chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-MAR-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and for the long term prevention of shingles and zoster related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 28-SEP-2016, the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-OCT-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster related injuries. The vaccine did not prevent shingles and zoster-related injuries as intended. In or around OCTOBER 2016, the patient was treated by a healthcare facility/hospital, for the onset of a rash, which was diagnosed as Herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX vaccine for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require 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.
Sex: U
Vaccine: MENB
Symptoms: Headache, Photophobia
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and sensitivity to light in eyes. Outcome of the events was unknown. Information on batch and lot numbers has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (mother). A female patient of an unspecified age received the first dose of TRUMENBA, via an unspecified route of administration on 08Aug2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain on the site of injection on 09Aug2018. The mother wanted to know how long it will last. The outcome of the event was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Headache, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unknown age, gender and race received TRUMENBA at single dose for immunization on unknown date. Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced nausea, body ache, headache. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. This Physician reported similar events for 3 patients. This is 1st of 3 reports. A patient of unspecified age and gender received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician reported 3 kids (including the patient) last 2 years; patient reported flu-like symptoms with high fevers after the use of meningococcal group b rlp2086. No other vaccine given at the time. Some went to the ER and were diagnosed with having vaccine reaction. The outcome of the events, flu-like symptoms and high fevers, was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018325374 Same reporter and suspect drug, similar events in different patients; US-PFIZER INC-2018325373 Same reporter and suspect drug, similar events in different patients
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. This Physician reported similar events for 3 patients. This is 2nd of 3 reports. A patient of unspecified age and gender received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician reported 3 kids (including the patient) last 2 years; patient reported flu-like symptoms with high fevers after the use of meningococcal group b rlp2086. No other vaccine given at the time. Some went to the ER and were diagnosed with having vaccine reaction. The outcome of the events, flu-like symptoms and high fevers, was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018325368 Same reporter and suspect drug, similar events in different patients; US-PFIZER INC-2018325374 Same reporter and suspect drug, similar events in different patients.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. This Physician reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unspecified age and gender received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician reported 3 kids (including the patient) last 2 years; patient reported flu-like symptoms with high fevers after the use of meningococcal group b rlp2086. No other vaccine given at the time. Some went to the ER and were diagnosed with having vaccine reaction. The outcome of the events, flu-like symptoms and high fevers, was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018325373 Same reporter and suspect drug, similar events in different patients; US-PFIZER INC-2018325368 Same reporter and suspect drug, similar events in different patients.
Sex: M
Vaccine: PPV
Symptoms: Pain, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician. A 65-year-old male patient receive pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (trade name, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization  The patient's medical history and concomitant medications were not reported. The patient experienced allergies with pneumococcal vaccine, hives and extreme pain on an unspecified date. The outcome of the events was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Sex: U
Vaccine: PNC13
Symptoms: Body temperature increased, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was not feeling really good, had got a really bad headache, had 101 temperature, arm was red; really swollen, and just felt really tired and achy. Outcome of the events was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was not feeling really good, had got a really bad headache, had 101 temperature, arm was red; really swollen, and just felt really tired and achy. Outcome of the events was unknown. Information on the batch number has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced redness, itching and swelling at injection site which was persisting a few days after vaccination (he was still experiencing on 8/13). As of 8/14 symptoms were almost resolved.
Age: 1.67
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt had no Adverse reaction to this. Was instructed to fill this out because tdap was given and not Dtap.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: Chills body and muscle aches fever sore arm headache.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills body and muscle aches fever sore arm headache.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Erythema, Fatigue, Full blood count, Impaired driving ability
Clinical narrative: The morning following the vaccine he was extremely tired. He felt light headed. Could not drive home he later had a fever of 102.4. Symptoms continued for 5 days. On day 4 he noted large area of redness and edema to his arm and deltoid.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Metabolic function test, Oedema, Pyrexia
Clinical narrative: The morning following the vaccine he was extremely tired. He felt light headed. Could not drive home he later had a fever of 102.4. Symptoms continued for 5 days. On day 4 he noted large area of redness and edema to his arm and deltoid.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Injection site induration, Injection site reaction, Local reaction, Vomiting
Clinical narrative: Few hours after vaccination patient became dizzy, 3 episodes of vomiting and developed local reaction at both sites. At follow up vomiting resolved local reaction at site of MENACTRA (right arm) is improved, but site of Men B (left arm) was still slightly indurated on 8/14/18.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Lethargy, Pyrexia, Vomiting
Clinical narrative: Fever, severe vomiting, crying, lethargy.
Age: 17.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: HIVES AND ITCHING; WAS GIVEN STEROID INJECTION AND STEROID DOSE PACK FOR 5 DAYS; ALSO ADVISED USE OF OTC BENADRYL AND PEPCID.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient presents 2 days after her vaccination with redness below the injection site, swelling, and pain.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cellulitis, Erythema, Fatigue, Heart rate increased
Clinical narrative: Recieved the shot around 1pm on 8/13. Little less than an hour later patient started to feel tired. Arm was red and tender. Arm became painful overnight. Patient went to walkin around 1030 AM on 8/14. Doctor diagnosed it with cellulitits. The infection caused A-fib and a heart rate over 140. They brought her to Hospital where she recieved IV antibiotics and stayed over night. On 8/15 she was discharged and prescribed oral cephalexin 500mg three times a day for 7 days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Pain in extremity, Tenderness
Clinical narrative: Recieved the shot around 1pm on 8/13. Little less than an hour later patient started to feel tired. Arm was red and tender. Arm became painful overnight. Patient went to walkin around 1030 AM on 8/14. Doctor diagnosed it with cellulitits. The infection caused A-fib and a heart rate over 140. They brought her to Hospital where she recieved IV antibiotics and stayed over night. On 8/15 she was discharged and prescribed oral cephalexin 500mg three times a day for 7 days.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Chills, Headache, Hot flush, Hyperaesthesia
Clinical narrative: 12-15 hours following the vaccination: uncontrollable shivering without a cold sensation, hot flashes, headache, muscle pain, joint pain, skin sensitivity.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Myalgia
Clinical narrative: 12-15 hours following the vaccination: uncontrollable shivering without a cold sensation, hot flashes, headache, muscle pain, joint pain, skin sensitivity.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Diarrhoea, Migraine, Pain in extremity, Vision blurred
Clinical narrative: Had shot at 3pm by midnight serious pain/aching in thighs. Around 5am awoke with temp of 102.  Migraine headache, blurred vision. Followed by vomiting, diarrhea. Lasted approximately 12 hours then dissipated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Had shot at 3pm by midnight serious pain/aching in thighs. Around 5am awoke with temp of 102.  Migraine headache, blurred vision. Followed by vomiting, diarrhea. Lasted approximately 12 hours then dissipated.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash, Urticaria
Clinical narrative: Started to feel tingling under the arm that had the vaccine. Then he noticed rash. Has hive-type rash on inside/underside of his left arm and along left chest wall initially. A couple of hours later developed a couple of spots on anterior part of arm/antecubital fossa.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Redness and mild itching at injection site that spread down arm over at least 4 days. No signs of infection or systemic allergic reaction so no treatment was given. Outcome implied resolution.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mass, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever of 100 which would not break with TYLENOL for 24-36 hours, lump and growing large red circle, 4 x 4" week later.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Eye movement disorder, Immediate post-injection reaction, Moaning, Posture abnormal, Seizure
Clinical narrative: Immediately after administration, patient slumped forward to the left side and started moaning. This lasted several seconds. Upon sitting him up right, his eyes rolled back and he started shaking (seizing). This lasted several seconds. He then asked "what happened?" His B/P at that time was 95/53.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Tremor
Clinical narrative: Immediately after administration, patient slumped forward to the left side and started moaning. This lasted several seconds. Upon sitting him up right, his eyes rolled back and he started shaking (seizing). This lasted several seconds. He then asked "what happened?" His B/P at that time was 95/53.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site pustule
Clinical narrative: Patient returned to store approx 10:30 am on 8/15/18 and stated that he woke up in the morning with pus oozing out of injection site. He squeezed out what he could, and covered with non-stick pad. I advised patient to visit urgent care immediately for follow-up.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Emotional distress, Injection site erythema, Injection site pain, Syncope
Clinical narrative: After injection pt c/o pain at injection site. She had syncope spell along with "jerking" that couldn't be controlled. Injection site became very red and pt became very upset. She stated she "didn't know what happened" when questioned. VS were stable.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via company representative regarding an adult female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient in her late 20's received vaccination with PNEUMOVAX 23 (lot#, expiration date, strength, dosing details and route of administration were not reported) for prophylaxis. On an unknown date, the patient experienced a severe site reaction further described as marked swelling from injection site to elbow (vaccination site swelling and swelling). The patient visited physician to seek medical attention. Treatment given for the events was unknown. The outcome of vaccination site swelling and swelling was unknown. Causality assessment was not provided by the reporting physician.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Hepatitis A adult dose given instead of pediatric dose.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: 11 hrs after receiving, BEXSERO #2, he developed a fever, chills, and headache. He vomited x 5hrs. He was evaluated by Dr. about 22hrs, after all was well-appearing, having only a mild residual headache and no lesions at the injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: About 3 weeks after the vaccine, the patient developed a rash over the trunk of her body. It covered most of her torso. Her doctor gave her a MEDROL DOSE PACK to help clear up the rash.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Same day reaction, came into the clinic two days later with redness and swelling around the injection site on (R) deltoid where the Tdap was given. Pt saw a provider and was given antibiotic (Doxycycline 100mg BID x 7 days).
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Defaecation urgency
Clinical narrative: Pt described as "urgent evacuation of total bowel" about 15 hours after vaccine, also experienced chills and left work early.
Age: 14.0
Sex: F
Vaccine: HEP, HPVX, MMRV, TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pallor, Presyncope
Clinical narrative: Right after I got the tdap vaccine, I turned super pale and almost fainted, 11 hours later I started to get diarrhea, and nauseous, then at 4 AM I threw up. My stomach hasn't stopped hurting since, and its been five days.
Age: 14.0
Sex: F
Vaccine: HEP, HPVX, MMRV, TDAP
Symptoms: Vomiting
Clinical narrative: Right after I got the tdap vaccine, I turned super pale and almost fainted, 11 hours later I started to get diarrhea, and nauseous, then at 4 AM I threw up. My stomach hasn't stopped hurting since, and its been five days.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Chills, shivering, rapid heart rate, fever, headache, muscle aches 1:00 AM to 8:00 AM.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash left upper arm. Spreading to chest extending to right side of chest.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash left upper arm. Spreading to chest extending to right side of chest.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red area, hot to touch, painful, treatment: DEPO-MEDROL, ZYRTEC.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Injection site swelling, Pain, Skin discolouration, Urticaria
Clinical narrative: MD office called to let us know of ADE and that Pt wanted to go to hospital. They stated she had hives all over, swelling at injection site, pain that was going away, and discoloration of skin like a bruise.
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 demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 31-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product packaging issue
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the reporter opened a box of VARIVAX and one of the vials in the box did not have a flip cap on the vial. The flip cap was not found in the box. On an unknown date, the patient was vaccinated with a different vial of VARIVAX lot # N031939, expiry date: 13-NOV-2019, for prophylaxis (dose was not reported). No adverse symptoms were reported. Product quality complaint was involved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included infection (infection has not worsened or improved since she received a dose of SHINGRIX). On 6th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, several hours after receiving SHINGRIX, the patient experienced shoulder pain, fatigue and pain. On an unknown date, the outcome of the shoulder pain, fatigue and pain were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, fatigue and pain to be related to SHINGRIX. Additional details were provided as follows: The patient noted she developed a mild infection prior to her dose of SHINGRIX. The patient noted infection had not worsened or improved since she received a dose of SHINGRIX. The patient was taking antibiotics for mild infection. At approximately 19:00, the patient was administered SHINGRIX in the right arm. The patient woke up the next morning with shoulder pain and fatigue. Shoulder pain was described as soreness. Fatigue was described as feeling like her body was hit by something.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 16-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019) for prophylaxis. Co-suspect products included MENVEO (batch number A17041, expiry date 30th April 2019) for prophylaxis. On 9th May 2018, the patient received the 1st dose of BEXSERO and MENVEO. On 11th May 2018, 2 days after receiving BEXSERO and MENVEO, the patient experienced fever (serious criteria other: as per reporter). On 13th May 2018, the patient experienced swelling of fingers (serious criteria other: as per reporter) and rash (serious criteria other: as per reporter). The patient was treated with prednisone. On an unknown date, the outcome of the fever, swelling of fingers and rash were recovered/resolved. It was unknown if the reporter considered the fever, swelling of fingers and rash to be related to BEXSERO and MENVEO. Additional details were provided as follows: This case was reported by the Medical Assistant (MA). At 16:30 hours, the patient received Bexsero in left deltoid and Menveo in right deltoid. The patient developed fever of 102 degrees. Three days after receiving BEXSERO and MENVEO, the patient developed bilateral hand and finger swelling. The patient went to the emergency room and was started on Prednisone. A few hours later the patient developed a rash on his hands, chest, and arms. The patient went to an allergist after the rash developed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th August 2018, 3 days after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The patient was vaccinated at a pharmacy. She was at the physician's office at the time of reporting, with what looked like shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Pain, Swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. 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 pain, headache, fatigue, erythema and swelling. On an unknown date, the outcome of the pain, headache, fatigue, erythema and swelling were unknown. It was unknown if the reporter considered the pain, headache, fatigue, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The case was received by the office manager. The age at vaccination was not reported. The patient was in her 60's. At the time of report, therapy dates and onset date were not known.
Sex: F
Vaccine: DTAP
Symptoms: Coeliac disease, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of celiac disease in a female patient who received DTPa (DTaP vaccine) for prophylaxis. Co-suspect products included paracetamol (Acetaminophen) unknown for drug use for unknown indication. The patient had a Family History of celiac disease (the patient's mother). On an unknown date, the patient received DTaP vaccine at an unknown dose and Acetaminophen at an unknown dose and frequency. On an unknown date, unknown after receiving DTaP vaccine and Acetaminophen, the patient experienced celiac disease (serious criteria GSK medically significant) and pandas. The action taken with Acetaminophen was unknown (Dechallenge was unknown). Rechallenge with Acetaminophen was unknown. On an unknown date, the outcome of the celiac disease and pandas were unknown. It was unknown if the reporter considered the celiac disease and pandas to be related to DTaP vaccine and Acetaminophen. Additional details were provided as follows: The age at vaccination was not reported. The patient's mother had celiac disease and believed that she and her children (the patient) might have had a genetic predisposition to develop these disorders but that vaccination might be the trigger and acetaminophen use around the time of vaccination might also have had an effect. The patient received routine vaccinations and reporter believed some were GlaxoSmithKline's, including but not limited to DTaP vaccine. The patient developed Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS) disease a short time after receiving her routine vaccines. The reporter was going to contact Centers for Disease Control and Prevention (CDC) and Certified Information Systems Auditor (CISA) project to saw if her case or situation could be reviewed for further expert review. She was willing to be followed up with GlaxoSmithKline.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Haemorrhage subcutaneous
Clinical narrative: Red hemorrhagic spots on left arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: Arm ache started almost immediately after injection. Was more severe 3 hours later. Headache and muscle aches with stiffness started 12 hours later.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Around 10-15 minutes after injection, patient experienced increase heart rate. Her blood pressure kept increasing (over 180/103). Called her relatives and sent her to emergency room. Called her daughter this morning (8.15), her daughter said she is ok. She got home around 5 am from ER. They will follow up with primary care.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 20-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 06-AUG-2018, the patient was vaccinated with pediatric dose of VAQTA, intramuscularly (dose, units, frequency, lot# and expiration date unknown). The patient experienced no adverse event. There was no product quality compliant reported.
Sex: F
Vaccine: VARZOS
Symptoms: 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. In approximately 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for the intended purpose of lifetime prevention from shingles and zoster related diseases. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 16-AUG-2016, the patient was diagnosed with shingles by a physician. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the lifetime prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX. On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, difficulty breathing, fever, injection site discoloration, injection site erythema, joint pain and weird feeling. In August 2018, the patient experienced myalgia, light headedness, headache, shivering, fatigue and cough. On an unknown date, the outcome of the influenza-like symptoms, difficulty breathing, injection site discoloration, injection site erythema, myalgia, light headedness, headache, shivering, fatigue, cough and weird feeling were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the joint pain was unknown. It was unknown if the reporter considered the influenza-like symptoms, difficulty breathing, fever, injection site discoloration, injection site erythema, myalgia, light headedness, headache, shivering, fatigue, joint pain, cough and weird feeling to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient stated that the next morning after receiving vaccine, he experienced a fever and body temperature was recorded as 100.2 F, his arm was discolored at the injection site, it was hard to breathe and his joints were aching and felt like he had the flu. Less than a week after receiving vaccine, the patient stated that he also experienced headache, myalgia, fatigue, shivering. Patient stated that the fever resolved within a few hours. Patient stated that he was feeling 75 percent better than he did on previous Thursday and stated that his arm was clearing up as well, however, it was a little red at the time of reporting. Patient stated that if he talked too much he started coughing and still felt a little weird. Patient went in to his physician's office and saw the nurse practitioner for his symptoms. The reporter also reported these symptoms to his pharmacy. Patient disconnected the call before any additional information could be clarified or provided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Injection site discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX. On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, difficulty breathing, fever, injection site discoloration, injection site erythema, joint pain and weird feeling. In August 2018, the patient experienced myalgia, light headedness, headache, shivering, fatigue and cough. On an unknown date, the outcome of the influenza-like symptoms, difficulty breathing, injection site discoloration, injection site erythema, myalgia, light headedness, headache, shivering, fatigue, cough and weird feeling were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the joint pain was unknown. It was unknown if the reporter considered the influenza-like symptoms, difficulty breathing, fever, injection site discoloration, injection site erythema, myalgia, light headedness, headache, shivering, fatigue, joint pain, cough and weird feeling to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient stated that the next morning after receiving vaccine, he experienced a fever and body temperature was recorded as 100.2 F, his arm was discolored at the injection site, it was hard to breathe and his joints were aching and felt like he had the flu. Less than a week after receiving vaccine, the patient stated that he also experienced headache, myalgia, fatigue, shivering. Patient stated that the fever resolved within a few hours. Patient stated that he was feeling 75 percent better than he did on previous Thursday and stated that his arm was clearing up as well, however, it was a little red at the time of reporting. Patient stated that if he talked too much he started coughing and still felt a little weird. Patient went in to his physician's office and saw the nurse practitioner for his symptoms. The reporter also reported these symptoms to his pharmacy. Patient disconnected the call before any additional information could be clarified or provided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX. On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, difficulty breathing, fever, injection site discoloration, injection site erythema, joint pain and weird feeling. In August 2018, the patient experienced myalgia, light headedness, headache, shivering, fatigue and cough. On an unknown date, the outcome of the influenza-like symptoms, difficulty breathing, injection site discoloration, injection site erythema, myalgia, light headedness, headache, shivering, fatigue, cough and weird feeling were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the joint pain was unknown. It was unknown if the reporter considered the influenza-like symptoms, difficulty breathing, fever, injection site discoloration, injection site erythema, myalgia, light headedness, headache, shivering, fatigue, joint pain, cough and weird feeling to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient stated that the next morning after receiving vaccine, he experienced a fever and body temperature was recorded as 100.2 F, his arm was discolored at the injection site, it was hard to breathe and his joints were aching and felt like he had the flu. Less than a week after receiving vaccine, the patient stated that he also experienced headache, myalgia, fatigue, shivering. Patient stated that the fever resolved within a few hours. Patient stated that he was feeling 75 percent better than he did on previous Thursday and stated that his arm was clearing up as well, however, it was a little red at the time of reporting. Patient stated that if he talked too much he started coughing and still felt a little weird. Patient went in to his physician's office and saw the nurse practitioner for his symptoms. The reporter also reported these symptoms to his pharmacy. Patient disconnected the call before any additional information could be clarified or provided.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Yellow skin
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of yellow skin in a 79-year-old female patient who received BOOSTRIX (batch number X9YP3, expiry date 2nd October 2020) for prophylaxis. On 17th July 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 17th July 2018, less than a day after receiving BOOSTRIX, the patient experienced yellow skin and sweating. On 18th July 2018, the outcome of the yellow skin and sweating were recovered/resolved. It was unknown if the reporter considered the yellow skin and sweating to be related to BOOSTRIX. Additional details were provided as follows: The patient told the pharmacist that the day she received the BOOSTRIX vaccine she got sweaty and the skin on her face turned yellow. This lasted for about 1 day before resolving.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 3rd August 2018 10:05, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX vaccine in right arm. The patient had denied permission to contact their physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of red blotches in a 65-year-old female patient who received SHINGRIX (batch number TZ9L5, expiry date 22nd November 2020) for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced red blotches and injection site reaction. On an unknown date, the outcome of the red blotches and injection site reaction were unknown. It was unknown if the reporter considered the red blotches and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The health care professional stated the patient received SHINGRIX on left arm and experienced a red blotch where SHINGRIX was administered on her left arm. The health care professional was not sure if she received it subcutaneously or intramuscularly. This case was reported by her friend to the HCP a day before reporting so the red blotch occurred within the 48 hours after injection. The health care professional was not sure if the patient was still experiencing the red blotch.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: Two weeks before the reporting date, the patient developed shingles. The reporter provided lot number from medical record, but was unsure if lot number was from vial or carton.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Gastrointestinal pain, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 5th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, headache, gut pain, fever, chills, weakness, appetite lost, tingling sensation and skin blotches. On an unknown date, the outcome of the injection site pain, injection site swelling, headache, gut pain, fever, chills, weakness, appetite lost, tingling sensation and skin blotches were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, headache, gut pain, fever, chills, weakness, appetite lost, tingling sensation and skin blotches to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received  SHINGRIX in left arm. The patient declined to provide full demographics for herself. Less than a week after receiving SHINGRIX, the patient experienced headache, gut pain, fever, chills, weakness, loss of appetite, blotchy skin down her legs and tingling sensation in the skin around her abdomen.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Paraesthesia, Pyrexia, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 5th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, headache, gut pain, fever, chills, weakness, appetite lost, tingling sensation and skin blotches. On an unknown date, the outcome of the injection site pain, injection site swelling, headache, gut pain, fever, chills, weakness, appetite lost, tingling sensation and skin blotches were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, headache, gut pain, fever, chills, weakness, appetite lost, tingling sensation and skin blotches to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received  SHINGRIX in left arm. The patient declined to provide full demographics for herself. Less than a week after receiving SHINGRIX, the patient experienced headache, gut pain, fever, chills, weakness, loss of appetite, blotchy skin down her legs and tingling sensation in the skin around her abdomen.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Formication, Gastrointestinal disorder, Malaise, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of formication in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced formication, reaction gastrointestinal, malaise, fatigue and fever. On an unknown date, the outcome of the formication, reaction gastrointestinal, malaise, fatigue and fever were recovered/resolved. It was unknown if the reporter considered the formication, reaction gastrointestinal, malaise, fatigue and fever to be related to SHINGRIX. Additional details were provided as follows: This information was received via chat. The age at vaccination was not reported. The healthcare professional (HCP) stated that, the patient had a full week of adverse reactions to SHINGRIX that included; fatigue, fever, malaise, gastrointestinal reaction, and formication. The HCP stated that, the SHINGRIX was administered at another location and he did not have vaccine information for the reported adverse events. This case is 1 of the 2 cases reported by the same reporter.