chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Illness, Memory impairment
Clinical narrative: Got extremely sick after each of the original 2 shots/Could not get out of bed; Dizzy; Didnt know who was in the room; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 1, 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: ILLNESS (non-serious), outcome "unknown", described as "Got extremely sick after each of the original 2 shots/Could not get out of bed"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Didnt know who was in the room". The events "got extremely sick after each of the original 2 shots/could not get out of bed", "dizzy" and "didnt know who was in the room" required emergency room visit.  Additional information: Patient just got booster shot and got sick all over again. Patient got extremely sick after each of the original 2 shots, could not get out of bed, dizzy, didn't know who was in the room. Patient was taken to the ER. Patient was in good health.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201283470 same patient/drug/events, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Illness, Memory impairment
Clinical narrative: got extremely sick after each of the original 2 shots/could not get out of bed; dizzy; didnt know who was in the room; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "dizzy", "got extremely sick after each of the original 2 shots", "could not get out of bed Activities of daily living impaired", "didnt know who was in the room". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got extremely sick after each of the original 2 shots/could not get out of bed"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "didnt know who was in the room". The events "got extremely sick after each of the original 2 shots/could not get out of bed", "dizzy" and "didnt know who was in the room" required emergency room visit.  Additional information: the patient was taken to the ER even though she was in good health.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201283469 same patient/drug/events, different dose;US-PFIZER INC-PV202200098797 same patient/drug/events, different dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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), COVID-19 (medically significant), outcome "unknown" and all described as "covid".  Clinical course: It was reported that patient received Pfizer covid vaccine. It was reported that patient opt out of the call due to dealing with covid. Exact date of being diagnosed with covid was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events drug ineffective/COVID-19 cannot be ruled out.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 09:00 as dose number unknown, single (Lot number: EL 3246) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 28Oct2022 to 01Nov2022.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fever; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 2, single (Lot number: EN6201) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pacemaker" (unspecified if ongoing), notes: Eliquis: been taking this for years, she has a pacemaker. If stopped or ongoing unknown; "Heart medication" (unspecified if ongoing); "plaque" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: COVID in the very beginning. Concomitant medication(s) included: ATORVASTATIN taken for oropharyngeal plaque; ELIQUIS taken for cardiac disorder; LOSARTAN taken for cardiac disorder; SYNTHROID taken for cardiac disorder. Vaccination history included: BNT162b2 (Dose-1, Lot: EL9265, NDC/Expiry: Unknown, not on the CDC Vaccine record card., Dose: Unknown strength/volume/dose injection to right arm), administration date: 07Feb2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "Chills", "Fever", "Achy". The following information was reported: CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, pain.  Additional information: With the first 2 doses she was achy, had chills, fever for about 24 hours.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201279824 Same patient, different dose, different AE;US-PFIZER INC-202201279870 Same patient, different dose, different AE;US-PFIZER INC-202201279869 Same patient, different dose, different AE;
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; he did get COVID; was sick enough that he was hospitalized; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 84-year-old male patient (height probably 5'9") received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ACETAMINOPHEN; ATORVASTATIN; CALCIUM CITRATE; CARVEDILOL; CLOPIDOGREL; COENZYME Q10 [UBIDECARENONE]; VITAMIN B12 [COBAMAMIDE]; EZETIMIBE; FEXOFENADINE; TAMSULOSIN HCL; ZINC; VITAMIN D NOS. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset Sep2022, outcome "unknown"; COVID-19 (hospitalization, medically significant) with onset Sep2022, outcome "unknown", described as "he did get COVID; was sick enough that he was hospitalized". The events "vaccination failure" and "he did get covid; was sick enough that he was hospitalized" required emergency room visit. Therapeutic measures were taken as a result of vaccination failure, covid-19 (he received the IV drug in the ER and in the hospital. It was the IV drip. No further information provided). He just finished rehab for 5 weeks following his hospitalization.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: expected to feel under the weather; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing), notes: For years; "Depression" (ongoing), notes: For years; "Positive ANA", start date: 2019 (ongoing); "Hypertension" (ongoing), notes: For years. Concomitant medication(s) included: ASPIRIN 81 oral; CYANOCOBALAMIN oral; CALCIUM CARBONATE AND VITAMIN D3 oral. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "expected to feel under the weather".
