chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.; No adverse event; Vaccine was administered to patient after temperature excursion occurred; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 5yp3l) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion reached minimum of 15.6A°F for 21 hours out of range. Administered to 1 patient.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred).    No concomitant medication was reported.  No treatment information was reported.
Age: 0.5
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: no adverse event; given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.; 6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.), UNDERDOSE (6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter) and NO ADVERSE EVENT (no adverse event) in a 6-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 26-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.) and UNDERDOSE (6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.), UNDERDOSE (6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (given a dose from the Moderna vial with pink cap. They were supposed to get a dose from the vial with a blue cap. It was administered now or today 26-Jun-2023.) and UNDERDOSE (6 month old patient received 0.20 milliliter dose instead of 0.25 milliliter).    Concomitant product use was not provided by the reporter.  It was reported that reporter HCP wants to know what was the concentration of the two vials so she can figure out if she gave a lower or higher-than-authorized dose to the patient and the dose counts or not.  Treatment information was not provided.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient contracted COVID with heavy symptoms; Patient contracted COVID with heavy symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jun2023, outcome "recovering" and all described as "Patient contracted COVID with heavy symptoms". The event "patient contracted covid with heavy symptoms" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other vaccine in four weeks. Patent contracted COVID with heavy symptoms (extreme fatigue, body aches, sinus congestion, fever and very sore throat) despite getting the vaccines and booster shot. Events resulted in emergency room/department or urgent care. Patient received Paxlovid as treatment. No covid prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blindness, Dysarthria, Magnetic resonance imaging, Retinal tear
Clinical narrative: No strength on his left side, he can't walk; left side weakness; They found a small eye bleed, a retina tear; lost eyesight of his left eye; he has slurred speech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8734) at the age of 64 years, in left arm and on 25Apr2021 as dose 2, single (Lot number: ER8736), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cataract surgery both eyes" (unspecified if ongoing), notes: cataract surgery both eyes, over a decade ago, maybe 15 years. Concomitant medication(s) included: MORPHINE; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]. Vaccination history included: Flu vaccines (Flu vaccines always made him feel terrible. manufacturer unknown lot unknown. took one in 2015 and it made him feel terrible.), administration date: 2015, for Immunization, reaction(s): "feel terrible".  The following information was reported: WALKING DISABILITY (hospitalization, disability), outcome "unknown", described as "No strength on his left side, he can't walk"; ASTHENIA (hospitalization), outcome "unknown", described as "left side weakness"; RETINAL TEAR (hospitalization, medically significant), outcome "unknown", described as "They found a small eye bleed, a retina tear"; BLINDNESS (hospitalization, medically significant), outcome "unknown", described as "lost eyesight of his left eye"; DYSARTHRIA (non-serious), outcome "unknown", described as "he has slurred speech". The events "they found a small eye bleed, a retina tear" and "lost eyesight of his left eye" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (21Apr2023) Unknown results, notes: Result: Not Provided; Unit: Not Provided.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232941 Same product, patient, different AEs, different dose;
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Walking disability
Clinical narrative: No strength on his left side, he can't walk; left side weakness; They found a small eye bleed, a retina tear; lost eyesight of his left eye; he has slurred speech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8734) at the age of 64 years, in left arm and on 25Apr2021 as dose 2, single (Lot number: ER8736), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cataract surgery both eyes" (unspecified if ongoing), notes: cataract surgery both eyes, over a decade ago, maybe 15 years. Concomitant medication(s) included: MORPHINE; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]. Vaccination history included: Flu vaccines (Flu vaccines always made him feel terrible. manufacturer unknown lot unknown. took one in 2015 and it made him feel terrible.), administration date: 2015, for Immunization, reaction(s): "feel terrible".  The following information was reported: WALKING DISABILITY (hospitalization, disability), outcome "unknown", described as "No strength on his left side, he can't walk"; ASTHENIA (hospitalization), outcome "unknown", described as "left side weakness"; RETINAL TEAR (hospitalization, medically significant), outcome "unknown", described as "They found a small eye bleed, a retina tear"; BLINDNESS (hospitalization, medically significant), outcome "unknown", described as "lost eyesight of his left eye"; DYSARTHRIA (non-serious), outcome "unknown", described as "he has slurred speech". The events "they found a small eye bleed, a retina tear" and "lost eyesight of his left eye" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (21Apr2023) Unknown results, notes: Result: Not Provided; Unit: Not Provided.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232941 Same product, patient, different AEs, different dose;
