chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Raynaud's phenomenon, SARS-CoV-2 test
Clinical narrative: Raynaud's Syndrome in both hands; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 2, single (Lot number: EN6208) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6203), administration date: 24Feb2021, when the patient was 47-year-old, for COVID-19 immunization. The following information was reported: RAYNAUD'S PHENOMENON (disability) with onset Oct2021, outcome "not recovered", described as "Raynaud's Syndrome in both hands". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If COVID tested post vaccination: Yes. Therapeutic measures were not taken as a result of raynaud's phenomenon.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 13:30 as dose 1 (toppac), single (Lot number: HG4629) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "GERD (Gastroesophageal reflux disease)" (unspecified if ongoing); "Hx sinusitis" (unspecified if ongoing), notes: Hx sinusitis; "colon polyps" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Batch/Lot No: GL2042, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 08Jun2023, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (Batch/Lot No: GH9694, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 07Sep2022, when the patient was 68-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; very mild symptoms from the onset of symptoms and throughout the five-day course of Paxlovid from 05Mar2024 to 09Mar2024
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 8 (Booster), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 7 (Booster), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 6 (Booster), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 5 (Booster), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 4 (Booster), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 3 (Booster), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID 19 Treatment from 08Mar2024 to 13Mar2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever up to 102 F; This is a spontaneous report received from an Other HCP. An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever up to 102 F". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was stated that the patient was not diagnosed with COVID-19 prior to vaccination. She was also tested with COVID-19 since the vaccination (unknown results).   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: PNC20
Symptoms: Impaired work ability, Malaise
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.  Additional information: Patient called for assistance with Prevnar 20. The agent triaged the caller and asked for their yearly income. Last year was about and that was from unemployment and haven't been able to work due to being sick.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had the virus after the vaccine; had the virus after the vaccine; This is a spontaneous report received from a Physician from medical information team, Program ID. An elderly female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had the virus after the vaccine".  Additional information: The patient (over 65 years old) received the most recent Pfizer vaccine in Oct2023. It was stated that the patient had the virus after the vaccine. The physician wanted to know if the patient should get another vaccine after 4 months since they're recommending that they're over 65 to get it.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: inappropriate administration of IPOL that was no longer suitable for use to patients with no reported adverse event; Initial information received on 11-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2024SA074397, 2024SA082167, 2024SA082816, 2024SA082981, and 2024SA081652.  This case involves a 9 years 5 months old female patient who experienced inappropriate administration of IPV (Vero) [Ipol] that was no longer suitable for use to patient 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP); Diphtheria Vaccine Toxoid, Hepatitis B Vaccine (HEP B VAX) ;and Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR Vaccin) all for Prophylactic Vaccination.  On 27-Feb-2024, the patient had inappropriate administration of 0.5 ml of IPV (Vero) (Suspension for injection) (lot W1C751M, expiry date: 18-Nov-2025, strength not reported) via intramuscular route in the right arm for Immunization that was no longer suitable for use to patient with no reported adverse event (poor quality product administered)(latency: same day).  It was reported that "The Ipol was administered to 8 patients".    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 and Regulatory Authority 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: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult patient received DTaP  vaccine with no reported adverse event; Initial information received on 15-Mar-2024 regarding an unsolicited valid non-serious case received from a Patient.  This case involves Adult female patient who received diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] vaccine with no reported adverse event.  The patient's past medical history included Headache.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via intramuscular route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (product administered to patient of inappropriate age) (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 and Regulatory Authority 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: 11.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: post excursion punctured IPOL has been administered to patient with no reported adverse event; Initial information received on 15-Mar-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 11-year-old female patient and reporter stated post excursion punctured IPV (VERO) [IPOL] has been administered to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN) for Prophylactic vaccination; hepatitis B vaccine for Prophylactic vaccination; meningococcal vaccine A/C/Y/W CONJ (CRM197) (Menveo) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 13-Mar-2024, the patient received a 0.5 ml dose of suspect IPV (VERO), Suspension for injection (strength: unknown) (lot: W1A191M, expiry date: 16-Feb-2025) via unknown route in unknown administration site for immunization and post excursion punctured ipol has been administered to patient with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, Reason: Unknown. Max/low temperature reached: 1.5C Duration out of labelled range: 15 hours and 43 minutes Human error: NO and Caller stated that these vaccines were also involved in a previous excursion of 18.1C for 17 hours (punctured IPOL from this excursion was not involved in the previous excursion    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 and Regulatory Authority 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: 0.5
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired ipol dose was given to two patient with no reported adverse event; Initial information received on 18-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who had an expired IPV (VERO) [IPOL] given to patient 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 CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) for Prophylactic vaccination.  On 14-Mar-2024, the patient received an expired dose 3 with dosage 0.5 ml of suspect IPV (VERO) (lot V1A021M, Expiry: 17-Feb-2024 with unknown strength) via subcutaneous route in the right thigh as Immunization 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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: opened ipol mdv- four doses administered post excursion with no reported adverse event; Initial information received on 18-Mar-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves 4 patient(s) where reporter reported opened IPV (vero) [IPOL]- four doses administered post excursion 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 a dose 4 of suspect IPV (vero) Suspension for injection (lot- W1A191M and expiration date- 16-Feb-2025) via unknown route in unknown administration site (strength: 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 and Regulatory Authority 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: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal lymphadenopathy, Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased
Clinical narrative: Patient developed symptoms of MISC on 3/1/24; fevers began on 3/1/24 with a Tmax of 39.8 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, elevated BNP, cough, thrombocytopenia (known to be a baseline finding for this patient), abdominal pain, vomiting, diarrhea, elevated liver enzymes, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, elevated BNP, decreased platelets, elevated bilirubin, and elevated AST/ALT. ECHO was normal and showed only trivial mitral regurgitation. Chest x-rays were normal. Abdominal CT showed a right indirect inguinal hernia, small bowel distention without obstruction, mesenteric lymphadenopathy, and findings of portal hypertension. Patient was admitted to the hospital on 3/11/24 and treated with low flow nasal cannula, IVIG, infliximab; he was discharged on 3/15/24. He did not require admission to the PICU.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide increased, C-reactive protein increased, COVID-19, Chest X-ray normal, Computerised tomogram abdomen abnormal
Clinical narrative: Patient developed symptoms of MISC on 3/1/24; fevers began on 3/1/24 with a Tmax of 39.8 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, elevated BNP, cough, thrombocytopenia (known to be a baseline finding for this patient), abdominal pain, vomiting, diarrhea, elevated liver enzymes, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, elevated BNP, decreased platelets, elevated bilirubin, and elevated AST/ALT. ECHO was normal and showed only trivial mitral regurgitation. Chest x-rays were normal. Abdominal CT showed a right indirect inguinal hernia, small bowel distention without obstruction, mesenteric lymphadenopathy, and findings of portal hypertension. Patient was admitted to the hospital on 3/11/24 and treated with low flow nasal cannula, IVIG, infliximab; he was discharged on 3/15/24. He did not require admission to the PICU.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Conjunctivitis, Cough, Diarrhoea, Echocardiogram abnormal
Clinical narrative: Patient developed symptoms of MISC on 3/1/24; fevers began on 3/1/24 with a Tmax of 39.8 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, elevated BNP, cough, thrombocytopenia (known to be a baseline finding for this patient), abdominal pain, vomiting, diarrhea, elevated liver enzymes, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, elevated BNP, decreased platelets, elevated bilirubin, and elevated AST/ALT. ECHO was normal and showed only trivial mitral regurgitation. Chest x-rays were normal. Abdominal CT showed a right indirect inguinal hernia, small bowel distention without obstruction, mesenteric lymphadenopathy, and findings of portal hypertension. Patient was admitted to the hospital on 3/11/24 and treated with low flow nasal cannula, IVIG, infliximab; he was discharged on 3/15/24. He did not require admission to the PICU.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hepatic enzyme increased, Illness, Immunoglobulin therapy, Inguinal hernia
Clinical narrative: Patient developed symptoms of MISC on 3/1/24; fevers began on 3/1/24 with a Tmax of 39.8 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, elevated BNP, cough, thrombocytopenia (known to be a baseline finding for this patient), abdominal pain, vomiting, diarrhea, elevated liver enzymes, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, elevated BNP, decreased platelets, elevated bilirubin, and elevated AST/ALT. ECHO was normal and showed only trivial mitral regurgitation. Chest x-rays were normal. Abdominal CT showed a right indirect inguinal hernia, small bowel distention without obstruction, mesenteric lymphadenopathy, and findings of portal hypertension. Patient was admitted to the hospital on 3/11/24 and treated with low flow nasal cannula, IVIG, infliximab; he was discharged on 3/15/24. He did not require admission to the PICU.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Intestinal dilatation, Mitral valve incompetence, Platelet count decreased, Portal hypertension, Pyrexia
Clinical narrative: Patient developed symptoms of MISC on 3/1/24; fevers began on 3/1/24 with a Tmax of 39.8 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, elevated BNP, cough, thrombocytopenia (known to be a baseline finding for this patient), abdominal pain, vomiting, diarrhea, elevated liver enzymes, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, elevated BNP, decreased platelets, elevated bilirubin, and elevated AST/ALT. ECHO was normal and showed only trivial mitral regurgitation. Chest x-rays were normal. Abdominal CT showed a right indirect inguinal hernia, small bowel distention without obstruction, mesenteric lymphadenopathy, and findings of portal hypertension. Patient was admitted to the hospital on 3/11/24 and treated with low flow nasal cannula, IVIG, infliximab; he was discharged on 3/15/24. He did not require admission to the PICU.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test positive, Skin lesion, Thrombocytopenia, Vomiting
Clinical narrative: Patient developed symptoms of MISC on 3/1/24; fevers began on 3/1/24 with a Tmax of 39.8 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, elevated BNP, cough, thrombocytopenia (known to be a baseline finding for this patient), abdominal pain, vomiting, diarrhea, elevated liver enzymes, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, elevated BNP, decreased platelets, elevated bilirubin, and elevated AST/ALT. ECHO was normal and showed only trivial mitral regurgitation. Chest x-rays were normal. Abdominal CT showed a right indirect inguinal hernia, small bowel distention without obstruction, mesenteric lymphadenopathy, and findings of portal hypertension. Patient was admitted to the hospital on 3/11/24 and treated with low flow nasal cannula, IVIG, infliximab; he was discharged on 3/15/24. He did not require admission to the PICU.
Age: 1.92
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Influenza A virus test negative, Influenza B virus test negative, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Developed fever to 103 degrees and hives three days after vaccine. Has had fevers for five days and developed facial swelling and redness.
Age: 1.92
Sex: F
Vaccine: HEPA
Symptoms: Streptococcus test negative, Swelling face, Urticaria
Clinical narrative: Developed fever to 103 degrees and hives three days after vaccine. Has had fevers for five days and developed facial swelling and redness.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Cardiac stress test, Chest pain, Myocarditis, Scan myocardial perfusion, Troponin
Clinical narrative: myocarditis from RSV.  went to ER and admitted for chest pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 3/13 -- Muscles across shoulder and arms extremely tight and sore evening of same day and into following day (3/14).  Extremely tired for about 3 days, Morning of 3/14 had a large, hard, red swollen area around injection site that was very tender and warm to the touch -- this continued to grow for the next couple of days reaching approx 2-2.5 inches in diameter.  It is still slightly tender and my arm/bicep muscle and the back part of my trapizoid and around my shoulder continued to ache -- they are still sore and feel heavy today.  3/15 my neck, chest and arm started to itch -- I took a benadryl to contol itching.  In February, I had a steroid shot to relieve tendenitis in my left arm/shoulder-- and I believe the Moderna shot reversed all the positive effects of the steroid shot
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Limb discomfort, Muscle tightness, Myalgia, Pruritus
Clinical narrative: 3/13 -- Muscles across shoulder and arms extremely tight and sore evening of same day and into following day (3/14).  Extremely tired for about 3 days, Morning of 3/14 had a large, hard, red swollen area around injection site that was very tender and warm to the touch -- this continued to grow for the next couple of days reaching approx 2-2.5 inches in diameter.  It is still slightly tender and my arm/bicep muscle and the back part of my trapizoid and around my shoulder continued to ache -- they are still sore and feel heavy today.  3/15 my neck, chest and arm started to itch -- I took a benadryl to contol itching.  In February, I had a steroid shot to relieve tendenitis in my left arm/shoulder-- and I believe the Moderna shot reversed all the positive effects of the steroid shot
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Dizziness, Eye pain, Fatigue, Headache
Clinical narrative: Symptoms started 12/2/2023 -  Body aches, headache, dizziness, nausea, Heat on forehead, teeth pain, Hotness on arms and legs, leg cramps, bilateral eye pain, sinus pressure, Temp 99.5, light sensitivity, fatigue, loss of appetite.  These symptoms went on through 1/2/2024  Then continued with ongoing migraine and optical neuralgia, right eye.  Diagnosed by Neuro Dr. on Feb. 13, 2024. On medication for this. Pain is finally resolving (Mid March 2024) with medication.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Migraine, Muscle spasms, Nausea, Occipital neuralgia, Pain
Clinical narrative: Symptoms started 12/2/2023 -  Body aches, headache, dizziness, nausea, Heat on forehead, teeth pain, Hotness on arms and legs, leg cramps, bilateral eye pain, sinus pressure, Temp 99.5, light sensitivity, fatigue, loss of appetite.  These symptoms went on through 1/2/2024  Then continued with ongoing migraine and optical neuralgia, right eye.  Diagnosed by Neuro Dr. on Feb. 13, 2024. On medication for this. Pain is finally resolving (Mid March 2024) with medication.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paranasal sinus discomfort, Photophobia, Platelet count increased, Skin warm, Toothache
Clinical narrative: Symptoms started 12/2/2023 -  Body aches, headache, dizziness, nausea, Heat on forehead, teeth pain, Hotness on arms and legs, leg cramps, bilateral eye pain, sinus pressure, Temp 99.5, light sensitivity, fatigue, loss of appetite.  These symptoms went on through 1/2/2024  Then continued with ongoing migraine and optical neuralgia, right eye.  Diagnosed by Neuro Dr. on Feb. 13, 2024. On medication for this. Pain is finally resolving (Mid March 2024) with medication.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Patient mother called clinic the next day, since she tried calling same day, but clinic was already closed. Mother stated 2 hours after getting Covid-19 first dose, she started noticing red bumps or "hives" appearing on patient's bilateral feet and right arm, but none on the injected area. Mother gave patient Benadryl and red bumps or "hives" started disappearing. The day the vaccine was given patient stayed at the clinic for 20 minutes for observation and was given VIS, before vaccine was administered.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Anaemia, Arthralgia, Asthenia, Condition aggravated, Diarrhoea
Clinical narrative: Upper GI Bleed (acute) -> anemia Worsen of osteoporosis/osteoarthritis Torn rotator cuff shoulder Pyelonephritis kidneys Four days post vaccination with RSV vaccine I had severe nausea, vomiting, diarrhea complicated by severe pain in the (R) shoulder, entire spine & pain in both knees. I saw a pain management specialist on 11/8/23 who prescribed tizanidine & an xray of the shoulder. It became much worse and was unable to ambulate to the bathroom. I collapsed on the floor. I had to be carried out of my apartment via ambulance on 11/12/23. I was admitted to hospital for 10 days for generalized weakness, severe pain swelling (R) shoulder synovitis/no rotator cuff, an acute GI bleed, pyelonephritis, worsening of the osteoarthritis/osteoporosis.This vaccine caused a permanent disability. I required 4 weeks of subacute rehab post hospitalization. I have never have had a severe reaction to other vaccines. A warning should be placed on the handout directing patients to the ER. Also, a heads up to the medical providers.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Disability, Gait inability, Magnetic resonance imaging, Nausea, Osteoarthritis
Clinical narrative: Upper GI Bleed (acute) -> anemia Worsen of osteoporosis/osteoarthritis Torn rotator cuff shoulder Pyelonephritis kidneys Four days post vaccination with RSV vaccine I had severe nausea, vomiting, diarrhea complicated by severe pain in the (R) shoulder, entire spine & pain in both knees. I saw a pain management specialist on 11/8/23 who prescribed tizanidine & an xray of the shoulder. It became much worse and was unable to ambulate to the bathroom. I collapsed on the floor. I had to be carried out of my apartment via ambulance on 11/12/23. I was admitted to hospital for 10 days for generalized weakness, severe pain swelling (R) shoulder synovitis/no rotator cuff, an acute GI bleed, pyelonephritis, worsening of the osteoarthritis/osteoporosis.This vaccine caused a permanent disability. I required 4 weeks of subacute rehab post hospitalization. I have never have had a severe reaction to other vaccines. A warning should be placed on the handout directing patients to the ER. Also, a heads up to the medical providers.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Osteoporosis, Peripheral swelling, Pyelonephritis, Red blood cell transfusion, Rotator cuff syndrome
Clinical narrative: Upper GI Bleed (acute) -> anemia Worsen of osteoporosis/osteoarthritis Torn rotator cuff shoulder Pyelonephritis kidneys Four days post vaccination with RSV vaccine I had severe nausea, vomiting, diarrhea complicated by severe pain in the (R) shoulder, entire spine & pain in both knees. I saw a pain management specialist on 11/8/23 who prescribed tizanidine & an xray of the shoulder. It became much worse and was unable to ambulate to the bathroom. I collapsed on the floor. I had to be carried out of my apartment via ambulance on 11/12/23. I was admitted to hospital for 10 days for generalized weakness, severe pain swelling (R) shoulder synovitis/no rotator cuff, an acute GI bleed, pyelonephritis, worsening of the osteoarthritis/osteoporosis.This vaccine caused a permanent disability. I required 4 weeks of subacute rehab post hospitalization. I have never have had a severe reaction to other vaccines. A warning should be placed on the handout directing patients to the ER. Also, a heads up to the medical providers.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Spinal pain, Syncope, Synovitis, Upper gastrointestinal haemorrhage, Vomiting
Clinical narrative: Upper GI Bleed (acute) -> anemia Worsen of osteoporosis/osteoarthritis Torn rotator cuff shoulder Pyelonephritis kidneys Four days post vaccination with RSV vaccine I had severe nausea, vomiting, diarrhea complicated by severe pain in the (R) shoulder, entire spine & pain in both knees. I saw a pain management specialist on 11/8/23 who prescribed tizanidine & an xray of the shoulder. It became much worse and was unable to ambulate to the bathroom. I collapsed on the floor. I had to be carried out of my apartment via ambulance on 11/12/23. I was admitted to hospital for 10 days for generalized weakness, severe pain swelling (R) shoulder synovitis/no rotator cuff, an acute GI bleed, pyelonephritis, worsening of the osteoarthritis/osteoporosis.This vaccine caused a permanent disability. I required 4 weeks of subacute rehab post hospitalization. I have never have had a severe reaction to other vaccines. A warning should be placed on the handout directing patients to the ER. Also, a heads up to the medical providers.
Age: 74.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Asthenia, Injection site pain, Pain, Vaccination site movement impairment
Clinical narrative: Within an hour of immunization pt developed severe (R) shoulder pain. He has continued to have pain + limited mobility in the (R) shoulder no numbness/tingling. Has weakness related to pain
Age: 16.0
Sex: F
Vaccine: HIBV, HIBV, MEN
Symptoms: Wrong product administered
Clinical narrative: No additional adverse event; Medical assistant called and reported that a 16 year old patient received PEDVAX HIB instead of meningococcal vaccine due to human error; Medical assistant called and reported that a 16 year old patient received PEDVAX HIB instead of meningococcal vaccine due to human error; This spontaneous report was received from a medical assistant referring to a 16-year-old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 13-MAR-2024, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dose, lot #W028536, expiration date: 12-MAY-2025, administered for prophylaxis (strength and route of administration were not provided) instead of meningococcal vaccine (manufacturer unknown) due to a human error.  No additional adverse events were reported.
Age: 16.0
Sex: F
Vaccine: HIBV, HIBV, MEN
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse event; Medical assistant called and reported that a 16 year old patient received PEDVAX HIB instead of meningococcal vaccine due to human error; Medical assistant called and reported that a 16 year old patient received PEDVAX HIB instead of meningococcal vaccine due to human error; This spontaneous report was received from a medical assistant referring to a 16-year-old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 13-MAR-2024, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dose, lot #W028536, expiration date: 12-MAY-2025, administered for prophylaxis (strength and route of administration were not provided) instead of meningococcal vaccine (manufacturer unknown) due to a human error.  No additional adverse events were reported.
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: the patient did not suffer from any symptomatic adverse events; patient received VARIVAX on 12/07/2023 and on the same day found out she was pregnant.; This spontaneous report was received from a nurse and refers to a 25-year-old female. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On 07-DEC-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter injection, 0.5 milliliter, (lot #X017487, expiration date: 25-JUL-2025, valid lot number per internal review), administered for varicella immunisation (strength, and route of administration were not provided). On the same date, she found out she was pregnant (Exposure during pregnancy) and did nor suffer any symptomatic adverse events.
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: the patient did not suffer from any symptomatic adverse events; patient received VARIVAX on 12/07/2023 and on the same day found out she was pregnant.; This spontaneous report was received from a nurse and refers to a 25-year-old female. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On 07-DEC-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter injection, 0.5 milliliter, (lot #X017487, expiration date: 25-JUL-2025, valid lot number per internal review), administered for varicella immunisation (strength, and route of administration were not provided). On the same date, she found out she was pregnant (Exposure during pregnancy) and did nor suffer any symptomatic adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Inbound call from nurse reporting TE. Nurse reports VARIVAX product that experienced temperature excursion on 2/19/2024 was administered on 2/22/2024 to one patient.  ?    Names of vaccines involved (including lot/exp) VARIVAX X006979 3/7/2025; This spontaneous report was received from Nurse Practitioner and refers to a patient of unknown age.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 19-FEB-2024, varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot number X006979 had been verified to be valid lot number for varicella virus vaccine live (OKA/MERCK) [VARIVAX III] expiration date reported and validated as 07-MAR-2025) was storage at a temperature of 6°F to 14°F (5.7F) for 0 hours 12 minutes, and 6°F to 14°F (12.6F) for 1 hour 6 minutes. On 22-FEB-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot number X006979 had been verified to be valid lot number for varicella virus vaccine live (OKA/MERCK) [VARIVAX III] expiration date reported and validated as 07-MAR-2025)(strength, dose, frequency, route of administration and anatomical injection site were not provided) (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 07JAN2024 but was administered to a patient on 01MAR2024. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report was received from a physician regarding a patient of an unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-MAR-2024, the was patient was invertedly vaccinated with expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine live (recombinant human albumin [rHA]), injection (lot number W019428 had been verified to be a valid lot number for measles, mumps, and rubella [Wistar RA 27-3] virus vaccine, live, expiration date provided and validated as 07-JAN-2024) administered for prophylaxis (strength, dose, anatomical injection site and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: F
Vaccine: PNC15
Symptoms: Accidental exposure to product, No adverse event, Occupational exposure to product
Clinical narrative: No additional AE reported; Inbound call from nurse who reports on night shift last night she was administering VAXNEUVANCE and the product splashed in her eye during administration. / product splashed onto her forehead and eye.; Inbound call from nurse who reports on night shift last night she was administering VAXNEUVANCE and the product splashed in her eye during administration. / product splashed onto her forehead and eye.; This spontaneous report was received from a female nurse regarding herself. Her medical history, concurrent conditions, previous drug allergies and reactions and concomitant therapies were not reported.  On 13-MAR-2024, the nurse, (also reported as last night), was administering pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) to another person (information captured in MARRS #2403USA005032) and after pushing the full dose and removing the needle from the patient's leg, the product splashed in her eye and forehead (Occupational exposure to product, Accidental exposure to product). She confirmed that the product was not broken or damaged prior to or after administration and has no information on lot number or expiration date as she stated that the product was discarded. She reported that she flushed her eye with water and reported no redness or symptoms at this time (no adverse event).  This is one of two cases from the same reporter. ; Sender's Comments:  US-009507513-2403USA005032:
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: Knock me down; It felt like I had the flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza like illness (Verbatim: It felt like I had the flu) and feeling abnormal (Verbatim: Knock me down). The outcome of the influenza like illness was resolved (duration 2 days) and the outcome of the feeling abnormal was resolved.   It was unknown if the reporter considered the influenza like illness and feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the influenza like illness and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-Mar-2024 This case was reported by the patient via interactive digital media. The patient stated that he/she took the first shot it was not so bad, but the second shot knocked him/her down for two days, and it felt like had the flu. The patient stated that after those couple of days no more issues he/she experienced. The patient stated that he/she had did it again too though because shingles were way worse. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: pt developed pain, swelling at the injection site and fever on 3/15/2024. the area of inflammation increased over 3/15 to 3/20/2024 when she was seen for evalaution. she was afebrile at the time of eval with tenderness at the injection spot and erythma and tenderness in the left upper outer arm ~20x 15 cm area. it was extending distally.   pt presented to the clinic twice but was not evaluated. on 3/20/2024, she was evaluated on her third visit to the health center  she was prescribed keflex 500 TID for 7 days on 3/20/2024.
Age: 6.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Urticaria
Clinical narrative: Mild urticaria to abdomen and back at 11pm 3/20/2024; Mom  started a virtual visit. Mom was advised to give OTC benadryl and apply hydrocortisone cream. Pt had no evidence of anaphylaxis.  Reported mild pain to injection site. Injection site without evidence of swelling or infection. Pt was stable at disconnect.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Rotator cuff syndrome
Clinical narrative: Severe left shoulder pain that persisted after vaccination. Dr months later, I had mri that showed torn rotator cuff with biceps tendonitis and subacromial bursitis. I also had the flu vaccine in October 2023 and made the mistake of having them do it in my right shoulder and have had persistent pain since
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Tendonitis
Clinical narrative: Severe left shoulder pain that persisted after vaccination. Dr months later, I had mri that showed torn rotator cuff with biceps tendonitis and subacromial bursitis. I also had the flu vaccine in October 2023 and made the mistake of having them do it in my right shoulder and have had persistent pain since
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Joint range of motion decreased, Weight bearing difficulty
Clinical narrative: Severe right shoulder pain at the time of injection that has continued to persist. Decreased range of motion and difficulty carrying heavy objects 2/2 pain
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 36 hrs after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2024 This case was reported by the patient via interactive digital media. The patient stated that he/she got the vaccine two years ago and within 36 hours came down with shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: little tired for one day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: little tired for one day). The outcome of the tiredness was resolved (duration 1 day).   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     It was unknown if the company considered the tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had chickenpox as a kid, so he/she got the vaccine.  No side effects except a little tired for one day. Sure beat the pain of shingles.