chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Speech sound disorder
Clinical narrative: he is sick as a dog; shivers; I sound like mule when I called; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he is sick as a dog"; CHILLS (non-serious), outcome "unknown", described as "shivers"; SPEECH SOUND DISORDER (non-serious), outcome "unknown", described as "I sound like mule when I called". Additional information: The patient says he was sick as a dog and he wanted to know what to do. This was the second day and he had the shivers before that. And said that his wife was sick also (no further information).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Hot flashes; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 (BNT162B2), (Lot number: ER8730), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "menopause" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension; BRILINTA; MULTIVITAMIN & MINERAL; LEVOTHYROXINE; ROSUVASTATIN taken for hypertension; RAMIPRIL. The following information was reported: HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes". Additional Information: Consumer stated, "I am here to complaint about one of the side effect that I have. I have hot flashes. I am 70 years old. I have been having them from the last 2 years since I had my Pfizer shot, (Clarified as Pfizer COVID-19 Vaccine) will be for the last 3 years. I have already gone through menopause. I went to menopause in my 50." Age (At time of event): Consumer stated, "67 years old." Site of administration or anatomical location: Consumer stated, "It is on the right arm."
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EN5318) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for osteoarthritis. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared".  Additional information: Reporter stated, "Well, I wanted to either you direct me to someone or discuss some really unusual and positive after effects of the COVID vaccine and it has not happened once and it also happened with Moderna. I am mentioning this because I think you guys are much closer than you think to helping people with arthritis". Patient have horrible osteoarthritis and the pain in every joint was unbearable and the best thing the patient can do was, some Aspirin and that's it was about it but after the Pfizer shot all of the pain in all of his joints went away. It was not the first time, patient have taken four or five shots and after each one his arthritis goes away between 3 days in a week. Patient do not know, he have more flexibility. Patient do not know, if it was adding some kind of moisture into the joint or restoring it, some of it to some degree. That is why the patient think it was important to look at that. Patient was 71 most, senior citizens just kind of take their pain or no pain for granted but patient was very aware of what goes on with his body since he have been coaching forever but so with this awareness reporter wanted to get this to someone there that could follow through a little bit with this. Patient reported that there was something here and whatever in this product, there was a piece of it that works for arthritis that works for both Pfizer and Moderna oddly enough. Reporter stated, "I want to get you to guys to do further research in to, How this affects and a positive way Arthritis in a positive way arthritis and I want to add to that it did not give me some relief, it took the pain away completely. This is not a concern, this is a positive reinforcement on whatever it is you are doing.". He stated that "I wanted to make sure that I was not loosing my mind and this actually was consistent which it is, so like I said I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared". Patient stated that he never had any other reaction except getting rid of his arthritis pain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300450072 Same patient, drug and event; different dose;US-PFIZER INC-202300450074 Same patient, drug and event; different dose;US-PFIZER INC-202300450073 Same patient, drug and event; different dose;US-PFIZER INC-202300450075 Same patient, drug and event; different dose;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Sep2023 as dose 1, single (Lot number: H64621) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prior prostate cancer" (unspecified if ongoing), notes: Prior prostate cancer (5 years ago) treated with radiation.; "sensory peripheral polyneuropathy" (unspecified if ongoing), notes: Currently have diagnosis of sensory peripheral polyneuropathy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Had 2 negative tests 48 hours apart; Positive, notes: positive in evening on 3rd day after Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19, Anti-viral details: COVID 19 Treatment (Paxlovid) from 08Dec2023 to 13Dec2023,  Clinical course: Covid rebound. Had 2 negative tests 48 hours apart but then symptoms appeared 3 days later. Tested negative (2nd time) in morning but positive in evening on 3rd day after Paxlovid. Symptoms were more sever than first infection, but improved at about same rate. Home antigen test showed higher viral load than original infection. Prior prostate cancer (5 years ago) treated with radiation. Currently have diagnosis of sensory peripheral polyneuropathy. No other medication taken in 2 weeks. No Known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 3 (booster), single (Lot number: FN2908) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for osteoarthritis. Past drug history included: Aspirin for Joint pain. Vaccination history included: BNT162b2 (DOSE 1, SINGLE (Lot Number: EN5318)), administration date: 26Jan2021, for COVID-19 immunisation, reaction(s): "I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared"; BNT162b2 (DOSE 2, SINGLE (Lot Number: EN6198)), administration date: 23Feb2021, for COVID-19 immunisation, reaction(s): "I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared".  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared".  Additional information: The patient wanted to discuss some really unusual and positive after effects of the COVID vaccine and it has not happened once and it also happened with Moderna. The patient had horrible Osteoarthritis (Intent: History) and the pain in every joint was unbearable and the best thing the patient could do was some Aspirin. After the Pfizer shot, all the pain in all of his joints went away. It was not the first time; the patient had taken four or five shots and after each one his arthritis went away between 3 days in a week. The patient had more flexibility. The patient did not know if it added some kind of moisture into the joint or restoring it, some of it to some degree. The patient was 71-year-old and most senior citizens just kind of take their pain or no pain for granted but the patient very aware of what goes on with his body since he had been coaching forever. The patient stated that there was something here and whatever in this product, there was a piece of it that worked for arthritis that worked for both Pfizer and Moderna oddly enough.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300449913 Same patient/drug/AE, different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech: COVID 19 Treatment; Pfizer / BioNTech: COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Pfizer / BioNTech: COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient used Paxlovid 150 mg 100mg dose pack (Lot number: GK8507) treatment started on 18Dec2023 for the COVID-19 treatment.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dental caries, Impaired healing, Skin disorder, Skin lesion
Clinical narrative: causing my teeth to rot in my mouth; skin blemishes; sores on my body that don't heal properly; sores on my body that don't heal properly; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DENTAL CARIES (non-serious), outcome "unknown", described as "causing my teeth to rot in my mouth"; SKIN DISORDER (non-serious), outcome "unknown", described as "skin blemishes"; SKIN LESION (non-serious), IMPAIRED HEALING (non-serious), outcome "unknown" and all described as "sores on my body that don't heal properly". Additional information: the patient stated that as a result of 2 COVID-19 Pfizer shots and 4 boosters the vaccine was "causing teeth to rot in my mouth" and "I have skin blemishes" and "sores on my body that don't heal properly". Patient's doctor denied it's the vaccine but the patient stated that "I know it is. I was fine pre COVID-19".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dental caries, Impaired healing, Skin disorder, Skin lesion
Clinical narrative: causing teeth to rot in mouth; skin blemishes; sores on body that don't heal properly; sores on body that don't heal properly; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation, reaction(s): "causing teeth to rot in mouth", "sores on body that don't heal properly", "skin blemishes", "sores on body that don't heal properly". The following information was reported: DENTAL CARIES (non-serious), outcome "unknown", described as "causing teeth to rot in mouth"; SKIN DISORDER (non-serious), outcome "unknown", described as "skin blemishes"; SKIN LESION (non-serious), IMPAIRED HEALING (non-serious), outcome "unknown" and all described as "sores on body that don't heal properly". Additional information: as a result of 2 COVID-19 Pfizer shots and 4 boosters the vaccine was causing patient's teeth to rot in mouth and had skin blemishes and sores on body that did not heal properly. The doctor denied it was the vaccine. The patient knew it was and was fine pre COVID-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300181745 same patient, events after different doses of the vaccine;
Sex: U
Vaccine: COVID19
Symptoms: Dental caries, Impaired healing, Skin disorder, Skin lesion
Clinical narrative: causing my teeth to rot in my mouth; skin blemishes; sores on my body that don't heal properly; sores on my body that don't heal properly; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for COVID-19 immunisation, reaction(s): "causing my teeth to rot in my mouth", "sores on my body that don't heal properly", "skin blemishes"; Bnt162b2 (Dose 2, lot number unknown), for COVID-19 immunisation, reaction(s): "causing my teeth to rot in my mouth", "sores on my body that don't heal properly", "skin blemishes". The following information was reported: DENTAL CARIES (non-serious), outcome "unknown", described as "causing my teeth to rot in my mouth"; SKIN DISORDER (non-serious), outcome "unknown", described as "skin blemishes"; SKIN LESION (non-serious), IMPAIRED HEALING (non-serious), outcome "unknown" and all described as "sores on my body that don't heal properly".  Additional information: the patient stated that as a result of 2 COVID-19 Pfizer shots and 4 boosters the vaccine was "causing teeth to rot in my mouth" and "I have skin blemishes" and "sores on my body that don't heal properly". Patient's doctor denied it's the vaccine but the patient stated that "I know it is. I was fine pre COVID-19".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300181745 same patient, events after different doses of the vaccine;
Sex: U
Vaccine: COVID19
Symptoms: Dental caries, Impaired healing, Skin discolouration, Skin lesion
Clinical narrative: causing my teeth to rot in my mouth; skin blemishes; sores on my body that don't heal properly; sores on my body that don't heal properly; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), sngle (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization, reaction(s): "Tooth decay", "healing delayed", "Skin discoloration", "Skin lesion"; Bnt162b2 (dose 2), for COVID-19 immunization, reaction(s): "Tooth decay", "healing delayed", "Skin discoloration", "Skin lesion"; Bnt162b2, bnt162b2 omi ba.4-5 (dose 3), for COVID-19 immunization, reaction(s): "Tooth decay", "healing delayed", "Skin discoloration", "Skin lesion". The following information was reported: DENTAL CARIES (non-serious), outcome "unknown", described as "causing my teeth to rot in my mouth"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "skin blemishes"; SKIN LESION (non-serious), IMPAIRED HEALING (non-serious), outcome "unknown" and all described as "sores on my body that don't heal properly". Additional information: the patient stated that as a result of 2 COVID-19 Pfizer shots and 4 boosters the vaccine was "causing teeth to rot in my mouth" and "I have skin blemishes" and "sores on my body that don't heal properly". Patient's doctor denied it's the vaccine but the patient stated that "I know it is. I was fine pre COVID-19".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300181745 Same patient, drug and event, different dose (Booster Dose 6);
Sex: U
Vaccine: COVID19
Symptoms: Dental caries, Impaired healing, Skin discolouration, Skin lesion
Clinical narrative: causing my teeth to rot in my mouth; skin blemishes; sores on my body that don't heal properly; sores on my body that don't heal properly; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization, reaction(s): "Tooth decay", "Healing delayed", "Skin discoloration", "Skin lesion"; Bnt162b2 (dose 2), for COVID-19 immunization, reaction(s): "Tooth decay", "Healing delayed", "Skin discoloration", "Skin lesion"; Bnt162b2, bnt162b2 omi ba.4-5 (dose 3), for COVID-19 immunization, reaction(s): "Tooth decay", "Healing delayed", "Skin discoloration", "Skin lesion"; Bnt162b2, bnt162b2 omi ba.4-5 (dose 4), for COVID-19 immunization, reaction(s): "Tooth decay", "Healing delayed", "Skin discoloration", "Skin lesion". The following information was reported: DENTAL CARIES (non-serious), outcome "unknown", described as "causing my teeth to rot in my mouth"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "skin blemishes"; SKIN LESION (non-serious), IMPAIRED HEALING (non-serious), outcome "unknown" and all described as "sores on my body that don't heal properly". Additional information: the patient stated that as a result of 2 COVID-19 Pfizer shots and 4 boosters the vaccine was "causing teeth to rot in my mouth" and "I have skin blemishes" and "sores on my body that don't heal properly". Patient's doctor denied it's the vaccine but the patient stated that "I know it is. I was fine pre COVID-19".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300181745 Same patient, drug and event, different dose (Booster Dose 6);
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died from that God damn vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died from that God damn vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter said "So you mentioned not to take if you have a weakened immune system, well the bioweapon that you forced everybody to get that would pretty much include most of the population, of not only America, but the world. That must have been why you wanted to wait 75 years before you release the data on the covid-19 vaccine. I know six people that died from that God damn vaccine".   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300204932 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died from that God damn vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died from that God damn vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died from that God damn vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter said "So you mentioned not to take if you have a weakened immune system, well the bioweapon that you forced everybody to get that would pretty much include most of the population, of not only here, but the world. That must have been why you wanted to wait 75 years before you release the data on the covid-19 vaccine. I know six people that died from that God damn vaccine".   