chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Erythema, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: 1st dose: A few hours after the shot the arm turned fiery red and the patient felt sick for three days, her body ached all over, and she felt like she was in a fog. She delayed getting the second shot because she was worried about a repeat of the episode. (a different location, lot number unknown) 2nd dose: Her arm was not as red as the first time, but the muscles and bone hurt bad enough that she had difficulty sleeping and it hurt for four days. She only felt tired the second day rather than in a sort of fog, and it only lasted for one day.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain
Clinical narrative: 1st dose: A few hours after the shot the arm turned fiery red and the patient felt sick for three days, her body ached all over, and she felt like she was in a fog. She delayed getting the second shot because she was worried about a repeat of the episode. (a different location, lot number unknown) 2nd dose: Her arm was not as red as the first time, but the muscles and bone hurt bad enough that she had difficulty sleeping and it hurt for four days. She only felt tired the second day rather than in a sort of fog, and it only lasted for one day.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Pyrexia, Rash, Rash pustular
Clinical narrative: pt developed rash and pustuales within 36 hrs after vaccine and fever
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; a patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-APR-2019, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot # N020688, expiration date 09-MAR-2019 (dose was not reported) for prophylaxis. There was no adverse event reported. Product quality complaint was not involved. The outcome of expired product administered was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: a rash all over the body except for the face; This spontaneous report was received from a pharmacist refers to a 82-year-old female patient. The pharmacist is also the patient's spouse. The patient's pertinent medical history included hypertension, high cholesterol, unspecified cancer, and pulmonary scar tissue. The patient had allergy to neomycin. Concomitant medications included unspecified cholesterol and hypertension medications and a "nebulizer treatments daily".  On an unknown date in 2010, reported as around nine years ago the patient was vaccinated with zoster vaccine live (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis.   On an unknown date in 2010, one week after vaccination, the patient developed a rash all over the body except for the face. The pharmacist reported that on an unspecified date, the patient went to a dermatologist and was give an unspecified antihistamine medication as treatment for the rash. There was no lab diagnostics or studies performed.  The pharmacist reported that the patient used over the counter oatmeal (AVEENO) bath to help with the rash. On an unknown date, the patient recovered form the rash. The relatedness between the events and zoster vaccine live (manufacturer unknown) was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received their first dose of GARDASIL 9 in November 2018. The second dose of GARDASIL 9 was administered 23-APR-2019.; No adverse effect reported.; This spontaneous report as received from a pharmacy intern refers to a 19 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  In November 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (frequency, route of administration, lot number and expiration date were not reported).   On 23-APR-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscular in the left arm for prophylaxis (lot # R024264 and expiration date on 29-OCT-2019)(Inappropriate schedule of vaccine administered).No adverse effect reported. The outcome for the event inappropriate schedule of vaccine administered was unknown at the time of this report.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 25 year old male patient received a dose of PROQUAD; No adverse effects were reported in the patient; This spontaneous report was received from a medical assistant and refers to a 25 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On an unknown date, reported as on an unknown recent date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), subcutaneously (strength, dose, anatomical location, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported in the patient.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event reported; the patient was inadvertently administered a third dose of MMR-ll; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, past drug reactions/ allergies and concomitant therapies were not provided.   On 24-APR-2012, and 31-JUL-2015, the patient was vaccinated with the first and second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) respectively, as prophylaxis (strengths, doses, routes of administration, lot numbers and dates of expiration were not provided). On 15-APR-2019 the patient was inadvertently administered a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(rHA) lot # reported as R010474, date of expiration: 10-APR-2020, as prophylaxis (overdose)(strength, dose, and route of administration were not provided). No adverse event reported. No further information was provided. No product quality complaint (PQC) was filed.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No adverse effects reported; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On unknown date, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis (which had a lot number R027322 and expiration date on 09-JUL-2021; however, dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 33.6 F for 24 hours and 30 minutes, as recorded by data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.; Sender's Comments:  US-009507513-1904USA012028: US-009507513-1904USA012027:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects; 18-year-old patient received an adult dose of VAQTA; This spontaneous report was received from a licensed practical nurse and refers to an 18-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  On 24-APR-2019, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA), intramuscular route (formulation, strength, dose, frequency, anatomical location, indication, lot #, and expiration date were not reported). No adverse effects.
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No adverse effects reported; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On unknown date, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis (which had a lot number R014263 and expiration date on 26-MAR-2021; however, dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 33.6 F for 24 hours and 30 minutes, as recorded by data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.; Sender's Comments:  US-009507513-1904USA011405: US-009507513-1904USA012028:
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; No adverse effects reported; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On unknown date, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis (which had a lot number R014263 and expiration date on 26-MAR-2021; however, dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 33.6 F for 24 hours and 30 minutes, as recorded by data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.; Sender's Comments:  US-009507513-1904USA011405: US-009507513-1904USA012027:
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; worst flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received flu vaccine once. That year, the patient experienced the worst flu. The patient neither had the flu nor would again. It was all for money. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Product storage error
Clinical narrative: Product Storage Error; Injection site reaction; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis.   On 3rd April 2019, the patient received Shingrix. In April 2019, less than a month after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the injection site reaction and incorrect storage of drug were unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: Shingrix lyophilized vaccine left at room temperature for 4 days, administered to the patient last week. The reporter did not give consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia, Headache, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose received in December 2018, refer case US2019GSK073562). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), pain in hand, shoulder pain, neck pain, headache and mobility decreased. On an unknown date, the outcome of the fainting and mobility decreased were recovered/resolved and the outcome of the pain in hand, shoulder pain, neck pain and headache were unknown. It was unknown if the reporter considered the fainting, pain in hand, shoulder pain, neck pain, headache and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2019, the patient received a dose of SHINGRIX at the clinic. In 2019, the patient was fainted and experienced a lot of pain in her hand and hand motion was not normal. The patient was unable to move her hand but at the time of reporting, felt better after getting massage therapy. The pain in hand was goes to shoulder, neck and head. At the time of reporting, the patient had headaches. The patient mentioned that, a case was legal. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose received in December 2018, refer case US2019GSK073562). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), pain in hand, shoulder pain, neck pain, headache and mobility decreased. On an unknown date, the outcome of the fainting and mobility decreased were recovered/resolved and the outcome of the pain in hand, shoulder pain, neck pain and headache were unknown. It was unknown if the reporter considered the fainting, pain in hand, shoulder pain, neck pain, headache and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2019, the patient received a dose of SHINGRIX at the clinic. In 2019, the patient was fainted and experienced a lot of pain in her hand and hand motion was not normal. The patient was unable to move her hand but at the time of reporting, felt better after getting massage therapy. The pain in hand was goes to shoulder, neck and head. At the time of reporting, the patient had headaches. The patient mentioned that, a case was legal. The reporter consented to follow up.
Sex: F
Vaccine: PPV, UNK
Symptoms: Influenza, Pneumonia
Clinical narrative: She got a flu vaccine and pneumonia shot ( does not know the name of the vaccines ) but two months ago got pneumonia and an week ago got a flu; She got a flu vaccine and pneumonia shot ( does not know the name of the vaccines ) but two months ago got pneumonia and an week ago got a flu; flu; The initial case was missing the following minimum criteria: Invalid for Other-Non-Pfizer product. Upon receipt of follow-up information on 28Mar2019, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown) at single dose for pneumonia shot, influenza vaccine (FLU VACCINE VII) at unknown dose for flu shot, both via an unspecified routes of administration on an unspecified date. The patient's medical history and concomitant medications were not reported. The reporter stated in the early part of the winter she got the flu shot and the pneumonia shot. Two months later she got pneumonia and then last week in Mar2019 she got the flu. She stated she thought if she got the shots, she should not have gotten pneumonia or the flu. She stated she did not know the names of the products and did not even know if Pfizer made them. She stated she didn't know any better and got them at the same time, but people have since told her she should not have gotten them at the same time. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus generalised, Swelling face, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable physician. An 18-year-old female patient received first dose of TRUMENBA, via an unspecified route of administration on 12Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced facial swelling, itchiness/generalized itching and a sensation that throat was closing up on an unspecified date. The patient went to the emergency room (ER) and received treatment for more than 24 hours with steroids and BENADRYL. The reporter wanted to know if they can administer the 2nd dose. Outcome of the events was unknown. Information on the lot/batch number has been requested. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported events facial swelling, itching and throat closing up.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Extra dose administered, Pain in extremity, Peripheral swelling
Clinical narrative: inadvertently being administered a 2nd dose of prevnar 13; pain; redness; swelling that extended from elbow to shoulder; This is a spontaneous report from a contactable other HCP via Pfizer sales representative. A 72-year-old female patient  received a second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, 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 previously received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) about four months ago for immunization. On an unspecified date, the patient experienced pain, redness, and swelling that extended from elbow to shoulder after inadvertently being administered a 2nd dose of pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Autism spectrum disorder, Feeding disorder, Food intolerance, Sensory loss, Speech disorder developmental
Clinical narrative: Sudden onset of Autistic features with loss of language milestones after second dose of Hep A vaccine 9/28/15. Patient is here with mom to establish care. He was diagnosed with Autism by group (in Dec 2016 at age 2 9/12). He met all milestones, speaking in complete sentences, until 2 years of age when he stopped speaking. Recent sensory issues with tapping chin with hand, arm flapping, feeding issues. No aggression. Seeking treatment and management for Autism, diet/gut health, supplement management, allergy and food sensitivities evaluation.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: My son's arm was swollen for two weeks with significant bruising and painful to the touch.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Eye pain, Fatigue, Gait disturbance, Ocular discomfort, Oral pain
Clinical narrative: On April 21st, patient began complaining of pain in his eyes (pressure at the sides, not in the middle), when looking to the sides he felt pressure and 'pain'/discomfort.  His mouth was also hurting  in 'certain spots'.  Describes a 'pain' but not an 'ache'.  He also intermittently complained of being very tired.  He was complaining of pain in his foot as well and limped occasionally.    On April 24th, I (mother) noticed some small red bumps behind and below his left ear.  I took a second look but was not alarmed at this point.  On the 25th, at 4:00, patient complained he had a rash.  After inspecting him myself, the small red spots I observed the night before had spread to his torso, arms and upper thighs.    We brought him to Hospital at 5:30 pm and were brought into a negative pressure room with patient wearing a mask as a precaution for having an active case of measles.  After vital signs were taken, and a visual inspection of the rash and mouth including visually observed Koplik spots, along with a verbal discussion of symptoms and timelines , patient was diagnosed with measles.  We were told he was contagious until Sunday/Monday, April  28/29, 2019 and he was not to go out in public, was to drink lots of fluids, and get rest.  Also we were told to follow up with his primary caregiver.  I did this at 10:00 am on 4/26/2019 and after the nurse conferred with the doctor on staff as well as the CDC, I was told that they decided patient did NOT have measles, but was suffering from and adverse reaction to the MMR shot administered about 2 weeks prior.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity, Rash, Rash erythematous, Vaccination complication
Clinical narrative: On April 21st, patient began complaining of pain in his eyes (pressure at the sides, not in the middle), when looking to the sides he felt pressure and 'pain'/discomfort.  His mouth was also hurting  in 'certain spots'.  Describes a 'pain' but not an 'ache'.  He also intermittently complained of being very tired.  He was complaining of pain in his foot as well and limped occasionally.    On April 24th, I (mother) noticed some small red bumps behind and below his left ear.  I took a second look but was not alarmed at this point.  On the 25th, at 4:00, patient complained he had a rash.  After inspecting him myself, the small red spots I observed the night before had spread to his torso, arms and upper thighs.    We brought him to Hospital at 5:30 pm and were brought into a negative pressure room with patient wearing a mask as a precaution for having an active case of measles.  After vital signs were taken, and a visual inspection of the rash and mouth including visually observed Koplik spots, along with a verbal discussion of symptoms and timelines , patient was diagnosed with measles.  We were told he was contagious until Sunday/Monday, April  28/29, 2019 and he was not to go out in public, was to drink lots of fluids, and get rest.  Also we were told to follow up with his primary caregiver.  I did this at 10:00 am on 4/26/2019 and after the nurse conferred with the doctor on staff as well as the CDC, I was told that they decided patient did NOT have measles, but was suffering from and adverse reaction to the MMR shot administered about 2 weeks prior.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Antineutrophil cytoplasmic antibody, C-reactive protein, Full blood count, Metabolic function test, Urine analysis
Clinical narrative: The night that she received the SHINGRIX vaccine (3/28/19) the patient developed vasculitis on bilateral lower extremities. The provider checked labs at the appointment on 3/29/19. Symptoms were resolved at follow up appointment on 4/25/19.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vasculitis
Clinical narrative: The night that she received the SHINGRIX vaccine (3/28/19) the patient developed vasculitis on bilateral lower extremities. The provider checked labs at the appointment on 3/29/19. Symptoms were resolved at follow up appointment on 4/25/19.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Cold sweat, Confusional state, Dizziness, Dyskinesia, Headache
Clinical narrative: on 4-23-19 child returned to clinic and was administered: TD IPV, MMR, and HeP B. 2 to 3 minutes later, child complained of dizziness and nausea, then a minute or 2 after he had < 10 second seizure: Blank stare, left arm was straight forward and rigid with mild jerking. Child was pale and clammy  with some  confusion after seizure episode. BP 117/70 Hr 61.EMS called and child assessment preformed. Mom was told by EMS team that the child was stable and no emergency room visit was need it at the time. Mom refused to visit emergency room because she had other children with her at the time.Additional information for Item 18:  on 4-26-19 @10: 20am I called parents and spoke to mom and patient is well with no signs of seizures. Mom was advised to seek a pediatrician to monitor patient's health and inform MD of the episodes. Mom stated that she has no health insurance at this time ,but she will try to apply for Charity care.  Before the episode on 4-23-19 ,patient visit the clinic on 3-19-19 for the first time.  Mom reported that she lost her child's vaccine records during the migration from another country. Mom was made aware that child need it to restart all vaccines.   On 3-19-19 I administered:  1. tdap: Sanofi, lot# C5566AA, IM, Right  Arm.  2.  Menactra:  SANOFI, LOT # U6152AA, IM, RIGHT ARM.  3.  IPV: SANOFI, LOT # P1A432M, IM, LEFT ARM.  4. PROQUAD: MERCK, LOT # RO18779, SUBQ, RIGHT ARM. 5. Hep A:  MERCK, LOT # R027431, IM, RIGHT ARM  6. Hep B: MERCK ,LOT # R021372 IM, LEFT ARM 7. HPV:MERCK, LOT # R023608 IM, LEFT ARM.  Immediately after last vaccine (HPV )child had a brief syncope episode and he complained of headache and dizziness. At that time he was cold, pale, and clammy, B/P 107/74, HR 63. He recovered quickly and went home.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Immediate post-injection reaction, Muscle rigidity, Nausea, Pallor, Peripheral coldness
Clinical narrative: on 4-23-19 child returned to clinic and was administered: TD IPV, MMR, and HeP B. 2 to 3 minutes later, child complained of dizziness and nausea, then a minute or 2 after he had < 10 second seizure: Blank stare, left arm was straight forward and rigid with mild jerking. Child was pale and clammy  with some  confusion after seizure episode. BP 117/70 Hr 61.EMS called and child assessment preformed. Mom was told by EMS team that the child was stable and no emergency room visit was need it at the time. Mom refused to visit emergency room because she had other children with her at the time.Additional information for Item 18:  on 4-26-19 @10: 20am I called parents and spoke to mom and patient is well with no signs of seizures. Mom was advised to seek a pediatrician to monitor patient's health and inform MD of the episodes. Mom stated that she has no health insurance at this time ,but she will try to apply for Charity care.  Before the episode on 4-23-19 ,patient visit the clinic on 3-19-19 for the first time.  Mom reported that she lost her child's vaccine records during the migration from another country. Mom was made aware that child need it to restart all vaccines.   On 3-19-19 I administered:  1. tdap: Sanofi, lot# C5566AA, IM, Right  Arm.  2.  Menactra:  SANOFI, LOT # U6152AA, IM, RIGHT ARM.  3.  IPV: SANOFI, LOT # P1A432M, IM, LEFT ARM.  4. PROQUAD: MERCK, LOT # RO18779, SUBQ, RIGHT ARM. 5. Hep A:  MERCK, LOT # R027431, IM, RIGHT ARM  6. Hep B: MERCK ,LOT # R021372 IM, LEFT ARM 7. HPV:MERCK, LOT # R023608 IM, LEFT ARM.  Immediately after last vaccine (HPV )child had a brief syncope episode and he complained of headache and dizziness. At that time he was cold, pale, and clammy, B/P 107/74, HR 63. He recovered quickly and went home.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Seizure, Staring, Syncope
