chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: REDNESS/INFLAMMING OF THE SITE OF INJECTION. FEVER. HEADACHE.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Rash, Skin warm, Swelling, Tenderness
Clinical narrative: Reaction: On 06/14/2018 (2 days later) developed: rash with redness/swelling, tenderness, hot to the touch, approximately 3.5 x 7. No abnormal oral temperature, drainage, or difficulty breathing or moving. Duration: 3 days Medications Taken: ALEVE.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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 was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-SEP-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-JUL-2016 the patient was treated by a physician/MD for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 20-JUL-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 18-JUL-2016, the patient was treated at an Emergency care for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-APR-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, 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 condition of herpes zoster. On or about 03-JUL-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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. On or about 09-FEB-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, 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 condition of herpes zoster. On or about 08-SEP-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. 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. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, 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 condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves years old female patient who was administered with an expired dose of IMOVAX RABIES (batch number: M13142M, Expiration date: 19-Jun-2018, dose was not reported) in the left deltoid on 22-Jun-2018. The patient's medical history, previous medications were not reported. The patient was not pregnant, but last menstrual period was not known. It was a case of expired vaccine used. It was not known whether the patient experienced any adverse events 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 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: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two-months old male patient who was vaccinated with an expired dose of PENTACEL (batch number, expiration date, dose, dose in series, were not reported) in left thigh via intramuscular route on an unknown date. The patient's concomitant medications included PREVENAR for Immunisation; ROTAVIRUS VACCINE for Immunisation; and HEPATITIS B VACCINE for Immunisation. It was a case of an actual medication error due to expired vaccine used. It was not known whether the patient experienced any adverse events or not. It was unknown if any adverse event occurred 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 party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from other Health Care Professional on 19-Jun-2018. This case involves a five months male patient who were vaccinated with PENTACEL (batch number: C5325BA and expiry date: 14-Nov-2019) and MEASLES VACCINE; MUMPS VACCINE; RUBELLA VACCINE; VARICELLA ZOSTER VACCINE (batch number and expiry date not reported) (dose, dose in series, route and site of administration were not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination patient exhibited a 101 fever at night and when he woke up he presented with a lower grade fever. No Lab data was reported. It was unknown if patient received any corrective treatment. The patient outcome was recovered/resolved on an unknown date for the event. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involve two months male patient who received PENTACEL (batch number, expiry date, route of administration were not reported) in thigh. It was a case of actual medication error due Expired vaccine used as caller was extremely hard to hear and spoke very fast. She wanted to know if someone was given an expired vaccine. It was unknown if any adverse event occurred. 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: TYP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an 18 months old (age not reported) patient who was inadvertently injected with a dose of TYPHIM VI (Batch number, expiry date, dose, 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 as the nurse inadvertently injected a 18 month old child with the TYPHIM VI. Laboratory test was not reported. It was not reported if the patient received a corrective treatment. 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. Document held by sender: None.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old female patient who received 0.5 ml first dose of PENTACEL VACCINE (lot C5439AA, expiry date: 29-Oct-2018) once via intramuscular route in the right thigh on 27-Jun-2018 for which diluent used was sterile water. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR for Immunisation; and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to Inappropriate reconstitution technique. It was reported that the patient was inadvertently injected with PENTACEL that had been improperly mixed with diluent from VARIVAX vaccine. It was reported that there were no signs or symptoms indicating an adverse reaction. 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. Documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist via phone. This case involves a 06 month old patient who received 0.5 ml injection of PENTACEL (frequency one dose, batch number, expiry date was not reported) intramuscularly in left thigh on 29 June 2018. It was a case of actual medication error due to Inappropriate reconstitution technique as PENTACEL injection given without the diluent being reconstituted. It was unknown if any Adverse event occurred. 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: Expired product administered
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves a 2 months old patient who was administered expired dose of PENTACEL. The patient past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications were not reported. On 29-Jun-2018, the patient received a 0.5 ml dose of suspect Diphtheria, Tetanus, AC Pertussis, IPV and HIB vaccine, lot C5400AA in the left thigh, expiry date 24 Jun 2018. This was a case of actual medication error due to expired product administered. The patient outcome is reported as Not Applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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.
