chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye pain, Headache, Herpes zoster, Keratitis
Clinical narrative: Pt suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. Pt was diagnosed with posterior vitreous detachment; Pt suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. Pt was diagnosed with postherpetic neuralgia.; Pt suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. Pt was diagnosed with keratoconjunctivitis of both eyes; Pt suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. Pt was diagnosed with multiple occurrences of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 19-JUL-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. The patient was diagnosed with multiple occurrences of shingles (herpes zoster), post herpetic neuralgia, posterior vitreous detachment (vitreous detachment) and keratoconjunctivitis of both eyes (keratitis). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).  Keratitis, herpes zoster, vitreous detachment and post herpetic neuralgia were considered to be disabling.  Upon internal review, vitreous detachment was considered a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Swelling face, Vitreous detachment
Clinical narrative: Pt suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. Pt was diagnosed with posterior vitreous detachment; Pt suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. Pt was diagnosed with postherpetic neuralgia.; Pt suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. Pt was diagnosed with keratoconjunctivitis of both eyes; Pt suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. Pt was diagnosed with multiple occurrences of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 19-JUL-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered severe headache pain, facial swelling on the left side and behind the eye with blistering on the skin. The patient was diagnosed with multiple occurrences of shingles (herpes zoster), post herpetic neuralgia, posterior vitreous detachment (vitreous detachment) and keratoconjunctivitis of both eyes (keratitis). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).  Keratitis, herpes zoster, vitreous detachment and post herpetic neuralgia were considered to be disabling.  Upon internal review, vitreous detachment was considered a medically significant event.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Blood pressure decreased, Disorientation, Syncope
Clinical narrative: SYNCOPE; Blood Pressure Decreased; DESORIENTATION; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  This spontaneous report refers to a 19 year old male patient. The patient's concurrent conditions, concomitant and historical medications were not reported. The patient had no known allergies. The patient's historical conditions included asthma and psoriasis.    On 24-APR-2018 the patient was vaccinated with the second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #: N028567, expiration date not reported, but upon internal validation established as 17-MAY-2020), intramuscular in the left arm for prophylaxis and hepatitis a virus vaccine inactivated (HAVRIX) (lot # 4H37Y, expiration date 08-OCT-2020) administered by intramuscular route in the right arm.   On 24-APR-2018, the patient experienced a syncope event lasting less than 5 seconds, a few minutes after receiving the vaccines. His blood pressure dropped to 70s/50s (blood pressure decreased), and he appeared slightly disoriented (disorientation).   At the reporting time, the outcome of the events was reported as recovered. Additionally, the reporter did not assess the causality between the event and the therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and hepatitis a virus vaccine inactivated(HAVRIX).  Follow-up information was received from an registered nurse via FDA on 29-OCT-2019, referring the patient. The patient's concurrent conditions included asthma and psoriasis (previously reported as historical conditions). The patient had never had an adverse event following any previous vaccine. The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and hepatitis a virus vaccine inactivated(HAVRIX) on 24-APR-2018 11:20. The patient experienced the events on 24-APR-2018 11:21. The outcome of the events was recovered. The causality assessment was unknown.  Follow-up information was received from  a registered nurse on 07-JAN-2020.   The date and vaccination information was confirmed.  On the same date post vaccine administration, at 11:23 am, blood pressure was 79/37 (units not provided) and heart rate was 49 (units not provided); at 11:25 am blood pressure was 76/34 (units not provided) and heart rate was 57 (units not provided); at 11:28 am blood pressure was 109/51 (units not provided) and heart rate was 57 (units not provided). 15 minutes post vaccination student denied dizziness, Lightheadedness or other symptoms.   The subject recovered from the event blood pressure decreased after 15 minutes.   Causality assessment for the events syncope and blood pressure decreased were reported as related.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Astigmatism, Conjunctivitis, Corneal abrasion, Dry eye, Eye irritation
Clinical narrative: She developed severe conjunctivitis and itching following administration of Shingrix. After vigorous rubbing of eyes, she developed a corneal abrasion requiring ED visit and ophthalmologic follow-up. To this day, she has persisted with very dry eyes and she has required refraction of her lenses 4 times. She has also developed a new astigmatism.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Refraction disorder
Clinical narrative: She developed severe conjunctivitis and itching following administration of Shingrix. After vigorous rubbing of eyes, she developed a corneal abrasion requiring ED visit and ophthalmologic follow-up. To this day, she has persisted with very dry eyes and she has required refraction of her lenses 4 times. She has also developed a new astigmatism.
Age: 22.0
Sex: F
Vaccine: JEV1
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient is 5 weeks pregnant and received JEV vaccination. No adverse effects have taken place as of this moment to patient or the pregnancy.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Injection site pain, Lethargy, Lymphadenopathy, Pain in extremity
Clinical narrative: I want to report that within a day or two of receiving  my first injection of Shingrix, in addition to right arm pain and soreness at the injection site and general lethargy the first day after, I DEVELOPED A NOTICEABLE SWELLING OF LYMTH NODE IN RIGHT ARMPIT THE SIZE OF AN ORANGE WHICH WAS EXTREMELY PAINFUL WHEN PRESSED. THE SWELLING WOKE ME FROM SLEEP THE SECOND NIGHT AFTER  INJECTION. I HAVE HAD AN ULTRASOUND OF MY RIGHT ARMPIT YESTERDAY 01/14/2020 which confirms the enlarged lymph glands.  Some swelling and soreness of my armpit still remains. I AM CONCERNED ABOUT TAKING THE SECOND DOSE OF SHINGRIX.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Ultrasound scan abnormal
Clinical narrative: I want to report that within a day or two of receiving  my first injection of Shingrix, in addition to right arm pain and soreness at the injection site and general lethargy the first day after, I DEVELOPED A NOTICEABLE SWELLING OF LYMTH NODE IN RIGHT ARMPIT THE SIZE OF AN ORANGE WHICH WAS EXTREMELY PAINFUL WHEN PRESSED. THE SWELLING WOKE ME FROM SLEEP THE SECOND NIGHT AFTER  INJECTION. I HAVE HAD AN ULTRASOUND OF MY RIGHT ARMPIT YESTERDAY 01/14/2020 which confirms the enlarged lymph glands.  Some swelling and soreness of my armpit still remains. I AM CONCERNED ABOUT TAKING THE SECOND DOSE OF SHINGRIX.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity, Pyrexia, Ultrasound scan
Clinical narrative: I want to report that within a day or two of receiving  my first injection of Shingrix, in addition to right arm pain and soreness at the injection site and general lethargy the first day after, I DEVELOPED A NOTICEABLE SWELLING OF LYMTH NODE IN RIGHT ARMPIT THE SIZE OF AN ORANGE WHICH WAS EXTREMELY PAINFUL WHEN PRESSED. THE SWELLING WOKE ME FROM SLEEP THE SECOND NIGHT AFTER  INJECTION. I HAVE HAD AN ULTRASOUND OF MY RIGHT ARMPIT YESTERDAY 01/14/2020 which confirms the enlarged lymph glands.  Some swelling and soreness of my armpit still remains. I AM CONCERNED ABOUT TAKING THE SECOND DOSE OF SHINGRIX.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain, Pyrexia
Clinical narrative: extremely painful injection site; redness upper arm; fever 101.2, chills self treated with fluids and acetaminophen
Sex: M
Vaccine: HPV4
Symptoms: Off label use, Pathology test
Clinical narrative: off label use; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 23 year old male patient with hoarseness and poor voice projection without improvement from speech therapy or medical anti-reflux medication. The patient had squamous cell papilloma. The patient's historical drugs included bevacizumab and cidofovir.  On an unknown date, the patient was vaccinated with a dose quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration date, dose, rout and site of vaccination were not reported) for squamous cell papilloma (off-label use). COncomitant therapies included celecoxib.  A copy of the published article is attached as further documentation of the patient's experience
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 13-NOV-2009 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site mass, Injection site pain, Injection site papule
Clinical narrative: Localized pink papule left deltoid; Mild tenderness; lump beneath skin approx 2 cms x 2 cms in left deltoid area; This spontaneous report was received from an unspecified health care professional referring to a white male patient of unknown age. The patient did not have medical history or concurrent conditions. The patient did not take concomitant medications.   On an unknown date, the patient was vaccinated in his left arm with a dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R011628, intramuscular (strength, and expiration date were not provided). Other suspect therapies included a dose in his right arm of influenza virus split virion 3v vaccine inactivated(FLUZONE) lot # UJ087A5, intramuscular (strength, and expiration date were not provided). Both therapies for prophylaxis.  On an unknown date, the patient experienced localized pink papule in his left deltoid. Additionally, lump beneath skin approximately 2 cm x 2 cm in his left deltoid area (skin mass) with mild tenderness without redness and warmth.  At the time of the report, the outcome of papule, skin mass and tenderness was reported as not recovered.  The reporter did not assess the relatedness between papule, skin mass and tenderness and suspect therapies.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Experienced really bad injection site pain all trough the night; Information has been received from a male patient of unknown age, concerning himself. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). Subsequently, the patient experienced really bad injection site pain all through the night. The outcome of the injection site pain was unknown.  The causal relationship between the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the injection site pain was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects.; a patient received an expired dose of M-M-R II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about medical history and concurrent conditions was not provided.  On 10-JAN-2020, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N034002, expiration date 04-DEC-2019; dose and route were not provided) for prophylaxis (expired product administered). No known adverse effects.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingrix (unknown). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in early December and he complains that he has shivering intermittently.  The shivering as come and go, but when the shivering onsets, it comes on strong and feels as if he cannot get warm enough. The reporter was the daughter of the patient.  The reporter had limited vaccination information and was okay with follow up.
Sex: U
Vaccine: MENB
Symptoms: Myalgia
Clinical narrative: soreness in muscle; This is a spontaneous report from a contactable physician via a company representative. An adolescent patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in leg muscle on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced soreness in muscle (non-serious) on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: FLUX
Symptoms: Memory impairment
Clinical narrative: he could not recall the name of the flu shot that he took; Initial information was received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 76 year old male patient who could not recall the name of the flu shot that he took(memory impairment), while he received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in September 2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site.  On an unknown date,the patient developed non-serious unable to recall the name of the flu shot that he took (memory impairment) Unknown latency following the administration of INFLUENZA VACCINE.  Detail of laboratory data was not reported.  Final diagnosis was memory impairment  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of the event was reported as Unknown for memory impairment.  Information on the batch number was requested.
Sex: F
Vaccine: HIBV
Symptoms: Injury associated with device, Limb injury, Syringe issue
Clinical narrative: the nurse incuring a finger stick; Flip cap did not detach all the way; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves female patient who incuring a finger stick (limb injury), while administrating the HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, patient incured a finger stick (limb injury), while administrating the HIB (PRP/T) VACCINE [ACT-HIB] [Batch number: UJ135ABA, expiry date: 26-Nov-2020, diluent batch number: UJ135A, expiry date: 26-Feb-2021, Combo Batch number: U6477AA, expiry date: 26-Nov-2020], via unknown route at an unknown administration site.  It was also the case of syringe issue.  Details of laboratory data not reported.  Final diagnosis was limb injury.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown as it not reported.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Diplopia, Dizziness, Immediate post-injection reaction, Nausea, Vision blurred
Clinical narrative: Patient was immediately nauseated after the vaccines, then became dizzy.  Within 15min  developed double vision and blurry vision.  Dizziness and blurry vision never resolved (more than 12 hours later at this point).
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Swelling and pain within 2 hours. After 12 hours - nausea, vomiting, fever, chills.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Swelling and pain within 2 hours. After 12 hours - nausea, vomiting, fever, chills.
Age: 60.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: patient states she had Redness, swelling, warmth, tenderness to the touch and pain with not  contact to the upper outer Right deltoid near the injection site, about 4 1/2 inch area, also large inflamed lump above the elbow 4 inches and 1/3 around the arm.
Age: 60.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site warmth
Clinical narrative: patient states she had Redness, swelling, warmth, tenderness to the touch and pain with not  contact to the upper outer Right deltoid near the injection site, about 4 1/2 inch area, also large inflamed lump above the elbow 4 inches and 1/3 around the arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Feeling abnormal, Headache
Clinical narrative: Chills, aches, weakness, headache, lightning bolt feelings in head, joint pain
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Chills, aches, weakness, headache, lightning bolt feelings in head, joint pain
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Fatigue, Influenza B virus test positive, Oropharyngeal pain, Pyrexia
Clinical narrative: child developed 102 F fever, fatigue, sore throat and cough at 02:00 on 11Jan2020 treatment with motrin and tylenol as of 15Jan2020 child is still recovering
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: vaccine was given after exp date
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, C-reactive protein, Full blood count, Metabolic function test, Rash erythematous
Clinical narrative: 2 red spots on right breast- faded 3 spots on left breast- very itchy, faded then returned Scattered spots on torso- itchy, faded then returned
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: 2 red spots on right breast- faded 3 spots on left breast- very itchy, faded then returned Scattered spots on torso- itchy, faded then returned
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Culture stool, Diarrhoea haemorrhagic, Pyrexia
Clinical narrative: Some blood noted in diarrhea with 100.5 fever(x1) on 1/7/2020. Baby is better now and improving. Unknown cause of the bloody diarrhea now better. Since event happen approximate 30 days off the vaccine I wanted to report it.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Significant muscle pain at injection site ~4hours after injection. Severe nausea early morning the day after injection, followed by severe headache the entire day.  Required alternating ibuprofen and acetaminophen every 2 hours to provide limited relief. Moderate nausea and severe headache 2nd day after injection.  Required alternating ibuprofen and acetaminophen every 2 hours to provide partial relief. Mild nausea and significant headache 3rd day after injection.  Required ibuprofen every 4 hours to provide relief. Mild nausea and moderate headache off and on daily for 2 weeks following injection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Headache, Myalgia, Pain
Clinical narrative: LARGE AREAS OF RED BLISTERS ON BACK OF THIGH ON ONE LEG.  VERY ITCHY, WARM TO TOUCH, PAINFULL..  ALSO HAD FEVER, HEADACHE AND MUSCLE ACHES
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Skin warm
Clinical narrative: LARGE AREAS OF RED BLISTERS ON BACK OF THIGH ON ONE LEG.  VERY ITCHY, WARM TO TOUCH, PAINFULL..  ALSO HAD FEVER, HEADACHE AND MUSCLE ACHES
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed scant hives in office within five minutes of receiving vaccine. Hives were present on back and torso. Provider examined the patient and hives were beginning to resolve without intervention within an additional five minutes.  Mother called the office the day following vaccine administration (1/14/20) to report that hives had spread and become itchy - no respiratory involvement. Advised to administer Benadryl every 6 hours as needed for hives - patient to be seen if any lip swelling, pain, vomiting, or trouble breathing. Mother did confirm non of these symptoms were present, just the hives.  Mother called 1/15/20 to report hives on forehead, cheeks, behind ears, and persisting on back and torso. Patient seen in office for evaluation, prescribed prednisolone.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Employee complained of redness, swelling and a rash at the injection site.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash, Injection site urticaria, Peripheral swelling
Clinical narrative: right and Left hand swelling in fingers with "hives" rash starting about 5 hours after HPV injection in right deltoid
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient "returning to office today for next dose; no additional adverse events; This spontaneous report was received from a medical assistant and refers to a 16-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  In July 2019, the patient was vaccinated with a dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot number R017624, expiration date not reported but upon internal validation estalished as 17-MAR-2021 (dose, route and anatomical location were not reported) for prophylaxis.  It was reported that on 07-JAN-2020 (reported as today), the patient would return to the office for next dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  This is one of two reports form the same source.; Sender's Comments:  US-009507513-2001USA002954:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: patient was administered her first dose of GARDASIL 9 / 01/08/2020 a urine pregnancy test was done which was positive; This spontaneous prospective pregnancy report was received from a nurse, referring to a 25 year old female patient. The patient did not have any historical drugs, medical history, concomitant therapies and concurrent conditions.  