Clinical narrative: on 4-23-19 child returned to clinic and was administered: TD IPV, MMR, and HeP B. 2 to 3 minutes later, child complained of dizziness and nausea, then a minute or 2 after he had < 10 second seizure: Blank stare, left arm was straight forward and rigid with mild jerking. Child was pale and clammy  with some  confusion after seizure episode. BP 117/70 Hr 61.EMS called and child assessment preformed. Mom was told by EMS team that the child was stable and no emergency room visit was need it at the time. Mom refused to visit emergency room because she had other children with her at the time.Additional information for Item 18:  on 4-26-19 @10: 20am I called parents and spoke to mom and patient is well with no signs of seizures. Mom was advised to seek a pediatrician to monitor patient's health and inform MD of the episodes. Mom stated that she has no health insurance at this time ,but she will try to apply for Charity care.  Before the episode on 4-23-19 ,patient visit the clinic on 3-19-19 for the first time.  Mom reported that she lost her child's vaccine records during the migration from another country. Mom was made aware that child need it to restart all vaccines.   On 3-19-19 I administered:  1. tdap: Sanofi, lot# C5566AA, IM, Right  Arm.  2.  Menactra:  SANOFI, LOT # U6152AA, IM, RIGHT ARM.  3.  IPV: SANOFI, LOT # P1A432M, IM, LEFT ARM.  4. PROQUAD: MERCK, LOT # RO18779, SUBQ, RIGHT ARM. 5. Hep A:  MERCK, LOT # R027431, IM, RIGHT ARM  6. Hep B: MERCK ,LOT # R021372 IM, LEFT ARM 7. HPV:MERCK, LOT # R023608 IM, LEFT ARM.  Immediately after last vaccine (HPV )child had a brief syncope episode and he complained of headache and dizziness. At that time he was cold, pale, and clammy, B/P 107/74, HR 63. He recovered quickly and went home.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Pruritus, Urticaria
Clinical narrative: 2:30-injection 2:45-warming sensation/redness-2" circle noted 2:50-itching, redness turned to hives and spread down arm 3:10 -face, neck, chest covered with hives and itchy 5:00-Full body hives Benadryl 100 mg Pox's 3 days and 50 mg for 2 days
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nausea, Pain in extremity
Clinical narrative: About 2 hrs after vaccine, was nauseous and pain in left arm. By 8PM I could not move my left arm from my side, 3 days and nights of nausea. Still have pain in upper left arm.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Rash generalised
Clinical narrative: Body rash and excessive crying
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: injection site pain, swelling, hot to touch, bright red color, very tired, lack of energy, loss of appetite, very irritable, some difficulty sleeping 44 hours post vaccination returned to doctors office for pre-scheduled blood draw at which time she complained about above symptoms. Doctor prescribed antibiotic, which is currently being taken.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Irritability
Clinical narrative: injection site pain, swelling, hot to touch, bright red color, very tired, lack of energy, loss of appetite, very irritable, some difficulty sleeping 44 hours post vaccination returned to doctors office for pre-scheduled blood draw at which time she complained about above symptoms. Doctor prescribed antibiotic, which is currently being taken.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dizziness, Pallor
Clinical narrative: After the visit as pt. Was checking out she became dizzy and pale in color.  I had mom bring pt. Back to a room and we layed her flat on her back with knees bent and gave OJ.  Pt. Refused to drink the OJ, so I gave her a bottle of water.   She sipped that.  Within a few minutes the color came back into her lips and she was feeling better, playing on mom's phone.  Dr. assessed her and d/c her.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Antinuclear antibody negative, Blood culture negative, CSF test normal, Full blood count normal
Clinical narrative: One day following vaccine pt developed malaise and body aches; she had mental status change 6 days later and was found by family in bed 8 days later lying in feces and urine. She has no recollection of time period between 6 and 9 days after vaccine. Hospitalization could not determine reason for mental status change.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Memory impairment, Mental status changes, Metabolic function test normal, Pain
Clinical narrative: One day following vaccine pt developed malaise and body aches; she had mental status change 6 days later and was found by family in bed 8 days later lying in feces and urine. She has no recollection of time period between 6 and 9 days after vaccine. Hospitalization could not determine reason for mental status change.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Toxicologic test normal, Transaminases increased, West Nile virus test negative
Clinical narrative: One day following vaccine pt developed malaise and body aches; she had mental status change 6 days later and was found by family in bed 8 days later lying in feces and urine. She has no recollection of time period between 6 and 9 days after vaccine. Hospitalization could not determine reason for mental status change.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site reaction, Pruritus, Rash, Rash erythematous
Clinical narrative: 4/23/19 redness noted to injection sight and below the injection site of right arm, 4/25/19, redness increased and started to have "red/pimple looking bumps" to elbow, forearm and wrist to both arms accompanied with itching.  Medicated with Benadryl and cold compresses.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT STATED SHE DEVELOPED SHINGLES ON 04/15/2019. DR ESCRIBED VALTREX ON 04/18/2019.
