chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 72-year-old male patient who received HAB (Twinrix adult) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix) and Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 04-JAN-2024, the patient received the 3rd dose of Twinrix adult. On 04-JAN-2024, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too short 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: 25-Jan-2024 The reporter reported that the patient inadvertently received an early third dose of Adult Twinrix vaccine.  The patient had the prior doses on schedule. The reporter wanted to know how to proceed and does the patient need another dose in a few months. The patient received 3rd dose of Twinrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was administered on 17-NOV-2021).   On 24-JAN-2024, the patient received the 2nd dose of Shingrix. On 24-JAN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-JAN-2024 Consumer was the reporter. The patient had her first dose of Shingrix on 17-NOV-2021 and the second dose administered on 24-JAN-2024. No further information was known. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 month old female received Kinrix; received Kinrix instead of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On 23-JAN-2024, the patient received Kinrix. On 23-JAN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 month old female received Kinrix) and wrong vaccine administered (Verbatim: received Kinrix instead of Pediarix). The outcome of the inappropriate age at vaccine administration and wrong vaccine 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: 25-JAN-2024 A nurse supervisor reported that a 4 month old female received Kinrix on 23 January 2024 instead of Pediarix which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up via mail.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: the use of Arexvy in pregnant; a patient who received the Arexvy vaccine, instead of Pfizer Abrysvo; the use of Arexvy in pregnant; mother gave birth to the baby; This non-serious retrospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. An unknown time after receiving Arexvy, the patient experienced live birth (Verbatim: mother gave birth to the baby). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: the use of Arexvy in pregnant), wrong vaccine administered (Verbatim: a patient who received the Arexvy vaccine, instead of Pfizer Abrysvo) and inappropriate age at vaccine administration (Verbatim: the use of Arexvy in pregnant). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered, inappropriate age at vaccine administration and live birth were unknown.   Pregnancy exposure: Estimated Delivery/Due date  Pregnancy Details (Neonate 1):  Pregnancy Outcome: Live neonate with no apparent congenital anomaly Delivery Notes: mother gave birth to the baby 3 months ago   Additional Information: GSK Receipt Date: 25-JAN-2024 A pediatric nurse called to ask for information regarding a patient who received the Arexvy vaccine, instead of Pfizer Abrysvo, while she was pregnant (exact date of administration was not provided) which led to vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration. The mother gave birth to the baby 3 months ago and the Healthcare professional asked for information regarding the use of Arexvy in pregnant women and how to proceed with the baby's immunization against RSV. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Impaired healing, Injection site discolouration, Injection site injury, Injection site necrosis, Injection site pain
Clinical narrative: necrotic wound at injection site; necrotic wound at injection; blue at injection site/black at injection site; injection site raised and sore; injection site raised and sore; This serious case was reported by a consumer via call center representative and described the occurrence of injection site necrosis in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ll942, expiry date 23-MAR-2025) for prophylaxis.   On 15-NOV-2023, the patient received the 1st dose of Arexvy (left arm). In NOV-2023, less than a week after receiving Arexvy, the patient experienced injection site swelling (Verbatim: injection site raised and sore) and injection site pain (Verbatim: injection site raised and sore). On 12-DEC-2023, the patient experienced injection site necrosis (Verbatim: necrotic wound at injection site) (serious criteria GSK medically significant) and injection site injury (Verbatim: necrotic wound at injection). In DEC-2023, the patient experienced injection site coloration (Verbatim: blue at injection site/black at injection site). The patient was treated with citalopram hydrobromide (Prisma). The outcome of the injection site necrosis and injection site injury were not resolved and the outcome of the injection site swelling, injection site pain and injection site coloration were unknown.   It was unknown if the reporter considered the injection site necrosis, injection site injury, injection site swelling, injection site pain and injection site coloration to be related to Arexvy.     It was unknown if the company considered the injection site necrosis, injection site injury, injection site swelling, injection site pain and injection site coloration to be related to Arexvy.   Additional Information: GSK receipt date:25-JAN-2024 The patient received Arexvy vaccine and approximately 4 days later the patient reported the left arm at injection site was raised and sore.  Less than a month after the vaccination, at thanksgiving the patient reported that the site of injection was turning blue.  On 4th December 2023, the patient was called his doctor and was told to take Benadryl and ice the site of injection.  On 11th December 2023 the consumer was examined by his doctor and the site of injection was black.  The doctor referred the consumer to the wound clinic.  On 12th December 2023 the wound clinic described the site of injection as necrotic. The site of injection was cleaned and dressed with Prisma.  The patient reported to wound care clinic once weekly for these dressings.  The wound was deep enough to see the muscle and the wound was healing but at a very slow pace. The patient reported that he did have pictures of the wound and was willing to provide those to GlaxoSmithKline.  The reporter Consented to follow up.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Injection site reaction, Injection site swelling, Wound, Wound necrosis, Wound treatment
Clinical narrative: necrotic wound at injection site; necrotic wound at injection; blue at injection site/black at injection site; injection site raised and sore; injection site raised and sore; This serious case was reported by a consumer via call center representative and described the occurrence of injection site necrosis in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ll942, expiry date 23-MAR-2025) for prophylaxis.   On 15-NOV-2023, the patient received the 1st dose of Arexvy (left arm). In NOV-2023, less than a week after receiving Arexvy, the patient experienced injection site swelling (Verbatim: injection site raised and sore) and injection site pain (Verbatim: injection site raised and sore). On 12-DEC-2023, the patient experienced injection site necrosis (Verbatim: necrotic wound at injection site) (serious criteria GSK medically significant) and injection site injury (Verbatim: necrotic wound at injection). In DEC-2023, the patient experienced injection site coloration (Verbatim: blue at injection site/black at injection site). The patient was treated with citalopram hydrobromide (Prisma). The outcome of the injection site necrosis and injection site injury were not resolved and the outcome of the injection site swelling, injection site pain and injection site coloration were unknown.   It was unknown if the reporter considered the injection site necrosis, injection site injury, injection site swelling, injection site pain and injection site coloration to be related to Arexvy.     It was unknown if the company considered the injection site necrosis, injection site injury, injection site swelling, injection site pain and injection site coloration to be related to Arexvy.   Additional Information: GSK receipt date:25-JAN-2024 The patient received Arexvy vaccine and approximately 4 days later the patient reported the left arm at injection site was raised and sore.  Less than a month after the vaccination, at thanksgiving the patient reported that the site of injection was turning blue.  On 4th December 2023, the patient was called his doctor and was told to take Benadryl and ice the site of injection.  On 11th December 2023 the consumer was examined by his doctor and the site of injection was black.  The doctor referred the consumer to the wound clinic.  On 12th December 2023 the wound clinic described the site of injection as necrotic. The site of injection was cleaned and dressed with Prisma.  The patient reported to wound care clinic once weekly for these dressings.  The wound was deep enough to see the muscle and the wound was healing but at a very slow pace. The patient reported that he did have pictures of the wound and was willing to provide those to GlaxoSmithKline.  The reporter Consented to follow up.
Age: 0.58
Sex: F
Vaccine: RV1, RV5
Symptoms: Incorrect product administration duration, Interchange of vaccine products
Clinical narrative: a patient received a dose of Rotarix after having received RotaTeq as the first dose of the series; Late dose 2 of series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 7-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number Y4NG3, expiry date 03-OCT-2025) for prophylaxis.   Co-suspect products included Rotavirus vaccine live reassort oral 5v (Rotateq) for prophylaxis.   On 24-JAN-2024, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On an unknown date, the patient received Rotateq. On 24-JAN-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced interchange of vaccine products (Verbatim: a patient received a dose of Rotarix after having received RotaTeq as the first dose of the series) and drug administration duration too long (Verbatim: Late dose 2 of series). The outcome of the interchange of vaccine products and drug administration duration too long 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: 25-JAN-2024 Pharmacy technician reported a patient received a dose of Rotarix after having received RotaTeq as the first dose of the series, which led to interchange of vaccine products. The second dose was late, per the reporter, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: patient received only the liquid CYW component of Menveo; patient received only the liquid CYW component of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 24-JAN-2024, the patient received Menveo. On 24-JAN-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid CYW component of Menveo) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid CYW component of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-JAN-2024 The reporter reported that the patient received only the liquid CYW component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 34YF7, expiry date 23-JAN-2023) for prophylaxis.   On 01-OCT-2021, the patient received Shingrix. On 01-OCT-2021, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-JAN-2024 A Pharmacist contacted inquiring about Shingrix and what information was available about the recommendations for the administration of Shingrix after the recommended time interval. Partial information about event, patient and product given. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 16.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received Twinrix first dose on 21-JUL-2023 and a Twinrix second dose on 18-SEP-2023; 17 year old patient received Twinrix first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old female patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On 18-SEP-2023, the patient received the 2nd dose of Twinrix. On 21-JUL-2023, the patient received the 1st dose of Twinrix. On 21-JUL-2023, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 17 year old patient received Twinrix first dose). On 18-SEP-2023, the patient experienced drug dose administration interval too long (Verbatim: patient received Twinrix first dose on 21-JUL-2023 and a Twinrix second dose on 18-SEP-2023). The outcome of the inappropriate age at vaccine administration and drug dose administration interval too long 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: 25-JAN-2024 The reporter stated that patient did not suffer any side effects besides the regular ones after a vaccine. The reporter consented to follow up. The patient received 1st dose of Twinrix below the recommended age schedule, which led to inappropriate age at vaccine administration. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: RSV
Symptoms: Cardiac failure congestive
Clinical narrative: congestive heart failure; This serious case was reported by a physician via call center representative and described the occurrence of congestive heart failure in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 2 weeks after receiving Arexvy, the patient experienced congestive heart failure (Verbatim: congestive heart failure) (serious criteria hospitalization and GSK medically significant). The outcome of the congestive heart failure was unknown.   It was unknown if the reporter considered the congestive heart failure to be related to Arexvy.     It was unknown if the company considered the congestive heart failure to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-JAN-2024 A GSK field representative stated that a reporter reported an adverse event for Arexvy. The reporter stated that the patient over the age of 65 years old was hospitalized 2 weeks after receiving the vaccine Arexvy for congestive heart failure (CHF). It was unknown if the patient had this as a previous condition or if it was for complications. It was unknown when the vaccine was administered and in which arm. Lot and expiration date were not provided. No additional information was provided. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient is schedule for a nurse visit this afternoon at 3:45 pm for the second Shingrix shot...We can call him to cancel his appointment if he does not need the Shingrix shot; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose on 11-DEC-2020).   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 patient is schedule for a nurse visit this afternoon at 3:45 pm for the second Shingrix shot...We can call him to cancel his appointment if he does not need the Shingrix shot). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 29-JAN-2024 The reporter received another dose of Shingrix in 2023, should he receive the second dose in 2023 or would the second dose in 2023 complete his Shingrix series. The reporter believed he forgot to get the second dose in 2020. The patient was schedule for a nurse visit this afternoon at 3:45 pm for the second Shingrix shot. They could call him to cancel his appointment if he did not need the Shingrix shot. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest
Clinical narrative: DROPPED DEAD AT ONE, WAS REVIVED AND THEN IN ICU FOR A WEEK; This solicited report received from a patient via PPSCVM000196: Janssen Account concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced dropped dead at one, was revived and then in icu for a week (Dose number in series 1). Neighbor dropped dead at one, was revived and then in ICU for a week with baffled doctors that had no idea what was wrong or how to treat it. Patient alive only by a miracle and  tried to look her up on vaers, but no one made a report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dropped dead at one, was revived and then in icu for a week was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and dropped dead at one, was revived and then in icu for a week as not related.  This report was serious (Hospitalization Caused).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-Cardio-respiratory arrest.The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Acquired immunodeficiency syndrome
Clinical narrative: JNJ'S VACCINE GAVE HIM AIDS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  The user claimed that JNJ's vaccine gave him AIDS (Acquired Immunodeficiency Syndrome)  (dose number in series 1) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of JNJ's vaccine gave him aids was not reported. This report was serious (Other Medically Important Condition).  This case, involving the same patient is linked to 20231269836 and 20231241429.; Sender's Comments: V0: Acquired immunodeficiency syndrome: The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with     the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective
Clinical narrative: LACK OF EFFECT; This spontaneous report received from a consumer Via another company concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: scallops and tuna allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported (dose number in series 1), administered on 30-MAR-2021 to Left Arm for covid-19 prophylaxis. The batch number was not reported. The company is unable to request the batch number. Non-company suspect vaccine included: tozinameran (intramuscular, batch number: 32030BD, batch number: FP7150, batch number: GJ5342, batch number: HD9876, form of admin was not reported) dose was not reported, administered on 21-DEC-2021 (dose number in series 2), (dose number in series 3) 29-JUL-2022, (dose number in series 4) 02-JAN-2023, and on 30-SEP-2023 (dose number in series 5) for prophylactic vaccination.  No concomitant medications were reported.  On 08-JAN-2024, the patient was treated with nirmatrelvir/ritonavir for covid-19 (lack of effect). The patient took 5 days of Paxlovid. Started feeling better on day 7. On Day 10, the patient started low grade temperature again and full head with headache and slight sore throat. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of lack of effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. The event has a compatible/suggestive temporal relationship, and is labeled. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: caught tinnitus which is a ringing in the ear; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of TINNITUS (caught tinnitus which is a ringing in the ear) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. In 2021, the patient experienced TINNITUS (caught tinnitus which is a ringing in the ear). At the time of the report, TINNITUS (caught tinnitus which is a ringing in the ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Pharyngeal swelling
Clinical narrative: swollen throat; swollen throat and glands and pain; She can't even touch her throat because of the pain; swollen throat and glands; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (swollen throat), PAIN (swollen throat and glands and pain), OROPHARYNGEAL PAIN (She can't even touch her throat because of the pain) and LYMPHADENOPATHY (swollen throat and glands) in a 56-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Thyroidectomy (thyroid removed in 2007) in 2007. Previously administered products included for Product used for unknown indication: Pfizer (Both vaccines seemed to give her the same side effects) in April 2022, Pfizer (Both vaccines seemed to give her the same side effects) in April 2022, Pfizer (Both vaccines seemed to give her the same side effects) in April 2022 and Pfizer (Both vaccines seemed to give her the same side effects) in April 2022. Past adverse reactions to the above products included Glands swollen with Pfizer; Pain with Pfizer; Throat pain with Pfizer; and Throat swelling with Pfizer. Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN for Arthritis.   On 26-Oct-2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2022, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced PHARYNGEAL SWELLING (swollen throat), PAIN (swollen throat and glands and pain), OROPHARYNGEAL PAIN (She can't even touch her throat because of the pain) and LYMPHADENOPATHY (swollen throat and glands). At the time of the report, PHARYNGEAL SWELLING (swollen throat), PAIN (swollen throat and glands and pain) and LYMPHADENOPATHY (swollen throat and glands) had not resolved and OROPHARYNGEAL PAIN (She can't even touch her throat because of the pain) outcome was unknown.            Patient at the reporting was 58 years old. It was reported that the side effects started couple of hours after the shot and were still ongoing. The pain was on and off. The swelling didn' t change but she had no problem swallowing food or taking medications. Patient saw HCP and did some tests and nothing was found. Her pharmacist told her also that it was normal for those side effects to occur. No treatment medication was reported.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: Syringe twists off; unable to use the vaccine; device broke; The initial case was missing the following minimum  criteria: product complaint only. Upon  receipt of follow-up information on 22Jan2024, this  case now contains all required information to be  considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HG1756, Expiration Date: May2025) for immunisation, Device Lot Number: HM9851, Device Expiration Date: Mar2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Syringe twists off; unable to use the vaccine; device broke".   Additional information: It was reported, "I am calling because there is a product quality concern because we have a, we using the vaccine, the Abrysvo and yesterday when I was mixing it to dispense it to a patient, the syringe twists off so I am unable to use the vaccine, so the device broke."   The reporter considered "syringe twists off; unable to use the vaccine; device broke" not related to rsv vaccine prot.subunit pref 2v. Causality for "syringe twists off; unable to use the vaccine; device broke" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: RSV
Symptoms: Product closure issue, Syringe issue
Clinical narrative: when trying to reconstitute Abrysvo the top part of it is defective and the diluent leaked out.; when trying to reconstitute Abrysvo the top part of it is defective and the diluent leaked out.; This is a spontaneous report received from a Pharmacist, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HR4390, Expiration Date: Feb2025), Device Lot Number: HA3218, Device Expiration Date: Mar2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "when trying to reconstitute Abrysvo the top part of it is defective and the diluent leaked out.".  Additional information: Pharmacist on the other line calling because caller mentioned when trying to reconstitute Abrysvo the top part of it is defective and the diluent leaked out. Caller wants to see if caller can get a replacement or credit.Full amount of diluent didn't go into the vial so caller didn't know if the vaccine was still able to be administered: Confirmed no patients involved with the Abrysvo that had the issue, that is why caller called, the full amount of diluent didn't go into the vial so caller didn't know if the vaccine was still able to be administered without the full amount of diluent.   Causality for "when trying to reconstitute abrysvo the top part of it is defective and the diluent leaked out." was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood test abnormal, Decreased appetite, Weight, Weight decreased
Clinical narrative: blood went down; started losing weight I lost 42 pounds; lost my appetite; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD TEST ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "blood went down"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "lost my appetite"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "started losing weight I lost 42 pounds". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was going to her doctor for a regular checkup and everything was fine and she started at the newdoctor in 2016 and then everything was pretty normal until. From 2016 to 2020, her blood was pretty stable not little up or down but in 2021, it started going down, all the different parts of her blood it went on down and then she started losing weight. She lost 42 pounds. She lost her appetite and seeming terrible. The only thing she can relate to vaccine to is it all started going downhill is when she took the Pfizer shot, 3 of them and the booster and all her blood things have been going down, down.   The information on the batch/lot number for BNT162b2, BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400023695 same patient/vaccine, different dose number/AE;
Age: 40.0
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 (patient herself).  A 40-year-old female patient (not pregnant) received BNT162B2 OMI XBB.1.5 (BNT162B2 OMI XBB.1.5), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillins" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE NUMBER 3), administration date: 27Nov2021, when the patient was 38-year-old, for Covid-19 Immunization; BNT162b2 (DOSE NUMBER 2), administration date: 24Apr2021, when the patient was 37-year-old, for Covid-19 Immunization; BNT162b2 (DOSE NUMBER 1), administration date: 03Apr2021, when the patient was 37-year-old, for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER 4), administration date: Sep2022, when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19 test: (unspecified date) Positive; (28Jan2024) Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, COVID-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID) starting from 18Jan2024.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 will be requested and submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Doses 1 to 5: Pfizer / BioNTech; dose 6: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 52 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FP2588) and as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9269) and on 02Mar2021 as dose 2, single (Lot number: EN6199) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Sep2023 at 16:00 as dose 6 (Lot number: AU3832B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Doses 1 to 5: Pfizer / BioNTech; dose 6: Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had Paxlovid for treatment of COVID-19, therapy started on 19Jan2024 and stopped on 23Jan2024.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Dysarthria, Mouth swelling, Pharyngeal swelling
Clinical narrative: swelling in mouth/throat resulting in difficulty to speak clearly.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: non-tender pink warm swelling of left deltoid
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Condition aggravated, Culture urine, Dysuria, Micturition urgency
Clinical narrative: I was diagnosed with covid bladder after having covid in July 2022.  I have been stable and asymptomatic since late August/early September 2023.  I got the updated vaccine and then a few days later, I got a terrible UTI that came on strong and fast.  I had blood in my urine, terrible burning, and urgency/frequency to urinate.  Even post antibiotic treatment, I am still slightly symptomatic, just as what occurred back in 2022 for many months.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Urinary tract infection
Clinical narrative: I was diagnosed with covid bladder after having covid in July 2022.  I have been stable and asymptomatic since late August/early September 2023.  I got the updated vaccine and then a few days later, I got a terrible UTI that came on strong and fast.  I had blood in my urine, terrible burning, and urgency/frequency to urinate.  Even post antibiotic treatment, I am still slightly symptomatic, just as what occurred back in 2022 for many months.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Behcet's syndrome, Blister, Enthesopathy, Gout
Clinical narrative: 5/31/23 presented with shoulder pain, given Triamcinolone Acetonide 40 mg.  presented 6/15/23 with podagra, 6/28/23 presented with Achilles enthesiopathy, 7/3/23, started getting rash that started as pustules, progressed to bullae, scabbed over, and had difficulty healing located on bilateral lower extremities, buttocks, scrotum and mouth ulcerations.  Further polyarthralgia developed.  Eval by rheumatology diagnosed with Behcet's disease.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Impaired healing, Mouth ulceration, Rash, Rash pustular, Scab
