chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Echocardiogram, Electrocardiogram, Erythema, HIV test, Measles antibody
Clinical narrative: 23rd April 2019 (8 hours after injection; became congested and was snoring in sleep); 26th April 2019 @0600 woke up with rash erupting around naval area, low grade fever; 26th April 2019 @12noon, rash erupting under arm pits; itchy, fever 101.3, given Tylenol; 26th April 2019@1400, rash still erupting, fever higher, taken to Hospital; 27th April 2019@2200, fever 104.5; taken to Hospital:  hands red, fever continues to return after medication wears off (giving Tylenol, or Ibuprofen every 4.5 to 6 hours).
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test, Pruritus, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: 23rd April 2019 (8 hours after injection; became congested and was snoring in sleep); 26th April 2019 @0600 woke up with rash erupting around naval area, low grade fever; 26th April 2019 @12noon, rash erupting under arm pits; itchy, fever 101.3, given Tylenol; 26th April 2019@1400, rash still erupting, fever higher, taken to Hospital; 27th April 2019@2200, fever 104.5; taken to Hospital:  hands red, fever continues to return after medication wears off (giving Tylenol, or Ibuprofen every 4.5 to 6 hours).
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Rotavirus test, Rubella antibody test, Snoring
Clinical narrative: 23rd April 2019 (8 hours after injection; became congested and was snoring in sleep); 26th April 2019 @0600 woke up with rash erupting around naval area, low grade fever; 26th April 2019 @12noon, rash erupting under arm pits; itchy, fever 101.3, given Tylenol; 26th April 2019@1400, rash still erupting, fever higher, taken to Hospital; 27th April 2019@2200, fever 104.5; taken to Hospital:  hands red, fever continues to return after medication wears off (giving Tylenol, or Ibuprofen every 4.5 to 6 hours).
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Patient states pain in arm increased throughout the evening until quite painful. Patient took 2 motrin and pain is better.  Patient is still sore and has some swelling at site. No signs o rash or anyphylaxis.  Recommended patient notifies pcp of reaction to determine if will get second dose in series.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine had expiration date of 5/2/2019. Vaccine was administered 5/4/2019 two days after the expiration date.
Age: 52.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine had expiration date of 5/2/2019. Vaccine was administered 5/4/2019 two days after the expiration date.
Age: 32.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Expired product administered
Clinical narrative: Expiration date on Box is 5/2/2019..vaccine was administered on 5/5/2019..3 days after expiration date on box
Age: 32.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expiration date on Box is 5/2/2019..vaccine was administered on 5/5/2019..3 days after expiration date on box
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Extreme pain and inability to lift with arm of injection. Pain is less after 2 days bu the are of injection is red and slightly swollen, very tender to the touch in a radius of about 4 by 4 inches.
Age: 44.0
Sex: F
Vaccine: MMRV
Symptoms: Syncope
Clinical narrative: Patient came in receive MMR-II vaccine with our pharmacy - reported previous dizziness, fainting and/or reactions to vaccines and blood draws. Patient denied history of epilepsy. Patient was doing well through vaccine administration however at completion stated she needed to lay down. I helped support the patient and lay on 2 chairs during the duration of the incident when she fainted. Ambulance was called however patient came to and refused ambulance. I sat with the patient and she stayed in the pharmacy for a good duration until she was feeling much better.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Awakened at 3AM , approximately 12 hours post injection,with severe headache, chills, and body aches.  Headache , chills, and body aches continued all day May 1, 2019. Fever of 100.6 F appeared approximately 24 hours post injection   Returned to normal temperature by 9 pm  May 1.  Treated with 1000 mg Tylenol every 6 hours.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever, nausea, chills, very tired
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Headache, body aches, pain at injection site,, nausea, exhaustion, chills.  All symptoms severe enough to prevent me from going to work. Taking Ibuprofen helped very little.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Headache, body aches, pain at injection site,, nausea, exhaustion, chills.  All symptoms severe enough to prevent me from going to work. Taking Ibuprofen helped very little.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness and Painful for several days.  Significant swelling.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Severe muscle ache, fever, nausea
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Dizziness, Headache, Influenza like illness
Clinical narrative: Experienced lightheadedness within a few hours, woke in the middle of the night with violent shivers, fever of 101° . Experiencing flulike symptoms. Some muscle weakness, headache, sensitivity to light, some disorientation and dizziness. Significant pain at injection site, and a hard lump.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pain, Middle insomnia, Muscular weakness
Clinical narrative: Experienced lightheadedness within a few hours, woke in the middle of the night with violent shivers, fever of 101° . Experiencing flulike symptoms. Some muscle weakness, headache, sensitivity to light, some disorientation and dizziness. Significant pain at injection site, and a hard lump.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Pyrexia
Clinical narrative: Experienced lightheadedness within a few hours, woke in the middle of the night with violent shivers, fever of 101° . Experiencing flulike symptoms. Some muscle weakness, headache, sensitivity to light, some disorientation and dizziness. Significant pain at injection site, and a hard lump.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Shingrex vaccine. Pain redness swelling at site getting progressive through day 4. Bumps pain swelling noticed several inches from injection site as well. Continuing through day 5. Fatigue noticed day 2,3.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Vitreous floaters
Clinical narrative: The morning after vaccination patient awoke with floater the shape of a jellyfish in my eye and sparkly shooting around the outer ring of my left eye.
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Starting one week after the first dose (day of birth) of Hepatitis B, parents noticed redness at injection site.  It progressed to a fluid filled vesicle.  It then opened and resolved.  It has subsequently contined to be red and new vesicles continue to form in that same area and then resolve and form again.  Baby is now 4 months old and this continues to happen.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; patient was inadvertently administered an expired dose of MMRII; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 16-APR-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) subcutaneously, lot # N009171, expiry date 20-MAR-2019 (exact dose and site of administration were not reported) for prophylaxis. There was no temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: not adverse event; PROQUAD stored at 10F for 6 hours administered to paitent; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history was not provided. Concomitant therapy included sterile diluent.  On 18-APR-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (OKA-Merck) virus vaccine live (PROQUAD) (lot # R011802, expiration date: 21-OCT-2019; therapy type: rHa, strength, dose and route were not reported) for prophylaxis. The vaccine was were stored at 10 Fahrenheit for 6 hours. A digital data logger was involved. There was no previous temperature excursion. No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received a total of 4 doses of GARDASIL 9; No adverse information provided; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age, gender and ethnicity.  The patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On an unspecified date, the patient was administered a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was reported that the patient received a total of 4 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No adverse symptoms reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects were reported in the patient.; a patient received one dose each of PROQUAD and VARIVAX on 23-APR-2019.; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.  