chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Patient reported red, swollen sore (~5 inches in diameter) that developed the same night she received the vaccine. She also reported a fever that lasted for 5 days. Outcome unknown.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: C/o dizziness. Observed for 20 min, provided lollipop,  BPs monitored, placed in supine position, elevated legs, dizziness resolved. Discharged to mom feeling better.
Age: 5.0
Sex: M
Vaccine: HIBV
Symptoms: Chest pain, Crying
Clinical narrative: Crying from chest pain saying heart hurts
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient received the Menveo vaccine in her right deltoid and Tdap vaccine in her left deltoid- was given orange juice prior to vaccines- 2 min post vaccines pt fainted on exam room table- no injuries occurred- had LOC for 2-3 seconds - was monitored X 45 min in office - reviewed with APN and was discharged home. Pt has had a history of syncope not only related to vaccines.
Sex: U
Vaccine: HIBV
Symptoms: Chest pain, Crying
Clinical narrative: Crying from chest pain and saying heart hurts.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: extreme soreness of the arm, fatigue, achey joints, head ache, slight fever
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Chest pain, Crying
Clinical narrative: Crying from chest pain saying heart hurts
Age: 0.75
Sex: F
Vaccine: MMR
Symptoms: Cough, Ear infection, Rash generalised, Rash macular, Rhinorrhoea
Clinical narrative: Mild vaccine rash developed 5/31/19 (14 days post-vaccine).  Diffuse flat (non-raised) circular red spots across body, focused primarily on torso but also some on head, face, legs, arms, feet.  Non-itchy, requiring no medication to treat.  No associated fever, change in appetite.  Baby did not appear in distress.  Spots beginning to fade 3 days after first appeared.  Baby was diagnosed with an ear infection on 5/28/19, and treated with amoxicillin oral suspension for 10 days.  Also URI (cough, runny nose) since 6/1/19 (no medical treatment).
Age: 0.75
Sex: F
Vaccine: MMR
Symptoms: Upper respiratory tract infection
Clinical narrative: Mild vaccine rash developed 5/31/19 (14 days post-vaccine).  Diffuse flat (non-raised) circular red spots across body, focused primarily on torso but also some on head, face, legs, arms, feet.  Non-itchy, requiring no medication to treat.  No associated fever, change in appetite.  Baby did not appear in distress.  Spots beginning to fade 3 days after first appeared.  Baby was diagnosed with an ear infection on 5/28/19, and treated with amoxicillin oral suspension for 10 days.  Also URI (cough, runny nose) since 6/1/19 (no medical treatment).
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: parents stated child was lethargic with a high temp. temp was 99 F, vomiting went to ER vaccines were given one month early
Age: 20.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 1 x 1.5 cm urticaria within 2 cm of injection site with 2-5 minutes of injection.  Skin was normal prior to injection.
Age: 55.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Chills, Mouth ulceration, Pyrexia
Clinical narrative: Patient had fever and chills for 2 days after the shot. Patient also had mouth ulcers since the shot was given. He went to the doctor for mabex solution.
Age: 21.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Erythema and swelling; no fever; no drainage; evaluated by PCP on 5/03/19; Dx Cellulitis right arm and treated with oral antibiotic; Doxycycline Hyclate
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Approximately 24 hours after injection the patient complained of injection site swelling, redness, and blistering. Patient immediately went to her prescriber her gave her Bactroban cream in hopes of preventing an infection.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Chills, Headache, Influenza virus test negative, Nausea
Clinical narrative: Fever up to 104, nausea, vomiting, arthalgia, particularly in his elbows. Headache and chills.   He was diagnosed with a Pilonidal cyst vs abscess on 4/19/19.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Streptococcus test negative, Vomiting, White blood cell count increased
Clinical narrative: Fever up to 104, nausea, vomiting, arthalgia, particularly in his elbows. Headache and chills.   He was diagnosed with a Pilonidal cyst vs abscess on 4/19/19.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Received immunization around 11:30 am. Starting feeling bad not long after. Thought it was seasonal allergies so took off work and went home to bed. States she woke up at 5 or 6 in the evening and felt fine. States That evening the injection site became hard like a knot and red, raised, swollen left deltoid/upper arm.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site and muscle.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Muscle spasms
Clinical narrative: Discomfort in LefT ARM After Resting in Lounge ChAIR I StARTed  to get up ANd had A complete Left Leg  muscle CRAmp from LoweR hip AReA T. totAL CRAmp to ANKle + foot MADE A ShaRP TuRn to RighT I would hAve fallen forward TowARds coffee Table or TV STANd. I fell BAcKwARd INTO  ChAIR +had to mersarge Leg to hAve cRAmpiNg go AWAy.
Sex: F
Vaccine: HPV9
Symptoms: Bipolar disorder, Headache, Laboratory test, Lethargy, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act referring to a 15 year old female patient. The patient's concurrent condition included warts on the foot. Information about concomitant medication and medical history was not provided. On 03-MAY-2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot # L038503, expiration date, dose and frequency unknown, intramuscular in the left arm) for prophylaxis. On 07-JUN-2017, the patient's stepmom stated that the human papillomavirus (HPV) vaccine had given patient a lot of symptoms including hand tremors, nausea, lethargy, personality changes, bipolar symptoms as well as hives, weight gain, jaw pain, nausea, vomiting and headaches. The patient did not present for medical evaluation. The patient's current status is undocumented. On an unknown date, the patient's stepmom came into the office for consult without patient. Rheumatology referral was sent per stepmom's request. The outcome of the events was reported as not recovered. The causality assessment was not provided. Follow-up information has been received from the patient's mother and the vaccine administrator via the FDA (agency# 701180) on request by the Company under the Freedom of Information Act on 15-APR-2019. It was reported that the patient received the first dose of GARDASIL 9 (lot number and expiration date not provided) on 24-MAR-2015 and the second one on 03-MAY-2016 (previously reported as a third dose). Regarding the onset of the event, it was reported as: "2 years of illness". Additionally, it was reported that "they were doing lab tests". Follow up information has been received from  a Nurse on 30-MAY-2019. The nurse did not wanted to share any additional identifying information for patient. The nurse shared that the patient had the events prior to her vaccination. She also reported that the physician did not think the vaccine caused any of these events.
Sex: F
Vaccine: HPV9
Symptoms: Pain in jaw, Personality change, Tremor, Urticaria, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act referring to a 15 year old female patient. The patient's concurrent condition included warts on the foot. Information about concomitant medication and medical history was not provided. On 03-MAY-2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot # L038503, expiration date, dose and frequency unknown, intramuscular in the left arm) for prophylaxis. On 07-JUN-2017, the patient's stepmom stated that the human papillomavirus (HPV) vaccine had given patient a lot of symptoms including hand tremors, nausea, lethargy, personality changes, bipolar symptoms as well as hives, weight gain, jaw pain, nausea, vomiting and headaches. The patient did not present for medical evaluation. The patient's current status is undocumented. On an unknown date, the patient's stepmom came into the office for consult without patient. Rheumatology referral was sent per stepmom's request. The outcome of the events was reported as not recovered. The causality assessment was not provided. Follow-up information has been received from the patient's mother and the vaccine administrator via the FDA (agency# 701180) on request by the Company under the Freedom of Information Act on 15-APR-2019. It was reported that the patient received the first dose of GARDASIL 9 (lot number and expiration date not provided) on 24-MAR-2015 and the second one on 03-MAY-2016 (previously reported as a third dose). Regarding the onset of the event, it was reported as: "2 years of illness". Additionally, it was reported that "they were doing lab tests". Follow up information has been received from  a Nurse on 30-MAY-2019. The nurse did not wanted to share any additional identifying information for patient. The nurse shared that the patient had the events prior to her vaccination. She also reported that the physician did not think the vaccine caused any of these events.
Sex: F
Vaccine: HPV9
Symptoms: Weight increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act referring to a 15 year old female patient. The patient's concurrent condition included warts on the foot. Information about concomitant medication and medical history was not provided. On 03-MAY-2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot # L038503, expiration date, dose and frequency unknown, intramuscular in the left arm) for prophylaxis. On 07-JUN-2017, the patient's stepmom stated that the human papillomavirus (HPV) vaccine had given patient a lot of symptoms including hand tremors, nausea, lethargy, personality changes, bipolar symptoms as well as hives, weight gain, jaw pain, nausea, vomiting and headaches. The patient did not present for medical evaluation. The patient's current status is undocumented. On an unknown date, the patient's stepmom came into the office for consult without patient. Rheumatology referral was sent per stepmom's request. The outcome of the events was reported as not recovered. The causality assessment was not provided. Follow-up information has been received from the patient's mother and the vaccine administrator via the FDA (agency# 701180) on request by the Company under the Freedom of Information Act on 15-APR-2019. It was reported that the patient received the first dose of GARDASIL 9 (lot number and expiration date not provided) on 24-MAR-2015 and the second one on 03-MAY-2016 (previously reported as a third dose). Regarding the onset of the event, it was reported as: "2 years of illness". Additionally, it was reported that "they were doing lab tests". Follow up information has been received from  a Nurse on 30-MAY-2019. The nurse did not wanted to share any additional identifying information for patient. The nurse shared that the patient had the events prior to her vaccination. She also reported that the physician did not think the vaccine caused any of these events.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients received one separate dose each of the improperly stored PROQUDA; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  There were three separate patients received one separate dose each of the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number reported as R022566 and expiration date 04-FEB-2020, subcutaneously for prophylaxis) (product storage error). The three separate doses of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were administered on 22-FEB-2019, 19-MAR-2019 and 15-APR-2019. It was unknown as to which patient which dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on which day. It was unspecified if the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored properly. No adverse effects were reported. No product quality complaint (PQC) was involved.  The other two patients were captured in case# 1906USA000042 and 1906USA000043.; Sender's Comments:  US-009507513-1906USA000042: US-009507513-1906USA000043:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; a patient received improperly stored PROQUAD on 5/13/2019.; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On 13-MAY-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant Human albumin (rHA); lot # R018778 with expiration date auto calculated as 29-DEC-2019 (also reported as 23-JUL-2020); strength, dose detail and route were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Temperature and time of the vaccine exposed was unknown. There was no previous temperature excursion. No adverse effect reported. Data logger was involved.
Age: 38.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect reported.; Nurse reported that 1 dose of PROQUAD was administered to patient 38 years old on 3/26/2019; This spontaneous report was received from a nurse referring to a 38 years old patient of unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reaction/allergy was not provided.  On 26-MAR-2019, the nurse reported that 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter (ml) (lot # R020678 with expiration date 15-JAN-2020; strength was not reported) was administered subcutaneously to the patient for prophylaxis (adult use of a child product ). It was unknown whether sterile diluent (lot# and expiration date was unknown) was stored in proper range. No adverse effect reported. The causality of the event was not provided.
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 69 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) 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 an advanced registered nurse practitioner (ARNP) for herpes zoster. The outcome of the event herpes zoster 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: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-FEB-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) 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 physician assistant for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
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 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 05-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) 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 healthcare provider for herpes zoster. 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 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In November 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) 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 herpes zoster. 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: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored M-M-R II; expired M-M-R II; This spontaneous report was received from a medical assistant, referring to a 28 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications.   On 14-MAY-2019, the patient received an improperly stored and expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), in left arm, lot # N013868 (expiration date: 04-MAY-2019), for prophylaxis (strength, dose, frequency, route of administration was not reported). Other suspect therapy included sterile diluent (STERILE DILUENT), lot #M037021 (expiration date:04-MAY-2019) for prophylaxis (strength, dose, frequency, route of administration was not reported). Temperature excursion was above 47°F (52.7 F, multiple) for 35 min, as recorded by a data logger. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Received an improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs, drug reactions and allergies was not provided. The patient's concomitant therapies included sterile diluent.   On 14-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(rha) lot # R004441, expiration date 12-AUG-2019 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range of -14°C to -10°C (-14.3°C) for 2 hours and 7 minutes. There was previous temperature excursion from -14°C to -10°C (-12.8°C) for 51 minutes and from -9°C to 8°C (-8.2°C) for 37 minutes. It was reported that digital data logger was involved. No adverse effects were reported.  This is one of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA009915: US-009507513-1905USA012682: US-009507513-1905USA012683:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported.; an unspecified patient "in their twenties" was administered the first two doses of the three dose regimen of GARDASIL 9 on schedule but "forgot" about the third dose and it has been two years since the second dose.; This spontaneous report was received from a pharmacist regarding an adult patient (reported as: "in their twenties") of unknown age and gender. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On an unknown date, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), and on an unspecified date in 2017 (reported as: "two years since the second dose"), the patient received the second dose (route, anatomical site, lot numbers and expiration dates were not reported) for prophylaxis. It was reported that the patient "forgot" about their third dose and it had been two years. It was not clarified if the patient visited the physician's office on 28-MAY-2019 (reported as: "today") to receive the third dose. No adverse effects were reported.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; VAQTA was given to an infant before he turned 12 months old; This spontaneous report was received from a registered nurse referring to a 10 month old male patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 05-APR-2019, the patient was vaccinated with 1 dose of hepatitis a vaccine, inactivated (VAQTA) VIAL 25/0.5, intramuscularly, in the right thigh, lot number R024007 and expiration date of 12-OCT-2019, for prophylaxis because he was traveling outside of the country. No adverse effects were reported
Age: 50.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; GARDASIL 9 given to a 50 year old patient; This spontaneous report was received from a registered nurse referring to a 50 year old patient of unknown gender. The patient's concurrent conditions included diagnosis of precancerous moderate squamous dysplasia precancerous lesion in perianal area. No information was provided regarding the patient's medical history, drug reactions or allergies and concomitant medication.  On 10-APR-2019,  due to the diagnosis 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) intramuscularly, lot number R026380 and expiration date of 23-JUN-2021, for prophylaxis (anatomical location was not reported). No adverse effects were reported
Age: 13.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: titers negative hepatitis B antibodies; This spontaneous report as received from a registered nurse refers to a five unspecified patient between the ages of 13  15 years old. The patients' concurrent conditions, medical history and concomitant therapies were not reported.   On unspecified date, the unspecified patients were vaccinated for prophylaxis with the full series of hepatitis b vaccine (recombinant)(manufacturer unknown) (dosage regimen, route of administration, lot number and expiration date were not reported). On unknown date, the unspecified patients had titers negative for hepatitis B antibodies (Hepatitis B antibody negative). At the time of this report the patients had not recovered from the adverse event of Hepatitis B antibody negative.  The causal relationship between hepatitis B antibody negative and hepatitis b vaccine (recombinant) (manufacturer unknown) was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; received expired dose M-M-R II on 23-MAY-2019; This spontaneous report as received from medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition were unknown.Concomitant medications included sterile diluent. On 23-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type: RHA, lot # N013866, expiration date: 04-MAY-2019 (strength, dose, dose number and anatomical location unknown) via subcutaneously for prophylaxis (expired product administered). The lot number and expiration dates were not known for the properly stored sterile diluent, which was used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No adverse effects were reported. No product quality complaints(PQC) was involved.     This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1905USA012962:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Therapeutic response decreased
Clinical narrative: the vaccine was not strong enough; diagnosed with shingles; This spontaneous report was received from a 63 years old female patient referring herself. The patient's concurrent condition was not reported. The patient's drug reactions/allergies included, antibiotics, sulfa drugs, Bacitracin. On an unknown date in May 2017 (reported as mid May of 2017) the patient was vaccinated with zoster vaccine live (ZOSTAVAX), subcutaneously in upper arm (strength, dose, lot/batch number, expiration date was unknown) for shingles.  On an unknown date in April 2019 (reported as a month ago), the patient experienced severe headache on the left side of the head. On an unknown date in May 2019 (reported as about a week ago), the patient experienced itching, pain, puffiness, redness, watery eyes, flu like symptoms, and blisters on face and underneath the eyes. The patient visited the physician and was diagnosed with shingles (herpes zoster). The physician stated that the patient got the shingles as the vaccine was not strong enough (therapeutic response decreased). On an unknown date in May 2019 (reported as weekend of holiday), the patient visited the urgent care and was prescribed with antiviral medicine Valacyclovir to help with itching and pain. No product quality complaint was involved. The outcome of therapeutic response decreased and herpes zoster was reported as not recovered/not resolved. Causality assessment was not provided.  Upon internal review the event shingles (herpes zoster) was determined to be medically significant.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 17-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0,5 milliliter injection, intramuscularly, lot # N007750, expiration date 29-NOV-2019 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA008566: US-009507513-1905USA014100:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 08-FEB-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0,5 milliliter injection, intramuscularly, lot # N007750, expiration date 29-NOV-2019 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA008566: US-009507513-1905USA014096: US-009507513-1905USA014100:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0,5 milliliter injection, intramuscularly, lot # N007750, expiration date 29-NOV-2019 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA008566:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 05-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R018735, expiration date 06-APR-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA008566: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 07-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly lot # R018735, expiration date 06-APR-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA008566: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 07-FEB-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0,5 milliliter injection, intramuscularly, lot # N007750, expiration date 29-NOV-2019 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA008566: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 08-FEB-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0,5 milliliter injection, intramuscularly, lot # N007750, expiration date 29-NOV-2019 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA008566: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a physician via pfizer refers to a 66 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2013(reported as 6years ago) the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(lot#, expiry date was unknown) for prophylaxis. On an unknown date, the patient experienced shingles. The outcome of the event was unknown. The causality was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients received one separate dose each of the improperly stored PROQUDA; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  There were three separate patients received one separate dose each of the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number reported as R022566 and expiration date 04-FEB-2020, subcutaneously for prophylaxis) (product storage error). The three separate doses of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were administered on 22-FEB-2019, 19-MAR-2019 and 15-APR-2019. It was unknown as to which patient which dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on which day. It was unspecified if the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored properly. No adverse effects were reported. No product quality complaint (PQC) was involved.  The other two patients were captured in case# 1906USA000043 and 1905USA003408.; Sender's Comments:  US-009507513-1905USA003408: US-009507513-1906USA000043:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients received one separate dose each of the improperly stored PROQUDA; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  There were three separate patients received one separate dose each of the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number reported as R022566 and expiration date 04-FEB-2020, subcutaneously for prophylaxis) (product storage error). The three separate doses of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were administered on 22-FEB-2019, 19-MAR-2019 and 15-APR-2019. It was unknown as to which patient which dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on which day. It was unspecified if the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored properly. No adverse effects were reported. No product quality complaint (PQC) was involved.  The other two patients were captured in case# 1906USA000042 and 1905USA003408.; Sender's Comments:  US-009507513-1906USA000042: US-009507513-1905USA003408:
Sex: M
Vaccine: HPV9
Symptoms: Injection site oedema, Injection site reaction
Clinical narrative: Severe edema; injection site reaction; This spontaneous report was received from a physician via company representative and referred to a male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date ,the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dosing details, route, frequency and lot# were unknown) and had an injection site reaction that consisted of severe oedema that covered the whole deltoid area of an unspecified arm. It was reported that the oedema was 4 cm in diameter.The outcome of oedema and injection site reaction was unknown. Causality assessment was not provided. No PQC found.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incontinence
Clinical narrative: Incontinence; This case was reported by a other health professional via call center representative and described the occurrence of incontinence in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   On 21st May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st May 2019, less than a day after receiving Shingrix, the patient experienced incontinence. On an unknown date, the outcome of the incontinence was not recovered/not resolved.   It was unknown if the reporter considered the incontinence to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left arm. The concomitant medication included diuretic. The patient experienced incontinence following a Shingrix dose.  The patient reported it to pharmacy on 22nd May 2019. The patient was still experiencing incontinence as of 23rd May 2019. The reporter gave permission to follow up. This case had been linked to the case US2019094040, reported by same reporter. As per sales data sheet reported batch number was changed from 23JKS to 23JK5.
