chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA, HPV9, PNC13, HPV9
Symptoms: Vaccination error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of three years old. The patient's pertinent medical history, concurrent condition and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 19-APR-2018 the patient was vaccinated with a dose GARDASIL 9, 1 DF, intramuscularly for prophylaxis. No adverse effects reported. No product quality complaint involved.
Sex: U
Vaccine: HEPA, HPV9, PNC13, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of three years old. The patient's pertinent medical history, concurrent condition and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 19-APR-2018 the patient was vaccinated with a dose GARDASIL 9, 1 DF, intramuscularly for prophylaxis. No adverse effects reported. No product quality complaint involved.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a medical assistant regarding a pediatric patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant medications were unknown. On 05-APR-2018, the pediatric patient was inadvertently vaccinated with one adult dose of VAQTA 50/1.0 U/mL (lot # N028743, expiry 23-NOV-2018, intramuscularly) for prophylaxis. No adverse effect was reported. No PQC was involved.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a pediatric patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant medications were unknown. On 05-APR-2018, the pediatric patient was inadvertently vaccinated with one adult dose of VAQTA 50/1.0 U/mL (lot # N028743, expiry 23-NOV-2018, intramuscularly) for prophylaxis. No adverse effect was reported. No PQC was involved.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast discomfort, Breast pain, Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date unknown). Concomitant products included calcium + Colecalciferol and fish oil capsule. On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th April 2018, 1 days after receiving SHINGRIX, the patient experienced breast tenderness and breast heaviness. On 13th April 2018, the patient experienced rash. In April 2018, the patient experienced burning sensation skin, pain of skin, injection site pain, sleeplessness and pain. On 17th April 2018, the patient experienced shingles. On an unknown date, the patient experienced skin discomfort and injection site injury. On an unknown date, the outcome of the shingles, sleeplessness and pain were unknown and the outcome of the breast tenderness, burning sensation skin, pain of skin, rash, skin discomfort and breast heaviness were not recovered/not resolved and the outcome of the injection site pain and injection site injury were recovered/resolved. The reporter considered the shingles, breast tenderness, burning sensation, pain of skin, rash, skin discomfort, breast heaviness, sleeplessness and pain to be related to SHINGRIX. The reporter considered the injection site pain and injection site injury to be probably related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient was able to provide the lot number but did not have the expiry date of SHINGRIX. The patient stated that she received the SHINGRIX vaccine last Wednesday on 11th April 2018 and 24 hours after receiving SHINGRIX, she noticed breast tenderness and heaviness on her right side. The patient stated that on Friday that is on 13th April 2018, she noticed 2 quarter sized rashes under the right armpit area and she ignored it at first but then it began spreading and by Sunday she had a rash on the right breast and right deltoid area. The patient called the advice line at her doctor's office, and sent a photo to her doctor and her doctor told her that it looked like shingles. The patient was also experiencing a painful sensation and pressure at the site of the rash she also stated that she had injection site pain for 3 days and there was a puncture at the injection site that she described as a little red dot like a bull's eye. The patient called to provide updated details as treating physician officially diagnosed symptoms as shingles on Tuesday 17th April 2018. The patient also reported inability to sleep at night due to intense burning and pain.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast discomfort, Breast tenderness, Herpes zoster, Injection site injury, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date unknown). Concomitant products included calcium + Colecalciferol and fish oil capsule. On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th April 2018, 1 days after receiving SHINGRIX, the patient experienced breast tenderness and breast heaviness. On 13th April 2018, the patient experienced rash. In April 2018, the patient experienced burning sensation skin, pain of skin, injection site pain, sleeplessness and pain. On 17th April 2018, the patient experienced shingles. On an unknown date, the patient experienced skin discomfort and injection site injury. On an unknown date, the outcome of the shingles, sleeplessness and pain were unknown and the outcome of the breast tenderness, burning sensation skin, pain of skin, rash, skin discomfort and breast heaviness were not recovered/not resolved and the outcome of the injection site pain and injection site injury were recovered/resolved. The reporter considered the shingles, breast tenderness, burning sensation, pain of skin, rash, skin discomfort, breast heaviness, sleeplessness and pain to be related to SHINGRIX. The reporter considered the injection site pain and injection site injury to be probably related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient was able to provide the lot number but did not have the expiry date of SHINGRIX. The patient stated that she received the SHINGRIX vaccine last Wednesday on 11th April 2018 and 24 hours after receiving SHINGRIX, she noticed breast tenderness and heaviness on her right side. The patient stated that on Friday that is on 13th April 2018, she noticed 2 quarter sized rashes under the right armpit area and she ignored it at first but then it began spreading and by Sunday she had a rash on the right breast and right deltoid area. The patient called the advice line at her doctor's office, and sent a photo to her doctor and her doctor told her that it looked like shingles. The patient was also experiencing a painful sensation and pressure at the site of the rash she also stated that she had injection site pain for 3 days and there was a puncture at the injection site that she described as a little red dot like a bull's eye. The patient called to provide updated details as treating physician officially diagnosed symptoms as shingles on Tuesday 17th April 2018. The patient also reported inability to sleep at night due to intense burning and pain.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Pain of skin, Rash, Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date unknown). Concomitant products included calcium + Colecalciferol and fish oil capsule. On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th April 2018, 1 days after receiving SHINGRIX, the patient experienced breast tenderness and breast heaviness. On 13th April 2018, the patient experienced rash. In April 2018, the patient experienced burning sensation skin, pain of skin, injection site pain, sleeplessness and pain. On 17th April 2018, the patient experienced shingles. On an unknown date, the patient experienced skin discomfort and injection site injury. On an unknown date, the outcome of the shingles, sleeplessness and pain were unknown and the outcome of the breast tenderness, burning sensation skin, pain of skin, rash, skin discomfort and breast heaviness were not recovered/not resolved and the outcome of the injection site pain and injection site injury were recovered/resolved. The reporter considered the shingles, breast tenderness, burning sensation, pain of skin, rash, skin discomfort, breast heaviness, sleeplessness and pain to be related to SHINGRIX. The reporter considered the injection site pain and injection site injury to be probably related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient was able to provide the lot number but did not have the expiry date of SHINGRIX. The patient stated that she received the SHINGRIX vaccine last Wednesday on 11th April 2018 and 24 hours after receiving SHINGRIX, she noticed breast tenderness and heaviness on her right side. The patient stated that on Friday that is on 13th April 2018, she noticed 2 quarter sized rashes under the right armpit area and she ignored it at first but then it began spreading and by Sunday she had a rash on the right breast and right deltoid area. The patient called the advice line at her doctor's office, and sent a photo to her doctor and her doctor told her that it looked like shingles. The patient was also experiencing a painful sensation and pressure at the site of the rash she also stated that she had injection site pain for 3 days and there was a puncture at the injection site that she described as a little red dot like a bull's eye. The patient called to provide updated details as treating physician officially diagnosed symptoms as shingles on Tuesday 17th April 2018. The patient also reported inability to sleep at night due to intense burning and pain.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date unknown). Concomitant products included calcium + Colecalciferol and fish oil capsule. On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th April 2018, 1 days after receiving SHINGRIX, the patient experienced breast tenderness and breast heaviness. On 13th April 2018, the patient experienced rash. In April 2018, the patient experienced burning sensation skin, pain of skin, injection site pain, sleeplessness and pain. On 17th April 2018, the patient experienced shingles. On an unknown date, the patient experienced skin discomfort and injection site injury. On an unknown date, the outcome of the shingles, sleeplessness and pain were unknown and the outcome of the breast tenderness, burning sensation skin, pain of skin, rash, skin discomfort and breast heaviness were not recovered/not resolved and the outcome of the injection site pain and injection site injury were recovered/resolved. The reporter considered the shingles, breast tenderness, burning sensation, pain of skin, rash, skin discomfort, breast heaviness, sleeplessness and pain to be related to SHINGRIX. The reporter considered the injection site pain and injection site injury to be probably related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient was able to provide the lot number but did not have the expiry date of SHINGRIX. The patient stated that she received the SHINGRIX vaccine last Wednesday on 11th April 2018 and 24 hours after receiving SHINGRIX, she noticed breast tenderness and heaviness on her right side. The patient stated that on Friday that is on 13th April 2018, she noticed 2 quarter sized rashes under the right armpit area and she ignored it at first but then it began spreading and by Sunday she had a rash on the right breast and right deltoid area. The patient called the advice line at her doctor's office, and sent a photo to her doctor and her doctor told her that it looked like shingles. The patient was also experiencing a painful sensation and pressure at the site of the rash she also stated that she had injection site pain for 3 days and there was a puncture at the injection site that she described as a little red dot like a bull's eye. The patient called to provide updated details as treating physician officially diagnosed symptoms as shingles on Tuesday 17th April 2018. The patient also reported inability to sleep at night due to intense burning and pain.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MENB, HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was given to patient at time of visit. Vaccine expired on 3/31/2018. Mother was called and notified of the event and the need to re-vaccinate by Provider. Mother verbalized understanding.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MENB, HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given to patient at time of visit. Vaccine expired on 3/31/2018. Mother was called and notified of the event and the need to re-vaccinate by Provider. Mother verbalized understanding.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Patient said she had a 100 fever the day after vaccine and has a 98 fever today (which is high for her) Sore arm that is getting better.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient said she had a 100 fever the day after vaccine and has a 98 fever today (which is high for her) Sore arm that is getting better.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: Severe fatigue, muscle pain in legs/arms back, chills/shivering/headaches...could barely walk without experiencing much pain. I am a healthy and fit athlete, and it took me down for 2 full days. Could not sleep through generalized muscle pain. This was worse then any full body flu symptons ever experienced.. I had just completed my annual physical 3 days prior..perfect lab work. Expected many of these symptons as it was listed in the information and warnings..however..this was far more debilitating and scary then anything described in the warnings, and the incidence of these symptons are more frequent on online information than described in the literature.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia
Clinical narrative: Severe fatigue, muscle pain in legs/arms back, chills/shivering/headaches...could barely walk without experiencing much pain. I am a healthy and fit athlete, and it took me down for 2 full days. Could not sleep through generalized muscle pain. This was worse then any full body flu symptons ever experienced.. I had just completed my annual physical 3 days prior..perfect lab work. Expected many of these symptons as it was listed in the information and warnings..however..this was far more debilitating and scary then anything described in the warnings, and the incidence of these symptons are more frequent on online information than described in the literature.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood culture negative, Erythema, Fall, Hypotension, Joint range of motion decreased
Clinical narrative: Patient had a severe local reaction with pain, swelling, erythema and limited range of motion. He also had a severe systemic reaction which included fever to 39.4, hypotension to 81/54, tachycardia to 130, and a fall at home after which he could not get up. The systemic reaction was not distinguishable from sepsis thought possibly due to treatment failure of doxycycline and amox/clav for treatment of cellulitis with polymicrobial abscess due to cat scratch. However, the infected site was well healing and all cultures at the time of illness were negative. Patient improved on Piperacillin/Tazobactam.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Pain, Polymerase chain reaction, Pyrexia, Swelling
Clinical narrative: Patient had a severe local reaction with pain, swelling, erythema and limited range of motion. He also had a severe systemic reaction which included fever to 39.4, hypotension to 81/54, tachycardia to 130, and a fall at home after which he could not get up. The systemic reaction was not distinguishable from sepsis thought possibly due to treatment failure of doxycycline and amox/clav for treatment of cellulitis with polymicrobial abscess due to cat scratch. However, the infected site was well healing and all cultures at the time of illness were negative. Patient improved on Piperacillin/Tazobactam.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tachycardia, Urine analysis normal
Clinical narrative: Patient had a severe local reaction with pain, swelling, erythema and limited range of motion. He also had a severe systemic reaction which included fever to 39.4, hypotension to 81/54, tachycardia to 130, and a fall at home after which he could not get up. The systemic reaction was not distinguishable from sepsis thought possibly due to treatment failure of doxycycline and amox/clav for treatment of cellulitis with polymicrobial abscess due to cat scratch. However, the infected site was well healing and all cultures at the time of illness were negative. Patient improved on Piperacillin/Tazobactam.
Age: 60.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified pharmacy technician refers to a patient of an unknown age and gender. The patient's relevant medical history and concurrent condition were not reported. On 07-APR-2018, the patient was inadvertently vaccinated with an expired dose of M-M-R II injection, lot#M011166 (expiry date: 31-MAR-2018), subcutaneous left arm for prophylaxis (dose not reported). Concomitant therapy included ZOSTAVAX; and sterile diluent (MRK) which was reconstituted with M-M-R II. The patient was in a 30 day period of expiration. The patient felt fine after vaccination, no adverse effect/ illness at the time of vaccination reported. No treatment was given for the event. No product quality complaint (PQC) was involved. There was no temperature excursion as a result of a reading from a digital data logger. Lot number [M011166] is an invalid lot number for M-M-R II.
Sex: F
Vaccine: HPVX
Symptoms: Alopecia, Emotional distress, Stress
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with the 1st, 2nd and 3rd doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) (Dose, frequency, anatomical location, route, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) (Dose, frequency, anatomical location, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date, after receiving her 3rd vaccination, it was noticed that her hair had fallen out. Approximately on an unknown date in 2017 (Also reported as over the past year), the patient's hair had completely fallen out and had not grown. The patient had then been diagnosed with alopecia. It was reported that there was nothing wrong with her before. All her labs had not suggested any disorders. It was reported that there were others who like the reporter had determined that the Human Papilloma Virus (HPV) vaccine was the main cause of their daughter's hair loss. It was reported that the patient went from donating her hair every 3 years to needing a wig of her own. This had caused so much stress in her life as she was then in high school and felt embarrassed. The reporter stated that something needed to be done about that situation. The outcome of the event of alopecia was not recovered. The outcome of the events of stress, emotional distress and product origin unknown was unknown. The causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a currently 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. The patient's concomitant medications included DILUENT MRK INJ lot# L040453 expiration date 17-MAY-2018. On an unspecified date, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD injection, subcutaneously, lot # N014758, and expiration date 08-NOV-2018, route not specified, for prophylaxis (dose number and anatomical location were not provided). The vaccine experienced a temperature excursion in the range between 6°F to 14°F during 36 hours as recorded by a data logger. Also, the vaccines had a previous temperature excursions in the range between 6°F to 14°F during 24 hours. There was no adverse effect reported. No further information was available. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1804USA007011: US-009507513-1804USA002530.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. The patient's concomitant medications included DILUENT MRK INJ lot# L040453 expiration date 17-MAY-2018. On an unspecified date, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD injection, subcutaneously, lot # N014758, and expiration date 08-NOV-2018, route not specified, for prophylaxis (dose number and anatomical location were not provided). The vaccine experienced a temperature excursion in the range between 6°F to 14°F during 36 hours as recorded by a data logger. Also, the vaccines had a previous temperature excursions in the range between 6°F to 14°F during 24 hours. There was no adverse effect reported. No further information was available. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1804USA006354: US-009507513-1804USA002530.
Sex: U
Vaccine: HIBV, HPV9, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to unknown number of patients of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with unknown number of doses of improperly stored PNEUMOVAX 23 injection (strength, dose and route of administration were not reported) (lot # M041686, expiration date: 20-MAY-2018), GARDASIL 9 (strength, dose and route of administration were not reported) (lot # N013276, expiration date: 21-JAN-2020 and lot # M043731, expiration date: 22-JUN-2019) and LIQUID PEDVAXHIB (strength, dose and route of administration were not reported) (lot # M046133, expiration date: 26-SEP-2019 and lot # M006710, expiration date: 06-DEC-2018) for prophylaxis (product storage error). The vaccines were stored in 53.4 degrees Fahrenheit (F) for 24 hours and 20 F for 2 weeks. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No other information was available. There was no product quality complaint (PQC) reported. This is a non-valid case due to lack of patient identifiers.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 15-APR-2018, the patient was vaccinated with expired dose of VAQTA (dose, units and frequency not reported) (lot # N005605 and expiration date: 08-APR-2018) intramuscularly (expired product administered). No adverse effect reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA012473.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 15-APR-2018,  the patient was inadvertently vaccinated with expired dose of VAQTA (dose, units and frequency not reported) (lot # N005605 and expiration date: 08-APR-2018) intramuscularly (expired product administered). No adverse effect reported. No product quality complaint was involved. Sender's Comments: US-009507513-1804USA008882:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 01-NOV-2017, the patient was vaccinated with first dose of GARDASIL 9 and the second dose of GARDASIL 9 (0.5 ml) intramuscularly for prophylaxis (lot # N022728, expiry date: 31-MAY-2020), on 19-APR-2018 (inappropriate schedule of drug administration). No adverse effects reported. No product quality complaint involved.
Sex: M
Vaccine: HEP, HPV9, MMR
Symptoms: No adverse event
Clinical narrative: Information has been received from a 26 year old male patient referring to himself. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with (wistar ra 27-3) M-M-R II, 1 DF (1 injection), (lot # N023154, expiry date: 24-AUG-2019) intramuscularly for prophylaxis, GARDASIL 9 and ENGERIX-B one hour apart (inappropriate schedule of drug administration). Per the prescribing information for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), it is indicated that (wistar ra 27-3) M-M-R II should be given one month before or after administration of other live viral vaccines. It was not indicated in the prescribing information that GARDASIL 9 is a live vaccine. It is uncertain if ENGERIX-B is or is not a live viral vaccine. Patient confirmed that he did not experience any adverse effects after taking the vaccines. No product quality complaint reported.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 44-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 20-APR-2018, the patient was vaccinated with expired dose of (wistar ra 27-3) M-M-R II therapy type rHA (dose, units and frequency unknown) (lot # M004305 and expiration date 25-JAN-2018). No adverse effects were reported. No product quality complaint was reported.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. Concomitant therapy included DILUENT MRK INJ. On 20-APR-2018 the patient was vaccinated with expired dose of (wistar ra 27-3) M-M-R II therapy type rHA (dose, units and frequency unknown) (lot # M016234 and expiration date 31-MAR-2018). The DILUENT MRK INJ (lot# N007760, expiration 31-MAY-2018), used for reconstitution of (wistar ra 27-3) M-M-R II was properly stored. It was reported the expired (wistar ra 27-3) M-M-R II had no temperature excursions prior to being administered. No adverse effects reported. No product quality complaint was reported.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 15 month old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included Diluent Mrk Inj. on 26-JAN-2018, the patient was vaccinated with M-M-R II (dose, units and frequency not reported) (lot# and expiration date unknown) subcutaneously and VARIVAX (dose, units and frequency not reported) (lot number and expiration date unknown) subcutaneously. On 18-APR-2018, the patient was vaccinated with M-M-R II (dose, units and frequency not reported) (lot# N013295 and expiration date: 28-APR-2019) subcutaneously and VARIVAX (dose, units and frequency not reported) (lot number N030406 and expiration date: 30-OCT-2019) subcutaneously. Patient had received second dose of M-M-R II and VARIVAX on 18-APR-2018, which was less than 3 months from previously administered dose of each vaccine on 26-JAN-2018 (inappropriate schedule of drug administration). No adverse effects reported. No product quality complaint was involved. Lot number [N013295] has been verified to be a valid lot number for M-M-R II.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from nurse refers to a 16 year old male patient. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. The patient's concomitant medication included DILUENT MRK INJ (lot # R002036, expiry date: 25-JAN-2020). On 20-APR-2018 the patient was vaccinated with incomplete dose of Oka-Merck PROQUAD injection (dosing details was not reported) (lot # N028443, expiry date: 09-APR-2019) subcutaneous for prophylaxis, due to needle leakage from patient movement. No adverse effects were reported. No product quality complaint was involved. Lot number [N028443] has been verified to be a valid lot number for (Oka-Merck PROQUAD. Albumin status for PROQUAD is recombinant human albumin (rHA).
Age: 21.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 21-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On an unknown date, the 21-year-old patient was inadvertently vaccinated with first dose of Oka-Merck) PROQUAD (dose, units, frequency, Lot# and expiry date unknown). It was reported that there were no state records that showed the patient was ever vaccinated with (wistar ra 27-3) M-M-R II or Oka/Merck VARIVAX. No adverse symptoms reported. No product quality complaint was reported.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 5 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 27-MAR-2018, the patient was administered an improperly stored VARIVAX (lot reported as: N022978; Expiry date: 23-AUG-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours and 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an 18 months old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 15-MAR-2018, the patient was administered an improperly stored (Oka/Merck) VARIVAX (lot reported as: N022978; Expiry date: 23-AUG-2019) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours and 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an 18 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot reported as: N026814; Expiry date: 15-JUL-2020 and lot reported as: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 2 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 15-MAR-2018, the patient was administered an improperly stored VARIVAX (lot reported as: N022978; Expiry date: 23-AUG-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours and 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 7 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored (Oka/Merck) VARIVAX (lot reported as: N022978; Expiry date: 23-AUG-2019) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours and 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Anxiety, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, reporting on a patient of unknown gender and age. The patient's pertinent medical history included splenectomy and anxiety. Concomitant medication the patient was taking included XANAX; LEXAPRO; levothyroxine sodium; and, unspecified vitamin D. It was reported that the patient did not have any drug reactions or allergies. The nurse reported that, on 25-APR-2018, the patient experienced anxiety after being vaccinated with improperly stored PNEUMOVAX 23 injection, for prophylaxis (dose, route and anatomical site of administration were not provided. Lot number N023650; expiration date 20-MAY-2019). The reporter stated that, on the same date (reported as "after a couple of minutes"), the patient recovered from anxiety. The nurse mentioned that the patient did not look for medical attention; no treatment was administered and no any laboratory or diagnostics studies were performed to the patient. Additionally, the nurse mentioned that PNEUMOVAX 23 were exposed to a temperature excursion of 32° up to 35° (35.1°) degrees Fahrenheit (°F) during a time frame of 30 minutes; which was detected by the data logger. Previous temperature excursion was not reported. The nurse did not provide any causality assessment to anxiety in regards with PNEUMOVAX 23 administration.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 25-APR-2018 the patient was vaccinated with expired dose of, VAQTA (dose, units and frequency unknown) (lot # N005605 and expiration date 08-APR-2018). No adverse effects reported. No product quality complaint was reported. This is one of the two reports received from the same reporter.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a 36 year old female patient, regarding herself. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 07-APR-2017 the patient was vaccinated with first dose of RECOMBIVAX HB injection 5/0.5 mcrg/ml, on 11-MAY-2017 the patient was vaccinated with second dose of RECOMBIVAX HB and on 27-OCT-2017 the patient was vaccinated with first dose of RECOMBIVAX HB (dose, frequency and route were not reported (lot # M034894, expiry date: 11-NOV-2018) for prophylaxis. The patient reported that, all three doses in the vaccination series were pediatric doses instead of recommended adult dose. No adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to unspecified number of female patients of unknown age. Patients' concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, patients were vaccinated with GARDASIL 9 (dose, units, route and frequency not reported). On an unknown date, patients had subsequently had PAP tests and that were positive human papilloma virus (HPV) (papilloma viral infection). The outcome of the event was not reported. The reporter did not provide the causal relationship for the event with suspect therapy GARDASIL 9. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-APR-2018, the patient was inadvertently administered one dose of (Oka-Merck) PROQUAD (lot: M042500) subcutaneously which was expired on 17-APR-2018 (expired drug administered). No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 25-APR-2018, the patient was vaccinated with expired dose of VAQTA (dose, units and frequency unknown) (lot # N005605 and expiration date 08-APR-2018). No adverse effects reported. No product quality complaint was reported. This is one of the two reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 26-JAN-2016 and 01-APR-2017, the patient was vaccinated with VARIVAX (lot number L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly (reported as vaccine temperature excursion) (Product storage error).
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was also a Nurse, reporting on herself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in 2015 (reported as "3 years ago"), the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). After the administration of PNEUMOVAX 23 the patient experienced a very large, warm, red knot on her arm. On an unspecified date, the patient was evaluated by her physician. The patient fully recovered from the event on an unknown date. The reporter did not assess the causal relationship between vaccination with PNEUMOVAX 23 and the event.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Infection, Laboratory test normal, Loss of consciousness
Clinical narrative: This spontaneous report has been received from a consumer via social media, regarding multiples unspecified female patients. The patients had no medical history, concomitant medications, drug reactions/allergies or concurrent conditions. On unknown dates, the patients were vaccinated with a dose GARDASIL injection, (dose, frequency, route, lot number and expiration date were not provided), for prophylaxis. On unknown dates, the patients passed out (syncope), felt dizzy and light headed (dizziness), felt floaters in their eyes (eye disorder), did not feel well (malaise), felt really tired and exhausted all the time (fatigue) and after the vaccination, the patients sought medical attention with multiples doctors and specialist, and as a result, the patients underwent some unspecified laboratories in which the result showed that the patient had some type of infection that their bodies was trying to fight off (infection). Furthermore, it was also reported that some additional unspecified laboratories that were performed to the patients, had results that were coming back to normal, however, it was stated that the patients were still feeling really tired and sick all the time. At the time of reporting, the outcome of syncope, eye disorder, malaise, fatigue and dizziness was unknown. The outcome of infection was reported as recovering. The reporter considered dizziness, eye disorder, syncope, malaise, fatigue and infection to be related to GARDASIL. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1804USA009584.
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Vitreous floaters
Clinical narrative: This spontaneous report has been received from a consumer via social media, regarding multiples unspecified female patients. The patients had no medical history, concomitant medications, drug reactions/allergies or concurrent conditions. On unknown dates, the patients were vaccinated with a dose GARDASIL injection, (dose, frequency, route, lot number and expiration date were not provided), for prophylaxis. On unknown dates, the patients passed out (syncope), felt dizzy and light headed (dizziness), felt floaters in their eyes (eye disorder), did not feel well (malaise), felt really tired and exhausted all the time (fatigue) and after the vaccination, the patients sought medical attention with multiples doctors and specialist, and as a result, the patients underwent some unspecified laboratories in which the result showed that the patient had some type of infection that their bodies was trying to fight off (infection). Furthermore, it was also reported that some additional unspecified laboratories that were performed to the patients, had results that were coming back to normal, however, it was stated that the patients were still feeling really tired and sick all the time. At the time of reporting, the outcome of syncope, eye disorder, malaise, fatigue and dizziness was unknown. The outcome of infection was reported as recovering. The reporter considered dizziness, eye disorder, syncope, malaise, fatigue and infection to be related to GARDASIL. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1804USA009584.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse via company representative regarding a 2 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (lot#, expiration date and dosing details were not reported), intramuscularly for prophylaxis (drug administered to patient of inappropriate age). No product quality complaint was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a 21 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in 2008 (reported as about 10 years ago), the patient received the first dose in the human papilloma virus (HPV) vaccination series with GARDASIL or GARDASIL 9 (unidentified Merck HPV vaccine) (dose, route, lot#, and expiration date unknown) for prophylaxis. On 26-APR-2018 (reported as today), the patient was at the pharmacy to receive the second dose in the HPV vaccination series with GARDASIL 9 (dose, route, lot#, and expiration date unknown) for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported.