chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: I lost my hearing after having the vaccine on my left side; I now have a high pitch sound on my left ear; I have sensitivity to sound; 2nd booster dose.; 2nd booster dose.; 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 59-year-old female patient received BNT162b2 (COMIRNATY), on 10Jun2022 at 16:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 10Jun2022 at 16:00, outcome "unknown" and all described as "2nd booster dose."; EAR DISORDER (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I have sensitivity to sound"; DEAFNESS (medically significant) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I lost my hearing after having the vaccine on my left side"; TINNITUS (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I now have a high pitch sound on my left ear". Therapeutic measures were taken as a result of deafness, tinnitus, ear disorder.  Clinical Course: Caller called to report an adverse reaction she experienced with 2nd booster dose of the Pfizer Covid19 vaccine she received last Friday, 10June2022. I lost my hearing after having the vaccine on my left side, now have a high pitch sound on my left ear and have sensitivity to sound. Caller stated that she did not have any questions regarding the vaccine and that she wanted to report the adverse reaction she experienced with the booster dose. Transferring agent stated, "I do have a patient on the other line. This one is for the Pfizer COVID-19 vaccine second booster dose she said that she get this last Friday and has experienced adverse reaction for the vaccine, for the booster dose rather." Adverse reactions: Transferring agent stated, "She didn't say that to me and she just wanted to report it directly so, I transferred her immediately to you." On Paraphrasing: Consumer stated, "Yes, is this call being recorded? Good. I think it's horrible that Pfizer with all of the money they are making from this is using labor, from the third world country to get this information. Just once again more company greed. So, what would you like to know."  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Deafness, Discomfort, Headache, Pain
Clinical narrative: I lost my hearing after having the vaccine on my left side; I now have a high pitch sound on my left ear; I have sensitivity to sound; 2nd booster dose.; 2nd booster dose.; 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 59-year-old female patient received BNT162b2 (COMIRNATY), on 10Jun2022 at 16:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 10Jun2022 at 16:00, outcome "unknown" and all described as "2nd booster dose."; EAR DISORDER (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I have sensitivity to sound"; DEAFNESS (medically significant) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I lost my hearing after having the vaccine on my left side"; TINNITUS (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I now have a high pitch sound on my left ear". Therapeutic measures were taken as a result of deafness, tinnitus, ear disorder.  Clinical Course: Caller called to report an adverse reaction she experienced with 2nd booster dose of the Pfizer Covid19 vaccine she received last Friday, 10June2022. I lost my hearing after having the vaccine on my left side, now have a high pitch sound on my left ear and have sensitivity to sound. Caller stated that she did not have any questions regarding the vaccine and that she wanted to report the adverse reaction she experienced with the booster dose. Transferring agent stated, "I do have a patient on the other line. This one is for the Pfizer COVID-19 vaccine second booster dose she said that she get this last Friday and has experienced adverse reaction for the vaccine, for the booster dose rather." Adverse reactions: Transferring agent stated, "She didn't say that to me and she just wanted to report it directly so, I transferred her immediately to you." On Paraphrasing: Consumer stated, "Yes, is this call being recorded? Good. I think it's horrible that Pfizer with all of the money they are making from this is using labor, from the third world country to get this information. Just once again more company greed. So, what would you like to know."  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: I lost my hearing after having the vaccine on my left side; I now have a high pitch sound on my left ear; I have sensitivity to sound; 2nd booster dose.; 2nd booster dose.; 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 59-year-old female patient received BNT162b2 (COMIRNATY), on 10Jun2022 at 16:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 10Jun2022 at 16:00, outcome "unknown" and all described as "2nd booster dose."; EAR DISORDER (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I have sensitivity to sound"; DEAFNESS (medically significant) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I lost my hearing after having the vaccine on my left side"; TINNITUS (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I now have a high pitch sound on my left ear". Therapeutic measures were taken as a result of deafness, tinnitus, ear disorder.  