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 16Jun2023 to 21Jun2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 13:00 as dose 3 (booster), single at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing); "eat GF diet" (unspecified if ongoing), notes: eat GF diet due to food intolerances & barley allergy; "barley allergy" (unspecified if ongoing), notes: eat GF diet due to food intolerances & barley allergy; "known allergies: shellfish" (unspecified if ongoing); "known allergies: oregano, Paprika" (unspecified if ongoing); "food intolerances" (unspecified if ongoing), notes: eat GF diet due to food intolerances & barley allergy. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body height, Urticaria
Clinical narrative: hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "scoliosis" (ongoing), notes: scoliosis was diagnosed at least 10 years or 7-8 years ago; "Osteoporosis" (ongoing); "Arthritis" (ongoing); "spinal stenosis" (ongoing); "she had polio as a child" (unspecified if ongoing); "two little fractures in her lower bones in her back" (unspecified if ongoing); "she also has a walker she uses" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (medically significant) with onset Mar2021, outcome "not recovered", described as "hives". The event "hives" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results, notes: Had a lot of blood tests and they were trying to figure out why the hives and apparently the doctor figured it was the Pfizer vaccine; Body height: 5 feet 5 inches. Therapeutic measures were taken as a result of urticaria. Additional information: For her Pfizer Covid vaccine, the 1st was administered on 10Mar2021 with lot EN6208; the 2nd dose was administered on 31Mar2021 with ER8737 at the same facility; the booster dose was on 04Oct2021 with lot FF8811. Since she had the injections she has been dealing with severe outbreak of hives just on the right side and so she has gone to her primary care physician and dermatologist over and over these three years and they do not know what to do. She was sent to an allergist and they did an extreme amount of blood tests and checked her and the hives and came to the conclusion that the hives were caused by the Pfizer Injection. She was age 81 when the hives began as it was Mar2021 and after two vaccines and then the booster. As of Dec2022 she was started on injections in each arm called Xlara (also reported as Explar, Xlair) and carries an epi-pen with it and her last injection of Xlara was Friday and her hives were unbelievable at time of reporting and she can't believe nothing was working. When she first started going to the provider, she thought back in October or November of last year, she had the Xlair injections and had two of them one in each arm and the first three times she did that she would sit in the waiting room for 2 hours and was then ready to go and had to be alert in case she went into whatever and has not had to use her epi-pen; the Xlair injections began Dec2022 or so about in October or Nov2022 was when she started seeing him because her primary care and dermatologist gave up; they were putting her on prednisone all the time and that's not safe.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232978 same patient, different dose;US-PFIZER INC-202300233529 same patient, different dose;
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 4: Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2022, outcome "unknown", described as "Dose 4: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Jun2023) Negative, notes: symptomatic 3 days after initial negative test; (Jun2023) Positive, notes: Rebound COVID-19; positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events interchange of vaccine products, drug ineffective, covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: feeling yucky; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 08May2021 as dose 2, single (Lot number: EW0199) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: ER8731), administration date: 15Apr2021, when the patient was 54-year-old, for COVID-19 immunization, reaction(s): "feeling yucky". The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "recovered", described as "feeling yucky".  Additional information: Had three or 4 other injections prior and had no other side effects other than feeling yucky for a day but never had rashes. Clarified injections as all Pfizer COVID-19 Vaccines.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: feeling yucky; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: ER8731), administration date: 15Apr2021, when the patient was 54-year-old, for COVID-19 immunization, reaction(s): "feeling yucky"; BNT162b2 (DOSE 2, SINGLE, LOT: EW0199), administration date: 08May2021, when the patient was 54-year-old, for Covid-19 immunization, reaction(s): "feeling yucky". The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "feeling yucky".  Additional information: Had three or 4 other injections prior and had no other side effects other than feeling yucky for a day but never had rashes. Clarified injections as all Pfizer COVID-19 Vaccines.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have had a rash for four months after getting my booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "I have had a rash for four months after getting my booster".  Additional information: Rash four month. Patient had a rash for four months after getting booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ2524) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Additional information: Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than equals to 12 years-15/15 mcg per dos. Caller stated he received his bivalent booster on 23Sep2022, he had a friend who took the same lot number ended up getting Covid a few weeks ago.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: FATIGUE (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea
Clinical narrative: developed shortness and a cough; developed shortness and a cough; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Apr2022 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: DYSPNOEA (non-serious), COUGH (non-serious), outcome "not recovered" and all described as "developed shortness and a cough"; ASTHENIA (non-serious), outcome "not recovered", described as "weakness". The events "developed shortness and a cough" and "weakness" required physician office visit.  Additional information: After my last Covid vaccine on 15Apr2022 I started having some problems that, at first, I didn't connect to the vaccine. I've seen several doctors since then but to no avail. I started having sudden bouts of weakness which became a permanent condition, and eventually developed shortness and a cough. This has worsened to the point that I have had problems coughing because it makes me short of breath and I can't get the cough out. Is there a way to reverse the effects of the vaccine?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: feeling yucky; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8731) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "feeling yucky".  Additional information: Had three or 4 other injections prior and had no other side effects other than feeling yucky for a day but never had rashes. Clarified injections as all Pfizer COVID-19 Vaccines.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: lost his only very athletic son due to 2 doses of your vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 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 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "lost his only very athletic son due to 2 doses of your vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: a reporter's dear friend lost his only very athletic son due to 2 doses of Pfizer vaccine for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: lost his only very athletic son due to 2 doses of your vaccine
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site infection, Injection site mass, Injection site pruritus
Clinical narrative: PATIENT REPORTED ON WEDNESDAY MORNING OF 06/28/23 THAT THE SITE OF INJECTION HAS BEEN INFECTED ACCORDING TO HER DOCTOR. PER OBSERVATION OF INJECTION SITE AND PATIENTS DESCRIPTION, THE SURROUNDING RASH WAS ABOUT MORE THAN 2 INCHES IN DIAMETER, VERY ROUND, SWOLLEN, DARK BROWNISH-RED IN COLOR, ITCHY, WARM, AND DESCRIBED AS A HARD LUMP. DR. DID PRESCRIBE PATIENT ANTIBIOTIC THERAPY.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT REPORTED ON WEDNESDAY MORNING OF 06/28/23 THAT THE SITE OF INJECTION HAS BEEN INFECTED ACCORDING TO HER DOCTOR. PER OBSERVATION OF INJECTION SITE AND PATIENTS DESCRIPTION, THE SURROUNDING RASH WAS ABOUT MORE THAN 2 INCHES IN DIAMETER, VERY ROUND, SWOLLEN, DARK BROWNISH-RED IN COLOR, ITCHY, WARM, AND DESCRIBED AS A HARD LUMP. DR. DID PRESCRIBE PATIENT ANTIBIOTIC THERAPY.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Dizziness, Headache, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: headache, dizziness, stuffy nose
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I'm so sick of hearing about Covid! I had the [Pfizer] shots and l still got Covid so they didn't do me any good.; I'm so sick of hearing about Covid! I had the [Pfizer] shots and l still got Covid so they didn't do me any good.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (201189). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I'm so sick of hearing about Covid! I had the [Pfizer] shots and l still got Covid so they didn't do me any good.". Clinical course: Thinking of the advertising you just saw, please enter anything you felt, thought, or were reminded of while viewing it. Everything is acceptable. There are no right or wrong answers, no silly or dumb feelings. Don't worry about spelling, punctuation, or grammar. I'm so sick of hearing about Covid! I had the [Pfizer] shots and l still got Covid so they didn't do me any good.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: HIB vaccine  was not properly reconstituted, only the sterile diluent was administered.  No adverse reaction for the patient.
Age: 20.0
Sex: M
Vaccine: MENB, VARCEL
Symptoms: Abdominal pain upper, Dizziness, Eye movement disorder, Hyperhidrosis, Mydriasis
Clinical narrative: Patient received Bexsero Vaccine in right arm. Aferwards, patient then received Varivax in Right arm as well. Prior to vaccinating other arm, patient asked me to wait, because he started feeling a little dizzy. After a couple of minutes has passed, patient reported to me that he cannot see well, but he can still hear my clearly. Patient described vision as "TV Static" and "Blurry and Black". After a few more minutes, patient started to lean in chair and fainted. I was able to catch patient and continue to stay with him the entire time. Patient's eyes were dilated and they were rolled back when he fainted. Syncope lasted about 30 seconds before patient came back. Patient was still having vision issues upon coming back, yet he was able to respond to sound to me. I gave patient water, since he was feeling thirsty, but he was also feeling like he was sweating and had some stomach pains. EMS was called and they arrived shortly and took over from here.
Age: 20.0
Sex: M
Vaccine: MENB, VARCEL
Symptoms: Syncope, Thirst, Vision blurred, Visual impairment
Clinical narrative: Patient received Bexsero Vaccine in right arm. Aferwards, patient then received Varivax in Right arm as well. Prior to vaccinating other arm, patient asked me to wait, because he started feeling a little dizzy. After a couple of minutes has passed, patient reported to me that he cannot see well, but he can still hear my clearly. Patient described vision as "TV Static" and "Blurry and Black". After a few more minutes, patient started to lean in chair and fainted. I was able to catch patient and continue to stay with him the entire time. Patient's eyes were dilated and they were rolled back when he fainted. Syncope lasted about 30 seconds before patient came back. Patient was still having vision issues upon coming back, yet he was able to respond to sound to me. I gave patient water, since he was feeling thirsty, but he was also feeling like he was sweating and had some stomach pains. EMS was called and they arrived shortly and took over from here.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Peripheral swelling
Clinical narrative: Patient stopped in to report adverse response on 6/26/23.  Patient experienced swelling from shoulder to knuckles, itching and hard lump at site of injection later that day after receiving injection.  She contacted prescriber and was told to take Benadryl 25mg twice daily.   Patient stated she has been taking  once or twice daily dosing for 10 days.  Hard lump has been dissipating , swelling almost entirely gone and itching subsiding.  Patient stated she has tons of allergies and wasn't surprised with reaction.  Patient is doing well.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Gait disturbance, Hyperhidrosis, Hypertension
Clinical narrative: First, the shot was given incorrectly, which caused some of the adverse affect.   I asked for the right arm as she was preparing for the left, and the provider ended up injecting me high on the shoulder, and I felt an unusual pressure inside my arm, rather than the usual zing of the needle.   My first symptom was the onset of excrusiating pain in my right shoulder, which I believe is because of the bad placement.   This continued through the first night, but gradually improved the next morning (now 85% relieved?) I also had the expected mild flue type symptoms the next day, but was able to do a few things.   By the middle of this second day, my lower back started hurting - a lot.   Similar to the shoulder in that it was unexpected and not in line with 'normal' Shingrix symptoms.   I couldn't stand up straight or do much of anything because it hurt so much.   I spent the rest of the day laying down and trying not to make it worse. The next day (#3 - 6/28) it was still there, so I did the same thing in the morning - just tried not to move much.   In the afternoon I thought better of that and looked up some physical therapy exercises for this type of pain and tried them, I walked (slowly) on our treadmill and used a heating pad and ice.   Either it worked or the same thing happened as with my shoulder and it just started to get better.   I was more comfortable that night and decided to go to work today (6/29). The lower back pain is not yet gone - it's about half better.   I can walk around without tears, but I'm not completely upright and it is physically stressful (it makes me sweat).   I tried to take it easy, though my job is not all at a desk.   I made an appointment late in the day to go discuss this at the same clinic, and I'm planning an evening of ice and rest.   My blood pressure was pretty high at the Dr. office. In our discussion we pretty much agree on the cause of the arm pain, though they will be looking into it further.  But why the lower back?   This doesn't seem to add up to anything related to the bad shot or Shingrix that we find online.    The mild flue symptoms have not occured today - that's over - and I have nothing happening besides the backach and remnant of the shoulder pain.   How could it move from one place to the other?   I haven't had any other back stress or occurance to cause this pain and it is very coincidental with the other issues this week.   So are they related?  My first Shingrix shot was 4/5/2023, at the same clinic.  Given correctly and only a few mild flu-like symptoms.   No problem.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Injection site pain, Limb discomfort, Mobility decreased
Clinical narrative: First, the shot was given incorrectly, which caused some of the adverse affect.   I asked for the right arm as she was preparing for the left, and the provider ended up injecting me high on the shoulder, and I felt an unusual pressure inside my arm, rather than the usual zing of the needle.   My first symptom was the onset of excrusiating pain in my right shoulder, which I believe is because of the bad placement.   This continued through the first night, but gradually improved the next morning (now 85% relieved?) I also had the expected mild flue type symptoms the next day, but was able to do a few things.   By the middle of this second day, my lower back started hurting - a lot.   Similar to the shoulder in that it was unexpected and not in line with 'normal' Shingrix symptoms.   I couldn't stand up straight or do much of anything because it hurt so much.   I spent the rest of the day laying down and trying not to make it worse. The next day (#3 - 6/28) it was still there, so I did the same thing in the morning - just tried not to move much.   In the afternoon I thought better of that and looked up some physical therapy exercises for this type of pain and tried them, I walked (slowly) on our treadmill and used a heating pad and ice.   Either it worked or the same thing happened as with my shoulder and it just started to get better.   I was more comfortable that night and decided to go to work today (6/29). The lower back pain is not yet gone - it's about half better.   I can walk around without tears, but I'm not completely upright and it is physically stressful (it makes me sweat).   I tried to take it easy, though my job is not all at a desk.   I made an appointment late in the day to go discuss this at the same clinic, and I'm planning an evening of ice and rest.   My blood pressure was pretty high at the Dr. office. In our discussion we pretty much agree on the cause of the arm pain, though they will be looking into it further.  But why the lower back?   This doesn't seem to add up to anything related to the bad shot or Shingrix that we find online.    The mild flue symptoms have not occured today - that's over - and I have nothing happening besides the backach and remnant of the shoulder pain.   How could it move from one place to the other?   I haven't had any other back stress or occurance to cause this pain and it is very coincidental with the other issues this week.   So are they related?  My first Shingrix shot was 4/5/2023, at the same clinic.  Given correctly and only a few mild flu-like symptoms.   No problem.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site, Stress, Wrong technique in product usage process
Clinical narrative: First, the shot was given incorrectly, which caused some of the adverse affect.   I asked for the right arm as she was preparing for the left, and the provider ended up injecting me high on the shoulder, and I felt an unusual pressure inside my arm, rather than the usual zing of the needle.   My first symptom was the onset of excrusiating pain in my right shoulder, which I believe is because of the bad placement.   This continued through the first night, but gradually improved the next morning (now 85% relieved?) I also had the expected mild flue type symptoms the next day, but was able to do a few things.   By the middle of this second day, my lower back started hurting - a lot.   Similar to the shoulder in that it was unexpected and not in line with 'normal' Shingrix symptoms.   I couldn't stand up straight or do much of anything because it hurt so much.   I spent the rest of the day laying down and trying not to make it worse. The next day (#3 - 6/28) it was still there, so I did the same thing in the morning - just tried not to move much.   In the afternoon I thought better of that and looked up some physical therapy exercises for this type of pain and tried them, I walked (slowly) on our treadmill and used a heating pad and ice.   Either it worked or the same thing happened as with my shoulder and it just started to get better.   I was more comfortable that night and decided to go to work today (6/29). The lower back pain is not yet gone - it's about half better.   I can walk around without tears, but I'm not completely upright and it is physically stressful (it makes me sweat).   I tried to take it easy, though my job is not all at a desk.   I made an appointment late in the day to go discuss this at the same clinic, and I'm planning an evening of ice and rest.   My blood pressure was pretty high at the Dr. office. In our discussion we pretty much agree on the cause of the arm pain, though they will be looking into it further.  But why the lower back?   This doesn't seem to add up to anything related to the bad shot or Shingrix that we find online.    The mild flue symptoms have not occured today - that's over - and I have nothing happening besides the backach and remnant of the shoulder pain.   How could it move from one place to the other?   I haven't had any other back stress or occurance to cause this pain and it is very coincidental with the other issues this week.   So are they related?  My first Shingrix shot was 4/5/2023, at the same clinic.  Given correctly and only a few mild flu-like symptoms.   No problem.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, UNK
Symptoms: Barium enema, Blood culture, C-reactive protein, Culture urine, Full blood count
Clinical narrative: Intussusception diagnosed on 5/10 (15 days following the rota virus vaccine)
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, UNK
Symptoms: Intussusception, Occult blood, Procalcitonin, Ultrasound abdomen, Urine analysis
Clinical narrative: Intussusception diagnosed on 5/10 (15 days following the rota virus vaccine)
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, UNK
Symptoms: Intussusception, Metabolic function test, Occult blood, Procalcitonin, Ultrasound abdomen
Clinical narrative: Intussusception diagnosed on 5/10 (15 days following the rota virus vaccine)
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, UNK
Symptoms: Urine analysis
Clinical narrative: Intussusception diagnosed on 5/10 (15 days following the rota virus vaccine)
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered.  Expired June 24, 2023.  The expiration on the syinge was printed as "23JUN24" and was interpreted as June 23, 2024.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody, Disability, Impaired work ability, Laboratory test, Mixed connective tissue disease
Clinical narrative: I had a Shingrix vax that has left my health in shambles! I've been completely disabled because of the vaccine where I now cannot even work on the work program. I'm SO angry that the FDA hasn't done anything about the amount of people that are having adverse effects from the Shingrix vaccine!!! My life's been destroyed... Shingrex causes much more than Guillain-Barre that the box states!!! More auto immune issues! Please do studies regarding this!
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever to 103 after Shingles vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: She reported taking her Pfizer COVID shots and 2 booster, with second booster on 10/28/2021. At optometry visit 11/11/22, she was found to have vision loss in her left eye and have now progress to worsen in the right eye as well. This can potentially be one of the long-term adverse effect or complication after receiving the vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose was administered 04-Mar-2021 / 2nd dose was administered 24-Mar-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 04-Mar-2021 / 2nd dose was administered 24-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 04-Mar-2021 / 2nd dose was administered 24-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 04-Mar-2021 / 2nd dose was administered 24-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered 04-Mar-2021 / 2nd dose was administered 24-Mar-2021).    Patient did not received any other vaccines in the 4 weeks prior to COVID 19. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2023-730177 (Patient Link).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Varicella vaccine administered on 23-AUG-2001 and on 17-AUG-2012; This spontaneous report has been received from a physician, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (MARRS # 2102USA001836), concerning a 12 year old female patient.      On 23-AUG-2001, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported). On 17-AUG-2012, the patient was vaccinated with another dose of varicella virus vaccine live (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported) (Inappropriate schedule of vaccine administered). Concomitant vaccines included pneumococcal vaccine conj and measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).; Sender's Comments:  US-009507513-2102USA001836: