chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL-punctured and unopened Max/Lowest Temp reached: 10.76F -13hrs 50minutes/ Max/Lowest Temp reached: 10.76F -13hrs 50minutes,with no reported adverse event; Initial information received on 30-Apr-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 years old male patient where reporter reported IPV (Vero) [IPOL] -punctured and unopened max/lowest temp reached: 10.76f -13hrs 50minutes/ max/lowest temp reached: 10.76f -13hrs 50minutes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Apr-2024, the patient received a dose of suspect IPV (VERO) Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: take another dose on 4/29 /24 and missed the dose with no reported adverse event; Initial information received on 01-May-2024 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves an unknown age female patient where she need to take another rabies (HDC) vaccine [Imovax Rabies] dose on 4/29 /24 and missed the dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Apr-2024, the patient received a dose 1 of suspect RABIES (HDC) VACCINE Powder and solvent for suspension for injection lot number not reported via unknown route in unknown administration site. On 29-Apr-2024 she also received a dose 2 of vaccine with an unknown batch number via unknown route in unknown administration site (strength, lot/batch number and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On 29-Apr-2024 patient need to take another dose and missed the dose with no reported adverse event (product dose omission issue) (latency- 3 days).  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: 12.0
Sex: U
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: off-label use as per local labelling due to patient receiving a second menacwy dose at age 12 rather than 13 with no reported ae; Initial information was received on 02-May-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 12 years old and unknown gender patient who experienced off-label use as per local labelling due to patient receiving a second meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] dose at age 12 rather than 13 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose (dose 2) of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot number, expiry date, strength: unknown) via unknown route in unknown administration site for Immunization and off-label use as per local labelling due to patient receiving a second menacwy dose at age 12 rather than 13 with no reported ae (off label use) (unknown latency).  Reportedly, The patient was given her first dose of meningococcal vaccine (Menactra or MENQUADFI) early, at age 9, because it was required for a sleep-away camp.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ACT-HIB has been administered to a patient after 32 days past its expiration date, with no reported adverse event; Initial information received on 02-May-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 1-year-old male patient and HIB (PRP/T) vaccine [ACT-HIB] has been administered to a patient after 32 days past its expiration date, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine and polio vaccine for Prophylactic vaccination.  On 26-Apr-2024, the patient received a dose 1 of 0.5 ml dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown) (lot: UJ862AA, expiry date: 20-Mar-2024) via intramuscular route in the right vastus lateralis for Immunization and act-hib has been administered to a patient after 32 days past its expiration date, with no reported adverse event (expired product administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered an expired dose of adacel to the patient with no reported adverse event; Initial information received on 02-May-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 27 years old female patient who was inadvertently administered an expired dose of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant vaccines.    On 02-May-2024, the patient received 0.5 ml total of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5988AA) (with an unknown strength, expiry date) via intramuscular route in the left deltoid for immunization.  On 02-May-2024, the patient was inadvertently administered an expired dose of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event (expired product administered) (latency: same day).  It was reported, Pharmacist is asking how to proceed as he just gave a 2-week expired ADACEL vaccine to a patient. Pharmacist did not have information on the patient's treating physician/healthcare provider.  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: 33.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Client reports that with first dose of Jynneos there was some redness and swelling that resolved without issues.  On the evening of the May 1 there was some redness and swelling about 2 cm in size at the injection site but when she woke the morning of May 2 her right upper arm was swollen and red from her armpit to her elbow.  On May 2 the client went to Urgent Care, where the provider stated it was an immune response to the vaccine and no treatment provided.  Once home from the Urgent Care the client outlined the redness with pen and by the evening the redness had extended another 2 inches from the outlined area.  Client called clinic, this nurse encouraged client to go to the ER for further evaluation.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Malaise
Clinical narrative: Resident received the COVID vaccine on 5/7/2024 in the morning. Resident complained of feeling generally unwell and soreness at the injection site on 5/8/2024 at approximately 12:00 p.m. Resident reports no other symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arteriosclerosis, Atrial fibrillation, Cardiac ablation, Catheterisation cardiac abnormal, Cerebellar artery thrombosis
Clinical narrative: Stroke, atrial fibrillation, atherosclerosis
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Stent placement
Clinical narrative: Stroke, atrial fibrillation, atherosclerosis
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Pain, Walking aid user, Wheelchair user
Clinical narrative: Pt called pharmacy 5/9/24 to report her adverse reaction to Shingrix 50mcg vaccine she received 6/9/2021. Stated 3 weeks after receiving vaccine she was hospitalized and diagnosed with Guillain-Barre syndrome. Since then, she has been in severe pain and uses a wheelchair/walker at times.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fall
Clinical narrative: Resident received COVID vaccine on 5/7/2024 in the morning. Resident had an unwitnessed fall on 5/8/2024 at approximately 10:00 p.m. Resident reported that his room was hot and attempted to turn on a fan. No obvious injuries and no other symptoms reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Platelet count increased
Clinical narrative: Pain in shoulder muscle that received vaccine, needing to take Advil to help alleviate and be able to do ADLs for that evening, and the next 2 days. Headache, low grade fever, tiredness, general feeling of being unwell. I took Advil for the two days mentioned, and the symptoms did resolve.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Pain in shoulder muscle that received vaccine, needing to take Advil to help alleviate and be able to do ADLs for that evening, and the next 2 days. Headache, low grade fever, tiredness, general feeling of being unwell. I took Advil for the two days mentioned, and the symptoms did resolve.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy
Clinical narrative: given outside recomendations for pregnancy during months september to january
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Deep vein thrombosis, Gait inability, Pain in extremity, Scan abnormal
Clinical narrative: Chronic deep vein thrombosis in left knee and calf. 3 1/2 months after the second dose I noticed a pain in my left calf that felt like a pulled muscle. About 3 weeks later I woke up and could no longer walk. I went to the ER and was diagnosed with DVT?s. Over the course of the next two years they have twirled a total of 3 times. I was just diagnosed in also of 2024 with chronic DVT?s and told I will have to take blood thinners for the rest of my life. My doctor also sent me to the hematologist to find out why I keep getting them and they told me that it was not hereditary, not genetic, and not a mutation and there was no reason why I keep getting them. I asked if the vaccine was the cause and the doctor told need he could not tell me that.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Chronic deep vein thrombosis in left knee and calf. 3 1/2 months after the second dose I noticed a pain in my left calf that felt like a pulled muscle. About 3 weeks later I woke up and could no longer walk. I went to the ER and was diagnosed with DVT?s. Over the course of the next two years they have twirled a total of 3 times. I was just diagnosed in also of 2024 with chronic DVT?s and told I will have to take blood thinners for the rest of my life. My doctor also sent me to the hematologist to find out why I keep getting them and they told me that it was not hereditary, not genetic, and not a mutation and there was no reason why I keep getting them. I asked if the vaccine was the cause and the doctor told need he could not tell me that.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Client received the vaccine too soon after her last dose -- She received it at 2 1/2 months instead of after 4 months from previous dose. Client tolerated the injection - no complaints afterwards. Nurse contacted Client to inform her as per MD instructions to look out for a more intense reaction from the vaccines - more sore in the arm than normal
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Resident received COVID vaccine on 5/7/2024 in the morning. On 5/9/2024 at approximately 11:00 a.m., resident complained of left upper extremity pain with movement and weakness. COVID vaccine given in left deltoid. No other symptoms at this time.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Blood glucose normal, Electrocardiogram, Fall, Hyporesponsive to stimuli, Hypotonia
Clinical narrative: HYPOTONIC-HYPORESPONSIVE EPISODE ~48H following vaccination; pt running on playground, unwitnessed fall, patient remembers going "limp" ; collapsed face first, not unconscious but hyporesponsive when teacher approached ; associated pallor ; happened twice back to back same day; EMT eval -- > MEDICAL CENTER ED evaluation
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pallor, Syncope
Clinical narrative: HYPOTONIC-HYPORESPONSIVE EPISODE ~48H following vaccination; pt running on playground, unwitnessed fall, patient remembers going "limp" ; collapsed face first, not unconscious but hyporesponsive when teacher approached ; associated pallor ; happened twice back to back same day; EMT eval -- > MEDICAL CENTER ED evaluation
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives developed over the trunk and extremities, Epipen given
Age: 14.0
Sex: M
Vaccine: RAB, TYP
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Immediately after administering both vaccines the patient suddenly became lightheaded and fainted.  Patient fell unconscious for about 30seconds and began to slide out of the chair. Patient was caught and put gently on a flat surface with feet elevated. Patient did not sustain any injuries and made a full recovery in about 10 minutes
Age: 1.0
Sex: F
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Vaxelis and Rotateq was given at 12 months old. No adverse events. No treatment. Excellent outcome.  Just wrong vaccines given.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Palpitations, Tinnitus
Clinical narrative: Tinnitus I?m left ear, throbbing heart beat and sharp pains, shortness of breath.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Wrong technique in product usage process
Clinical narrative: Certified immunizer was unable inject the content of vaccine due to training issues.  Same vaccine was reinjected with a new needle by another immunizer.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncopal episode 5-10 min after administration. Self-resolved. Clinically stable.
Age: 73.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; HCP called to report an additional dose of MMR II was inadvertently administered on 04/29/2024 to a 73-year-old patient six days after the first dose of the series which was administered on 04/23/2024.; HCP called to report an additional dose of MMR II was inadvertently administered on 04/29/2024 to a 73-year-old patient six days after the first dose of the series which was administered on 04/23/2024.; HCP called to report an additional dose of MMR II was inadvertently administered on 04/29/2024 to a 73-year-old patient six days after the first dose of the series which was administered on 04/23/2024.; This spontaneous report was received from a physician, referring to a 73-year-old patient of unknown gender.  The patient's concurrent conditions, medical history, concomitant therapies, and drug reactions/allergies were not reported.  On 23-APR-2024, the patient was vaccinated with the first dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). On 29-APR-2024, the patient was inadvertently administered with an additional dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (Inappropriate schedule of product administration, Extra dose administered). No side effects or symptoms were reported (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose of Heplisav-B, and Received Second Dose of Engerix B; Initial report received on 19-Apr-2024.  A nurse reported that a 59-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received ENGERIX-B as the second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 10-Nov-2023, the patient received the first dose of HEPLISAV-B (lot # 943011, expiration date 31-Oct-2025; NDC # not reported) intramuscularly in the left deltoid.   On 19-Jan-2024, 71 days after having been vaccinated with HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine ENGERIX-B (lot # 3X937, expiration date 07-Dec-2025, and NDC # 58160082143) intramuscularly in the left deltoid. No adverse side effects were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count, Platelet count decreased, Rheumatoid arthritis, Systemic lupus erythematosus
Clinical narrative: I got a shot of Novavax in October 2022. 2 months later, I had problems with my platelets; I got a shot of Novavax in October 2022. 2 months later, I had problems with my platelets. My low platelets are chronic.; ITP is a platelet issue; I have lupus and RA; I have lupus and RA. My hematologist it was too much protein and hit my lupus and took it out of remission.; I have lupus and RA; On 13-SEP-2023, a non-serious, initial spontaneous safety report was received from a consumer via the contact center.   This case was assessed as Invalid based on: Incomplete - No identifiable patient.  On 30-APR-2024 and 06-MAY-2024, additional information was received from a consumer via the contact center with the following information provided:  Patient details were reported: A female of unspecified age was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted in October 2022.   The following medical history was reported: Lupus, RA, and ITP.   No concomitant medications were reported.   On an unspecified date after vaccination, the patient experienced Immune thrombocytopenia (Other Medically Important Condition), Systemic lupus erythematosus (Other Medically Important Condition), Rheumatoid arthritis (Other Medically Important Condition), and Platelet count decreased. The patient was hospitalized for an unspecified duration, where she was given medicine for Lupus, steroids, IVIG treatment, and Nplate.   The patient added that on 18-JAN-2023, the platelets were 2,000 and should have been 150.   At the time of reporting, the event of Immune thrombocytopenia, Systemic lupus erythematosus, Rheumatoid arthritis, and Platelet count decreased was considered Not Recovered/Not Resolved/Ongoing.; Sender's Comments: This female of an unspecified age experienced Immune thrombocytopenia, Systemic lupus erythematosus, Rheumatoid arthritis, and Platelet count decreased after vaccination with Novavax COVID-19 Vaccine, Adjuvanted.  The event Immune thrombocytopenia, Systemic lupus erythematosus, Rheumatoid arthritis, and Platelet count decreased was reported as serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Immune thrombocytopenia, Systemic lupus erythematosus, Rheumatoid arthritis, and Platelet count decreased is considered Possible. Considering the current knowledge of the vaccine, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Immune thrombocytopenia, Systemic lupus erythematosus, Rheumatoid arthritis, and Platelet count decreased is considered Possible.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient got 2 doses of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2H3X4, expiry date 17-APR-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 29-SEP-2023 of batch number 7942h, expiry date 02-March-2025).   On 17-APR-2024, the patient received the 2nd dose of Arexvy. On 17-APR-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient got 2 doses of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date:30-APR-2024 The pharmacist reported that a patient got 2 doses of Arexvy which led to extra dose administered. No patient details were provided. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: she only gave the diluent to patient and did not mix with the powder; she only gave the diluent to patient and did not mix with the powder; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 29-APR-2024, the patient received Menveo. On 29-APR-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: she only gave the diluent to patient and did not mix with the powder) and inappropriate dose of vaccine administered (Verbatim: she only gave the diluent to patient and did not mix with the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-APR-2024 A nurse had an incident at the time of reporting with the 2 vial Menveo, she only gave the diluent to patient and did not mix with the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  Supervisor would do an incident report and patient was returning for the correct dose.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: They gave a 4 to 6 years old doses of Kinrix to a pair of twins 5 months old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2TP74, expiry date 10-JUN-2024) for prophylaxis.   On 29-APR-2024, the patient received Kinrix. On 29-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: They gave a 4 to 6 years old doses of Kinrix to a pair of twins 5 months old). The outcome of the inappropriate age at vaccine administration 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: 29-APR-2024 The reporter gave a 4 to 6 years old patient, doses of Kinrix , which led to inappropriate age at vaccine administration. The case had been linked to US2024054891, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024054891:Twin number 1
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Shingrix over a year ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Shingrix over a year ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-APR-2024 The second dose of Shingrix was not yet given as of time of call.  The patient records were not on file with pharmacy, so exact date of administration, lot, and expiration of administered dose were not available.  No further details were provided. The pharmacist consented to follow up from safety. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2024054898 , reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024054898:same reporter/ Different patient
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Underdose; a 15 month baby supposed to get DTAP (Infanrix) instead got boostrix; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   Previously administered products included DTaP vaccine (on unknown day received 1st dose), DTaP vaccine (on unknown day received 2nd dose) and DTaP vaccine (on unknown day received 3rd dose).   On 29-APR-2024, the patient received Boostrix. On 29-APR-2024, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: Underdose), wrong vaccine administered (Verbatim: a 15 month baby supposed to get DTAP (Infanrix) instead got boostrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the underdose, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 29-APR-2024 The Medical assistant reported a 15 month baby supposed to get DTAP (Infanrix) instead got boostrix today on  April 29th 2024, which led to underdose, wrong vaccine administered and inappropriate age at vaccine administration. The reporter asked if should another vaccine be administered.  3 DTAP series was over and this was supposed to be the 4th DTAP dose. The reporterconsented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling face
Clinical narrative: swelling around the face; Red spot on arm and back; This non-serious case was reported by a nurse and described the occurrence of facial swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced facial swelling (Verbatim: swelling around the face) and localized erythema (Verbatim: Red spot on arm and back). The outcome of the facial swelling and localized erythema were not reported.   It was unknown if the reporter considered the facial swelling and localized erythema to be related to Shingrix.     It was unknown if the company considered the facial swelling and localized erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-APR-2024 The nurse reported that, the patient had a reaction to the 1st dose of Shingrix. The patient had swelling around the face, red spots on arm and back.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: got one while pregnant (with no reported adverse event); Initial information received on 03-May-2024 regarding an unsolicited valid  non-serious case received from a Patient.  This case involves an unknown age female patient who was exposed to vaccine INFLUENZA VACCINE in context of got one while pregnant (with no reported adverse event). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was unknown. The reported got one while pregnant (with no reported adverse event) occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the pregnant patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, dose, form and expiry not reported) via unknown route in unknown administration site as immunization (with no reported adverse event) (exposure during pregnancy) (latency: same day).  It was reported "Can you tell me the supply of preservative free flu vaccines available in 2004? I worked at a pharma company; and got one while pregnant - don't recall if they found one without preservative and I didn't know then the risk or what I know now. Do you have any record of what was supplied to them or the general supply this year?"
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Blood test, Imaging procedure, Laboratory test, Pericarditis
Clinical narrative: Unresolved pericarditis, PMR, and other autoimmune disorders over last 3 years
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Unresolved pericarditis, PMR, and other autoimmune disorders over last 3 years
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: Reported Symptoms:  Narrative:  Patient received his 2023-2024 Spikevax formulation on 2/9/24. This was his 4th total dose. He called on 2/12/24 stating that he woke up on the morning on 2/11/24 with a large lump in his axillary region. He was advised that is was likely axillary lymphadenopathy and that it could potentially take months to subside. There was no mention of pain or irritation, and there was no further mention in any more recent notes. Other Relevant HX:  Other: LYMPHADENOPATHY
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Biopsy skin, Erythema, Mobility decreased, Skin warm
Clinical narrative: Patient described to pharmacist 1st time on 5/9/24  of the limited arm movement , redness, hotness of area roughly 4 inches by 4 inches. Adverse events gradually gotten worse since morning of 5/4/24.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenopia, Chills, Erythema, Eye pain
Clinical narrative: insomnia that night (~3hr broken sleep), headache, increased ear ringing, terrible muscle/joint/skin pain (could hardly tolerate sitting, standing, or lying down in any position), stiffness, mild redness/swelling of toes, tired eyes, chills, sore throat, ibuprofen did not help much, unable to nap, pain at injection site (not too bothersome in comparison to everything else); today the headache persists as does the injection-site pain, the over-all pains/stiffness have reduced a lot, my eyes are still tired/sore
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Middle insomnia, Musculoskeletal stiffness, Myalgia
Clinical narrative: insomnia that night (~3hr broken sleep), headache, increased ear ringing, terrible muscle/joint/skin pain (could hardly tolerate sitting, standing, or lying down in any position), stiffness, mild redness/swelling of toes, tired eyes, chills, sore throat, ibuprofen did not help much, unable to nap, pain at injection site (not too bothersome in comparison to everything else); today the headache persists as does the injection-site pain, the over-all pains/stiffness have reduced a lot, my eyes are still tired/sore
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain of skin, Peripheral swelling, Tinnitus
Clinical narrative: insomnia that night (~3hr broken sleep), headache, increased ear ringing, terrible muscle/joint/skin pain (could hardly tolerate sitting, standing, or lying down in any position), stiffness, mild redness/swelling of toes, tired eyes, chills, sore throat, ibuprofen did not help much, unable to nap, pain at injection site (not too bothersome in comparison to everything else); today the headache persists as does the injection-site pain, the over-all pains/stiffness have reduced a lot, my eyes are still tired/sore
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Injection site scar, Injection site urticaria, Skin disorder, Urticaria
Clinical narrative: Hive and welt at site of injection followed by persistent scar/skin change
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: After receiving the initial 2 Moderna Covid Vaccinations, I went in to have a booster vaccination on 11/23/2021. Shortly after this shot I began experiencing ringing in both ears. This continued for 3 months before I went to my doctor. I thought maybe it was just plugged ears or an ear infection. I sought medical attention. My doctor prescribed a course of antibiotics, decongestants, nasal sprays, and antihistimines. The tinnitus in my ears has continued non-stop to this day and I believe the Covid Vaccine was the cause of my tinnitus.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Ears started getting clogged in October of 2021.  Lasted for three to four months.  Would lessen up and come back once a month.  Ringing of ears would also appear periodically.  Now for last few months of 2024  it rings all day, everyday
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Colectomy, Infantile vomiting, Intestinal operation, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Five days after vaccine administration patient developed vomiting. She was seen one day later and admitted to Hospital. She was treated with antibiotics but continued having emesis. An ultrasound three days after admission revealed intussusception. This required surgery and a hemicolectomy was performed. She was discharged home after nine days in the hospital.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Vomiting
Clinical narrative: Five days after vaccine administration patient developed vomiting. She was seen one day later and admitted to Hospital. She was treated with antibiotics but continued having emesis. An ultrasound three days after admission revealed intussusception. This required surgery and a hemicolectomy was performed. She was discharged home after nine days in the hospital.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Haematemesis, Haematochezia, Occult blood, Urinary system X-ray
Clinical narrative: bloody spit up and stool
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pain in extremity, Rotator cuff syndrome, Sleep disorder
Clinical narrative: I had a sore arm and could not lie on it for several days. After the pain at the site decreased, I noticed a shoulder issue, where I couldn't lift my arm to the ceiling without pain. The orthopedic MD diagnosed me with a rotator cuff tear on the same side as the injection. I am an infection prevention RN and didn't put these two things together until hearing about others with this type of injury post-injection.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb
Clinical narrative: I had a sore arm and could not lie on it for several days. After the pain at the site decreased, I noticed a shoulder issue, where I couldn't lift my arm to the ceiling without pain. The orthopedic MD diagnosed me with a rotator cuff tear on the same side as the injection. I am an infection prevention RN and didn't put these two things together until hearing about others with this type of injury post-injection.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Hyperventilation, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Upon exiting office, patient began to feel lightheaded and dizzy. This even was not witnessed to me but it was communicated by (nurse) that patient was "stiff" and hyperventilating. She sat in a chair, and appeared to lose consciousness while still hyperventilating. Patient was brought into a room by wheeling the chair, placed on the table and SpO2 checked. 99% HR 74. Pt unresponsive at this time. Dr. came into room at that time and attempted sternal rub while calling to patient. Pt continued to hyperventilate, noted to be trembling slightly. Eyes closed, rolled upwards. No active convulsing. Supplemental O2 applied to pt face via mask. No response. Attempted to cover pt mouth and nose with bag as she continued hyperventilating with no response. EMS called approximately 10 minutes after start of episode.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Upon exiting office, patient began to feel lightheaded and dizzy. This even was not witnessed to me but it was communicated by (nurse) that patient was "stiff" and hyperventilating. She sat in a chair, and appeared to lose consciousness while still hyperventilating. Patient was brought into a room by wheeling the chair, placed on the table and SpO2 checked. 99% HR 74. Pt unresponsive at this time. Dr. came into room at that time and attempted sternal rub while calling to patient. Pt continued to hyperventilate, noted to be trembling slightly. Eyes closed, rolled upwards. No active convulsing. Supplemental O2 applied to pt face via mask. No response. Attempted to cover pt mouth and nose with bag as she continued hyperventilating with no response. EMS called approximately 10 minutes after start of episode.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Developed erythema and edema at the site of the vaccine that extended down the thigh. Area is very red and warm to touch. No itching or fever.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: Patient reports mild pain shortly after the injection. It became very severe about a day or two . As of 5/8 she reports the pain in her arm is still a constant level 3-4 and absolutely excruciating when she lifts her arm. Has a hard time sleeping  because she cannot tolerate the pain when she puts pressure on her shoulder.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC20
Symptoms: Expired product administered
Clinical narrative: ActHIB was expired vaccination
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Transient ischaemic attack
Clinical narrative: Woke up the next morning with symptoms of a stroke went to hospital and diagnosed with TIA. Stayed overnight and discharged in the morning.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 13cm area of swelling and erythema on left arm
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: erythematous, itching , and lump at site of injection on left thigh,  RX diphenhydramine 12.5mg/ 5ml oral take 8ml PO every 4-6 hours as needed, RX hydrocortisone 2.5% topical cream  apply 2 times every day a thin layer to affected area. to return on 5/11/2024 for re evaluation  if needed.  massage, heat, no pain meds unless fever above 102, fluids,
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Impaired healing
Clinical narrative: Hospitalized 12/12/22-12/15/22 Non-healing wound, cellulitis,
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Hypoxia, Pneumonia
Clinical narrative: Hospitalized 12/20/22-12/25/22 SOB, lightheaded, chest pain, PE, hypoxia, PNA,
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Alice in wonderland syndrome, Allodynia, Anxiety
Clinical narrative: Chronic migraines with aura, intractable, with status migrainosus (in constant pain since 11/2021 with no reprieve), full body neuropathy with numbness, hallucinations of all five senses (labeled schizoaffective), paranoia (feelings of doom), anxiety/panic attacks and depression with suicidal thoughts, minimal strength in my legs, increased pain from standing still, walking, bending, crouching, reaching, looking up or down, increased heartrate, sensitive to hot temperatures, and certain posture positions. I have a multitude of triggers to my migraines. There are no definitive causes or patterns to my migraines.  Tested for all possible medical causes through imagining and bloodwork. I am unable to work in any compacity due to my symptoms and triggers.  SYMPTOMS: Aching limbs, abdominal pain, Alice in Wonderland Syndrome, allodynia, Anxiety/panic attacks, Anxiousness/depression, auras, blurry vision, body chills/sweating, brain fog/cognitive issues, chest pressure/pain, confusion, constipation, diarrhea, dilated pupil(s), difficulty sleeping/insomnia, dizziness/lightheadedness, ear pain, ear pressure/fullness, excessive urination, excessive yawning, experience strange tastes or smells, facial drooping, fever, flushed face, frequent hiccups, gastro-intestinal discomfort/pain, Hallucinations (visual, auditory, tactile, smell, and taste), heartburn/GERD, increased pain when bending over or reaching above head, increased thirst, lack of appetite, loss of balance/coordination/unsteadiness, loss of consciousness, language difficulties (speaking/mixing words/remembering words), memory/naming problems, mood changes/irritability, muscle/motor weakness, nausea, neck pain/stiffness, neuropathy (idiopathic radiculopathy, bilateral carpel tunnel syndrome, ulnar nerve compression left elbow, bilateral S1 and S2 nerve root lesion, bilateral peroneal neuropathy, intercoastal neuropathy, trigeminal neuropathy, and nerve damage in both feet), numbness/tingling in head, hands, and feet, ocular pain, pale skin, pins-and-needles sensation, puffy eyelids, scalp tenderness, sensitivities to food, light, sound, movement, smell, touch, and visual stimuli, sinus pain/pressure, slurred or difficulty speaking, specific food cravings, TMJ/jaw muscle pain, tooth pain, unable to write, uncontrollable shaking/tremors, vertigo, vomiting, and watery eyes.   PAIN: Burning, cranial pressure, dull ache/soreness, gnawing cramp like, lightning strike, needle or icepick, piercing/stabbing, radiating, and throbbing/pulsating.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Asthenia, Aura, Balance disorder, Blood test
Clinical narrative: Chronic migraines with aura, intractable, with status migrainosus (in constant pain since 11/2021 with no reprieve), full body neuropathy with numbness, hallucinations of all five senses (labeled schizoaffective), paranoia (feelings of doom), anxiety/panic attacks and depression with suicidal thoughts, minimal strength in my legs, increased pain from standing still, walking, bending, crouching, reaching, looking up or down, increased heartrate, sensitive to hot temperatures, and certain posture positions. I have a multitude of triggers to my migraines. There are no definitive causes or patterns to my migraines.  Tested for all possible medical causes through imagining and bloodwork. I am unable to work in any compacity due to my symptoms and triggers.  SYMPTOMS: Aching limbs, abdominal pain, Alice in Wonderland Syndrome, allodynia, Anxiety/panic attacks, Anxiousness/depression, auras, blurry vision, body chills/sweating, brain fog/cognitive issues, chest pressure/pain, confusion, constipation, diarrhea, dilated pupil(s), difficulty sleeping/insomnia, dizziness/lightheadedness, ear pain, ear pressure/fullness, excessive urination, excessive yawning, experience strange tastes or smells, facial drooping, fever, flushed face, frequent hiccups, gastro-intestinal discomfort/pain, Hallucinations (visual, auditory, tactile, smell, and taste), heartburn/GERD, increased pain when bending over or reaching above head, increased thirst, lack of appetite, loss of balance/coordination/unsteadiness, loss of consciousness, language difficulties (speaking/mixing words/remembering words), memory/naming problems, mood changes/irritability, muscle/motor weakness, nausea, neck pain/stiffness, neuropathy (idiopathic radiculopathy, bilateral carpel tunnel syndrome, ulnar nerve compression left elbow, bilateral S1 and S2 nerve root lesion, bilateral peroneal neuropathy, intercoastal neuropathy, trigeminal neuropathy, and nerve damage in both feet), numbness/tingling in head, hands, and feet, ocular pain, pale skin, pins-and-needles sensation, puffy eyelids, scalp tenderness, sensitivities to food, light, sound, movement, smell, touch, and visual stimuli, sinus pain/pressure, slurred or difficulty speaking, specific food cravings, TMJ/jaw muscle pain, tooth pain, unable to write, uncontrollable shaking/tremors, vertigo, vomiting, and watery eyes.   PAIN: Burning, cranial pressure, dull ache/soreness, gnawing cramp like, lightning strike, needle or icepick, piercing/stabbing, radiating, and throbbing/pulsating.