chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot# N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) (19F). The previous temperature excursions were 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682; US-009507513-1805USA007507; US-009507513-1805USA007508; US-009507513-1805USA007509; US-009507513-1805USA007504; US-009507513-1805USA007510; US-009507513-1805USA007505; US-009507513-1805USA007506.
Sex: U
Vaccine: PNC13
Symptoms: Pneumococcal infection
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age, race, ethnicity and gender was fully vaccinated for immunization on an unspecified date with PREVNAR 13 (unspecified number of single doses given). The patient medical history and concomitant medications were not reported. On an unspecified date the patient contracted invasive pneumococcal disease which was not caused by one of the 13 strains against which the vaccine offered protection. Outcome was unknown. The information on the batch/lot number has been requested.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Crying, Feeling abnormal, Full blood count, Hypersensitivity
Clinical narrative: Patient became very ill quickly, low grade fever, bilateral arm pain, chills and crying that he "didn't feel right". Sent to ER for eval. (Dx: Allergic reaction.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Malaise, Metabolic function test, Pain in extremity, Pyrexia
Clinical narrative: Patient became very ill quickly, low grade fever, bilateral arm pain, chills and crying that he "didn't feel right". Sent to ER for eval. (Dx: Allergic reaction.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Rash, Rash erythematous
Clinical narrative: Vaccines administered approx. at 10AM. Mother noticed rash and irritability at 2:30pm (red rash to forehead) called office advised to return to clinic. (mother had given TYLENOL at 9:45am and again at 1:45pm). Child arrived at 4:46 at office. Irritable with multiform rash to face, head. T99 no stridor - no facial or arm swelling - today color good, good strong cry. TYLENOL 160/5ml 1.25ml given at around 5pm. Child observed (Approx 45 min) examined by Nurse Practitioner. Instructions given to mother what to do, observe for if needed to go to ER and return to office in the AM. 5/18/18 at 8:30 child seen, doing well, slight redness to forehead. Normal vital signs, temp 99.3. According to mother child did well after leaving office. Slept and ate well, did administer TYLENOL at 8:45pm just in case.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pharyngeal paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pharyngeal paresthesia in a 69-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced pharyngeal paresthesia. In May 2018, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the pharyngeal paresthesia was recovered/resolved and the outcome of the injection site erythema and injection site swelling were recovering/resolving. The reporter considered the pharyngeal paresthesia to be possibly related to SHINGRIX. The reporter considered the injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional information was reported as follows: The patient experienced throat tingling the evening after vaccination with SHINGRIX, which was resolved by its own. The following morning after vaccination with SHINGRIX, the patient experienced severe redness and swelling. On 5th May 2018, three days after vaccination, the patient presented to the pharmacy with a redness having the size of a grapefruit, which the patient stated that it was actually an improvement. The healthcare professional had not seen the patient since 5th May 2018, but believed that the redness was continuing to improve. The reporter stated that the patient felt fairly certain that the diameter of the red area was greater than 100 mm.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. After reporting the medical complications to the pharmacists, he said her husband was the 2nd person to have an adverse reaction. This case was linked to the case US2018GSK080294, reported by the same reporter for the other patient.
Sex: F
Vaccine: HEP
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject who received Hepatitis B vaccine. The subject received Hepatitis B vaccine during the first trimester of pregnancy. The subject's last menstrual period was unknown and estimated date of delivery was unknown. On an unknown date, less than a year after receiving Hepatitis B vaccine, the subject developed spontaneous abortion. Serious criteria included GSK medically significant. Additional event(s) included exposure during pregnancy. The outcome of spontaneous abortion was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Hepatitis B vaccine. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion (SAB) in a pregnant female of unspecified age who was vaccinated with unspecified recombinant hepatitis B virus (HBV) vaccine (manufacturer unknown) during 1st trimester of pregnancy. The patient was part of the study that evaluated on HBV vaccination in pregnancy and impact on pregnancy outcomes. Database was searched in Jan 2018 using the search terms: Hepatitis B vaccine, pregnancy, major congenital malformations (MCMs), preterm birth, spontaneous abortion (SAB), and foetal/neonatal death. The search identified 1 randomized controlled trial (RCT), 5 prospective cohort studies, and 1 Vaccine Adverse Event Reporting System (VAERS) study. 5 of 7 studies were conducted in the 1980's-90's. No information on patient's medical or family history or concomitant medication was provided. On an unspecified date during 1st trimester of pregnancy, the patient received unspecified recombinant HBV vaccine (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, the RCT and 2 cohort studies examined recombinant HBV vaccines in 284 pregnant women. Vaccination occurred in the 1st trimester in the cohort studies and 3rd trimester in the RCT]. The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient had spontaneous abortion. Treatment was unknown. The authors did not comment on the relationship between the event of spontaneous abortion and unspecified HBV vaccine. The authors concluded "The majority of the prospective studies identified are old, have limited sample sizes, and inappropriate exposure windows. The VAERS study is recent but has limitations (recall bias, inconsistent data, lack of denominator data) due to the spontaneous/voluntary nature of the reporting of adverse events. While the data from these limited studies are reassuring, more research is needed".
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Ultrasound scan
Clinical narrative: Reports right lateral upper arm pain since injection in November. Started the day of injection. Hurts more at night. Patient returned to clinic 5 days after administration with significant amount of swelling of right deltoid area.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever of 101, body aches, headache, tired. Sleep and ADVIL. Began 12 hours after given vaccine and lasted 24 hours.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site swelling, Muscular weakness, Peripheral swelling
Clinical narrative: Fever of 101, body aches, headache, tired. Sleep and ADVIL. Began 12 hours after given vaccine and lasted 24 hours.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 101, body aches, headache, tired. Sleep and ADVIL. Began 12 hours after given vaccine and lasted 24 hours.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per patients mother, approximately 24hrs after injection (5/15), the area became reddened and sore and client had a low grade temperature. Mother reports providing child with ibuprofen for pain. Per mother, on 5/16/18 the arm had swelled from just above the elbow to the shoulder and was hot to touch and red. Mother had brought child to Hospital Emergency room, and was evaluated by PA and diagnosed with cellulitis of the right arm and placed on cephalexin 500mg three times a day. Per pt's mother on 5/17/18, arm remains swollen, but has improved. Recovery is on-going.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Per patients mother, approximately 24hrs after injection (5/15), the area became reddened and sore and client had a low grade temperature. Mother reports providing child with ibuprofen for pain. Per mother, on 5/16/18 the arm had swelled from just above the elbow to the shoulder and was hot to touch and red. Mother had brought child to Hospital Emergency room, and was evaluated by PA and diagnosed with cellulitis of the right arm and placed on cephalexin 500mg three times a day. Per pt's mother on 5/17/18, arm remains swollen, but has improved. Recovery is on-going.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Immediate post-injection reaction, Injection site rash, Injection site vesicles
Clinical narrative: Pt left voicemail stating that right after the vaccine, she had a rash w/ blisters at injection site of her right deltoid. Dr. spoke to her on the phone, and she described the rash on neck and shoulder, close to clavicle and painful to touch. She sent photos to Dr., and he suspected highly suggestive of shingles. He sent a prescription of valacyclovir 1000mg 1 tab PO TID for 7 days to her pharmacy and advised she do a viral culture test on vesicle fluid, cells at base of vesicle. He stated that it is very unusual to have zoster after both the live virus vaccine (patient had ZOSTAVAX on 4/2/2013) and the first dose of SHINGRIX.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash, Viral test
Clinical narrative: Pt left voicemail stating that right after the vaccine, she had a rash w/ blisters at injection site of her right deltoid. Dr. spoke to her on the phone, and she described the rash on neck and shoulder, close to clavicle and painful to touch. She sent photos to Dr., and he suspected highly suggestive of shingles. He sent a prescription of valacyclovir 1000mg 1 tab PO TID for 7 days to her pharmacy and advised she do a viral culture test on vesicle fluid, cells at base of vesicle. He stated that it is very unusual to have zoster after both the live virus vaccine (patient had ZOSTAVAX on 4/2/2013) and the first dose of SHINGRIX.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash, Injection site vesicles, Rash, Tenderness
Clinical narrative: Pt left voicemail stating that right after the vaccine, she had a rash w/ blisters at injection site of her right deltoid. Dr. spoke to her on the phone, and she described the rash on neck and shoulder, close to clavicle and painful to touch. She sent photos to Dr., and he suspected highly suggestive of shingles. He sent a prescription of valacyclovir 1000mg 1 tab PO TID for 7 days to her pharmacy and advised she do a viral culture test on vesicle fluid, cells at base of vesicle. He stated that it is very unusual to have zoster after both the live virus vaccine (patient had ZOSTAVAX on 4/2/2013) and the first dose of SHINGRIX.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Bone pain, Burning sensation, Herpes zoster, Musculoskeletal pain
Clinical narrative: Pt left voicemail stating that right after the vaccine, she had a rash w/ blisters at injection site of her right deltoid. Dr. spoke to her on the phone, and she described the rash on neck and shoulder, close to clavicle and painful to touch. She sent photos to Dr., and he suspected highly suggestive of shingles. He sent a prescription of valacyclovir 1000mg 1 tab PO TID for 7 days to her pharmacy and advised she do a viral culture test on vesicle fluid, cells at base of vesicle. He stated that it is very unusual to have zoster after both the live virus vaccine (patient had ZOSTAVAX on 4/2/2013) and the first dose of SHINGRIX.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neck pain, Neuralgia, Pruritus, Rash erythematous
Clinical narrative: Pt left voicemail stating that right after the vaccine, she had a rash w/ blisters at injection site of her right deltoid. Dr. spoke to her on the phone, and she described the rash on neck and shoulder, close to clavicle and painful to touch. She sent photos to Dr., and he suspected highly suggestive of shingles. He sent a prescription of valacyclovir 1000mg 1 tab PO TID for 7 days to her pharmacy and advised she do a viral culture test on vesicle fluid, cells at base of vesicle. He stated that it is very unusual to have zoster after both the live virus vaccine (patient had ZOSTAVAX on 4/2/2013) and the first dose of SHINGRIX.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Vaccination failure, Varicella virus test positive
Clinical narrative: Pt left voicemail stating that right after the vaccine, she had a rash w/ blisters at injection site of her right deltoid. Dr. spoke to her on the phone, and she described the rash on neck and shoulder, close to clavicle and painful to touch. She sent photos to Dr., and he suspected highly suggestive of shingles. He sent a prescription of valacyclovir 1000mg 1 tab PO TID for 7 days to her pharmacy and advised she do a viral culture test on vesicle fluid, cells at base of vesicle. He stated that it is very unusual to have zoster after both the live virus vaccine (patient had ZOSTAVAX on 4/2/2013) and the first dose of SHINGRIX.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Injection site rash, Pain, Pyrexia
Clinical narrative: 2 days after the injections fever/chills/body aches. 7 days after injection rash developed on right arm (site of shot). Called doctor, treated rash with OTC meds (CORTIZONE 10 lotions and ibuprofen), continued to worsen. 5/12/18 - rash worsened and became very painful. 5/15/19 - rash blistered. 5/16/18 - returned to doctor - diagnosed with shingles - started treatment.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: 2 days after the injections fever/chills/body aches. 7 days after injection rash developed on right arm (site of shot). Called doctor, treated rash with OTC meds (CORTIZONE 10 lotions and ibuprofen), continued to worsen. 5/12/18 - rash worsened and became very painful. 5/15/19 - rash blistered. 5/16/18 - returned to doctor - diagnosed with shingles - started treatment.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Abnormal dreams, Dizziness, Dyskinesia, Hunger, Loss of consciousness
Clinical narrative: Hep A and MENACTRA were given in left deltoid IM without any apparent initial reaction. About one minute later GARDASIL 9 was given in right deltoid IM and within 5 seconds of giving vaccine patient had a quick jerking reaction and then passed out which lasted about 20 seconds or less. When patient came to he asked if he was still alive because he had a vivid dream (couldn't remember what) and knew something had happened. Patient also states he was suddenly very hungry and did not eat breakfast. He also C/O being a little dizzy. Patient was given water and CHEEZ-ITS to eat and then a fruit cup of peaches and cup of orange juice. After about 20 minutes of the episode patient stated he felt like himself again and was ready to return to class. Made sure BP was normal and that patient was able to ambulate without any dizziness prior to returning to class. Provider notified parent also.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling abnormal, Headache, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received SHINGRIX. On 6th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, several hours after receiving SHINGRIX, the patient experienced headache, erythema of extremities, chills, nausea and feeling bad. The patient was treated with TYLENOL. In May 2018, the outcome of the headache, chills and nausea were recovered/resolved. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved and the outcome of the feeling bad was unknown. The reporter considered the headache, erythema of extremities, chills and nausea to be related to SHINGRIX. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced a bad headache which she described as dreadful with nausea, shivering and chills after SHINGRIX. The patient began feeling badly late in the afternoon (less than a day after vaccination) and got in bed and took TYLENOL. The redness in her arm she described as two inches across and 4 inches high which was unresolved at the time of reporting. The patient also indicated that her pharmacist and certified pharmacy technician (CPhT) claimed that the SHINGRIX only required one shot. The patient had denied permission to contact their physician.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Redness and heat of entire upper arm, fever of 102 F x 2 days.
Age: 78.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Peripheral swelling, Soft tissue swelling
Clinical narrative: Soft tissue swelling of the upper arm between elbow and shoulder.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical student and refers to a 29-year-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection (dose, route of administration, lot number and expiration date were not reported). The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (dose, lot number and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was inadvertently vaccinated subcutaneously with her first dose of GARDASIL 9 (exact dose, frequency, lot # and expiration date were not reported). On an unknown date, the patient developed bruising and swelling at the injection site. The patient was advised, by an unspecified provider, to apply a cold compresses to the site. The outcome of bruising and swelling at the injection site was unknown. No causality assessment was provided.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from the patient's mother regarding her non-pregnant  16 years old daughter. The patient did not had any medical history or concomitant medications. The patient had allergy to Sulfa medication. On an unspecified date in April 2007, the patient received a dose of GARDASIL per intramuscular route (frequency, strength, lot number and expiration date were not reported) for prophylaxis. That day, within 4 hours after vaccination, the patient experienced a fever of 105 degrees (units not provided). The patient contacted her physician and was treated with unspecified medications. The patient recovered from the event a week later, on an unspecified date in 2007. The causality assessment between GARDASIL and pyrexia was unknown. There was no Product Quality Complaint.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a consumer of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 13-JAN-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-JAN-2016, the patient was treated by a physician for 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: F
Vaccine: VARZOS
Symptoms: Blister, Emotional disorder, Herpes zoster, Malaise, 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 was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose for the prevention of shingles. ZOSTAVAX 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 by a physician for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. She suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 17-MAY-2018, the patient was vaccinated with expired dose of PNEUMOVAX 23, lot # M038216, expiration date 09-MAY-2018, for prophylaxis (dose and route of administration were not reported). There was no adverse event reported.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles, Lip swelling, Pruritus
Clinical narrative: Pt reported bottom of lips became swollen and he started itching 3-4 days after he received the 2nd dose of SHINGRIX. Also, the site where the injection was given blistered. Pt denied shortness of breath. Event was reported to clinic 5/17/2018 at which time pt reported symptoms were better new (blisterd burst and swelling reduced).
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Joint stiffness, Musculoskeletal pain, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: HOUR AFTER RECIEVING INJECTION, EMPLOYEE EXPERIENCED FEVER LIKE SYMPTOMS, BLURRY VISION, TINGLING SENSATION TO TONGUE, TINGLING TO FINGER, TINGLING FEELING TO THE BACK OF HER HEAD, STIFFNESS TO JAW, NECK, ACHE AND PAIN TO SHOULDER AND UPPER BACK AREA.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia oral, Pyrexia, Vision blurred
Clinical narrative: HOUR AFTER RECIEVING INJECTION, EMPLOYEE EXPERIENCED FEVER LIKE SYMPTOMS, BLURRY VISION, TINGLING SENSATION TO TONGUE, TINGLING TO FINGER, TINGLING FEELING TO THE BACK OF HER HEAD, STIFFNESS TO JAW, NECK, ACHE AND PAIN TO SHOULDER AND UPPER BACK AREA.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Hyperhidrosis, Pyrexia
Clinical narrative: Sweating, shaking, chills, dizzy, fever (101 degrees F) weakness. This was the "newest" shingles vaccine.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Sweating, shaking, chills, dizzy, fever (101 degrees F) weakness. This was the "newest" shingles vaccine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Hypotension, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of low blood pressure in a 62-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2018). Co-suspect products included hydrochlorothiazide for an unknown indication. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and hydrochlorothiazide 12.5 mg at an unknown frequency. On 1st May 2018, 1 days after receiving SHINGRIX, the patient experienced low blood pressure, weakness and feeling unwell. The action taken with hydrochlorothiazide was unknown (Dechallenge was unknown). Rechallenge with hydrochlorothiazide was unknown. On an unknown date, the outcome of the low blood pressure, weakness and feeling unwell were recovered/resolved. It was unknown if the reporter considered the low blood pressure, weakness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: Last Friday or Saturday from the day of reporting, the patient returned to the pharmacy and informed the pharmacist (caller), that he experienced a drop in blood pressure the next day. The patient stated he normally runs 140/90 but because he did not feel well, was weak and had no energy he checked his blood pressure and it was 111/60. The reporter stated the patient also mentioned his doctor was manipulating his blood pressure medication, and it was discovered with this call he had also picked up HCTZ, for the first time, the same day he got the vaccination. She was encouraged to had discuss the issues with his physician. The prescribing information reviewed for reported adverse events. The pharmacist also stated the patient picked up a prescription of enalapril on 2nd May 2018, which was after the vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Metal taste in mouth about 10 minutes after receiving immunization lasting 10 to 15 minutes. Relieved after drinking juice and taking eating something. She had the same symptom after the first injection, lasting 1/2 hour.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Depression, Suicidal ideation, Tearfulness
Clinical narrative: Acute onset, lasting 24 hours, of severe depression, suicidal, tearful and resolved after 25 hours.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: VACCINE EXPIRED ON 5/12/18 AND WAS GIVEN ON 5/18/18.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: On 5/9/18, diagnosed with intussusception. Not sure if it is related to vaccine or not.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's  arm was red and swollen and warm to touch.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Influenza like illness, Pruritus, Pyrexia
Clinical narrative: Fever of at least 102 for three days. Flu-like symptoms. Itchy skin.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt has large red bumps near arm pit aprox 1 month after small pox vaccination. Complains of itching, denies any other symptoms. Area evaluated by allergist and ER department. Determined likely unrelated to the smallpox vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Bed rest, Chills, Headache, Myalgia
Clinical narrative: 12 hrs. after administration, experienced fever, chills, muscle aches, headache, stomach pain, nausea. Bedrest and pain med (OTC) for 24 hrs.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: 12 hrs. after administration, experienced fever, chills, muscle aches, headache, stomach pain, nausea. Bedrest and pain med (OTC) for 24 hrs.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of injection site swelling, redness and soreness.
Sex: F
Vaccine: VARZOS
Symptoms: Blepharitis, Blister, Corneal opacity, Eyelid irritation, Herpes zoster
Clinical narrative: 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 an unknown date during 2012, the patient was inoculated at a pharmacy with the 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 condition of herpes zoster. On or about 18-SEP-2014, the patient was treated for a blistering vesicular outbreak on her eyelids, which was diagnosed as herpes zoster dermatitis of the eyelid. On or about 17-OCT-2014, the patient sought subsequent treatment for a persistent ocular rash, which was diagnosed as anterior uveitis with elevated IOP (intraocular pressure) OS (left eye). On or about 18-NOV-2016, the patient sought further treatment at an eye center for worsening eye symptoms, which were diagnosed as zoster iridocyclitis OS, which affected the central opacity of the left eye which is secondary to herpes zoster. On or about the dates of 27-JAN-2017 and 17-FEB-2017, the patient received additional treatment at the eye center for ongoing zoster iridocyclitis secondary to zoster which had resulted in scar tissue that inhibited her vision. The patient was prescribed a year regimen of topical steroids to help heal her inflammation and irritation of her eyelid for the diagnosis of zoster iridocyclitis. The outcome of the herpes zoster dermatitis of the eyelid (shingles of the eyelid) and anterior uveitis/zoster iridocyclitis left eye was not recovered. The outcome of the other events is unknown. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Upon internal review, herpes zoster dermatitis of the eyelid and anterior uveitis/zoster iridocyclitis left eye were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Intraocular pressure increased, Iridocyclitis, Ophthalmic herpes zoster, Rash, 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 was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2012, the patient was inoculated at a pharmacy with the 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 condition of herpes zoster. On or about 18-SEP-2014, the patient was treated for a blistering vesicular outbreak on her eyelids, which was diagnosed as herpes zoster dermatitis of the eyelid. On or about 17-OCT-2014, the patient sought subsequent treatment for a persistent ocular rash, which was diagnosed as anterior uveitis with elevated IOP (intraocular pressure) OS (left eye). On or about 18-NOV-2016, the patient sought further treatment at an eye center for worsening eye symptoms, which were diagnosed as zoster iridocyclitis OS, which affected the central opacity of the left eye which is secondary to herpes zoster. On or about the dates of 27-JAN-2017 and 17-FEB-2017, the patient received additional treatment at the eye center for ongoing zoster iridocyclitis secondary to zoster which had resulted in scar tissue that inhibited her vision. The patient was prescribed a year regimen of topical steroids to help heal her inflammation and irritation of her eyelid for the diagnosis of zoster iridocyclitis. The outcome of the herpes zoster dermatitis of the eyelid (shingles of the eyelid) and anterior uveitis/zoster iridocyclitis left eye was not recovered. The outcome of the other events is unknown. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Upon internal review, herpes zoster dermatitis of the eyelid and anterior uveitis/zoster iridocyclitis left eye were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Scar, Visual impairment
Clinical narrative: 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 an unknown date during 2012, the patient was inoculated at a pharmacy with the 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 condition of herpes zoster. On or about 18-SEP-2014, the patient was treated for a blistering vesicular outbreak on her eyelids, which was diagnosed as herpes zoster dermatitis of the eyelid. On or about 17-OCT-2014, the patient sought subsequent treatment for a persistent ocular rash, which was diagnosed as anterior uveitis with elevated IOP (intraocular pressure) OS (left eye). On or about 18-NOV-2016, the patient sought further treatment at an eye center for worsening eye symptoms, which were diagnosed as zoster iridocyclitis OS, which affected the central opacity of the left eye which is secondary to herpes zoster. On or about the dates of 27-JAN-2017 and 17-FEB-2017, the patient received additional treatment at the eye center for ongoing zoster iridocyclitis secondary to zoster which had resulted in scar tissue that inhibited her vision. The patient was prescribed a year regimen of topical steroids to help heal her inflammation and irritation of her eyelid for the diagnosis of zoster iridocyclitis. The outcome of the herpes zoster dermatitis of the eyelid (shingles of the eyelid) and anterior uveitis/zoster iridocyclitis left eye was not recovered. The outcome of the other events is unknown. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Upon internal review, herpes zoster dermatitis of the eyelid and anterior uveitis/zoster iridocyclitis left eye were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 19-OCT-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-JUN2016, the patient was treated in a medical office for 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: F
Vaccine: VARZOS
Symptoms: Burning sensation, Emotional distress, Herpes zoster, Ill-defined disorder, Pain
Clinical narrative: 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 or about 13-DEC-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. Upon being vaccinated, the patient experienced a pain and burning sensation throughout her arms and fingertips. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster and severe complications. Several days post-inoculation, the patient broke out in a painful vesicular outbreak. On or about 08-AUG-2016, the patient was admitted to the hospital for symptoms of a blistering rash and severe illness, which was diagnosed as severe herpes zoster, or shingles. The patient was hospitalized for a period of three days for the severity of her symptoms. She was prescribed valacyclovir and gabapentin for management of her painful symptoms and chronic pain. She suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX, 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 ZOSTAVAX did not prevent shingles and the painful vesicular outbreak/persistent strain of herpes zoster was unknown. The outcome of herpes zoster and severe complications/shingles is not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, 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 was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-DEC-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. Upon being vaccinated, the patient experienced a pain and burning sensation throughout her arms and fingertips. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster and severe complications. Several days post-inoculation, the patient broke out in a painful vesicular outbreak. On or about 08-AUG-2016, the patient was admitted to the hospital for symptoms of a blistering rash and severe illness, which was diagnosed as severe herpes zoster, or shingles. The patient was hospitalized for a period of three days for the severity of her symptoms. She was prescribed valacyclovir and gabapentin for management of her painful symptoms and chronic pain. She suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX, 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 ZOSTAVAX did not prevent shingles and the painful vesicular outbreak/persistent strain of herpes zoster was unknown. The outcome of herpes zoster and severe complications/shingles is not recovered. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11 week old female patient. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-OCT-2017 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis. The ROTATEQ vaccines were stored between 44 Fahrenheit degrees (F) and 77 F for 45 minutes. There was no previous temperature excursion. There was no previous temperature excursion. The medical assistant also stated that a data logger was involved on 23-OCT-2017 that prompted her to call the company. This is one of the many reports from the same source. Sender's Comments: US-009507513-1710USA012197: US-009507513-1805USA007926: US-009507513-1805USA007927: US-009507513-1805USA007928: US-009507513-1805USA007929.
Age: 0.0
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 8 week old male patient. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-OCT-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis (product storage error). On 04-APR-2017 the patient was vaccinated with second dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis. The ROTATEQ vaccines were stored between 44 Fahrenheit degrees (F) and 77 F for 45 minutes. There was no previous temperature excursion. There was no previous temperature excursion. The medical assistant also stated that a data logger was involved on 23-OCT-2017 that prompted her to call the company. This is one of the many reports from the same source. Sender's Comments: US-009507513-1710USA012197; US-009507513-1805USA007925; US-009507513-1805USA007927; US-009507513-1805USA007928; US-009507513-1805USA007929.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old male patient. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 27-FEB-2017 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis (product storage error). The ROTATEQ vaccines were stored between 44 Fahrenheit degrees (F) and 77 F for 45 minutes. There was no previous temperature excursion. There was no previous temperature excursion. The medical assistant also stated that a data logger was involved on 23-OCT-2017 that prompted her to call the company. This is one of the many reports from the same source. Sender's Comments: US-009507513-1710USA012197; US-009507513-1805USA007925; US-009507513-1805USA007926; US-009507513-1805USA007928; US-009507513-1805USA007929.