chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Lethargy, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse and refers to a 11 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was vaccinated with GARDASIL 9)for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced injection site swelling, fever and lethargy. The outcome of the events injection site swelling, fever and lethargy and the causal relationship between all aforementioned events and therapy with GARDASIL 9 were not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Unresponsive to stimuli, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold. Concurrent medical conditions included allergy (unspecified). In March 2019, the patient received SHINGRIX. In March 2019, 12 hrs after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), unresponsive to stimuli (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the passed out and unresponsive to stimuli were recovered/resolved and the outcome of the vomiting was unknown.  It was unknown if the reporter considered the passed out, unresponsive to stimuli and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine 2 weeks before the date of reporting. The patient passed out which was described as non-responsive for 30 to 40 seconds. After becoming responsive, she vomited. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have the patient information. The batch number and expiry date of SHINGRIX was not reported. After vaccination with SHINGRIX, the patient experienced mild rash, that went away.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Dyspnoea, Eye movement disorder, Feeling hot, Malaise, Muscle rigidity
Clinical narrative: Patient received both vaccines, one in each arm and waited in the exam room for 15 minutes. Patient then went to the lab to have blood drawn. When patient was in the lobby, she stated that she felt hot and didn't feel well and a nurse told her to sit down. The nurse at the front desk and went to check on the patient. The patient then got very pale, eyes rolled back into her head, nostrils sucked in, was gasping, then she got rigid and appeared to stop breathing, legs started to turn in and the nurse called for help. Multiple staff responded. One of the nurses noted that her left leg had a tremor for a few seconds. Patient was given a wet washcloth for her head and started to perk up and she was given some water. BP was taken and was within normal limits. After her color came back, she was placed in a wheelchair and taken back to the exam room for evaluation. She was assessed by her provider twice before it was determined that she had a response to the vaccines and was OK to go home. Patient was walked to her vehicle.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Pallor, Respiratory arrest, Tremor, Vaccination complication
Clinical narrative: Patient received both vaccines, one in each arm and waited in the exam room for 15 minutes. Patient then went to the lab to have blood drawn. When patient was in the lobby, she stated that she felt hot and didn't feel well and a nurse told her to sit down. The nurse at the front desk and went to check on the patient. The patient then got very pale, eyes rolled back into her head, nostrils sucked in, was gasping, then she got rigid and appeared to stop breathing, legs started to turn in and the nurse called for help. Multiple staff responded. One of the nurses noted that her left leg had a tremor for a few seconds. Patient was given a wet washcloth for her head and started to perk up and she was given some water. BP was taken and was within normal limits. After her color came back, she was placed in a wheelchair and taken back to the exam room for evaluation. She was assessed by her provider twice before it was determined that she had a response to the vaccines and was OK to go home. Patient was walked to her vehicle.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Contusion
Clinical narrative: bruising to leg that lasted ~ 2 months
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: The shot was given deeply in the left arm in the middle of the deltoid muscle. At the time of the injection, the shot felt deep and painful. I said, "ouch, that hurt." Following the vaccine, my left arm muscle has been sore for an extended period of time. I am unable to raise my arm, put on my coat, wear my purse, lift my child, etc. without sore pain in my left arm. This has been going on since the date of the vaccine on March 28th.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Petechiae
Clinical narrative: PT RECEIVED VACCINES APPROX 1215PM, MOTHER CALLED TO REPORT PETECHIAE AROUND NECK AT 1625; MOTHER BROUGHT PT UP TO CLINIC TO ALLOW VISUAL EXAMINATION OF REACTION. PT DENIES ANY DISCOMFORT, DIFFICULTY BREATHING, ITCHING.  DOES NOT APPEAR ILL. MOTHER STATES WILL WATCH AN IF WORSE GO TO ER.  EMPLOYEE CONTACTED MOTHER AFTER LEFT AND SPOKE WITH MOTHER TO EDUCATE SIMILAR EVENTS FOUND REPORT ON VAERS AND THAT MAY WANT TO TAKE TO ER JUST AS RULE OUT/SAFETY PRECAUTION. MOTHER STATES IF GETS WORSE WILL TAKE CHILD TO ER.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site abscess
Clinical narrative: Patient experienced abscess all over the arm and shoulder where the injection was given but not the other arm. Patient reported the adverse event after 2 months (all the signs were gone) when she came for the second shot. Patient was advised to postpone the 2nd shot until further notice to check with her PCP and manufacture.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abscess limb, Injection site abscess, Injection site ulcer, Skin ulcer
Clinical narrative: Patient experienced abscess all over the arm and shoulder where the injection was given but not the other arm. Patient reported the adverse event after 2 months (all the signs were gone) when she came for the second shot. Patient was advised to postpone the 2nd shot until further notice to check with her PCP and manufacture.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Swelling, Ultrasound scan normal
Clinical narrative: Patient reports moderate swelling to left clavicle area starting around 03/10/2019, then having severe pain in left deltoid area on 03/15/2019 preventing her from being able to lift her left arm above her head.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: Patient developed nausea, chest pain, and difficulty breathing on 01APR. Presented to clinic on 05APR and EKG showed diffuse ST elevation, went sent to the ER. Troponins, CK and CKMB were all elevated. Echo was obtained. Patient diagnosed with perimyocarditis with pericardial effusion.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram ST segment elevation, Myocarditis, Nausea, Pericardial effusion, Troponin increased
Clinical narrative: Patient developed nausea, chest pain, and difficulty breathing on 01APR. Presented to clinic on 05APR and EKG showed diffuse ST elevation, went sent to the ER. Troponins, CK and CKMB were all elevated. Echo was obtained. Patient diagnosed with perimyocarditis with pericardial effusion.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Throat tightness
Clinical narrative: Approx 2 minutes after getting the vaccine, patient complained of her throat feeling tight, but she was not having difficulty breathing. Patient was given 25mg of oral BENADRYL and monitored. Pt's BP 126/62 HR 71, patient stable and responsive with no difficutly breating, but she started to complain about headache and feeling nausea and dizziness. Since patient was not improving after 15 minutes 911 was notified. Patient was examined and cleared as non emergency, and gave patient option to either be taken by ambulance or to go to her doctor instead. Patient opted to be taken to the ER by ambulance.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Erythema, Influenza like illness, Injection site pain, Injection site reaction
Clinical narrative: Pt says she got vaccine at pharmacy and then developed redness, temperature, flu like symptoms and pain at injection site. I saw her 4/5/2019. Redness at injection site was still there. She said she was improving and wanted to let me know about what had happened.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Skin exfoliation
Clinical narrative: patient describes red rash beginning 2 days after immunization and skin peeling approximately 1 week after injection
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Feeling abnormal, Myalgia, Pruritus, Rash
Clinical narrative: Patient awoke Saturday am 4/6/19 with feeling like she had "been hit by a truck", low grade temp, severe myalgia, Rash noted on left inner forearm approximately the size of an entire hand.  Rash right flank and abdominal wall 3 hands large.  C/o itching.  This lasted the entire day into the evening.  Finally felt somewhat better on Sunday 4/7/19.  No other symptoms of GI or respiratory.   This patient is in the medical field - a surgeon - and has never had any type of reaction to a vaccine previously.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient was administered the PPV23 vaccine instead of the required PPV13.  Error was not made known until the following Monday on 04/08/2019 when the billing for the visit was being implemented. Patient's parent was immediately notified by phone call of the event and plans are made for the patient to come in on 04/12/2019 for the necessary vaccine.
Age: 0.33
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Adverse reaction, Chills, Developmental delay, Electroencephalogram, Neurological symptom
Clinical narrative: The morning after (11/8/2016) my son got his second round of DTaP and Prevnar undeniably started to have full body shivers / neurological activity. He's developmental progress also seem to slow for about 6 months starting that day.   I did notice the same "shivers" after his first set of these shots that took place on 9/13/2016 but they didn't start happening so frequently and close together until he received his second doses. After the second does I knew he without a doubt was having an adverse reaction.   Over the period of November through December of 2016 the activity got really bad. Up to 15 to 20 full body shakes in a hour. I stopped shots completely at this point.  Then in January 2017 they slowly starting being less and less and by July 2017 they had stopped. Today, at the age of 2 he still doesn't have them anymore.
Age: 0.33
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Tremor
Clinical narrative: The morning after (11/8/2016) my son got his second round of DTaP and Prevnar undeniably started to have full body shivers / neurological activity. He's developmental progress also seem to slow for about 6 months starting that day.   I did notice the same "shivers" after his first set of these shots that took place on 9/13/2016 but they didn't start happening so frequently and close together until he received his second doses. After the second does I knew he without a doubt was having an adverse reaction.   Over the period of November through December of 2016 the activity got really bad. Up to 15 to 20 full body shakes in a hour. I stopped shots completely at this point.  Then in January 2017 they slowly starting being less and less and by July 2017 they had stopped. Today, at the age of 2 he still doesn't have them anymore.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Malaise, Nausea, Pyrexia
Clinical narrative: A hard red lump formed at injection site pt spiked a low grade fever, nausea, and malaise - redness spread overnight 24 hrs all over the arm and then after another 12 to 24 hrs it subsided and pt is now feeling a lot better but still following up with the pcp.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 12 hours of receiving her second dose of SHINGRIX the patient reports redness, swelling and pain around the injection site. She reported to the pharmacy where the vaccine was given and she was counseled to follow up with her primary care physician. Swelling, redness and pain extended to an area >100 mm. Photographs were taken as documentation.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient says they developed a rash on their left arm that spread.  She says the doctor believes it was a shingles rash.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine given, expired 4/1/2019 and given to patient on 4/9/19
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient experienced rash at injection site and starting to spread further down her arm.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Injection site pain, Malaise, Tendon pain, Tendonitis
Clinical narrative: Very painful injection site, Malaise, joint and tendon pain all resolved within 5 days, except some lingering tendonitis
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Laboratory test normal, Loss of personal independence in daily activities, Panic attack
Clinical narrative: My daughter got her second HPV shot on February 18, 2019. Since then my daughter has been suffering from constant stomach pain. This stomach pain has caused her to have many panic attacks. We have been in and out of the emergency room five times, pediatrician twice, gastrointestinal doctor, therapist, psychiatrist, and just had a week stay in the hospital. Every test possible has been completed and nothing has been found to be the cause. She has been put on many prescriptions during this time. She is now on five prescriptions. She has been unable to participate in her normal activities. She's missed swimming championships, band concert, and even her own birthday party. Before this she was a perfectly normal very active girl. I've mentioned this to every doctor and they see it as coincidence. She was hospitalized for a week with many tests done. I truly believe this shot is the cause.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nasopharyngitis, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient reported on 04/09/2019 in morning that she had a reaction. She was having mild fever, pain all over the body, could not sleep, head cold and congestion. She took tylenol for pain and fever.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Approx. 15 min after vaccine administration patient developed hives to site where injection was administered and around to back. No breathing problems occurred. Pt. was given topical steroid cream and hives resolved approx. 4 days later.
Age: 65.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient developed a painful swelling on the left arm hours after receiving SHINGRIX shot. The pain and swelling subsided the next day without any intervention.
Age: 49.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Received vaccines and developed Stevens Johnson Syndrome.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nausea, Vomiting
Clinical narrative: Localized swelling at injection site ongoing  for 5days Nausea with vomiting 48 hours after vaccine
Age: 83.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Report of red painful 8x11 cm area on left arm.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal mass, Injection site pruritus, Limb mass, Pruritus
Clinical narrative: itchiness started around on 4/6/2019 early afternoon on injection site, spread to abdomen, and back. On 4/8/19 Monday, there is a small lump on the injection arm and the opposite arm and on abdomen. Patient said he went to emergency room and the physician told him that might be an allergic reaction to the vaccine. Itchiness relieved by benadryl and prednisone.
Sex: F
Vaccine: FLU3
Symptoms: Eczema, Rash
Clinical narrative: eczema; bumps on her arms and legs; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via Health Authorities under reference 774121-1.  This case involves a 12 months old female patient who experienced eczema and bumps on her arms and legs, while she received vaccine INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE [FLUZONE INTRADERMAL].  The patient's past medical history included Ear infection in NOV-2007. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); and VARICELLA ZOSTER VACCINE LIVE (VARICELLA VACCINE, LIVE).  On 29-Nov-2007, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On 01-Dec-2007, the patient developed a non-serious eczema and bumps on her arms and legs (rash papular) 2 days following the administration of INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE. The patient visited the doctor on 20-Dec-2018 where the doctor told that she had eczema.  (Other relevant tests included No lab data reported.)  Final diagnosis was bumps on her arms and legs and eczema.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for eczema and as Not Recovered / Not Resolved on an unknown date for bumps on her arms and legs.
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: trouble lifting arm; severe pain in deltoid and shoulder area; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from other healthcare professional via Health Authorities under reference 785814-1.  This case involves a 70 years old female patient who experienced trouble in lifting arm and severe pain in deltoid and shoulder area, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included epilepsy. The patient's past medical treatment included penicillin and barbiturate with allergy. The patient's past vaccination(s) and family history were not provided.  Concomitant medications included PHENYTOIN (DILANTIN [PHENYTOIN]).  On 02-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ006AA via intramuscular route in the left arm.  On 03-Nov-2018, the patient developed a non-serious trouble in lifting arm (injected limb mobility decreased) and severe pain in deltoid and shoulder area (injection site pain) one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests not reported.          Final diagnosis was injection site pain and injected limb mobility decreased.  It was reported that on 06-Nov-2018, had a Dr visit, prescribed prednisone for 3 days.  The patient recovered from all the events.  List of documents held by sender- none.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Malaise, Pyrexia, Rash macular, Swelling face
Clinical narrative: general malaise; blotchy redness around both eyes; facial swelling; fever 24 hours after vaccine; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional via Health Authorities (under the reference number: 785888-1).  This case involves a 6 months old female patient who experienced blotchy redness around both eyes, general malaise, fever and facial swelling, while she received vaccines ROTATEQ, PREVNAR 13, PEDIARIX and HIB (PRP/T) VACCINE [ActHIB].  The patient's past medical history, medical treatment(s), vaccination(s) and were not provided. The patient's family history included patient's brother had the same symptoms recently after receiving his kindergarten shots at another facility.  On 22-Jun-2018, the patient received a second dose of suspect HIB (PRP/T) VACCINE lot UI860AA via intramuscular route in the left thigh, a second dose of suspect PEDIARIX lot 2F977 via intramuscular route in the right thigh, a second dose of suspect PREVNAR 13 lot W61547 via intramuscular route in the left thigh, and a second dose of suspect ROTATEQ lot N021308 via oral route.  On 23-Jun-2018, the patient developed a non-serious fever (pyrexia) 24 hours following the administration of HIB (PRP/T) VACCINE, PEDIARIX, PREVNAR 13 and ROTATEQ. On an unknown date, the patient developed a non-serious blotchy redness around both eyes (rash macular), general malaise (malaise) and facial swelling (swelling face) (latency: reported as 2 and 3 days later) following the administration of HIB (PRP/T) VACCINE, PEDIARIX, PREVNAR 13 and ROTATEQ.  Other relevant tests were not reported.  Final diagnosis was facial swelling, fever, general malaise and blotchy redness around both eyes.  It was not reported if the patient received a corrective treatment.  The patient recovered from all the events.  List of documents held by sender: none.
Age: 95.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 95-year-old male patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th March 2019, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain, weakness and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, pain, weakness and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, pain, weakness and feeling bad to be related to SHINGRIX. Additional case details were provided as follows: The patient received dose SHINGRIX in the left arm and experienced flu like symptoms described as achy, weak, and generally feeling lousy. The events began 2 days after the injection and has not been resolved. The patient given the consent for follow up.
Age: 95.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 95-year-old male patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th March 2019, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain, weakness and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, pain, weakness and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, pain, weakness and feeling bad to be related to SHINGRIX. Additional case details were provided as follows: The patient received dose SHINGRIX in the left arm and experienced flu like symptoms described as achy, weak, and generally feeling lousy. The events began 2 days after the injection and has not been resolved. The patient given the consent for follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Cold sweat, Electrocardiogram, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of syncopal attack in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of malaise (received a couple of years before the time of reporting). Concurrent medical conditions included seasonal allergy. On 20th March 2019, the patient received the 1st dose of SHINGRIX .5 µg. In March 2019, less than a day after receiving SHINGRIX, the patient experienced headache dull, restlessness, sleeplessness, influenza and pain. On 20th March 2019, the patient experienced injection site pain. On 21st March 2019, the patient experienced syncopal attack (serious criteria GSK medically significant), tiredness, vomiting, cold sweat, chills and slow response to stimuli. On an unknown date, the outcome of the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, tiredness, vomiting, cold sweat, chills and slow response to stimuli were recovered/resolved and the outcome of the influenza and pain were unknown. It was unknown if the reporter considered the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, influenza, pain, tiredness, vomiting, cold sweat, chills and slow response to stimuli to be related to SHINGRIX. Additional details were reported as follows: A week before the vaccination, the patient had been sick with a cold, but that had resolved. The patient received a dose of SHINGRIX on the right arm. The patient noted that, it was painful during the injection more than with any other vaccine ever received. The night of the vaccination, the patient awoke with a dull headache, achy like and had the flu. The patient was then very restless and had difficulty getting back to sleep. The next day of vaccination, the patient was very tired and the patient's husband was calling her name but the patient would not respond to him. When the patient came out of it and the patient vomited and had cold sweats and chills. The patient also noted that, the patient looked at her heart rate was 72, which was normal for her. The patient called her primary physician after the episode, who referred the patient to the local emergency room. The patient went and they did blood work and an electrocardiogram (EKG), which were all normal.  The physician was advised her not to receive the 2nd dose of SHINGRIX. The patient noted that, the patient had a syncopal episode. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Poor quality sleep, Somnolence, Syncope, Urine analysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of syncopal attack in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of malaise (received a couple of years before the time of reporting). Concurrent medical conditions included seasonal allergy. On 20th March 2019, the patient received the 1st dose of SHINGRIX .5 µg. In March 2019, less than a day after receiving SHINGRIX, the patient experienced headache dull, restlessness, sleeplessness, influenza and pain. On 20th March 2019, the patient experienced injection site pain. On 21st March 2019, the patient experienced syncopal attack (serious criteria GSK medically significant), tiredness, vomiting, cold sweat, chills and slow response to stimuli. On an unknown date, the outcome of the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, tiredness, vomiting, cold sweat, chills and slow response to stimuli were recovered/resolved and the outcome of the influenza and pain were unknown. It was unknown if the reporter considered the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, influenza, pain, tiredness, vomiting, cold sweat, chills and slow response to stimuli to be related to SHINGRIX. Additional details were reported as follows: A week before the vaccination, the patient had been sick with a cold, but that had resolved. The patient received a dose of SHINGRIX on the right arm. The patient noted that, it was painful during the injection more than with any other vaccine ever received. The night of the vaccination, the patient awoke with a dull headache, achy like and had the flu. The patient was then very restless and had difficulty getting back to sleep. The next day of vaccination, the patient was very tired and the patient's husband was calling her name but the patient would not respond to him. When the patient came out of it and the patient vomited and had cold sweats and chills. The patient also noted that, the patient looked at her heart rate was 72, which was normal for her. The patient called her primary physician after the episode, who referred the patient to the local emergency room. The patient went and they did blood work and an electrocardiogram (EKG), which were all normal.  The physician was advised her not to receive the 2nd dose of SHINGRIX. The patient noted that, the patient had a syncopal episode. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of syncopal attack in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of malaise (received a couple of years before the time of reporting). Concurrent medical conditions included seasonal allergy. On 20th March 2019, the patient received the 1st dose of SHINGRIX .5 µg. In March 2019, less than a day after receiving SHINGRIX, the patient experienced headache dull, restlessness, sleeplessness, influenza and pain. On 20th March 2019, the patient experienced injection site pain. On 21st March 2019, the patient experienced syncopal attack (serious criteria GSK medically significant), tiredness, vomiting, cold sweat, chills and slow response to stimuli. On an unknown date, the outcome of the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, tiredness, vomiting, cold sweat, chills and slow response to stimuli were recovered/resolved and the outcome of the influenza and pain were unknown. It was unknown if the reporter considered the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, influenza, pain, tiredness, vomiting, cold sweat, chills and slow response to stimuli to be related to SHINGRIX. Additional details were reported as follows: A week before the vaccination, the patient had been sick with a cold, but that had resolved. The patient received a dose of SHINGRIX on the right arm. The patient noted that, it was painful during the injection more than with any other vaccine ever received. The night of the vaccination, the patient awoke with a dull headache, achy like and had the flu. The patient was then very restless and had difficulty getting back to sleep. The next day of vaccination, the patient was very tired and the patient's husband was calling her name but the patient would not respond to him. When the patient came out of it and the patient vomited and had cold sweats and chills. The patient also noted that, the patient looked at her heart rate was 72, which was normal for her. The patient called her primary physician after the episode, who referred the patient to the local emergency room. The patient went and they did blood work and an electrocardiogram (EKG), which were all normal.  The physician was advised her not to receive the 2nd dose of SHINGRIX. The patient noted that, the patient had a syncopal episode. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Chills, Cold sweat, Electrocardiogram normal, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of syncopal attack in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of malaise (received a couple of years before the time of reporting). Concurrent medical conditions included seasonal allergy. On 20th March 2019, the patient received the 1st dose of SHINGRIX .5 µg. In March 2019, less than a day after receiving SHINGRIX, the patient experienced headache dull, restlessness, sleeplessness, influenza and pain. On 20th March 2019, the patient experienced injection site pain. On 21st March 2019, the patient experienced syncopal attack (serious criteria GSK medically significant), tiredness, vomiting, cold sweat, chills and slow response to stimuli. On an unknown date, the outcome of the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, tiredness, vomiting, cold sweat, chills and slow response to stimuli were recovered/resolved and the outcome of the influenza and pain were unknown. It was unknown if the reporter considered the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, influenza, pain, tiredness, vomiting, cold sweat, chills and slow response to stimuli to be related to SHINGRIX. Additional details were reported as follows: A week before the vaccination, the patient had been sick with a cold, but that had resolved. The patient received a dose of SHINGRIX on the right arm. The patient noted that, it was painful during the injection more than with any other vaccine ever received. The night of the vaccination, the patient awoke with a dull headache, achy like and had the flu. The patient was then very restless and had difficulty getting back to sleep. The next day of vaccination, the patient was very tired and the patient's husband was calling her name but the patient would not respond to him. When the patient came out of it and the patient vomited and had cold sweats and chills. The patient also noted that, the patient looked at her heart rate was 72, which was normal for her. The patient called her primary physician after the episode, who referred the patient to the local emergency room. The patient went and they did blood work and an electrocardiogram (EKG), which were all normal.  The physician was advised her not to receive the 2nd dose of SHINGRIX. The patient noted that, the patient had a syncopal episode. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza, Injection site pain, Insomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of syncopal attack in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of malaise (received a couple of years before the time of reporting). Concurrent medical conditions included seasonal allergy. On 20th March 2019, the patient received the 1st dose of SHINGRIX .5 µg. In March 2019, less than a day after receiving SHINGRIX, the patient experienced headache dull, restlessness, sleeplessness, influenza and pain. On 20th March 2019, the patient experienced injection site pain. On 21st March 2019, the patient experienced syncopal attack (serious criteria GSK medically significant), tiredness, vomiting, cold sweat, chills and slow response to stimuli. On an unknown date, the outcome of the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, tiredness, vomiting, cold sweat, chills and slow response to stimuli were recovered/resolved and the outcome of the influenza and pain were unknown. It was unknown if the reporter considered the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, influenza, pain, tiredness, vomiting, cold sweat, chills and slow response to stimuli to be related to SHINGRIX. Additional details were reported as follows: A week before the vaccination, the patient had been sick with a cold, but that had resolved. The patient received a dose of SHINGRIX on the right arm. The patient noted that, it was painful during the injection more than with any other vaccine ever received. The night of the vaccination, the patient awoke with a dull headache, achy like and had the flu. The patient was then very restless and had difficulty getting back to sleep. The next day of vaccination, the patient was very tired and the patient's husband was calling her name but the patient would not respond to him. When the patient came out of it and the patient vomited and had cold sweats and chills. The patient also noted that, the patient looked at her heart rate was 72, which was normal for her. The patient called her primary physician after the episode, who referred the patient to the local emergency room. The patient went and they did blood work and an electrocardiogram (EKG), which were all normal.  The physician was advised her not to receive the 2nd dose of SHINGRIX. The patient noted that, the patient had a syncopal episode. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Restlessness, Slow response to stimuli, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of syncopal attack in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of malaise (received a couple of years before the time of reporting). Concurrent medical conditions included seasonal allergy. On 20th March 2019, the patient received the 1st dose of SHINGRIX .5 µg. In March 2019, less than a day after receiving SHINGRIX, the patient experienced headache dull, restlessness, sleeplessness, influenza and pain. On 20th March 2019, the patient experienced injection site pain. On 21st March 2019, the patient experienced syncopal attack (serious criteria GSK medically significant), tiredness, vomiting, cold sweat, chills and slow response to stimuli. On an unknown date, the outcome of the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, tiredness, vomiting, cold sweat, chills and slow response to stimuli were recovered/resolved and the outcome of the influenza and pain were unknown. It was unknown if the reporter considered the syncopal attack, injection site pain, headache dull, restlessness, sleeplessness, influenza, pain, tiredness, vomiting, cold sweat, chills and slow response to stimuli to be related to SHINGRIX. Additional details were reported as follows: A week before the vaccination, the patient had been sick with a cold, but that had resolved. The patient received a dose of SHINGRIX on the right arm. The patient noted that, it was painful during the injection more than with any other vaccine ever received. The night of the vaccination, the patient awoke with a dull headache, achy like and had the flu. The patient was then very restless and had difficulty getting back to sleep. The next day of vaccination, the patient was very tired and the patient's husband was calling her name but the patient would not respond to him. When the patient came out of it and the patient vomited and had cold sweats and chills. The patient also noted that, the patient looked at her heart rate was 72, which was normal for her. The patient called her primary physician after the episode, who referred the patient to the local emergency room. The patient went and they did blood work and an electrocardiogram (EKG), which were all normal.  The physician was advised her not to receive the 2nd dose of SHINGRIX. The patient noted that, the patient had a syncopal episode. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blood lactate dehydrogenase normal, Borrelia test negative, C-reactive protein increased
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pericarditis in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pericarditis (for tolerance of 1st dose refer case US2019GSK060524). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant). The patient was treated with immunosuppressive agents (Immunosuppressive Therapy (Nos)). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pericarditis was not recovered/not resolved. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Several weeks after the second injection, the patient had pericarditis which was not resolved even after immunosuppressive therapy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Complement factor C3, Complement factor C4, Complement factor normal, Electrophoresis protein normal, Hepatitis B core antibody negative
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pericarditis in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pericarditis (for tolerance of 1st dose refer case US2019GSK060524). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant). The patient was treated with immunosuppressive agents (Immunosuppressive Therapy (Nos)). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pericarditis was not recovered/not resolved. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Several weeks after the second injection, the patient had pericarditis which was not resolved even after immunosuppressive therapy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hepatitis C antibody negative, Immunosuppressant drug therapy, Inflammatory marker increased, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging heart
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pericarditis in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pericarditis (for tolerance of 1st dose refer case US2019GSK060524). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant). The patient was treated with immunosuppressive agents (Immunosuppressive Therapy (Nos)). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pericarditis was not recovered/not resolved. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Several weeks after the second injection, the patient had pericarditis which was not resolved even after immunosuppressive therapy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pericardial drainage, Pericarditis, Pleural effusion, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pericarditis in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pericarditis (for tolerance of 1st dose refer case US2019GSK060524). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant). The patient was treated with immunosuppressive agents (Immunosuppressive Therapy (Nos)). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pericarditis was not recovered/not resolved. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Several weeks after the second injection, the patient had pericarditis which was not resolved even after immunosuppressive therapy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Serum ferritin normal
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pericarditis in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pericarditis (for tolerance of 1st dose refer case US2019GSK060524). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant). The patient was treated with immunosuppressive agents (Immunosuppressive Therapy (Nos)). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pericarditis was not recovered/not resolved. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Several weeks after the second injection, the patient had pericarditis which was not resolved even after immunosuppressive therapy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immunosuppressant drug therapy, Pericarditis, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pericarditis in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pericarditis (for tolerance of 1st dose refer case US2019GSK060524). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant). The patient was treated with immunosuppressive agents (Immunosuppressive Therapy (Nos)). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pericarditis was not recovered/not resolved. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Several weeks after the second injection, the patient had pericarditis which was not resolved even after immunosuppressive therapy.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypersomnia, Poor feeding infant
Clinical narrative: After vaccines were given, sleeping more than normal, the next night was frustrated at the breast.