chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from other health care professional (Medical assistant). This case is linked to case 2018SA196604 for twin with initial CD. This case involves a 20 years old male patient who was given BEXSERO instead of [MENACTRA]. The patients past medical history, concomitant medication and family history were not provided. On 16-Jul-2018, the patient received a 0.5ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5841Aa, expiry date 08 Mar 2019 via intramuscular route in the left deltoid instead of injection of BEXSERO not produced by Sanofi Pasteur lot number not reported. The patient had already had two doses of MENACTRA previously and this would have been a third unneeded dose. It was unknown whether patient experienced any adverse reaction after the injection. 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 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: MEN, MNQ
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Initial unsolicited report received from nurse on 16-July-2018. This case involves a patient (age and gender not reported) who was vaccinated with an extra dose of MENACTRA 0.5 ml intramuscularly in left arm on 11 July 2018 instead of Meningococcal vaccine B (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines). It was reported that 2 doses of MENACTRA were given at scheduled times. This was a 3rd dose given in error. Patient was supposed to receive meningococcal B but received another MENACTRA vaccine. Patient received second dose on 02 April 2018. It was an actual medication error due to extra dose administered and wrong vaccine administered. Patient was doing fine. 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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from physician (Practitioner) on 17-JUL-2018. This case is linked with case 1-1431861995 (2018SA198341) (same reporter). This case involves a four-month old male patient who was vaccinated with an expired dose of PENTACEL in left thigh (Batch number: C5400AA, expiration date: 24 June 2018, dose, route of administration was not reported) on 17 July 2018. Package: NDC: 4928151005, Lot: C5400AA, exp date: JUN242018, DTAP IPV: NDC 4928156005, LOT: 64999AB, exp. date: 24JUN2018, HIB vial: NDC 4928154515, LOT: C5400AA, exp date: 24JUN2018. It was an actual medication error due to expired vaccine used. It was not reported whether any adverse events occurred. 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: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from physician (Practitioner) 17-JUL-2018. This case is linked with case 1-1432083702 (2018SA198300, male patient) (same reporter). This case involves a four-month old female patient who was vaccinated with an expired dose of PENTACEL in left thigh (Batch number: C5400AA, expiration date: 24 June 2018, dose, route of administration was not reported) on 17 July 2018. It was an actual medication error due to expired vaccine used. It was not reported whether any adverse events occurred. 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 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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA183350, 2018SA201512, 2018SA201513, 2018SA201514. This case involves a four-years old patient (gender not reported) who received a IPOL from shipment which should be returned due to it being in transport a day longer than it should have, no adverse event. This is the case of actual medication error as the vaccine was administered to the patient, which was incorrectly stored. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose 0.5 ml of suspect IPV, lot N1K92 via unknown route in unknown administration site on 12 Jun 2018. Caller reported that by the time they received notification that their IPOL shipment should be returned due to it being in transport a day longer than it should have, they had administered 5 doses to patients already. All of the patients were 4 years of age. It is unknown who administered each dose. There were no adverse reactions reported for any of the patients who received the doses. The doses were administered on June 8th, June 12th, June 13th, June 14th, June 18th and June 21st. Caller stated they were aware that the parents will have to be notified and the children will have to be re-vaccinated. Caller stated that she had already talked to someone about returning the shipment. 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: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Same day of injection, patient spiked fever 102. injection site red and sore. She c/o nausea and joint pain. Ibuprofen did bring fever down and relieved joint pain.