Clinical Course: Caller called to report an adverse reaction she experienced with 2nd booster dose of the Pfizer Covid19 vaccine she received last Friday, 10June2022. I lost my hearing after having the vaccine on my left side, now have a high pitch sound on my left ear and have sensitivity to sound. Caller stated that she did not have any questions regarding the vaccine and that she wanted to report the adverse reaction she experienced with the booster dose. Transferring agent stated, "I do have a patient on the other line. This one is for the Pfizer COVID-19 vaccine second booster dose she said that she get this last Friday and has experienced adverse reaction for the vaccine, for the booster dose rather." Adverse reactions: Transferring agent stated, "She didn't say that to me and she just wanted to report it directly so, I transferred her immediately to you." On Paraphrasing: Consumer stated, "Yes, is this call being recorded? Good. I think it's horrible that Pfizer with all of the money they are making from this is using labor, from the third world country to get this information. Just once again more company greed. So, what would you like to know."  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness, Ear disorder, Immunisation, Off label use, Tinnitus
Clinical narrative: I lost my hearing after having the vaccine on my left side; I now have a high pitch sound on my left ear; I have sensitivity to sound; 2nd booster dose.; 2nd booster dose.; 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 59-year-old female patient received BNT162b2 (COMIRNATY), on 10Jun2022 at 16:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 10Jun2022 at 16:00, outcome "unknown" and all described as "2nd booster dose."; EAR DISORDER (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I have sensitivity to sound"; DEAFNESS (medically significant) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I lost my hearing after having the vaccine on my left side"; TINNITUS (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I now have a high pitch sound on my left ear". Therapeutic measures were taken as a result of deafness, tinnitus, ear disorder.  Clinical Course: Caller called to report an adverse reaction she experienced with 2nd booster dose of the Pfizer Covid19 vaccine she received last Friday, 10June2022. I lost my hearing after having the vaccine on my left side, now have a high pitch sound on my left ear and have sensitivity to sound. Caller stated that she did not have any questions regarding the vaccine and that she wanted to report the adverse reaction she experienced with the booster dose. Transferring agent stated, "I do have a patient on the other line. This one is for the Pfizer COVID-19 vaccine second booster dose she said that she get this last Friday and has experienced adverse reaction for the vaccine, for the booster dose rather." Adverse reactions: Transferring agent stated, "She didn't say that to me and she just wanted to report it directly so, I transferred her immediately to you." On Paraphrasing: Consumer stated, "Yes, is this call being recorded? Good. I think it's horrible that Pfizer with all of the money they are making from this is using labor, from the third world country to get this information. Just once again more company greed. So, what would you like to know."  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Burning sensation, Rash, Rash erythematous, Rash vesicular
Clinical narrative: skin peeling; red skin rash with burning scaly skin over my entire body.; burning; Blistering; 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), on 25Sep2021 at 08:30 as dose 3 (booster), single (Lot number: ff2589) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FISH OIL; VITAMIN B12 [VITAMIN B12 NOS]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Er8732, Vaccine Administration Time: 12:00 AM), administration date: 30Mar2021, when the patient was 70-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Cn6200, Location of injection: Arm Right, Vaccine Administration Time: 08:30 AM), administration date: 26Feb2021, when the patient was 70-year-old, for Covid-19 Immunization. The following information was reported: BLISTER (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "Blistering"; SKIN BURNING SENSATION (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "burning"; RASH (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "red skin rash with burning scaly skin over my entire body."; SKIN EXFOLIATION (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "skin peeling". The events "skin peeling", "red skin rash with burning scaly skin over my entire body.", "burning" and "blistering" required physician office visit. Therapeutic measures were taken as a result of skin exfoliation, rash, skin burning sensation, blister.  Additional information: Blistering, burning, skin peeling rash that started on my right collarbone and spread to my head and chest, then my back, them my thighs, then my lower legs and feet. Over several months the rash Changed to a red skin rash with burning scaly skin over my entire body. Ae resulted in: Doctor or other healthcare professional office/clinic visit Disability or permanent damage. Ae treatment: steroid creams, doxycycline, prednisone, calcipotr.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation
Clinical narrative: skin peeling; red skin rash with burning scaly skin over my entire body.; burning; Blistering; 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), on 25Sep2021 at 08:30 as dose 3 (booster), single (Lot number: ff2589) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FISH OIL; VITAMIN B12 [VITAMIN B12 NOS]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Er8732, Vaccine Administration Time: 12:00 AM), administration date: 30Mar2021, when the patient was 70-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Cn6200, Location of injection: Arm Right, Vaccine Administration Time: 08:30 AM), administration date: 26Feb2021, when the patient was 70-year-old, for Covid-19 Immunization. The following information was reported: BLISTER (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "Blistering"; SKIN BURNING SENSATION (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "burning"; RASH (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "red skin rash with burning scaly skin over my entire body."; SKIN EXFOLIATION (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "skin peeling". The events "skin peeling", "red skin rash with burning scaly skin over my entire body.", "burning" and "blistering" required physician office visit. Therapeutic measures were taken as a result of skin exfoliation, rash, skin burning sensation, blister.  Additional information: Blistering, burning, skin peeling rash that started on my right collarbone and spread to my head and chest, then my back, them my thighs, then my lower legs and feet. Over several months the rash Changed to a red skin rash with burning scaly skin over my entire body. Ae resulted in: Doctor or other healthcare professional office/clinic visit Disability or permanent damage. Ae treatment: steroid creams, doxycycline, prednisone, calcipotr.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Rash, Skin burning sensation, Skin exfoliation
Clinical narrative: skin peeling; red skin rash with burning scaly skin over my entire body.; burning; Blistering; 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), on 25Sep2021 at 08:30 as dose 3 (booster), single (Lot number: ff2589) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FISH OIL; VITAMIN B12 [VITAMIN B12 NOS]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Er8732, Vaccine Administration Time: 12:00 AM), administration date: 30Mar2021, when the patient was 70-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Cn6200, Location of injection: Arm Right, Vaccine Administration Time: 08:30 AM), administration date: 26Feb2021, when the patient was 70-year-old, for Covid-19 Immunization. The following information was reported: BLISTER (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "Blistering"; SKIN BURNING SENSATION (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "burning"; RASH (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "red skin rash with burning scaly skin over my entire body."; SKIN EXFOLIATION (non-serious) with onset 10Oct2021 at 08:00, outcome "recovering", described as "skin peeling". The events "skin peeling", "red skin rash with burning scaly skin over my entire body.", "burning" and "blistering" required physician office visit. Therapeutic measures were taken as a result of skin exfoliation, rash, skin burning sensation, blister.  Additional information: Blistering, burning, skin peeling rash that started on my right collarbone and spread to my head and chest, then my back, them my thighs, then my lower legs and feet. Over several months the rash Changed to a red skin rash with burning scaly skin over my entire body. Ae resulted in: Doctor or other healthcare professional office/clinic visit Disability or permanent damage. Ae treatment: steroid creams, doxycycline, prednisone, calcipotr.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Skin disorder
Clinical narrative: The skin on on my arms has been destroyed since my vaccination; 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), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious) with onset 2021, outcome "unknown", described as "The skin on on my arms has been destroyed since my vaccination".  Additional information: It was reported that the patient was harmed by Covid vaccine which received in Feb and Mar of 2021. The skin on arms has been destroyed since vaccination. It was suggested by a friend that patient contact you about this (as reported). This supposedly save vaccine was not safe for patient and thus far have no remedy.  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-202200840493 same patient/event/reporter, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Has Covid for second time and had 4 Covid shots; Has Covid for second time and had 4 Covid shots; little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: first time getting Covid. 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 "Has Covid for second time and had 4 Covid shots"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little sore arm". The patient stated they have COVID. Call was originally regarding Xeljanz 11mg. Patient stated it is the second time she is having COVID. If she sounds muffled, it is because she just put Cbd oil in her mouth. The first time she had COVID, she had 4 shots. Then, a month later, and was extremely careful because her husband is on 4 heart medicines, they would not allow her to get another shot. Was told her by pharmacy that she needs to get a shot every 4 months because her vaccine would be waning. After 5 months, she still got COVID. Clarified that the patient had 4 shots before she got COVID the first time. Patient stated she is taking CBD oil for pain relief. Clarified that the shots and vaccine the patient has been referring to is the Pfizer COVID vaccine. Had the first and second vaccine and had the booster in Aug2021. She is also immunocompromised and just jumped on the bandwagon. Patient has been trying to get her Xeljanz since Jan2022. As far as the vaccine, half of the vaccines were not any worse than an allergy shot. Has a little sore arm and keeps moving it. Was well worth getting the shot. Her second time having COVID is going better than the first time getting COVID. Was vaccinated with less severity and has had 3 antiviral meds and the with the dosage, she had an allergic to them so, she stopped. Thinks the second round of COVID was better and doesn't really question that.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pain in extremity
Clinical narrative: Has Covid for second time and had 4 Covid shots; Has Covid for second time and had 4 Covid shots; little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: first time getting Covid. 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 "Has Covid for second time and had 4 Covid shots"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little sore arm". The patient stated they have COVID. Call was originally regarding Xeljanz 11mg. Patient stated it is the second time she is having COVID. If she sounds muffled, it is because she just put Cbd oil in her mouth. The first time she had COVID, she had 4 shots. Then, a month later, and was extremely careful because her husband is on 4 heart medicines, they would not allow her to get another shot. Was told her by pharmacy that she needs to get a shot every 4 months because her vaccine would be waning. After 5 months, she still got COVID. Clarified that the patient had 4 shots before she got COVID the first time. Patient stated she is taking CBD oil for pain relief. Clarified that the shots and vaccine the patient has been referring to is the Pfizer COVID vaccine. Had the first and second vaccine and had the booster in Aug2021. She is also immunocompromised and just jumped on the bandwagon. Patient has been trying to get her Xeljanz since Jan2022. As far as the vaccine, half of the vaccines were not any worse than an allergy shot. Has a little sore arm and keeps moving it. Was well worth getting the shot. Her second time having COVID is going better than the first time getting COVID. Was vaccinated with less severity and has had 3 antiviral meds and the with the dosage, she had an allergic to them so, she stopped. Thinks the second round of COVID was better and doesn't really question that.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: HPV9
Symptoms: Condition aggravated, Off label use, Squamous cell carcinoma
Clinical narrative: two patients (a 52-year-old man and a man in his 60s) were administered nonavalent HPV vaccine to potentially reduce the number of new skin cancers; This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 52-year-old male patient.  The patient's concurrent conditions included Crohn's disease, multiple cutaneous warts, basal cell carcinoma, squamous cell carcinoma and immunosuppression. The patient's medical history was not reported. Concomitant therapies included mercaptopurine and nicotinamide.  The patient had Crohn's disease and had been taking mercaptopurine 100 mg daily since his diagnosis over 22 years ago. He had a history of multiple cutaneous warts and keratinocyte carcinomas (KCs). Over a 4-year period (2015-2019), prior to the first dose of the vaccine, he had 15 KCs (8 squamous cell carcinoma (SCCs) and 7 basal cell carcinoma (BCCs)).  In October 2019, the patient was administered nonavalent human papillomavirus (HPV) vaccine (manufacturer unknown) to potentially reduce the number of new skin cancers (off label use). Since starting the HPV vaccine series (manufacturer unknown) and niacinamide 500 mg twice a day, he had two SCCs.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports derived from the literature article (cross referenced with MARRS # US-009507513-2206USA005068).  Literature Report: Sender's Comments:  US-009507513-2206USA005068:
Sex: U
Vaccine: MMR, MMRV, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; patient who is 18 years old received a dose of PROQUAD yesterday, May 18, 2022; patient received their second dose of MMR on April 7, 2008 followed by their second dose of VARIVAX that was administered on April 16, 2008; a patient was administered their first dose of MMR on April 16, 2005 and their first dose of VARIVAX on April 27, 2005; This spontaneous report was received from a medical assistant and concerns an 18-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-APR-2005, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.   On 27-APR-2005, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  On 07-APR-2008, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.   On 16-APR-2008, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The healthcare professional (HCP) was aware that the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) were administered less than one month apart from each other.  On 18-MAY-2022, the patient (who was 18-year-old at the time) was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, lot number: U029296, expiration date 19-MAR-2023 (dose, route and site of administration were not reported) for prophylaxis (product administered to patient of inappropriate age) which was reconstituted by a sterile diluent. No additional adverse events were reported (no adverse event).
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HBP reporting AE for improperly stored administered vaccine.   Names of vaccines involved/ ROTATEQ/ Temperature (28.0F) BELOW 36°F Time frame 96Hours; This spontaneous report was received from an office manager and concerns an 8-week-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-MAY-2022, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, once, one injection, orally, lot number: U038909 was confirmed to be valid, expiration date: 26-MAR-2023 for prophylaxis (exact dose was not reported).The administered dose was exposed to the temperature excursion of 28 degrees Fahrenheit (F) for 96 hours. There were no previous temperature excursions reported. An other healthcare worker stated that the form would be filled and sent back all available information. No further information provided.; Sender's Comments:  US-009507513-2205USA005882: US-009507513-2205USA005906: US-009507513-2205USA005914: US-009507513-2205USA005815: US-009507513-2205USA005621:
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: no additional AEs; MMR II was administered on 6/1/2020 and VARIVAX was administered on 6/4/2020; This spontaneous report was received from Other Health Professional and refers to a 4-year-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-JUN-2020, the patient received dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, lot #S023656, expiration date: 30-JUL-2021 with therapy type rHA, administered subcutaneously for prophylaxis (dose unknown). On 04-JUN-2020, administered 3 days after the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #S032357, expiration date: 14-OCT-2021, administered subcutaneously for prophylaxis (dose was not provided). No adverse event were reported.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Description: Caller is a nurse who reports a pediatric dose of RECOMBIVAX HB was given to 25 year old; Caller is a nurse who reports a pediatric dose of RECOMBIVAX HB was given to 25 year old. Patient had no symptoms or adverse effects from receiving dose. Reporter states that this was the patient's first dose in his series; he had to get titers for; This spontaneous report was received from a nurse (also reported as medical assistant ) and refers to a 25-year-old male patient. The patient had never been vaccinated for hepatitis B. His hepatitis B antibody and hepatitis B antigen test were negative. The patient's concomitant therapies were not reported.  On 19-MAY-2022, the patient was vaccinated with the first pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal-free intramuscular injection, 0.5 milliliter, lot #U001837 was confirmed to be valid, expiration date: 21-NOV-2022, for prophylaxis as "he had to get titers for school" (strength, route and site of administration were not provided) (incorrect dose administered). The patient had no symptoms or adverse effects from receiving dose.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 06-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U024220, expiration date was reported as 03-AUG-2023 but upon internal validation established as 04-AUG-2023, 0.5 milliliter; strength and dose number were not reported) subcutaneously(SQ) for prophylaxis after temperature excursion (product storage error). The storage temperature of the vaccine was 10 degrees Fahrenheit (F) for a time frame of 14 minutes. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) reported.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: No adverse event; 9 year old patient was accidentally administered the second dose of GARDASIL 9 intended for another patient; This spontaneous report was received from an administrator, referring to a 9-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions/allergy were not reported.  On 19-MAY-2022, the wrong patient was administered a "booster dose" of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient was accidentally administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) formulation prefilled syringe, 0.5 milliliter, lot #U035286, expiration date: 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided), which intended for another patient (wrong patient received product). The patient who received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not have any prior vaccination history with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse event reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: device or device component malfunction; no additional AE details; TE vaccine administered; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-APR-2022, the patient was vaccinated with an improperly stored first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date reported and established as 19-AUG-2023, administered subcutaneously (dose and site of administration not provided) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for a total of 3 hours and a temperature excursion of -10 degrees Celsius up to 8 degrees Celsius for 1 hour 30 minutes. There were no previous temperature excursions. Additionally, a device or device component malfunction was reported (unspecified, conflicting information, varicella virus vaccine live [Oka/Merck] [VARIVAX] is not manufactured/ provided with a device component). The patient experienced no additional  adverse event (AE).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA007852: US-009507513-2205USA007821:
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Exposure during pregnancy, Injection site pain, Pain in extremity
Clinical narrative: She unknowingly got GARDASIL 9 while pregnant.; Her left arm and shoulder are hurting around the area of the injection.; Her left arm and shoulder are hurting around the area of the injection. She states that typically when she gets a vaccine she will have one or two days of arm soreness, but this pain has lasted for three weeks.; Her left arm and shoulder are hurting around the area of the injection.; This spontaneous report was received from a 33-year-old, female consumer referring to herself.  The patient's concurrent conditions included traumatic brain injuries, anxiety, and depression. It was reported a drug reaction/allergy to tramadol. Her medical history was not reported. The concomitant medications included sertraline hydrochloride (ZOLOFT) and omeprazole (PRILOSEC).   The patient's last menstrual period (LMP) was on 10-APR-2022. On an unspecified date in 2022, she got pregnant. On 10-MAY-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in left arm (strength, lot #, expiry date, and route of administration were not provided) as prophylaxis. Later, she stated that her left arm (pain in extremity) and shoulder (arthralgia) were hurting around the area of the injection (vaccination site pain). Typically, when she gets a vaccine, she would have one or two days of arm soreness, but this pain has lasted for three weeks. On an unspecified date in 2022, the patient found out that she was pregnant, and stated that at the vaccination time she would be around 4 weeks pregnant (exposure during pregnancy). She denied any other associated symptoms and did not specify which other vaccines may have caused her shorter-term soreness. No other information was provided. No other adverse event was reported. At the reporting time, she was currently about 7 weeks pregnant, and she was recovering from pain in extremity, arthralgia, and vaccination site pain. It was reported that the therapy (HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)) was discontinued.  The causal relationship between the events pain in extremity, arthralgia, and vaccination site pain and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Nurse administered a dose of VARIVAX that had experienced temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided   On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) valid lot # U025205, expiration date 13-AUG-2023 for prophylaxis (strength, and route of administration were not provided). The vaccine underwent a temperature excursion (Product storage error). No additional details were available. The patient did not experience any adverse event.
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: did not respond to PPV23; Literature Report:   This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 37-year-old female  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose , lot #, expiry date, and route of administration were not provided). On an unknown date, the patient did not response to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). At the time of reporting, the outcome of the event was not known.   The event  was considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2206USA005089:
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE details provided; expired dose of MMR II was given to 15 month old patient; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (lot number U026364 was confirmed to be valid, expiration date: 08-NOV-2023).  On 13-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) subcutaneous injection, lot number T016197, expiration date: 11-MAY-2022 (dose, strength, and route of administration were not provided) for prophylaxis (expired product administered). The medical assistant stated that both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent were stored according to prescribing information through date of administration. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Nurse reports possible administration of improperly stored vaccines; This spontaneous report was received from Other Health Professional, referring to unspecified patients.  Nurse reported possible administration of improperly stored vaccines. No additional adverse events were reported.   The names of vaccines involved (including lot/exp): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9): Lot: 1775808  Expiration: 20-AUG-2023; Lot: T030749  expiration date: 16-MAR-2023; Lot: 1687293  expiration date: 30-APR-2023; hepatitis a vaccine, inactivated (VAQTA): Lot: T031202, expiration date; 14-JUN-2022, Lot: U026792 expiration date: 28-OCT-2022; hepatitis b vaccine (recombinant) (RECOMBIVAX HB): Lot: T021327, expiration date: 14-NOV-2022; Lot: U008328, expiration date: 16-DEC-2022.  All lot number were verified to be valid, (route and anatomical location were not reported) administered for prophylaxis.   It was reported that the vaccines had been incorrectly stored at -0.3C for 5 minutes and then at 0.3C for 45 minutes. There was no previous temperature excursion  Follow up information was received from the nurse on 09-JUN-2022.  The patient's demographics were provided for all the patients involved in previous event of improperly stored vaccines.  This spontaneous report was referring to a 2-year-old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 02-MAY-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, and route of administration were not provided), lot # T026792, expiry date 28-OCT-2022, which was found to be an invalid lot number for hepatitis a vaccine, inactivated (VAQTA). Lot number T026792 did not match any Company product as confirmed by Lot Verification team.    This is one of multiple reports received from the same source.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information reported; Nurse reporting administration of improperly stored GARDASIL 9.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-JUN-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #U034201, expiration date was reported 21-NOV-2023, upon internal validation established as 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). The patient was aware of this event.  It was reported that the suspect vaccine was exposed to a temperature of minus 24 degree Celsius for a time frame of 1500 hours (2 months, from 14-APR-2022 to 15-JUN-2022). There were no previous temperature excursions.   No additional adverse event (AE) information was provided.
Age: 50.0
Sex: M
Vaccine: HPV9
Symptoms: Off label use
Clinical narrative: two patients (a 52-year-old man and a man in his 60s) were administered nonavalent HPV vaccine to potentially reduce the number of new skin cancers; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a male patient in his 60's.  The patient's concurrent conditions included immunosuppression, squamous cell carcinoma, basal cell carcinoma and liver transplant. The patient's medical history was not reported. Concomitant therapies included tacrolimus.  The patient had multiple keratinocyte carcinomas (KCs) after his liver transplant in 1995. He was treated with tacrolimus from 1995 to 2016. To potentially reduce the number of new skin cancers, the nonavalent human papillomavirus (HPV) vaccine (manufacturer) was administered intramuscularly at 0, 2, and 6-months (April, June, and October 2016) (off label use). Prior to the first intramuscular vaccine at month 0 (April 2015-April 2016), the patient was diagnosed with 9 new KCs (8 squamous cell carcinoma (SCCs) and 1 basal cell carcinoma (BCC)).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports derived from the literature article (cross referenced with MARRS # US-009507513-2205USA005371).  Literature Report: .; Sender's Comments:  US-009507513-2205USA005371:
Sex: F
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: experienced poor response to Pneumovax 23; Literature Report:   This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 35-year-old female.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose , lot #, expiry date, and route of administration were not provided).On an unknown date, the patient experienced poor response to vaccine, particularly pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). At the time of reporting, the outcome of the event of poor response to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and onset date were not known.   The event of poor response to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2206USA002718: