chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: worst pain she has ever had at left arm injection site; Shingrix administered subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-MAR-2024, the patient received Shingrix (subcutaneous, left arm). On 22-MAR-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: worst pain she has ever had at left arm injection site) and intramuscular formulation administered by other route (Verbatim: Shingrix administered subcutaneously). The outcome of the injection site pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2024. The pharmacist reported that patient had worst pain she has ever had at left arm injection site. The patient received the vaccine subcutaneously which led to Intramuscular formulation administered by other route.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site bruising, Injection site vesicles, Product administered at inappropriate site
Clinical narrative: at the injection site, a large bruise; looked ready to blister; Kinrix administered at the anterior part of left leg; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site bruising in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 22-MAR-2024, the patient received Kinrix. On 22-MAR-2024, an unknown time after receiving Kinrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Kinrix administered at the anterior part of left leg). On 24-MAR-2024, the patient experienced injection site bruising (Verbatim: at the injection site, a large bruise) and injection site blisters (Verbatim: looked ready to blister). The outcome of the injection site bruising and injection site blisters were not reported and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site bruising and injection site blisters to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site bruising and injection site blisters to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   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: 24-MAR-2024 The physician (pediatrician) reported that, Kinrix was administered to a 4 year old patient.  On Sunday 24th March 2024 the physician received a call from the parents, and they mentioned that, at the injection site the patient had a large bruise that looked ready to blister.  The vaccine was administered on the anterior part of the left leg which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Impaired work ability
Clinical narrative: Guillain Barre syndrome; hands and feet numb and Tingling; hands and feet numb and tingling; feels like I'm walking on a sandy beach (every time I walk); legs and feet feel weird; no control of feet; Having a hard time being employed; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-NOV-2021, the patient received the 2nd dose of Shingrix. On 17-MAR-2022, 133 days after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced tingling feet/hands (Verbatim: hands and feet numb and Tingling), numbness of extremities (Verbatim: hands and feet numb and tingling), walking difficulty (Verbatim: feels like I'm walking on a sandy beach (every time I walk)), limb discomfort (Verbatim: legs and feet feel weird), lower extremities weakness of (Verbatim: no control of feet) and impaired work ability (Verbatim: Having a hard time being employed). The outcome of the guillain barre syndrome, tingling feet/hands, numbness of extremities, walking difficulty, limb discomfort and impaired work ability were not resolved and the outcome of the lower extremities weakness of was unknown.   It was unknown if the reporter considered the guillain barre syndrome, tingling feet/hands, numbness of extremities, walking difficulty, limb discomfort, lower extremities weakness of and impaired work ability to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome, tingling feet/hands, numbness of extremities, walking difficulty, limb discomfort, lower extremities weakness of and impaired work ability to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAR-2024 The patient reported that she received the Shingrix vaccine since then she has been to walk in clinic several times. She was diagnosed with Guillen Barre Syndrome and spent months in the hospital and 2 months in rehab. She stated that she felt like she walking on a sandy beach at all times. She stated her hands and feet are numb and tingling. She stated her legs and feet feel weird and has no control of her feet. She mentioned she was having a hard time being employed because of this. She wanted the information to the legal department so her attorney could contact GlaxoSmithKline. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Muscular weakness, Musculoskeletal disorder, Paraesthesia
Clinical narrative: Guillain Barre syndrome; hands and feet numb and Tingling; hands and feet numb and tingling; feels like I'm walking on a sandy beach (every time I walk); legs and feet feel weird; no control of feet; Having a hard time being employed; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-NOV-2021, the patient received the 2nd dose of Shingrix. On 17-MAR-2022, 133 days after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced tingling feet/hands (Verbatim: hands and feet numb and Tingling), numbness of extremities (Verbatim: hands and feet numb and tingling), walking difficulty (Verbatim: feels like I'm walking on a sandy beach (every time I walk)), limb discomfort (Verbatim: legs and feet feel weird), lower extremities weakness of (Verbatim: no control of feet) and impaired work ability (Verbatim: Having a hard time being employed). The outcome of the guillain barre syndrome, tingling feet/hands, numbness of extremities, walking difficulty, limb discomfort and impaired work ability were not resolved and the outcome of the lower extremities weakness of was unknown.   It was unknown if the reporter considered the guillain barre syndrome, tingling feet/hands, numbness of extremities, walking difficulty, limb discomfort, lower extremities weakness of and impaired work ability to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome, tingling feet/hands, numbness of extremities, walking difficulty, limb discomfort, lower extremities weakness of and impaired work ability to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAR-2024 The patient reported that she received the Shingrix vaccine since then she has been to walk in clinic several times. She was diagnosed with Guillen Barre Syndrome and spent months in the hospital and 2 months in rehab. She stated that she felt like she walking on a sandy beach at all times. She stated her hands and feet are numb and tingling. She stated her legs and feet feel weird and has no control of her feet. She mentioned she was having a hard time being employed because of this. She wanted the information to the legal department so her attorney could contact GlaxoSmithKline. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the administration for Shingrix after the recommended interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, the patient received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the administration for Shingrix after the recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 27-MAR-2024 An healthcare professional called in to request information about the administration for Shingrix after the recommended interval. The reporter requested to remain anonymous not providing information about the patient and ending the call abruptly. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25-MAR-2024) for prophylaxis.   On 01-APR-2024, the patient received Pediarix. On 01-APR-2024, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was 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: 01-APR-2024 A medical assistant reported that he/she had an expired Pediarix vaccine that was administered to a patient today which led to expired vaccine used. The vaccine administration facility was same as the primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient not received 2nd dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on September 2023 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 01-APR-2024 A reporter reported that a patient received 1st dose in September 2023 and would like 2nd dose, it was outside of recommended 2-4 months window.  The reporter wanted to know should she repeat entire 2 dose series. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Malaise, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat (grade 2); nasal congestion; rhinorrhea; malaise; fever (grade 1); Cough (nonproductive); This is a spontaneous report received from a Physician.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Mar2024 at 15:15 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024), described as "Cough (nonproductive)"; OROPHARYNGEAL PAIN (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024), described as "Sore throat (grade 2)"; PYREXIA (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024), described as "fever (grade 1)"; MALAISE (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024); NASAL CONGESTION (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024); RHINORRHOEA (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024), described as "rhinorrhea". Therapeutic measures were not taken as a result of oropharyngeal pain, nasal congestion, rhinorrhoea, malaise, pyrexia, cough.  Additional information: Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received other medications within 2 weeks of vaccination.   Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Sore throat (grade 2); nasal congestion; rhinorrhea; malaise; fever (grade 1); Cough (nonproductive); This is a spontaneous report received from a Physician.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Mar2024 at 15:15 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024), described as "Cough (nonproductive)"; OROPHARYNGEAL PAIN (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024), described as "Sore throat (grade 2)"; PYREXIA (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024), described as "fever (grade 1)"; MALAISE (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024); NASAL CONGESTION (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024); RHINORRHOEA (non-serious) with onset 01Apr2024 at 23:00, outcome "recovered" (Apr2024), described as "rhinorrhea". Therapeutic measures were not taken as a result of oropharyngeal pain, nasal congestion, rhinorrhoea, malaise, pyrexia, cough.  Additional information: Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received other medications within 2 weeks of vaccination.   Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had Covid in the past and now I got it again; had Covid in the past and now I got it again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 81-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: "had Covid in the past" (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 "had Covid in the past and now I got it again". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Patient trusted Pfizer and chose Pfizer and got the Pfizer vaccinations before. He had Covid in the past and now he got it again, he didn't know what happened. But, he trusted the medication. It was not known if the reporter considered event caused by suspect product.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 4.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; Administered after Temperature Excursion; This spontaneous report has been received from a nurse practitioner and refers to a 4-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 25-OCT-2023, the patient was vaccinated haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #X003664, expiration date: 10-NOV-2025, administered for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) after temperature excursion.  No additional adverse event (AE).
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: patient got Bexsero product but she intended to give Menveo; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number A2JX7, expiry date 31-OCT-2026) for prophylaxis.   On 25-MAR-2024, the patient received Bexsero. On 25-MAR-2024, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient got Bexsero product but she intended to give Menveo). The outcome of the wrong vaccine administered was 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: 28-MAR-2024 A physician reported that a patient got Bexsero product, but she intended to give Menveo which led to wrong vaccine administered.  No further details provided. The physician did not provide further details on the call, all information provided as given. Physician grants permission for safety to follow up as long as they do not send spam. The reporter consented to follow up.
