and hopes that it would help the vaccine take effect faster. Consulted with (Name) of Pfizer Customer Service.