On 23-APR-2019, the patient was vaccinated one dose each of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously (strength and dose were not reported; lot # S000622 and expiration date 06-JUL-2020) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, doses, route of administration were not reported; lot number R030610 and expiration date 23-OCT-2020) (overdose); both as prophylaxis. No adverse effects were reported in the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation refers to a currently 70-year-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided. On approximately (reported as "on or around") 30-SEP-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) for long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster, for which she was treated by a healthcare provider. The outcome of herpes zoster was not provided. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).     Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 81 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-JUL-2013, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for the event. The outcome of the event was not reported.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 79 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unspecified date in 2008, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose#, administration route and anatomical location were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster. On an unknown date, the patient was treated by a physician for the herpes zoster resulting from the zoster vaccine live (ZOSTAVAX) use. The outcome of the herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; one unspecified patient received third dose in vaccination series of GARDASIL 9 "four months late" on 04/29/2019; This spontaneous report as received from a Pharmacy Technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 29-APR-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot # R001262 and expiration date 10-NOV-2020 per intramuscular route for prophylaxis four months late of the appropiate scheduele. Pharmacy Technician reported that patient received first dose and second dose in vaccination series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as per the prescribing information. No adverse effects were reported.       This is a non-valid case due to no patient identifier.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; patient received an expired dose of PROQUAD; This spontaneous report was received from a medical assistant refers to a patient of unknown demographics. Patient's pertinent medical history, concurrent conditions and drug allergies or reactions and concomitant medication were not reported. On 25-APR-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dosage schedule not reported, lot # N029156, route: subcutaneous, expiry date: 16-APR-2019) for prophylaxis. On 25-APR-2019, the patient received an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (expired product administered). No adverse event was reported.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: MMR-II titer done in 1982 for her nursing school which was negative / titer done in February of 2019 for her empleyment and her titers were negative again; MMR-II titer done in 1982 for her nursing school which was negative, and was vaccinated again with MMR-II (third vaccination); This spontaneous report was received from a consumer who was also a nurse, concerning about herself, a currently 57-year-old female patient.      No information was provided regarding the patient's concurrent conditions, medical history, past drug reactions / allergies or concomitant medications.      On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On an unspecified date in 1978, she had a booster of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), because her mother was pregnant. On an unspecified date in 1982, a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) titer was done for her nursing school which was negative (antibody test negative), and she was vaccinated again with MMR-II (third vaccination) (overdose). On an unspecified date in February 2019, another measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) titer was done for her employment and her titers were negative again (antibody test negative), therefore, she was vaccinated again with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 01-MAY-2019, due to negative titer. All measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccines were administered as prophylaxis (strengths, doses, routes of administration, lots number and dates of expiration were not provided). It was reported that the patient received treatment (unspecified) for the event. No product quality complaint was filed.  The causality assessment between the event antibody test negative, and the suspect vaccine was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event reported; The patient was inadvertently administered a dose of PROQUAD that was expired; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 29-APR-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), lot # N029672 with expiration date 21-APR-2019, (dose, frequency and route of administration were not provided), for prophylaxis. No adverse event was reported. No further information was provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect; inadvertently received one dose of MMR II via the intramuscular route; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. No information was provided regarding the patient's medical history and concurrent conditions.  On 19-APR-2019, the pharmacist reported that one patient received inadvertently one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), via the intramuscular route (incorrect route of product administration), lot # R019391 (expiration date: 05-JUL-2020), for prophylaxis (strength and frequency were not reported). No adverse effect was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; An adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant and refers to an adult patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported.  On 29-APR-2019, the patient received a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) (incorrect dose administered) intramuscularly for prophylaxis (strength, dose number, anatomical site of injection, lot number and expiration date were not reported). No adverse effects or product quality complaints were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient received improperly stored dose of PROQUAD; NO ADVERSE EFFECT; This spontaneous report as received from a Nurse regarding to a patient of unknown age and gender. The patients' pertinent medical history,and drug reactions/allergies were not reported. The concomitant medication included sterile diluent which was reported to be stored properly.  On 25-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015741, expiry date: 02-DEC-2019) for prophylaxis.  It was reported that the vaccine was exposed to temperature of 6 degree Fahrenheit to 14 degree Fahrenheit (-14 degree Celsius to -10 degree celsius) (7.9 Fahrenheit) for a time frame 1 hour 55 minutes and temperature 6 degree Fahrenheit to 14 degree Fahrenheit (-14 degree celsius to -10 degree celsius) (10.4 Fahrenheit) for a time frame 3 hour 15 minutes. There was previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. No additional information was provided.   Albumin status for lot number R015741 was rHA.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; altering dosing schedule; first dose given on 06-MAY-2013 and the second dose given on 6-JUL-2015.; This spontaneous report was received from a medical assistant, refers to a 23-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were unknown.   The medical assistant reported that on 06-MAY-2013, the patient was vaccinated with the first dose of, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis or quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. The second dose was given on 6-JUL-2015 (inappropriate schedule of product administration).  The reporter was not certain if both doses were hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), or of the patient might have received one of each (Interchange of vaccine products). No adverse effects were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effects reported; received one dose of M-M-R II intramuscularly; This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 01-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(strength, frequency were unknown) (lot # R030809, expiry date 24-OCT-2020) dose 1 intramuscularly for prophylaxis (incorrect route of product administration). No adverse effects were reported (no adverse event). No product quality issue was reported for this case.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction; Improperly stored vaccines; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 11-APR-2019 the patient was vaccinated with improperly stored 1 dose of varicella virus vaccine live (oka/merck)(VARIVAX) (1 dose, 0.5 ml) (lot # R018933, expiry date: 02-JUN-2020) subcutaneously for prophylaxis. It was not known how the sterile diluent(DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction; Improperly stored vaccines; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 25-APR-2019 the patient was vaccinated with improperly stored 1 dose of varicella virus vaccine live (oka/merck)(VARIVAX) (1 dose, 0.5 ml) (lot # R018933, expiry date: 02-JUL-2020) subcutaneously for prophylaxis. It was not known how the sterile diluent(DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction; Improperly stored vaccines; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 26-APR-2019 the patient was vaccinated with improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 1 dose, 0.5 ml (lot # R015739, expiry date: 02-DEC-2019) subcutaneously for prophylaxis. It was not known how the sterile diluent(DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored.  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse reaction; Patient received PROQUAD intramuscularly; Improperly stored vaccines; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 26-APR-2019 the patient was vaccinated with improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 1 dose, 0.5 ml (lot # R015739, expiry date: 02-DEC-2019) intramuscularly for prophylaxis (subcutaneous injection formulation administered by other route). It was not known how the sterile diluent(DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored.  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Induration, Mobility decreased, Pain
Clinical narrative: Severe upper extremity swelling; Erythema; Warm hard painful swelling; Induration; Warm hard painful swelling; Joint pain; Deltoid tenderness; Couldn't raise her arm well; A spontaneous report was received from a health care professional via telephone on 06MAR2019. The health care professional reported that the patient received her BioThrax (anthrax vaccine adsorbed) initial series with boosters then worked for awhile, and then changed jobs and restarted the series. She then received yearly boosters. On 18AUG2009 she received her annual booster and the following day, on 19AUG2009 she experienced severe upper extremity swelling, erythema, warm hard painful swelling, induration, joint pain in the knuckles of her fingers, deltoid tenderness, and she couldn't raise her arm well. She was treated with motrin, zytrec, and ibuprofen. Her next evaluation was on 24AUG2009 and it was reported that she had no joint involvement, and she still had induration but it had decreased, and the site was non-tender. The patient was told in the future to receive boosters every other year at a half dose, and she started with half doses yearly in AUG2010, and two weeks later got another half dose, and she has had some variation of half doses since then. On 28JUL2010, the patient was reported to be in good health.  Previous vaccination dates from the patient record: 29-JAN-2002 12-FEB-2002 26-FEB-2002 30-JUL-2002 30-JAN-2003 30-JUL-2003 29-JUL-2004 01-AUG-2005 09-AUG-2006 10-AUG-2007 15-AUG-2008 18-AUG-2009  Allergies reported as "penicillin mold" and codeine  No further information is expected.
