chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Besides the tenderness, redness, and inflammation, I have experienced general malaise, lethargy, just feeling punky, on days 3, 4, and 5 after vaccination.  I?m am otherwise healthy and well rested.  My husband received his second shot of Shingrex at the same time, and also experienced the same general sense of malaise.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient states she started getting redness at the site on June 8. The vaccine was given to her on june 5.  She went to the MD on June 10 and they prescribed her antibiotics
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fluid retention, Pruritus, Rash, Swelling
Clinical narrative: PATIENT EXPERIENCED RASH, REDNESS, SWELLING, FLUID (WATER POCKETS) AND ITCHING ALONG ENTIRE LEFT SIDE OF BODY INCLUDING ARM, LEG, TRUNK, NECK AND HEAD (LEFT SIDE ONLY)
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Gait disturbance, Pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: My daughter had a combination vaccine given yesterday, Dtap and IPV, not sure the brand. This evening I noticed she started limping and complaining about pain and also her entire thigh, from knee up is visibly swollen, tender and sore.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: I have had many dozens of injections and vaccines in my life.  I have donated platelets and red blood cells dozens of times.  None have ever bothered me.  I have NEVER had an injection that hurt like this.  I thought she missed my Deltoid and hit bone.  Once needle was removed, pain went away temporarily.  Within an hour or two, I couldn't move my arm without severe pain (8+).  A few hours later, even keeping my arm and body absolutely still was causing severe pain.  Called clinic, explained, and was told to take Xtra strength Tylenol and call if there is swelling, fever or redness.  I was also told that my pain might be caused by the nurse accidentally hitting a nerve in my arm.  I never got  any other symptoms at the site.  I did however feel no appetite and a bit nauseous by the evening, but I believe that was due to several hours of severe pain without any meds.  I started taking the Xtra strength Tylenol that evening.   Even on the third day, any movement of my arm still caused severe pain, but at least if I didn't move it at all, the pain was only moderate because of the Tylenol.  It took about a week before movement caused only moderate pain.  Today, almost 3 weeks after the shot, I still have mild pain, but only when raising my arm out to the side.  I have emailed my doctor 3 times give her updates.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pruritus, Skin reaction, Skin warm
Clinical narrative: swelling of (L) upper arm starting 1-2" below site of injection,  6/3 Dr. took measurements. Red, warm, itchy, pain. Also, a smaller red patch (much redder) in the same area on KEFLEX and Lotrimin since 6/3/19
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema, Dehydration, Diarrhoea haemorrhagic, Dry mouth, Fontanelle depressed
Clinical narrative: RV given 5/17/19. Pt did well till 5/25/19. Pt started vomiting several times & developed signs of dehydration including sunken fontanelle & eyes  , dry mouth & decreased urination. Referred to ER. Diagnosed with dehydration. Received IV Fluids, tolerated Pedialyte po, Dc'd home. Same day @ 9 pm pt developed bloody diarrhea & returned to ER. An U/S was done, which revealed large intussusception in mid & (L) abd. Barium enema to treat intussusception was unsuccessful. Pt brought to surgery on 5/26/19 @ 7:30AM & remained in hospital till D/C at 5/29/19 with no complications
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Lid sulcus deepened, Procedural failure, Surgery, Ultrasound abdomen abnormal
Clinical narrative: RV given 5/17/19. Pt did well till 5/25/19. Pt started vomiting several times & developed signs of dehydration including sunken fontanelle & eyes  , dry mouth & decreased urination. Referred to ER. Diagnosed with dehydration. Received IV Fluids, tolerated Pedialyte po, Dc'd home. Same day @ 9 pm pt developed bloody diarrhea & returned to ER. An U/S was done, which revealed large intussusception in mid & (L) abd. Barium enema to treat intussusception was unsuccessful. Pt brought to surgery on 5/26/19 @ 7:30AM & remained in hospital till D/C at 5/29/19 with no complications
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urine output decreased, Vomiting
Clinical narrative: RV given 5/17/19. Pt did well till 5/25/19. Pt started vomiting several times & developed signs of dehydration including sunken fontanelle & eyes  , dry mouth & decreased urination. Referred to ER. Diagnosed with dehydration. Received IV Fluids, tolerated Pedialyte po, Dc'd home. Same day @ 9 pm pt developed bloody diarrhea & returned to ER. An U/S was done, which revealed large intussusception in mid & (L) abd. Barium enema to treat intussusception was unsuccessful. Pt brought to surgery on 5/26/19 @ 7:30AM & remained in hospital till D/C at 5/29/19 with no complications
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: swelling. redness. hot to the touch
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Approximately 18 hours after receiving immunizations, patient reported to ER with 104.4'F temp. Tylenol & Motrin was given. Temp decreased and patient was discharged.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Mass, Pain, Pruritus generalised
Clinical narrative: Spherical red, painful, hard lump about 4 inches in diameter the evening 6/4/2019. Irritation of skin, highly itchy allover body. Took benadryl. As of today, no lump or redness but still itch. She talked to her allergist.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: Spherical red, painful, hard lump about 4 inches in diameter the evening 6/4/2019. Irritation of skin, highly itchy allover body. Took benadryl. As of today, no lump or redness but still itch. She talked to her allergist.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: Large red rash on shoulder, itchy spreading to entire triceps, hot to touch x 2 days after vaccine, self-resolving
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Gait disturbance, Injection site bruising, Injection site swelling, Injection site warmth, Pain
Clinical narrative: On 5/23/2019 Patient's injection site was bruised, hot to touch, and swollen. On 5/24/2019 Woke up at 6am screaming in pain couldn't get off the couch, couldn't walk either and had a fever of 101°F. By 12am the patient was recovered from reaction
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Screaming
Clinical narrative: On 5/23/2019 Patient's injection site was bruised, hot to touch, and swollen. On 5/24/2019 Woke up at 6am screaming in pain couldn't get off the couch, couldn't walk either and had a fever of 101°F. By 12am the patient was recovered from reaction
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cough, Pain in extremity, Rhinorrhoea, Secretion discharge
Clinical narrative: Pt had no reaction the day after. No warm to touch, pain in left arm of injection site. But 3 days after pt had cough, mucus, runny nose w/ yellow mucus. Pt had seen her PCP, orthopedic and rheumatologist she describes pain in agony from top left side of her body leg, hip and ankle. Had prednisone, percocet and is still in pain on scale from 1-10, describes pain as 10-11.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Laboratory test, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt had no reaction the day after. No warm to touch, pain in left arm of injection site. But 3 days after pt had cough, mucus, runny nose w/ yellow mucus. Pt had seen her PCP, orthopedic and rheumatologist she describes pain in agony from top left side of her body leg, hip and ankle. Had prednisone, percocet and is still in pain on scale from 1-10, describes pain as 10-11.
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Injection site swelling, Pain, Rash
Clinical narrative: Pt allergic to vaccine Rash covered whole back. Arm swollen at site of injection. Pain & rash
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain
Clinical narrative: The morning after receiving vaccine patient reports feeling feverish, injection site pain, 4 inch diameter red area surrounding injection site, fatigue.  She was seen by MD, who was concerned about cellulitis. Antibiotics were prescribed, patient reports feeling better starting 24 hours after antibiotics were started. All symptoms were resolved 5 days after vaccine administration.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: The morning after receiving vaccine patient reports feeling feverish, injection site pain, 4 inch diameter red area surrounding injection site, fatigue.  She was seen by MD, who was concerned about cellulitis. Antibiotics were prescribed, patient reports feeling better starting 24 hours after antibiotics were started. All symptoms were resolved 5 days after vaccine administration.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: developed a "localized reaction at left deltoid injection site"; This spontaneous report was received from a licensed practical nurse referring to a 64 year old male patient. The patient's pertinent medical history, drug reactions and allergies were unknown by the reporter. The patient's concomitant medications included loratadine (CLARITIN).  On 04-JUN-2019, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 milliliter by intramuscular route), lot# S004547 with expiration date on 12-AUG-2020, indicated for prophylaxis (strength and anatomical location were not reported).   On 05-JUN-2019, the patient developed a localized reaction at left deltoid injection site (injection site reaction). The patient received a treatment with prednisone at the pulmonary department after being advised by nurse.  It was unknown if laboratory diagnostics and studies were performed.   The outcome of injection site reaction was reported as not resolved. The causal relationship between injection site reaction with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: developed a "localized reaction at left deltoid injection site"; This spontaneous report was received from a licensed practical nurse referring to a 64 year old male patient. The patient's pertinent medical history, drug reactions and allergies were unknown by the reporter. The patient's concomitant medications included loratadine (CLARITIN).  On 04-JUN-2019, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 milliliter by intramuscular route), lot# S004547 with expiration date on 12-AUG-2020, indicated for prophylaxis (strength and anatomical location were not reported).   On 05-JUN-2019, the patient developed a localized reaction at left deltoid injection site (injection site reaction). The patient received a treatment with prednisone at the pulmonary department after being advised by nurse.  It was unknown if laboratory diagnostics and studies were performed.   The outcome of injection site reaction was reported as not resolved. The causal relationship between injection site reaction with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: soreness in right shoulder; This case was reported by a pharmacist via sales rep and described the occurrence of shoulder pain in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2017-2018 season) for prophylaxis.  In August 2017, the patient received Fluarix Quadrivalent 2017-2018 season. On an unknown date, unknown after receiving Fluarix Quadrivalent 2017-2018 season, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Fluarix Quadrivalent 2017-2018 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix Quadrivalent 2017-2018 season and had intermittent soreness in right shoulder after vaccination that lasted up to 30 days. Maybe 3 other colleagues who got shot at same time reported similar. The reporter would like to request, if possible, the health care professional address for the case attached. The reporter has agreed to follow up. This case linked with US2019AMR099437, reported by same reporter.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles without having had chicken pox but after recieving the vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait disturbance, Muscle spasms, Myalgia, Tremor
Clinical narrative: About 9:30pm on 6/8/2019 I began to feel muscle aches. At midnight  uncontrollable trembling, chills, difficulty walking, possible fever - I did not take my temperature. This lasted for approximately 5 hours. I also had sudden and severe cramps in my calfs and feet from about 11:00pm till about 5:00am on 6/9/2019.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Investigation, Motor developmental delay, Speech disorder developmental
Clinical narrative: Child had a complete speech regression within 1 week of vaccine. He had been using approximately  a dozen words spontaneously, appropriately, and with clear intent.  Within days of this vaccine he regressed to using zero words, and as of now (10 months later) he has not regained any words.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Agitation, Fatigue, Headache, Pollakiuria, Poor quality sleep
Clinical narrative: Fever, uncontrolled shaking, agitated thinking and tossing attempting to sleep, frequent urination, severe headache, small rash with raised bumps on left forearm, extreme fatigue.   Symptoms abated in 2 days
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Tremor
Clinical narrative: Fever, uncontrolled shaking, agitated thinking and tossing attempting to sleep, frequent urination, severe headache, small rash with raised bumps on left forearm, extreme fatigue.   Symptoms abated in 2 days
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Pain, Swelling
Clinical narrative: Intense pain,swelling,dizzy,chills.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadventently administered a dose of MMRII which was reconstituted with expired diluent; This spontaneous report was received from a Pharmacy intern referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.   On 26-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (albumin status of rHA(recombinant human albumin)) (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # N023153, expiration date: 24-AUG-2019) subcutaneous for prophylaxis. The reporter mentioned that the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was inadvertently reconstituted with expired sterile diluent (lot # N027945, expiration date: 24-MAY-2019). No adverse effects were reported. There was no temperature excursion.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored dose administered; NO ADVERSE EFFECT; This spontaneous report was received from a nurse refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 23-MAY-2019, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 5/0.5 mcrg/ml (thimerosal status or therapy type: Thimerosal free), (frequency and route unknown) lot # R021372, 25-MAY-2021, 1 dose for prophylaxis. No adverse effect reported.  Temperature: above 47-degree F; time frame: 1 hour, 24 minutes. There was no previous temperature excursion. The case was reported because of a data logger.  Product quality complaints was not involved.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 9 week old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 15-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ((dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.   Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.  This is one of several reports received from the same reporter.  This is an amended report. The reference "US-009507513-1903USA013366" was captured as E2B Linked Report.; Sender's Comments:  US-009507513-1903USA013366:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 9-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 18-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.  This is one of several reports received from the same reporter.  This is an amended report. The reference "US-009507513-1903USA013366" was captured as E2B Linked Report; Sender's Comments:  US-009507513-1903USA013366:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered one dose of expired VAQTA; This spontaneous report was received from an office manager and refers to a patient of unknown age, race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 18-APR-2019, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, inactivated (VAQTA)lot number reported as M037245 with expiration date on 21-FEB-2019 (frequency and route of administration was not reported) for prophylaxis. No adverse effects were reported. At the moment of this report the outcome of expired vaccine used was unknown.  Lot number M037245 is an invalid lot number for Hepatitis A Vaccine, inactivated.; Sender's Comments:  US-009507513-1906USA002588:
Sex: F
Vaccine: VARZOS
Symptoms: Functional gastrointestinal disorder, Herpes zoster, Pain, Rash, Urinary tract disorder
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the routine health maintenance and for the prevention of shingles. On an unspecified date after the vaccination, the patient suffered a painful rash in her pelvic region, which has caused her considerable pain and impacted her bowl and urine function. As a result of these symptoms, the patient presented to a medical provider and was diagnosed with Herpes Zoster. Thereafter, the patient has continued to suffer the effects of Herpes Zoster. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the routine health maintenance and for the prevention of shingles. On an unspecified date after the vaccination, the patient suffered a painful persistent rash. As a result of these symptoms, the patient presented to a medical provider and was diagnosed with Herpes Zoster. Thereafter, the patient has continued to suffer the effects of Herpes Zoster. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; Patient received a dose of Prevnar 13 on 29-MAY-2019 and was inadvertently administered a dose of Pneumovax 23 on 06-JUN-2019; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 29-MAY-2019, the patient was vaccinated with a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and on 06-JUN-2019, was inadvertently administered a dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (route, frequency, lot # and expiry date not reported) for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 89 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2013, the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) prescribed by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.    