Age: 50.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Asthenia, Palpitations, Somnolence, Vomiting
Clinical narrative: Vomiting from about 8:30 AM until 4:00 PM.  Not keeping anything down. Only trying to drink water , tried eating a banana and cracker. Sleeping on and off all day.   Unable to stay awake for more than an hour all day.   Better the next day, but having weakness and heart palpitations for two days.
Age: 0.08
Sex: F
Vaccine: 6VAX-F, PNC13, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction reported by mother or noted at office visit to establish care at Family Practice on May 31/2019.   It was recommended by RN, BSN Educator  to report DTaP, Hib, Polio, Prevnar and Rotavirus given at 4 weeks of age, 2 week prior  to the earliest ACIP recommendation by patients provider prior to moving.   This is from RN's email to the Immunization Registry: Doses administered too close together or at too young an age can lead to a suboptimal immune response. Doses of any vaccine administered ?5 days earlier than the minimum interval or age should not be counted as valid doses and should be repeated as age appropriate. If the first dose in a series is given ?5 days before the recommended minimum age, the dose should be repeated on or after the date when the child reaches at least the minimum age.?  This is considered a vaccine administration error.  Please encourage the facility staff where the error occurred to determine how the error occurred and to take appropriate actions to put strategies in place to prevent it from happening in the future.  We also strongly suggest contacting the EMR vendor to determine if there is an error in their programing and/or what their forecasting is based on. In addition, we encourage providers to report all vaccine administration errors?even those not associated with an adverse event ? to the Vaccine Adverse Event Reporting System (VAERS).
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: rash, itch, and swelling at injection site, fever the following morning that continued for apx. 12 hours. still itchy.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Diarrhoea, Pyrexia, Rash erythematous
Clinical narrative: RED SPOTS ON HEAD AND TRUNK. NOTICED TODAY (6/3/19)   LOW GRADE FEVER FOR ONE DAY. . DIARRHEA FOR ABOUT ONE WEEK.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pt started to get a fever around 10 pm that same evening that he had the vaccine, temp peaked at 4 am to 103.6 . pt reported feeling fine 8 am on 6/3/19
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Depressed mood, Emotional disorder, Hypoaesthesia, Insomnia, Lethargy
Clinical narrative: Numbness and tingling started on the soles of the feet and continued upward.  Within days the numbness went  over the tops of the feet, ankles and daily would advance until it was up over the knees.  Fingers and hands also began to have numbness and tingling.  While this process continued I had lethargy, insomnia, and became depressed and emotiona.   I had all the symptoms of GBS.    After I figured out what happened, it took over a  year to detox and return to somewhat formal function.  Currently I struggle with some return of the symptoms and have to do a detox regime again.    So many people have the same issue after these injections or others and no one tells them they are connected to the vaccine.  They just give them a new diagnosis and some new prescriptions and send them on their way.     I find this unacceptable!
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Numbness and tingling started on the soles of the feet and continued upward.  Within days the numbness went  over the tops of the feet, ankles and daily would advance until it was up over the knees.  Fingers and hands also began to have numbness and tingling.  While this process continued I had lethargy, insomnia, and became depressed and emotiona.   I had all the symptoms of GBS.    After I figured out what happened, it took over a  year to detox and return to somewhat formal function.  Currently I struggle with some return of the symptoms and have to do a detox regime again.    So many people have the same issue after these injections or others and no one tells them they are connected to the vaccine.  They just give them a new diagnosis and some new prescriptions and send them on their way.     I find this unacceptable!
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Patient received third dose of Hep B after new employee physical recommended. Patient reported five days later the area of injection was burning and continuously itching. Patient has been taking benedryl. Patient is not in distress.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Placental disorder, Stillbirth
Clinical narrative: First pregnancy.  Due date was anticipated for June.    Still birth death on May 10, 2018 (at 9 months).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Headache, Influenza like illness, Nausea
Clinical narrative: Patient had redness/pain that went up arm and started at neck that was diagnosed at cellulitis at ER , she experienced fever, nausea, headache and flu like symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Patient had redness/pain that went up arm and started at neck that was diagnosed at cellulitis at ER , she experienced fever, nausea, headache and flu like symptoms.