On 02-JAN-2020, 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 # S008154, expiration date 20-NOV-2021, for prophylaxis (strength, dose and frequency date were not reported).  On 08-JAN-2020, the patient sought medical attention and came back to an office procedure and a urine pregnancy test was performed, the result was reported as positive, with a last menstrual period (LMP) of 04-DEC-2019 and estimated date of delivery (EDD) of 09-SEP-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 4 week(s). The pregnancy outcome was pending. The patient did not receive any treatment.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation concerning a male patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  On an unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) as long-term prevention of shingles and/or zoster-related conditions (dose, vaccine schedule, route of administration, site of administration, lot number and expiration date were not provided).  On an unspecified date in 2015, subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient experienced shingles (herpes zoster). The patient received treatment and was suffering ongoing injuries, mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of these injuries, including medical losses and costs include care for hospitalization (on an unknown date), physician care, monitoring, treatment, medications, supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death; aggravations of pre-existing conditions and activation of latent conditions; and other losses and damages. At the time of the report, the patient had not recovered from herpes zoster.  The causality assessment between zoster vaccine live (ZOSTAVAX) and herpes zoster was considered related.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient "returning to office today for next dose; no additional adverse events; This spontaneous report was received from a medical assistant and refers to a 18-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  In July 2019, the patient was vaccinated with a dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  It was reported that on 07-JAN-2020 (reported as today), the patient would return to the office for next dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  This is one of two reports form the same source.; Sender's Comments:  US-009507513-2001USA002257:
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: had a blood work and his MMRII and VARIVAX titers were negative; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), and with varicella virus vaccine live (oka/merck) (VARIVAX), both for prophylaxis (dose, dose number, route of administration, anatomical injection site, lot number and expiration date were not reported, for both suspect therapies).   On an unknown date, the patient had a blood work and his measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) titers were negative  (antibody test negative). If was unknown if the vaccines were administered on the same date that the blood work was done.  At the reporting time, the outcome of antibody test negative and the causality assessment between the event and the suspect therapies were not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was inadvertently administered the pediatric dose ofVAQTA. The patient was supposed to get the adult dose of the vaccine.; The patient did not experience any symptoms.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was inadvertently administered the pediatric dose of hepatitis A vaccine, inactivated (VAQTA) (Lot # S021092 and expiration date 18-MAY-2020) (dose and route were not reported) for prophylaxis. The patient was supposed to get the adult dose of the vaccine. The patient did not experience any symptoms.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray, Computerised tomogram head, Electrocardiogram, Influenza virus test positive, Laboratory test
Clinical narrative: Patient states Left ARM weakness 2 days post vaccine. Patient went to urgent care on 1/4/20 and sent to ER on 1/4/20 For left Arm weakness and positive for Influenza
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Patient states Left ARM weakness 2 days post vaccine. Patient went to urgent care on 1/4/20 and sent to ER on 1/4/20 For left Arm weakness and positive for Influenza
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, body aches, headache, exhaustion, sore arm at injection site
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Arm swelling and redness at the injection site, arm pain, and  fever >102F
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster related conditions (the dosage regimen information was not reported). Subsequently, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient received ProQuad that may have been stored at an improper temperature
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Generalized muscle ache and soreness, most noticeable on between knee to hip, and in shoulders.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient received ProQuad that may not have stored at the proper temperature
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient may have received ProQuad that was not stored at the recommended temperature.  No reaction or adverse event
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received vaccine that may have been stored outside of recommended temperature. No adverse reaction.  Will revaccinate in 4 weeks.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received ProQuad that may not have been stored at the proper temperature.  No adverse effect.  Will revaccinate in 4 weeks.
Age: 15.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was approximately 4 months pregnant.  Patient is due in April 2020.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came to office after mother noticied this morning left thigh was red, warm to touch and large area around immunization site was swollen,  Parent advised by MD to apply Cool compress to left thigh as often as practical for the next 2 days and then warm compress thereafter;
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Malaise
Clinical narrative: Patient experienced an erythematous patches encompassing the entire left upper extremity at its peak with reported 103F fever and malaise. Seven days after administration,  a 3cm tender erythematous indurated patch persists over injection site.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient experienced an erythematous patches encompassing the entire left upper extremity at its peak with reported 103F fever and malaise. Seven days after administration,  a 3cm tender erythematous indurated patch persists over injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness, redness, and swelling in arm that injection was given on
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chest X-ray, Death
Clinical narrative: PARENT REPORTED INFANT DEATH. PATIENT WAS FOUND IN CRIB, FACE DOWN DECEASED ON 01/13/2020 IN THE AFTERNOON.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Developed itching during the night, about  40 hours after vaccination.  Found itchy red elevated welts on upper legs, hips, upper arm, upon waking, about 44 hours after vaccination.   Symptoms are not debilitating, self treated with topical antihistamine (Benadryl).
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site pain
Clinical narrative: patient developed inflammation and redness above and below the right deltoid muscle where pneumovax 23 was injected. patient also had a lot of pain on the right deltoid. because the severity of the pain, patient had to go to ER.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea & vomiting for 3 days
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Chronic disease, Loss of personal independence in daily activities
Clinical narrative: daughter went from being a competitive varsity lacrosse player in high school to somebody whose chronically ill; This spontaneous report was received from a physician referring to his daughter who is a female patient of unknown age. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with the dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis, or the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. It was unspecified if the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On an unknown date, the patient experienced unspecified chronic disease as the reporter stated that his daughter "went from being a competitive varsity lacrosse player in high school to somebody whose chronically ill". The outcome of the event was unknown. Relatedness between the event and suspect therapies was not provided.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Encephalitis
Clinical narrative: the patient was hospitalized / in serious condition with encephalitis; This spontaneous report was received from a physician and refers to a 14-year-old female patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patient's immunization history was uncertain.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot number and expiration date were not provided) intramuscularly for prophylaxis. The reporter was not sure if it was the patient's first dose or not but stated it was the only vaccine administered that day.  On an unspecified date, reported as a few days later or a few days after the vaccination, the patient was hospitalized in a serious condition for encephalitis. She was in the hospital for about 6 weeks, received an unspecified treatment and on an unknown date, was discharged. The patient fully recovered on an unknown date after leaving the hospital (reported as now back in school fully recovered).  The relatedness between the event of encephalitis and the suspect vaccine was not provided.  Upon internal review, the event of encephalitis was considered to be medically significant.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Hypotonia, Lethargy, Somnolence
Clinical narrative: Mother of patient states 1.5-2 hours after immunization given, patient became very sleepy, "limp and lethargic".  Patient did not wake on his own for feeds for approx 4 hours.  He was eating routine by middle of the night.  He was fine by next morning
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dysstasia, Feeling abnormal, Insomnia, Mobility decreased
Clinical narrative: That night, arm was sore and painful; so had problems sleeping.  Next day, area was more tender, warm and painful to touch. Patient had problems with arm mobility, felt weak, had problems standing up and was trembling. Patient could not sleep well on 2nd and 3rd day also.  Patient did not take any medicine or treated area.  Patient called doctor on 4th day and was encouraged to take Advil  or ice area.  Friday patient did not feel good enough to leave the house.   Symptoms resolved after 4th day but decided to file a report since symptoms lasted longer than expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Poor quality sleep, Skin warm, Tenderness
Clinical narrative: That night, arm was sore and painful; so had problems sleeping.  Next day, area was more tender, warm and painful to touch. Patient had problems with arm mobility, felt weak, had problems standing up and was trembling. Patient could not sleep well on 2nd and 3rd day also.  Patient did not take any medicine or treated area.  Patient called doctor on 4th day and was encouraged to take Advil  or ice area.  Friday patient did not feel good enough to leave the house.   Symptoms resolved after 4th day but decided to file a report since symptoms lasted longer than expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: That night, arm was sore and painful; so had problems sleeping.  Next day, area was more tender, warm and painful to touch. Patient had problems with arm mobility, felt weak, had problems standing up and was trembling. Patient could not sleep well on 2nd and 3rd day also.  Patient did not take any medicine or treated area.  Patient called doctor on 4th day and was encouraged to take Advil  or ice area.  Friday patient did not feel good enough to leave the house.   Symptoms resolved after 4th day but decided to file a report since symptoms lasted longer than expected.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal discomfort, Dizziness, Lip swelling, Swelling face
Clinical narrative: Patient complained of lightheadedness and upset stomach. Patient was instructed to lay down on the floor, and patient recovered within 5 minutes. After standing back up, his nose and upper lip were slightly swollen. No signs of airway obstruction or difficulty breathing, but patient was given a dose of diphenhydramine oral liquid and was urged to seek medical care. Patient's mom brought patient to his school and had him checked out by the school nurse, before returning to classes for the rest of the day.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, IPV, MNQ, TDAP
Symptoms: Chest X-ray normal, Chest pain, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: Patient reports being sick 2 days after receiving vaccinations: symptoms included:  headaches, congestion, chest pain, difficulty sleeping, foggy brain, decreased appetite. Patient states that the symptoms have continued since receiving the vaccines. She was seen at the medical center on 14Jan2020 for the above symptoms. Patient was prescribed medications, chest x-ray completed which was unremarkable, and was instructed to follow up in one week if symptoms do not improve with medications.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, IPV, MNQ, TDAP
Symptoms: Insomnia, Respiratory tract congestion
Clinical narrative: Patient reports being sick 2 days after receiving vaccinations: symptoms included:  headaches, congestion, chest pain, difficulty sleeping, foggy brain, decreased appetite. Patient states that the symptoms have continued since receiving the vaccines. She was seen at the medical center on 14Jan2020 for the above symptoms. Patient was prescribed medications, chest x-ray completed which was unremarkable, and was instructed to follow up in one week if symptoms do not improve with medications.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Diarrhoea, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Extreme headache,  very sore neck and back, rash at injection site and on my back, numb and tingling feet and my toes felt raw, nausea and diarrhea, and blurry vision. I took Benadryl orally, injected myself with my Epi-Pen, put Hydrocorticone on the rash, took Tylenol and 1of  my Methocarbamol 750mg.  I called the 24 hour pharmacy that was on the recording and they were "experiencing problems with their phones".  So, as a Certified EMT, I monitored myself and felt I was ok to stay home.  I am experiencing some of the side effects today, but of less intensity.  I did talk with my doctors office and she was off today, but they were to send her a message with all this info and if I get worse, I am to go to Urgent Care right away.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash, Nausea, Neck pain, Paraesthesia, Vision blurred
Clinical narrative: Extreme headache,  very sore neck and back, rash at injection site and on my back, numb and tingling feet and my toes felt raw, nausea and diarrhea, and blurry vision. I took Benadryl orally, injected myself with my Epi-Pen, put Hydrocorticone on the rash, took Tylenol and 1of  my Methocarbamol 750mg.  I called the 24 hour pharmacy that was on the recording and they were "experiencing problems with their phones".  So, as a Certified EMT, I monitored myself and felt I was ok to stay home.  I am experiencing some of the side effects today, but of less intensity.  I did talk with my doctors office and she was off today, but they were to send her a message with all this info and if I get worse, I am to go to Urgent Care right away.