chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Pericarditis, Pleural effusion, Pulmonary mass, Pyrexia, Rash
Clinical narrative: DAY 1 ? 08/17/2022 Patient had an appointment with her pediatrician for recent weight loss and intermittent fever/joint pain. She had multiple labs drawn on this day. She received the HPV vaccine in the left arm. She received a Meningococcal B OMV and MCV4O/MCV4P vaccine in the right arm.  Within 2-3 hours after the vaccines were administered, she developed a half-dollar sized, flat, reddened area at the HPV vaccination site. Within 6 hours of the vaccinations, she developed a fever of 102+, body aches, and headache.   DAY 2 ? 08/18/202 Patient continued to have high fever, body aches, and headache. She developed chest discomfort, a dry cough, and weakness.  The reddened area at the HPV vaccine site had spread to the upper left arm (from shoulder to elbow) and had changed to numerous, slightly raised, non-itchy, non-painful areas of redness. Her pediatrician was notified, and we were advised that her labs from 08/17/2022 were abnormal and were instructed to have her evaluated at the Emergency Room.  She was discharged from ED visit #1 with instructions for close monitoring.  DAY 3 ? 08/19/2022 Patient continued to have high fever, body aches, headache, dry cough, and weakness.  Her chest discomfort progressed to sharp chest pain, and she developed rapid heart rate, rapid breathing, nausea, and abdominal pain. Her rash remained unchanged. Her pediatrician was notified and again we were instructed to have her evaluated at the Emergency Room.  Due to her symptoms and our location, she was evaluated at the closest facility, the Emergency Room. She was transferred to Emergency Department for further evaluation.  She was discharged from ED visit #2 with instructions for close monitoring, to establish new patient care with Rheumatology, and to follow-up with pediatrician.  DAY 3 ? 08/2022 Within 6 hours of discharge from Emergency Department, Patient woke up suddenly with severe shortness of breath and pale/clammy skin. She continued to have chest pain, tachycardia, rapid breathing, high fever, body aches, headache, dry cough, weakness, abdominal pain, and nausea. She was evaluated and treated at a local ED, Hospital. She was transferred to Hospital for low oxygen levels, abnormal labs, ground glass opacities in lungs, fluid overload, and a pulmonary mass. She was admitted to Hospital and was also diagnosed with hepatosplenomegaly, bilateral pleural effusions, pericarditis, and thyroiditis.  She was oxygen dependent for 5 days. She underwent a left-side pleurocentesis and had multiple abnormal labs. She remained hospitalized until 09/02/2023.  Since this hospitalization, she as been hospitalized twice. Both of those hospitalizations were in February 2023. Due to this issue and the continued sequalae, Patient is not able to attend school. She has had numerous follow-ups with multiple physicians. She will continue to have follow-ups until they can determine the cause of this issue and see if there is any ongoing and long-term damage.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Respiratory rate increased, Sleep disorder, Tachycardia, Thyroiditis, Vaccination site erythema
Clinical narrative: DAY 1 ? 08/17/2022 Patient had an appointment with her pediatrician for recent weight loss and intermittent fever/joint pain. She had multiple labs drawn on this day. She received the HPV vaccine in the left arm. She received a Meningococcal B OMV and MCV4O/MCV4P vaccine in the right arm.  Within 2-3 hours after the vaccines were administered, she developed a half-dollar sized, flat, reddened area at the HPV vaccination site. Within 6 hours of the vaccinations, she developed a fever of 102+, body aches, and headache.   DAY 2 ? 08/18/202 Patient continued to have high fever, body aches, and headache. She developed chest discomfort, a dry cough, and weakness.  The reddened area at the HPV vaccine site had spread to the upper left arm (from shoulder to elbow) and had changed to numerous, slightly raised, non-itchy, non-painful areas of redness. Her pediatrician was notified, and we were advised that her labs from 08/17/2022 were abnormal and were instructed to have her evaluated at the Emergency Room.  She was discharged from ED visit #1 with instructions for close monitoring.  DAY 3 ? 08/19/2022 Patient continued to have high fever, body aches, headache, dry cough, and weakness.  Her chest discomfort progressed to sharp chest pain, and she developed rapid heart rate, rapid breathing, nausea, and abdominal pain. Her rash remained unchanged. Her pediatrician was notified and again we were instructed to have her evaluated at the Emergency Room.  Due to her symptoms and our location, she was evaluated at the closest facility, the Emergency Room. She was transferred to Emergency Department for further evaluation.  