Sex: U
Vaccine: ANTH
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Severe upper extremity swelling; Erythema; Warm hard painful swelling; Induration; Warm hard painful swelling; Joint pain; Deltoid tenderness; Couldn't raise her arm well; A spontaneous report was received from a health care professional via telephone on 06MAR2019. The health care professional reported that the patient received her BioThrax (anthrax vaccine adsorbed) initial series with boosters then worked for awhile, and then changed jobs and restarted the series. She then received yearly boosters. On 18AUG2009 she received her annual booster and the following day, on 19AUG2009 she experienced severe upper extremity swelling, erythema, warm hard painful swelling, induration, joint pain in the knuckles of her fingers, deltoid tenderness, and she couldn't raise her arm well. She was treated with motrin, zytrec, and ibuprofen. Her next evaluation was on 24AUG2009 and it was reported that she had no joint involvement, and she still had induration but it had decreased, and the site was non-tender. The patient was told in the future to receive boosters every other year at a half dose, and she started with half doses yearly in AUG2010, and two weeks later got another half dose, and she has had some variation of half doses since then. On 28JUL2010, the patient was reported to be in good health.  Previous vaccination dates from the patient record: 29-JAN-2002 12-FEB-2002 26-FEB-2002 30-JUL-2002 30-JAN-2003 30-JUL-2003 29-JUL-2004 01-AUG-2005 09-AUG-2006 10-AUG-2007 15-AUG-2008 18-AUG-2009  Allergies reported as "penicillin mold" and codeine  No further information is expected.
Sex: M
Vaccine: HEP
Symptoms: Gene mutation, Malaise, Seizure
Clinical narrative: seizure; sick; genetic mutation; This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a male patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced seizure (serious criteria GSK medically significant), sickness and gene mutation. On an unknown date, the outcome of the seizure, sickness and gene mutation were unknown.   It was unknown if the reporter considered the seizure, sickness and gene mutation to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported by the reporter for her youngest grandson. The age at vaccination was not reported. The reporter, her daughter, her daughter's boyfriend, and her 3 grandkids live with her. The patient had 57 seizures from the Hepatitis B vaccine. He was a very sick child.  No patient information provided for the report.  No further information provided for the report. No medical information was requested. This is 1 of the 3 cases reported by the same reporter. Unable to find the link cases due to hidden reporter information.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: redness all the way down to her elbow; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness all the way down to her elbow. The reporter did not have any patient information and did not know the date of vaccination, lot, and expiration.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: felt like she was going to faint/feel Dizzy; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number GA5Z5, expiry date 3rd May 2020) for prophylaxis.   On 17th April 2019, the patient received Shingrix (intramuscular). On 22nd April 2019, the patient received Boostrix (intramuscular). On 22nd April 2019, 5 days after receiving Shingrix and immediately after receiving Boostrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix and Boostrix.  Additional details were reported as follows: When the Bostrix was administered, the patient felt like she was going to faint, and continued to feel dizzy afterwards. The patient reported the symptoms about 15 min after the dose and the patient still felt dizzy at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported, but the patient was 73 years old at the time of reporting. The patient experienced shingles outbreak. No further details were available. It was reported that the the patient would encourage her friend to contact Glaxosmithkline (GSK) to provide more details regarding the report.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles infection; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 15th February 2019, 143 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The lot number and expiation date not specified. The patient experienced shingles. The patient has not received the second dose of Shingrix yet due to the shingles. The patient was still recovering from Shingles.  The reporter was consented for follow up.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: inadvertently administered DTap-IPV component of Pentacel without reconstituting it with Hib vial to a patient; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from other health care professional (Office staff manager).  This case involves a 18 months female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history and family history were not provided.  Concomitant medications included MMR VACCINE and VARICELLA VACCINE on unknown date.   On 30-Apr-2019, the patient received a fourth dose in series, 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ084AA, expiry date 24-Jul-2020 via intramuscular route in the left thigh.  It is an actual medication error due to inappropriate reconstitution technique.  It was reported that patient who was inadvertently administered DTap-IPV component of Pentacel without reconstituting it with Hib vial.  It was not reported if the patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Dizziness, Laboratory test, Loss of consciousness, Seizure