Age: 1.08
Sex: F
Vaccine: MMR, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: Seen 7/2/18 in office and received MMR (L thigh) and PREVNAR (R thigh). Later found out that patient had received MMR, PREVNAR, VARIVAX, Hep A and Hib on 6/8/18. Dad had the paperwork from office at the visit, but did not provide it to the nurse or provider prior to receiving immunizations at well child check. Mom noted small amount of redness on right thigh at injection site on evening on 7/2/18. Yesterday the redness got larger. Mom feels a lump within the red area. Red area got yet bigger this morning. Area is tender. Yesterday developed fever to 103. MOTRIN and TYLENOL are controlling the fever.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccination expired. No treatment necessary. Contacted local health department for instructions.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Electrocardiogram, Injection site erythema, Injection site warmth
Clinical narrative: Patient had injection site reaction (red and hot to the touch), 102 fever, and also went into A fib.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient had injection site reaction (red and hot to the touch), 102 fever, and also went into A fib.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Somnolence
Clinical narrative: Chills, soreness all over the body and very sleepy. Experienced this on the day of the injection. Went to the MD the MD on 06-27-18 and the MD gave him an injection which made him feel better but he does not know what it is. Then on 07-04-18 at 1:30 pm he felt the same way again.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Itchy spots over entire body. Started 2 - 3 days post shot.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy spots over entire body. Started 2 - 3 days post shot.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain at injection site immediately, but manageable (5:00pm). Onset of lethargy, then joint pain, muscular pain (especially neck), headache (7:00am following day), as well as swelling/pain of injection site. Fever, chills, and rash on left arm (2" diameter) observed at (9:00pm). Fever subsided with 2 doses of ADVIL (overnight), but pain and swelling at injection site remain, as well as heat to touch at injection site, rash on left arm remains, lump under rashy area. All other symptoms remain, but less pronounced compared to previous day.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Limb mass, Myalgia
Clinical narrative: Pain at injection site immediately, but manageable (5:00pm). Onset of lethargy, then joint pain, muscular pain (especially neck), headache (7:00am following day), as well as swelling/pain of injection site. Fever, chills, and rash on left arm (2" diameter) observed at (9:00pm). Fever subsided with 2 doses of ADVIL (overnight), but pain and swelling at injection site remain, as well as heat to touch at injection site, rash on left arm remains, lump under rashy area. All other symptoms remain, but less pronounced compared to previous day.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Pain at injection site immediately, but manageable (5:00pm). Onset of lethargy, then joint pain, muscular pain (especially neck), headache (7:00am following day), as well as swelling/pain of injection site. Fever, chills, and rash on left arm (2" diameter) observed at (9:00pm). Fever subsided with 2 doses of ADVIL (overnight), but pain and swelling at injection site remain, as well as heat to touch at injection site, rash on left arm remains, lump under rashy area. All other symptoms remain, but less pronounced compared to previous day.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: DTaP was ordered, but patient received PEDIARIX. Patient received 2 doses of IPV in the same day. No symptoms have been reported.
Age: 69.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Balance disorder, Chills, Dizziness, Heart rate increased, Injection site erythema
Clinical narrative: Day following immunization patient reported that she developed fever, chills, body aches. Pain, swelling and redness at injection site. PT reported dizziness and imbalance. Pain and chills worsened over next day so she came to our urgent care for evaluation on 6/29/18. SHe had an elevated heart rate at time of evaluation. She was treated with 1 Liter of Normal saline IV fluid in office at time of exam. She had labs drawn. She was sent home on a steroid course and allergy medications. Patient had improvement of heart rate and some symptoms following IV fluids. On 7/3/18 due to ongoing pain, she underwent an ultrasound of the injection site to evaluate for blood clot. this test was negative.
Age: 69.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site pain, Injection site swelling, Laboratory test normal, Pain, Pyrexia
Clinical narrative: Day following immunization patient reported that she developed fever, chills, body aches. Pain, swelling and redness at injection site. PT reported dizziness and imbalance. Pain and chills worsened over next day so she came to our urgent care for evaluation on 6/29/18. SHe had an elevated heart rate at time of evaluation. She was treated with 1 Liter of Normal saline IV fluid in office at time of exam. She had labs drawn. She was sent home on a steroid course and allergy medications. Patient had improvement of heart rate and some symptoms following IV fluids. On 7/3/18 due to ongoing pain, she underwent an ultrasound of the injection site to evaluate for blood clot. this test was negative.