She was discharged from ED visit #2 with instructions for close monitoring, to establish new patient care with Rheumatology, and to follow-up with pediatrician.  DAY 3 ? 08/2022 Within 6 hours of discharge from Emergency Department, Patient woke up suddenly with severe shortness of breath and pale/clammy skin. She continued to have chest pain, tachycardia, rapid breathing, high fever, body aches, headache, dry cough, weakness, abdominal pain, and nausea. She was evaluated and treated at a local ED, Hospital. She was transferred to Hospital for low oxygen levels, abnormal labs, ground glass opacities in lungs, fluid overload, and a pulmonary mass. She was admitted to Hospital and was also diagnosed with hepatosplenomegaly, bilateral pleural effusions, pericarditis, and thyroiditis.  She was oxygen dependent for 5 days. She underwent a left-side pleurocentesis and had multiple abnormal labs. She remained hospitalized until 09/02/2023.  Since this hospitalization, she as been hospitalized twice. Both of those hospitalizations were in February 2023. Due to this issue and the continued sequalae, Patient is not able to attend school. She has had numerous follow-ups with multiple physicians. She will continue to have follow-ups until they can determine the cause of this issue and see if there is any ongoing and long-term damage.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site swelling, Weight decreased
Clinical narrative: DAY 1 ? 08/17/2022 Patient had an appointment with her pediatrician for recent weight loss and intermittent fever/joint pain. She had multiple labs drawn on this day. She received the HPV vaccine in the left arm. She received a Meningococcal B OMV and MCV4O/MCV4P vaccine in the right arm.  Within 2-3 hours after the vaccines were administered, she developed a half-dollar sized, flat, reddened area at the HPV vaccination site. Within 6 hours of the vaccinations, she developed a fever of 102+, body aches, and headache.   DAY 2 ? 08/18/202 Patient continued to have high fever, body aches, and headache. She developed chest discomfort, a dry cough, and weakness.  The reddened area at the HPV vaccine site had spread to the upper left arm (from shoulder to elbow) and had changed to numerous, slightly raised, non-itchy, non-painful areas of redness. Her pediatrician was notified, and we were advised that her labs from 08/17/2022 were abnormal and were instructed to have her evaluated at the Emergency Room.  She was discharged from ED visit #1 with instructions for close monitoring.  DAY 3 ? 08/19/2022 Patient continued to have high fever, body aches, headache, dry cough, and weakness.  Her chest discomfort progressed to sharp chest pain, and she developed rapid heart rate, rapid breathing, nausea, and abdominal pain. Her rash remained unchanged. Her pediatrician was notified and again we were instructed to have her evaluated at the Emergency Room.  Due to her symptoms and our location, she was evaluated at the closest facility, the Emergency Room. She was transferred to Emergency Department for further evaluation.  She was discharged from ED visit #2 with instructions for close monitoring, to establish new patient care with Rheumatology, and to follow-up with pediatrician.  DAY 3 ? 08/2022 Within 6 hours of discharge from Emergency Department, Patient woke up suddenly with severe shortness of breath and pale/clammy skin. She continued to have chest pain, tachycardia, rapid breathing, high fever, body aches, headache, dry cough, weakness, abdominal pain, and nausea. She was evaluated and treated at a local ED, Hospital. She was transferred to Hospital for low oxygen levels, abnormal labs, ground glass opacities in lungs, fluid overload, and a pulmonary mass. She was admitted to Hospital and was also diagnosed with hepatosplenomegaly, bilateral pleural effusions, pericarditis, and thyroiditis.  She was oxygen dependent for 5 days. She underwent a left-side pleurocentesis and had multiple abnormal labs. She remained hospitalized until 09/02/2023.  Since this hospitalization, she as been hospitalized twice. Both of those hospitalizations were in February 2023. Due to this issue and the continued sequalae, Patient is not able to attend school. She has had numerous follow-ups with multiple physicians. She will continue to have follow-ups until they can determine the cause of this issue and see if there is any ongoing and long-term damage.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Laboratory test, Magnetic resonance imaging
Clinical narrative: Also Flu SHot.. Stroke
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Injection site pain, Migraine, Photopsia, Vitreous floaters
Clinical narrative: Severe pain at injection site, Light flashes in left eye, Migraine Headache, Floaters in left eye
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Hot raises redness, swelling, itchiness, soreness
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was punctured 1st on 4/19/23 at 10:40AM and beyond the recommended stability duration.
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Bursitis, Magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: Patient states she had increasing aching and pain with movement in arm/shoulder for 7-10 days. She went to healthcare provider to receive steroid injection on 11/3/22. She said it helped for 4 months. She received a second steroid injection  in early March. She did not get relief.  Last week she got an MRI. She states she has bursitis and rotator cuff injury.
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Rotator cuff syndrome
Clinical narrative: Patient states she had increasing aching and pain with movement in arm/shoulder for 7-10 days. She went to healthcare provider to receive steroid injection on 11/3/22. She said it helped for 4 months. She received a second steroid injection  in early March. She did not get relief.  Last week she got an MRI. She states she has bursitis and rotator cuff injury.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Polycystic ovaries
Clinical narrative: Over the years after the shot I have a diagnosis of pcos and others
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Pt is 35 weeks pregnant and on 4/20/23 came in for her 1st updated Bivalent booster. The vaccine of 0.5ml was given of lot #011H22A that expires on 5/23/23.  The bottle had puncture date of 4/19/23 at 10:40am.  We contacted the pt on error and notified Moderna for further update.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Patient was intended to receive COVID Bivalent Booster and instead received Prevnar 20 vaccine. Patient was able to receive Covid booster once error recognized.  Lot number, dose, site, route, manufacturer and lot number for Prevnar 20 is not available.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None COVID 19 EXPIRED 2/8/2023 GIVEN 3/3/2023
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Axillary pain, Diarrhoea, Fatigue, Oedema peripheral
Clinical narrative: Pain and swelling by vaccine site, swelling and pain in underarm.  Pain to the touch and when i move it. Body aches, stomachache, diarrhea and very tired.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Tenderness, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain and swelling by vaccine site, swelling and pain in underarm.  Pain to the touch and when i move it. Body aches, stomachache, diarrhea and very tired.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: none covid 19 vaccine expires 2/8/2023 given 2/27/2023
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Death, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid on     10-1-22  had cough                       , deceased on    12-7-22                        .  Given paxlovid at residential facility
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: NONE
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram head normal, Confusional state, Facial paralysis, Fall
Clinical narrative: Facial paralysis on left side as well as left side weakness and inability to feel left side (arm, leg, foot).   Balance and falling due to left side weekness, confusion, severe headache.  Possible Guillain Syndrome per neurologist.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hemiparesis, Hypoaesthesia
Clinical narrative: Facial paralysis on left side as well as left side weakness and inability to feel left side (arm, leg, foot).   Balance and falling due to left side weekness, confusion, severe headache.  Possible Guillain Syndrome per neurologist.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Death, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: to er due to altered mental status and acute on chronic subdural hematoma .  tested + for covid.  12-6-22    was placed on nonheroic measures and comfort care and hospice and deceased on 12-13-22 at in patient hospice medical center  Presented to the er initiallly with altered mental status
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Subdural haematoma
Clinical narrative: to er due to altered mental status and acute on chronic subdural hematoma .  tested + for covid.  12-6-22    was placed on nonheroic measures and comfort care and hospice and deceased on 12-13-22 at in patient hospice medical center  Presented to the er initiallly with altered mental status
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; Blood sugar went high and she believes it was because of her COVID in Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM5318), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198), in right arm, on 05Jan2022 as dose 3 (booster), single (Lot number: FE3594), in left arm and on 12May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood sugar abnormal" (unspecified if ongoing); "blood pressure abnormal" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Blood sugar went high and she believes it was because of her COVID in Jul2022"; COVID-19 (medically significant) with onset Jul2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood glucose: (2022) high; SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Prescribed Paxlovid and then last Jul2022, she did Paxlovid for 5 days. Husband had COVID too. Both of them got COVID, but he was given IV because he was past the 5 days. He did not want to test and she did. Mom passed away in 2013 and had Diabetes. She takes Blood sugar and blood pressure medication and had been taking it and nothing new. She had those before the very first Pfizer COVID vaccine - over 5 years. Maybe 7 years ago. Blood sugar went high and she believes it was because of her COVID in Jul2022, because nothing changed. Exercise and everything was the same.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300159823 Same patient/drug/ different dose/event;
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M normal, Hypergammaglobulinaemia benign monoclonal, Light chain analysis increased, Light chain analysis normal
Clinical narrative: MONOCLONAL GAMMOPATHY OF UNCERTAIN SIGNIFICANCE, AN IgM GAMMOPATHY
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Monoclonal gammopathy
Clinical narrative: MONOCLONAL GAMMOPATHY OF UNCERTAIN SIGNIFICANCE, AN IgM GAMMOPATHY
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: As soon as I wake up until I go to bed, ringing in ears/head & headaches. The only thing that helps is background noise and tylenol for the headache.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: Patient was scheduled for 2nd dose of Pfizer COVID-19 vaccine and inadvertently received the Janssen COVID-19 vaccine. Event is mixed doses of COVID-19 vaccines, none dose of Pfizer and one dose of Janssen. Also the patient does not qualify for Janssen COVID-19 Vaccine due to being under the age of 18. Patient did not report any side effects and went to work after his 15 minute observation.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Haemoglobin decreased, Headache, Nausea, Vomiting
Clinical narrative: 15-year-old male presents to the emergency department with mother for some nausea and vomiting as well as frontal headache that started this evening. Apparently got the polio vaccine around 430, seem to have developed a headache that was progressive after that. Denies any head injury or trauma. Patient has had some progressive weakness and fatigue over the last several months, did have a low iron level previously, was told that his hemoglobin was in the eights today based on rapid check in the office however it was 14.2 on labs done today. Denies fever, vision changes, chest pain or shortness of breath, cough, congestion sore throat, hematemesis, abdominal pain, change in bowel or bladder habits, Of note mother does not state that he has had headaches intermittently for the last several months.
Sex: U
Vaccine: PNC20, VARZOS
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Arm soreness, swollen lymph nodes reported after one week. MD recommended Ibuprofen - OTC
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 03-Feb-2023 and was administered on 22-Mar-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Feb-2023 and was administered on 22-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 22-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Feb-2023 and was administered on 22-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Feb-2023 and was administered on 22-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 03-Feb-2023 and was administered on 22-Mar-2023).    No concomitant information was reported. The size of the vial and dosage text of suspect product was unknown. It was reported that two patients that received Moderna bivalent booster dose one was at day 31 of the medication being in the fridge, and another was at day 47. The patient did not report any adverse reaction that the pharmacist was aware of. The vial did not underwent any temperature excursions. This case is reported for patient 2 out of 2 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720010 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720010:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; The patient received doses on 4/9/2018, 10/11/2018, and 4/5/2023.; This spontaneous report was received from a licensed practical nurse (L.P.N.) referring to a currently 16-year-old patient of unknown gender. Information of the patient's medical history, concurrent condition and concomitant therapy was not reported.  On 09-APR-2018 and 11-OCT-2018, the patient was administrated hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis. On 05-APR-2023, the patient was administrated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #w011264, expiration date: 05-SEP-2024, strength and route of administration were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse events (AEs) were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs/no PQCs.; HCP reported that an expired dose of VARIVAX was administered to a patient on 4/17/23.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided.  On 17-APR-2023, the patient was vaccinated with one expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous Injection (valid lot number U012222 with an expiration date on 16-APR-2023) (dose, dose number, vaccination scheme, frequency and anatomical injection site were not provided) for prophylaxis (expired product administered).  No additional (adverse events) reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired dose of VARIVAX administered.; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided.  On 17-APR-2023, the patient was vaccinated with one expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous Injection, 0.5 milliliter (ml) administered intramuscularly (valid lot number U012222 with an expiration date on 16-APR-2023) (dose number, vaccination scheme, frequency and anatomical injection site were not provided) administered concomitantly with sterile diluent (dose, frequency, lot number and expiration date were not provided) for prophylaxis (expired product administered).  No additional (adverse events) reported.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involving a punctured IPOL with no reported adverse event; five patients received the punctured IPOL post excursion with no reported adverse event; Initial information received on 13-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case is linked to cases 2023SA119119 and 2023SA119126.  This case involves a 13 years old male patient who  received the punctured ipol post excursion and temperature excursion involving a punctured ipol with no reported adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On 22-Mar-2023, the patient received a suspect IPV (VERO) dose number 2  at dose of 0.5 ml  (lot V1B901M, Expiry date: 02-Jun-2024) via intramuscular route in the left arm for prophylactic vaccination  On 22-MAR-2023 the patient diagnosed with a non-serious temperature excursion involving a punctured ipol (product storage error), five patients received the punctured ipol post excursion with no reported adverse event (poor quality product administered)  following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.    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.; Sender's Comments:  US-SA-2023SA115479: US-SA-2023SA120330: US-SA-2023SA119119: US-SA-2023SA119961: US-SA-2023SA119119:
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administration of punctured IPOL after excursion with no reported adverse event; Initial information received on 13-Apr-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 years old male patient who had administration of punctured IPV (vero) [IPOL] after excursion 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 Hepatitis B Vaccine for Immunisation.  On 22-Mar-2023, the patient received 0.5 mL of dose 2 of suspect IPV (vero) Suspension for injection (lot: V1B901M; expiry date: 02-Jun-2024) via intramuscular route in the left arm for immunization after excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administration of punctured ipol after excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA119943:
Age: 1.92
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: ACTHIB vial with an expired diluent twas given to a patient; Initial information received on 14-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 23 months old female patient who received ACTHIB vial with an expired diluent twas.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 13-Apr-2023, the patient received suspect HIB (PRP/T) VACCINE Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test = 0.5 ml (lot UJ671ABA, Expiry date: 27-May-2023) via intramuscular route in the right vastus lateralis for prophylactic vaccination (immunization).  On 13-Apr-2023 the patient diagnosed with a non-serious acthib vial with an expired diluent twas given to a patient (expired product administered) (same day latency) following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown    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: U
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: 3 doses of menquadfi were administered to patients post-excursion with no reported adverse event; 3 doses of menquadfi were administered to patients post-excursion with no reported adverse event; Initial information received on 14-Apr-2023 regarding an unsolicited non-valid  non-serious case received via other health professional.  This case involves 3 doses of menquadfi were administered to unspecified patients post-excursion with vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation, strength: unknown) at dose of 3 DF (Dosage Formulation) at dose number 3 (lot U7633AA, Expiry date: 25-Apr-2025)  via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious 3 doses of menquadfi were administered to patients post-excursion with no reported adverse event (poor quality product administered) (product storage error) (same day latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   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: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACT-HIB vaccine administered to 2 patients with no reported adverse event; Initial information received on 14-Apr-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an unknown age and unknown gender patients who had administered expired haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a standard expired dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total  (lot UJ644AA, expiry date- 02 -Apr-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  It was reported, The nurse can only provide lot number and expiration date and has no information regarding the patients and the health care provider. Nurse was also confirming regarding re-vaccination.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.67
Sex: F
Vaccine: DTAP, MMR
Symptoms: Febrile convulsion, Grunting, Tremor
Clinical narrative: febrile seizure. Was uncontrollably shaking for a few minutes but still conscious. Was grunting with her breathing for about an hour after.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache
Clinical narrative: headache, severe joint pain, chest pain. headache lasted a couple months. i don?t feel the joint pain has ever fully gone away. the chest pain lasted 4 to 6 weeks and i often wonder if it damaged my heart. so i decided to finally report this in case i have heart problems in the future.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: Underarm rash, both arms. Itchy and some burning sensation.  As of 4/20/23 at 11pm I still have it but no other symptoms.
Sex: M
Vaccine: COVID19-2
Symptoms: Rash pruritic
Clinical narrative: Rash on neck and back described the rash was very itchy/had the same rash as with the first monovalent booster; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Rash on neck and back described the rash was very itchy/had the same rash as with the first monovalent booster) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash on neck and back described the rash was very itchy/had the same rash as with the first monovalent booster). At the time of the report, RASH PRURITIC (Rash on neck and back described the rash was very itchy/had the same rash as with the first monovalent booster) outcome was unknown.      No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2023-720199 (Patient Link).
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an 8 year old patient received Kinrix; 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 8-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 11-APR-2023, the patient received Kinrix. On 11-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: an 8 year old patient received Kinrix). 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: 11-APR-2023 The reporter declined to provide patient's initials. The reporter stated that 8 years old patient received Kinrix. The Vaccine administration facility was the same as Primary Reporter. The reporter consented to follow up via postal. The reporter stated that 8 years old patient received Kinrix, which led to inappropriate age at vaccine administration.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 months old was given Kinrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 12-APR-2023, the patient received Kinrix (left thigh). On 12-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 months old was given Kinrix). 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:13-APR-2023 The reporter was the patient's mother. She stated that his 2 months old baby was administered Kinrix a day before yesterday. The reporter consented to follow up. The patient administered the Kinrix vaccine at wrong age which led to Inappropriate age at vaccine administration.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Headache-Medium
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Headache-Medium
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Throat irritation
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient started experiencing rediness on the face and behind the ears area, along with itchy sensation around the throat area after the bivalent administration. Patient had 1st and 2nd monovalent shot with no issues. Benadryl and epi-pen was administered. Patient denied the call for 911 and ambulance and patient insisted to have her boyfriend to drive her to the Emergency room.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: PATIENT REPORTED TO PHARMACY CONSULT AREA SHOWING LEFT UPPER ARM RED AND REPORTING PAIN. CONSULTED TO TAKE BENEDRYL AND WE WOULD FOLLOW UP TO SEE THE PROGRESSION OF THIS REACTION
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Glomerular filtration rate decreased, Metabolic function test
Clinical narrative: Kidney efgr drop 20 points
Age: 59.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Pyrexia, Rash, Varicella virus test positive
Clinical narrative: On 4/11 the patient started to have fatigue and HA. On 4/15 patient started to have rash, fever. 4/1823 patient tested positive for chicken pox.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Headache, Hypertension, Tinnitus
Clinical narrative: I received two Johnson and Johnson covid19 vaccines and shortly after, developed high BP. My BP was perfectly fine before your ineffective and dangerous vaccines. Despite MANY months of trying to get it back to perfect 120/80 or less that it was for 60 yrs with lifestyle changes, my BP got worse FROM THE DAMAGED CUASED TO MY VESSELS FROM THE DANGEROUS VACCINE. First I was Rxed Losartan but that didn't work well and then caused high blood K so I had to stop it. I was prescribed 10mg of Lisinopril, I took one dose on 4/18 and went to bed only to be woken up by a loud tapping/pounding in my head/ears. The next day and still two, I have LOUD tinnitus. I only took the one dose and figured anything that causes this horrific tinnitus is damaging. This is a problem of MANY people and its likely damaging their ears. Why would you keep such an obvious Ototoxic product on the market? This better go away.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: The was no adverse event , reporting due to the recommendations of the FDA.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Lacunar stroke, Symptom recurrence, Thalamic stroke
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE OF THALAMUS, UNSPECIFIED TYPE AND ARTERY HYPOXEMIA 6/1/2022, 6/29/2022, 6/30/2022. & 2/8/2023 - RECURRENCE OF SAME SYMPTOMS
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mammogram abnormal
Clinical narrative: A general mammogram was performed 28MAR2023 and unusual findings were detected that requires further testing to be performed 23MAY2023.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weakness, hospitalization
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypoxia
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram cerebral, Computerised tomogram head, Headache
Clinical narrative: 2/4/2023 I started with headaches in the right occipital lobe. I have had MRA, CT  and find no growth or other issues. I have unexplained headaches that come and go in the back of my head. I go back in two weeks for a check up.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Dizziness, Hypoaesthesia oral
Clinical narrative: A 44 yr old male with c/o feeling dizzyness and peri oral numbness in mouth 2 minutes s/p COVID Bivalent vaccine while seeing provider. HCT RN to bedside. Pt semi fowlers. VSS. Elevated diastolic on first BP and then elevated systolic and diastolic on repeat BP. See Nurse vitals. Dr. notified. Pt states he is feeling better within minutes. Assisted to sitting position and then to standing with minimal assistance. Tolerated well. Pt states Im feeling much better now. Pt has no further questions or concerns at this time and is in approval with the plan of care. Completed by: RN, April 20, 2023, 10:49 AM
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiogenic shock
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  CARDIOGENIC SHOCK
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: I experienced stuffy nose, sore throat and headaches.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: PT WAS SUPPOSE TO GET DTAP(INFANRIX) BUT RECEIVED TDAP (BOOSTRIX)
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: I had like a cold, slight cough and that's it. It lasted maybe four or five days. I tested positive for the COVID-19 virus at home on 30JAN2023. I was prescribed Paxlovid by my Doctor.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Vaccine.  No reactions
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chronic kidney disease, Condition aggravated, End stage renal disease, Fatigue
Clinical narrative: Extreme fatigue and joint pain. Severe headache all within a day after vaccine. Fatigue  has never improved  One and only kidney GFR plummeted 10 points to end stage 3  renal disease.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Glomerular filtration rate decreased, Headache, Renal failure, Single functional kidney
Clinical narrative: Extreme fatigue and joint pain. Severe headache all within a day after vaccine. Fatigue  has never improved  One and only kidney GFR plummeted 10 points to end stage 3  renal disease.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Atrial fibrillation, Chest pain, Hypertension, Tachycardia
Clinical narrative: Heart pain and chest pain with boutd of a fib, high blood pressure and tachycardia
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Lichen striatus
Clinical narrative: Patient developed lichen striatus skin finding 2 days after receiving vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: COVID-19, Chills, Exposure during pregnancy, Exposure to SARS-CoV-2, Fatigue
Clinical narrative: 3/21/23  I had been  exposed to COVID. I began having a scratchy throat and I took an at home COVID Test that was negative. I called my doctor, they said to let it run its course.  On 3/22/23, I had full body aches, chills, general aches that hurt everywhere and a fever that I had trouble controlling. My rapid COVID test was positive.  I called the doctor back and told me the parameters to go to the Emergency Room if my fever got too high. From 3/21/23 ? 3/28-23 I had general cold symptoms, congestion, fatigue and did not feel well.  I also had a lingering positive COVID test.    My delivery date was at 38 weeks. No complications. The baby?s birthweight was 7lb12oz.