chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report, with reference number 2023SA055890 (Inquiry number # 01495388), was received by the partner on 16-FEB-2023 and forwarded on 17-FEB-2023, from other health professional.  This case was considered non-valid due to no patient identifiers (temperature excursion only).   Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use." and Vaxelis was assessed as not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received on 23-FEB-2023, from a HCP. The case is maintained as non-serious and upgraded to valid.   The HCP confirmed that there were no adverse events following Vaxelis administration.  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis remained not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004562, MCM-004563, MCM-004564, MCM-004565, and MCM-004566, due to same reporter.
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Caller reported that she gave VAXELIS and HIBIRIX to a patient on the same day (patient received 2 Hib doses) to catch up, instead of VAXELIS and PCV; Wrong vaccine administered; This non-serious spontaneous safety report, with reference number 2023SA057617/ Inquiry# 01495467 was received by a partner on 16-FEB-2023 and forwarded on 20-FEB-2023 from a physician.   Due to the nature of the event, the causality between the events "Caller reported that she gave VAXELIS and HIBIRIX to a patient on the same day (patient received 2 Hib doses) to catch up, instead of VAXELIS and PCV" and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388).  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004541, MCM-004563, MCM-004564, MCM-004565, and MCM-004566, due to same reporter.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388).  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004564, MCM-004565, and MCM-004566, due to same reporter.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report, was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388).  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004563, MCM-004565, and MCM-004566, due to same reporter.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, RV1
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report, was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388).  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004564, MCM-004565, and MCM-004563, due to same reporter.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: Patient who was previously administered PENTACEL on 03/15/2022, on 06/09/2022, and on 01/10/2022 was administered VAXELIS via VAXELIS Prefilled Syringe at 15 Months on 02/20/2023; Patient who was previously administered PENTACEL on 03/15/2022, on 06/09/2022, and on 01/10/2022 was administered VAXELIS via VAXELIS Prefilled Syringe at 15 Months on 02/20/2023; This spontaneous safety report, with reference number 02340148 (Interaction # 02340145), was received by the partner on 21-FEB-2023 and forwarded on 23-FEB-2023, from a physician.  Due to the nature of the event, the causality between the events "Patient who was previously administered PENTACEL on 03/15/2022, on 06/09/2022, and on 01/10/2022 was administered VAXELIS via VAXELIS Prefilled Syringe at 15 Months on 02/20/2023" and Vaxelis was not applicable.  No further information is expected given that the reporter did not give consent for further follow-up communication.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 20 year old patient was administered Vaxelis instead of TD; 20 year old patient was administered Vaxelis instead of TD; This non-serious spontaneous safety report, with case number 2023SA085919/01534523, was received by partner on 15-MAR-2023 on 16-MAR-2023 from a physician.  Due to the nature of the event the causal relationship between Vaxelis and the reported event "20-year-old patient was administered Vaxelis instead of TD" was assessed as not applicable.  Case was considered off-label use due to Vaxelis being administered to a 20-year-old patient.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Medical assistant reported VAXELIS was administered after a temperature excursion (8.8°C); This non-serious spontaneous safety report with reference number 02354967 was received by a partner on 16-MAR-2023 and forwarded on 17-MAR-2023 from a HCP.  Due to the nature of the event, the causality between Vaxelis and the reported event "Medical assistant reported VAXELIS was administered after a temperature excursion (8.8°C)" was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaxelis was administered after a temperature excursion to a patient. No additional AE reported. Temperature:8.8C. Time Frame:54 minutes; This spontaneous safety report, with reference number 02355015 (Interaction # 02354956) was received by the partner on 16-MAR-2023 and forwarded on 17-MAR-2023, from a health professional.    Due to the nature of the event, the causality between the event "Vaxelis was administered after a temperature excursion to a patient. No additional AE reported. Temperature:8.8C. Time Frame:54 minutes" and Vaxelis was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave extra dose of Hep B; Gave extra dose of Hep B; This case was retrieved during the Reporting System monitoring on 12-JAN-2023 with the following. The original narrative from the sender is the following:   On Oct 24th I gave pt his 6 month vaccines, Vaxelis, hep B, Rota, and PCV13. I gave pt an extra dose of Hep B 0.5 on right tigh, mom of pt was notified of incident, and I called both manufacturers, to report and ask if there was any data on giving an extra dose of Hep B. They GSK and SANOFI both stated there was no harm per their data base and the report. There was no symptoms reported by parents.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Extra dose administered" and "Overdose".  No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Device physical property issue, Syringe issue
Clinical narrative: Three damaged Prevnar 13 syringes/Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle; The initial case was missing the following minimum criteria: reportable event. Upon receipt of follow-up information on 23Mar2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. A child patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EY0433, Expiration Date: Nov2023) for immunisation, Device Lot Number: EY0433, Device Expiration Date: Nov2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Three damaged Prevnar 13 syringes/Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle". Additional information: NDC number of Prevnar 13: 0005197101. Three damaged Prevnar 13 syringes: Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on and went to administer, or well when just had gotten air out. Fortunately, was not in kids leg, leaked straight out of middle neck part. The reporter would like to know if Pfizer would give credit. They still had the Prevnar 13 syringes. Occurred fortunately before and another Prevnar 13 syringe was gotten out to be used. The reporter also clarified there were three separate patients involved, all prior to administration when preparing drawing up and never really got in room with the patients. The reporter did not have the patient information on hand to complete individual reports. Did not make to patient; therefore, the reporter did not keep the patient information. Unable to clarify which Prevnar 13 were involved with which patient. Unable to also clarify which Prevnar 13 were involved with which occurrence. The sample of the product was available to be returned.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300129342 same reporter/ vaccine/ event, different patients;US-PFIZER INC-202300129343 same reporter/ vaccine/ event, different patients;
Sex: U
Vaccine: PNC13
Symptoms: Device physical property issue, Syringe issue
Clinical narrative: Three damaged Prevnar 13 syringes/Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on; The initial case was missing the following minimum criteria: reportable event. Upon receipt of follow up information on 23Mar2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A child patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: GD1168, Expiration Date: Apr2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Three damaged Prevnar 13 syringes/Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on".  Additional information: NDC number of Prevnar 13: 0005197101. Three damaged Prevnar 13 syringes: Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on and went to administer, or well when just had gotten air out. Fortunately, was not in kids leg, leaked straight out of middle neck part. The reporter would like to know if Pfizer would give credit. They still had the Prevnar 13 syringes. Occurred fortunately before and another Prevnar 13 syringe was gotten out to be used. The reporter also clarified there were three separate patients involved, all prior to administration when preparing drawing up and never really got in room with the patients. The reporter did not have the patient information on hand to complete individual reports. Did not make to patient; therefore, the reporter did not keep the patient information. Unable to clarify which Prevnar 13 were involved with which patient. Unable to also clarify which Prevnar 13 were involved with which occurrence. The sample of the product was available to be returned.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300129299 Same reporter/ vaccine/ AE, different patients.;US-PFIZER INC-202300129343 Same reporter/ vaccine/ AE, different patients.;
Sex: U
Vaccine: PNC13
Symptoms: Device physical property issue, Syringe issue
Clinical narrative: syringes actually broke at the neck/syringe leaked when put the needle on; The initial case was missing the following minimum criteria: reportable event. Upon receipt of follow-up information on 23Mar2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A child patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EY0433, Expiration Date: Nov2023) for immunisation, Device Lot Number: EY0433, Device Expiration Date: Nov2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "syringes actually broke at the neck/syringe leaked when put the needle on ". Additional information: NDC number of Prevnar 13: 0005197101. Three damaged Prevnar 13 syringes: Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on and went to administer, or when just had gotten air out. Fortunately, was not in kids leg, leaked straight out of middle neck part. The reporter clarified there were three separate patients involved, all prior to administration when preparing drawing up and never really got in room with the patients. The sample of the product was available to be returned.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300129342 same reporter, suspect drug and event; different patient;US-PFIZER INC-202300129299 same reporter, suspect drug and event; different patient;
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Axillary pain, Diarrhoea, Fatigue, Injection site pain, Injection site warmth
Clinical narrative: Fatigue; I became ill; I had pain in the injection site; Fever at the injection site; Vomited; Diarrhea; Body fever; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Mar2023 at 07:45 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; LIPITOR; ACTOS. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious) all with onset Mar2023, outcome "not recovered" and all described as "I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit"; PYREXIA (non-serious) with onset 24Mar2023, outcome "unknown", described as "Body fever"; DIARRHOEA (non-serious) with onset 24Mar2023, outcome "unknown", described as "Diarrhea"; VACCINATION SITE WARMTH (non-serious) with onset 24Mar2023, outcome "unknown", described as "Fever at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 24Mar2023, outcome "unknown", described as "I had pain in the injection site"; VOMITING (non-serious) with onset 24Mar2023, outcome "unknown", described as "Vomited"; MALAISE (non-serious) with onset 24Mar2023 at 15:00, outcome "unknown", described as "I became ill"; FATIGUE (non-serious) with onset 25Mar2023, outcome "recovering".  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: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Malaise, Oedema peripheral, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Fatigue; I became ill; I had pain in the injection site; Fever at the injection site; Vomited; Diarrhea; Body fever; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Mar2023 at 07:45 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; LIPITOR; ACTOS. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious) all with onset Mar2023, outcome "not recovered" and all described as "I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit"; PYREXIA (non-serious) with onset 24Mar2023, outcome "unknown", described as "Body fever"; DIARRHOEA (non-serious) with onset 24Mar2023, outcome "unknown", described as "Diarrhea"; VACCINATION SITE WARMTH (non-serious) with onset 24Mar2023, outcome "unknown", described as "Fever at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 24Mar2023, outcome "unknown", described as "I had pain in the injection site"; VOMITING (non-serious) with onset 24Mar2023, outcome "unknown", described as "Vomited"; MALAISE (non-serious) with onset 24Mar2023 at 15:00, outcome "unknown", described as "I became ill"; FATIGUE (non-serious) with onset 25Mar2023, outcome "recovering".  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: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, Vaccination site pain, Vaccination site warmth, Vomiting
Clinical narrative: Fatigue; I became ill; I had pain in the injection site; Fever at the injection site; Vomited; Diarrhea; Body fever; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Mar2023 at 07:45 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; LIPITOR; ACTOS. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious) all with onset Mar2023, outcome "not recovered" and all described as "I still have pain when I lift my arm above my shoulder but the pain and swelling is at the side of my arm and it goes down into my armpit"; PYREXIA (non-serious) with onset 24Mar2023, outcome "unknown", described as "Body fever"; DIARRHOEA (non-serious) with onset 24Mar2023, outcome "unknown", described as "Diarrhea"; VACCINATION SITE WARMTH (non-serious) with onset 24Mar2023, outcome "unknown", described as "Fever at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 24Mar2023, outcome "unknown", described as "I had pain in the injection site"; VOMITING (non-serious) with onset 24Mar2023, outcome "unknown", described as "Vomited"; MALAISE (non-serious) with onset 24Mar2023 at 15:00, outcome "unknown", described as "I became ill"; FATIGUE (non-serious) with onset 25Mar2023, outcome "recovering".  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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Chills, Feeling cold, Interchange of vaccine products, Knee operation
Clinical narrative: She just had Knee surgery; Chills; She is cold all of the time; She is moving slowly; Interchange of vaccine products; 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 COVID-19 Vaccine - Manufacturer Unknown, on 16Nov2021 as dose 3 (booster), single (Lot number: 065F21A) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, Lot Number: 011J20A, Manufacturer: Moderna), administration date: 19Jan2021, when the patient was 70-year-old, for COVID-19 immunization; moderna coviD-19 vaccine (DOSE 2, Lot Number: Unknown, Manufacturer: Moderna), administration date: 16Feb2021, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown"; KNEE OPERATION (medically significant), outcome "unknown", described as "She just had Knee surgery"; CHILLS (non-serious), outcome "not recovered"; FEELING COLD (non-serious), outcome "not recovered", described as "She is cold all of the time"; BRADYKINESIA (non-serious), outcome "unknown", described as "She is moving slowly".  Clinical Course: The reporter wanted to ask a question about the Pfizer COVID Vaccine that she received, she states she has been getting chills for about a year now, she was thinking it was just because she is getting old, but wondered if it could be connected. She stated that she doesn't know whether to take more boosters or not because she suffers with these chills. She also discovered that she actually received the Moderna COVID 19 Vaccines instead of the Pfizer COVID 19 Vaccines.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives/broke out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 28Dec2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jul2022 (unspecified if ongoing). Concomitant medication(s) included: YELLOW FEVER VACCINE. The following information was reported: URTICARIA (non-serious), outcome "not recovered", described as "Hives/broke out in hives". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient asked if the Pfizer COVID -19 Vaccine has affected 1% of the population with hives. Patient has been under her doctor's care for this and was given prednisone, antihistamine and creams. Patient stated that the antihistamines have not been working for her. Patient took Benadryl which dried off her mouth. Patient also took Zyrtec. Patient took Allegra for hives which she plans to stop. Patient also takes prescription cream which she has been using all over her body. Patient only took the Pfizer COVID Vaccine for her supposed travel for a wedding in Feb. Patient had her first dose on 28Dec2022 and 2nd dose at the end of Jan2023. Caller also took yellow fever shots. Last visit, doctor told her it may take 8 weeks to get over the hives. Patient described the hives as debilitating to her sleep pattern. Patient mentioned that Pfizer should make an antidote. Patient mentioned about her friend who works in the medical community and had a COVID shot when it first came out. Patient's friend has been itching for 2 years and had gone to different allergists. Patient was not sure if her friend has hives. Patient blames Pfizer on it.  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-202300135898 Same patient/vaccine, different dose, similar event;
Sex: U
Vaccine: COVID19-2, FLUX
Symptoms: Headache, Hypersensitivity, Interchange of vaccine products, Lacrimation increased, Off label use
Clinical narrative: allergic reactions; Really bad allergic; my eyes are watering; my nose is running; just really bad; I am having allergic reactions; Headache; I have had all the Moderna shots, they have been Moderna all of them, Omicron this last one, then I took the other one yours (Pfizer COVID-19 Vaccine); I had one shot for the COVID, the Omicron and then I had one shot for the Influenza in the other arm; I had one shot for the COVID, the Omicron and then I had one shot for the Influenza in the other arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Mar2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (Primary Immunization series complete (Dose number unknown)), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 27Mar2023, outcome "unknown" and all described as "I had one shot for the COVID, the Omicron and then I had one shot for the Influenza in the other arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "I have had all the Moderna shots, they have been Moderna all of them, Omicron this last one, then I took the other one yours (Pfizer COVID-19 Vaccine)"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reactions"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "Really bad allergic; my eyes are watering"; RHINORRHOEA (non-serious), outcome "unknown", described as "my nose is running; just really bad; I am having allergic reactions"; HEADACHE (non-serious), outcome "unknown".  Clinical course: Patient had a Flu shot (Name not specified)). Patient had one shot for the COVID, the Omicron and then had one shot for the Influenza in the other arm. Patient further stated, then nothing happened, patient didn't have any adverse, 15 minutes after the shot patient left, no problem rest of the night. Patient woke up this morning, no problem but later on in the morning, patient started developing like a really bad allergic things like you know, patient eyes are watering and nose is running and just really bad, though patient face is not swelled, throat is not swelled but patient is having allergic reactions. Patient doesn't know what to do, patient doesn't have an EpiPen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19-2, FLUX
Symptoms: Product use issue, Rhinorrhoea
Clinical narrative: allergic reactions; Really bad allergic; my eyes are watering; my nose is running; just really bad; I am having allergic reactions; Headache; I have had all the Moderna shots, they have been Moderna all of them, Omicron this last one, then I took the other one yours (Pfizer COVID-19 Vaccine); I had one shot for the COVID, the Omicron and then I had one shot for the Influenza in the other arm; I had one shot for the COVID, the Omicron and then I had one shot for the Influenza in the other arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Mar2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (Primary Immunization series complete (Dose number unknown)), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 27Mar2023, outcome "unknown" and all described as "I had one shot for the COVID, the Omicron and then I had one shot for the Influenza in the other arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "I have had all the Moderna shots, they have been Moderna all of them, Omicron this last one, then I took the other one yours (Pfizer COVID-19 Vaccine)"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reactions"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "Really bad allergic; my eyes are watering"; RHINORRHOEA (non-serious), outcome "unknown", described as "my nose is running; just really bad; I am having allergic reactions"; HEADACHE (non-serious), outcome "unknown".  Clinical course: Patient had a Flu shot (Name not specified)). Patient had one shot for the COVID, the Omicron and then had one shot for the Influenza in the other arm. Patient further stated, then nothing happened, patient didn't have any adverse, 15 minutes after the shot patient left, no problem rest of the night. Patient woke up this morning, no problem but later on in the morning, patient started developing like a really bad allergic things like you know, patient eyes are watering and nose is running and just really bad, though patient face is not swelled, throat is not swelled but patient is having allergic reactions. Patient doesn't know what to do, patient doesn't have an EpiPen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: The caller is asking if that will matter because right now she's only feeling the soreness that she originally felt when she first got the Pfizer booster shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2), for COVID-19 Immunization; Bnt162b2 (DOSE 3), for COVID-19 Immunization, reaction(s): "The caller is asking if that will matter because right now she's only feeling the soreness that she originally felt when she first got the Pfizer booster shot.". The following information was reported: PAIN (non-serious), outcome "unknown", described as "The caller is asking if that will matter because right now she's only feeling the soreness that she originally felt when she first got the Pfizer booster shot.". Additional information: The caller said she got the Pfizer booster shot, but she realized that she already got the same booster shot a year and a month ago. The caller is asking if that will matter because right now she's only feeling the soreness that she originally felt when she first got the Pfizer booster shot. The caller mentioned that she neglected to let her provider know that she already had the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Tinnitus
Clinical narrative: I have a, constant, have had ringing in my ear, non-stop; anatomical location and route of administration, consumer stated, "It was the left shoulder."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: EW0150) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Joint pain" (unspecified if ongoing), notes: Joint pain. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: ER2613), administration date: 16Mar2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "ringing in his ears", "increasingly harder for him to hear". The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "I have a, constant, have had ringing in my ear, non-stop"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "anatomical location and route of administration, consumer stated, "It was the left shoulder."  Additional information: Consumer stated that he had written a letter this morning about reporting his adverse reaction which he had for quite a while now and he just thought he would report and see if there was anything that can be done on any kind of reaction to the COVID-19 Vaccines (clarified as Pfizer COVID-19 Vaccine). He received the Vaccine 2 the couple of years ago when it first came out. He got the Booster, he got the 2 shots and a Booster, and he had a constant ringing in his ear non-stop. He went to his Physician, and he also spoke with his allergist, and they both have come to the conclusion that it was Tinnitus. He wanted to know if there was anything that Pfizer was doing for people that had adverse reactions to this vaccine. He was having constant ringing in both ears all the time. He was querying what Pfizer was doing for the patients that were having the same problem as he was. He read articles that he was not the only one experiencing this particular issue. When probed for the start date of the side effect, consumer stated that he got it after his first vaccine. It was like a week after that (25Mar2021). When probed for the anatomical location and route of administration, consumer stated that it was the left shoulder. For other medical condition, consumer stated that he doesn't have any hypertension or blood pressure. HE had joint pain, but that was it. When probed for medication for joint pain, consumer stated that there was no medication. He could not continue the medication (Further clarification unknown). Patient did not have any vaccination prior to the first COVID shot. Consumer also asked if he still need to call the medical info, because it was not really much to keep him out of his pain, he just needed to  know what happens next.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Body temperature, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Mar2023 at 12:00 as dose 5 (booster), single (Lot number: GJ6743) at the age of 71 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Cardiac bypass surgery 14 years ago" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; ROSUVASTATIN; METOPROLOL; OMEPRAZOLE. 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; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 28Mar2023 at 14:00, outcome "not recovered", described as "General weakness"; PAIN (non-serious) with onset 28Mar2023 at 14:00, outcome "not recovered", described as "body aches"; PYREXIA (non-serious) with onset 28Mar2023 at 14:00, outcome "not recovered", described as "fever (99-100.5)"; OROPHARYNGEAL PAIN (non-serious) with onset 28Mar2023 at 14:00, outcome "not recovered", described as "minor sore throat". The events "general weakness", "minor sore throat", "fever (99-100.5)" and "body aches" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, oropharyngeal pain, pyrexia, pain. Additional information: The events general weakness, minor sore throat, body aches and fever (99-100.5) has persisted for 3 days (at the time of reporting). The patient's body temperature in Mar2023 was 99-100.5. Treatment for the events asthenia, oropharyngeal pain, pyrexia, and pain included acetaminophen (TYLENOL). Prior to the vaccination, the patient was not diagnosed COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated
Clinical narrative: But after my 3rd dose, I suffered a major flare; 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 15Dec2021 as dose 3 (booster), single (Lot number: 33Q30BD) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity with no other pre-existing conditions" (unspecified if ongoing). Facility where the most recent COVID-19 vaccine was administered on Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient did not have COVID prior to vaccination. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1 , Batch/Lot No: EN6208 , Location of injection: Arm Right), administration date: 17Mar2021, when the patient was 38-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0150 , Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "NSVT", "Tremors: The day after my 2nd, it started with a mild tremor in my hands", "Attacks of tachycardia", "Dysautonomia".  The following information was reported: CONDITION AGGRAVATED (hospitalization, disability), outcome "recovering", described as "But after my 3rd dose, I suffered a major flare". The patient was hospitalized for condition aggravated (hospitalization duration: 1 day(s)). The event "but after my 3rd dose, i suffered a major flare" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of condition aggravated. Clinical course: The day after patient's second, it started with a mild tremor in her hands. Over time symptoms progressed to attacks of tachycardia, NSVT, and tremors. She was as broadly diagnosed with Dysautonomia. At first, she didn't suspect vaccine and thought it was safe and effective. But after her third dose, she suffered a major flare and have improved since refraining from more boosters, though was still not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: But after my 3rd dose, I suffered a major flare; 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 15Dec2021 as dose 3 (booster), single (Lot number: 33Q30BD) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity with no other pre-existing conditions" (unspecified if ongoing). Facility where the most recent COVID-19 vaccine was administered on Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient did not have COVID prior to vaccination. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1 , Batch/Lot No: EN6208 , Location of injection: Arm Right), administration date: 17Mar2021, when the patient was 38-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0150 , Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "NSVT", "Tremors: The day after my 2nd, it started with a mild tremor in my hands", "Attacks of tachycardia", "Dysautonomia".  The following information was reported: CONDITION AGGRAVATED (hospitalization, disability), outcome "recovering", described as "But after my 3rd dose, I suffered a major flare". The patient was hospitalized for condition aggravated (hospitalization duration: 1 day(s)). The event "but after my 3rd dose, i suffered a major flare" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of condition aggravated. Clinical course: The day after patient's second, it started with a mild tremor in her hands. Over time symptoms progressed to attacks of tachycardia, NSVT, and tremors. She was as broadly diagnosed with Dysautonomia. At first, she didn't suspect vaccine and thought it was safe and effective. But after her third dose, she suffered a major flare and have improved since refraining from more boosters, though was still not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 07Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: 33Q30BD) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity with no other pre-existing conditions" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 07Mar2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 07Mar2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Mar2023) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300139822 Same patient/drug/ different dose/event;US-PFIZER INC-202300139873 Same patient/drug/ different dose/event;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 07Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: 33Q30BD) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity with no other pre-existing conditions" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 07Mar2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 07Mar2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Mar2023) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300139822 Same patient/drug/ different dose/event;US-PFIZER INC-202300139873 Same patient/drug/ different dose/event;