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Laboratory test, Thyroiditis, Thyroxine free, Tri-iodothyronine
Clinical narrative: COVID MRNA VACCINE INDUCED THYROIDITIS; This is a literature report.  While cases of Thyroiditis after COVID mRNA vaccination are reported, the recovery duration is not yet determined. Therefore, the authors present the time course of two healthy middle-aged patients who developed symptomatic, biochemical, and radiological evidence of Thyroiditis following COVID 19(mRNA) vaccine administration. Despite being more than six months post-vaccination, both are still hypothyroid, requiring levothyroxine replacement.  Case Description: Case 1: A 35-year-old male presented with palpitations and neck pain ten days after receiving the first dose of the Pfizer-BioNTech vaccine, initial labs showing biochemical hyperthyroidism TSH -0.07uIU/mL (0.450-4.50uIU/mL), Free T 4 (0.82-1.77ng/dL4) -3.04ng/dl, TotalT3 (71-80ng/dl) -200ng/dl. He was started on propranolol and ibuprofen for symptom control. During four months of follow up, he was euthyroid with TSH -2.060 uIU/mL Free T4 1.04ng/dl, Total T3 122ng/dl, and five months of follow up showed hypothyroidism with TSH -5.730uIU/mL, Free T4 -1.00ng/dl, Total T3 109ng/dl. Due to fatigue and weight gain symptoms, he was started on Levothyroxine 25mcg daily. Discussion: Thyroiditis is an inflammatory disorder diagnosed based on clinical and laboratory findings. While there have been cases reports of Subacute Thyroiditis following immunizations, such as the influenza vaccine, the mechanism of thyroiditis after the COVID mRNA vaccine remains unclear. Subacute Thyroiditis typically manifests as a triphasic clinical course of thyrotoxicosis, followed by hypothyroidism and a return to the euthyroid state; however, mRNA vaccine-induced Thyroiditis seems to have a different disease course. In the observation of these case series, both patients remained in the hypothyroid state requiring Levothyroxine replacement eight-and twelve-months post-vaccination, respectively. Whether they developed permanent thyroid damage or are able to recover with prolonged recovery time is still unclear, which needs further follow-up in the future.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Thyroiditis. 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.,Linked Report(s) : US-PFIZER INC-202201282091 Same article/drug/event, different patients;
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: COVID MRNA VACCINE INDUCED THYROIDITIS; This is a literature report.  While cases of Thyroiditis after COVID mRNA vaccination are reported, the recovery duration is not yet determined. Therefore, the authors present the time course of two healthy middle-aged patients who developed symptomatic, biochemical, and radiological evidence of Thyroiditis following COVID 19(mRNA) vaccine administration. Despite being more than six months post-vaccination, both are still hypothyroid, requiring levothyroxine replacement.  Case Description: Case 1: A 35-year-old male presented with palpitations and neck pain ten days after receiving the first dose of the Pfizer-BioNTech vaccine, initial labs showing biochemical hyperthyroidism TSH -0.07uIU/mL (0.450-4.50uIU/mL), Free T 4 (0.82-1.77ng/dL4) -3.04ng/dl, TotalT3 (71-80ng/dl) -200ng/dl. He was started on propranolol and ibuprofen for symptom control. During four months of follow up, he was euthyroid with TSH -2.060 uIU/mL Free T4 1.04ng/dl, Total T3 122ng/dl, and five months of follow up showed hypothyroidism with TSH -5.730uIU/mL, Free T4 -1.00ng/dl, Total T3 109ng/dl. Due to fatigue and weight gain symptoms, he was started on Levothyroxine 25mcg daily. Discussion: Thyroiditis is an inflammatory disorder diagnosed based on clinical and laboratory findings. While there have been cases reports of Subacute Thyroiditis following immunizations, such as the influenza vaccine, the mechanism of thyroiditis after the COVID mRNA vaccine remains unclear. Subacute Thyroiditis typically manifests as a triphasic clinical course of thyrotoxicosis, followed by hypothyroidism and a return to the euthyroid state; however, mRNA vaccine-induced Thyroiditis seems to have a different disease course. In the observation of these case series, both patients remained in the hypothyroid state requiring Levothyroxine replacement eight-and twelve-months post-vaccination, respectively. Whether they developed permanent thyroid damage or are able to recover with prolonged recovery time is still unclear, which needs further follow-up in the future.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Thyroiditis. 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.,Linked Report(s) : US-PFIZER INC-202201282091 Same article/drug/event, different patients;
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: Red circle hard lump at injection shot of the Pfizer booster; Red circle hard lump at injection shot of the Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE MASS (non-serious), outcome "unknown" and all described as "Red circle hard lump at injection shot of the Pfizer booster".  Additional information: Red circle hard lump at injection shot of the Pfizer booster. Event took place after use of product.  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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Immune system disorder, Suspected COVID-19
Clinical narrative: Got COVID; Got COVID; Compromised immune system; 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), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), (Batch/Lot number: unknown). 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"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Compromised immune system". The action taken for cilgavimab, tixagevimab was unknown. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient had 3 Pfizer vaccines as part of initial treatment, 2 Pfizer Boosters, and the current bivalent Booster along with cilgavimab, tixagevimab. When patient got COVID this fall patient was able to be treated with monoclonal antibodies and stayed home. Patient had a very compromised immune system.   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.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Illness, Memory impairment
Clinical narrative: Got my booster shot and got sick all over again/Could not get out of bed; Dizzy; Didn't know who was in the room; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 75-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Dizzy", "extremely sick", "Could not get out of bed", "Didnt know who was in the room"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Dizzy", "extremely sick", "Could not get out of bed", "Didnt know who was in the room". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got my booster shot and got sick all over again/Could not get out of bed"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Didn't know who was in the room". The events "got my booster shot and got sick all over again/could not get out of bed", "dizzy" and "didn't know who was in the room" required emergency room visit.  Additional information: The patient was taken to the ER though the patient was in good health.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201283470 same patient/drug/events, different dose;
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, Disease recurrence
Clinical narrative: Since I have asthma; Since I have asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "History of Bronchitis" (unspecified if ongoing); "colds" (unspecified if ongoing), notes: Often develop bronchitis. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: unknown, Site and route of injection: Upper arm, Intramuscular), administration date: 15Jan2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: unknown, Site and route of injection: Upper arm, Intramuscular), administration date: 06Feb2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown, Site and route of injection: Upper arm, Intramuscular), administration date: 28Sep2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: unknown, Site and route of injection: Upper arm, Intramuscular), administration date: 15Apr2022, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious), DISEASE RECURRENCE (non-serious) all with onset 2022, outcome "unknown" and all described as "Since I have asthma". Therapeutic measures were taken as a result of asthma, disease recurrence.  Additional information: Patient had booster on 21Sep2022 in AM. By evening started to feel a sore throat and cough begin. On morning of 22Sep2022 definitely felt sick, took rapid COVID test which came in mail from Government. She tested positive, her husband did not, very bad cough, some throat, fever 100-101. Since she had asthma, she called her doctor, had televisit (word not legible). MD prescribed anti COVID medication for 5 days and special cough medication benzoate. After completion of anti COVID pills, she tested negative, then her husband developed symptoms and tested positive positive 08Oct or 09Oct. She started feeling sick again, some throat and lots of sneezing, no cough. Next day she tested positive again. Felt like a very bad cold, no fever, just took COVID/flu medication-over the counter.  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.; Sender's Comments: Linked Report(s): PFIZER INC-202201198008 same patient, different vaccine dose/AE.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: Alopecia Areata; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ALOPECIA AREATA (non-serious), outcome "unknown".  Additional information: The patient stated that vaccine gave Alopecia Areata about 3-4 weeks after receiving the booster.  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.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: had an infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: INFECTION (non-serious), outcome "unknown", described as "had an infection".  Additional information: Caller asked if Pfizer still makes zithromax. Also wanted to confirm the NDC # of Zithromax. Caller also mentioned that she's been vaccinated with the Pfizer COVID 19 vaccines and had an infection. Cold Transferred - Created and submitted Manual AE form # because caller mentioned that she had infection after getting the Pfizer COVID-19 vaccines. Medical Information: Forwarded: Yes, medical inquiry was forwarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, White blood cell count, White blood cell count increased
Clinical narrative: increase of White blood cell; lymph nodes began to swell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4176868 (AbbVie).  A 62-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: GAZYVA. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 Immunization, reaction(s): "lymph nodes began to swell", "increase of White blood cell". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "lymph nodes began to swell"; WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "not recovered", described as "increase of White blood cell". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The events did not abate after the stopping the drug.  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-PV202200097131 Same reporter/patient/event, different doses;
Sex: U
Vaccine: PNC20
Symptoms: Dermatitis allergic
Clinical narrative: Patient had an allergic type reaction (dermatitis type reaction) after being vaccinated with Prevnar 20; This is a spontaneous report received from contactable reporter (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS ALLERGIC (non-serious), outcome "unknown", described as "Patient had an allergic type reaction (dermatitis type reaction) after being vaccinated with Prevnar 20". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Eczema
Clinical narrative: SHE GOT A FLU SHOT RECENTLY AND ENDED UP WITH FULL BLOWN ECZEMA ON HER FOREARMS AFTER THIS; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 53 years old female patient (129.2 kg) who got a flu shot recently and ended up with full blown eczema on her forearms after receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergies: latex, doxycycline hyclate, demerol, penicillin vk, benadryl, zyrtec, sulfamethoxazole, cefuroxime notes: allergies: latex, doxycycline hyclate, demerol, penicillin vk, benadryl, zyrtec, sulfamethoxazole, cefuroxime.   On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 300 mg /2 mL Pre-filled syringe QOW via subcutaneous route (with an unknown batch number and expiry date) for Dermatitis atopic.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got a flu shot recently and ended up with full blown eczema on her forearms after this (eczema) (unknown latency) following the first dose intake of DUPILUMAB and following the administration of INFLUENZA VACCINE.  Action taken with DUPILUMAB (DUPIXENT) was unknown. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 52 years old female patient who received an expired dose of fluzone quadrivalent with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 52 years old female patient who received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 17-Oct-2022, the patient received expired dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AA) (expired product administered) (latency same day) (dose, formulation, strength, and expiry date: unknown) via intramuscular route in unknown administration site for flu (influenza).  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 01-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, I still got the flu.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: residents under the age of 65 receive Fluzone High Dose in error with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an adult patients of unknown demographics who were a residents under the age of 65 receive fluzone high dose(INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) in error with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site as Immunization.  On an unknown date the residents under the age of 65 receive fluzone high dose in error with no adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. There were 3 residents.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (residents under the age of 65 receive Fluzone High Dose in error with no adverse event).  At time of reporting, the outcome was Unknown for the event     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 27.0
Sex: F
Vaccine: FLUR3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Flubok was given to pregnant women with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 27 years old female patient who was pregnant  and who got the Flubok vaccine, with no reported adverse event. (INFLUENZA QUADRIVALENT RECOMBINANT VACCINE).  The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies.  On 27-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE 0.5ml lot UJ893AA at expiry date of 09-JUN-2023 via intramuscular route in the right arm for Immunization.  On 27-OCT-2022 the patient developed a non-serious flubok was given to pregnant women with no reported adverse event (exposure during pregnancy) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Flubok was given to pregnant women with no reported adverse event).  At time of reporting, the outcome was Unknown for the event flubok was given to pregnant women with no reported adverse event.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, Wrong product administered
Clinical narrative: flu vaccine administered instead of Covid vaccine with no reported AE; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 87 years old female patient who experienced flu vaccine administered instead of covid vaccine with no reported ae while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine rha 3v (baculovirus) (flublok) for Immunisation.  On an unknown date, the patient received a  dose of suspect influenza quadrival a-b high dose hv vaccine lot UJ933AA via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious flu vaccine administered instead of covid vaccine with no reported ae (wrong product administered) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported "Nurse reports that a patient received 2 different flu vaccines, 1 week apart. Nurse states that they had a vaccination clinic yesterday, and an 87 year-old woman received a FLUBLOK vaccine. This morning, that patient's daughter called. The woman had already received a FLUZONE HIGH-DOSE QUADRIVALENT last week, at the facility where she lives. The daughter stated that she had made the appointment at the vaccination clinic for a Covid vaccine, but when the patient's son-in-law brought her to the appointment, he misunderstood and requested the the Flublok instead".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event flu vaccine administered instead of covid vaccine with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: gave a patient a double dose of MENQUADFI vaccine by accident with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who experienced gave a patient a double dose of menquadfi vaccine by accident with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2022, the patient received a  dose of suspect meningococcal a-c-y-w135 (t conj) vaccine two doses lot U7373AB of ex[iry date 06-Aug-2024 via intramuscular route in the left deltoid for Immunization..  On 24-Oct-2022 the patient developed a non-serious gave a patient a double dose of menquadfi vaccine by accident with no reported adverse event (extra dose administered) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  It was reported "Caller is reporting that they gave a patient a double dose of the MENQUADFI vaccine by accident and they are asking if there are any potential symptoms or adverse reactions they need to be on the lookout for, 16 year old patient was administered two doses of MenQuadfi. She asks for appropriate follow-up. She asks what are the potential adverse reactions".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a patient under 65 years of age received HIGH DOSE QUADRIVALENT was given not Fluzone QIV vaccine with no reported AE; a patient under 65 years of age received HIGH DOSE QUADRIVALENT was given not Fluzone QIV vaccine with no reported AE; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 61 years old female patient who was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 27-Oct-2022, the patient received a once total dose of suspect influenza quadrival A-B high dose HV vaccine (lot UJ875AD , expiry date: 30-Jun-2023) at an unknown dose via  an unknown route  route in the left arm for immunisation.  On 27-Oct-2022, the patient who was under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: hypersensitivity; experience intense itching/ itching is inside of my body; urticaria extends from top of head to toes, including eyelids/welts; bumps all over; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 82 years old male patient who experienced bumps all over, hypersensitivity, experience intense itching/ itching is inside of my body and urticaria extends from top of head to toes, including eyelids/welts after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past vaccination(s) included FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. At the time of the event, the patient had ongoing Neuropathy, Demyelinating polyneuropathy and Cardiac arrhythmia.  Concomitant medications included tramadol for neuropathy and a beta-blocker for cardiac arrythmia.  On 01-Oct-2022, the patient received a  dose of suspect influenza quadrival A-B high dose HV vaccine (dose, frequency,formulation, lot number and expiry day not reported) via unknown route in unknown administration site for immunization.  On 03-OCT-2022 the patient developed bumps all over (generalised oedema), intense itching/ itching is inside of my body (pruritus) and urticaria extends from top of head to toes, including eyelids/welts (urticaria) (latency: 3 days). On an unknown date the patient developed a non-serious hypersensitivity (unknown latency). He states that he tried taking Benadryl, but that did nothing for him. Now he's taking Zyrtec, but so far that's done nothing either. Dr. states that he does have a demylinating neuropathy, and he wonders if the vaccine somehow traveled in those nerves, causing general irritation of them. He reports that there is no visible rash, the itching is "inside of my body". He states that the urticaria extends from the top of his head to his toes, including his eyelids.   Action taken: not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Urticaria.  At time of reporting, the outcome was Unknown for all the events.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: received FLUZONE HIGH DOSE QUADRIVALENT and some medication trickled down the consumers arm with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 73 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and some medication trickled down the consumers arm with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient was intended to received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ918AC and expiry date: 30-Jun-2023) via intramuscular route in the arm nos for prophylactic vaccination.  On 11-Oct-2022, (latency: same day) the patient received fluzone high dose quadrivalent and some medication trickled down the consumers arm with no reported adverse event (incorrect dose administered).  It was reported, a consumer received FLUZONE HIGH DOSE QUADRIVALENT and some medication trickled down the consumer's arm. Consumer came back in the store concerned about not getting the full dose. Less than recommended dose was administered.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.