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging spinal, Pain, X-ray limb
Clinical narrative: Parsonage Turner Syndrome (extreme pain began April 10, 2018; diagnosed late April, 2018).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: Extreme pain in right arm, unable to raise arm for 3 days. Extreme redness and selling at the shot site. Nausea night of inoculation - continued for one day. Note: Husband received same inoculation from same batch with no side effects except mild pain at site on right shoulder. Husband's pain subsided within 24 hours.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-JUL-2018 the patient was vaccinated with an improperly stored  dose of VAQTA (lot # R003739 exp date 17-MAR-2019) (dose not reported) intramuscularly. There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1807USA010173: US-009507513-1807USA010174: US-009507513-1807USA010175: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010178: US-009507513-1807USA010214:
Sex: M
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure via skin contact, Occupational exposure to product, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 1 year old male patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, during the process of withdrawing the reconstituted VARIVAX (lot # N034553; expiry date: 05-DEC-2019) for prophylaxis from the vial into syringe, "it just sprayed like an aerosol can all over nurse's hands, arms and the counter top, very little liquid went into syringe", due to which, the patient missed his dose during the office visit (accidental exposure to product, drug dose omission). A 25-gauge 5/8 inch needle and 3cc syringe was used which was inside the vial when the leaking occurred and the product vial was pierced with once. The syringe needle was free of any obstruction and was below the liquid line. The spray was from the vial and was forceful. The sterile diluent (MERCK STERILE DILUENT) (unknown lot and expiration date) used for reconstitution was stored at a temperature between 2 Celsius (C) to 8C. Very little was withdrawn in the syringe since most of the product sprayed on the nurse and counter top. It was reported that the reporter already disposed of sterile diluent (MERCK STERILE DILUENT) and syringe. She only had the VARIVAX vial that could be retrieved from the office. A Product quality complaint was filed.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown gender, over the age of 12. No medical history, concurrent condition and concomitant medications were reported. On 09-JUL-2018 the patient was vaccinated with PROQUAD (lot#R004441, expiry date AUG-2019) for prophylaxis (drug administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (Merck sterile diluent). No adverse effect was reported. No product quality complaint was present.
Sex: F
Vaccine: HPV4
Symptoms: Exposure to communicable disease
Clinical narrative: This spontaneous report was received from a physician assistant refers to herself, a female patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. Approximately on an unknown date in July-2006 (reported as 12 years ago), the patient was vaccinated with GARDASIL for prophylaxis (lot#, expiry date, route and dosage details were not reported). Approximately on an unknown date in July-2016 (reported as 2 years ago), the physician assistant was potentially exposed to an unknown type of human papillomavirus (HPV) during a procedure to burn off anal warts in a patient. It was known that the anal warts were HPV positive, but the physician assistant did not know exactly what HPV type. The physician assistant also had not been tested for HPV since this procedure and did not know if she was HPV positive. The outcome of the events was unknown. The reporter did not provide any causality assessment. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA009641.
Sex: M
Vaccine: HPV9
Symptoms: Culture negative, Diarrhoea, Injection site swelling, Laboratory test, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 12 years old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 27-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 in the left deltoid, lot# N026812 and 22-JUN-2020 expiration date, for prophylaxis (strength and frequency were not reported). Then, on 02-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 in the right deltoid, lot# N026812 and 22-JUN-2020  expiration date for prophylaxis (strength and frequency were not reported). On 03-JUL-2018, the parent of the patient contacted the physician and reported that the patient's right shoulder up to his neck was swollen and he had pain (pain and swelling). The patient's was seen in the physician's office and was treated with ibuprofen (manufacturer unknown) and ice. On 04-JUL-2018, the patient's pain increased and the patient was experiencing diarrhea with a fever of 101 (pyrexia), then patient was instructed to bring the patient to an unspecified emergency room. In the unspecified emergency room an unspecified labs and sonogram were performed. The sonogram showed the lymph nodes were swollen on the right side (lymphadenopathy), but there was no drainage. In the emergency room the patient was treated with clindamycin (manufacturer unknown). Additionally, unspecified cultures were made and came back negative. The patient was discharged on 04-JUL-2018 and put on oral clindamycin for 3 days. On 09-JUL-2018, the patient returned to physician's office with no fever, decreased swelling and slight discomfort when moving the right arm. On 12-JUL-2018, the patient had recovered from the events.