Clinical narrative: dizzy; started to convulse, convulsions; fainted; blacked out; Seriousness Criteria- Medically significant  Initial information received on 26-Apr-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 12 years old female patient who started to convulse, convulsions, fainted and was dizzy, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications not reported.   On 26-Apr-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6213AA (Exp. Date not reported) via unknown route in the right arm.  On 26-Apr-2019, the patient started to convulse (convulsions) (seizure), fainted (syncope) with blacked out (loss of consciousness) 5 minutes following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These event were assessed as medically significant.  On an unknown date, the patient was dizzy (dizziness) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also reported patient was supposed to get other vaccine but she didn't get it because an ambulance came to pick her up take her to the hospital. She states that she was told the other vaccine she was supposed to get was prone to the same symptoms.  It was reported that, patient had taken to the hospital via ambulance.  Patient had blood work and test done.  Final diagnosis was fainted, started to convulse, convulsions and dizzy.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient was not recovered from dizziness and for rest all events outcome was not reported.  List of documents held by sender: none.; Sender's Comments: This case concerns 12 years old female patient who developed syncope and seizure 5 minutes after vaccination and dizziness unknown time after vaccination with ADACEL. The time to onset is compatible for syncope and seizure. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: dizzy; started to convulse, convulsions; fainted; blacked out; Seriousness Criteria- Medically significant  Initial information received on 26-Apr-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 12 years old female patient who started to convulse, convulsions, fainted and was dizzy, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications not reported.   On 26-Apr-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6213AA (Exp. Date not reported) via unknown route in the right arm.  On 26-Apr-2019, the patient started to convulse (convulsions) (seizure), fainted (syncope) with blacked out (loss of consciousness) 5 minutes following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These event were assessed as medically significant.  On an unknown date, the patient was dizzy (dizziness) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also reported patient was supposed to get other vaccine but she didn't get it because an ambulance came to pick her up take her to the hospital. She states that she was told the other vaccine she was supposed to get was prone to the same symptoms.  It was reported that, patient had taken to the hospital via ambulance.  Patient had blood work and test done.  Final diagnosis was fainted, started to convulse, convulsions and dizzy.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient was not recovered from dizziness and for rest all events outcome was not reported.  List of documents held by sender: none.; Sender's Comments: This case concerns 12 years old female patient who developed syncope and seizure 5 minutes after vaccination and dizziness unknown time after vaccination with ADACEL. The time to onset is compatible for syncope and seizure. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: TDAP, TTOX
Symptoms: Extra dose administered
Clinical narrative: patient was given the Adacel and it was then realized afterward that the patient had a tetanus shot previously; Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who previously taken a dose of TETANUS TOXOID (lot number and expiry date not reported via unknown route in unknown administration site) on an unknown date and again received a single dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6141AB , expiry date 15-Dec-2020) via intramuscular route in the left arm on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); and HPV VACCINE (HPV VACCINE).  It was a case of actual medication error due to extra dose administered.  It was not reported if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, IPV, UNK
Symptoms: Extra dose administered, No adverse event, Product preparation issue
Clinical narrative: gave a 2mo male a DTaP/IPV diluent of Pentacel only today. She thought she was giving the HIB. She also gave a DTAP and IIPOL, no adverse event; gave a 2mo male a DTaP/IPV diluent of Pentacel only today. She thought she was giving the HIB. She also gave a DTAP and POL, no adverse event; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a two months old male patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] lot UJ073AAA, expiry date: 13-Jun-2020 via unknown route in unknown administration site on an unknown date, IPV (VERO) [IPOL] lot P1A17 and expiry date: P1A17 via unknown route in the left thigh and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5366AA, expiry date : 07-Feb-2020 via unknown route in the left thigh on 29-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included was PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error due to inappropriate reconstitution technique and extra dose administered. A 2 month old patient received DTaP/IPV diluent of Pentacel only today instead of Hib diluent and also received DTaP and Ipol on 29-Apr-2019 separately.  No adverse event not reported.  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.  Information on the batch number was requested.  List of documents held by sender: none.