chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: shingles; I got so sick my doctor told me not to take the second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles) and sickness (Verbatim: I got so sick my doctor told me not to take the second shot). The outcome of the shingles and sickness were not reported.   It was unknown if the reporter considered the shingles and sickness to be related to Shingles vaccine.   It was unknown if the company considered the shingles and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2024 This case was reported by a patient via interactive digital media. The patient had shingles but he/she got so sick so his/her doctor told that do not receive the second dose Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Sore arm; Inappropriate site of administration; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 07-JUN-2024, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 07-JUN-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Inappropriate site of administration). On an unknown date, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUN-2024 and 11-JUN-2024 The reporter reported that a healthcare professional administered a 2nd dose of Shingrix at the insistence of the patient in the buttocks, which led to vaccine administered at inappropriate site. The patient experienced a sore arm on the first injection. The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Administration of an expired dose; 5 year-old and this was the first Priorix dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received MMR (Priorix) (batch number 2AR75, expiry date 11-MAY-2024) for prophylaxis.   On 11-JUN-2024, the patient received the 1st dose of Priorix. On 11-JUN-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose) and inappropriate age at vaccine administration (Verbatim: 5 year-old and this was the first Priorix dose). The outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JUN-2024 The reporter reported that a 5-year-old patient was administered with expired dose of Priorix, which led to expired vaccine used and inappropriate age at vaccine administration. The nurse asked recommendations on this situation as well as safety data concerning the administration of an expired dose. The reporter reported that patient had never been vaccinated before with MMR.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not have a record of the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th May 2019).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not have a record of the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-JUN-2024 A pharmacist called in to request data about how to proceed after a patient received their first dose of Shingrix in 2019 but did not have a record of the second dose. They did not wish to provide the patients initials and did not know the expiration date or lot number. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170563:Same reporter US-GLAXOSMITHKLINE-US2021169814:Same reporter US-GSK-US2020086053:Same reporter US-GSK-US2019075235:Same reporter
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: patient received a dose of Priorix intradermally; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 4-year-old male patient who received MMR (Priorix) (batch number 9594A, expiry date 31-DEC-2024) for prophylaxis.   On 14-JUN-2024, the patient received Priorix (intradermal). On 14-JUN-2024, an unknown time after receiving Priorix, the patient experienced intramuscular formulation administered by other route (Verbatim: patient received a dose of Priorix intradermally). The outcome of the intramuscular formulation administered by other route 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: 17-JUN-2024 The pharmacist reported a patient received a dose of Priorix intradermally, which led to intramuscular formulation administered by other route. Consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site mass
Clinical narrative: Comirnaty was given subcutaneously and not intramuscularly; If you looked at it it would look like a lipoma, a little smaller than a jelly bean size; This is a spontaneous report received from a Nurse and a Pharmacist from medical information team.  A 77-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "recovered", described as "Comirnaty was given subcutaneously and not intramuscularly"; VACCINATION SITE MASS (non-serious), outcome "recovered", described as "If you looked at it it would look like a lipoma, a little smaller than a jelly bean size".  Causality for "comirnaty was given subcutaneously and not intramuscularly" and "if you looked at it it would look like a lipoma, a little smaller than a jelly bean size" was determined associated to device constituent of BNT162b2 omi xbb.1.5.  Additional information: Comirnaty for adults plastic syringe and that the product was not given intramuscularly but was given subcutaneously. The patient wanted to know if it is effective. The patient came on the line and the call recording disclaimer was provided. She was a nurse practitioner. She explained that Comirnaty was given subcutaneously and not intramuscularly. If you looked at it it would look like a lipoma, a little smaller than a jelly bean size, so it was evidence of a subcutaneous shot almost like a PPD shot. She rubbed on the subcutaneous area for it to absorb and it did, the lump went away and resolved. The pharmacist wanted to immediately give her another shot but she refused. She wanted any clinical information that would be able to assure the uptake of the vaccine and whether there is any injury to the tissue from having the shot in the area.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "allergies"; Percocet, reaction(s): "allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2024, outcome "recovered" (12Jun2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2024) positive; (12Jun2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received PAXLOVID as COVID-19 treatment from 06Jun2024 to 11Jun2024. After completing PAXLOVID dosages, the next day (12Jun2024) the patient tested negative and all symptoms were gone.   The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Feb2024 as dose number unknown, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Feb2024, outcome "recovered"; COVID-19 (medically significant) with onset Jun2024, 9 months 17 days after the suspect product(s) administration, outcome "recovered" (Jun2024); DRUG INEFFECTIVE (medically significant) with onset Jun2024, 9 months 17 days after the suspect product(s) administration, outcome "recovered" (Jun2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2024) Negative, notes: after 5 days of testing neg. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 07Jun2024 to 11Jun2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; Vaccination Failure; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Feb2024 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cisplatin, reaction(s): "Known allergies: Cisplatin". Vaccination history included: sarS-cov-2 vacc moderna us (Dose Number: 1, Batch/Lot No: 012L20A, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 21Jan2021, when the patient was 68-year-old, for COVID-19 immunization; sarS-cov-2 vacc moderna us (Dose Number: 2, Batch/Lot No: 023M20A, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 18Feb2021, when the patient was 68-year-old, for COVID-19 immunization; sarS-cov-2 vacc moderna us (Dose Number: 3, Batch/Lot No: 051F21A, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 13Nov2021, when the patient was 68-year-old, for COVID-19 immunization; sarS-cov-2 vacc moderna us (Dose Number: 4, Batch/Lot No: 058A22-2A, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 11Jun2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: GL2042, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 12May2023, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Jun2024, outcome "unknown", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset Jun2024, outcome "unknown", described as "Vaccination Failure ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2024) Positive; (10Jun2024) Negative; (Jun2024) Positive, notes: I began displaying symptoms for COVID on 14Jun2024 and tested positive again; (18Jun2024) Positive, notes: Today, 18Jun2024 I'm still positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: HPV9
Symptoms: Inability to afford medication, Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; patient missed her third dose of the GARDASIL 9 vaccine because she could not afford; patient missed her third dose of the GARDASIL 9 vaccine because she could not afford; This spontaneous report was received from a nurse and refers to a female patient of a not reported age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in October 2023, the patient was vaccinated with first dose of  with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, then, on an unknown date in November 2024, the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) both times at a dose of 0.5 milliliter for prophylaxis (strengths, lot #s, expiry dates, and routes of administration were not provided).  On an unknown date in 2024, the patient missed her third dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  vaccine because she could not afford it (Product dose omission issue, Inability to afford medication). No additional adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pain in extremity
Clinical narrative: Redness around the injection site; pain in arm; Sore to lift; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (on an unknown date received 1st dose and experienced arm pain, injection site erythema, reference case US2024AMR074469).   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 injection site erythema (Verbatim: Redness around the injection site), pain in arm (Verbatim: pain in arm) and mobility decreased (Verbatim: Sore to lift). Rechallenge with Shingrix was positive. The outcome of the injection site erythema and mobility decreased were not reported and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm and mobility decreased to be related to Shingrix.     It was unknown if the company considered the injection site erythema, pain in arm and mobility decreased to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR074469   Additional Information: GSK receipt date: 13-JUN-2024 This case was reported by patient itself. The patient reports significant pain in arm. She said it was very sore for a few days. The patient had redness around the injection site. The patient was still able to attend work, but she said the arm was very sore to lift. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2024AMR074469:Same patient
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Scheduling 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 short in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap).   On 08-DEC-2020, the patient received the 2nd dose of Shingrix. On 08-DEC-2020, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate Scheduling of Vaccine). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 17-JUN-2024 The caller stated he received dose 1 of Shingrix and dose 2 (3 weeks apart), which led to shortening of vaccination schedule. He stated his state vaccine registry did not show the second dose being given but he had 2 Shingrix lot with the paperwork that it was given.  He also got a TDAP vaccine.  No other information provided.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 51 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Aug2023, outcome "recovered" (Aug2023); DRUG INEFFECTIVE (medically significant) with onset Aug2023, outcome "recovered" (Aug2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Negative, notes: I tested negative every day before that; (Aug2023) Negative, notes: I tested negative after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 12Aug2023 to 16Aug2023.
Sex: F
Vaccine: RSV
Symptoms: Cerebrovascular accident, Delivery, Exposure during pregnancy
Clinical narrative: Stroke; This is a spontaneous report received from an Other HCP.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovering", described as "Stroke". Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: Nurse practitioner mentioned she currently has a patient under her care who is recovering from a stroke which she believes occurred 4 days after the pregnant patient delivered her child. She believes this patient may have received an Rsv vaccine during the pregnancy but was not certain. She said the stroke was severe and the patient was still not fully recovered. The reporter considered the scenario as non-serious.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event stroke with ABRYSVO can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: PNC20
Symptoms: Haematoma, Nausea, Oedema, Pain
Clinical narrative: edema; nausea; multiple hematomas on my legs; pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Apr2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OEDEMA (non-serious) with onset 2024, outcome "recovered" (2024), described as "edema"; HAEMATOMA (non-serious) with onset 2024, outcome "recovered" (2024), described as "multiple hematomas on my legs"; NAUSEA (non-serious) with onset 2024, outcome "recovered" (2024); PAIN (non-serious) with onset 2024, outcome "unknown".  Additional information: The patient received a Prevnar 20 vaccine and had an adverse reaction which lasted 10 weeks: edema, nausea, multiple hematomas on legs. The patient was in pain all that time and will likely be for weeks to come.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 62-year-old 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: "Covid-19" (unspecified if ongoing), notes: COVID-19 two times in the past, hospitalized and was on oxygen for 4 months; "scarring on lungs" (unspecified if ongoing), notes: from COVID-19. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization; Bnt162b2 (DOSE 2), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER)), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The clinical course was reported as follows: The patient reported this was their 3rd time having COVID, Have had 5 shots, all Pfizer shots and did not know why they kept getting it. Reported was already feeling it, it went straight to their lungs, the heaviness. It pretty much has ruined their life (as reported).
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Blood bilirubin, Chemokine test, Cold agglutinins, Coombs direct test
Clinical narrative: COVID vaccine (single dose of Pfizer vaccine)-induced ITP/refractory ITP; This is a literature report for the following literature source(s).  Introduction: Vaccine-induced de novo cases of immune thrombocytopenic purpura (ITP) after COVID-19 vaccination have been described in the literature, with severity thought to be directly correlated with vaccine potency in inducing an immunologic response in the patient. Most cases, however, were found to be benign and responsive to typical immunosuppressive therapies1. Here describe a case of refractory ITP first induced by the COVID-19 vaccine, as well as subsequent development of biopsy-proven secondary Hemophagocytic Lymphohistiocytosis (HLH). Case: 71-year-old female with a complex history of COVID vaccine (single dose of Pfizer vaccine)- induced ITP diagnosed in March 2021. In prior admissions, she was treated with steroids, romiplostim, vincristine and IVIG, and eventually started on rituximab. Her current admission was for syncope secondary to warm autoimmune hemolytic anemia with admission hemoglobin level of 4.7. Hemolysis was confirmed by reduced haptoglobin, indirect hyperbilirubinemia, anemia and negative cold agglutinins, positive DAT IgG antibodies. Initial treatment included IVIG, alternate day plasmapheresis and high dose steroids. Extensive infectious, autoimmune and malignancy work up was done and found to be negative. Slow improvement in hemoglobin was noted, but the case was complicated by severe refractory thrombocytopenia and hypofibrinogenemia. Hematology recommended a bone marrow biopsy, which demonstrated hemophagocytosis suggesting a diagnosis of secondary HLH thought to be secondary to an autoimmune process. Soluble CD25 (soluble IL-2 receptor alpha) was elevated and CXCL9 was negative. Currently, she is improving but remains inpatient, and is on mycophenolate with a slow steroid taper. Discussion and conclusion: This case illustrates an example of refractory ITP that is non-responsive to multiple lines of therapy with treatment ongoing as of this writing. Furthermore, the patient's course is complicated by warm autoimmune hemolytic anemia and biopsy-proven HLH secondary to a likely autoimmune etiology.; Sender's Comments: Based on the temporal relationship, the association between the event refractory thrombocytopenia with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Haptoglobin, Immune thrombocytopenia, Interleukin-2 receptor assay, Investigation
Clinical narrative: COVID vaccine (single dose of Pfizer vaccine)-induced ITP/refractory ITP; This is a literature report for the following literature source(s).  Introduction: Vaccine-induced de novo cases of immune thrombocytopenic purpura (ITP) after COVID-19 vaccination have been described in the literature, with severity thought to be directly correlated with vaccine potency in inducing an immunologic response in the patient. Most cases, however, were found to be benign and responsive to typical immunosuppressive therapies1. Here describe a case of refractory ITP first induced by the COVID-19 vaccine, as well as subsequent development of biopsy-proven secondary Hemophagocytic Lymphohistiocytosis (HLH). Case: 71-year-old female with a complex history of COVID vaccine (single dose of Pfizer vaccine)- induced ITP diagnosed in March 2021. In prior admissions, she was treated with steroids, romiplostim, vincristine and IVIG, and eventually started on rituximab. Her current admission was for syncope secondary to warm autoimmune hemolytic anemia with admission hemoglobin level of 4.7. Hemolysis was confirmed by reduced haptoglobin, indirect hyperbilirubinemia, anemia and negative cold agglutinins, positive DAT IgG antibodies. Initial treatment included IVIG, alternate day plasmapheresis and high dose steroids. Extensive infectious, autoimmune and malignancy work up was done and found to be negative. Slow improvement in hemoglobin was noted, but the case was complicated by severe refractory thrombocytopenia and hypofibrinogenemia. Hematology recommended a bone marrow biopsy, which demonstrated hemophagocytosis suggesting a diagnosis of secondary HLH thought to be secondary to an autoimmune process. Soluble CD25 (soluble IL-2 receptor alpha) was elevated and CXCL9 was negative. Currently, she is improving but remains inpatient, and is on mycophenolate with a slow steroid taper. Discussion and conclusion: This case illustrates an example of refractory ITP that is non-responsive to multiple lines of therapy with treatment ongoing as of this writing. Furthermore, the patient's course is complicated by warm autoimmune hemolytic anemia and biopsy-proven HLH secondary to a likely autoimmune etiology.; Sender's Comments: Based on the temporal relationship, the association between the event refractory thrombocytopenia with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: have all over body aches for about 12-24 hours; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US101837 (Novartis Pharmaceuticals Corporation).  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovering", described as "have all over body aches for about 12-24 hours". Additional information: patient had all over body aches for about 12-24 hours, almost like a Covid vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: ended up coming down with COVID about two years ago; ended up coming down with COVID about two years ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), on 29Mar2021 as dose 2, single (Lot number: ER8730) and on 02Oct2021 as dose 3 (booster), single (Lot number: FC3184) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "ended up coming down with COVID about two years ago".  Clinical course: As reported, "my wife and I both ended up coming down with COVID about two years ago (2022). We went right on the pax [Paxlovid]. You know, four days later-it tired me out-four days later, you know, we were healthy again. So we've been very good in terms of keeping up with our boosters. You know, as I say with my background and I understand epidemiology and I understand disease vectors and what and what. It's a no-brainer and the first time, you know, every time I hear from my local pharmacist. You know, we've got a new vaccine based in place. We're usually first in line to get it."  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400196461 Same patient, different vaccine doses and different event.;
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diabetes mellitus, Hypertension
Clinical narrative: diabetes; high blood pressure; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "itching with site injections" (unspecified if ongoing), notes: she got all vaccinations and had a problem with itching with site injections. The patient's concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High.  Clinical course: The patient reported that her last vaccination was 11Oct2023 for Pfizer vaccination and has no reaction to it.She also said that prior to that she got all vaccinations and had a problem with itching with site injections. She wanted to know where to find a local place that carried Pfizer vaccination and try to get vaccination there. Her Doctor suggested she get Pfizer because she has diabetes and high blood pressure after getting the Pfizer Covid-19 vaccine.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Granulomatous lymphadenitis, Investigation, Lymphadenopathy mediastinal, Pathology test
Clinical narrative: Granulomatous lymphadenitis; Mediastinal Lymphadenopathy after COVID-19 vaccine; This is a literature report for the following literature source(s).  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Melanoma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: GRANULOMATOUS LYMPHADENITIS (medically significant), 21 days after the suspect product(s) administration, outcome "unknown"; LYMPHADENOPATHY MEDIASTINAL (medically significant), 21 days after the suspect product(s) administration, outcome "unknown", described as "Mediastinal Lymphadenopathy after COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Lymph node site/size (mm): site: Mediastinal; size: 23mm; Pathology test: Granulomatous lymphadenitis. Therapeutic measures were taken as a result of granulomatous lymphadenitis, lymphadenopathy mediastinal including surgical excision.; Sender's Comments: As there is limited information in the case provided, the causal association between the events granulomatous lymphadenitis, lymphadenopathy mediastinal and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: Severe immune thrombocytopenic purpura after SARS-CoV-2 vaccine; This is a literature report for the following literature source(s).  A 24-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dysfunctional uterine bleeding" (ongoing), notes: Comorbidities; "asthma" (ongoing), notes: Comorbidities; "vitamin D deficiency" (ongoing), notes: Comorbidities. The patient's concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "Severe immune thrombocytopenic purpura after SARS-CoV-2 vaccine". The patient underwent the following laboratory tests and procedures: Platelet count: 1 x10 9/l, notes: lowest; 427 x10 9/l, notes: highest. Therapeutic measures were taken as a result of immune thrombocytopenia included Prednisone and IVIG. Treatment duration was 46 days, patient responded to IVIG. Therapy continued upon discharge.; Sender's Comments: Based on the temporal relationship, the association between the event immune thrombocytopenic purpura with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick in and out of er; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 OMI XBB.1.5), 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: ILLNESS (non-serious), outcome "unknown", described as "sick in and out of er". The events "sick in and out of er" required emergency room visit. Additional information: the patient stated that "You guys should be sending me and every other American who took your product a check in the mail for compensation for the reactions my body had after the shot. I was sick in and out of ER and every dr possible because of not knowing what was wrong until after the shots being the only common denominator."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: PENTACEL was mixed with a sterile diluent instead of the diluent that the PENTACEL comes with no reported adverse event; Initial information was received on 14-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient for whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was mixed with a sterile diluent instead of the diluent that the pentacel comes with no reported adverse event while receiving vaccine   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine and pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance) for Immunisation.  On 13-Jun-2024, 0.5 ml, total (dose 1) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UJ983AA, expiry date: unknown, Strength: standard) via intramuscular route in the right thigh for Immunisation and pentacel was mixed with a sterile diluent instead of the diluent that the pentacel comes with no reported adverse event (product preparation error) (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: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has itchiness, swelling, pain, redness at injection site that is still there 6 days after the vaccination. Patient is instructed to use hydrocortisone cream and contact doctor if it didn't get better.
Age: 72.0
Sex: F
Vaccine: MMRV
Symptoms: Eye pain, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: Headache, painful eyes to touch as well as eye movement back and forth, nausea, swollen glands in groin, on 4th day some little bumps on checks and face
Age: 72.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Headache, painful eyes to touch as well as eye movement back and forth, nausea, swollen glands in groin, on 4th day some little bumps on checks and face
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Joint range of motion decreased, Joint swelling
Clinical narrative: swelling and pain to right shoulder limiting range of motion, starting 16 days after vaccination
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Rash
Clinical narrative: between 5-10 minutes after vaccine administration, pt developed rash on bilateral thighs.  No trouble breathing. Pt referred to allergist for further evaluation and clearance for future vaccines.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Malaise, Syncope
Clinical narrative: Vasovagal syncope - patient reported feeling unwell a couple minutes after receiving vaccine. He fainted for a second before recovering. He did not fall or sustain other injuries. He reported sweating and chills that resolved about 10 minutes following the fainting episode.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Immunisation reaction, Visual impairment
Clinical narrative: PT SAID HE STARTED VISION PROBLEM ONE WEEK AFTER THE VACCINE. HE WENT TO THE DR AND THE DR TOLD HIM THIS IS THE SIDE EFFECT OF TETANUS VACCINE .
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hyperhidrosis, Nausea, Tremor, Vomiting
Clinical narrative: Donor reported tremors, nausea, headache, vomiting, diaphoresis 30 minutes following second dose. Applied cold compress to donor's chest and back, and provided water and crackers to help with symptoms. Donor still complains of nausea at this time. Took donor's temperature which was 97.8.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Discomfort, Immunisation reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Vaccine administered by pharmacist in left arm.  Discomfort and pain increased all week.  Visited my physician. He suspected cellulitis due to the vaccination.  Prescribed one week of antibiotics. Pain continued for several months and finally eased up. In May, the severe pain at the site of injection returned and the sharp pain went up my arm toward the shoulder.  I have severe pain and do not have total mobility of my left arm and shoulder,
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Pain
Clinical narrative: Vaccine administered by pharmacist in left arm.  Discomfort and pain increased all week.  Visited my physician. He suspected cellulitis due to the vaccination.  Prescribed one week of antibiotics. Pain continued for several months and finally eased up. In May, the severe pain at the site of injection returned and the sharp pain went up my arm toward the shoulder.  I have severe pain and do not have total mobility of my left arm and shoulder,
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Dizziness, Hepatitis, Vomiting
Clinical narrative: Diarrhea, dizziness, vomiting, liver inflammation
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Neck pain, Pain in extremity
Clinical narrative: My left arm started hurting worse than previous covid 19 shots while at work.  My left ear?s hearing was ?stuffy? feeling, like cotton was in it.  After I arrived at home my arm hurt up my left shoulder into my left side of my neck.  I put a LARGE ice pack on it and went to bed.  My stuffy ear got worse into the night that I looked up the Covid shot side effects on the webpage that told me to send in this form.  By 2ish am, my arm stopped hurting and I could remove the ice pack.  My hearing returned to normal by the time I got up for work, 4:30ish, May 23, 2024.  I did take 2 advil.  It did not help with the armNone pain, but the ice pack worked great.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD