chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA331476, 2018SA331477 and 2018SA331166 (same reporter). This case involves a nine- years old patient (gender was not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (formulation Suspension for injection in pre-filled syringe) (lot number, was reported as unknown, dose, dose in series, route and site of administration was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported if the patient experienced any adverse events following the vaccination. 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 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. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 12 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ087AA, expiration date: 30-Jun-2019, route: intramuscular and site of administration: right deltoid) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. Shipping delivery delay causing invalid dose of FLUZONE QUADRIVALENT which was administered to 12 year old male. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 62 years old female patient who received a 0.5ml standard immunization of the FLUZONE HIGH DOSE (formulation Suspension for injection in pre-filled syringe) lot UJ052AB, Expiry date 09 June 2019, via unknown route in the left deltoid on 30 Nov 2018. The patient past medical history, medical treatments, vaccinations and family history were not provided. It was a case of actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that 62 years old received a FLUZONE HD. No adverse event reported. 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 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. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist via phone. This case is linked to case 2018SA331501. This case involves an elderly male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ04AB, expiration date: 20-Jun-2019, site of administration: right deltoid and route was not reported) on an unknown date instead of Pneumonia vaccine. The patient had also received a prior FLUZONE HIGH DOSE (Batch number, expiration date, site of administration and route was not reported) at her HCP's office in Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered and extra dose administered. FLUZONE HD vaccine was administered today to a husband and wife for the second time this season instead of the Pneumonia vaccine. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist via phone. This case is linked to case 2018SA331498. This case involves an elderly female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ04AB, expiration date: 20-Jun-2019, site of administration: right deltoid and route was not reported) on an unknown date instead of Pneumonia vaccine. The patient had also received a prior FLUZONE HIGH DOSE (Batch number, expiration date, site of administration and route was not reported) at her HCP's office in Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered and extra dose administered. FLUZONE HD vaccine was administered today to a husband and wife for the second time this season instead of the Pneumonia vaccine. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Age: 0.0
Sex: U
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 01-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a one-day old patient (gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT instead of Hepatitis B Vaccine (lot number and Exp. Date not reported) via intramuscular route in unknown administration site on 01-Dec-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered. There were no AE noted at the time. 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 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. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves Adolescent male patient (age unknown) who experienced entire upper arm swelled up (from elbow to shoulder), while he received vaccine MENACTRA (formulation Solution for injection). The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious entire upper arm swelled up (from elbow to shoulder) (extensive swelling of vaccinated limb) with unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Lab data was not provided. Final diagnosis was entire upper arm swelled up (from elbow to shoulder). It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for entire upper arm swelled up (from elbow to shoulder). List of documents held by sender- none.
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA333678 (same reporter). This case involves an adult male patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was reported as a nurse made a mistake and gave the pediatric dose to two adults using the pre-filled syringe. It was not reported whether the patient experienced any adverse events following the vaccination. 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 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 03-Dec-2018 in the united states regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA333646 (same reporter). This case involves an adult female patient (age not reported) who was vaccinated with a pediatric dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was not reported whether the patient experienced any adverse events following the vaccination. 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 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. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who experienced hives on his body, while he received vaccine MENACTRA. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Jul-2018, the patient received a dose of suspect MENACTRA lot U5833AA, expiration date: 25-Feb-2019 via unknown route in the left deltoid. On an unknown date, the patient experienced a non-serious hives on his body (urticaria) (Unknown latency) following the administration of MENACTRA. Other relevant tests included no lab data. Final diagnosis was hives on his body. It was not reported if the patient received a corrective treatment. The patient was recovered from the event. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Product preparation error
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old female patient and reports that received ACTHIB reconstituted with sterile water diluent, while she received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medications included PREVENAR; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR). On 29-Nov-2018, the patient received a dose of 0.5 ml suspect HIB (PRP/T) VACCINE (lot number: UI905AA and expiry date: 24-Oct-2019) (dose in series and route was not reported) in the right thigh. It was a case of actual medication error due to wrong solution used in drug reconstitution as ActHib reconstituted with a diluent other than the specific ACTHIB diluent, reconstituted with Merck sterile water instead of proper diluent. It was unknown if the patient had any 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 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. List of documents held by sender: none.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient who received a 0.5 ml expired dose (fourth) of vaccine ACT-HIB (lot UI817AA) via unknown route in the left thigh on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. It was a case of actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Sex: M
Vaccine: FLU4, HEP, IPV, JEVX, MMR, RAB, TYP
Symptoms: Antibody test negative
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 54 years old male patient titer was done that showed 0.1 (showing immunity less than 0.1 below detection unit), while he received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis b vaccine (hepatitis b vaccine), japanese encephalitis vaccine (japanese encephalitis vaccine), polio vaccine inact 3v (vero) (ipol [polio vaccine inact 3v (vero)]) on 06-Oct-2017 and measles vaccine, mumps vaccine, rubella vaccine (MMR), hepatitis b vaccine (hepatitis b vaccine), AFLURIA, TYPHIM VI and hepatitis a vaccine inact (havrix) used as product used for unknown indication on 08-Sep-2018 via unknown route of administration and unknown site. The patient received three shots series 0.5 mL dose of suspect RABIES (HDC) VACCINE (lot M12962M), expiry date:12-Jun-2018 via unknown route in the right deltoid on date 08-Sep-2017, 15-Sep-2017 and 06-Oct-2017 respectively. On an unspecified date, the patient was performed titer that showed 0.1 (showing immunity less than 0.1 below detection unit) (antibody test negative) following the administration of RABIES (HDC) VACCINE. Other relevant tests included no lab test done. Final diagnosis was antibody test negative. It was not reported if the patient received a corrective treatment. List of documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 24 years old male patient who received 1 ml dose of an expired vaccine IMOVAX RABIES (lot number: M1565, expiry date: 23-Oct-2018, dose in series and route not reported) in right deltoid on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. This was a case of actual medication error due to expired vaccine used and overdose because the patient was received 1 ml expired dose of IMOVAX. It was not reported if any adverse event occurred or not following the vaccination. 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 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.  Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Underdose
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient of unknown demographics who received half the dose of PENTACEL (Suspension for injection). The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received half dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported. It was a case of actual medication error due to vaccine underdose. It was unknown if adverse event occurred or not. 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 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. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five-years old female patient who received a second dose of 0.25 ml instead of 0.5ml of vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included a dose of FLUZONE QUADRIVALENT in Nov-2017 but did not receive 2nd dose in 2017. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medication was none. On 02-Nov-2018, the patient received 0.5 ml of first dose of suspect Influenza Quadrival A-B Vaccine lot number not reported via unknown route. On an unknown date (reported as today) she also received 0.25 ml of Second dose of the same vaccine lot UT6259MA via unknown route in the left deltoid. It was a case of actual medication error due to Vaccine under dose. It was not reported if any adverse reaction was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 33 months old female patient who accidentally received the child 0.5ml instead of the 0.25ml dose while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ069AA via intramuscular route in the left thigh after receiving the 0.25 ml first dose on 23-Oct-2018. It was a case of actual medication error due to overdose. No adverse event were noted at the time of 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient of unknown age who was exposed to 0.5ml vaccine FLUBLOK QIV (batch number: QSAA1828, expiry date: 30-Jun-2019) via intramuscular route on 12-Oct-2018 while she was pregnant as patient did not inform about the menstrual delay at the time of vaccination. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received the FLUBLOK QIV while pregnant occurred at 28th week of pregnancy. The gestation period at onset and gestation period at exposure data needs to be populated. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. It was a case of Vaccine exposure during pregnancy. No adverse event was experienced. Additionally, at time of reporting, the outcome of the pregnancy is unknown. List of documents held by sender- none.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a Healthcare Professional. This case involves a 12 year old male patient who received 0.5ml of  vaccine FLUBLOK QIV (batch number: QFAA1810, expiry date: 30-Jun-2019) (route and series of dose were not reported) in the right deltoid on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if any adverse reaction was experienced or not. It was also reported that No treatment needed at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB, FLU4, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21-months old male patient who received 2 doses (0.25ml) of FLUZONE QUADRIVALENT (Batch number: UT6315UA, expiration date: 30-JUN-2019) via intramuscular in the right thigh on 03-DEC-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PENTACEL and Hepatitis (unclear type) for Immunisation. It was actual medication error due to extra dose administered. It was reported that the patient had no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Underdose
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown demographic patient who was vaccinated with only half dose of vaccine PENTACEL (lot number, Exp. Date, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to vaccine underdose. It was not reported whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Around 12 hours after vaccine given patient experienced shivering/vomiting/diarrhea and general weakness. Experience these symptoms with the initial SHINGRIX 9/7/18 (which was coadministered with FLUZONE HD.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Periarthritis
Clinical narrative: Left shoulder adhesive capsulitis.
Age: 83.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Blood test, Immediate post-injection reaction, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Immediately after the injection was given....it was sore, as always in the past, so thought it would take a few days to disappear....not so....Lots of pain on the shoulder, down the arm....three months later finally saw the doctor....here it is now four months later, and still has pain.
Age: 83.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: Immediately after the injection was given....it was sore, as always in the past, so thought it would take a few days to disappear....not so....Lots of pain on the shoulder, down the arm....three months later finally saw the doctor....here it is now four months later, and still has pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: EXTREME REDNESS AND SWELLING AND HEATED AREA ABOUT THE SIZE OF A SALAD PLATE ON THE UPPER ARM OF THE PATIENT.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: Began last night with a sore arm that made it difficult to sleep. Since this morning, I have had a headache and upset stomach, feeling a little nauseous. Tired, a little achy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Began last night with a sore arm that made it difficult to sleep. Since this morning, I have had a headache and upset stomach, feeling a little nauseous. Tired, a little achy.
Age: 53.0
Sex: F
Vaccine: HEP, HIBV, PNC13, TDAP
Symptoms: Aspiration bursa, Joint range of motion decreased, Musculoskeletal pain, Product administered at inappropriate site, Ultrasound scan
Clinical narrative: Patient received second round of inactivated vaccines s/p allogeneic stem cell transplant on 11/19/2018. Shortly thereafter, patient reports developing worsening shoulder pain and now with some limited range of motion. Aspiration performed under ultrasound today (12/10/2018) to elucidate cause. From site of entry demonstrated by patient after vaccine, concern that IM injection accidentally injected into subacromial subdeltoid bursa.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling hot, Influenza like illness, Injection site pain
Clinical narrative: Patient states her head felt hot from the inside - her ears and eyes were hot, but she did not have a fever. She felt very tired and weak almost as if she had the flu. She took naproxen on the morning of 12/8 and again that night, and by Sunday she said she felt fine. On 12/10 the injection site was still sore, but not red or inflamed.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Condition aggravated, Dizziness, Dyspepsia, Eye irritation
Clinical narrative: Per parent, sx started around noon with nausea. Progressed to "stomach burning and hurting", dizziness and a sore throat around 3pm. 9:41pm reports headache, sore throat, shaking, congestion, eyes burning and vomiting after eating and drinking.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Oropharyngeal pain, Respiratory tract congestion, Tremor
Clinical narrative: Per parent, sx started around noon with nausea. Progressed to "stomach burning and hurting", dizziness and a sore throat around 3pm. 9:41pm reports headache, sore throat, shaking, congestion, eyes burning and vomiting after eating and drinking.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Per parent, sx started around noon with nausea. Progressed to "stomach burning and hurting", dizziness and a sore throat around 3pm. 9:41pm reports headache, sore throat, shaking, congestion, eyes burning and vomiting after eating and drinking.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Fall, Syncope
Clinical narrative: Patient stated that she fainted on Memorial day and fell backwards into the bath tub. She needed to be taken to the hospital by ambulance and was in the hospital for a couple weeks. She stated that this immunization caused her to have Bell's Palsy.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-NOV-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 03-JAN-2017, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 17-MAR-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 26-SEP-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 04-JAN-2017, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Upon internal review, varicella pneumonia was determined significant medical event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown gender and age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2013, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 03-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On or about 27-AUG-2014, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about July 2015, the patient was treated at an urgent care for shingles.As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-DEC-2018, the patient was inadvertently orally vaccinated with an expired dose of ROTATEQ lot # N009964, expiration date 22-NOV-2018 (dose was not reported). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified pediatric patient of an unknown age and gender. The patient's pertinent drug allergies, concurrent conditions, medical history and concomitant medications were not reported. On 06-DEC-2018, the nurse reported that an unspecified pediatric patient was administered a properly stored but expired VAQTA (strength, dose, route and indication were unknown) with a lot# N023953 and expiry date 05-NOV-2018(expired product administered) and no adverse effects reported (no adverse event). No additional information was provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Fall, Headache, Heart rate decreased, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blackout in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 20th August 2018, refer case US2018218417). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st December 2018, 1 days after receiving SHINGRIX, the patient experienced blackout (serious criteria GSK medically significant), nausea, pain in arm, headache, excess sweating, fall, blood pressure decreased, pulse decreased and friction burn. On an unknown date, the outcome of the blackout, nausea, excess sweating, fall, blood pressure decreased and pulse decreased were recovered/resolved and the outcome of the pain in arm and headache were unknown and the outcome of the friction burn was not recovered/not resolved. It was unknown if the reporter considered the blackout, nausea, pain in arm, headache, excess sweating, fall, blood pressure decreased, pulse decreased and friction burn to be related to SHINGRIX. Additional information received as follows: The patient stated that in the next morning after receiving SHINGRIX he experienced nausea, pain in left arm and a massive headache. The patient stated that around 10:00 am the day after receiving the 2nd dose, he started sweating profusely and when he attempted to get up from the chair, he blacked out and his wife found him on the floor. The patient checked his blood pressure and it was 92/40 with a pulse of 68. The patient laid down in the bed and 30 minutes later when he rechecked his blood pressure, it was 113/59 with a pulse of 78. The patient stated that later that day (on 1st December 2018), he went to visit his family physician. The patient stated that his physician noticed that he had a rug burn on his left forearm that was approximately 8 inches in length that he developed as a result of him blacking out and falling on the floor. The reporter gave consent to follow up. The emergency room visit was required. The contact details of the physician were provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea, Pain in extremity, Skin abrasion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blackout in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 20th August 2018, refer case US2018218417). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st December 2018, 1 days after receiving SHINGRIX, the patient experienced blackout (serious criteria GSK medically significant), nausea, pain in arm, headache, excess sweating, fall, blood pressure decreased, pulse decreased and friction burn. On an unknown date, the outcome of the blackout, nausea, excess sweating, fall, blood pressure decreased and pulse decreased were recovered/resolved and the outcome of the pain in arm and headache were unknown and the outcome of the friction burn was not recovered/not resolved. It was unknown if the reporter considered the blackout, nausea, pain in arm, headache, excess sweating, fall, blood pressure decreased, pulse decreased and friction burn to be related to SHINGRIX. Additional information received as follows: The patient stated that in the next morning after receiving SHINGRIX he experienced nausea, pain in left arm and a massive headache. The patient stated that around 10:00 am the day after receiving the 2nd dose, he started sweating profusely and when he attempted to get up from the chair, he blacked out and his wife found him on the floor. The patient checked his blood pressure and it was 92/40 with a pulse of 68. The patient laid down in the bed and 30 minutes later when he rechecked his blood pressure, it was 113/59 with a pulse of 78. The patient stated that later that day (on 1st December 2018), he went to visit his family physician. The patient stated that his physician noticed that he had a rug burn on his left forearm that was approximately 8 inches in length that he developed as a result of him blacking out and falling on the floor. The reporter gave consent to follow up. The emergency room visit was required. The contact details of the physician were provided.
Sex: U
Vaccine: PNC13
Symptoms: Chromaturia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received PREVNAR 13 (lot number and expiration date were unknown), via an unspecified route of administration on 16Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)  2 weeks ago (16Nov2018). The patient noticed dark orange to light orange urine for about 10 days on Nov2018. The outcome of the event dark orange to light orange urine was unknown. Information on the batch/lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, IBCC (Inbound Call Center for HCPs). A non-contactable consumer reported that a female patient of an unspecified age received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced allergy on an unspecified date. The outcome of the event was unknown.