Clinical narrative: 5/31/23 presented with shoulder pain, given Triamcinolone Acetonide 40 mg.  presented 6/15/23 with podagra, 6/28/23 presented with Achilles enthesiopathy, 7/3/23, started getting rash that started as pustules, progressed to bullae, scabbed over, and had difficulty healing located on bilateral lower extremities, buttocks, scrotum and mouth ulcerations.  Further polyarthralgia developed.  Eval by rheumatology diagnosed with Behcet's disease.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Ear pain, Headache, Injection site reaction, Myalgia
Clinical narrative: It was the spikevax I had muscle pain headache joint pain fever vomit ear pain bad injection site reaction
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Vomiting
Clinical narrative: It was the spikevax I had muscle pain headache joint pain fever vomit ear pain bad injection site reaction
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Pain, Pyrexia
Clinical narrative: In addition to common adverse effects such as pain fever, the most serious effect was seriously swelling the top lip at least 10 times of normal size.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness
Age: 83.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: PROLONGED SORE ARM LASTING FROM 01/18/2024 TO AT LEAST 02/01/2024 (IF NOT LONGER). AS WELL A MINOR RASH APPEARING ON THE SHOULDER OF THE INJECTION SITE, RED AND PATCHY, NOT RAISED, APPROXIMATELY 6 SPOTS AROUND 2-4 INCHES APART AND APPROXIMATELY 1/4-1/2 INCH IN DIAMETER. ALL OCCURING ON THE RIGHT SIDE ONLY (AREXVY IMMUNIZATION SIDE).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Delayed site reaction, occurring over 24 hrs post injection. At around 1900, I noticed the site is red, warm to the touch, itchy, and noticeably swollen. Approx 3 in diameter.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Bell's palsy
Clinical narrative: 12/23/23. Was taken to the ED to rule out stroke. Diagnosed with Bells Palsy.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site mass, Injection site pruritus, Pain
Clinical narrative: On the 3rd week after injection the arm began to have constant burning shooting pain. Develope what looked like a bruise but more red in color. Had itching at site with sharp shooting burning pain, also developed a lump in the area. The situation is still ongoing. Placed on antibiotics, Prednisone, Gabapentin
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: On the 3rd week after injection the arm began to have constant burning shooting pain. Develope what looked like a bruise but more red in color. Had itching at site with sharp shooting burning pain, also developed a lump in the area. The situation is still ongoing. Placed on antibiotics, Prednisone, Gabapentin
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; MMR II that has exceeded expiry date has been administered to a patient. Product expired 1/7/2024 and was administered 1/19/2024. Product had not experienced any prior temperature excursions through date of administratio; This spontaneous report was received from licensed practical nurse (LPN) concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 19-JAN-2024, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) injection, lot number W019425 with expiration date 07-JAN-2024, administered as prophylaxis (dosage regimen, and route of administration was not reported) (Expired product administered). The vaccine had not experienced any prior temperature excursion through date of administration. No additional adverse event was reported (No adverse event).
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Cough, Immediate post-injection reaction
Clinical narrative: coughed immediately after; This spontaneous report was received from a Medical assistant, referring to a 4 months-old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided.  On 23-JAN-2024, the patient was vaccinated with a dose of rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) orally (2 ml, lot # 1965567, expiration date: 30-AUG-2024) for prophylaxis and the patient coughed immediately after and some fluid may have come out.  The reporter stated she was not sure if the fluid got into her eye or if she is "imagining things" (captured in MARRS: 2401USA014374); the reporter noted that she was experiencing no irritation or reaction, she was not sure if it was a true exposure.   The outcome of the cough was unknown and the causality between this event and the vaccination with rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA014374:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sore throat, runny nose, cough/Test Binax-Result Positive; Sore throat, runny nose, cough/Test Binax-Result Positive; This is a spontaneous report received from a Consumer or other non HCP.  A 26-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's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: FLUVACCIN taken for influenza immunisation, in Oct2023 as dose number unknown, single; DUPIXENT; SPIRIVA [TIOTROPIUM BROMIDE MONOHYDRATE]; TRETINOIN. The patient also took other concomitant therapy. Vaccination history included: Comirnaty (DOSE 1, SINGLE, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 immunisation; Comirnaty (DOSE 2, SINGLE, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2024, outcome "recovering" and all described as "Sore throat, runny nose, cough/Test Binax-Result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Mucinex, Advil, Zicam. Clinical course: other medications in two weeks: birth control.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.