Age: 69.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Ultrasound Doppler normal
Clinical narrative: Day following immunization patient reported that she developed fever, chills, body aches. Pain, swelling and redness at injection site. PT reported dizziness and imbalance. Pain and chills worsened over next day so she came to our urgent care for evaluation on 6/29/18. SHe had an elevated heart rate at time of evaluation. She was treated with 1 Liter of Normal saline IV fluid in office at time of exam. She had labs drawn. She was sent home on a steroid course and allergy medications. Patient had improvement of heart rate and some symptoms following IV fluids. On 7/3/18 due to ongoing pain, she underwent an ultrasound of the injection site to evaluate for blood clot. this test was negative.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm became painful, red, hot, swollen and then a dime sized blister formed, then popped, then reformed. Duration total 4 - 5 days.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Lethargy
Clinical narrative: High fever, lethargy, Pain at injection site that expanded, became hard, and had redness and inflammation. The reaction was spreading down arm. Continued for 5 days.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: High fever, lethargy, Pain at injection site that expanded, became hard, and had redness and inflammation. The reaction was spreading down arm. Continued for 5 days.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Has had site soreness since day after immunization. Call to office today 7/5/2018 to report continued site soreness. No problem with range of motion. Will continue to monitor and follow-up as needed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Patient returned to pharmacy 23 days after administration complaining of activity limiting muscle pain from shoulder to fingers in left arm. Patient states that pain began as soon as vaccine administered and has remained constant since administration. Patient sought medical treatment after the event and received a medrol dose pack the next day after administration.
Sex: M
Vaccine: CHOL
Symptoms: Expired product administered
Clinical narrative: This spontaneous case report was received from medical assistant (PVX2018-1149) on 19-Apr-2017. The report describes a male consumer who "consumed expired VAXCHORA". The consumer was receiving VAXCHORA (lot number: 7000002; expiry date: Feb 2018) for cholera vaccine. It was reported that a medical assistant gave an expired pack of VAXCHORA to the consumer and the consumer took it on the same day (19-Apr-2018). The action taken with VAXCHORA with respect to the event "consumed expired VAXCHORA" was not applicable. The clinical outcome of the event "consumed expired VAXCHORA" was unknown. The causality of the event "consumed expired VAXCHORA" was considered as not applicable. Sender's Comments: The causality of the event "consumed expired VAXCHORA" was considered as not applicable.
Age: 22.0
Sex: F
Vaccine: CHOL
Symptoms: Oral administration complication
Clinical narrative: This spontaneous case report was received from a nurse (PVX2018-1725) on 01-Jun-2018. The report describes a 22-year-old adult female consumer who "ate granola bar 45 minutes before receiving VAXCHORA". The consumer was receiving oral VAXCHORA as cholera vaccine. It was reported that consumer took the first dose of VAXCHORA on 01-Jun-2018. She ate a granola bar 45 minutes before the taking the dose. The action taken with VAXCHORA with respect to the event "ate granola bar 45 minutes before receiving VAXCHORA" was not applicable. The clinical outcome of the event "ate granola bar 45 minutes before receiving VAXCHORA" was unknown. Sender's Comments: Company's Comment: The causality of the event "ate granola bar 45 minutes before receiving VAXCHORA" was considered as not applicable.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 18 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. Approximately in April 2018, reported as 2 months ago, the patient was vaccinated with one dose GARDASIL 9 by an intramuscular route of administration (dose, lot # and expiration date were not provided) for prevention of HPV. It was reported that, on the same date, the patient fainted (syncope) shortly after receiving the vaccine. The reporter stated that the patient recovered the same day the vaccine was administered while in the office. The causality between the event and GARDASIL 9 was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a physician/MD for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2011, the patient was inoculated with ZOSTAVAX at a healthcare facility/office for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUL-2016, the patient was treated (by an unspecified healthcare professional) at a healthcare facility/office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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 was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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. On or about 05-JUN-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, 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 condition of herpes zoster. On or about 21-APR-2015, the patient was treated at the clinic by a physician for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX and oxycodone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 12-JUN-2017, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-OCT-2007, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. On or about 01-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. On or about 15-JUL-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 23-AUG-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and lidocaine for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Lip swelling, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a 87-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included NORTHERA, XARELTO, paroxetine and SYNTHROID. On 21st June 2018, the patient received SHINGRIX. On 21st June 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities. On 22nd June 2018, the patient experienced lip swelling. On 24th June 2018, the patient experienced back pain and stiff back. On an unknown date, the outcome of the lip swelling was unchanged and the outcome of the back pain, stiff back and erythema of extremities were recovering/resolving. The reporter considered the lip swelling, back pain, stiff back and erythema of extremities to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient reported that a swollen lip, redness on the arm, near the elbow rather than at the injection site which was given higher up the arm, and back pain after receiving SHINGRIX. The patient noted she could not get out of bed. At time of reporting, symptoms had improved except for the swollen lip.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site pain, Product availability issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness at injection site for 3 to 4 days and redness for another 5 days. The patient was upset because of availability of the product and was unable to find pharmacy with product in stock, which led to incomplete course of vaccination. The patient did not provide further details.
Age: 64.0
Sex: F
Vaccine: FLU4, HEP, VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Injection site discolouration, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of prickly heat in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis and Hepatitis B vaccine for prophylaxis. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml, Influenza vaccine 2017-2018 season and Hepatitis B vaccine. On 23rd April 2018, 3 days after receiving SHINGRIX, Influenza vaccine 2017-2018 season and Hepatitis B vaccine, the patient experienced prickly heat, fever, chills, extensive swelling of vaccinated limb, injection site discoloration, pain in arm, burning skin and itchy rash. On an unknown date, the outcome of the prickly heat, burning skin and itchy rash were not recovered/not resolved and the outcome of the fever, chills, extensive swelling of vaccinated limb, injection site discoloration and pain in arm were recovered/resolved. The reporter considered the prickly heat, fever, chills, extensive swelling of vaccinated limb and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration, burning skin and itchy rash to be related to SHINGRIX. It was unknown if the reporter considered the prickly heat, fever and chills to be related to Influenza vaccine 2017-2018 season and Hepatitis B vaccine. Additional details were provided as follows: The patient received flu shot or hepatitis B in the right arm. The patient received the SHINGRIX in left arm. The patient had a prickly rash appear 3 days after the vaccination. The patient also had the other side effects of fever, chills, swelling of her arm from her elbow to her shoulder, big round bulls eye at the site of the injection and her arm was very sore these all had resolved. The first case of the prickly rash which she described as very painful, felt like a burn and was itchy and resolved, but the rash reappeared past Thursday before the time of reporting. The patient was given either the flu shot or Hepatitis B shot in the right arm on the same date but she could not remember which. The patient was constantly being vaccinated due to the nature of her job but she had not experienced this effects before.
Age: 64.0
Sex: F
Vaccine: FLU4, HEP, VARZOS
Symptoms: Rash pruritic, Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of prickly heat in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis and Hepatitis B vaccine for prophylaxis. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml, Influenza vaccine 2017-2018 season and Hepatitis B vaccine. On 23rd April 2018, 3 days after receiving SHINGRIX, Influenza vaccine 2017-2018 season and Hepatitis B vaccine, the patient experienced prickly heat, fever, chills, extensive swelling of vaccinated limb, injection site discoloration, pain in arm, burning skin and itchy rash. On an unknown date, the outcome of the prickly heat, burning skin and itchy rash were not recovered/not resolved and the outcome of the fever, chills, extensive swelling of vaccinated limb, injection site discoloration and pain in arm were recovered/resolved. The reporter considered the prickly heat, fever, chills, extensive swelling of vaccinated limb and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration, burning skin and itchy rash to be related to SHINGRIX. It was unknown if the reporter considered the prickly heat, fever and chills to be related to Influenza vaccine 2017-2018 season and Hepatitis B vaccine. Additional details were provided as follows: The patient received flu shot or hepatitis B in the right arm. The patient received the SHINGRIX in left arm. The patient had a prickly rash appear 3 days after the vaccination. The patient also had the other side effects of fever, chills, swelling of her arm from her elbow to her shoulder, big round bulls eye at the site of the injection and her arm was very sore these all had resolved. The first case of the prickly rash which she described as very painful, felt like a burn and was itchy and resolved, but the rash reappeared past Thursday before the time of reporting. The patient was given either the flu shot or Hepatitis B shot in the right arm on the same date but she could not remember which. The patient was constantly being vaccinated due to the nature of her job but she had not experienced this effects before.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a adult male patient who received SHINGRIX for prophylaxis. On 18th May 2018, the patient received the 1st dose of SHINGRIX. On 19th May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, arthralgia, chills, myalgia, nausea and fever. On an unknown date, the outcome of the headache, arthralgia, chills, myalgia, nausea and fever were recovered/resolved. The reporter considered the headache, arthralgia, chills, myalgia, nausea and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The lot number or expiration date was not provided. The reporting physician was the patient, who experienced the events lasting for approximately 24 hours. The vaccine was administered in a pharmacy. The healthcare professional did not provide further information.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a adult male patient who received SHINGRIX for prophylaxis. On 18th May 2018, the patient received the 1st dose of SHINGRIX. On 19th May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, arthralgia, chills, myalgia, nausea and fever. On an unknown date, the outcome of the headache, arthralgia, chills, myalgia, nausea and fever were recovered/resolved. The reporter considered the headache, arthralgia, chills, myalgia, nausea and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The lot number or expiration date was not provided. The reporting physician was the patient, who experienced the events lasting for approximately 24 hours. The vaccine was administered in a pharmacy. The healthcare professional did not provide further information.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st June 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved. The reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: On Tuesday, 17:30 the patient received SHINGRIX on the left arm. The patient was given the vaccine and then woke up on Thursday with a rash at the top of her back. By Friday night, the patient had shingles. The patient had to go to the urgent care Saturday evening and had shingles on the right side of her back, shoulder and arm. The name of the physician was provided.