On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was unknown.   Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.    On an unknown date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was unknown.     Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse events; patient received one dose of MMR II inadvertently intramuscular, instead of subcutaneous; This spontaneous report was received from a pharmacist referring to a 62-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 13-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (strength, dose, frequency were not provided) administered intramuscularly, for prophylaxis. The Lot No. R036583 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported as 17-DEC-2020.  But the reporter stated that the patient received the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) inadvertently via intramuscular, instead of subcutaneous (incorrect route of product administration), on this date. No adverse effects were reported. And no additional information provided or product quality complaint (PQC).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Patient received improperly stored PROQUAD on 6/6/2019.; This spontaneous report was received from a medical assistance concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 06-JUN-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)  for prophylaxis, lot # R026721 and expiration date: 17-MAR-2020 (strength, dose, route of administration and frequency were no reported), it was reported that a sterile diluent properly stored was used to reconstituted the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD). The administered dose of the vaccine experienced a temperature of 6 to 14 Fahrenheit for 20 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect was reported.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; received second dose of HPV series on 9/24/2015 and 3rd dose of HPV series on 9/9/2016 after received 1st dose of HPV series, GARDASIL, on 7/21/2015; This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 21-JUL-2015, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route, lot# and expiry date were not reported) for prophylaxis.  Other suspect therapies included quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (route, lot# and expiry date were not reported) for prophylaxis.   On 24-SEP-2015, the patient received the second dose in the HPV vaccination series   It was unknown if it was Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).   On 09-SEP-2016, the patient received the third dose in the HPV vaccination series and It was unknown if it was Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration) (unidentified Merck hpv vaccine administered (name and lot number not provided).  It was reported that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was chosen as product although it was unknown if Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) for second and third doses of HPV series. No adverse effects reported. No  additional information provided. Causality was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no advesre effect; patient received her first dose of gardasil 9 on an unspecified date about a year ago and was in the office on 6/10/2019 to receive second dose; This spontaneous report was received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in approximately 2018 (reported as about a year ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# and expiry date were not reported) for prophylaxis and the patient was in the office on 10-JUN-2019 to receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration). It was reported that there was no adverse affects reported (no adverse event). No PQC was involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administered first dose of gardasil 9 series on an unspecified date over a year ago . the pateint is in the office on 6/10/2019 to have the second dose administered; no adverse effect; This spontaneous report was received from a nurse refers to a 26-year-old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date (reported as over 1 year ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, frequency, lot # and expiry date not reported) for prophylaxis. It was mentioned that the patient was in the office on 10-JUN-2019 to be administered with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse effects were reported.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Swelling
Clinical narrative: knot under skin; feeling rotten; This case was reported by a consumer via patient assistance programs and described the occurrence of local swelling in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 30th April 2019, the patient received Shingrix .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced local swelling and feeling bad. On an unknown date, the outcome of the local swelling and feeling bad were unknown.   It was unknown if the reporter considered the local swelling and feeling bad to be related to Shingrix.  Additional details were provided as follows: This case was received from the healthcare provider via the vaccine patient assistance program. The patient reported having a knot under her skin and feeling rotten after receiving the Shingrix vaccine (single dose vial). This case did not include product complaint. Lot or expiry date was unknown.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: fever; fatigue; myalgia; headache; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever, fatigue, myalgia and headache. On an unknown date, the outcome of the fever, fatigue, myalgia and headache were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue, myalgia and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by a medical assistant. The patient received 1st dose and had fever, fatigue, myalgia, headache 2 days after lasting 1 day with vaccines. For tolerances of 2nd dose refer case US2019GSK095433.