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via company representative, referring to a 11-year-old male patient. The patient's concurrent conditions and medical history was not reported. Concomitant medications included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and meningococcal vaccine (unspecified) (manufacturer unknown). Approximately on 14-APR-2019 (reported as "about 10 days ago"), the patient was vaccinated with the first dose GARDASIL 9 in the right arm (route, lot# and expiration date not reported) for the prevention of human papilloma virus. On that day, after GARDASIL 9 was administered, the patient fainted (syncope). It was reported that the patient sought medical attention and no treatment was given for the event. On an unspecified day in April 2019, the patient recovered from syncope. The causal relationship between GARDASIL 9 and syncope was not reported. Upon internal review, the event of faint was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient got shingles after getting SHINGRIX. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test details were not provided at the time of reporting. The reported did not consent for follow up contact.
Sex: M
Vaccine: MNQ
Symptoms: Cerebral ventricle dilatation, Congenital central nervous system anomaly, Foetal exposure during pregnancy, Premature baby, Septum pellucidum agenesis
Clinical narrative: This pregnancy case was reported by a physician via registry and described the occurrence of cerebral ventriculomegaly in a male infant exposed to MENVEO (batch number M17101, expiry date 31st August 2019) in utero. The mother received the product for prophylaxis. On 8th October 2018, the mother received MENVEO. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was diagnosed with cerebral ventriculomegaly (serious criteria congenital anomaly), corpus callosum agenesis (serious criteria GSK medically significant and congenital anomaly), septum pellucidum agenesis (serious criteria GSK medically significant and congenital anomaly) and supraventricular tachycardia (serious criteria congenital anomaly). On an unknown date, the infant experienced drug exposure in utero. On an unknown date, the outcome of the cerebral ventriculomegaly, corpus callosum agenesis, septum pellucidum agenesis, supraventricular tachycardia and drug exposure in utero were unknown. It was unknown if the reporter considered the cerebral ventriculomegaly, corpus callosum agenesis, septum pellucidum agenesis and supraventricular tachycardia to be related to MENVEO. Additional details were provided as follows: The patient's mother received a dose of MENVEO and mother was not aware that she was pregnant. The mother of patient did not receive any prenatal care. On 21st March 2019, the patient was born with several birth defects, such as ventriculomegaly, absent corpus callosum and absent cavum septum pellucidum. The patient also developed supraventricular tachycardia. Gestational age at delivery was between 33-37 weeks. Estimated date of delivery was unknown. See case US2019AMR072240 for details regarding the mother case.
Sex: M
Vaccine: MNQ
Symptoms: Supraventricular tachycardia
Clinical narrative: This pregnancy case was reported by a physician via registry and described the occurrence of cerebral ventriculomegaly in a male infant exposed to MENVEO (batch number M17101, expiry date 31st August 2019) in utero. The mother received the product for prophylaxis. On 8th October 2018, the mother received MENVEO. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was diagnosed with cerebral ventriculomegaly (serious criteria congenital anomaly), corpus callosum agenesis (serious criteria GSK medically significant and congenital anomaly), septum pellucidum agenesis (serious criteria GSK medically significant and congenital anomaly) and supraventricular tachycardia (serious criteria congenital anomaly). On an unknown date, the infant experienced drug exposure in utero. On an unknown date, the outcome of the cerebral ventriculomegaly, corpus callosum agenesis, septum pellucidum agenesis, supraventricular tachycardia and drug exposure in utero were unknown. It was unknown if the reporter considered the cerebral ventriculomegaly, corpus callosum agenesis, septum pellucidum agenesis and supraventricular tachycardia to be related to MENVEO. Additional details were provided as follows: The patient's mother received a dose of MENVEO and mother was not aware that she was pregnant. The mother of patient did not receive any prenatal care. On 21st March 2019, the patient was born with several birth defects, such as ventriculomegaly, absent corpus callosum and absent cavum septum pellucidum. The patient also developed supraventricular tachycardia. Gestational age at delivery was between 33-37 weeks. Estimated date of delivery was unknown. See case US2019AMR072240 for details regarding the mother case.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. The patient was treated with cetirizine hydrochloride (Zyrtec), benadryl (nos) (Benadryl) and cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were provided as follows: The patient's age at vaccination was not applicable for this report. The age group was not reporetd but was captured as adult as per the vaccine indication. The two to four patients received the dose of Shingrix and experienced rash. The pharmacist instructed them to take Zyrtec in the morning and Benadryl at night and use Cortisone cream 4 times a day and it worked for them. Afterwards, the patients were feeling better. No information was available regarding the patients or product. This was the case linked to US2019065871, reported by the same reporter.
