chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Paralysis, Sensory loss, X-ray
Clinical narrative: Diagnoses with Gillian Barre' syndrome.                                                      Hands got numb, than left leg would not work. Ambulance was called, then began paralysis of entire body including diaphragm. Was put on ventilator, and at some point, was deprived of oxygen and now has brain damage. Went to 4 facilities and end up in long term facility (nursing home).  This happened in Oct 2023, it is now, March 2024 and she still is unable to move her torso and legs. Can't even feel when she goes to the bathroom.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: Pain in left upper arm, worse with movement, concern for swelling, causing sleep difficulties. Pain present since time of vaccination.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling and heat/ inflammation at injection site.  Swelling to bottom of arm under armpit 3 inches.  Redmark on deltoid muscle was 4'' high and 3'' across. Very inflamed, red,  and swollen.  Pt took tylenol and Put ice on the site.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: patient says got redness on arm of injection and redness area on leg
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Medical assistant administered vaccine as directed by provider. After it was administered provider realized patient was not due yet.
Age: 68.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered
Clinical narrative: pt got 2 arexvy shots first 9/8/23 and again 3/6/24
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Earlier this morning we got a shipment of vaccines that included Varicella. Per Website they hadn't been entered into the system yet and to ask a tech for help. I went and asked tech who told me I can use it, but I will have to hold on documentation and to send her the MRN, so she can document the discrepancy with the vaccine report. About half an hour later she comes and tells me as the vaccines arrived a day late, they are under quarantine. Report made per Website instructions.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: Needle not screwed on all the way, while injecting the vaccine started coming through screw site. Guessing about half vaccine was injected but unsure.
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Rash, Rash pruritic
Clinical narrative: Individual called stating she developed a full body rash about 1 week after vaccination. She continues to still have this rash from head to toe, it is painful and itchy. She went to her primary care provider and he told her to take Zyrtec in February 2024. Individual called today stating the rash is still severe. She has an appointment with a dermatologist next week.  Pt. states she is is good health, does have type 1 diabetes.
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Antinuclear antibody increased, Erythema, Urticaria
Clinical narrative: Individual called stating she developed a full body rash about 1 week after vaccination. She continues to still have this rash from head to toe, it is painful and itchy. She went to her primary care provider and he told her to take Zyrtec in February 2024. Individual called today stating the rash is still severe. She has an appointment with a dermatologist next week.  Pt. states she is is good health, does have type 1 diabetes.
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Rash, Rash pruritic
Clinical narrative: Hives (coin-like lesion) all over the body, Some lesions are raised, redness- Began 1 week post vaccination and has been ongoing for 2.5 months.
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Antinuclear antibody increased, Erythema, Urticaria
Clinical narrative: Hives (coin-like lesion) all over the body, Some lesions are raised, redness- Began 1 week post vaccination and has been ongoing for 2.5 months.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Vaccination site nodule, Vaccination site pain, Vaccination site warmth
Clinical narrative: day later noticing a knot under the skin; pain and heat during and immediately following the injection; pain and heat during and immediately following the; Information has been received from a 39 year-old female patient reporting on herself.  The patient's concurrent conditions included allergy to egg and gluten. Medical history, concomitant therapies or historical therapies where not reported.  On 23-JAN-2024, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) ( strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On the same date, the patient reported  experiencing pain and heat during and immediately following the injection (Vaccination site pain, Vaccination site warmth). She also reported that about 1 day later, on 24-JAN-2024, she noticed a knot under the skin (Vaccination site nodule), and she feel like it may have gotten a little bigger and that was still painful and felt like a wasp sting. There was no visible redness at the injection site.  The Patient reported to have cancelled future doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  The outcome of the events was reported as not recovered. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP calling to report adverse event regarding improperly stored and administered VARIVAX.  HBP stated that a VARIVAX dose was administered at this facility after a temperature excursion occurred.  HBP stated that the temperature excursion occurred on; No additional adverse event; This spontaneous report was received from office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X017487, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). On 13-FEB-2024, this vaccine underwent temperature excursion (Product storage error). No additional adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 6 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK received date: 28-Feb-2024 This case was reported by a patient via interactive digital media. Patient got the shingles about six months after the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-FEB-2024 This case was reported by a patient via interactive digital media. The patient was reporter's mother. The patient got shingles bad even after she had the vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Product administered at inappropriate site