Age: 68.0
Sex: U
Vaccine: TTOX, VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Arm is tender; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS TOXOID (TETANUS) for prophylaxis.   Previously administered products included Tetanus (booster dose was received in December 2011).   On 13th May 2019, the patient received Shingrix and TETANUS. On 14th May 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: On the day before reporting date, the patient was vaccinated with Shingrix. At the same time, the patient inadvertently administered Tetanus shot which was meant for another patient. The patient's arm was tender but generally the patient did not felt it too bad. It was unknown if the reporter considered the pain in arm to be related to Tetanus.  The patient also raised concern about the cost of Shingrix vaccine and information about adverse events associated with combination of Shingrix and tetanus vaccines given at the same time but the GlaxoSmithKline employee stated that, no information available about the combination of these two vaccines.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Blood test, Dyspnoea, Electrocardiogram
Clinical narrative: fever; joint pain; back pain; leg pain; shortness of breath; This case was reported by a consumer and described the occurrence of fever in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose received on 9th January 2019).   On 29th April 2019, the patient received the 2nd dose of Shingrix. On 2nd May 2019, 3 days after receiving Shingrix, the patient experienced fever, joint pain, back pain, leg pain and shortness of breath. The patient was treated with ibuprofen, paracetamol (Acetaminophen), diazepam, cyclobenzaprine hydrochloride (Cyclobenzaprine Hcl Oral Tablet), methocarbamol and naproxen. On an unknown date, the outcome of the fever, joint pain and shortness of breath were unknown and the outcome of the back pain and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, joint pain, back pain, leg pain and shortness of breath to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient could be 73 or 74 years old. On 10th May 2019, the patient visited the physician had blood test and Electrocardiogram done, the patient was prescribed with Ibuprofen 600mg and Acetaminophen 500mg and Cyclobenzaprine HCl. On 15th May 2019, the patient went to emergency department in hospital had blood test and X-ray. The patient was told not to take Cyclobenzaprine HCI and was put on Methocarbamol 750 mg and Diazepam 2mg. The patient still had back pain and leg pain. On 17th May 2019, informed patient  that he should go to the emergency room at clinic. The patient informed that he would not obtain ride on that day. On 18th May 2019, The patient was driven to emergency room and had blood test and informed that emergency room that hospital told him that he should not obtain a MRI of spine. The did not do that nor did they admitted him over night for observation but put him on Naproxen 375mg and Diazepam 2mg.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, X-ray
Clinical narrative: fever; joint pain; back pain; leg pain; shortness of breath; This case was reported by a consumer and described the occurrence of fever in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose received on 9th January 2019).   On 29th April 2019, the patient received the 2nd dose of Shingrix. On 2nd May 2019, 3 days after receiving Shingrix, the patient experienced fever, joint pain, back pain, leg pain and shortness of breath. The patient was treated with ibuprofen, paracetamol (Acetaminophen), diazepam, cyclobenzaprine hydrochloride (Cyclobenzaprine Hcl Oral Tablet), methocarbamol and naproxen. On an unknown date, the outcome of the fever, joint pain and shortness of breath were unknown and the outcome of the back pain and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, joint pain, back pain, leg pain and shortness of breath to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient could be 73 or 74 years old. On 10th May 2019, the patient visited the physician had blood test and Electrocardiogram done, the patient was prescribed with Ibuprofen 600mg and Acetaminophen 500mg and Cyclobenzaprine HCl. On 15th May 2019, the patient went to emergency department in hospital had blood test and X-ray. The patient was told not to take Cyclobenzaprine HCI and was put on Methocarbamol 750 mg and Diazepam 2mg. The patient still had back pain and leg pain. On 17th May 2019, informed patient  that he should go to the emergency room at clinic. The patient informed that he would not obtain ride on that day. On 18th May 2019, The patient was driven to emergency room and had blood test and informed that emergency room that hospital told him that he should not obtain a MRI of spine. The did not do that nor did they admitted him over night for observation but put him on Naproxen 375mg and Diazepam 2mg.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: fever; fatigue; myalgia; headache; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose in July 2018, refer case US2019AMR092966).   In September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever, fatigue, myalgia and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, fatigue, myalgia and headache were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue, myalgia and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by a medical assistant. The patient received 2nd dose and had fever, fatigue, myalgia, headache 2 days after lasting 1 day with vaccines. Symptoms were greater with the 2nd dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: redness at injection site/band around arm; warm to touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 29th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and skin warm. On an unknown date, the outcome of the injection site erythema and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient developed redness at the injection site and a band around her arm that was warm to the touch.  At the time of reporting, this event was ongoing. The reported batch number for Shingrix G722D did not exist, and was updated to G72ZD as per the sales database. There is a discrepancy in the reporting the outcome was reported in the structured field as not recovered/not resolved, but the outcome reported in the source document recovering/ resolving, however outcome is retain as per database fields.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain, Pain in extremity, Skin ulcer
Clinical narrative: Shingles; leg Pain/ pains on the left side of his thigh and leg and back area; Sore; pains on the left side of his thigh and leg and back area; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 27th June 2021) for prophylaxis.   On 9th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patient experienced shingles, leg pain, pain and back pain. The patient was treated with antivirals for systemic use (nos) (Antiretrovirals (Nos)). On an unknown date, the outcome of the shingles, leg pain, pain and back pain were unknown.   It was unknown if the reporter considered the shingles, leg pain, pain and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter states that a patient received the 1st dose of Shingrix and developed symptoms about a month later that included pains on the left side of his thigh and leg, and back area. The patient also developed a sore and non-severe pain in association with the sore. The physician diagnosed the patient with shingles and started him on started him on antiretrovirals.  The reporter declined to leave additional patient demographics.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram change, Myocarditis
Clinical narrative: Chest pain 11 days post vaccination with AVA and SPV. Admitted, elevated troponin I (peaked 9.96) and EKG changes. Neg echo and MRI. DX myopericarditis  Symptoms: CHEST PAIN, UNSPECIFIED(R079), SHORTNESS OF BREATH(R0602).
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Troponin I increased
Clinical narrative: Chest pain 11 days post vaccination with AVA and SPV. Admitted, elevated troponin I (peaked 9.96) and EKG changes. Neg echo and MRI. DX myopericarditis  Symptoms: CHEST PAIN, UNSPECIFIED(R079), SHORTNESS OF BREATH(R0602).
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram pelvis, Diarrhoea
Clinical narrative: 6/5/19 c/o indigestion; mintox administered and effective 6/7/19 c/o abd pain, diarrhea and emesis, v/s T 98.9, HR 91, RR 18, BP 124/71; transferred to hospital for eval
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspepsia, Vomiting
Clinical narrative: 6/5/19 c/o indigestion; mintox administered and effective 6/7/19 c/o abd pain, diarrhea and emesis, v/s T 98.9, HR 91, RR 18, BP 124/71; transferred to hospital for eval
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives. On 06/10/2019 at 10:30 PM, noticed the hives on both sides of face about an inch away from each ear.  On 06/11/2019, the hives also appeared on both sides of the neck and down the back.  On 06/12/2019, the hives on the back are beginning to itch.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Dtr started with high temp on 05/18/2019  was as high as 104.9 -lasted about 5 days- had bumps on her face arms and legs = ruled out for Hand Foot and Mouth and was listed as "virus" - Dtr had been bitten by tick 04/26- MD stated unlikely lyme.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test abnormal, Retinal vein occlusion, Vision blurred, Visual acuity reduced
Clinical narrative: pt called the office on 6/12/19 to say the day after receiving the MMR vaccine she woke up with  totally blurred vision in her left eye.  Pt was seen by the eye doctor the following week and found to have decreased visual acuity even with glasses and vein occlusion in the retina.  She was given a growth hormone injection in the eye to stop any further oozing and sent for bloodwork (completed ion 6/4/19)by her PCP.  She was noted to have an elevation in her autoimmune antibodies.  She has followup in one week with her eye doctor to see if another injection in the eye is needed and will f/u with her PCP for the elevated autoimmune antibodies.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) lot#, expiration date, dose, dose# and route of administration not specified) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles and was treated by a healthcare provider for the event. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 65.0
Sex: M
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 72-years-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.    On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of herpes zoster was unknown.     Additional information has been requested.