Age: 64.0
Sex: F
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 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1 (toppac), single (Lot number: HG4629) at the age of 64 years, in left arm for covid-19 immunisation, Device Lot Number: HG4629. The patient's relevant medical history included: "CLL" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naprosyn, reaction(s): "known allergies: Naprosyn". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 21Mar2024 to 25Mar2024.  No follow-up attempts are possible.
Age: 63.0
Sex: F
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 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single (Unknown Manufacturer)), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single (Unknown Manufacturer)), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single (Unknown Manufacturer)), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single (Unknown Manufacturer)), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (Booster), Single (Unknown Manufacturer)), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: covid 19 treatment, treatment start date=24Mar2024, stop date=28Mar2024, indication=Treatment of COVID-19. Continuing to test positive for COVID 6 days after completing paxlovid. Mild cold symptoms. Known allergies: No.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 44-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Lot number: HD9876) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Meniere Disease" (unspecified if ongoing); "appendicitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4, (BOOSTER) SINGLE, Batch/Lot No: GJ2524), administration date: 07Oct2022, when the patient was 43-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3, (BOOSTER) SINGLE, Batch/Lot No: FP4554), administration date: 31Mar2022, when the patient was 42-year-old, for COVID-19 Immunization; moderna (DOSE 2, (BOOSTER) SINGLE, Batch/Lot No: 066F21A), administration date: 30Oct2021, when the patient was 42-year-old, for COVID-19 Immunization; janssen (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 08Apr2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "recovered" (26Mar2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Apr2024) faint line, notes: faint line after 15 minutes on 01Apr evening; (03Apr2024) solid black line, notes: solid black line after just 2 seconds on 03Apr morning. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 treatment: Brand: Paxlovid. Treatment start date: 25Mar2024. Treatment stop date: 30Mar2024. Lot Number: HG8680. Indication: Treatment of COVID-19. Adverse event: Covid rebound: Took Paxlovid from 25Mar afternoon until 30Mar morning. After being symptom free from 26Mar night until 02Apr morning (1 week), Known allergies: No. Other medical history: Meniere's Disease, appendicitis. Device timestamp: 03Apr2024.  No follow-up attempts are possible.
Sex: U
Vaccine: COVID19
Symptoms: Skin burning sensation, Skin discolouration
Clinical narrative: Has some skin discoloration, burning sometimes; Has some skin discoloration, burning sometimes; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious), SKIN BURNING SENSATION (non-serious), outcome "unknown" and all described as "Has some skin discoloration, burning sometimes".  Additional information: Patient has question about Pfizer shot he got about 3/4 years ago, the second shot. Patient reported, it was the second shot after the first shot, not the booster. Patient had some skin discoloration, burning sometimes. Wondering if that was part of the side effects of the shot, a possible reaction?  Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given a dose of COVID vaccine 2 weeks after receiving one. No symptoms noted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Extra dose administered, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Patient was completely vaccinated with Shingrix in 2020. System flagged she was due for a shingles shot. Third vaccine received of Shingrix. Patient symptoms on Day 1 included fever and nausea. Patient took Tylenol to help symptoms. On Day 2 post vaccination, she experienced swollen lymph nodes and Diarrhea
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Extra dose administered, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Patient was completely vaccinated with Shingrix in 2020. Pharmacy system flagged she was due for a shingles shot. Third vaccine received of Shingrix. Patient symptoms on Day 1 included fever and nausea. Patient took Tylenol to help symptoms. On Day 2 post vaccination, she experienced swollen lymph nodes and Diarrhea
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: patient came in to pharmacy 4/5/24 stating that she is picking up medications for arm soreness and stiffness that she believes she has had since her 2nd shingles vaccination on 3/15/24.  she has pain along shoulder and to scapula but not going further down back than scapula.  she said she has experienced tightness as well.  she states she had similar effects from a flu vaccination in the past but that date was unknown.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: patient came in to pharmacy 4/5/24 stating that she is picking up medications for arm soreness and stiffness that she believes she has had since her 2nd shingles vaccination on 3/15/24.  she has pain along shoulder and to scapula but not going further down back than scapula.  she said she has experienced tightness as well.  she states she had similar effects from a flu vaccination in the past but that date was unknown.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Decreased appetite, Dizziness, Headache, Irritability, Neck pain
Clinical narrative: headache, neck pain, dizziness, decreased appetite, fever, irritability
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: headache, neck pain, dizziness, decreased appetite, fever, irritability
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Rhinorrhoea, Sneezing
Clinical narrative: I have never had seasonal allergies. The day after my vaccine I began sneezing, uncontrollable runny nose, and cough.  In the hose, with an air purifier on, I?m better. Outside, especially near fields my symptoms are terrible. I am taking allergy meds, nasal sprays, sinus rinse, but nothing seems to help.
Age: 63.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Arthroscopic surgery, Dyspnoea, Laboratory test, Malaise, Meniscus removal
Clinical narrative: After the first Pfizer booster vaccine (after initial Janssen) 5-6 weeks a DVThrombosis developed (was not reported and home treated). After the second booster end of Oct 2023 possible COVID illness - COVID symptoms beginnning of Dec 2024 for 3 days. On 01/23/2024 an arthroscopic menisectomy was done and light shortness of breath noticed. After 2-3 weeks after (taking Aspirin daily) a PE (Pulmonary Embolism) developed and needed to be treated in a hospital. The build up of blood clotss and their moving into the lungs could be possibly connected to the vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: After the first Pfizer booster vaccine (after initial Janssen) 5-6 weeks a DVThrombosis developed (was not reported and home treated). After the second booster end of Oct 2023 possible COVID illness - COVID symptoms beginnning of Dec 2024 for 3 days. On 01/23/2024 an arthroscopic menisectomy was done and light shortness of breath noticed. After 2-3 weeks after (taking Aspirin daily) a PE (Pulmonary Embolism) developed and needed to be treated in a hospital. The build up of blood clotss and their moving into the lungs could be possibly connected to the vaccine.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: There were no other adverse events or symptoms reported; The HCP called to report that a patient was inadvertently administered an expired dose of MMR II. The MMR II expired on 12/16/2023 and was administered today on 04/03/2024. The dose was supported by the post expiry memo. There were no other adverse e; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 03-APR-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL (lot # u039909, expiration date: 16-DEC-2023, albumin status stablished as rHA) (route of administration, anatomical location not provided) as prophylaxis. It was reported that the dose was supported by the post expiry memo, and that there were no other adverse events or symptoms reported.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: There were no other adverse events or symptoms reported; The HCP called to report that a patient was inadvertently administered an expired dose of MMR II. The MMR II expired on 12/16/2023 and was administered today on 04/03/2024. The dose was supported by the post expiry memo. There were no other adverse e; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 03-APR-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL (lot # u039909, expiration date: 16-DEC-2023, albumin status stablished as rHA) (route of administration, anatomical location not provided) as prophylaxis. It was reported that the dose was supported by the post expiry memo, and that there were no other adverse events or symptoms reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller is a pharmacy student who reports expired MMR II administered to a patient. Product expired 1/7/2024 and was administered to a patient 3/6/2024. Diluent used to reconstitute the MMR II expired 1/30/2024.; This spontaneous report has been received from pharmacy student and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-MAR-2024, the patient was vaccinated with an expiry dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (recombinant Human albumin (rHA)) (M-M-R II) injection (strength, and route of administration were not provided), 0.5 milliliter, lot #W019428, expiration date reported as 07-JAN-2024, reconstituted with an expiry sterile diluent, lot # X004655, expiration date reported as 30-JAN-2024 administered for prophylaxis (Expired product administered). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA, MMRV, PNC20
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; Caller reports a second dose of PROQUAD was administered to a patient (2 years 6 months old) prior to the patient being 4 years of age; Caller also reports a third dose of VAQTA was administered to this same patient on 3/5/2024; second dose of VAQTA on 1/9/2024/ third dose of VAQTA was administered to this same patient on 3/5/2024; This spontaneous report was received from a medical assistant, referring to a 2-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.   On 19-SEP-2022, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), the first dose of hepatitis a vaccine, inactivated (VAQTA) (strengths, anatomical sites of vaccination routes of administration, lot numbers and expiration dates were not reported) as prophylaxis.  On 09-JAN-2024, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On 05-MAR-2024, the patient was vaccinated with the third dose of hepatitis a vaccine, inactivated (VAQTA), at a dose of 0.5 milliliter (ml) (strength, anatomical site of vaccination and route of administration were not reported; lot number X015939, expiration date was reported and validated as 05-DEC-2024), and the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 ml (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported), both therapies as prophylaxis (product administered to patient of inappropriate age, inappropriate schedule of product administration and extra dose administered).  A sterile diluent was used.  No additional adverse event (AE) was reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP calling to report T/E. HCP stated it was administered during T/E. T/E was supported. No additional AE reported. No PQC reported.   Names of vaccines involved (including lot/expiration): VARIVAX, X017484, 6/25/2025 Temperature:  -13C Time frame:; This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 02-APR-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X017484, expiration date: 25-JUN-2025 (strength, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion (TE) at -13 degrees Celsius (C) for 28 minutes. Previous TE were reported at -14.8 C during 30 minutes and -13 C for 45 minutes. No data logger was called and the TE was supported. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: She reported getting vaccinated with GARDASIL 9 and experienced syncope. She reported they had to give her smelling salts to keep her alert; Information has been received from a physician, referring on herself, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose description, lot #, expiry date, route of administration, and indication were not provided) as prophylaxis.  On an unspecified date, the patient experienced a syncope. She reported that they had to give her smelling salts to keep her alert. The patient stated that the physician was not concerned about the event at time of reporting.  At the time of reporting, the outcome of the event of syncope was unknown.  The causal relationship between the syncope and the vaccination with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the syncope was considered as a medically significant event.
Sex: U
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: Diabetes; This serious, initial spontaneous safety report from the country was received by Novavax on 29-MAR-2024 from a consumer, via the contact center.  A female of an unspecified age and race was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted 10 ug/mL suspect COVID-19 vaccine dose 1 and dose 2 on unspecified dates "in the beginning."  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual had diabetes (PT: Diabetes mellitus) (Serious: Medically Significant). The individual was trying to find out if she was eligible for an additional dose. No additional information was provided.  At the time of reporting, the event outcome of Diabetes mellitus was not recovered/not resolved.  Lot number was not provided in the report.; Sender's Comments: This female of an unspecified age experienced: Diabetes mellitus after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Diabetes mellitus was assessed as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event is considered Possible.
Age: 1.08
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally administered an expired dose of the act-hib with no reported ae; Initial information received on 02-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 months old and unknown gender patient who was accidentally administered an expired dose of the HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination; and Pneumococcal Vaccine 13v (Pneumococcal 13 Valent Vaccine) for Prophylactic vaccination.  On 01-Apr-2024, the patient received a dose of 0.6 ml of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) lot UJ833AA,Expiry date: 31-Mar-2024, strength was unknown via intramuscular route in the right thigh for Prophylactic vaccination (Immunization) and accidentally administered an expired dose of the act-hib with no reported adverse event (expired product administered) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received a double dose of vaccine with no reported adverse event; Initial information received on 02-Apr-2024 regarding an unsolicited valid  non-serious case received from a Non-Healthcare Professional.  This case involves a 4 years old male patient who received a double dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)], Measles, Mumps and Rubella Vaccine (Live), Hepatitis A Vaccine , Pneumococcal Vaccine CONJ 7V (CRM197) [Prevnar] and IVP with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received double dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (Suspension for injection) (lot, expiry date strength not reported) and patient also received Hepatitis A Vaccine produced by unknown manufacturer, Measles, Mumps and Rubella Vaccine (Live), Prevnar both not produced by Sanofi Pasteur and IPV (formulation, strength, expiry date, lot not reported for all) (extra dose administered) (latency: same day) with no reported adverse event all via unknown route in unknown administration site for prophylactic vaccination.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 doses of act-hib were administered after the expiration date with no reported adverse event; Initial information received on 02-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who was administered a dose of HIB (PRP/T) Vaccine [ACT-HIB] after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient had received (dose and units unknown) of suspect  HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ863AA; expiry date: 25-Mar-2024 via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: same day).  Reportedly, 2 doses of act-hib were administered after the expiration date with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired ACTHIB was administered to one patient with no reported adverse event; Initial information received on 03-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old unknown gender patient who was administered expired HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of expired HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) with no reported adverse event (expired product administered) (latency: same day) (lot number, strength not reported), (expiry: 31-Mar-2024) via unknown route in unknown administration site for Immunization.Information regarding batch number will be requested in this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given Expired Vaccine
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given expired vaccine
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given Expired vaccine
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired vaccine
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired vaccine
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired vaccine