Sex: U
Vaccine: UNK
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received Flu Seasonal TIV Dresden (Fluarix 2012-13 season) for prophylaxis.   On an unknown date, the patient received Fluarix 2012-13 season at an unknown dose. On an unknown date, unknown after receiving Fluarix 2012-13 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Fluarix 2012-13 season.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient had an allergic reaction to a Flu vaccine.  No additional details was provided. The reporter declined to provide data. The vaccine was not given at the pharmacy calling.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The field representative called and stated a doctor mentioned to him that his (the doctor's) partner had flu-like symptoms for a week after receiving Shingrix.  This occurred during a casual conversation and no other information was collected by the field representative. The reporter did not give consent to follow up. The name of the doctor that reported the event was provided but (no contact information provided).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Angiocardiogram, Chest pain, Chills, Dyspnoea
Clinical narrative: chest pain; out of breath; shiverin; headache; fever; sleeping problems; upset stomach; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included coronary stent placement.   On 30th March 2019, the patient received the 1st dose of Shingrix. On 31st March 2019, 1 days after receiving Shingrix, the patient experienced chest pain, shortness of breath, shivering, headache, fever, sleep problem, upset stomach and muscle pain. The patient was treated with nitroglycerine. On an unknown date, the outcome of the chest pain, shortness of breath, shivering, headache, fever, sleep problem, upset stomach and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the chest pain, shortness of breath, shivering, headache, fever, sleep problem, upset stomach and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient had a history of a stent in his heart.  The patient reported that he had the 1st dose of Shingrix at the pharmacy. He started having the following symptoms the day after having the vaccine and he was still having all these symptoms. He feels like somebody was sitting on his chest (he clarified he meant chest pain),out of breath if he walks, shivering, headache, fever, sleeping problems, upset stomach, muscle pain down his leg.  He visited his physician and they thought that his chest pain that he was having was not heart related. He had a dose of nitroglycerine and that did not alleviate his chest pain.  He had a CT coronary angiogram with contrast on 2nd May. The reporter gave consent to follow up.      Lab Comments: CT coronary angiogram was done on 2nd May.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: chest pain; out of breath; shiverin; headache; fever; sleeping problems; upset stomach; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included coronary stent placement.   On 30th March 2019, the patient received the 1st dose of Shingrix. On 31st March 2019, 1 days after receiving Shingrix, the patient experienced chest pain, shortness of breath, shivering, headache, fever, sleep problem, upset stomach and muscle pain. The patient was treated with nitroglycerine. On an unknown date, the outcome of the chest pain, shortness of breath, shivering, headache, fever, sleep problem, upset stomach and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the chest pain, shortness of breath, shivering, headache, fever, sleep problem, upset stomach and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient had a history of a stent in his heart.  The patient reported that he had the 1st dose of Shingrix at the pharmacy. He started having the following symptoms the day after having the vaccine and he was still having all these symptoms. He feels like somebody was sitting on his chest (he clarified he meant chest pain),out of breath if he walks, shivering, headache, fever, sleeping problems, upset stomach, muscle pain down his leg.  He visited his physician and they thought that his chest pain that he was having was not heart related. He had a dose of nitroglycerine and that did not alleviate his chest pain.  He had a CT coronary angiogram with contrast on 2nd May. The reporter gave consent to follow up.      Lab Comments: CT coronary angiogram was done on 2nd May.