Clinical narrative: intended to give Infanrix to an 18-month-old patient but Pediarix was given instead; patient received 4th dose of Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 77J49, expiry date 09-FEB-2026) for prophylaxis.   On 27-FEB-2024, the patient received the 4th dose of Pediarix. On 27-FEB-2024, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: intended to give Infanrix to an 18-month-old patient but Pediarix was given instead) and extra dose administered (Verbatim: patient received 4th dose of Pediarix). The outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2024 A clinic administrator reported it was intended to give Infanrix to a patient, but Pediarix was given instead, which led to wrong vaccine administered. This would be the 4th dose of Pediarix for the patient, which led to extra dose administered.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidently administered Fluarix vaccine instead of a varicella vaccine; 2 month old patient was accidently administered Fluarix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 9ac53, expiry date 30-JUN-2024) for prophylaxis.   In FEB-2024, the patient received Fluarix Quadrivalent 2023-2024 season. In FEB-2024, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced wrong vaccine administered (Verbatim: accidently administered Fluarix vaccine instead of a varicella vaccine) and inappropriate age at vaccine administration (Verbatim: 2 month old patient was accidently administered Fluarix vaccine). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2024 The reporter stated that a 2 month old patient was accidently administered Fluarix vaccine instead of a Varicella vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: gave the patient the adult dose verses pediatric dose; gave the patient the adult dose verses pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 14-year-old female patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 08-FEB-2024, the patient received the 1st dose of Havrix adult. On 08-FEB-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: gave the patient the adult dose verses pediatric dose) and adult product administered to child (Verbatim: gave the patient the adult dose verses pediatric dose). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 The medical assistant reported that he/she gave the patient the adult dose of Havrix verses pediatric dose, which led to an overdose and adult product administered to child.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Paraesthesia, Vaccination failure
Clinical narrative: Suspected vaccination failure; The incidence of shingles after the administration of Shingrix; Tingling sensation; Had burning sensation; had pain; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: The incidence of shingles after the administration of Shingrix), tingling sensation (Verbatim: Tingling sensation), burning sensation (Verbatim: Had burning sensation) and pain (Verbatim: had pain). The outcome of the vaccination failure, tingling sensation and pain were unknown and the outcome of the shingles and burning sensation were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, tingling sensation, burning sensation and pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, tingling sensation, burning sensation and pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 28-FEB-2024 The physician to request information about the incidence of shingles after the administration of Shingrix, as the patient had received 2 doses and had pain and a burning sensation. The vaccine administration facility was the same as primary reporter. They gave partial information and consented to receive follow up.  This case was considered as suspected vaccination failure as details regarding completion time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Typical side effects to moderna vaccine; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of IMMUNISATION REACTION (Typical side effects to moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Typical side effects to moderna vaccine). At the time of the report, IMMUNISATION REACTION (Typical side effects to moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-058637 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058637:Master case
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Mobility decreased
Clinical narrative: lost the use of her legs/she knows of 2 other people who had the same results after the 2nd dose of the vaccine; She said that she could sit in a chair, but was unable to stand up on her own legs/she knows of 2 other people who had the same results after the 2nd dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (lost the use of her legs/she knows of 2 other people who had the same results after the 2nd dose of the vaccine) and GAIT DISTURBANCE (She said that she could sit in a chair, but was unable to stand up on her own legs/she knows of 2 other people who had the same results after the 2nd dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (lost the use of her legs/she knows of 2 other people who had the same results after the 2nd dose of the vaccine) and GAIT DISTURBANCE (She said that she could sit in a chair, but was unable to stand up on her own legs/she knows of 2 other people who had the same results after the 2nd dose of the vaccine). At the time of the report, MOBILITY DECREASED (lost the use of her legs/she knows of 2 other people who had the same results after the 2nd dose of the vaccine) and GAIT DISTURBANCE (She said that she could sit in a chair, but was unable to stand up on her own legs/she knows of 2 other people who had the same results after the 2nd dose of the vaccine) outcome was unknown.            This case was for first patient out of 2 reported.  No relevant concomitant medications were reported. Reporter lost the use of her legs for 8-10 hours after vaccination. Reporter said that she could sit in a chair, but was unable to stand up on her own legs. She was not able to get up out of her chair, however if she was assisted to a standing position, she was able to walk a little bit. The reporter stated that she knows of 2 other people who had the same results after the 2nd dose of the vaccine. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-105344 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-105344:Reporter case (2 other people)
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had received Moderna vaccine - subsequent Covid with rebound after course Paxlovid completed; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had received Moderna vaccine - subsequent Covid with rebound after course Paxlovid completed) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had received Moderna vaccine - subsequent Covid with rebound after course Paxlovid completed). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Had received Moderna vaccine - subsequent Covid with rebound after course Paxlovid completed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Testing positive for COVID-19 after being vaccinated.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Caller states that she is feeling tired after getting the vaccine a couple hours ago; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Caller states that she is feeling tired after getting the vaccine a couple hours ago) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 04-Mar-2024, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 04-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FATIGUE (Caller states that she is feeling tired after getting the vaccine a couple hours ago). At the time of the report, FATIGUE (Caller states that she is feeling tired after getting the vaccine a couple hours ago) outcome was unknown.            No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Despite being fully vaccinated and boosted against COVID-19, he contracted the infection but remained asymptomatic without flaring of his autoimmunity.; Despite being fully vaccinated and boosted against COVID-19, he contracted the infection but remained asymptomatic without flaring of his autoimmunity.; This is a literature report for the following literature source(s):  A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism (Hashimoto's disease)" (unspecified if ongoing), notes: at 3-years of age; "Evans syndrom" (unspecified if ongoing), notes: at 3-years of age; "autoimmune hemolytic anemia (AIHA)" (unspecified if ongoing); "thrombocytopenia" (unspecified if ongoing); "neutropenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Glucocorticoids; Prednisone; Ruxolitinib; Mycophenolate; Bortezomib. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Despite being fully vaccinated and boosted against COVID-19, he contracted the infection but remained asymptomatic without flaring of his autoimmunity."  Clinical course: He was immunized with the mRNACOVID-19 vaccine and did not experience any side effects. Despite being fully vaccinated and boosted against COVID-19,he contracted the infection but remained as aymptomatic without flaring of his autoimmunity.  No follow-up attempts are possible.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, based on the drug safety profile a contributory role of the suspect vaccine  to the Vaccination failure (LOE) and Covid 19 cannot be ruled out.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 at 12:00 as dose number unknown , single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "LPR" (unspecified if ongoing); "allergy induced asthma" (unspecified if ongoing); "allergy induced asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jan2024, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment was taken on 30Jan2024 to 03Feb2024.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1 (toppac), single (Lot number: HG4628) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM, start date: Jan2013; METFORMIN, start date: Jan2015; LOSARTAN POTASSIUM, start date: Jan2013; TRIAMTERENE HCTZ, start date: Jan2013; ALBUTEROL [SALBUTAMOL] nasal, start date: Jan2000; ROSUVASTATIN CALCIUM, start date: Jul2020; YUVAFEM vaginal, start date: Jan2022. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril"; Singulair, reaction(s): "Known allergies: Singulair"; Mobic, reaction(s): "Known allergies: Mobic"; Lactose, reaction(s): "Known allergies: Lactose". Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (vaccine dose number=7, vaccine lot number=GJ3268, vaccine location=Left arm), administration date: 01May2023, when the patient was 68-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose Number: 6, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 5, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 4, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 3, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Feb2024) Positive; (26Feb2024) Negative; (16Feb2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stated her husband tested positive for COVID on 15Feb2024. She did a home COVID test on 16Feb2024 and was negative. She started to feel sick with ''terrible head cold'' on 18Feb2024, so she took another test and was positive. She called her Doctor on the morning of 19Feb2024 and was prescribed Paxlovid, which she started taking that same day. She completed Paxlovid on 23Feb2024. She took another COVID test on 26Feb2024. That test was negative.
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Cardiovascular disorder, Postural orthostatic tachycardia syndrome
Clinical narrative: Cardiovascular; Autonomic Nervous System; POTS; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient 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 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunisation. The following information was reported: CARDIOVASCULAR DISORDER (non-serious), outcome "not recovered", described as "Cardiovascular"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), outcome "not recovered", described as "Autonomic Nervous System"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "not recovered", described as "POTS". The events "cardiovascular", "autonomic nervous system" and "pots" required physician office visit. It was unknown if therapeutic measures were taken as a result of cardiovascular disorder, autonomic nervous system imbalance, postural orthostatic tachycardia syndrome.  Additional information: It was unknown if the patient was diagnosed with  COVID-19 prior to the vaccination and if the patient has been tested for COVID-19 since the vaccination  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: RSV
Symptoms: Injection site pain
Clinical narrative: patient complained of internal arm burning from vaccine; This is a spontaneous report received from an Other HCP from a sales representative.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "patient complained of internal arm burning from vaccine".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Raised erythema edema; very sore and painful and touch; This is a spontaneous report and received from Other HCPs from medical information team.  An 18-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 27Feb2024 at 11:57 as dose number unknown, 0.5 ml single (Lot number: GH4067, Expiration Date: 30Aug2025) at the age of 18 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "ADHD" (ongoing); "Acne" (ongoing). Concomitant medication(s) included: VYVANSE oral taken for attention deficit hyperactivity disorder (ongoing); MINOCYCLINE oral taken for acne (ongoing). Vaccination history included: trumenba (Vaccine Name:  Trumenba , Lot Number / Expiry Date: DW2999, Route, Anatomical Location: IM, Right Deltoid), administration date: 16Mar2022, when the patient was 16-year-old, for Immunization. The following information was reported: ERYTHEMA (non-serious) with onset 28Feb2024, outcome "unknown", described as "Raised erythema edema"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2024, outcome "unknown", described as "very sore and painful and touch". Therapeutic measures were taken as a result of erythema, injection site pain included Benadryl, Zyrtec, Cold Compress, and Ibuprofen as needed for pain.  Additional information: This patient was followed up with a Tele-visit on 29Feb2024 as the other twin was seen directly in the office. There is a 5 to 6 inches long and 3 inches wide area located on left arm above the elbow that is raised erythemic edema It's like mid to upper left arm right before the elbow. It's a raised erythemic edema. It's very sore and painful to touch. This started late evening.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400056401 Same product/event, different patient;
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: Raised erythemic edema; area very sore and painful to touch; First dose on 17Mar2022/Second dose on 27Feb2024; This is a spontaneous report and received from Other HCPs from medical information team.  An 18-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 27Feb2024 at 11:55 as dose 2, 0.5 ml single (Lot number: GH4067, Expiration Date: 30Aug2025) at the age of 18 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "GI issues" (unspecified if ongoing), notes: happened about "week" before got vaccine. Concomitant medication(s) included: AMOXICILIN oral taken for gastrointestinal disorder (ongoing). Vaccination history included: trumenba (Dose 1; Lot Number / Expiry Date: DW2999/30Jun2023, Route, Anatomical Location: IM, Right Deltoid), administration date: 17Mar2022, for immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Feb2024, outcome "unknown", described as "First dose on 17Mar2022/Second dose on 27Feb2024"; ERYTHEMA (non-serious) with onset 28Feb2024, outcome "not recovered", described as "Raised erythemic edema"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2024, outcome "not recovered", described as "area very sore and painful to touch". The events "raised erythemic edema" and "area very sore and painful to touch" required physician office visit. Therapeutic measures were taken as a result of erythema, vaccination site pain.  Additional information: The patient had no other conditions. It was reported that there has been three adverse reactions within a 4 day span. They just opened a new box of Trumeba. The reporter explained the reactions occurred with a set of twin sisters. This patient had pretty much the same reaction as her twin sister. She had the raised erythemic edema, area was very sore and painful to touch. The raised erythemic edema was roughly 5 to 6 inches by 2-3 inches. This all started in the evening of 28Feb2024. Treatment included cool compression, Zyrtec once a day, and Benadryl every six hours as needed. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400056396 Same product/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 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: Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccination and medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 24Feb2024 to 28Feb2024  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Sore (upper right arm); This is a spontaneous report received from an Other HCP and a Physician.  An 18-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 27Feb2024 as dose number unknown, 0.5 ml single (Lot number: GH4067, Expiration Date: 30Aug2025) at the age of 18 years intramuscular, in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Mar2024, outcome "unknown", described as "Sore (upper right arm)". Therapeutic measures were taken as a result of pain in extremity. Additional information: Reported the reaction as being sore in the upper arm. Later clarified it was the right upper arm. Unsure if his upper right arm is still sore. Outcome unknown. Will be in today for a follow up. Treatment: Took Advil.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old male patient 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 included: "VKH" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose: 1), for COVID-19 immunization; Moderna (Dose: 2), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacture: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 4, Manufacture: Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment included Paxlovid from 28Feb2024 to 03Mar2024 via oral route. No known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 77.0
Sex: M
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 Consumer or other non HCP.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose number unknown (booster), single (Lot number: GL0446) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial flutter", start date: 14Jun2018 (unspecified if ongoing); "Right Total Knee Replacement", start date: 16Jun2020 (unspecified if ongoing); "Left Total Knee Replacement", start date: 11Oct2022 (unspecified if ongoing); "Obese" (unspecified if ongoing); "Profound hearing loss" (unspecified if ongoing), notes: Profound hearing loss. Concomitant medication(s) included: DILT-XR, start date: 14Jun2018; TAMSULOSIN, start date: 15Nov2019. Vaccination history included: Covid-19 vaccine (primary series complete, manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2024) Positive; (26Feb2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment for COVID-19 from 19Feb2023 to 24Feb2024. The patient had no known allergies.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 43 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (2024) and all described as "COVID-19". The clinical course was reported as follows: The patient started nirmatrelvir, ritonavir (PAXLOVID) treatment on 23Feb2024 and finished it on 28Feb2024, feeling great. Got symptoms again on 01Mar2024 (congestion/headache/sore throat) but tested negative. The patient underwent the laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received
Age: 54.0
Sex: F
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 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in right 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. Vaccination history included: Bnt162b2 (Dose Number: 4, Batch/Lot No: Unknown. Misplaced/discarded), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 3, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 2, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Positive, notes: positive COVID test 4 days late; (Feb2024) Negative, notes: Tested negative 2 days after taking Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 as patient was being treated with Paxlovid.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 61-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1 (toppac), single (Lot number: HG4665) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid received from 24Feb2024 to 28Feb2024 for the Treatment of COVID-19. No known allergies. Not resulted in death, no life threatening, no disabling/incapacitating, no congenital anomaly/birth defect and not required prolonged hospitalization.
Age: 73.0
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 Consumer or other non HCP.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Apr2023 at 14:15 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing), notes: Mild hypertension. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Negative, notes: Relapse after 3 days of negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid was given on 24Feb2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
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 Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, 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 from 23Feb2024 to 28Feb2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid from 29Feb2024 to 04Mar2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.