chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: taking paxlovid for 5 days; taking paxlovid for 5 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic sinus infections in the past" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "taking paxlovid for 5 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative days 5 and 10; Positive, notes: Positive on days 12 and 16. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 12Apr2022 to 17Apr2022. After taking paxlovid for 5 days, she felt better. The patient returned to work on day 10. Then on day 12, she got sick again  worse symptoms than the first time she got sick. She have been sick since then and on day 20. The also tested negative days 5 and 10. And then she tested positive on days 12 and 16.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had to test for a flight and came out positive twice.; I had to test for a flight and came out positive twice.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 25Mar2021 as dose 2, single (Lot number: EN4207), in left arm and on 23Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jan2022 at 18:00 as dose 4 (booster), single (Lot number: 012H21B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Heart Disorder - treated" (unspecified if ongoing), notes: Other medical history: Congenital Heart Disorder - treated. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had to test for a flight and came out positive twice.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: It happened about 5-6 days after I had been negative; (unspecified date) positive, notes: I had to test for a flight and came out positive twice; (21Apr2022) negative, notes: I was negative a day after the last dose; (02May2022) negative, notes: I'm negative again today.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4272751-00.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown) and on 06Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 14 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Feb2022, outcome "unknown", COVID-19 (medically significant) with onset Feb2022, outcome "recovered" (Feb2022) and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive; (Feb2022) negative. Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for HUMIRA(ADALIMUMAB): The reporter(s) causality for the event(s) of Covid-19 was not provided.  Causality for PFIZER BIONTECH COVID-19: The reporter's causality for the event(s) of Covid-19 was not reported. Since no determination has been received, the case is managed based on the company causality assessment.  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 events and the suspect drug cannot be excluded. The case will be reassessed once new information is available
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hyperhidrosis, Illness, Nausea, Pain in extremity
Clinical narrative: sweats appeared with terrible itching; throat closing; sick over 1.5 weeks; nausea; weak; sore arm; day 2 woke up with itching; 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 received BNT162b2 (BNT162B2), on 17Oct2021 as dose 2, single (Lot number: FH8027) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Anatomical site of injection: shoulder, Batch/lot number: 30130BA), administration date: 01Sep2021, for COVID-19 immunization, reaction(s): "Tired". The following information was reported: PRURITUS (non-serious) with onset 19Oct2021, outcome "unknown", described as "day 2 woke up with itching"; PAIN IN EXTREMITY (non-serious) with onset 19Oct2021, outcome "unknown", described as "sore arm"; NAUSEA (non-serious) with onset 20Oct2021, outcome "unknown"; ILLNESS (non-serious) with onset 20Oct2021, outcome "unknown", described as "sick over 1.5 weeks"; HYPERHIDROSIS (non-serious) with onset 20Oct2021, outcome "unknown", described as "sweats appeared with terrible itching"; THROAT TIGHTNESS (non-serious) with onset 20Oct2021, outcome "unknown", described as "throat closing"; ASTHENIA (non-serious) with onset 20Oct2021, outcome "unknown", described as "weak". Therapeutic measures were taken as a result of throat tightness.  Additional Information: Dose 1, administered on 01Sep2021, Anatomical site of injection: shoulder, Batch/lot number: 30130BA. Dose 2, administered on 17Oct2021, Anatomical site of injection: shoulder, Batch/lot number: FH8027. No Prior vaccination within 4 weeks. No Concomitant drugs. No Patient's medical history. Comments/Narrative: 1st Pfizer vaccine part A: No reaction, tired after 2 days. 2nd Pfizer vaccine part B: sore arm-day 2 woke up with itching. Day 3 very sore arm of well appeared with terrible itching. Day 3-night time throat closing urgent care said- don't come here- we cannot help you. Go where you got vaccine. Pharm at (facility name withheld) gave the Benadryl and took my report. Sick over 1.5 weeks and weak. Nausea 3 days.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: sweats appeared with terrible itching; throat closing; sick over 1.5 weeks; nausea; weak; sore arm; day 2 woke up with itching; 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 received BNT162b2 (BNT162B2), on 17Oct2021 as dose 2, single (Lot number: FH8027) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Anatomical site of injection: shoulder, Batch/lot number: 30130BA), administration date: 01Sep2021, for COVID-19 immunization, reaction(s): "Tired". The following information was reported: PRURITUS (non-serious) with onset 19Oct2021, outcome "unknown", described as "day 2 woke up with itching"; PAIN IN EXTREMITY (non-serious) with onset 19Oct2021, outcome "unknown", described as "sore arm"; NAUSEA (non-serious) with onset 20Oct2021, outcome "unknown"; ILLNESS (non-serious) with onset 20Oct2021, outcome "unknown", described as "sick over 1.5 weeks"; HYPERHIDROSIS (non-serious) with onset 20Oct2021, outcome "unknown", described as "sweats appeared with terrible itching"; THROAT TIGHTNESS (non-serious) with onset 20Oct2021, outcome "unknown", described as "throat closing"; ASTHENIA (non-serious) with onset 20Oct2021, outcome "unknown", described as "weak". Therapeutic measures were taken as a result of throat tightness.  Additional Information: Dose 1, administered on 01Sep2021, Anatomical site of injection: shoulder, Batch/lot number: 30130BA. Dose 2, administered on 17Oct2021, Anatomical site of injection: shoulder, Batch/lot number: FH8027. No Prior vaccination within 4 weeks. No Concomitant drugs. No Patient's medical history. Comments/Narrative: 1st Pfizer vaccine part A: No reaction, tired after 2 days. 2nd Pfizer vaccine part B: sore arm-day 2 woke up with itching. Day 3 very sore arm of well appeared with terrible itching. Day 3-night time throat closing urgent care said- don't come here- we cannot help you. Go where you got vaccine. Pharm at (facility name withheld) gave the Benadryl and took my report. Sick over 1.5 weeks and weak. Nausea 3 days.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: penetrating headache; headache like that has been kind of growing in frequency and in extremity, getting worse/my headache I am really hurting right now; 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), on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (dose:1), for Covid-19 Immunization; Moderna (dose:2), for Covid-19 Immunization; J and J (dose:3), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 27Apr2022, outcome "not recovered", described as "penetrating headache; headache like that has been kind of growing in frequency and in extremity, getting worse/my headache I am really hurting right now". Therapeutic measures were taken as a result of headache.  Additional information: Reporter consent to contact given: No. Consumer stated, "I have the Pfizer as my final booster shot (clarified as Pfizer Covid-19 vaccine), my fourth shot and my only Pfizer, the other two were Moderna and the third was J and J and the reason I am calling is the side effect. Is there any record of there been like a penetrating headache. I had the shot last Wednesday and I had a headache like that has been kind of been growing in frequency and in extremity, getting worse. This is what, Sunday I am going to see my practitioner tomorrow regarding it because it is like going almost 24 hours. I have been able to kind of control it with some medication(Treatment)." Consumer was informed about the role of Pfizer Drug Safety and informed that is the concerned department to answer the question. In response to further probing: Consumer stated, "No I can not. I got to go deal with my headache I am really hurting right now." Reassurance: Consumer stated, "No, not right now, thank you, thanks for the phone number." Further probing could not be initiated as consumer declined to complete the report. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call. Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Polycythaemia vera
Clinical narrative: I have developed Polycythemia vera which is I have high red blood cells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: ER2613) and as dose 2, single (Lot number: ER8731) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: POLYCYTHAEMIA VERA (medically significant), outcome "unknown", described as "I have developed Polycythemia vera which is I have high red blood cells".  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Systemic lupus erythematosus
Clinical narrative: Lupus erythematosus; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2K-163-4373609-00.  A 51-year-old female patient received BNT162b2 (BNT162B2), 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) at the age of 51 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "not recovered", described as "Lupus erythematosus". The action taken for adalimumab was unknown.  The reporter considered "lupus erythematosus" related to BNT162b2.  Causality for humira (adalimumab): The reporter(s) causality for the event(s) of lupus was possible opinion is that the event of lupus is not assessable.  Causality for Pfizer BioNTech covid-19 vaccine (Tozinameran): The reporter(s) causality for the event(s) of lupus was possible and manufacturer causality not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug 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: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colon cancer, Vaccination site pain
Clinical narrative: Cancerous Tumor in the Large Bowel; Vaccine caused sore arm; MARKETING PROGRMAE NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4373879-00 (AbbVie).  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 01Oct2021 as dose 2, single (Batch/Lot number: unknown) and on 31Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COLON CANCER (medically significant), outcome "recovered", described as "Cancerous Tumor in the Large Bowel"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Vaccine caused sore arm". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "cancerous tumor in the large bowel" and "vaccine caused sore arm" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's assessment of the causal relationship of Large intestine carcinoma (Colon cancer) was not reported and Vaccination site pain was possible.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of Cancerous Tumor in the Large Bowel and Vaccine caused sore arm was not provided.  AbbVie's opinion is that the event of Cancerous Tumor in the Large Bowel is not assessable. AbbVie's opinion is that there is no reasonable possibility that the event of Vaccine caused sore arm is related to HUMIRA (ADALIMUMAB).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, Vaccination site pain, Colon cancer and BNT162B2 is considered possible.
Sex: F
Vaccine: PNC13
Symptoms: Spleen disorder
Clinical narrative: patient with no spleen; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 70-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Jan2017 as dose number unknown, single (Batch/Lot number: unknown); pneumococcal vaccine polysacch 23v (PNEUMOVAX), in 2017 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPLEEN DISORDER (non-serious), outcome "unknown", described as "patient with no spleen".  Additional Context: This case has been considered invalid-other as info not qualifying for AE reporting-medical information initially. Caller had a question about Prevnar 20.  She has patient with no spleen that had Pneumovax and Prevnar 13 in 2017 and she wanted to know if she gives the Prevnar 20 vaccine is that good for the rest of patients life?  She said she does not have the patient's information and the patient called her with the question.  Caller declined to complete report.  Full details unable to be obtained.  Follow up (02May2022):The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (02May2022), this case now contains all required information to be considered valid. This is a spontaneous follow-up report from a contactable Pharmacist. This Pharmacist reported for a patient that: Updated information included: Patient age and gender.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: fever; Flu like symptom for 4 days following receiving the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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 (Manufacturer: Unknown, Primary immunization series complete), for Covid-19 Immunization; Comirnaty (Dose 3, Second Comirnaty second booster reaction), for Covid-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptom for 4 days following receiving the shot"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: Second Comirnaty second booster reaction. Flu like symptoms for 4 days following receiving the shot, including fever on 3rd day. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: went into rehab and got COVID when she went to rehab; went into rehab and got COVID when she went to rehab; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 86-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years 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 "went into rehab and got COVID when she went to rehab". Clinical course included that the patient received her 1st dose on 23Jan2021and also stated that went into rehab and got COVID when she went to rehab.   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 reported events: 'Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: HA; Chills; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), 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, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "HA"; CHILLS (non-serious), outcome "recovering"; MYALGIA (non-serious), outcome "recovering", described as "muscle aches". Therapeutic measures were taken as a result of headache.  Additional information: The reporter in good health experienced mild adverse effects after receiving Covid booster shot 2. Adverse effects started several hours after immunization and resolved late morning the next day. The reporter did not receive chronic medications. The reporter took ibuprofen for HA with good effect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of Efficacy - positive COVID swab + COVID symptoms; Lack of Efficacy - positive COVID swab + COVID symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 11Feb2021 as dose 2, single (Lot number: EL3247), in left arm and on 04Nov2021 as dose 3 (booster) , single (Lot number: FF8841) at the age of 39 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 02May2022, outcome "not recovered", COVID-19 (medically significant) with onset 02May2022, outcome "not recovered" and all described as "Lack of Efficacy - positive COVID swab + COVID symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not received other vaccine within 4 weeks of Coivd-19 vaccine. Patient did not had covid 19 prior to the vaccination and patient tested for covid post vaccination and no known allergy.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Chronic obstructive pulmonary disease
Clinical narrative: COPD; Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 04Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer", start date: 2019 (ongoing), notes: Spring 2019, Mastectomy, Cancer gone, in post cancer 5-year treatment; "Mastectomy" (unspecified if ongoing), notes: Mastectomy, Cancer gone, in post cancer 5-year treatment; "Weakened immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 2, Time: 10:00, Anatomical site of injection: Right Arm, Route of administration: Intramuscular), administration date: 04Feb2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "fatigue"; BNT162b2 (Dose: 1, Time: 10:00 AM , Anatomical site of injection: Right Arm, Route of administration: Intramuscular), administration date: 04Jan2021, when the patient was 75-year-old, for COVID-19 Immunization. The following information was reported: BRONCHITIS (non-serious) with onset 2021, outcome "not recovered"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2021, outcome "not recovered", described as "COPD". Therapeutic measures were taken as a result of chronic obstructive pulmonary disease, bronchitis. Additional information: Onset date of evet Bronchitis/COPD was Autumn 2021. The patient took anoro inhaler. Too many Relevant Test to recall would need 5 years Medical records and at least 5 typed pages.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Feeling hot, Vaccination site swelling
Clinical narrative: gave a shot to a patient and then 5 or 6 days the area has been red , redness started that thursday 28 April 2022; redness and swelling and hot to the touch it goes from the injection down to her elbow; redness and swelling and hot to the touch it goes from the injection down to her elbow; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 53-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Apr2022 as dose number unknown, single (Lot number: FJ2605, Expiration Date: 31Jul2023) at the age of 53 years. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LANTUS; NOVOLOG. The following information was reported: ERYTHEMA (non-serious) with onset 28Apr2022, outcome "unknown", described as "gave a shot to a patient and then 5 or 6 days the area has been red , redness started that thursday 28 April 2022"; VACCINATION SITE SWELLING (non-serious), FEELING HOT (non-serious) all with onset 28Apr2022, outcome "unknown" and all described as "redness and swelling and hot to the touch it goes from the injection down to her elbow".  Additional information: Concern: Transferring agent Stated, She is stating that a patient, a female patient 53 years old received a shot of Prevnar 20 on 20Apr2022. She has experienced redness that started the day of the vaccination. She said the patient has redness and swelling and its hot to the touch and it goes from the injection site down to her elbow. Her question was how long should it last or should the patient seek medical attention if it last longer than 10 days, which I provided information for but she needs to report the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: el3247), in left arm, on 12Apr2021 as dose 2, single (Lot number: el3247), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: fg3527) at the age of 47 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02May2022, outcome "unknown", COVID-19 (medically significant) with onset 02May2022, outcome "not recovered" and all described as "Contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: COVID test post vaccination COVID test type post vaccination: Nasal Swab,. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Afrin and Advil PM.  Clinical information: No known allergies. No other vaccine in four weeks. No COVID prior vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting; fever; fatigue; aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low Thyroid" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Sulpha drugs" (unspecified if ongoing), notes: Known allergies: Latex/Sulpha drugs; "Latex" (unspecified if ongoing), notes: Known allergies: Latex/Sulpha drugs. Concomitant medication(s) included: LEVOTHYROXINE; NORTEC. Vaccination history included: Covid-19 vaccine (Dose:3, 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 following information was reported: VOMITING (non-serious) with onset 02May2022 at 23:45, outcome "not recovered"; PAIN (non-serious) with onset 02May2022 at 23:45, outcome "not recovered", described as "aches"; CHILLS (non-serious) with onset 02May2022 at 23:45, outcome "not recovered"; FATIGUE (non-serious) with onset 02May2022 at 23:45, outcome "not recovered"; PYREXIA (non-serious) with onset 02May2022 at 23:45, outcome "not recovered", described as "fever". Therapeutic measures were not taken as a result of vomiting, pyrexia, fatigue, pain, chills.  Additional information: Other medications in two weeks: Levothyroxine/Nurtec. If Other vaccine in four weeks: No, Adverse event: Vomiting/fever/fatigue/aches/chills. If COVID prior vaccination: No, If COVID tested post vaccination: No, Known allergies: Latex/Sulpha drugs.   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: Suspected COVID-19
Clinical narrative: got COVID and then got his second shot of COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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: SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "got COVID and then got his second shot of COVID-19 Vaccine". Therapeutic measures were taken as a result of suspected covid-19.  Additional information: Agent reports she has a consumer on line reporting she has been taking Paxlovid and has had the beginning of a migraine. Agent reports the caller had a drug interaction question which was addressed. She states her other grandson after one shot of the COVID-19 vaccine got COVID and then got his second shot of the COVID-19 vaccine. Caller states she does not have the details on shots.  Reporter details: Caller states she probably has the longest name in the system. She stated she was not a doctor, nurse, or pharmacist but her husband is a doctor. Caller clarifies that her area code for her phone number. Caller declined to complete report on her brother, her son, and her grandson. Full details unable to be obtained. Caller states she is glad Pfizer has these vaccines and her symptoms could have been a lot worse if she didn't have the vaccines. There was a product complaint to report. Description of Product Complaint: Description of complaint: Her other grandson after one shot of the COVID-19 vaccine got COVID and then got his second shot of the COVID-19 vaccine.   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: Bedridden, Feeling abnormal, Feeling hot
Clinical narrative: he was in bed for a day after all 3 COVID-19 vaccines; her son felt like his body was on fire; thousand needles sticking in him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 44-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (dose 2, single, manufacturer unknown), for Covid-19 immunisation. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "he was in bed for a day after all 3 COVID-19 vaccines"; FEELING HOT (non-serious), outcome "unknown", described as "her son felt like his body was on fire"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "thousand needles sticking in him".  Additional information:She states after her son's COVID vaccine, her son felt like his body was on fire and a thousand needles sticking in him. Caller states her son is 44-year-old and he was in bed for a day after all 3 COVID-19 vaccines. Caller states her son lives in withheld and she is in withheld and her husband won't take time with doing the report. Caller declined to complete report on her son and husband at this time. Full details unable to be obtained. Caller asks if Pfizer Drug Safety can help her or can she be transferred so she can find out if she can stop taking Paxlovid or should she continue taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: Product administered to patient of inappropriate age; Rash; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 6-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EP6955) at the age of 6 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown". The event "rash" required physician office visit.  Additional information: Caller reported that her granddaughter was also a Pfizer recipient and had a little rash. Caller reported that her granddaughter has been to see a pediatrician, and she doesn't want to weigh in on it.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hodgkins Lymphoma survivor" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, manufacturer unknown), for Covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, which included Paxlovid from 19Apr2022 to 23Apr2022. After taking Paxlovid for 5 days and feeling great, the patient became sick again on 28Apr2022 with worse symptoms for which no treatment was given and she was recovering from it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes; This is a spontaneous report received from contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH (non-serious), outcome "unknown", described as "rashes".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
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 61-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic bronchitis in the past" (unspecified if ongoing), notes: Chronic bronchitis in the past. Concomitant medication(s) included: TYLENOL; ZINC; AIRBORNE. 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 covid-19. Reporter assessed events as non serious. The patient did not have any known allergies.  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: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: positive test result on 03May2022 at 8pm rapid test; positive test result on 03May2022 at 8pm rapid test; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), on 21Oct2021 as dose 3 (booster),  single (Batch/Lot number: unknown) and on 30Apr2022 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. The following information was reported: PYREXIA (non-serious) with onset 02May2022, outcome "unknown", described as "fever"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03May2022 at 20:00, outcome "unknown" and all described as "positive test result on 03May2022 at 8pm rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C, 30 minutes with a minimum of 12.3C and maximum of 15.6C, 1 hour with a minimum of negative 1.8C and maximum of 1.8C with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received from health professional received on 29-Apr-2022.  This case involves a 2 months old patient of unknown gender who was administered vaccine with reported total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2021, It was reported that temperature excursion of Pentacel vaccine occurred with total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, on 19-Oct-2021,  temperature excursion occurred with 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event (product temperature excursion issue). On 15-MAR-2022, the patient received a dose of suspect Pentacel vaccine (lot UJ578AAA, expiry date: 10-Sep-2022) (formulation, strength, dose, lot number, expiration date, route of administration and administration site: unknown) as prophylactic vaccination (immunization).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.
Age: 46.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C reported with no adverse  event; Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 46 years old and unknown gender patient who was administered with influenza quadrival A-B vaccine [Fluzone Qiv] which was having total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c reported with no adverse  event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Nov-2021, the patient received a  dose of suspect influenza quadrival A-B vaccine, suspension for injection (strength and formulation: unknown) (lot UT7325JA; Expiration Date: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date it was reported that total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c reported with no adverse  event (product storage error) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c reported with no adverse  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 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: 17.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C, 30 minutes with a minimum of 12.3C and maximum of 15.6C, 1 hour with a minimum of negative 1.8C and maximum of 1.8C with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received from health professional received on 29-Apr-2022.  This case involves a 17 years old patient of unknown gender who was administered vaccine with reported total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2021, It was reported that temperature excursion of Menactra vaccine occurred with total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, on 19-Oct-2021,  temperature excursion occurred with 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event (product temperature excursion issue). On 01-Apr-2022, the patient received a dose of suspect Menactra vaccine (lot U7268AA, expiry date: 22-Apr-2023) (formulation, strength, dose, lot number, expiration date, route of administration and administration site: unknown) as prophylactic vaccination (immunization).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.