chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion threatened, Exposure during pregnancy, Human chorionic gonadotropin positive, Inappropriate schedule of drug administration, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician, referring to a 29 years old female patient. The patient's pertinent medical history did not include any historical or current medical condition, drug reactions or allergies. The patient had a history of 1 previous pregnancy and 1 live birth (reported as "a prior pregnancy"). The patient was taking unspecified "prenatal vitamins" concomitantly. On 29-MAR-2018, the patient was vaccinated with the first dose of VARIVAX, the physician reported that the reason for administration of VARIVAX series was that "after a prior pregnancy (unspecified date), the patient was varicella non immune and it was recommended to receive the vaccine postpartum" (prophylaxis) (route and anatomical site of administration, lot number and expiration date were unknown by the physician). Other suspect therapies included sterile diluent (STERILE DILUENT). The patient became pregnant with last menstrual period (LMP) of 20-MAR-2018. The physician reported that on 18-APR-2018, the patient "found out she was pregnant via urine pregnancy test".  Additionally, the physician reported that, on the same day, the patient "came into the office complaining of vaginal bleeding of 4 days (since 14-APR-2018) and loss of tissue through the vagina". The physician mentioned that a serum beta human chorionic gonadotropin (hCG) test (reported as "serum beta HCG") was performed to the patient, which resulted in 50 (units were not provided); based on this, the patient was diagnosed with a threatened abortion. The physician stated that, on 24-APR-2018, when the patient went back to the office "the bleeding had stopped, and the patient had shown no pregnancy symptoms"; therefore she was vaccinated with the second dose of VARIVAX (inappropriate schedule of drug administration). The estimated delivery date (EDD) was estimated as 25-DEC-2018. By reporting time, the patient was reported to be "still pregnant", however her gestational age was unknown and further information was not provided. The physician did not provide any causality assessment for abortion threatened in regards with VARIVAX and sterile diluent (STERILE DILUENT) administration. Upon internal review, abortion threatened was determined to be medically significant.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaginal haemorrhage
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician, referring to a 29 years old female patient. The patient's pertinent medical history did not include any historical or current medical condition, drug reactions or allergies. The patient had a history of 1 previous pregnancy and 1 live birth (reported as "a prior pregnancy"). The patient was taking unspecified "prenatal vitamins" concomitantly. On 29-MAR-2018, the patient was vaccinated with the first dose of VARIVAX, the physician reported that the reason for administration of VARIVAX series was that "after a prior pregnancy (unspecified date), the patient was varicella non immune and it was recommended to receive the vaccine postpartum" (prophylaxis) (route and anatomical site of administration, lot number and expiration date were unknown by the physician). Other suspect therapies included sterile diluent (STERILE DILUENT). The patient became pregnant with last menstrual period (LMP) of 20-MAR-2018. The physician reported that on 18-APR-2018, the patient "found out she was pregnant via urine pregnancy test".  Additionally, the physician reported that, on the same day, the patient "came into the office complaining of vaginal bleeding of 4 days (since 14-APR-2018) and loss of tissue through the vagina". The physician mentioned that a serum beta human chorionic gonadotropin (hCG) test (reported as "serum beta HCG") was performed to the patient, which resulted in 50 (units were not provided); based on this, the patient was diagnosed with a threatened abortion. The physician stated that, on 24-APR-2018, when the patient went back to the office "the bleeding had stopped, and the patient had shown no pregnancy symptoms"; therefore she was vaccinated with the second dose of VARIVAX (inappropriate schedule of drug administration). The estimated delivery date (EDD) was estimated as 25-DEC-2018. By reporting time, the patient was reported to be "still pregnant", however her gestational age was unknown and further information was not provided. The physician did not provide any causality assessment for abortion threatened in regards with VARIVAX and sterile diluent (STERILE DILUENT) administration. Upon internal review, abortion threatened was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates in April 2017, the patient received two doses of M-M-R II injection (dose, site of administration, route of administration, lot # and expiration date were not reported) for prophylaxis, approximately 25 to 26 days apart. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 15-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During October 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster the very virus the ZOSTAVAX is intended to prevent. During July 2016, the patient was treated at a health care center for symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Abnormal behaviour, Autism spectrum disorder
Clinical narrative: This spontaneous report was received from a currently 28 year old male patient reporting on himself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The patient reported that after receiving GARDASIL 9 on an unspecified date, he was diagnosed with acoustic autism (autism spectrum disorder). He stated that the health care provider who diagnosed was from the trailer park. During the report the patient made "hic hic hic" noises. At the time of the report, the outcome of autism spectrum disorder was unknown. The patient did not mention the causality assessment between the event of autism spectrum disorder and GARDASIL 9. Upon internal review, autism spectrum disorder  was determined to be a medically significant event.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-JAN-2017, the patient was vaccinated with a first dose in vaccination series of GARDASIL intramuscularly (exact dose, lot# and expiry date were not reported) for prophylaxis. On 15-MAR-2017, the patient was vaccinated with a second dose in vaccination series of GARDASIL 9 intramuscularly (exact dose, lot# and expiry date were not reported) for prophylaxis, on 16-JUN-2017 with a third dose of the same vaccine, and on 09-JAN-2018 with the fourth dose (lot# N022952, expiry date 14-JUN-2020) via intramuscular route (exact dose was not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Circulatory collapse
Clinical narrative: This literature marketed report has been received from authors of the published article. It was reported in a Letter to the Editor, referring to a 76 year old female patient. The patient's medical history included tick bites, and only a few months following her recovery form Lyme disease, she had her first reaction to meat started 45 minutes after eating barbecue. Since then she had had multiple reactions of varying severity, some of which started less than 1 hour after ingestion of red meat. On an unknown date in 2007, the patient was vaccinated with ZOSTAVAX for prophylaxis. Twenty minutes after receiving the vaccine, the patient experienced anaphylaxis. She went into cardiovascular collapse, requiring emergency treatment and an overnight hospital stay. In 2010, the patient had ImmunoCAP IgE results as below: Total IgE: 645 kU/L Alpha-gal (z5): less than 0.35 kU/L, negative Chicken (f83): 0.40 kU/L Turkey (f284): less than 0.35 kU/L Beef (f27): 0.44 kU/L Mutton (f88): less than 0.35 kU/L Cat dander (al): less than 0.35 kU/L Pork (f26): less than 0.35 kU/L, negative Fel d 2 (e220) (cat serum albumin): less than 0.35 kU/L, negative Gelatin (c74): 5.00 kU/L Bovine gelatin (z21): 26.8 kU/L, high Porcine gelatin (z22): 62.9 kU/L, high Fish gelatin (z23): less than 0.35 kU/L The outcome of the event was unknown. The reporter considered anaphylaxis to be related to ZOSTAVAX. Upon internal review, anaphylaxis was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent (MERCK). On 16-MAY-2018, the patient was vaccinated with an inappropriate storage dose of PROQUAD 1 dosage form (strength and route of administration were unknown) with lot # N023965 and expiration date of 28-FEB-2019 for prophylaxis, which was stored at temperature ranges from 6 Fahrenheit degrees (°F) to 14°F for 2 hours and from 15°F to 46°F for 30 minutes. There was a digital data logger involved. Previous temperature excursion was from 15°F to 46°F for 78 hours and 51 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA007992: US-009507513-1805USA008117.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-DEC-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 02-JUN-2016, the patient was treated at an urgent care center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient was prescribed VALTREX and NORCO for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a first dose series of GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not provided), for prophylaxis. On an unknown date, the patient almost fainted after receiving the first dose in vaccination series (presyncope). At the time of reporting, the outcome of presyncope was unknown. The causal relationship between the event and the GARDASIL 9 was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On 15-MAY-2018, the patient was vaccinated with an expired dose of VAQTA injection, lot number N012324 with expiration date on 05-APR-2018 for prophylaxis (strength, dose, route of administration and anatomical location were not reported). No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 17-MAR-2018, the patients were vaccinated with an improperly stored dose of PEDVAXHIB (route, dose, frequency, and anatomical location were unknown) with one of these lot #s N034005 and expiration date 31-JAN-2020; N016992 and expiration date 07-MAR-2020; N031493 and expiration date 03-OCT-2019 for prophylaxis. The administered doses of the vaccines experienced the temperature excursion at or above 32°F up to 35°F (34.7°F) degrees Fahrenheit for 1 hour. There was a digital data logger involved, and there was a previous temperature excursion at or above 32°F up to 35°F (33.7°F) degrees Fahrenheit for 2 hours and 10 minutes. No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent (MERCK). On 10-MAY-2018, the patient was vaccinated with an inappropriate storage dose of PROQUAD (strength, dose and route of administration were unknown) with lot # N023965 and expiration date of 28-FEB-2019 for prophylaxis, which was stored at a temperature ranges from 15°F to 46°F for 62 hours. There was a digital data logger involved. Previous temperature excursion was from 15°F to 46°F for 78 hours and 51 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA007992: US-009507513-1805USA007365.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Caesarean section, Dizziness, Exposure during pregnancy, Gestational diabetes, Prenatal screening test
Clinical narrative: This serious clinical study case, initially received from other non-health professional on 26-Sep-2017, concerning a 33-year-old adult female pregnant subject of body weight 245 lbs, height 73 inches and (BMI) body mass index 32.3, enrolled in a study. The subject had no maternal and paternal history of major congenital malformations. The subject received birth control medications prior to pregnancy. The subject's concomitant medication included prenatal vitamins for healthy pregnancy. The subject's last menstrual period (LMP) date was 10-May-2017. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. On 21-Jul-2017: NxGen genetic prenatal test was done and no major congenital malformation was noted. On 25-Sep-2017, at gestation age of 19 weeks (second trimester), the subject was administered with FLUCELVAX vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported). On 26-Sep-2017, the subject experienced little dizziness. It was reported that, the event dizzy did not get better since it started, and it was continuous. There were no treatment measures associated with event. On an unspecified date, the subject was diagnosed with gestational diabetes mellitus. The subject started the treatment with Metformin (750 mg, BID, orally) (from 06-Dec-2017 to 28-Mar-2018) and LEVEMIR (100 units, QHS, subcutaneously) (from 20-Dec-2017 to 28-Mar-2018). At gestational age of 38.1 weeks, the subject delivered a live birth to a female infant by cesarean delivery method. The infant's body weight was 3770 gm at birth and Apgar score at 1 minute was 8, at 5 minutes was 9 and at 10 minutes it was 10. There was no congenital malformation (MCM) identified at birth. At the time of this report, the outcome of the event (gestational diabetes mellitus) was not reported. The estimated date of delivery was reported as 14-Feb-2018. Follow up report from investigator received on 06-Oct-2017: The outcome of the event dizziness from not recovered to recovered (within 24 hours of its starting) was updated. The narrative was amended accordingly. Follow up report from other health professional received on 10-May-2018: The subject's body weight (245 lbs), height (730 inches), BMI (32.3), prenatal test (NxGen genetic test on 21-Jul-2017), new serious event (gestational diabetes mellitus), treatment medications (Metformin and LEVEMIR) for gestational diabetes mellitus were updated. It was reported that, at gestational age of 38.1 weeks, the subject delivered a live birth to a female infant by cesarean delivery method. The infant's body weight was 3770 gm at birth and Apgar score at 1 minute was 8, at 5 minutes was 9 and at 10 minutes it was 10. There was no congenital malformation (MCM) identified at birth. The narrative was amended accordingly.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Influenza like illness
Clinical narrative: Extreme chills, could not get warm despite layers of clothing, socks and piles of blankets, body & teeth shivering, accompanied by flu-like body aches, especially in the back and back of the neck. Shivering and chills lasted 4 hours, mild body aches next morning. Took Naproxen and felt better throughout the day.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: REDNESS, LUMP, WARM TO TOUCH AND SORE AT INJECTION SITE.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician at the same medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, C-reactive protein increased, Fatigue, Groin pain, Insomnia
Clinical narrative: Patient complained of increased pain - both shoulder, back, shoulder blades, muscles in legs and hops are sore and tight, groin pain. Increased fatigue, difficulty sleeping, muscle fatigue and achiness.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle fatigue, Muscle tightness, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Patient complained of increased pain - both shoulder, back, shoulder blades, muscles in legs and hops are sore and tight, groin pain. Increased fatigue, difficulty sleeping, muscle fatigue and achiness.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased, X-ray limb
Clinical narrative: Patient complained of increased pain - both shoulder, back, shoulder blades, muscles in legs and hops are sore and tight, groin pain. Increased fatigue, difficulty sleeping, muscle fatigue and achiness.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient stated she experienced soreness after vaccination, worsening each day after. Then had pain, redness, swelling at injection site, requiring antibiotic course. Then started to spread to neck and face on 5-19-18.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient stated she experienced soreness after vaccination, worsening each day after. Then had pain, redness, swelling at injection site, requiring antibiotic course. Then started to spread to neck and face on 5-19-18.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Vaccine site: Lt arm swollen - red - hot to touch/ran fever: 100.8 3 days then came a case of shingles Lt side of back 4-25-18. Still in pain from case of shingles - starting 4-25-18 Lt. back of arm - shoulder and back. No more fever/some tenderness in vaccine site still.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccine site: Lt arm swollen - red - hot to touch/ran fever: 100.8 3 days then came a case of shingles Lt side of back 4-25-18. Still in pain from case of shingles - starting 4-25-18 Lt. back of arm - shoulder and back. No more fever/some tenderness in vaccine site still.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Decreased appetite, Fatigue
Clinical narrative: Within 18 hours of administration, developed headache, myalgia, fatigue, GI distress (abdominal cramping, loss of appetite, and nausea) and low grade fever with chills. Symptoms continued for 24 hours. Fatigue and mild GI distress (loss of appetite) continued for another 48 hours. Treated with TYLENOL and fluids. Site pain developed with 24 hours after administration, with decreasing intensity over the next 72 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Within 18 hours of administration, developed headache, myalgia, fatigue, GI distress (abdominal cramping, loss of appetite, and nausea) and low grade fever with chills. Symptoms continued for 24 hours. Fatigue and mild GI distress (loss of appetite) continued for another 48 hours. Treated with TYLENOL and fluids. Site pain developed with 24 hours after administration, with decreasing intensity over the next 72 hours.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Diarrhoea, Disturbance in attention, Malaise, Musculoskeletal stiffness
Clinical narrative: Nausea, vomiting, diarrhea, dehydration, stiff/painful neck, lack of focus, extreme sleepiness. Starting getting ill on Monday, May 14, 2018, and got progressively worse through Wednesday, May 16th. Could tolerate light food beginning Thursday, May 17th. Did not leave the house for a week. Last vomiting was Friday, May 18th. Diarrhea subsided Sunday, May 20th.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Somnolence, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, dehydration, stiff/painful neck, lack of focus, extreme sleepiness. Starting getting ill on Monday, May 14, 2018, and got progressively worse through Wednesday, May 16th. Could tolerate light food beginning Thursday, May 17th. Did not leave the house for a week. Last vomiting was Friday, May 18th. Diarrhea subsided Sunday, May 20th.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient was given varicella vaccine for pre employement on May 10th 2018 and had positive pregnancy test on May 17th 2018.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Headache, Myalgia, Pyrexia
Clinical narrative: Severe Headache, Severe Muscle Aches, Disorientated, Fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Somnolence
Clinical narrative: Shivering, headache and very sleepy.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: Patient has been experiencing tingling from point of vaccine up his neck to his ear on and off for 2 months multiple times a day (left side).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain, Swelling
Clinical narrative: She got the expected soreness that was listed on the side effects as we went over. However, she called me today (5/21/2018) in response to our follow up with our reaching out to see when she wanted to get her second shot to complete her SHINGRIX course. She told me that around April 23rd (2 months after her initial shot) she woke up with "intense pain" in her knees. She also had pain in her elbows to a lesser extent. She describes the pain as a "burning, radiating pain" - as an active person, she has been unable to exercise as normal. She has noticed some slight swelling, but no bruising. She doesn't have a primary doctor as she is very healthy. She wonders if the vaccine has triggered a autoimmune response or something else. We have determined to hold off on getting the second shot at this time.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: 7 hours post vaccine my son indicated site was hurting, I disregarded as regular response to IM vaccine. 16 hours post vaccine the site had red blush and he was saying it hurt to move his arm, still appeared within expected mild response according to hand out from clinic, I sent him to school. By the time I saw him at 28 hours post vaccine the site had become hot, deep pink swelling wrapped around upper arm into the arm pit, reported to be pruritic and painful. Two small blister hives were present, due to continued progression had to go to emergency room.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Pain
Clinical narrative: 7 hours post vaccine my son indicated site was hurting, I disregarded as regular response to IM vaccine. 16 hours post vaccine the site had red blush and he was saying it hurt to move his arm, still appeared within expected mild response according to hand out from clinic, I sent him to school. By the time I saw him at 28 hours post vaccine the site had become hot, deep pink swelling wrapped around upper arm into the arm pit, reported to be pruritic and painful. Two small blister hives were present, due to continued progression had to go to emergency room.
Age: 63.0
Sex: M
Vaccine: MMR
Symptoms: Contraindication to vaccination
Clinical narrative: The patient answered "no" to immunosuppressive therapy. After vaccination, it was discovered he is taking IMURAN 50mg daily.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Death
Clinical narrative: My two month old daughter passed a week after receiving shots.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling, redness. Pain in arm.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia
Clinical narrative: Pain at injection site. Also muscle aches and chills.
Age: 46.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Vomiting
Clinical narrative: Pt felt light headed after receiving vaccines and throw up. Emergency response activated Dr onsite Pt given Zofran PO 4mg monitored for 25min and released w/out limitations.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Bump progressively getting bigger every day, looks red, hurts a little bit - on exam: L upper arm with approx 2 cm indurated area 1cm redness overlying, slightly ttp, also with yellow bruise surrounding area, no streaking  - TX: Cool compresses, MOTRIN, gentle cleansing BID, KEFLEX 750 Mg Oral Capsule Take 1 capsule po bid x 10 days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Rash, Rash vesicular
Clinical narrative: Developed chills, achiness to R arm where had injection. Developed small rash, looks like shingles, under R arm. States they are painful.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Slight left arm soreness near injection site, aching in back, slight chills, but no fever, tiredness for 48 hours after injection. Pounding headache.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Swollen and painful to the touch at injection site for several days still some swelling and pain at this time. Severe fatigue for about 36 hours with some dizziness chills and nausea feelings.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Swollen and painful to the touch at injection site for several days still some swelling and pain at this time. Severe fatigue for about 36 hours with some dizziness chills and nausea feelings.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Gait disturbance
Clinical narrative: Extreme body and joint aches, fatigue, weakness (general). Symptoms lasted - 3-4 days fatigue - 3 weeks. Started a few hrs after shots rec'd. Headache - chills - hot flashes. (R) arm swollen - very painful for several days. It was difficult to walk because of the joint pain. I did not seek medical attention. I took liquid BENADRYL and TYLENOL for symptoms. Fatigue lasted around 3 weeks. Body aches acute 4 days Joint aches acute 4 days (mild/moderate - lasted about 3 weeks). I don't know if I will have any lasting effect from the vaccine because I don't know what it did to my body causing the symptoms I had. I will/was advised go to tell my health care provider, I have a physical the end of June: I still have joint discomfort but not sure if this is due to the vaccine or the cold winter! I do feel better after going to the GYN!
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hot flush, Musculoskeletal discomfort, Pain, Pain in extremity
Clinical narrative: Extreme body and joint aches, fatigue, weakness (general). Symptoms lasted - 3-4 days fatigue - 3 weeks. Started a few hrs after shots rec'd. Headache - chills - hot flashes. (R) arm swollen - very painful for several days. It was difficult to walk because of the joint pain. I did not seek medical attention. I took liquid BENADRYL and TYLENOL for symptoms. Fatigue lasted around 3 weeks. Body aches acute 4 days Joint aches acute 4 days (mild/moderate - lasted about 3 weeks). I don't know if I will have any lasting effect from the vaccine because I don't know what it did to my body causing the symptoms I had. I will/was advised go to tell my health care provider, I have a physical the end of June: I still have joint discomfort but not sure if this is due to the vaccine or the cold winter! I do feel better after going to the GYN!
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Extreme body and joint aches, fatigue, weakness (general). Symptoms lasted - 3-4 days fatigue - 3 weeks. Started a few hrs after shots rec'd. Headache - chills - hot flashes. (R) arm swollen - very painful for several days. It was difficult to walk because of the joint pain. I did not seek medical attention. I took liquid BENADRYL and TYLENOL for symptoms. Fatigue lasted around 3 weeks. Body aches acute 4 days Joint aches acute 4 days (mild/moderate - lasted about 3 weeks). I don't know if I will have any lasting effect from the vaccine because I don't know what it did to my body causing the symptoms I had. I will/was advised go to tell my health care provider, I have a physical the end of June: I still have joint discomfort but not sure if this is due to the vaccine or the cold winter! I do feel better after going to the GYN!
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 23 year old male patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date in August 2014, the patient was vaccinated with GARDASIL for prophylaxis (route of administration, lot number and expiration date were not reported). On an unknown date in March 2018, the patient received one dose of GARDASIL 9. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 10-MAY-2018, the patient was vaccinated with an improperly stored PEDVAXHIB lot # R000876 with an expiration date 26-SEP-2020 for prophylaxis (dose, route of administration and anatomical location were not reported). Administered dose of PEDVAXHIB was in the shipping container and it was unknown what temperature the vaccine reached and for how long. There was no adverse effect reported. There was no previous temperature excursion. A digital data logger was not involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 16-MAY-2017, the patient was vaccinated with first dose of GARDASIL 9, lot # N000326 with expiration date 14-OCT-2019 (strength, dose, frequency, route and anatomical location were not provided) and on 09-NOV-2017, the patient received the second dose of GARDASIL 9 intramuscularly, lot # N021571 with expiration date 29-APR-2020, both for prophylaxis. At the reporting time, there was no information about the third dose provided. The medical assistant reported that the second dose was administered 1 week too early according to the prescribing information. No adverse effect reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-SEP-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 07-DEC-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 13-JAN-2016, the patient sought subsequent treatment from another physician for continued and worsening symptoms of shingles that has spread to the eyes and neurological interference. The patient was diagnosed with herpes zoster keratitis (shingles in the eyes) and post-herpetic neuralgia. The patient was prescribed valacyclovir HCL (VALTREX) and gabapentin for management of his painful symptoms. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is not recovered. Upon internal review, herpes zoster keratitis (shingles in the eyes) was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-SEP-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 07-DEC-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 13-JAN-2016, the patient sought subsequent treatment from another physician for continued and worsening symptoms of shingles that has spread to the eyes and neurological interference. The patient was diagnosed with herpes zoster keratitis (shingles in the eyes) and post-herpetic neuralgia. The patient was prescribed valacyclovir HCL (VALTREX) and gabapentin for management of his painful symptoms. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is not recovered. Upon internal review, herpes zoster keratitis (shingles in the eyes) was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. "On or" 03-MAR-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a Physician's Assistant and a medical group for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Erythema, Eye swelling, Injection site swelling, Swelling face
Clinical narrative: "Anaphylaxis" swelling around eyes, cheeks, mouth, and at site of injection, redness and swelling. Used ZYRTEC (10 mg) per pill and ZANTAC (150 mg) per pill, each one pill each day until swelling subsided, about 7 days a week and BENADRYL 1 or 2 pills for 2 days.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 24 hours after administration patient reported a 4x4 indurated area from the vaccine on her left arm. We treated patient virtually after reviewing pictures she sent to us of her arm and felt she was having  an acute local reaction to the vaccine. Next steps: 1) Tylenol for pain 2) Cold cloth over the area for some relief 3) Monitor for any fevers, headache, fatigue. Patient reported no fever, headache or fatigue. The following morning patient reported to us with updated pictures and said the entire red area is warm, sore, and itchy. Redness/warmth has spread from initial induration to elbow over night. PCP recommended Start Bactrim DS BID, Start Prednisone 20 mg q am x 5 days, Start Benadryl/Zyrtec, Tylenol prn pain. Monitor size with circle, contact us immediately if any change, fever, chills. 72 hours after administration patient reported warmth and redness still spreading despite 2 doses of bactrim, steroids, and Zyrtec. PCP advised patient to seek consult at an urgent care or ER.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Swelling
Clinical narrative: Patient had a large painful bump and rash underneath her arm on the side of her thorax. Patient began feeling the pain a few hours after the vaccine and by Saturday (5/19/18) it had progressed and become larger and more painful. Patient came in on Monday (5/21/18) to report the adverse effect and to pick up a prescription for Cephalexin for it.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Fever, shivering, weak and aching muscles.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Patients husband came in today, approx 24 hours after the injection. He said his wife started experiencing pain last night. The pain was in her right shoulder, with swelling, redness, tenderness. She also started getting body aches/pains and was nauseaus. I suggested they try massaging the injection site, and try TYLENOL. I told him to call us and/or her dD if the symptoms got worse.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dysarthria, Headache, Mental impairment, Speech disorder
Clinical narrative: Headache, dizziness, slurred speech, difficulty collecting thought and speaking.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient reported a lot of pain and redness in arm. Her bicep area had a large red circle covering the majority of her arm. I advised it was a normal reaction and to foll-up with us or primary physician. I followed up with patient and symptoms have resolved.
Age: 0.83
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Aggression, Aphasia, Balance disorder, Crying, Diet refusal
Clinical narrative: Cried for the entire first 3 nights, would not nurse, extreme discomfort. Complete Loss of balance. Went from walking to not being able to take 2 steps without falling. He was not able to stand in one place alone, he constantly fell down. I bought him a helmet because he fell so many times, he would hit his head. He was so frustrated, it was awful for him and my family. We changed his shoes and everything. It has taken 4 months and he is up to 8 steps, still falls and balance is NOT 100%. Rash and welts day of shots and came back week 2 and week 3. Constant head banging for the first 5 weeks. He would bang his own head with his toys. He would bang his head on kitchen cabinets, and walls. Loss of speech. He used to say MAMA over 10 times a day. He has only said mama twice in the last 4 months. He used to say BALL 3 to 10 times a day. (Depending if he sees the ball he would pick it up and say BALL) He has never said the word ball since 1/26/18. Daycare said his behavior was aggressive for the first 3-4 weeks. Hitting and pushing kids, which he didn't do before. Constantly still cries and wants to be held all the time, loss of independence.
Age: 0.83
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Discomfort, Dysstasia, Fall, Gait disturbance, Head banging
Clinical narrative: Cried for the entire first 3 nights, would not nurse, extreme discomfort. Complete Loss of balance. Went from walking to not being able to take 2 steps without falling. He was not able to stand in one place alone, he constantly fell down. I bought him a helmet because he fell so many times, he would hit his head. He was so frustrated, it was awful for him and my family. We changed his shoes and everything. It has taken 4 months and he is up to 8 steps, still falls and balance is NOT 100%. Rash and welts day of shots and came back week 2 and week 3. Constant head banging for the first 5 weeks. He would bang his own head with his toys. He would bang his head on kitchen cabinets, and walls. Loss of speech. He used to say MAMA over 10 times a day. He has only said mama twice in the last 4 months. He used to say BALL 3 to 10 times a day. (Depending if he sees the ball he would pick it up and say BALL) He has never said the word ball since 1/26/18. Daycare said his behavior was aggressive for the first 3-4 weeks. Hitting and pushing kids, which he didn't do before. Constantly still cries and wants to be held all the time, loss of independence.