Sex: M
Vaccine: HPV9
Symptoms: Pain, Pyrexia, Ultrasound scan abnormal
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 12 years old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 27-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 in the left deltoid, lot# N026812 and 22-JUN-2020 expiration date, for prophylaxis (strength and frequency were not reported). Then, on 02-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 in the right deltoid, lot# N026812 and 22-JUN-2020  expiration date for prophylaxis (strength and frequency were not reported). On 03-JUL-2018, the parent of the patient contacted the physician and reported that the patient's right shoulder up to his neck was swollen and he had pain (pain and swelling). The patient's was seen in the physician's office and was treated with ibuprofen (manufacturer unknown) and ice. On 04-JUL-2018, the patient's pain increased and the patient was experiencing diarrhea with a fever of 101 (pyrexia), then patient was instructed to bring the patient to an unspecified emergency room. In the unspecified emergency room an unspecified labs and sonogram were performed. The sonogram showed the lymph nodes were swollen on the right side (lymphadenopathy), but there was no drainage. In the emergency room the patient was treated with clindamycin (manufacturer unknown). Additionally, unspecified cultures were made and came back negative. The patient was discharged on 04-JUL-2018 and put on oral clindamycin for 3 days. On 09-JUL-2018, the patient returned to physician's office with no fever, decreased swelling and slight discomfort when moving the right arm. On 12-JUL-2018, the patient had recovered from the events.
Sex: F
Vaccine: DTAP, MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient had no further vaccination history. The patient's other concurrent condition, medical history and concomitant therapy were not reported. On an unknown date (reported as "prior to school"), the patient was vaccinated with (Wistar RA 27-3) M-M-R II (dose, strength, route, lot# and expiration date unknown) for vaccination for school. The patient also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose, strength, route, lot# and expiration date unknown) for vaccination for school. On an unknown date, the patient had "medium titers" after receiving the vaccines. The outcome for "medium titer" was unknown. The reporter considered medium titers to be related with the suspect vaccines.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report has been received from the patient's cousin, concerning a 17 year old female patient. The patient's concurrent conditions and concomitant medications were unknown by reporter. Medical history included passing out on an unknown date. On 03-JUL-2018, the patient was vaccinated with the first of GARDASIL 9 0.5 ml, intramuscularly in the deltoid (frequency, lot number and expiration date were unknown by reporter) for prevention of human papillomavirus. On 03-JUL-2018, the patient passed out twice between medical office and her home. The patient sought medical attention and it was unknown by reporter if the patient received any treatment for the adverse event. There were none laboratories or studies performed. The outcome of syncope was reported as recovered. The causal relationship between the adverse event and the therapy was not assessed.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Polyneuropathy, 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 17-JUL-2014, at a pharmacy, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided), as recommended for routine adult health maintenance and for the long-term 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 15-SEP-2015, the patient was treated at a clinic by a certified physician assistant (PA-C) for the onset of a vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir and hydrocodone for management of her painful symptoms and chronic pain. On or about 29-SEP-2015, the patient sought subsequent treatment from the clinic, for a painful condition that affects the nerves of the skin, which was diagnosed as shingles polyneuropathy. The patient was prescribed LACLOTION, gabapentin and KEFLEX for management of her painful symptoms and excruciating pain. 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. Upon internal review, shingles polyneuropathy was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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 2009, the patient was inoculated with the ZOSTAVAX vaccine by physician as recommended for routine adult health maintenance for the long term 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, also known as shingles and other complications. On or about 13-NOV-2014, the patient was treated by a physician for severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir and hydrocodone for management of her painful symptoms and chronic pain. 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: M
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 male 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 Medical Center as recommended for routine adult health maintenance for the long term 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 25-JUL-2016 , the patient was treated by a physician at a Medical center for the 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the long term 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 25-NOV-2015, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as severe herpes zoster. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. 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: M
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 male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-APR-2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term 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 30-OCT-2013, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. 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: 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 2016, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term 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.  Later in 2016, the patient was treated at a hospital for the onset of a 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 outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included DILUENT MRK INJ used to reconstitute the (Oka-Merck) PROQUAD was properly stored. On 11-JUN-2018, the patient was vaccinated with improperly stored doses of (Oka-Merck) PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of (Oka-Merck) PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the medical assistant refers to a 4 year old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included sterile diluent (DILUENT MRK INJ) used to reconstitute the PROQUAD was properly stored. On 11-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments:  US-009507513-1806USA001756:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were not reported. On 10-JUL-2018, the patient was vaccinated with improperly stored Oka/Merck VARIVAX (lot # N034552, expiration date 05-DEC-2019) subcutaneously for prophylaxis (Product storage error), which was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1807USA010240.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JUL-2018 the patient was vaccinated with an improperly stored dose of VAQTA (lot # R003739, exp date 17-MAR-2019) (dose not reported) intramuscularly. There was a data logger issue reported. The temperature of excursion was 32 degrees F up to 35 degrees F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1807USA004813; US-009507513-1807USA010174; US-009507513-1807USA010175; US-009507513-1807USA010176; US-009507513-1807USA010177; US-009507513-1807USA010178; US-009507513-1807USA010214.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-JUL-2018 the patient was vaccinated with an improperly stored  dose of RECOMBIVAX HB (lot # R006746 exp date 09-NOV-2020) (dose not reported) intramuscularly.  There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1807USA004813: US-009507513-1807USA010173: US-009507513-1807USA010175: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010178: US-009507513-1807USA010214.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-JUL-2018 the patient was vaccinated with an improperly stored  dose of ROTATEQ (lot # N030174 exp date 13-JUN-2019) (dose not reported) orally. There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1807USA004813: US-009507513-1807USA010173: US-009507513-1807USA010174: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010178: US-009507513-1807USA010214:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-JUL-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # N030965, exp date 25-AUG-2019) (dose not reported) orally. There was a data logger issue reported. The temperature of excursion was 32 degrees F up to 35 degrees F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1807USA004813; US-009507513-1807USA010173; US-009507513-1807USA010174; US-009507513-1807USA010175; US-009507513-1807USA010177; US-009507513-1807USA010178; US-009507513-1807USA010214.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JUL-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # N030965, exp date 25-AUG-2019) (dose not reported) orally. There was a data logger issue reported. The temperature of excursion was 32 degrees F up to 35 degrees F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1807USA004813; US-009507513-1807USA010173; US-009507513-1807USA010174; US-009507513-1807USA010175; US-009507513-1807USA010176; US-009507513-1807USA010178; US-009507513-1807USA010214.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JUL-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # N030965 exp date 25-AUG-2019) (dose not reported) orally. There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1807USA004813: US-009507513-1807USA010174: US-009507513-1807USA010175: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010173: US-009507513-1807USA010214.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JUL-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # N030965 exp date 25-AUG-2019) (dose not reported) orally and an improperly stored dose of RECOMBIVAX HB (lot # R006746 exp date 09-NOV-2020) (dose and route not reported). There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1807USA010173: US-009507513-1807USA010174: US-009507513-1807USA010175: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010178: US-009507513-1807USA004813:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were not reported. On 13-JUL-2018, the patient was vaccinated with improperly stored Oka/Merck VARIVAX)(lot # N034552, expiration date 05-DEC-2019) subcutaneously for prophylaxis (Product storage error), which was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two cases from the same reporter. Sender's comments: US-009507513-1807USA009599.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 3 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 25-JAN-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site cellulitis, injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site cellulitis, injection site pain, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site cellulitis, injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced pain, swelling and redness at the injection site, which progressed into cellulitis and lasted for more than 3 days. This was the only information reported to the field representative. No additional details were provided.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Extensive swelling of vaccinated limb, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 47-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On 17th May 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema, pain, fever and dry skin. On 17th June 2018, the outcome of the extensive swelling of vaccinated limb was recovered/resolved. On an unknown date, the outcome of the erythema, pain, fever and dry skin were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, pain, fever and dry skin to be related to SHINGRIX. Additional details were received as follows: The patient had multiple other health issues. It was unknown if the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if health care professional consider the event to be life threatening. It was unknown if health care professional consider the event(s) to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the event require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. The reporter received a text that the patient needed her second shingle shot. The patient was insisted to take SHINGRIX. The patient experienced red dry area, pain unusual, feverish for two days and swelling to below elbow.
Age: 3.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age and gender not reported) who was inadvertently administered only the diluent from an ACT-HIB vaccine. The patient's past medical history, medical treatment, vaccination and family history were not provided. On 26-Jun-2018, the patient received a primary fourth dose of suspect HIB (PRP/T) VACCINE lot UI916AAA via intramuscular route in the left deltoid. It was an actual medication error due to wrong technique in product usage process. Final diagnosis was lpn inadvertently administered only the diluent from an acthib vaccine that had not been/no signs or symptoms of adverse (Wrong injection technique). 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient (age and gender not reported) who was vaccinated with expired dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Jul-2018, the patient received a dose of suspect PENTACEL lot C5388AA. It was an actual medication error due to expired product administered. It was unknown if 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 and Module VI of the 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: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Hyperhidrosis, Nausea
Clinical narrative: Received first dose SHINGRIX on 7/16/18, experienced excessive soreness extending under arm and nausea next morning and sweating.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Headache, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Received second SHINGRIX 50mcg inoculation in upper left (non-dominant arm) on 29 June 2018 from pharmacist at local pharmacy. Within six hours a red splotch began developing below (not at) the injection site. The splotch spread until it covered the entire upper arm bicep area including site, (which is large due to gym workouts) and was extremely sore to touch and squishy. It was bright red, like the very first hours of a very serious sun burn and remained that way for a week. At same time went to bed for two days with fever, chills, headaches, general malaise, and aching all over the body. After two days returned to more normal function but soreness and significant heat remained in red upper arm. After about two weeks red spot gradually diminished in color but not size, its outline and slighter tenderness and slight discoloration over entire area of red upper arm remain after two weeks. Tissue under continued discolored area remains squishy with slight soreness unlike right arm. Additional info: received a second pneumonia shot in upper right arm at same time with no noticeable reaction. I am a 69 year old male in extremely good health.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: Received second SHINGRIX 50mcg inoculation in upper left (non-dominant arm) on 29 June 2018 from pharmacist at local pharmacy. Within six hours a red splotch began developing below (not at) the injection site. The splotch spread until it covered the entire upper arm bicep area including site, (which is large due to gym workouts) and was extremely sore to touch and squishy. It was bright red, like the very first hours of a very serious sun burn and remained that way for a week. At same time went to bed for two days with fever, chills, headaches, general malaise, and aching all over the body. After two days returned to more normal function but soreness and significant heat remained in red upper arm. After about two weeks red spot gradually diminished in color but not size, its outline and slighter tenderness and slight discoloration over entire area of red upper arm remain after two weeks. Tissue under continued discolored area remains squishy with slight soreness unlike right arm. Additional info: received a second pneumonia shot in upper right arm at same time with no noticeable reaction. I am a 69 year old male in extremely good health.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Rash macular
Clinical narrative: Received second SHINGRIX 50mcg inoculation in upper left (non-dominant arm) on 29 June 2018 from pharmacist at local pharmacy. Within six hours a red splotch began developing below (not at) the injection site. The splotch spread until it covered the entire upper arm bicep area including site, (which is large due to gym workouts) and was extremely sore to touch and squishy. It was bright red, like the very first hours of a very serious sun burn and remained that way for a week. At same time went to bed for two days with fever, chills, headaches, general malaise, and aching all over the body. After two days returned to more normal function but soreness and significant heat remained in red upper arm. After about two weeks red spot gradually diminished in color but not size, its outline and slighter tenderness and slight discoloration over entire area of red upper arm remain after two weeks. Tissue under continued discolored area remains squishy with slight soreness unlike right arm. Additional info: received a second pneumonia shot in upper right arm at same time with no noticeable reaction. I am a 69 year old male in extremely good health.