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300204932 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died from that God damn vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died from that vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died from that vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter said "So you mentioned not to take if you have a weakened immune system, well the bioweapon that you forced everybody to get that would pretty much include most of the population, of not only here, but the world. That must have been why you wanted to wait 75 years before you release the data on the covid-19 vaccine. I know six people that died from that vaccine".   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300204932 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died from that vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died from that dang vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died from that dang vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter said "So you mentioned not to take if you have a weakened immune system, well the bioweapon that you forced everybody to get that would pretty much include most of the population, of not only here, but the world. That must have been why you wanted to wait 75 years before you release the data on the covid-19 vaccine. I know six people that died from that dang vaccine".   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300204932 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died from that dang vaccine
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: patient got COVID-19 at the "end of October/first of November 2023."; The patient did not have a COVID-19 test and was going off of the symptoms experienced,; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2023NVX-US-000001787.  A male patient received BNT162b2 (BNT162B2 NOS), in 2022 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: SUSPECTED COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "The patient did not have a COVID-19 test and was going off of the symptoms experienced,"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown", described as "patient got COVID-19 at the "end of October/first of November 2023." Clinical course: It was reported that a patient started treatment on an unreported dates with an unreported number of doses of Pfizer BioNTech COVID-19 vaccine for COVID-19 vaccination, with the last dose received in September/October of 2022. It was reported the patient got COVID-19 at the end of October/first of November 2023. The patient did not have a COVID-19 test and was going off of the symptoms experienced, including a runny nose, chills, slight fever, achy body the typical ones on unreported dates.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Still getting infected with Covid; Still getting infected with Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary Immunization series completed), for Covid-19 immunisation; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE ), for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Still getting infected with Covid". Clinical course: Patient stated that patient had gotten every Pfizer Covid vaccine and booster as soon as they were announced. Why were so many of them still getting infected with Covid. Patient thought vaccines prevent it and help make it disappear. Like small pox and measles.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died from that God damn vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died from that vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter said "So you mentioned not to take if you have a weakened immune system, well the bioweapon that you forced everybody to get that would pretty much include most of the population, but the world. That must have been why you wanted to wait 75 years before you release the data on the covid-19 vaccine. I know six people that died from that vaccine".   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300451168 same reporter/drug/event, different patient;US-PFIZER INC-202300451321 same reporter/drug/event, different patient;US-PFIZER INC-202300451323 same reporter/drug/event, different patient;US-PFIZER INC-202300451322 same reporter/drug/event, different patient;US-PFIZER INC-202300451324 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died from that vaccine
Sex: U
Vaccine: COVID19, RVX
Symptoms: Interchange of vaccine products, Therapeutic response unexpected
Clinical narrative: Interchange of vaccine products; All but Moderna and 3rd booster given in rt shoulder relieved pain in old injury for several days; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; rsv vaccine (RSV VACCINE). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Pfizer vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Pfizer vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Moderna (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "Unexpected therapeutic effect".  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "All but Moderna and 3rd booster given in rt shoulder relieved pain in old injury for several days". The action taken for rsv vaccine was unknown.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Peripheral sensory neuropathy
Clinical narrative: sensory neuropathy in my feet; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SENSORY NEUROPATHY (non-serious), outcome "unknown", described as "sensory neuropathy in my feet". Batch/lot number is not provided, and it cannot be obtained. Additional information: Patient got both a COVID and flu shot at the same time, and within 1 week developed sensory neuropathy in his/her feet.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: had a reaction from it last year; Initial information received on 13-Dec-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 64 years old female patient who had a reaction from it last year after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Nov-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection lot UT7751JA, expiry date- 30-JUN-2023 via intramuscular route in the left arm for immunization (strength, dose: unknown).  On an unknown date the patient had a reaction from it last year (immunisation reaction) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IPOL was given to 1 patient post temperature excursion with no reported adverse event; Initial information received on 14-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown age and gender who was administered IPV (VERO) [IPOL] post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Dec-2023, the patient received a dose of 0.5 ml once of suspect IPV (VERO) (Suspension for injection) (lot: W1C751M; expiry date: 18-Nov-2025; strength: standard) via unknown route in unknown administration site for Immunization post temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, "Vaccine Coordinator informed that the excursion happened on Saturday, 09Dec2023".  Reason: Power outage Max temperature reached: 13.2°C Duration out of labelled range: 3 hours 30 minutes Previous excursion? None Was it from a human error? No    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Feeling hot
Clinical narrative: Pt stated feeling hot and coughing
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Heart rate increased
Clinical narrative: Increase in heart rate over a 12 hr period. Monitoring, resolved on own.  Baseline ~75 increased to 135
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Syncope
Clinical narrative: Nausea and chills beginning the day after vaccination. One episode of syncope reported the day after vaccination in the evening.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: 1)arm had two red bumps on injection site, no treatment, has decreased since then but is still a little tender 2)headache a day later, was on and off for 3 weeks, treated with tylenol and that helped
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Bursitis, Condition aggravated, Gait disturbance, Mobility decreased, Muscular weakness
Clinical narrative: LEG WEAKNESS, RIGHT (ICD10-R29.898) MYALGIA AND MYOSITIS (ICD10-M60.9) WEAKNESS OF RIGHT ARM (ICD10-R53.1) Plan:  patient  developed LE weakness and RUE weakness and significant myalgia of LE approx 2-3 weeks after her RSV vaccine.  In addition she noted increase pain of areas of previous injury ( R hip bursitis, L sciatic injury from needle stick ) and swelling of old scar from age 19yo.   primarily difficulty walking and needing now to ambulate w/ walker - she was started on prednisone taper 11/29/23 and symptoms are starting to improve.  L leg no weakness now, just cannot move it until she moves her right leg. patient  reports this as a feeling her brain won't let her leg move.   --still slow difficult gait and objective weakness of hip extension while seated  --she noted improvement too of myalgia when dc metformin - she had been on this for years w/o incident other than diarrhea prior to vaccination.  - discussed guilliane barre and advised does not fit the criteria but does seem neurological  -- recommend neuro referral but patient  declines for today. -- she sees Dr ortho in follow up for her knees tomorrow.   -- finish pred taper then maintain 10 mg prednisone until folllow up here    on exam she does have RLE weakness discussed possibility of CVA - she denies slurred speech, word finding issues  SCHED MRI BRAIN  EMG  - continue off metfomin ( ? contributory ) check labs  continue prednisone - maintain 10 mg daily until f/u  f/u 1 mo - ER if symptoms worse
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Pain, Swelling, Walking aid user
Clinical narrative: LEG WEAKNESS, RIGHT (ICD10-R29.898) MYALGIA AND MYOSITIS (ICD10-M60.9) WEAKNESS OF RIGHT ARM (ICD10-R53.1) Plan:  patient  developed LE weakness and RUE weakness and significant myalgia of LE approx 2-3 weeks after her RSV vaccine.  In addition she noted increase pain of areas of previous injury ( R hip bursitis, L sciatic injury from needle stick ) and swelling of old scar from age 19yo.   primarily difficulty walking and needing now to ambulate w/ walker - she was started on prednisone taper 11/29/23 and symptoms are starting to improve.  L leg no weakness now, just cannot move it until she moves her right leg. patient  reports this as a feeling her brain won't let her leg move.   --still slow difficult gait and objective weakness of hip extension while seated  --she noted improvement too of myalgia when dc metformin - she had been on this for years w/o incident other than diarrhea prior to vaccination.  - discussed guilliane barre and advised does not fit the criteria but does seem neurological  -- recommend neuro referral but patient  declines for today. -- she sees Dr ortho in follow up for her knees tomorrow.   -- finish pred taper then maintain 10 mg prednisone until folllow up here    on exam she does have RLE weakness discussed possibility of CVA - she denies slurred speech, word finding issues  SCHED MRI BRAIN  EMG  - continue off metfomin ( ? contributory ) check labs  continue prednisone - maintain 10 mg daily until f/u  f/u 1 mo - ER if symptoms worse
Age: 69.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Expired product administered
Clinical narrative: MOderna vaccine was removed from the freezer on 11/10/2023 and refrigerated beyond use date was 12/10/2023. It was administered to patient  4 days past the beyond use date on 12/14/2023.   No adverse reaction reported
Age: 73.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: No adverse event, Product storage error
Clinical narrative: MOderna vaccine was removed from the freezer on 11/10/2023 and refrigerated beyond use date was 12/10/2023. It was administered to patient  1 day past the beyond use date on 12/11/2023.   No adverse reaction reported
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: MOderna vaccine was removed from the freezer on 11/10/2023 and refrigerated beyond use date was 12/10/2023. It was administered to patient  4 days past the beyond use date on 12/14/2023.   No adverse reaction reported
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: MOderna vaccine was removed from the freezer on 11/10/2023 and refrigerated beyond use date was 12/10/2023. It was administered to patient  4 days past the beyond use date on 12/14/2023.   No adverse reaction reported
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date (recorded 12/8/23, Pfizer has internal data for 2 additional days up to 12/10/23). No abnormal symptoms reported.
Age: 30.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date (recorded 12/8/23, Pfizer has internal data for 2 additional days up to 12/10/23). No abnormal symptoms reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Sensory loss
Clinical narrative: Describes 1 day after receiving flu and covid vaccines (both in L arm per pt report) acute onset of L lateral 4th finger and 5th finger numbness, tingling, paresthesias, sensation of swelling, worse late in the day most days. Ongoing symptoms 5wk later
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date (recorded 12/8/23, Pfizer has internal data for 2 additional days up to 12/10/23). No abnormal symptoms reported.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Large red swollen area when vaccine was injected. About the size of a soft ball. Low fever, headache, muscle pains.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date (recorded 12/8/23, Pfizer has internal data for 2 additional days up to 12/10/23). No abnormal symptoms reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Periarthritis, Pyrexia
Clinical narrative: Fever very tired. 48 hours later ?frozen shoulder ? very painful
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date (recorded 12/8/23, Pfizer has internal data for 2 additional days up to 12/10/23). No abnormal symptoms reported.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date (recorded 12/8/23, Pfizer has internal data for 2 additional days up to 12/10/23). No abnormal symptoms reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date (recorded 12/8/23, Pfizer has internal data for 2 additional days up to 12/10/23). No abnormal symptoms reported.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: The patient was accidentally administered the adjuvent suspension alone, rather than the reconstituted suspension.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date (recorded 12/8/23, Pfizer has internal data for 2 additional days up to 12/10/23). No abnormal symptoms reported.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Mass
Clinical narrative: Pt complained of a lump in her lymph node area after receiving covid vaccine.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt asked for hep a, got boostrix, no adverse effects noted
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Infant irritability, Insomnia, Mastocytosis, Rash, Urticaria pigmentosa
Clinical narrative: Declined Hep b at hospital was talked into it at 1 month appt, Patient developed mastocytosis uticaria pigmentosa was reffered to multiple specialist . Constant irritability and inability to sleep following this immunization. Full body rash that has never gone away.
Age: 28.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Epistaxis
Clinical narrative: Frequent, severe bloody nose in one nostril. Could be dry weather but nose bleeds started some time after my first Moderna covid shot, and hasn't happened for a while. This is the first one for a long time, and I haven't had a covid shot for about a year.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event noted at this time
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Respiratory tract congestion
Clinical narrative: Chest Congestion And Coughing
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: Hospitalization due to COVID-19 infection requiring MOLNUPIRAVIR and supportive care Other Relevant HX: Other: Hospitalization due to COVID-19 infection
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: None stated.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Confusional state, Cough, Diarrhoea
Clinical narrative: Reported Symptoms:  10010300:CONFUSION;  10012727:DIARRHEA;  10013773:DRY COUGH;  10016256:FATIGUE;  10028735:NASAL CONGESTION; 10047862:WEAKNESS;   Narrative:  Patient is a 69 year old MALE with PMH Hypertension, Type 2 diabetes, peripheral neuropathy, Hyperlipidemia, h/o DVT, venous insufficiency, Glaucoma who presents to the hospital for generalized weakness, fatigue, confusion, dry cough, nasal congestion and loose stools for the last 2 weeks. Patient is found to be positive for COVID19.  Per chart review, patient has received 3 doses of Moderna  so far. Patient denies recent travel, recent sick contact or COVID exposure. Patient may have just gotten COVID despite vaccines and no therapy was started and only used supportive care and discharged.  Other Relevant HX: Patient is a 69 year old MALE with PMH Hypertension, Type 2 diabetes, peripheral neuropathy, Hyperlipidemia, h/o DVT, venous insufficiency, Glaucoma who presents to the hospital for generalized weakness, fatigue, confusion, dry cough, nasal congestion and loose stools for the last 2 weeks. Patient is found to be positive for COVID19.  Per chart review, patient has received 3 doses of Moderna so far. Patient denies recent travel, recent sick contact or COVID exposure. Patient may have just gotten COVID despite vaccines and no therapy was started and only used supportive care and discharged.  Other: Generalized weakness, fatigue, dry cough, and nasal congestion
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10010300:CONFUSION;  10012727:DIARRHEA;  10013773:DRY COUGH;  10016256:FATIGUE;  10028735:NASAL CONGESTION; 10047862:WEAKNESS;   Narrative:  Patient is a 69 year old MALE with PMH Hypertension, Type 2 diabetes, peripheral neuropathy, Hyperlipidemia, h/o DVT, venous insufficiency, Glaucoma who presents to the hospital for generalized weakness, fatigue, confusion, dry cough, nasal congestion and loose stools for the last 2 weeks. Patient is found to be positive for COVID19.  Per chart review, patient has received 3 doses of Moderna  so far. Patient denies recent travel, recent sick contact or COVID exposure. Patient may have just gotten COVID despite vaccines and no therapy was started and only used supportive care and discharged.  Other Relevant HX: Patient is a 69 year old MALE with PMH Hypertension, Type 2 diabetes, peripheral neuropathy, Hyperlipidemia, h/o DVT, venous insufficiency, Glaucoma who presents to the hospital for generalized weakness, fatigue, confusion, dry cough, nasal congestion and loose stools for the last 2 weeks. Patient is found to be positive for COVID19.  Per chart review, patient has received 3 doses of Moderna so far. Patient denies recent travel, recent sick contact or COVID exposure. Patient may have just gotten COVID despite vaccines and no therapy was started and only used supportive care and discharged.  Other: Generalized weakness, fatigue, dry cough, and nasal congestion